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protocolSection identificationModule nctId: NCT06296446, orgStudyIdInfo id: disability fibromyalgia, briefTitle: Disability of People With Fibromyalgia in Poland, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Rzeszow, class: OTHER, descriptionModule briefSummary: Fibromyalgia is a syndrome characterized by chronic, generalized pain in muscles and joints with the presence of characteristic, symmetrically occurring so-called "tender points" - areas of the body that are excessively sensitive to pressure. The condition is associated with a feeling of chronic fatigue, mood and sleep disturbances and a sensation of body stiffness. These complaints are bothersome and significantly impair patients' functioning in every aspect of their lives. There are few studies evaluating the functioning and disability of people with fibromyalgia. No such study has been conducted in Poland to date. Therefore, the purpose of this study is to evaluate the functioning and disability of fibromyalgia patients and the relationship of the level of disability with selected factors, such as pain intensity, emotional state, sleep quality, etc., conditionsModule conditions: Fibromyalgia, conditions: Disabilities Multiple, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 700, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: disability, secondaryOutcomes measure: functioning, secondaryOutcomes measure: depression, secondaryOutcomes measure: Sociodemographic data, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Rzeszow, status: RECRUITING, city: Rzeszów, state: Podkarpacie, zip: 35-310, country: Poland, contacts name: Agnieszka Sozańska, professor, role: CONTACT, phone: +48 530172857, email: [email protected], geoPoint lat: 50.04132, lon: 21.99901, hasResults: False |
protocolSection identificationModule nctId: NCT06296433, orgStudyIdInfo id: HCB_2023_1196, briefTitle: Extended Reality-Assisted Therapy for Chronic Pain Management, acronym: XR-PAIN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Institut d'Investigacions Biomèdiques August Pi i Sunyer, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test a home-based virtual reality rehabilitation application in patients with chronic low back pain. The main question it aims to answer are:Is a prototype of a novel VR software application effective at reducing pain, improving daily function, improving range of motion, and reducing fear of movement in adult patients with chronic low back pain compared with a passive VR intervention? Participants in the treatment group will use the application daily for 20 minutes for a period of 3 weeks at home and unsupervised. Researchers will compare use of the VR application with a control group that watches 2D video to see if the treatment group have improved pain, disability, range of motion, and fear of movement., conditionsModule conditions: Chronic Pain, conditions: Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: VR rehabilitation, interventions name: VR video application, outcomesModule primaryOutcomes measure: Brief Pain Inventory, secondaryOutcomes measure: Roland-Morris Disability Questionnaire, secondaryOutcomes measure: Short-Form 12, secondaryOutcomes measure: Patient Global Impression of Change, secondaryOutcomes measure: Pain Catastrophization Scale, otherOutcomes measure: Spinal Range of motion, otherOutcomes measure: Adherence to treatment, otherOutcomes measure: Embodiment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IDIBAPS, city: Barcelona, zip: 08036, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False |
protocolSection identificationModule nctId: NCT06296420, orgStudyIdInfo id: 24C304, briefTitle: Dysphagia After Thyroidectomy, acronym: DYSPHATHYR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2026-11-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to develop a questionnaire for measuring swallowing and throat discomfort symptoms in patients with goiter or thyroidectomy, which complies with the model of Rasch and which satisfies the fundamental measurement axioms (e.g., unidimensionality, linearity, generalizability). Developing a scale with such characteristics would provide clinicians and researchers with a reliable tool for assessing the impact of goiter and for measuring the outcomes after surgery.Also, the study will assess the psychological impact of goiter and thyroidectomy, as well as the characteristics of the surgical scar after thyroidectomy.The questionnaire will be developed in the first phase of the study. Items and response categories will be identified through interviews performed with patients affected by goiter or after thyroidectomy.In the following phases of the study, the questionnaire will be administered to patients before and after thyroidectomy., conditionsModule conditions: Goiter, conditions: Thyroid Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 420, type: ESTIMATED, outcomesModule primaryOutcomes measure: The primary outcome measure will be the questionnaire which will be developed in the first phase of the study itself., secondaryOutcomes measure: Patient and Observer Scar Assessment Scale (POSAS) 2.0., secondaryOutcomes measure: Depression Anxiety Stress Scales-21 (DASS-21)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Auxologico Italiano, status: RECRUITING, city: Milan, state: MI, zip: 20122, country: Italy, contacts name: Stefano Scarano, MD, role: CONTACT, phone: +3902619116717, email: [email protected], geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06296407, orgStudyIdInfo id: 01C319, briefTitle: Psychophysical Analysis of Adolescent Patients With Obesity and Efficacy of the Respiratory Approach (PSICOFISADOLOB)., acronym: PSICOFISADOL, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-08, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: Specifically, the project aims to pursue the following objectives:1. To evaluate in male and female adolescents with obesity the interaction between different psycho-body aspects such as respiration - posture - self-perception and affectivity and tolerance to physical exercise;2. To evaluate in a subgroup of male and female adolescents the effectiveness of exercises aimed at respiratory muscles and of respiratory consciousness on the parameters above indicated and on their interaction.The final objective of this project is to define and propose "take home" specific respiratory exercises to promote greater body awareness and a condition of psychophysical well-being stable over time, creating a condition that can favor further interventions on obesity. Finally, the project aims to build solid scientific bases to insert respiratory exercise among the intervention guidelines to prevent and reduce obesity, particularly youth obesity., conditionsModule conditions: Obesity, Childhood, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Standard metabolic integrated rehabilitation protocol - duration 3 weeks, interventions name: Standard metabolic integrated rehabilitation protocol + respiratory exercises - duration 3 weeks, outcomesModule primaryOutcomes measure: Fat mass, primaryOutcomes measure: Fat-free mass, primaryOutcomes measure: Maximal Inspiratory Pressure, primaryOutcomes measure: Maximal Expiratory Pressure, primaryOutcomes measure: Interoceptive awareness, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano, Site Piancavallo, status: RECRUITING, city: Oggebbio, state: Verbania, zip: 28824, country: Italy, contacts name: Alessandro Sartorio, MD, role: CONTACT, phone: +390261911, phoneExt: 2426, email: [email protected], geoPoint lat: 45.99088, lon: 8.64663, hasResults: False |
protocolSection identificationModule nctId: NCT06296394, orgStudyIdInfo id: STUDY23080161, secondaryIdInfos id: 1R01HL161164-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01HL161164-01A1, secondaryIdInfos id: KAZMER22A0, type: OTHER_GRANT, domain: Cystic Fibrosis Foundation, briefTitle: Health Outcomes of Parents With Cystic Fibrosis-Aim 2, acronym: HOPeCF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2030-02-01, completionDateStruct date: 2031-02-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University of Pittsburgh, class: OTHER, collaborators name: Cystic Fibrosis Foundation, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The goal of this observational prospective study is to determine the health impact of parenthood on United States (US) people with CF in the era of CF transmembrane regulator protein (CFTR) modulators. The investigators will collect physical and mental health data to comprehensively evaluate the impact of parenthood in CF with widespread highly effective CFTR modulator use. The main hypotheses this study aims to examine are:H1: Parents with CF and moderate-to-severe depression have more rapid change in ppFEV1 (percent predicted forced expiratory volume in one second) versus those with mild or no depression.H2: Parents with CF who have more parental responsibility and/or stress have more rapid ppFEV1 (percent predicted forced expiratory volume in one second) change than those with less responsibility/stressH3: Parents using CFTR modulators have decreased ppFEV1 (percent predicted forced expiratory volume in one second) change versus those not using CFTR modulatorsParticipants will complete quarterly surveys during the first year of parenthood and biannual surveys, thereafter, using the computer-based survey system on an iPad protected for infection control or via personal device or computer via emailed survey link., conditionsModule conditions: Cystic Fibrosis, conditions: Parenthood Status, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 146, type: ESTIMATED, armsInterventionsModule interventions name: Parenthood, outcomesModule primaryOutcomes measure: Forced Expiratory Volume (FEV1), secondaryOutcomes measure: Pulmonary Function Tests (PFTs) - Forced Vital Capacity (FVC), secondaryOutcomes measure: Pulmonary Function Tests (PFTs) - Forced Expiratory Volume (FEV1), secondaryOutcomes measure: Pulmonary Function Tests (PFTs) - Forced Expiratory Flow at 25 and 75 percent (FEF25-75), secondaryOutcomes measure: History of CF Diagnosis, secondaryOutcomes measure: History of CF Genotype Information, secondaryOutcomes measure: History of CF Mutation, secondaryOutcomes measure: Number of Hospitalizations, secondaryOutcomes measure: Length of Hospitalizations, secondaryOutcomes measure: Number of Pulmonary Exacerbations, secondaryOutcomes measure: Severity of Pulmonary Exacerbations, secondaryOutcomes measure: Treatment of Pulmonary Exacerbations, secondaryOutcomes measure: Rate of Hospitalizations Due to Pulmonary Exacerbations, secondaryOutcomes measure: Clinic Visit Attendance, secondaryOutcomes measure: Microbiologic Profile, secondaryOutcomes measure: Medication use, secondaryOutcomes measure: History of CF-Related Diabetes Status, secondaryOutcomes measure: CF-Related Diabetes Control - Hemoglobin A1C, secondaryOutcomes measure: CF-Related Diabetes Control - Glucose Tolerance, secondaryOutcomes measure: CF-Related Diabetes Control - Insulin Prescription Usage, secondaryOutcomes measure: Liver Disease Status, secondaryOutcomes measure: Transplantation Status, secondaryOutcomes measure: Transplantation Type, secondaryOutcomes measure: BMI, secondaryOutcomes measure: Sleep Quality, secondaryOutcomes measure: Parental Stress, secondaryOutcomes measure: Life Stressors, secondaryOutcomes measure: Cystic Fibrosis Questionnaire to evaluate quality of life domains, secondaryOutcomes measure: Parental Responsibility, secondaryOutcomes measure: Daily Care Check-In, secondaryOutcomes measure: Social Support, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Self-Reported Adherence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama-Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: George M Solomon, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, locations facility: National Jewish Health, city: Denver, state: Colorado, zip: 80206, country: United States, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Northwestern University, city: Evanston, state: Illinois, zip: 60208, country: United States, contacts name: Manu Jain, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.04114, lon: -87.69006, locations facility: Indiana University, city: Indianapolis, state: Indiana, zip: 46202, country: United States, contacts name: Cynthia Brown, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.76838, lon: -86.15804, locations facility: University of Kansas Medical Center, city: Kansas City, state: Kansas, zip: 66160, country: United States, contacts name: Megan Behrman, role: CONTACT, email: [email protected], contacts name: Amanda Bruce, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.11417, lon: -94.62746, locations facility: Johns Hopkins University, city: Baltimore, state: Maryland, zip: 21218, country: United States, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Massachusetts General Hospital, city: Boston, state: Massachusetts, zip: 02114, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Boston Children's Hospital/Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Jonathan Greenberg, role: CONTACT, email: [email protected], contacts name: Manuela Cernadas, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Shijing Jia, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, locations facility: University of Minnesota, city: Minneapolis, state: Minnesota, zip: 55455, country: United States, geoPoint lat: 44.97997, lon: -93.26384, locations facility: Washington University School of Medicine, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Daniel Rosenbluth, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, locations facility: University of North Carolina, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, geoPoint lat: 35.9132, lon: -79.05584, locations facility: Oregon Health and Science University, city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Aaron Trimble, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, locations facility: University of Pennsylvania, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Denis Hadjiliadis, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, locations facility: University of Pittsburgh, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Medical University of South Carolina, city: Charleston, state: South Carolina, zip: 29425, country: United States, contacts name: Patrick Flume, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.77657, lon: -79.93092, locations facility: University of Texas-Southwestern, city: Dallas, state: Texas, zip: 75390, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: University of Washington, city: Seattle, state: Washington, zip: 98195, country: United States, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False |
protocolSection identificationModule nctId: NCT06296381, orgStudyIdInfo id: 6.131.540, briefTitle: Normative Values for Peripheral Muscle Strenght in Critical Patients and Healthy Individuals, acronym: HHD-ICU, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2027-12-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Pernambuco, class: OTHER, collaborators name: Universidade Federal de Pernambuco, collaborators name: Conselho Nacional de Desenvolvimento Científico e Tecnológico, descriptionModule briefSummary: Muscle strength is an important indicator of overall health and is a factor that has been associated with increased mortality in critical patients. Its measurement must be reliable and reproducible to ensure a quality outcome for clinical applicability. Recently, the use of digital handheld dynamometers in intensive care has gained support; however, analysis becomes challenging due to the absence of standardized reference equations for the Brazilian population. The aim of this study is to develop reference equations for the Brazilian population and define specific cutoff points for men, women, healthy individuals, and critical patients., conditionsModule conditions: Intensive Care Unit, conditions: Muscle Strength, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Peripheral muscle strength measured by hand held dynamometer, primaryOutcomes measure: Peripheral muscle strength measured by Medical Research Council score, secondaryOutcomes measure: Peripheral muscle strength measured by hand grip dynamometer, secondaryOutcomes measure: Mobility in ICU measured by Perme Intensive Care Unit Mobility Score, secondaryOutcomes measure: Level of frailty in older adults by the Multidimensional Assessment of Older People (AMPI-AB), secondaryOutcomes measure: Level of physical activity in young adults by the International Physical Activity Questionnaire - Short Form, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Federal University of Pernambuco (UFPE), status: RECRUITING, city: Recife, state: PE, zip: 50740-600, country: Brazil, contacts name: Shirley Campos, role: CONTACT, phone: +5581999413087, email: [email protected], contacts name: Pedro Vinicius Porfirio, role: CONTACT, phone: +5581993954400, email: [email protected], contacts name: Lucas Rafael da Silva Fraga, role: SUB_INVESTIGATOR, geoPoint lat: -8.05389, lon: -34.88111, locations facility: Hospital Otávio de Freitas, status: NOT_YET_RECRUITING, city: Recife, state: PE, zip: 50920-460, country: Brazil, contacts name: Shirley L Campos, role: CONTACT, phone: +5581999413087, email: [email protected], geoPoint lat: -8.05389, lon: -34.88111, locations facility: Hospital Nossa Senhora das Graças, status: RECRUITING, city: Recife, state: PE, zip: 51030-020, country: Brazil, contacts name: Lidier Roberta Moraes Nogueira, role: CONTACT, phone: +5581995479644, email: [email protected], contacts name: Shirley L Campos, role: CONTACT, phone: +5581999413087, email: [email protected], contacts name: Jose Douglas de Souza Cordeiro, role: SUB_INVESTIGATOR, geoPoint lat: -8.05389, lon: -34.88111, hasResults: False |
protocolSection identificationModule nctId: NCT06296368, orgStudyIdInfo id: LCCC2305, briefTitle: DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics, acronym: DISCOVERY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2029-04, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: UNC Lineberger Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate whether a novel decision support tool called PRIME (Preference Reporting to Improve Management and Experience), which combines values-elicitation with tailored feedback to patients and providers, improves patient-reported values-concordance of initial treatment decisions compared to usual care., conditionsModule conditions: Hematologic Malignancies, conditions: Lymphoma, conditions: Multiple Myeloma, conditions: Leukemia, conditions: Blood Cancers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Preference Reporting to Improve Management and Experience (PRIME), outcomesModule primaryOutcomes measure: Difference in COLLABORATE scores between arms, secondaryOutcomes measure: Difference in COLLABORATE scores between arms in a subgroup of patients, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lineberger Comphrehensive Cancer Center at University of North Carolina, city: Chapel Hill, state: North Carolina, zip: 27516, country: United States, contacts name: Mireille L Leone, role: CONTACT, phone: 919-445-0768, email: [email protected], contacts name: Daniel R Richardson,, MD, MA, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False |
protocolSection identificationModule nctId: NCT06296355, orgStudyIdInfo id: 24-0300d, briefTitle: Impacts of Warning Labels on Ultra-Processed Foods, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2024-06-20, completionDateStruct date: 2024-06-20, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: Robert Wood Johnson Foundation, descriptionModule briefSummary: Purpose: The overall purpose of this study is to identify the impacts of an ultra-processed (UPF) health warning label and UPF identify warning label compared to a control label (i.e., a barcode).Participants: \~4,000 US Latino adults of parental age (18-55 years), approximately 50% of whom will have limited English proficiency, recruited from a Latino-focused panel company.Procedures: Participants will be randomly assigned to view food products with one of three label types: health warning labels, identity labels, or barcode control labels. Participants will be asked a series of questions about the products and the label they were assigned., conditionsModule conditions: Health Behavior, conditions: Diet, Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 4000, type: ESTIMATED, armsInterventionsModule interventions name: Health Warning Label, interventions name: Identity Warning Label, interventions name: Barcode Label, outcomesModule primaryOutcomes measure: Identification of a product as ultra-processed, secondaryOutcomes measure: Perceived product healthfulness of ultra-processed products, secondaryOutcomes measure: Intentions to purchase ultra-processed products, secondaryOutcomes measure: Perceived message effectiveness, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: UNC Carolina Population Center, city: Chapel Hill, state: North Carolina, zip: 27516, country: United States, contacts name: Violet Noe, role: CONTACT, email: [email protected], geoPoint lat: 35.9132, lon: -79.05584, hasResults: False |
protocolSection identificationModule nctId: NCT06296342, orgStudyIdInfo id: 24-0300c, briefTitle: Message Framing and Policy Support for Front-of-package Labeling, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: Duke University, collaborators name: Stanford University, descriptionModule briefSummary: This study aims to assess whether different message framing about front-of-package labeling policies elicits more policy support than the control (no framing) among Latino and limited English proficiency populations. The study also seeks to identify which message framing elicits the most policy support., conditionsModule conditions: Diet, Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 4000, type: ESTIMATED, armsInterventionsModule interventions name: Exposure to information framing message, interventions name: Exposure to healthier choices framing message, interventions name: Exposure to industry framing message, outcomesModule primaryOutcomes measure: Support for the front-of-package labeling policy, proportion, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: The University of North Carolina at Chapel Hill's Gillings School of Global Public Health, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Marissa G Hall, role: CONTACT, phone: 919-445-1310, email: [email protected], geoPoint lat: 35.9132, lon: -79.05584, hasResults: False |
protocolSection identificationModule nctId: NCT06296329, orgStudyIdInfo id: 21C309, briefTitle: Rubber Hand Illusion in Anorexia Nervosa, acronym: RHI_size_AN, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2024-02-27, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, collaborators name: University of Turin, Italy, descriptionModule briefSummary: The present research project aims to verify a possible difference in the recalibration of the real hand position (i.e. proprioceptive drift) in relation to the dimensions of the plastic hand in the Rubber Hand Illusion, among a group of female participants with anorexia nervosa compared with a normal weight control group., conditionsModule conditions: Anorexia Nervosa, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Rubber Hand Illusion, outcomesModule primaryOutcomes measure: Proprioceptive drift in centimeters, secondaryOutcomes measure: Score at the Embodiment questionnaires, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe, status: RECRUITING, city: Piancavallo, state: VCO, zip: 28824, country: Italy, contacts name: Federica Scarpina, PhD, role: CONTACT, phone: +39032351, phoneExt: 4003, email: [email protected], hasResults: False |
protocolSection identificationModule nctId: NCT06296316, orgStudyIdInfo id: IU022, briefTitle: Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair, acronym: REPAIR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-21, primaryCompletionDateStruct date: 2031-12, completionDateStruct date: 2031-12, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Coloplast A/S, class: INDUSTRY, collaborators name: International Clinical Trials Association, descriptionModule briefSummary: The purpose of this study is to prospectively follow patients after a sacrocolpopexy with Restorelle® mesh for apical prolapse repair as part of routine care. It will help to describe the safety profile and to confirm the clinical benefits of Restorelle mesh for at least 5 to 8 years post-surgery., conditionsModule conditions: Genital Prolapse, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 428, type: ESTIMATED, armsInterventionsModule interventions name: Restorelle Polypropylene Mesh, outcomesModule primaryOutcomes measure: The incidence rate of a surgical reintervention related to Restorelle mesh use over at least the 5 first years of post-index procedure follow-up, secondaryOutcomes measure: Incidence rate of surgical reintervention related to Restorelle mesh use in patients, secondaryOutcomes measure: Number of patients who have only had surgical reintervention not related to Restorelle mesh use, secondaryOutcomes measure: Percentage of patients who have only had surgical reintervention not related to Restorelle mesh use, secondaryOutcomes measure: Number of patients who have had more than 1 surgical reintervention (unrelated to mesh use), secondaryOutcomes measure: Percentage of patients who have had more than 1 surgical reintervention (unrelated to mesh use), secondaryOutcomes measure: Description of patients who have had more than 1 surgical reintervention (unrelated to mesh use), secondaryOutcomes measure: Patient impression of improvement of surgical reintervention assessed by the PGI-I-Reintervention, secondaryOutcomes measure: Number of Adverse Device Effect, secondaryOutcomes measure: Percentage of Adverse Device Effect, secondaryOutcomes measure: Number of Restorelle mesh Device Deficiencies, secondaryOutcomes measure: Percentage of Restorelle mesh Device Deficiencies, secondaryOutcomes measure: Description of Restorelle mesh Device Deficiencies, secondaryOutcomes measure: Monitoring of postoperative pain related to Restorelle mesh use using the modified TOMUS/PREM questionnaire, secondaryOutcomes measure: Changes of prolapse symptoms, secondaryOutcomes measure: Prolapse symptoms - number, secondaryOutcomes measure: Prolapse symptoms - percentage, secondaryOutcomes measure: Assessment of health related quality of life using the EQ-5D-5L questionnaire, secondaryOutcomes measure: Assessment of health related quality of life using the PFIQ-7 questionnaire, secondaryOutcomes measure: Assessment of the sexual functioning by the PISQ-IR questionnaire, secondaryOutcomes measure: Assessment of the sexual functioning by the changes in dyspareunia status of patients who are sexually active., secondaryOutcomes measure: Number of patients defining success via patient global impression of improvement (PGI-I) scale, secondaryOutcomes measure: Percentage of patients defining success via patient global impression of improvement (PGI-I) scale, secondaryOutcomes measure: Number of patients satisfied after the index procedure as assessed by the Surgical Satisfaction Questionnaire (SSQ-8)., secondaryOutcomes measure: Percentage of patients satisfied after the index procedure as assessed by the Surgical Satisfaction Questionnaire (SSQ-8), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Polyclinique de la Baie, status: NOT_YET_RECRUITING, city: Avranches, state: Choisir Une Région, zip: 50300, country: France, contacts name: Frédéric Dubois, Dr, role: CONTACT, contacts name: Frédéric Dubois, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.68333, lon: -1.36667, locations facility: Centre Aliénor d'Aquitaine, status: NOT_YET_RECRUITING, city: Bordeaux, zip: 33076, country: France, contacts name: Claude Hocké, Pr, role: CONTACT, contacts name: Claude Hocké, Pr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.84044, lon: -0.5805, locations facility: CHU Pellegrin, status: NOT_YET_RECRUITING, city: Bordeaux, zip: 33076, country: France, contacts name: Grégoire Capon, Dr, role: CONTACT, contacts name: Grégoire Capon, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.84044, lon: -0.5805, locations facility: CH Paul Ardier d'Issoire, status: NOT_YET_RECRUITING, city: Issoire, zip: 63500, country: France, contacts name: Clément Bruhat, Dr, role: CONTACT, contacts name: Clément Bruhat, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Aslam Mansoor, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.55, lon: 3.25, locations facility: CH La Rochelle, status: RECRUITING, city: La Rochelle, zip: 17019, country: France, contacts name: Philippe Ferry, Dr, role: CONTACT, contacts name: Philippe Ferry, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Yannick Thirouard, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.16667, lon: -1.15, locations facility: Clinique Bon Secours, status: RECRUITING, city: Le Puy-en-Velay, zip: 43000, country: France, contacts name: Jacques Philippe Largeron, Dr, role: CONTACT, contacts name: Jacques Philippe Largeron, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Marlène Guandalino, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.04366, lon: 3.88523, locations facility: CH Général Robert Boulin, status: NOT_YET_RECRUITING, city: Libourne, zip: 33505, country: France, contacts name: Michel Briex, Dr, role: CONTACT, contacts name: Michel Briex, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.91667, lon: -0.23333, locations facility: Institut Mutualiste Montsouris, status: NOT_YET_RECRUITING, city: Paris, zip: 75014, country: France, contacts name: Isabelle Sauret, role: CONTACT, contacts name: Christine Louis Sylvestre, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Yael Levy Zauberman, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Camille Baraud, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Mathilde Allanche, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CH privé Saint Grégoire, status: NOT_YET_RECRUITING, city: Saint-Grégoire, zip: 35760, country: France, contacts name: Frédéric Dubois, Dr, role: CONTACT, contacts name: Frédéric Dubois, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.15085, lon: -1.68706, locations facility: CH de Saintonge, status: NOT_YET_RECRUITING, city: Saintes, zip: 17108, country: France, contacts name: Damien Emeriau, Dr, role: CONTACT, contacts name: Damien Emeriau, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.75, lon: -0.63333, hasResults: False |
protocolSection identificationModule nctId: NCT06296303, orgStudyIdInfo id: MBH24, briefTitle: Effect of Pulsed Magnetic Therapy Versus Phonophoresis in Discogenic Lumbar Radiculopathy Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-03, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Purposes of the studyTo investigate the effect of pulsed magnetic therapy versus phonophoresis in discogenic lumbar radiculopathy patients, conditionsModule conditions: Lumbar Radiculopathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Pulsed electromagnetic therapy, interventions name: Ultrasound phonophoresis, interventions name: Conventional physical therapy, outcomesModule primaryOutcomes measure: Pain, primaryOutcomes measure: Disability, primaryOutcomes measure: Sciatic nerve cross sectional area, secondaryOutcomes measure: H-reflex amplitude, secondaryOutcomes measure: H-reflex side-to-side amplitude (H/H) ratio, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06296290, orgStudyIdInfo id: CARDIOCOLD, briefTitle: Impact of Prolonged Cold-water Swimming on Heart Rate and Cardiac Function, acronym: CARDIOCOLD, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-04, primaryCompletionDateStruct date: 2022-06-06, completionDateStruct date: 2022-08-15, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University Hospital, Caen, class: OTHER, collaborators name: INSERM UMR U1075 Comète GIP Cyceron, unicaen, Caen Normandie, descriptionModule briefSummary: A significant medical risk associated with hypothermia during exercise in a cold environment cardiac arrhythmia due to a possible autonomic conflict. However, little is known about the changes in heart rate and cardiac function after prolonged cold water swimming.The investigators propose to measure the changes in core temperarure during and after a cold water swim at at a water temperature below 15.5°C qualifying for English Channel swim and to test the association with changes in heart rate variability, resting electrocardiogram and left ventricle function., conditionsModule conditions: Hypothermia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Heart rate from a resting ECG recording, primaryOutcomes measure: Heart rate from a 5-minute ECG recording, primaryOutcomes measure: Transthoracic echocardiography (TTE) analysis, primaryOutcomes measure: Change in Body Core Temperature, secondaryOutcomes measure: Body composition, body fat mass, secondaryOutcomes measure: Body composition, fat-free mass, secondaryOutcomes measure: Duration, secondaryOutcomes measure: Individual characteristics, gender, secondaryOutcomes measure: Individual characteristics, age, secondaryOutcomes measure: Individual characteristics, training in cold environment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Caen Normandie, city: Caen, zip: 14000, country: France, geoPoint lat: 49.18585, lon: -0.35912, hasResults: False |
protocolSection identificationModule nctId: NCT06296277, orgStudyIdInfo id: UPO#1!, briefTitle: Mechanical Ventilation in Surgical Patients, acronym: MEET VENUS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliero Universitaria Maggiore della Carita, class: OTHER, collaborators name: University Of Perugia, collaborators name: University of Chieti, collaborators name: Medical University of Vienna, collaborators name: The Netherlands Cancer Institute, collaborators name: Monash University, descriptionModule briefSummary: This is an investigator-initiated, international, multicenter, prospective, cross-sectional study that aims to 1) describe the incidence and types of postoperative pulmonary complications (PPCs), 2) describe patient demographics, baseline characteristics, and intraoperative ventilation management, 3) describe the occurrence of intraoperative adverse events (IAEs), and 4) their associations with PPCs, 5) assess the practice of intraoperative mechanical ventilation.Patients will be eligible for participation if: 1) adult and 2) receiving intraoperative ventilation during general anesthesia for surgery. Patients receiving ventilation outside of an operating room as well as patients receiving intraoperative ventilation during extracorporeal life support will be excluded, conditionsModule conditions: Surgery, conditions: Ventilator Lung, conditions: Postoperative Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule interventions name: Intraoperative mechanical ventilation for surgery, outcomesModule primaryOutcomes measure: Postoperative pulmonary complications (PPCs), secondaryOutcomes measure: Intraoperative adverse events (IAEs), secondaryOutcomes measure: Intraoperative mechanical ventilation practice, secondaryOutcomes measure: Postoperative clinical outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06296264, orgStudyIdInfo id: ULTRACATHLON, briefTitle: Ultra-portable Ultrasound vs. Standard Ultrasound to Help Place a Peripheral Catheter in Patients at Risk of Difficult Puncture, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Saint Joseph Saint Luc de Lyon, class: OTHER, descriptionModule briefSummary: The placement of an intravenous (IV) line is a common procedure when treating adult patients in critical care, in the emergency room or in the operating room. This simple and minimally invasive procedure can sometimes be made difficult depending on the patient's morphology or their clinical condition. The procedure then becomes time-consuming, anxiety-provoking, painful and its success is uncertain.The placement of intravenous (IV) lines under ultrasound by nurses is a rapidly developing alternative in intensive care, emergencies and the operating room., conditionsModule conditions: IV Line Placement With Ultrasound, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Standard ultrasound, interventions name: Ultra-portable ultrasound, outcomesModule primaryOutcomes measure: Intravenous (IV) line placement time, secondaryOutcomes measure: Placement of the IV line successfully obtained from the first puncture, secondaryOutcomes measure: Number of skin perforations, secondaryOutcomes measure: Overall success rate after 3 punctures, secondaryOutcomes measure: Use an alternative solution (central catheter), secondaryOutcomes measure: Patient satisfaction with IV line placement, secondaryOutcomes measure: Nurse satisfaction with IV line placement, secondaryOutcomes measure: Immediate complications related to intravenous access, secondaryOutcomes measure: Delayed complications related to intravenous access, secondaryOutcomes measure: Date of IV line placement and removal, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Saint Joseph Saint Luc Hospital, city: Lyon, state: Rhone-alpes, zip: 69007, country: France, contacts name: Emmanuel VIVIER, MD, role: CONTACT, phone: 0033478618209, email: [email protected], contacts name: Fanny DOROSZEWSKI, Mrs, role: CONTACT, phone: 0033478618398, email: [email protected], contacts name: Emmanuel VIVIER, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Raphaël STREIFF, MD, role: SUB_INVESTIGATOR, contacts name: Guillaume MARCOTTE, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.74848, lon: 4.84669, hasResults: False |
protocolSection identificationModule nctId: NCT06296251, orgStudyIdInfo id: BIO-2313, briefTitle: Dietary Supplementation on Body Fat Composition, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-12-27, completionDateStruct date: 2025-02-27, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Brightseed, class: INDUSTRY, descriptionModule 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 in otherwise generally healthy adults with risk factors (high BMI at dyslipidemia and/or pre-diabetes) for body fat composition. The primary hypothesis is that supplementation with plant derived phenolics will decrease body fat composition compared to placebo., conditionsModule conditions: Dyslipidemias, conditions: Pre-diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Placebo treatment, interventions name: Plant derived phenolics, outcomesModule primaryOutcomes measure: Body fat mass, secondaryOutcomes measure: Body composition, secondaryOutcomes measure: Android fat mass, secondaryOutcomes measure: Gynoid fat mass, secondaryOutcomes measure: Abdominal visceral fat mass, secondaryOutcomes measure: Abdominal circumference, secondaryOutcomes measure: Hip circumference, secondaryOutcomes measure: Chest circumference, secondaryOutcomes measure: Upper thigh circumference, secondaryOutcomes measure: Upper arm circumference, secondaryOutcomes measure: Waist to hip ratio, secondaryOutcomes measure: Fasting glucose, secondaryOutcomes measure: Fasting insulin, secondaryOutcomes measure: HbA1c, secondaryOutcomes measure: FGF21, secondaryOutcomes measure: Systolic blood pressure, secondaryOutcomes measure: Diastolic blood pressure, secondaryOutcomes measure: Total-Cholesterol, secondaryOutcomes measure: HDL-C, secondaryOutcomes measure: LDL-C, secondaryOutcomes measure: VLDL-C, secondaryOutcomes measure: non-HDL-C, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: Body Weight, secondaryOutcomes measure: Physical functioning, secondaryOutcomes measure: Bodily pain, secondaryOutcomes measure: Role limitations due to physical health, secondaryOutcomes measure: Role limitation due to personal or emotional problems, secondaryOutcomes measure: Emotional well-being, secondaryOutcomes measure: Social functioning, secondaryOutcomes measure: Energy/Fatigue, secondaryOutcomes measure: General health perceptions, secondaryOutcomes measure: Total kcals, secondaryOutcomes measure: Total fat, secondaryOutcomes measure: Total protein, secondaryOutcomes measure: Total carbohydrates, secondaryOutcomes measure: Fiber, secondaryOutcomes measure: Healthy Eating Index (HEI) score, secondaryOutcomes measure: ALT, secondaryOutcomes measure: AST, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06296238, orgStudyIdInfo id: 2023P000461, briefTitle: Nutrition and Inflammation in Pregnancy: Impacts on Early Human Brain Development in Ethiopia, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-02-15, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: Addis Continental Institute of Public Health, collaborators name: Boston Children's Hospital, collaborators name: New York University, descriptionModule briefSummary: The goal of this observational child follow-up study is to examine the effects of prenatal nutrition and infection management interventions on long-term child neurodevelopment.Participants are the offspring of mothers in the main study entitled "Enhancing Nutrition and Antenatal Infection Treatment (ENAT)" that was conducted in the rural Amhara region of Ethiopia. In the ENAT pragmatic clinical effectiveness study, 2399 pregnant women were randomized to receive routine prenatal care, a package of enhanced nutrition interventions (balanced energy protein supplement, iodized salt, iron-folic acid and counseling), a package of enhanced infection management interventions (genitourinary tract infection screening-treatment, deworming), or a combination of both packages. The impact of these antenatal nutrition and infection interventions on birth outcomes (infant birth size and gestational length) was examined in the main study. In this longitudinal cohort study, we will follow the offspring from the ENAT pregnancy cohort up to 24 months postnatal age and assess their growth, health and neurodevelopment.The main questions it aims to answer are:1. What are the effects of pregnancy interventions from the parent study (ENAT) on offspring neurodevelopmental outcomes?2. What are the associations between maternal-newborn iron status and inflammation on infant neurodevelopment?3. What are the associations between maternal iodine status and thyroid function on infant neurodevelopment?We will follow children of mothers from the parent ENAT study to monitor their growth, health, and neurodevelopment up to 24 months postnatal age., conditionsModule conditions: Prenatal Exposure Delayed Effects, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Visual Evoked Potential (VEP) P1 Latency, secondaryOutcomes measure: EEG Functional Connectivity, secondaryOutcomes measure: Cecile Attention Task, secondaryOutcomes measure: Infant Head Circumference, secondaryOutcomes measure: Bayley III, Cognition, secondaryOutcomes measure: MAAP - Accuracy and Speed, secondaryOutcomes measure: Hammersmith Infant Neurological Exam (HINE), eligibilityModule sex: ALL, minimumAge: 9 Months, maximumAge: 27 Months, stdAges: CHILD, contactsLocationsModule locations facility: Harvard Medical School, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Addis Continental Institute of Public Health, city: Addis Ababa, country: Ethiopia, geoPoint lat: 9.02497, lon: 38.74689, hasResults: False |
protocolSection identificationModule nctId: NCT06296225, orgStudyIdInfo id: CHRO-2023-07, briefTitle: Effect of Vibratory Tendon Stimulation on Muscle Fatigue in the Acute Post-stroke Phase, acronym: VIBRAMAIN1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Régional d'Orléans, class: OTHER, descriptionModule briefSummary: It seems that prolonged vibratory stimulation of the anterior forearm in healthy subjects leads to fatigue of the muscles concerned, with a reduction in their strength. The aim of this study is to evaluate the impact of vibratory tendon stimulation on grip force fatigue during the acute post-stroke phase.The investigations will be carried out by a specialized physiotherapist from the neurology department.The experiment consists of three successive phases:* First : measurement of the maximum handgrip force before any vibratory stimulation and then after the three sessions of ten-minute vibration.* Second : Rest period* Third: control phase with measurement of the maximum grip force every ten minutes without vibration., conditionsModule conditions: Stroke, conditions: Stroke, Acute, conditions: Fatigue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Vibration, outcomesModule primaryOutcomes measure: Maximum handgrip strength measured by a digital dynamometer, secondaryOutcomes measure: Fatigue evolution, secondaryOutcomes measure: Evolution of handgrip strength during the vibration session measured by a digital dynamometer, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CH de Chartres, status: NOT_YET_RECRUITING, city: Chartres, country: France, contacts name: Valentin BOHOTIN, Dr, role: CONTACT, email: [email protected], contacts name: Valentin BOHOTIN, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.44685, lon: 1.48925, locations facility: CHU d'ORLEANS, status: RECRUITING, city: Orleans, zip: 45067, country: France, contacts name: Canan OZSANCAK, Ph, role: CONTACT, email: [email protected], contacts name: Andreea AIGNATOAIE, Ph, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.90289, lon: 1.90389, locations facility: Hopital Pitie Salpetriere, status: NOT_YET_RECRUITING, city: Paris, country: France, contacts name: Charlotte ROSSO, Pr, role: CONTACT, email: [email protected], contacts name: Charlotte ROSSO, Pr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU de Tours, status: NOT_YET_RECRUITING, city: Tours, country: France, contacts name: Marco PASI, Dr, role: CONTACT, email: [email protected], contacts name: Marco PASI, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.38333, lon: 0.68333, hasResults: False |
protocolSection identificationModule nctId: NCT06296212, orgStudyIdInfo id: GLT-07-22, briefTitle: Study of Intravenous TAD® 600 mg/4 mL Solution for Injection to Evaluate Efficacy and Safety in Preventing Myocardial Injury in Patients With Pneumonia., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Biomedica Foscama S.p.A. Industria Chimico-Farmaceutica, class: INDUSTRY, descriptionModule briefSummary: The goal of this PHASE III clinical trial is to evaluate efficacy and safety of intravenous TAD® 600 mg/4 mL solution for injection in preventing myocardial injury in patients with pneumonia.The main question it aims to answer is:• could TAD® used as an add-on treatment to the standard therapy, due to the presence of the sodium salt glutathione, be effective and safe in preventing the risk of developing myocardial injury in hospitalized patients with pneumonia?Patients diagnosed with pneumonia (in the emergency department or hospital ward) will be asked to participate in the study and sign the Informed Consent Form (ICF) to assess their eligibility for enrollment.Eligible patients who meet the study inclusion criteria and complete the required Screening \& Baseline (V0) examinations, will be randomized with a 1:1 ratio allocation to the IMP Test group (TAD® treatment) or IMP Placebo group (Placebo treatment) in a double-blind manner, PI \& Patient blinded.TAD® (600 mg/4 mL reconstituted solution in 50 mL of 0.9% sodium chloride solution) or Placebo (50 mL of 0.9% sodium chloride solution) will be administered:* intravenously (with an infusion rate of 10 mL/min)* 2 times a day (with a dosing interval of 8 hours ± 30 minutes)* for 5 consecutive days (Day 1, Day 2, Day 3, Day 4 and Day 5)* patients will then be required to undergo five Follow-up Visits., conditionsModule conditions: Pneumonia, conditions: Myocardial Injury, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 178, type: ESTIMATED, armsInterventionsModule interventions name: TAD® 600 mg/4 mL powder and solvent for solution for injection, interventions name: Saline solution 0.9% of sodium chloride, outcomesModule primaryOutcomes measure: Assessment of the change of levels of high-sensitivity cardiac Troponin (hs-cTn) at V1 versus V0 in the two groups., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliero-Universitaria Pisana, city: Pisa, state: PI, zip: 56126, country: Italy, contacts name: Massimiliano Desideri, role: CONTACT, geoPoint lat: 43.70853, lon: 10.4036, locations facility: Fondazione Policlinico Universitario Campus Bio-Medico, city: Roma, state: RM, zip: 00128, country: Italy, contacts name: Francesco Grigioni, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata, city: Roma, state: RM, zip: 00133, country: Italy, contacts name: Francesco Barillà, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I, city: Roma, state: RM, zip: 00161, country: Italy, contacts name: Pasquale Pignatelli, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Azienda Ospedaliero-Universitaria Sant'Andrea, city: Roma, state: RM, zip: 00189, country: Italy, contacts name: Alberto Ricci, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Azienda Ospedaliera Santa Maria, city: Terni, state: TR, zip: 05100, country: Italy, contacts name: Giacomo Pucci, role: CONTACT, geoPoint lat: 42.56335, lon: 12.64329, locations facility: Ospedale Ca' Foncello, city: Treviso, state: TV, zip: 31100, country: Italy, contacts name: Marcello Rattazzi, role: CONTACT, geoPoint lat: 45.66673, lon: 12.2416, hasResults: False |
protocolSection identificationModule nctId: NCT06296199, orgStudyIdInfo id: 2024-2064, briefTitle: Music, Virtual Reality for Inpatients in IUGM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal, class: OTHER_GOV, descriptionModule briefSummary: Promoting good care, well-being and quality of life for geriatric patients is a long-standing initiative in Quebec, and one in which the Institut Universitaire de Gériatrie de Montréal (IUGM) has always been a leader. For example, the IUGM played a major role in drafting the reference framework for the AAPA (approach adapted to the needs of the elderly), which was introduced by the Ministère de la Santé et des Services Sociaux in 2011. The investigator propose to continue this work by focusing in this project on the development of a new intervention aimed at the well-being and quality of life of geriatric patients and based on music and VR.Thee investigator hypothesize (1) that a VR headset-based intervention based on listening to and observing a concert of musicians playing classical music is feasible for patients hospitalized at the IUGM's URFI, and (2) that this intervention can improve their mental health - i.e. their positive emotions, well-being and quality of life - and reduce their anxiety., conditionsModule conditions: Aging, conditions: Disorder, Neurologic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: VR, interventions name: Music only, outcomesModule primaryOutcomes measure: Feasability, secondaryOutcomes measure: Emotions variation, secondaryOutcomes measure: Affect variation, secondaryOutcomes measure: Well-Being Variation, secondaryOutcomes measure: Quality of life variation, secondaryOutcomes measure: Anxiety variation, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06296186, orgStudyIdInfo id: HT94252310669, briefTitle: Massed Prolonged Exposure for PTSD in Substance Use Treatment, acronym: PREVAIL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2027-08, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Veterans Medical Research Foundation, class: OTHER, collaborators name: University of Minnesota, collaborators name: Center for Veterans Research and Education, descriptionModule briefSummary: The goal of this clinical trial is to learn if receiving Prolonged Exposure Therapy for PTSD in massed format (multiple sessions weekly) is as effective as receiving it with sessions once per week among veterans with PTSD and substance use disorder in intensive outpatient substance use treatment. The main questions it aims to answer are:* Will the massed format help participants complete and benefit from Prolonged Exposure in terms of PTSD symptoms?* Will it help participants reduce substance use? Participants who are in intensive substance use treatment will be asked to complete Prolonged Exposure with either weekly sessions or multiple sessions per week., conditionsModule conditions: Stress Disorders, Post-Traumatic, conditions: Substance Use Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Prolonged Exposure Therapy, outcomesModule primaryOutcomes measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5), primaryOutcomes measure: Time Line Follow back (TLFB), primaryOutcomes measure: Psychotherapy Completion Rates, secondaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: Brief Psychosocial Functioning Inventory (B-IPF), secondaryOutcomes measure: Client Satisfaction Questionnaire-8 (CSQ-8), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VA San Diego Healthcare System, city: San Diego, state: California, zip: 92161, country: United States, contacts name: Sonya Norman, PhD, role: CONTACT, phone: 858-518-8266, email: [email protected], geoPoint lat: 32.71533, lon: -117.15726, locations facility: VA Tampa Healthcare System, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: Brittany Davis, PhD, role: CONTACT, phone: 813-972-2000, email: [email protected], geoPoint lat: 27.94752, lon: -82.45843, locations facility: VA Atlanta Healthcare System, city: Atlanta, state: Georgia, zip: 30033, country: United States, contacts name: Kristin Lamp, PhD, role: CONTACT, email: [email protected], geoPoint lat: 33.749, lon: -84.38798, locations facility: Hines VA Healthcare System, city: Chicago, state: Illinois, zip: 60141, country: United States, contacts name: Jonathan Bayer, PhD, role: CONTACT, email: [email protected], geoPoint lat: 41.85003, lon: -87.65005, hasResults: False |
protocolSection identificationModule nctId: NCT06296173, orgStudyIdInfo id: MP-02-2024-12094, briefTitle: Open Lung Protective Extubation Following General Anesthesia, acronym: OLEXT-3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Centre hospitalier de l'Université de Montréal (CHUM), class: OTHER, collaborators name: CHU de Quebec-Universite Laval, collaborators name: The Ottawa Hospital, collaborators name: University Health Network, Toronto, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: Perioperative respiratory complications are a major source of morbidity and mortality. Postoperative atelectasis plays a central role in their development. Protective "open lung" mechanical ventilation aims to minimize the occurrence of atelectasis during the perioperative period. Randomized controlled studies have been performed comparing various "open lung" ventilation protocols, but these studies report varying and conflicting effects. The interpretation of these studies is complicated by the absence of imagery supporting the pulmonary impact associated with the use of different ventilation strategies. Imaging studies suggest that the gain in pulmonary gas content in "open lung" ventilation regimens disappears within minutes after the extubation. Thus, the potential benefits of open-lung ventilation appear to be lost if, at the time of extubation, no measures are used to keep the lungs well aerated. Recent expert recommendations on good mechanical ventilation practices in the operating room conclude that there is actually no quality study on extubation.Extubation is a very common practice for anesthesiologists as part of their daily clinical practice. It is therefore imperative to generate evidence on good clinical practice during anesthetic emergence in order to potentially identify an effective extubation strategy to reduce postoperative pulmonary complications., conditionsModule conditions: Intra-abdominal Surgery, conditions: Anesthesia, conditions: Lung Injury, conditions: Ventilator-Induced Lung Injury, conditions: Atelectasis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: During surgical closure, the definitive ARISCAT score and exclusion criteria will be assessed. Patients will be randomized equally (1:1) using web-based allocation-concealed methods, with stratification by center and ARISCAT risk category. An unblinded research assistant will reveal group allocation to the anesthesiologist and monitor the emergence procedure., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Until surgical closure, all will be blinded to treatment allocation. Only specific healthcare professionals (anesthesiologist, respiratory therapist, operating room nurses, unblinded research assistant) will be present during emergence to maintain blinding. Other healthcare team members will remain blinded. Outcome adjudicators, Executive and Steering committee members, and the data analyst will also be blinded. No mechanism for unblinding is planned, as both interventions follow the same diagnostic and treatment algorithms for adverse effects., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 216, type: ESTIMATED, armsInterventionsModule interventions name: Protective "open-lung" extubation, interventions name: Conventional extubation, outcomesModule primaryOutcomes measure: Average weekly patient recruitment rate, primaryOutcomes measure: Protocol adherence rate, primaryOutcomes measure: Postoperative pulmonary complications outcome completion rate, secondaryOutcomes measure: Accuracy of self-reported protocol adherence compared to directly observed protocol adherence, secondaryOutcomes measure: Postoperative pulmonary complications, secondaryOutcomes measure: Amount of supplemental oxygen administered following discharge from the post-anesthesia care unit, secondaryOutcomes measure: Quality of recovery, secondaryOutcomes measure: Discharge disposition, secondaryOutcomes measure: Days alive and out of hospital, secondaryOutcomes measure: Health-related quality of life, otherOutcomes measure: Lowest oxygen saturation post-extubation in the operating room, otherOutcomes measure: Time in minutes with oxygen saturation < 85% post-extubation in the operating room, otherOutcomes measure: Re-intubation rate in the operating room and in the post-anesthesia care unit, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Ottawa Hospital, city: Ottawa, state: Ontario, zip: K1H 8L6, country: Canada, contacts name: Daniel I. McIsaac, MD, role: CONTACT, phone: 613-761-4940, email: [email protected], contacts name: Manoj Lalu, MD, role: CONTACT, email: [email protected], contacts name: Daniel I. McIsaac, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Manoj Lalu, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.41117, lon: -75.69812, locations facility: Unity Health Network, city: Toronto, state: Ontario, zip: M5B 1W8, country: Canada, contacts name: Michael C. Sklar, MD, role: CONTACT, phone: 416-864-5071, email: [email protected], contacts name: Ashwin Sankar, MD, role: CONTACT, email: [email protected], contacts name: Michael C. Sklar, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ashwin Sankar, MD, role: SUB_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Centre Hospitalier de l'Université de Montréal (CHUM), city: Montréal, state: Quebec, zip: H2X 0C1, country: Canada, contacts name: Martin Girard, MD, role: CONTACT, phone: 514-890-8000, email: [email protected], contacts name: Eva Amzallag, MSC, role: CONTACT, phone: 514-890-8000, email: [email protected], contacts name: Michael Chassé, MD, role: SUB_INVESTIGATOR, contacts name: François Martin Carrier, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.50884, lon: -73.58781, locations facility: CHU de Québec - Université Laval, city: Québec, zip: G1V 4G2, country: Canada, contacts name: Alexis F. Turgeon, MD, role: CONTACT, phone: 418-525-4444, phoneExt: 66058, email: [email protected], contacts name: Michael Verret, MD, role: CONTACT, phone: 418-525-4444, phoneExt: 66847, email: [email protected], contacts name: Alexis F. Turgeon, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Michael Verret, MD, role: SUB_INVESTIGATOR, geoPoint lat: 46.81228, lon: -71.21454, hasResults: False |
protocolSection identificationModule nctId: NCT06296160, orgStudyIdInfo id: MRC-01-23-035, secondaryIdInfos id: LUSAM-HD, type: OTHER_GRANT, domain: COMITE D'ETHIQUE du CHU BRUGMANN c/o Direction Médicale, briefTitle: A Simplified Lung Ultrasound Guided Management Protocol Of Pulmonary Congestion in Hemodialysis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-28, primaryCompletionDateStruct date: 2024-05-22, completionDateStruct date: 2024-05-22, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Hamad Medical Corporation, class: INDUSTRY, collaborators name: Brugmann University Hospital, descriptionModule briefSummary: Pulmonary congestion secondary to volume overload or interstitial tissue inflammation is common in chronic hemodialysis patients. This pulmonary congestion occurs mainly during the period between dialysis sessions and is an independent risk factor for cardiovascular event morbidity and mortality in this population. The evaluation of this pulmonary congestion and the estimation of the dry weight of hemodialysis patients according to conventional methods represent a real challenge for clinical nephrologists. Lung ultrasound is a new diagnostic approach validated in the assessment of pulmonary congestion. It would allow a better assessment of dry weight in chronic hemodialysis patients based on the results of preliminary studies, including our latest pilot study. However, there is little evidence comparing this novel approach to traditional approaches., conditionsModule conditions: End Stage Renal Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study will compare two groups according to the dry weight determination method:(1) Control arm- modification of dry weight according to standardized care only. The standard of care to modify dry weight is what nephrologists use actually to define the best theoretical dry weight, including clinical (blood pressure, edema, shortness of breath, lung auscultation, etc.) and laboratory measures (Protein concentration before and after dialysis sessions ...). (2) Intervention arm- modify patient's dry weight according to standard of care + B lines score on lung ultrasound BLS obtained after the midweek dialysis session, considered as Day one (Day 1), primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: It is a single-blinded trial as the treatment is blinded by Subjects only, meaning that the type of dry weight modification will not be disclosed to the subject, and they will not know which group he/she will be in at the time of consenting to limit the bias in opinion. The investigator and the research team must know the type of treatment, as the investigator will modify the dry weight according to the treatment group., whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Intervention Group, outcomesModule primaryOutcomes measure: Assess the effectiveness of adding B-line score evaluation through lung ultrasound to the standard of care to improve pulmonary congestion (measured by B lines score) in hemodialysis patients, secondaryOutcomes measure: The impact of utilizing B lines score based additional fluid removal on interdialytic ambulatory blood pressure., secondaryOutcomes measure: The impact of utilizing B lines score based additional fluid removal on intradialytic ambulatory blood pressure, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kaysi Saleh, status: RECRUITING, city: Bruxelles, state: Van Gehuchten, zip: 1020, country: Belgium, contacts name: Nortier Joelle, PHD, role: CONTACT, phone: +33643250634, email: [email protected], geoPoint lat: 50.85045, lon: 4.34878, hasResults: False |
protocolSection identificationModule nctId: NCT06296147, orgStudyIdInfo id: STUDY23080006, briefTitle: Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Pittsburgh, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate if a VR headset and/or aromatherapy can be used to reduce patient pain, anxiety, and embarrassment during a transperineal biopsy (TPBx) compared to standard of care (SOC). The primary objective is to evaluate differences in self-reported pain, fear, or embarrassment during and after the procedure between the VR Group, Aromatherapy Group, VR+Aromatherapy Group, and the Control group., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 208, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Reality Headset, interventions name: Aromatherapy Patch, interventions name: Standard of Care, outcomesModule primaryOutcomes measure: Levels of pain, fear, and embarrassment that each group experienced before the TPBx measured using a self-reported survey that asks about experience prior to biopsy. The survey will be provided after the procedure., primaryOutcomes measure: Levels of pain, fear, and embarrassment that each group experienced during the TPBx measured using a self-reported survey that asks about experience during the biopsy. The survey will be provided after the procedure., primaryOutcomes measure: Levels of pain, fear, and embarrassment that each group experienced after the TPBx measured using a self-reported survey that asks about experience after to biopsy. The survey will be provided after the procedure., secondaryOutcomes measure: Proportion of patients undergoing TPBx who would be interested in using a VR device or aromatherapy patch during the procedure., secondaryOutcomes measure: Safety and feasibility of using a VR device or aromatherapy patch during TPBx via the proportion of procedures completed successfully with no major complications or prolongations., eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Pittsburgh Medical Center Shadyside Hospital, status: RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15232, country: United States, contacts name: Divya Natesan, BS, role: CONTACT, email: [email protected], contacts name: John Myrga, MD, role: CONTACT, email: [email protected], contacts name: Bruce Jacobs, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False |
protocolSection identificationModule nctId: NCT06296134, orgStudyIdInfo id: 17501, briefTitle: Perineal Massage in Pregnancy to Reduce the Levator Ani Coactivation, acronym: CO-LAM23, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Azienda Sanitaria Universitaria Friuli Centrale, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the efficacy of the perineal massage in reducing the levator ani muscle (LAM) co-activation. This phenomenon is characterized by the LAM contraction rather than its relaxation during the Valsalva maneuver and it is associated with adverse obstetric outcome. Participants who co-activate will be enrolled and randomized in 2 groups: group A, where women themselves perform the perineal massage during the third trimester of pregnancy and group B, where women undergo the standard care. Researchers will compare these groups to see if the perineal massage is able to reduce LAM co-activation., conditionsModule conditions: Pelvic Floor Disorders, conditions: Levator Ani Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: perineal massage, outcomesModule primaryOutcomes measure: Comparison of the percentages of women without levator ani muscle co-activation after treatment or after standard care, evaluated at 37-38 weeks of gestation, using chi square test., secondaryOutcomes measure: Evaluation of significant differences in spontaneous or iatrogenic vaginal tears between the groups, secondaryOutcomes measure: percentage of women who completely adhere to perineal massage, i.e. who perform the perineal massage once a day, at least 5 days a week, from 34 gestational weeks until delivery., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Serena Xodo, city: Udine, zip: 33100, country: Italy, contacts name: Serena Xodo, role: CONTACT, phone: 0432-559699, email: [email protected], geoPoint lat: 46.0693, lon: 13.23715, hasResults: False |
protocolSection identificationModule nctId: NCT06296121, orgStudyIdInfo id: BCD-264-2, briefTitle: A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma, acronym: DARVIVA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-21, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Biocad, class: INDUSTRY, descriptionModule briefSummary: The aim of this study is to confirm the comparability of the efficacy and safety profiles of BCD-264 and Darzalex as monotherapy for relapsed and refractory multiple myeloma in subjects previously treated with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy., conditionsModule conditions: Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 252, type: ESTIMATED, armsInterventionsModule interventions name: BCD-264, interventions name: Darzalex, outcomesModule primaryOutcomes measure: Overall response rate according to IMWG (International Myeloma Working Group) criteria, secondaryOutcomes measure: Stringent complete response rate according to IMWG criteria, secondaryOutcomes measure: Complete response (CR) rate according to IMWG criteria, secondaryOutcomes measure: Very good partial response (VGPR) rate according to IMWG criteria, secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Time to progression, secondaryOutcomes measure: Time to response, secondaryOutcomes measure: Overall survival, otherOutcomes measure: Incidence and characteristics of adverse events, otherOutcomes measure: Proportion of subjects with BAbs/Nabs, otherOutcomes measure: Time to BAb/NAb development, otherOutcomes measure: AUC0-168, otherOutcomes measure: AUC0-∞, otherOutcomes measure: AUC0-336, ss, otherOutcomes measure: Cmax, otherOutcomes measure: Cmax, ss, otherOutcomes measure: Tmax, otherOutcomes measure: T1/2, otherOutcomes measure: Vd, otherOutcomes measure: Ctrough, ss, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chelyabinsk Regional Clinical Hospital, status: RECRUITING, city: Chelyabinsk, country: Russian Federation, contacts name: Alexander Korobkin, role: CONTACT, phone: +7 (351) 749-37-10, email: [email protected], geoPoint lat: 55.15402, lon: 61.42915, locations facility: Sverdlovsk Regional Clinical Hospital No. 1, status: RECRUITING, city: Ekaterinburg, country: Russian Federation, contacts name: Tatiana Konstantinova, role: CONTACT, phone: +7 (343) 363-03-03, email: [email protected], geoPoint lat: 56.8519, lon: 60.6122, locations facility: Kuzbass Regional Clinical Hospital named after S.V. Belyaev, status: RECRUITING, city: Kemerovo, country: Russian Federation, contacts name: Marina Kosinova, role: CONTACT, phone: 8(384-2)39-65-33, email: [email protected], geoPoint lat: 55.33333, lon: 86.08333, locations facility: Regional Clinical Hospital, status: RECRUITING, city: Krasnoyarsk, country: Russian Federation, contacts name: Elena Martynova, role: CONTACT, phone: +7 (391) 202-68-50, email: [email protected], geoPoint lat: 56.01839, lon: 92.86717, locations facility: Moscow City Clinical Hospital 52, status: RECRUITING, city: Moscow, country: Russian Federation, contacts name: Elena Misyurina, role: CONTACT, phone: +7 (495) 870-36-04, email: [email protected], geoPoint lat: 55.75222, lon: 37.61556, locations facility: S.P. Botkin Moscow City Clinical Hospital, status: RECRUITING, city: Moscow, country: Russian Federation, contacts name: Vadim Doronin, role: CONTACT, phone: +7 495 945 9972, email: [email protected], geoPoint lat: 55.75222, lon: 37.61556, locations facility: Almazov National Medical Research Centre, status: RECRUITING, city: Saint Petersburg, country: Russian Federation, contacts name: Yuri Osipov, role: CONTACT, phone: +7 (812) 660-37-06, email: [email protected], geoPoint lat: 59.93863, lon: 30.31413, locations facility: N.N. Petrov National Medicine Research Center of oncology, status: RECRUITING, city: Saint Petersburg, country: Russian Federation, contacts name: Ilya Zyuzgin, role: CONTACT, phone: +7(812)43-99-555, email: [email protected], geoPoint lat: 59.93863, lon: 30.31413, locations facility: Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency, status: RECRUITING, city: Saint Petersburg, country: Russian Federation, contacts name: Sergei Voloshin, role: CONTACT, phone: +78123097982, email: [email protected], geoPoint lat: 59.93863, lon: 30.31413, locations facility: St Petersburg State I.P. Pavlov Medical University, status: RECRUITING, city: Saint Petersburg, country: Russian Federation, contacts name: Ivan Moiseev, role: CONTACT, phone: (812) 338 67 48, email: [email protected], geoPoint lat: 59.93863, lon: 30.31413, locations facility: State budgetary healthcare institution Leningrad Regional Clinical Hospital, status: RECRUITING, city: Saint Petersburg, country: Russian Federation, contacts name: Margarita Ulyanova, role: CONTACT, phone: 8 (812) 670-18-88, email: [email protected], geoPoint lat: 59.93863, lon: 30.31413, locations facility: Samara State Medical University, status: RECRUITING, city: Samara, country: Russian Federation, contacts name: Igor Davydkin, role: CONTACT, phone: 8 (846) 374-91-00, email: [email protected], geoPoint lat: 53.20007, lon: 50.15, locations facility: Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory, status: RECRUITING, city: Sochi, country: Russian Federation, contacts name: Dmitrii Kirtbaya, role: CONTACT, phone: (862) 261-43-89, email: [email protected], geoPoint lat: 43.59917, lon: 39.72569, locations facility: Bashkir State Medical University, status: RECRUITING, city: Ufa, country: Russian Federation, contacts name: Bulat Bakirov, role: CONTACT, phone: 8 (347) 272-41-73, email: [email protected], geoPoint lat: 54.74306, lon: 55.96779, hasResults: False |
protocolSection identificationModule nctId: NCT06296108, orgStudyIdInfo id: I05-310-22, briefTitle: Risk Factors for Acute Kidney Injury in Patients Undergoing Arthroplasty, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Ankara University, class: OTHER, descriptionModule briefSummary: The authors aimed to determine the risk factors associated with postoperative acute kidney injury in patients undergoing total joint arthroplasty., conditionsModule conditions: Postoperative Acute Kidney Injury, conditions: Arthroplasty, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 911, type: ACTUAL, armsInterventionsModule interventions name: acute kidney injury, outcomesModule primaryOutcomes measure: Acute kidney injury in patients undergoing arthroplasty surgery, secondaryOutcomes measure: Risk factors causing acute kidney injury in patients undergoing arthroplasty surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara University Medical School Anesthesiology and ICU Department, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06296095, orgStudyIdInfo id: KDS-CUD-1, briefTitle: To Evaluate the Clinical Study of CUD005 Injection in Patients With Cirrhosis, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-08-09, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Anhui Provincial Hospital, class: OTHER_GOV, descriptionModule briefSummary: The study is a single-center, single-arm, open-label, dose-escalation clinical study, to evaluate the tolerability, safety and preliminary efficacy of CUD005 injection in patients with cirrhosis, conditionsModule conditions: Cirrhosis, Liver, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule interventions name: Cell therapy, outcomesModule primaryOutcomes measure: DLT,MTD, secondaryOutcomes measure: fibrosis staging and inflammatory grading, secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: TE（Transient elastography）, otherOutcomes measure: MELD（Model for End-stage Liver Disease）, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui province hospital, city: Hefei, state: Anhui, zip: 230000, country: China, geoPoint lat: 31.86389, lon: 117.28083, hasResults: False |
protocolSection identificationModule nctId: NCT06296082, orgStudyIdInfo id: 49317, briefTitle: Comparative Study of the Mechanism of Action of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity: a Proof of Concept Controlled Trial, acronym: STROKEPOC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Universiteit Antwerpen, class: OTHER, collaborators name: McGill University, collaborators name: Aragon Institute of Health Sciences, descriptionModule briefSummary: Trial design This study is a protocol of a phase II clinical trial which will be conducted in two countries (Belgium and Spain) to compare the effectiveness of DN and BTX A in reducing post-stroke spasticity in the plantar flexor muscles. This study is a prospective randomized, controlled, multiple-baseline design with blinded assessors. The study will be registered in ClinicalTrials.gov and will have a length of 19 weeksTrial population Inclusion Criteria: 1) aged 18-75 years old, 2) having lower limb post-stroke spasticity in ankle plantar flexors (MAS scores of 1, 1+ and 2); 3) having had a first stroke; 4) having no more than 12 months of evolution since stroke; 5) having no previous Dry Needling (DN) or Botulinum Toxin type A (BTX A) treatment for spasticity; 6) having ankle PROM ≥ 20° (approx.) when the knee is supported in \~30° flexion; 7) being able to walk independently with or without aids.Exclusion Criteria: 1) medical conditions interfering with data interpretation; 2) any contraindication to receiving BTX A or PS treatment; 3) If taking anti-spasticity medications, participants must be on stable medication for at least 3 months prior to the start of the study and neither the dose nor the medication can be changed during the tria Interventions Participants will be randomly allocated to the group receiving a session of BTX A or to the group receiving Dry Needling once weekly for 12 weeks. Blinded evaluators will assess the effects before, during, after treatment, and at 4-week follow-up.The trial will have regular monitoring visits by an independent external monitor to ensure compliance with the protocol and Good Clinical Practices. Monitors may review source documents to confirm accurate data on CRD. The investigator and institution will guarantee direct access to source documents for monitors and regulatory authorities., conditionsModule conditions: Stroke, conditions: Spasticity as Sequela of Stroke, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly allocated to the group receiving a session of BTX A or to the group receiving Dry Needling once weekly for 12 weeks. Each group will be assessed equally during the 19 weeks of the study duration., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Participant will be randomized but ultimately will know which treatment he/she receives. A distinct investigator/assessor and intervention therapist wil be selected to treat or assess the participant, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Botulinum toxin type A, interventions name: Dry Needling, outcomesModule primaryOutcomes measure: tonic stretch reflex threshold, secondaryOutcomes measure: Passive Resistance, secondaryOutcomes measure: Ultrasound Imaging: Morphometric Analysis, secondaryOutcomes measure: Ultrasound Imaging: Eco-textural Analysis of Muscle:, secondaryOutcomes measure: Dynamometry, secondaryOutcomes measure: Gait Analysis, secondaryOutcomes measure: 10 Meter Walk Test (10MWT), secondaryOutcomes measure: Timed up and Go Assessment (TUG), secondaryOutcomes measure: Quality of Life EuroQoL 5D, secondaryOutcomes measure: EQ visual analogue scale (EQ VAS), secondaryOutcomes measure: Cost-effectiveness, secondaryOutcomes measure: Patient Acceptance, otherOutcomes measure: Frequency and Severity of Adverse Events for DN and BTX A, otherOutcomes measure: Sample size, otherOutcomes measure: Sample size and drop out, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06296069, orgStudyIdInfo id: SwingIT-stroke, briefTitle: Exergames on an Unstable Surface in Stroke Inpatients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Eleftheria Giannouli, class: OTHER, descriptionModule briefSummary: Aim of this study is to assess the feasibility and effects of exergame-based cognitive-motor training on a labile platform on physical and cognitive functioning in stroke inpatients.This is two-armed pilot randomized controlled trial taking place in an inpatient neurologic rehabilitation clinic. A total of 30 persons that are undergoing inpatient rehabilitation due to a stroke will be randomly assigned to either the intervention group (IG) or the control group (CG). Participants of the IG will receive exergame-based motor-cognitive training on a labile surface, whereas participants of the CG will train on a stable surface. Primary outcome is feasibility comprising measures of adherence, attrition, safety and usability. Secondary outcomes will be measures of cognitive (psychomotor speed, inhibition, selective attention, cognitive flexibility, brain activity) and motor (functional mobility, gait speed, balance, proprioception) functioning., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: exergame-based cognitive-motor training on an unstable surface, interventions name: exergame-based cognitive-motor training on an stable surface, outcomesModule primaryOutcomes measure: Security incidents, primaryOutcomes measure: Attrition rate, primaryOutcomes measure: Adherence rate, primaryOutcomes measure: Usability, primaryOutcomes measure: Training Load, primaryOutcomes measure: Enjoyment, primaryOutcomes measure: User experience, primaryOutcomes measure: Training Goals, secondaryOutcomes measure: Changes in cognitive flexibility, secondaryOutcomes measure: Changes in psychomotor speed, secondaryOutcomes measure: Changes in selective attention, secondaryOutcomes measure: Changes in inhibition and brain activity, secondaryOutcomes measure: Changes in functional mobility, secondaryOutcomes measure: Changes in coordination, secondaryOutcomes measure: Changes in dynamic balance, secondaryOutcomes measure: Changes in static balance, secondaryOutcomes measure: Changes in gait, secondaryOutcomes measure: Changes in leg proprioception, secondaryOutcomes measure: Changes in balance confidence, secondaryOutcomes measure: Changes in gait confidence, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rehaklinik Zihlschlacht, status: RECRUITING, city: Zihlschlacht-Sitterdorf, state: Thurgau, zip: 8588, country: Switzerland, contacts name: Detlef Marks, role: CONTACT, phone: 071 424 37 51, geoPoint lat: 47.51401, lon: 9.26776, hasResults: False |
protocolSection identificationModule nctId: NCT06296056, orgStudyIdInfo id: SDH-combi, briefTitle: Phase I Study of Combined Immune Cell Therapy in Patients With Stage 4 Colorectal Cancer With Metastatic Lesion Who Failed Prior Standard of Care, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Nyamdavaa Tuul, class: OTHER, descriptionModule briefSummary: To evaluate the safety, immune response, and potential efficacy of combined immune cell therapy in patients with stage 4 colorectal cancer who have failed standard treatment and have unresectable lesions or metastatic lesions., conditionsModule conditions: Colorectal Cancer Stage IV, conditions: Metastatic Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Combi, outcomesModule primaryOutcomes measure: Number of Patients with grade 1-5 adverse events and list of adverse event frequency, primaryOutcomes measure: immune response, primaryOutcomes measure: potential efficacy, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06296043, orgStudyIdInfo id: SBU-FUT-01, briefTitle: The Effect of Su-Jok Application and Progressive Muscle Relaxation Exercises in Coping With Premenstrual Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-07-15, completionDateStruct date: 2024-08-15, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: The aim of this study is to determine the effect of su-jok application and progressive muscle relaxation exercise in coping with premenstrual syndrome., conditionsModule conditions: Premenstrual Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Three groups with su-jok group, progressive muscle relaxation exercise group and control group, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Double (Participant, Outcomes Assessor) Since the application will be performed by the researcher, participant will be blinded in this study. The statistician will be blinded in the evaluation of the data., whoMasked: PARTICIPANT, enrollmentInfo count: 135, type: ESTIMATED, armsInterventionsModule interventions name: Progressive Muscle Relaxation Exercise Group, interventions name: Su-Jok Intervention, outcomesModule primaryOutcomes measure: PAIN Visual Analog Scale (VAS)- (Min:0 - Max:10), primaryOutcomes measure: FATIGUE Visual Analog Scale (VAS)- (Min:0 - Max:10), primaryOutcomes measure: SLEEP STATE Visual Analog Scale (VAS)- (Min:0 - Max:10), primaryOutcomes measure: NAUSEA VOMITING Visual Analog Scale (VAS)- (Min:0 - Max:10), primaryOutcomes measure: Change in Premenstrual Symptoms (People with PMS scale scores over 104 points will be determined)., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06296030, orgStudyIdInfo id: 22-0010, briefTitle: Culturally Tailored ACT for Black Trauma, statusModule overallStatus: WITHDRAWN, startDateStruct date: 2021-09-01, primaryCompletionDateStruct date: 2022-09-01, completionDateStruct date: 2023-08-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Azusa Pacific University, class: OTHER, descriptionModule briefSummary: Blacks in America more frequently meet the criteria for posttraumatic stress disorder (PTSD) than any other US race or ethnicity. Yet, blacks are among the groups least likely to use mental health services for trauma. Thus, a large number of traumatized blacks suffer silently and remain untreated.Acceptance and Commitment Therapy (ACT) is an empirically-based psychological intervention that uses acceptance and mindfulness strategies, with commitment and behavior change strategies, to increase psychological flexibility and decrease anxiety outcomes. While culturally tailored mental health interventions have been shown useful for racial and ethnic minorities, there have been few efforts to tailor ACT for blacks. This NIH R21 would compare an ACT model specifically culturally tailored for blacks (POOF) to the classic ACT model in a randomized trial, where clinicians will conduct 12-session telehealth synchronous virtual groups. Eighty black participants who self-identify as suffering from stress or anxiety will be confidentially recruited. Two specific aims are proposed:Aim 1) It is expected that POOF participants will report higher levels of acceptability of treatment than classic ACT participants and that POOF participants will have better adherence to treatment regimens than traditional ACT participants.Aim 2) Given that race-based stress may mediate anxiety symptoms in U.S. based blacks, it is expected that POOF will decrease race-based stress, thereby mattering the most for improving anxiety outcomes for blacks.The proposed R21 pilot study will be the first randomized controlled trial to evaluate an ACT intervention tailored explicitly for black racial trauma. This study will provide critical data needed to plan and design a future R01 controlled longitudinal effectiveness study. The long-term objective is to significantly reduce the prevalence of stress and anxiety-related symptoms due to traumatic events for Blacks by increasing treatment acceptability for this population. Since blacks have the highest rates of trauma prevalence and chronicity, yet they are still underrepresented in mental health treatment, this tailored intervention can have a significant public health impact., conditionsModule conditions: Stress Disorders, Traumatic, conditions: Anxiety, conditions: Anxiety Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: This project's research design is a two-by-two factorial design. Factor one, the type of ACT intervention delivered, has two levels - POOF delivery (level 1) and a classic ACT delivery (level 2). Factor two, the facilitator's first group treatment delivery, also has two levels. There are four (4) group facilitators. The first two facilitators deliver traditional ACT first (level 1), and the second two facilitators deliver POOF first (level 2). Each facilitator providing group treatment will facilitate two groups (classic and POOF), one after the next. However, facilitators will be randomized to the order in which they deliver their first group to reduce experimenter/ clinician history bias. All of the facilitators are licensed, mental health clinicians., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 0, type: ACTUAL, armsInterventionsModule interventions name: POOF ACT program, interventions name: Classic ACT program, outcomesModule primaryOutcomes measure: Race-Based Traumatic Stress, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azusa Pacific University, city: Azusa, state: California, zip: 91702, country: United States, geoPoint lat: 34.13362, lon: -117.90756, hasResults: False |
protocolSection identificationModule nctId: NCT06296017, orgStudyIdInfo id: AEŞH- EK1- 2023-115, briefTitle: Effectiveness of Conservative Interventions in the Treatment of Trigger Finger, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-02, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: There is no study in the literature comparing the effectiveness of ESWT and splint therapy, which are the most commonly used approaches in the treatment of Trigger Finger (TF). The aim in this study is to investigate the effectiveness of ESWT and splint therapy used in the treatment of TF., conditionsModule conditions: Trigger Finger, conditions: Stenosing Tenosynovitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Experimental: Extracorporeal Shock Wave Therapy, interventions name: Trigger Finger Splint, interventions name: Extracorporeal Shock Wave Therapy+ Trigger Finger Splint, outcomesModule primaryOutcomes measure: Visual analog scale, secondaryOutcomes measure: Grip and pinch strength, secondaryOutcomes measure: Number of trigger, secondaryOutcomes measure: Functional assessment, secondaryOutcomes measure: Treatment satisfaction, secondaryOutcomes measure: Functional assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Feray Karademir, status: RECRUITING, city: Ankara, zip: 06100, country: Turkey, contacts name: Feray Karademir, role: CONTACT, phone: 90 505 313 75 82, email: [email protected], contacts name: Feray Karademir, role: CONTACT, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06296004, orgStudyIdInfo id: CAPILLAROSCOPY behcet disease, briefTitle: Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Relation between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease, conditionsModule conditions: Behçet's Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness by U.S, outcomesModule primaryOutcomes measure: measuring parameter of Nail Fold Capillaroscopy in behcet disease, primaryOutcomes measure: measuring parameter of Optical Coherence Tomography Angiography in behcet disease, primaryOutcomes measure: measuring parameter of Femoral Vein Wall Thickness in behcet disease, secondaryOutcomes measure: relation between Nail Fold Capillaroscopy and activity of behcet disease, secondaryOutcomes measure: relation between Optical Coherence Tomography Angiography and activity of behcet disease, secondaryOutcomes measure: relation between Femoral Vein Wall Thickness and activity of behcet disease, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06295991, orgStudyIdInfo id: 2023/005, briefTitle: The Effect of Lycra Garments on Spastic Diplegic Cerebral Palsy Patients With Scoliosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-03-21, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: The primary aim of this study was to investigate the effects of lycra clothing on balance and respiratory functions in individuals with cerebral palsy with scoliosis, and the secondary aim was to investigate the effects of lycra clothing on motor function, activity limitation and quality of life in these individuals., conditionsModule conditions: Balanced; Rearrangement, conditions: Respiratory Function Test, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Lycra garment, outcomesModule primaryOutcomes measure: Balance parameters, primaryOutcomes measure: Respiratory functions, primaryOutcomes measure: Respiratory muscle strength measurement, secondaryOutcomes measure: Gross motor function measurement, secondaryOutcomes measure: Functional independence assessment, secondaryOutcomes measure: Assessment of activity restriction, secondaryOutcomes measure: Quality of life assessment, secondaryOutcomes measure: Assessment of posture, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06295978, orgStudyIdInfo id: 4896, briefTitle: Multimarker Approach in Acute Chest Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-02-01, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: Chest pain is one of the most common causes of access in the Emergency Room, and it can be a clinical manifestation of a broad spectrum of diseases including those 'time dependent' conditions such as acute coronary syndrome (ACS). Diagnosis or exclusion of acute myocardial infarction (AMI) is a daily challenge in the emergency department (ED), especially when classic clinical criteria and ECG alone are unable to make the diagnosis. The ED physician has the extremely delicate task of managing patients with chest pain and being able to frame them correctly; therefore, he needs to make differential diagnosis since chest pain can be caused by non-cardiac vascular events but also extra-cardiovascular events, such as pulmonary, neurological, osteoarticular, gastrointestinal and psychological. Recently, the importance of inflammatory processes and endothelial damage in cardiovascular disease has been highlighted, and consequently the focus has been on new markers, in a "multimarker" approach in which the strengths of each are combined together to provide an optimal solution to a clinical problem.The data suggest how a future integration of these biomarkers in the routine approach to the patient with acute chest pain in the ED might allow a better patient stratification and proper management, allowing the clinician to make an early safe discharge or a timely admission for those who deserve in-depth diagnostic-therapeutic investigation., conditionsModule conditions: Cardiovascular Disease Other, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Biochemical marker assays, outcomesModule primaryOutcomes measure: The predictive value of markers for the risk of cardiovascular events in chest pain, secondaryOutcomes measure: Multimarker approach to improve cardiovascular risk stratification, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario "A. Gemelli" IRCCS, status: RECRUITING, city: Roma, zip: 00168, country: Italy, contacts name: ANDREA PICCIONI, Dr., role: CONTACT, phone: 0630153161, email: [email protected], geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06295965, orgStudyIdInfo id: RG1123813, secondaryIdInfos id: NCI-2023-10315, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: FHIRB0020162, type: OTHER, domain: Fred Hutch/University of Washington Cancer Consortium, secondaryIdInfos id: R01CA272594, type: NIH, link: https://reporter.nih.gov/quickSearch/R01CA272594, briefTitle: Clonal Hematopoiesis in Ovarian Cancer Survivors and Risk of Secondary Blood Cancers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2031-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University of Washington, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This study is being done to investigate clonal hematopoiesis and therapy-emergent myeloid neoplasms in patients with ovarian cancers. Researchers want to identify risk factors for developing these blood cancers as well as if there is/are a genetic/environmental component(s) to developing blood cancer., conditionsModule conditions: Recurrent Fallopian Tube Carcinoma, conditions: Recurrent Ovarian Carcinoma, conditions: Recurrent Primary Peritoneal Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Non-Interventional Study, outcomesModule primaryOutcomes measure: Determine the correlation between baseline TP53m VAF in blood with CH expansion in OC patients, primaryOutcomes measure: Identify risk of TMN for OC survivors with and without TP53m CH treated with platinum chemotherapy and PARP inhibitors, primaryOutcomes measure: Define the trajectories of clonal evolution and mechanisms of transformation from non-cancerous TP53m to TMN, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fred Hutch/University of Washington Cancer Consortium, status: RECRUITING, city: Seattle, state: Washington, zip: 98109, country: United States, contacts name: Swisher Lab Research Coordinators, role: CONTACT, phone: 206-616-8927, email: [email protected], contacts name: Elizabeth Swisher, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False |
protocolSection identificationModule nctId: NCT06295952, orgStudyIdInfo id: 23-371, briefTitle: A Study of Pasireotide in People With Prolactinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Memorial Sloan Kettering Cancer Center, class: OTHER, collaborators name: Evergreen Theragnostics, collaborators name: Recordati Pharmaceutical company, descriptionModule briefSummary: The researchers are doing this study to find out whether pasireotide is an effective treatment for people with prolactinoma who cannot receive dopamine agonist therapy. Another purpose of this study is to find out whether pasireotide is a safe treatment for people with prolactinoma., conditionsModule conditions: Prolactin-Producing Pituitary Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is an open label single-center pilot study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Pasireotide, outcomesModule primaryOutcomes measure: biochemical response rate, secondaryOutcomes measure: radiographic response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), status: RECRUITING, city: Basking Ridge, state: New Jersey, zip: 07920, country: United States, contacts name: Eliza Geer, MD, role: CONTACT, phone: 646-608-3797, geoPoint lat: 40.70621, lon: -74.54932, locations facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities), status: RECRUITING, city: Middletown, state: New Jersey, zip: 07748, country: United States, contacts name: Eliza Geer, MD, role: CONTACT, phone: 646-608-3797, geoPoint lat: 40.39652, lon: -74.09211, locations facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities), status: RECRUITING, city: Montvale, state: New Jersey, zip: 07645, country: United States, contacts name: Eliza Geer, MD, role: CONTACT, phone: 646-608-3797, geoPoint lat: 41.04676, lon: -74.02292, locations facility: Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities), status: RECRUITING, city: Commack, state: New York, zip: 11725, country: United States, contacts name: Eliza Geer, MD, role: CONTACT, phone: 646-608-3797, geoPoint lat: 40.84288, lon: -73.29289, locations facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities), status: RECRUITING, city: Harrison, state: New York, zip: 10604, country: United States, contacts name: Eliza Geer, MD, role: CONTACT, phone: 646-608-3797, geoPoint lat: 40.96899, lon: -73.71263, locations facility: Memorial Sloan Kettering Cancer Center, status: RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: Eliza Geer, MD, role: CONTACT, phone: 646-608-3797, contacts name: Andrew Lin, MD, role: CONTACT, phone: 212-639-8392, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities), status: RECRUITING, city: Uniondale, state: New York, zip: 11553, country: United States, contacts name: Eliza Geer, MD, role: CONTACT, phone: 646-608-3797, geoPoint lat: 40.70038, lon: -73.59291, hasResults: False |
protocolSection identificationModule nctId: NCT06295939, orgStudyIdInfo id: CA code 016/2565, 012/2566, briefTitle: Effect of Social Support Program on Grief of Pregnancy Loss in Sunpasitthiprasong Hospital, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-04-29, primaryCompletionDateStruct date: 2024-03-15, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Sanpasitthiprasong Hospital, class: OTHER_GOV, descriptionModule briefSummary: Research Question:Does participation in a social support program have an impact on the Perinatal Grief Scale of women who experience pregnancy loss through abortion? Research hypothesis1. The grief scores from pregnancy loss among women who had to terminate their pregnancies in the group receiving social support program were lower than those in the group receiving standard nursing care.2. The grief scores from pregnancy loss among women who had to terminate their pregnancies after receiving the social support program were lower than those before receiving the social support program.Primary Objectives:To study the grief and sorrow resulting from the loss of a fetus due to pregnancy termination in women who have undergone social support programs, in comparison to those who have received regular nursing care.Secondary Objectives:1. To investigate the grief and sorrow resulting from the loss of a fetus due to pregnancy termination after receiving social support programs compared to before receiving such programs.2. To examine the grief and sorrow following pregnancy termination before returning home and one month after miscarriage.3. To explore other outcomes of pregnancy termination, such as complete abortion, uterine curettage, and post-miscarriage complications., conditionsModule conditions: Pregnancy Loss, conditions: Grief, conditions: Social Support, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 1. The researcher provided information about a research project involving pregnant women diagnosed with fetal demise or abnormalities, who are recommended to undergo pregnancy termination at the third trimester abortion clinic.2. Pregnant women voluntarily consent to participate in the research by signing the informed consent form.3. Volunteer participants providing consent will be randomly divided into two groups using the randomization technique with Excel program.4. Divide into groups of 45 individuals each, totaling 90 participants in the entire sample., primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: social support program, interventions name: Routine nursing care, outcomesModule primaryOutcomes measure: The Perinatal Grief Assessment Questionnaire., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sanpasitthiprasong Hospital, city: Ubon Ratchathani, zip: 34000, country: Thailand, geoPoint lat: 15.23844, lon: 104.84866, hasResults: False |
protocolSection identificationModule nctId: NCT06295926, orgStudyIdInfo id: K5236, briefTitle: Serplulimab Combined With CCRT for LS-SCLC., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2027-01-25, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: Small cell lung cancer(SCLC) has a poor prognosis and a relatively short overall survival time, urgently requiring innovative treatment strategies to improve the prognosis of such patients. Immunotherapy has become an important component of first-line therapy for extensive-stage small cell lung cancer (ES-SCLC). Studies have found that, compared to chemotherapy alone, the combination of Surlidumab with carboplatin and etoposide can extend the median overall survival in ES-SCLC to over 15 months. However, to date, research on the use of immunotherapy in combination with concurrent chemoradiotherapy (CCRT) in limited-stage small cell lung cancer (LS-SCLC) remains limited. This study aims to explore the clinical benefits of Surlidumab in combination with concurrent chemoradiotherapy in LS-SCLC and evaluate the safety of immunotherapy in combination with CCRT as first-line treatment for LS-SCLC. At the same time, it seeks to identify tumor-related biomarkers that can effectively predict the efficacy of immunotherapy and prognosis., conditionsModule conditions: Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Serplulimab, outcomesModule primaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, secondaryOutcomes measure: objective response rate (ORR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital, city: Beijing, state: Beijing, zip: 100730, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06295913, orgStudyIdInfo id: HYTOLIVE15, briefTitle: Hydroxytyrosol Dietary Supplement and Prevention of Age-Related Diseases, acronym: HYTOLIVE15, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: National Research Council, Spain, class: OTHER_GOV, collaborators name: Genosa I+D, descriptionModule briefSummary: The primary objective of this study is to ascertain the effects of chronic consumption of a hydroxytyrosol-rich extract from olive (Hytolive®) in a population at high risk of developing age-related pathologies such as type 2 diabetes and cardiovascular diseases. The markers measured will be associated with oxidative stress, inflammation, and homeostasis glucose and lipid profiles. Improvements in these parameters could potentially prevent the onset of pathologies associated with aging., conditionsModule conditions: Overweight, conditions: PreDiabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Group 1, hydroxytyrosol-rich extract pill (Hytolive®); Group 2, placebo pill, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: Participants will be randomly allocated to treatment A and B. Both pills will have the same aspect and will be packed similarly, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Group 1, hydroxytyrosol-rich extract capsule (Hytolive®), interventions name: Group 2, capsule of placebo, outcomesModule primaryOutcomes measure: LDL-ox as marker of oxidative status, secondaryOutcomes measure: Emotional well-being determined by Warwick-Edinburgh Mental Well-being Scale, secondaryOutcomes measure: Sleep quality determined by Pittsburgh Sleep Quality Index, secondaryOutcomes measure: Fatigue test determined by Borg Rating Of Perceived Exertion, secondaryOutcomes measure: Fasting glucose, secondaryOutcomes measure: Fasting insulin, secondaryOutcomes measure: Glycated hemoglobin (HbA1c), secondaryOutcomes measure: Glucagon-like peptide-1 (GLP-1), secondaryOutcomes measure: Total cholesterol, secondaryOutcomes measure: High density lipoproteins (HDL), secondaryOutcomes measure: Low density lipoproteins (LDL) triglicéridos, apoliporpotein A1 and B), secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: Apoliporpotein A1, secondaryOutcomes measure: Apoliporpotein B, secondaryOutcomes measure: Total antioxidant status (TAS), secondaryOutcomes measure: Total oxidative status (TOS), secondaryOutcomes measure: Oxides of nitrogen (NOx), secondaryOutcomes measure: Thiobarbituric acid reactive substances (TBARS), secondaryOutcomes measure: C reactive protein, secondaryOutcomes measure: Interleukine 6 (IL-6), secondaryOutcomes measure: Tumor necrosis factor alpha (TNF-α), secondaryOutcomes measure: Interleukine 10 (IL-10), secondaryOutcomes measure: Alanine aminotransfesare (transaminases ALT), secondaryOutcomes measure: Aspartate aminotransferase (transaminase AST), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC), status: RECRUITING, city: Madrid, state: Comunidad Autónoma De Madrid, zip: 28040, country: Spain, contacts name: Raquel Mateos, PhD, role: CONTACT, phone: +34 915492300, phoneExt: 436341, email: [email protected], contacts name: Mª Ángeles Martín, PhD, role: CONTACT, phone: +34 915492300, phoneExt: 436340, email: [email protected], geoPoint lat: 40.4165, lon: -3.70256, hasResults: False |
protocolSection identificationModule nctId: NCT06295900, orgStudyIdInfo id: 19.10.2023/63, briefTitle: The Effect of Aromatherapy Massage on Sleep Quality, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Nilgün Erdoğan, class: OTHER, descriptionModule briefSummary: Sleep disturbance is one of the most common complaints of patients admitted to ICU. Insufficient sleep in intensive care units may be associated with environmental reasons such as excessive light at night, loud warning sounds and mechanical ventilation alarms, as well as non-environmental factors, including the situation at the time of admission. Sleep assessment is subjective in nature, so it is difficult to perform in the ICU. Since communication with the patient is prevented, clear information about perceived rest and disturbing factors cannot be provided. For this reason, night rest is an issue that is often forgotten and ignored. This study applied a mixture of lavender, medicinal chamomile and neroli oil (in 20 ml of sweet almond oil; lavender oil 2 drops, medicinal chamomile 4 drops, neroli oil 6 drops) to patients who were monitored in intensive care on high-flow and oxygen, once a day for three days. This study will be conducted to determine the effect of aromatherapy massage applied for a total of 30 minutes on sleep quality., conditionsModule conditions: Diabetes Mellitus, conditions: Respiratory Failure, conditions: Pneumonia, conditions: Respiratory Disease, conditions: Stroke, Ischemic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: It will be conducted as a randomized controlled single-blind study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 62, type: ESTIMATED, armsInterventionsModule interventions name: Intervention 1 Group, interventions name: Intervention 2 Group, interventions name: Placebo Control Group, outcomesModule primaryOutcomes measure: Patient Introduction Form, secondaryOutcomes measure: Patient Follow-up Form, otherOutcomes measure: Visual Comparison Sleep Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ömer Halisdemir University Training and Research Hospital, status: RECRUITING, city: Nigde, zip: 51100, country: Turkey, contacts name: nilgun erdogan, researcher, role: CONTACT, phone: 5312599220, email: [email protected], geoPoint lat: 37.96583, lon: 34.67935, hasResults: False |
protocolSection identificationModule nctId: NCT06295887, orgStudyIdInfo id: E-2402, briefTitle: Educational Efficacy of VR vs. Simulator in Emergency Medical Training, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-13, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, collaborators name: Seoul National University, descriptionModule briefSummary: It has not been revealed which is more effective: an education program using virtual reality technology or a simulation education program using Sim-man.In this study, the participants are new doctors who graduated from medical school and started working as interns at hospitals. The participants were divided into two groups. One group received a training program using virtual reality technology, and the other group received simulation training using Sim-man. The investigators would like to compare the increase in confidence and satisfaction before and after training.After the classes and surveys are completed for each group, the participants will be able to receive other educational methods if they wish., conditionsModule conditions: Simulation Training, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: control group vs. test group, 1:1, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 166, type: ESTIMATED, armsInterventionsModule interventions name: Educational Program using VR or simulator designed to improve medical intern's performance managing emergency situation, outcomesModule primaryOutcomes measure: self-rated confidence for managing emergency situation, primaryOutcomes measure: self-rated confidence for managing emergency situation, primaryOutcomes measure: performance in managing emergency situation, secondaryOutcomes measure: usability of Virtual Reality simulation program using User Experience Questionnaire Short, secondaryOutcomes measure: usability of Virtual Reality simulation program using Simulator Sickness Questionnaire, secondaryOutcomes measure: usability of Virtual Reality simulation program using System Usability Scale, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06295874, orgStudyIdInfo id: 12.10.2022/50, briefTitle: The Effect of Aromatherapy Massage on Pain, Anxiety and Comfort, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-05, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Nilgün Erdoğan, class: OTHER, descriptionModule briefSummary: Patients in the intensive care unit (ICU) experience physical and psychological discomfort, including pain. Anxiety is a condition frequently encountered in the ICU. The hospital environment, especially the ICU, is reported as a significant cause of anxiety for patients. Comfort is a holistic, subjective and multidimensional concept that is affected by physical, environmental, social and psycho-spiritual contexts and changes over time and space. Comfort in intensive care is often associated with pain relief and end-of-life care. Assessment tools have been developed to measure patient comfort in the ICU, including levels of pain, delirium, and sedation. This work; Patients who are monitored in intensive care under high-flow and oxygen are treated with a mixture of lavender, thyme and eucalyptus oil (20 ml; lavender oil 5 drops, thyme oil 4 drops, eucalyptus oil 3 drops and 20 ml almond oil) twice a day for three days. This study was conducted to determine the effect of aromatherapy massage applied for a total of 30 minutes on some physiological parameters, pain, anxiety and intensive care comfort of the patients., conditionsModule conditions: Respiratory Insufficiency, conditions: Pulmonary Disease, Chronic Obstructive, conditions: Diabetes Mellitus, Type 2, conditions: High Blood Pressure, conditions: Stroke, Ischemic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized controlled single blind study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 61, type: ESTIMATED, armsInterventionsModule interventions name: Effect of aromatherapy massage on vital signs, pain, anxiety and comfort level, outcomesModule primaryOutcomes measure: Patient Introduction Form, secondaryOutcomes measure: Patient Follow-up Form, otherOutcomes measure: Drug Monitoring Form, otherOutcomes measure: Visual Pain Scale, otherOutcomes measure: Face Anxiety Scale, otherOutcomes measure: Comfort Rating Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ömer Halisdemir University Training and Research Hospital, status: RECRUITING, city: Nigde, zip: 51100, country: Turkey, contacts name: nilgun erdogan, researcher, role: CONTACT, phone: 5312599220, email: [email protected], geoPoint lat: 37.96583, lon: 34.67935, hasResults: False |
protocolSection identificationModule nctId: NCT06295861, orgStudyIdInfo id: 2023-1194, briefTitle: Prospective Cohort Study of Panvascular Disease, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2028-11-30, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, descriptionModule briefSummary: To construct a comprehensive big data platform for Chinese people with panvascular disease, and establish a Chinese panvascular disease oriented to guide treatment decisions Cohort and imaging, biological database; According to the clinical features, morphological structure, pathological characteristics of panvascularization, vascular age As the core of the evaluation, a standard evaluation system and a risk prediction model of intervention technology suitable for the diagnosis and treatment of patients with panvascular disease in China were established. Into the Further optimize the treatment strategies, protocols and clinical pathways for panvascular disease to improve patient prognosis and promote its application., conditionsModule conditions: ASCVD, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50000, type: ESTIMATED, armsInterventionsModule interventions name: no different intervention between the two cohort., outcomesModule primaryOutcomes measure: Cardiovascular adverse events, primaryOutcomes measure: Cardiovascular mortality, secondaryOutcomes measure: Rate of receiving vascular revascularization, secondaryOutcomes measure: Readmission rate for vascular reasons, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Second Affiliated Hospital, School of Medicine, Zhejiang University, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False |
protocolSection identificationModule nctId: NCT06295848, orgStudyIdInfo id: KayseriCH005, briefTitle: The Effects of Cardiac Rehabilitation Programme in Hypertensive Rheumatoid Arthritis Patients, acronym: CARDIRA, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-15, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Kayseri City Hospital, class: OTHER_GOV, descriptionModule briefSummary: The aim of this study is to investigate the beneficial impacts of the 6-week standardized CR program applied to hypertensive RA patients whose disease activity is under control with regular pharmacological treatment.Subjects will be randomly assigned to one of two groups: 1.) standard of care (SOC) treatment or 2.) SOC plus a 6 week CR program., conditionsModule conditions: Cardiac Rehabilitation, conditions: Rheumatoid Arthritis, conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, outcomesModule primaryOutcomes measure: Framingham Risk Score(FRS), primaryOutcomes measure: QRISK-3 Risk Score, primaryOutcomes measure: 24-Hour Ambulatory Blood Pressure, primaryOutcomes measure: DAS28, primaryOutcomes measure: Maximal oxygen consumption (VO2max), secondaryOutcomes measure: The Six-Minute Walk Test (6MWT), secondaryOutcomes measure: The 36-Item Short Form Survey (SF-36), secondaryOutcomes measure: International Physical Activity Questionnaire (IPAQ) - Short Form, secondaryOutcomes measure: Beck Depression Inventory (BDI), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Health Sciences University, Kayseri Medicine Faculty, status: RECRUITING, city: Kayseri, state: Kocasinan, zip: 38080, country: Turkey, contacts name: HAVVA TALAY ÇALIŞ, PROFESSOR, role: CONTACT, phone: +905326874541, email: [email protected], contacts name: PROFESSOR, role: CONTACT, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False |
protocolSection identificationModule nctId: NCT06295835, orgStudyIdInfo id: CS-2024-0001, briefTitle: Method Comparison Study for Measuring Potassium (K) and Ionized Calcium (iCa) in Blood, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Abbott Point of Care, class: INDUSTRY, descriptionModule briefSummary: Method comparison study for Potassium (K) and ionized calcium (iCa)., conditionsModule conditions: Potassium (K) and Ionized Calcium (iCa) in Capillary Whole Blood, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Capillary whole blood specimens will be tested in duplicate on the i-STAT 1 Analyzer with the CG8+ cartridge and a blood analyte testing comparator device., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Fingerstick blood draw, outcomesModule primaryOutcomes measure: Performance comparison, primaryOutcomes measure: Performance comparison, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06295822, orgStudyIdInfo id: CMUH112-REC2-063, briefTitle: The Effectiveness of Chinese Medicine Nuan-gong-ye on Primary Dysmenorrhea, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: China Medical University Hospital, class: OTHER, descriptionModule briefSummary: Primary dysmenorrhea is a common under-diagnosed complaint, with a prevalence of about 45-95% in women of childbearing age and about 10-25% in severe cases. Menstrual pain can be classified as primary or secondary. Primary menstrual pain is a crampy pain in the lower abdomen without any pelvic pathology, which usually occurs 6 to 12 months after the first menstruation. Primary menstrual pain is usually most severe on the first day of the menstrual cycle and lasts for 8 to 72 hours. The cause is still unknown, but studies suggest that it may be related to increased prostaglandins, which cause painful contractions of the uterus. The pain is often accompanied by other menstrual discomfort symptoms, including headache, breast tenderness, drowsiness, nausea, vomiting, constipation or diarrhea, and psychological anxiety, depression or irritability. In the case of secondary menstrual pain, there are clear pelvic pathologies, such as endometriosis, uterine fibroids, and pelvic inflammatory disease., conditionsModule conditions: Chinese Medicine, conditions: Primary Dysmenorrhea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: Nuan-gong-ye, interventions name: Placebo, outcomesModule primaryOutcomes measure: Visual Analogue Scale (VAS), secondaryOutcomes measure: Short Form McGill Pain Questionnaire (MPQ-SF), eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: China Medical University Hospital, status: RECRUITING, city: Taichung, zip: 404, country: Taiwan, contacts name: HSUAN HSUAN WU, role: CONTACT, phone: +886928030693, email: [email protected], geoPoint lat: 24.1469, lon: 120.6839, hasResults: False |
protocolSection identificationModule nctId: NCT06295809, orgStudyIdInfo id: V940-007, secondaryIdInfos id: 2023-505712-37, type: OTHER, domain: EU CT, secondaryIdInfos id: U1111-1292-3589, type: OTHER, domain: UTN, secondaryIdInfos id: V940, type: OTHER, domain: Merck, briefTitle: A Study of (Neo)Adjuvant V940 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2029-04-30, completionDateStruct date: 2029-04-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Merck Sharp & Dohme LLC, class: INDUSTRY, collaborators name: Moderna TX, descriptionModule briefSummary: This is a two-part (Phase 2/Phase 3) study of V940, an individualized neoantigen therapy (INT), plus pembrolizumab in participants with locally resectable advanced cutaneous squamous cell carcinoma (LA cSCC). Phase 2 has three arms V940 plus pembrolizumab given as neoadjuvant and adjuvant treatment with standard of care (SOC), standard of care (surgical resection with/without adjuvant radiation therapy (RT) only at investigator's discretion) and pembrolizumab monotherapy given as neoadjuvant and adjuvant treatment with SOC. This phase will assess the safety and efficacy of V940 in combination with pembrolizumab as neoadjuvant and adjuvant therapy in participants with resectable LA cSCC as compared to standard of care SOC only. The primary hypothesis is that V940 plus pembrolizumab with SOC is superior to SOC only with respect to event free survival (EFS) as assessed by the investigator. Phase 3 expansion will be determined by prespecified Go-No-Go decision in which 412 additional participants will be randomized to V940 plus pembrolizumab with SOC and SOC only, without changing the inclusion/exclusion criteria for the additional enrollment or study endpoints., conditionsModule conditions: Carcinoma, Squamous Cell, conditions: Skin Neoplasms, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In the Phase 2 of the study design, approximately 600 participants will be randomly assigned into 3 arms in an approximate 5:5:2 ratio (250 to V940 plus pembrolizumab with SOC, 250 participants to SOC only, and 100 participants to pembrolizumab monotherapy with SOC). If the decision is made to expand the study to Phase 3, the 600 participants enrolled in Phase 2 will keep their originally assigned study intervention arms in the Phase 3 Expansion, and 412 new participants will be enrolled and randomly assigned in a 1:1 ratio to receive treatment with either V940 plus pembrolizumab with SOC or SOC only. New participants will not be randomized into the pembrolizumab monotherapy with SOC arm during the Phase 3 Expansion., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1012, type: ESTIMATED, armsInterventionsModule interventions name: Pembrolizumab, interventions name: V940, interventions name: Surgery, outcomesModule primaryOutcomes measure: Event Free Survival (EFS), secondaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Freedom from surgery (FFS) rate, secondaryOutcomes measure: Pathological complete response (pCR) rate, secondaryOutcomes measure: Major pathological response (mPR) rate, secondaryOutcomes measure: Disease-free survival (DFS), secondaryOutcomes measure: Disease-specific survival (DSS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Percentage of participants who experience and adverse event (AE), secondaryOutcomes measure: Percentage of participants who discontinue study intervention due to AEs, secondaryOutcomes measure: Change from baseline in Global health status/QoL score (QLQ-C30 Items 29 and 30), secondaryOutcomes measure: Change from baseline in physical functioning score of QLQ (C30 Items 1-5), secondaryOutcomes measure: Change from baseline in Role functioning score of QLQ-C30 Items 6-7, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: One Clinical Research ( Site 3211), status: RECRUITING, city: Nedlands, state: Western Australia, zip: 6009, country: Australia, contacts name: Study Coordinator, role: CONTACT, phone: +61862799466, geoPoint lat: -31.98184, lon: 115.8073, locations facility: Hadassah Medical Center ( Site 2201), status: RECRUITING, city: Jerusalem, zip: 9112001, country: Israel, contacts name: Study Coordinator, role: CONTACT, phone: 97226777825, geoPoint lat: 31.76904, lon: 35.21633, locations facility: Rabin Medical Center ( Site 2202), status: RECRUITING, city: Petah Tikva, zip: 4941 492, country: Israel, contacts name: Study Coordinator, role: CONTACT, phone: 97235305201, geoPoint lat: 32.08707, lon: 34.88747, hasResults: False |
protocolSection identificationModule nctId: NCT06295796, orgStudyIdInfo id: 8527-008, secondaryIdInfos id: MK-8527-008, type: OTHER, domain: Merck, briefTitle: A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-17, primaryCompletionDateStruct date: 2025-04-14, completionDateStruct date: 2025-04-14, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Merck Sharp & Dohme LLC, class: INDUSTRY, descriptionModule briefSummary: The goal of this study is to evaluate the effect of moderate and severe renal impairment (RI) on the pharmacokinetics (PK), safety, and tolerability of MK-8527. There will be no hypothesis testing in the study., conditionsModule conditions: Renal Impairment, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: MK-8527, outcomesModule primaryOutcomes measure: Area under the concentration versus time curve from time 0 to last quantifiable sample (AUC0-last) of MK-8527 in plasma, primaryOutcomes measure: Area under the concentration versus time curve from time 0 to infinity (AUC0-inf) of MK-8527 in plasma, primaryOutcomes measure: Maximum concentration (Cmax) of MK-8527 in plasma, primaryOutcomes measure: Time to Maximum concentration (Tmax) of MK-8527 in plasma, primaryOutcomes measure: Apparent terminal half-life (t1/2) of MK-8527 in plasma, primaryOutcomes measure: Apparent Clearance (CL/F) of MK-8527 in plasma, primaryOutcomes measure: Apparent volume of distribution during terminal phase (Vz/F) of MK-8527 in plasma, secondaryOutcomes measure: Number of participants who experience one or more adverse events (AEs), secondaryOutcomes measure: Number of participants who discontinue study due to an AE, secondaryOutcomes measure: AUC0-last of MK-8527-triphosphate (TP) in peripheral blood mononuclear cells (PBMCs), secondaryOutcomes measure: AUC0-inf of MK-8527-TP in PBMCs, secondaryOutcomes measure: Cmax of MK-8527-TP in PBMCs, secondaryOutcomes measure: Concentration at 168 hours (C168) of MK-8527-TP in PBMCs, secondaryOutcomes measure: Concentration at 672 hours (C672) of MK-8527-TP in PBMCs, secondaryOutcomes measure: Tmax of MK-8527-TP in PBMCs, secondaryOutcomes measure: t1/2 of MK-8527-TP in PBMCs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06295783, orgStudyIdInfo id: 2023-1059, secondaryIdInfos id: NCI-2024-01955, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Prospective Evaluation of the Relation Between Different Questionnaires Measuring Radiation-induced Side-effect, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-31, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To learn more about how you would rate the intensity or severity of your symptoms during or after radiation therapy using questionnaires with different rating scales., conditionsModule conditions: Radiation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: MDASI-HN, interventions name: EORTC QLQ-C30, interventions name: EORTC HN35, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Amy Moreno, MD, role: CONTACT, phone: 713-745-4590, email: [email protected], contacts name: Amy Moreno, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06295770, orgStudyIdInfo id: 23-006712, briefTitle: Obinutuzumab in Treatment of Fibrillary Glomerulonephritis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN)., conditionsModule conditions: Fibrillary Glomerulonephritis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Obinutuzumab, outcomesModule primaryOutcomes measure: Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab, secondaryOutcomes measure: Change in proteinuria from baseline to 6 months post treatment with Obinutuzumab, secondaryOutcomes measure: Rate of complete or partial remission, secondaryOutcomes measure: Improvement in serum albumin, secondaryOutcomes measure: Stabilization of kidney function, secondaryOutcomes measure: Serious Adverse Events (SAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Angela Reinke, role: CONTACT, phone: 507-266-1047, email: [email protected], contacts name: Nicholas Geroux, role: CONTACT, phone: 507-266-0956, email: [email protected], contacts name: Ladan Zand, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False |
protocolSection identificationModule nctId: NCT06295757, orgStudyIdInfo id: 2023LS102, briefTitle: Effects of Relighting on Smoke Toxicant Deliveries and Subjective Smoking Measures, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Masonic Cancer Center, University of Minnesota, class: OTHER, collaborators name: National Institutes of Health (NIH), descriptionModule briefSummary: Characterize effects of relighting on smoke toxicant deliveries and subjective smoking measures. This will be a within-subject comparison in a single experimental group of 30 smokers who report engaging in relighting behaviors. We will assess smoking intensity for relit and non-relit (i.e., smoked continuously without relighting) cigarettes in the natural environment and will conduct in-clinic measurements of smoking topography and subjective responses for relit and non-relit cigarettes. Information on relighting patterns and smoking topography collected from each participant will be used to compare machine-measured smoke yields of key harmful constituents when their usual cigarettes are smoked with and without relighting. Hypothesis: Relit cigarettes will produce higher levels of toxicants than non-relit cigarettes., conditionsModule conditions: Tobacco Use, conditions: Cigarette Smoking, conditions: Nicotine Dependence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Cigarettes, outcomesModule primaryOutcomes measure: Average Nicotine Level, secondaryOutcomes measure: Average Puff Volume, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06295744, orgStudyIdInfo id: 2023-1724, secondaryIdInfos id: Protocol Version 2/5/2024, type: OTHER, domain: UW Madison, secondaryIdInfos id: A533300, type: OTHER, domain: UW Madison, secondaryIdInfos id: UW23114, type: REGISTRY, domain: UWCCC OnCore ID, briefTitle: Outcomes and Cosmesis With Whole Breast Irradiation and Boost, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-17, primaryCompletionDateStruct date: 2029-02, completionDateStruct date: 2032-02, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, descriptionModule briefSummary: This study is being done to evaluate cosmetic, patient-reported outcome measures (PROMs), and toxicities for women undergoing ultra-short whole breast irradiation (WBI) therapy with simultaneous integrated boost (SIB). 50 participants will be on study for up to 60 months., conditionsModule conditions: Early-stage Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Radiation Therapy, outcomesModule primaryOutcomes measure: Harvard Breast Cosmesis Scale Score, secondaryOutcomes measure: Change in BREAST-Q Score, secondaryOutcomes measure: Incidence of Acute Toxicities, secondaryOutcomes measure: Incidence of Late Toxicities, secondaryOutcomes measure: Ipsilateral Breast Tumor Recurrence-Free Survival, secondaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UW Carbone Cancer Center, status: RECRUITING, city: Madison, state: Wisconsin, zip: 53792, country: United States, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False |
protocolSection identificationModule nctId: NCT06295731, orgStudyIdInfo id: INBRX106-01-201, secondaryIdInfos id: EU CT, type: OTHER, domain: 2024-511323-34, briefTitle: INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2029-05, completionDateStruct date: 2029-05, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Inhibrx, Inc., class: INDUSTRY, descriptionModule briefSummary: This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combined proportion score (CPS) ≥20., conditionsModule conditions: Head and Neck Squamous Cell Carcinoma (HNSCC), designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Phase 2: open label; Phase 3: double-blind, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 410, type: ESTIMATED, armsInterventionsModule interventions name: INBRX-106, interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Phase 2: Objective Response Rate (ORR), primaryOutcomes measure: Phase 3: Progression-Free Survival (PFS), primaryOutcomes measure: Phase 3: Overall Survival (OS), secondaryOutcomes measure: Phase 3: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Clinical Benefit Rate (CBR), secondaryOutcomes measure: Phase 3: Time to Chemotherapy (TTCtx), secondaryOutcomes measure: Time to Confirmed Deterioration (TTCD) in Pain Presence and Interference, secondaryOutcomes measure: TTCD in physical functioning (PF), secondaryOutcomes measure: TTCD in role functioning (RF), secondaryOutcomes measure: TTCD in Global Health Status/quality of life (GHS/QoL), secondaryOutcomes measure: Incidence and severity of Adverse Events (AEs), secondaryOutcomes measure: Number of patients who experienced abnormalities in vital signs and clinical laboratory parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06295718, orgStudyIdInfo id: 2023/51, briefTitle: Tele-assessment of Functional Performance and Quality of Life in Patients With Duchenne Muscular Dystrophy: Validity and Reliability Study, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2024-03-02, completionDateStruct date: 2024-05-10, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Sahra Şirvan, class: OTHER, descriptionModule briefSummary: Thanks to tele-assessment methods, it may be possible to evaluate DMD patients without traveling to clinical centers. In recent years, the applicability of remote assessment methods in DMD patients, as in many populations, is being investigated. However, studies have generally focused on a single evaluation parameter such as physical function, a special evaluation method or a special evaluation tool. The aim of this study is to investigate whether remote assessment of functional performance and quality of life in DMD patients is valid and reliable. If a valid and reliable tele-evaluation method that includes functional performance and quality of life parameters is found to be valid and reliable, the travel burden on patients and caregivers can be eased, patients\' stress and anxiety related to travel can be reduced, caregivers can save time and energy and provide patients with the best possible treatment., conditionsModule conditions: Duchenne Muscular Dystrophy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Timed Performance Tests, primaryOutcomes measure: Brooke Upper Extremity Functional Classification (BUEFS), primaryOutcomes measure: Vignos Lower Extremity Functional Classification (VAEFS), primaryOutcomes measure: PedsQL-3.0 Neuromuscular Module by PedsQL Multidimensional Fatigue Scale, eligibilityModule sex: MALE, minimumAge: 5 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: İstanbul University - Cerrahpaşa, city: Istanbul, zip: 34758, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06295705, orgStudyIdInfo id: 5230588, briefTitle: Exploring the Effectiveness of Dance as an Intervention to Promote Social-Emotional Health in Children With Autism Spectrum Disorder (ASD), acronym: ASD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Loma Linda University, class: OTHER, descriptionModule briefSummary: This study will explore the effectiveness of dance as an intervention to promote social-emotional health within children with ASD., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Hip-Hop Dance, outcomesModule primaryOutcomes measure: Child Description of Impact on Social-Emotional Health, secondaryOutcomes measure: Parent Perspective of Impact on Social-Emotional Health, secondaryOutcomes measure: Change in Social-Emotional Behavior, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 11 Years, stdAges: CHILD, contactsLocationsModule locations facility: Loma Linda University Health, status: RECRUITING, city: Loma Linda, state: California, zip: 92350, country: United States, contacts name: Julie Kugel, OTD, role: CONTACT, phone: 909-558-4628, phoneExt: 47473, email: [email protected], geoPoint lat: 34.04835, lon: -117.26115, hasResults: False |
protocolSection identificationModule nctId: NCT06295692, orgStudyIdInfo id: 77242113PSO3005, secondaryIdInfos id: 77242113PSO3005, type: OTHER, domain: Janssen Pharmaceutical K.K., briefTitle: A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-09, primaryCompletionDateStruct date: 2025-02-19, completionDateStruct date: 2027-12-23, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Janssen Pharmaceutical K.K., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate how effective JNJ-77242113 is in participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP)., conditionsModule conditions: Generalized Pustular Psoriasis, conditions: Erythrodermic Psoriasis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: JNJ-77242113, outcomesModule primaryOutcomes measure: Percentage of Participants With Generalized Pustular Psoriasis (GPP) who Experience Treatment Success Based on Clinical Global Impression (CGI) Scale According to Japanese Dermatological Association (JDA) Total Score at Week 16, primaryOutcomes measure: Percentage of Participants With Erythrodermic Psoriasis (EP) who Experience Treatment Success Based on CGI Scale at Week 16, secondaryOutcomes measure: Percentage of Participants With GPP who Experience Treatment Success Based on CGI Scale According to JDA Total Score Over Time, secondaryOutcomes measure: Percentage of Participants With EP who Experience Treatment Success Based on CGI Scale Over Time, secondaryOutcomes measure: Change From Baseline in Total Score of JDA Severity Index for GPP, secondaryOutcomes measure: Change From Baseline in Severity Classification of JDA Severity Index for GPP, secondaryOutcomes measure: Change From Baseline in Body Surface Area (BSA) for EP, secondaryOutcomes measure: Percentage of Participants who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1), secondaryOutcomes measure: Percentage of Participants who Achieve an IGA Score of Cleared (0), secondaryOutcomes measure: Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI), secondaryOutcomes measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score, secondaryOutcomes measure: Percentage of Participants who Achieve a DLQI Score of 0 or 1, secondaryOutcomes measure: Change From Baseline in EuroQol-5 Dimension 5-Level (EQ-5D-5L), secondaryOutcomes measure: Percentage of Participants With Adverse Events (AEs) and Serious AEs, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: JR Sapporo Hospital, status: RECRUITING, city: Hokkaido, zip: 060-0033, country: Japan, geoPoint lat: 43.41104, lon: 142.88878, locations facility: Ichinomiya Municipal Hospital, status: RECRUITING, city: Ichinomiya, zip: 491-8558, country: Japan, geoPoint lat: 35.3, lon: 136.8, locations facility: Teikyo University Hospital, status: RECRUITING, city: Itabashi Ku, zip: 173 8606, country: Japan, geoPoint lat: 35.74893, lon: 139.71497, locations facility: Hospital of the University of Occupational and Environmental Health, status: RECRUITING, city: Kitakyushu-shi, zip: 807-8556, country: Japan, geoPoint lat: 33.85181, lon: 130.85034, locations facility: Kumamoto University Hospital, status: RECRUITING, city: Kumamoto, zip: 860-8556, country: Japan, geoPoint lat: 32.80589, lon: 130.69182, locations facility: Nagoya City University Hospital, status: RECRUITING, city: Nagoya, zip: 467 8602, country: Japan, geoPoint lat: 35.18147, lon: 136.90641, locations facility: Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital, status: RECRUITING, city: Osaka, zip: 550 0006, country: Japan, geoPoint lat: 34.69374, lon: 135.50218, locations facility: Tohoku University Hospital, status: RECRUITING, city: Sendai, zip: 980-8574, country: Japan, geoPoint lat: 38.26667, lon: 140.86667, locations facility: Dokkyo Medical University Hospital, status: RECRUITING, city: Shimotsuga Gun, zip: 321-0293, country: Japan, locations facility: Tokyo Medical University Hospital, status: RECRUITING, city: Shinjuku, zip: 160-0023, country: Japan, geoPoint lat: 35.2946, lon: 139.57059, locations facility: Fujita Health University Hospital, status: RECRUITING, city: Toyoake, zip: 470-1192, country: Japan, geoPoint lat: 35.038, lon: 136.99931, locations facility: Mie University Hospital, status: RECRUITING, city: Tsu, zip: 514 8507, country: Japan, geoPoint lat: 34.73333, lon: 136.51667, hasResults: False |
protocolSection identificationModule nctId: NCT06295679, orgStudyIdInfo id: 20180442, briefTitle: A Study Assessing Repatha® in Combination With Standard of Care (SOC) Compared With SOC on Major Cardiovascular Events in Chinese Participants With Atherosclerotic Cardiovascular Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-19, primaryCompletionDateStruct date: 2028-12-19, completionDateStruct date: 2028-12-19, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Amgen, class: INDUSTRY, descriptionModule briefSummary: The primary objective of the study is to evaluate real-world effectiveness of treatment with Repatha® in combination with SOC, compared with SOC alone, on the risk for cardiovascular (CV) death, myocardial infarction (MI), stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in participants with established atherosclerotic CV disease (ASCVD) treated with SOC, according to local clinical practice., conditionsModule conditions: Major Cardiovascular Event, conditions: Established Atherosclerotic Cardiovascular Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 7000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Time to CV Death, MI, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization, Whichever Occurs First, secondaryOutcomes measure: Time to CV Death, MI, or Stroke, Whichever Occurs First, secondaryOutcomes measure: Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline, secondaryOutcomes measure: Percent Change in LDL-C From Baseline, secondaryOutcomes measure: Number of Participants Who Experienced Adverse Events, secondaryOutcomes measure: Number of Participants Who Experienced Adverse Drug Reactions, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 150 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: China Japan Friendship Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100029, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University First Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100034, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Haidian Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100086, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University Third Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100191, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100730, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Chongqing Emergency Medical Center, status: RECRUITING, city: Chongqing, state: Chongqing, zip: 400014, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Chongqing General Hospital, status: RECRUITING, city: Chongqing, state: Chongqing, zip: 401121, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Dongguan Songshan Lake Central Hospital, status: RECRUITING, city: Dong Guan, state: Guangdong, zip: 523127, country: China, locations facility: The First Peoples Hospital of Foshan, status: RECRUITING, city: Foshan, state: Guangdong, zip: 528000, country: China, geoPoint lat: 23.02677, lon: 113.13148, locations facility: The First Affiliated Hospital of Shantou University Medical College, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510280, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Zhujiang Hospital of Southern Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510280, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Nanfang Hospital, Southern Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510515, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital of Jinan University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510630, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: The Third Affiliated Hospital of Sun Yat-sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510630, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: The Third Peoples Hospital of Huizhou City, status: RECRUITING, city: Huizhou, state: Guangdong, zip: 516002, country: China, geoPoint lat: 23.11147, lon: 114.41523, locations facility: Zhuhai Peoples Hospital, status: RECRUITING, city: Zhuhai, state: Guangdong, zip: 519050, country: China, geoPoint lat: 22.27694, lon: 113.56778, locations facility: The First Peoples Hospital of Yulin, status: RECRUITING, city: Yulin, state: Guangxi, zip: 537006, country: China, geoPoint lat: 22.63333, lon: 110.15, locations facility: The Second Affiliated Hospital of Guilin Medical University, status: RECRUITING, city: Yulin, state: Guangxi, zip: 541199, country: China, geoPoint lat: 22.63333, lon: 110.15, locations facility: The Affiliated Hospital of Guizhou Medical University, status: RECRUITING, city: Guiyang, state: Guizhou, zip: 550001, country: China, geoPoint lat: 26.58333, lon: 106.71667, locations facility: Cangzhou Central Hospital, status: RECRUITING, city: Cangzhou, state: Hebei, zip: 061001, country: China, geoPoint lat: 38.31667, lon: 116.86667, locations facility: Tangshan Gongren Hosipital, status: RECRUITING, city: Tangshan, state: Hebei, zip: 063000, country: China, geoPoint lat: 39.63333, lon: 118.18333, locations facility: Heilongjiang Provincial Hospital, status: RECRUITING, city: Haerbin, state: Heilongjiang, zip: 150036, country: China, geoPoint lat: 31.8696, lon: 101.742, locations facility: Huaihe Hospital of Henan University, status: RECRUITING, city: Kaifeng, state: Henan, zip: 475000, country: China, geoPoint lat: 34.7986, lon: 114.30742, locations facility: Nanyang Central Hospital, status: RECRUITING, city: Nanyang, state: Henan, zip: 473000, country: China, geoPoint lat: 32.99472, lon: 112.53278, locations facility: The Seventh Peoples Hospital of Zhengzhou, status: RECRUITING, city: Zhengzhou, state: Henan, zip: 450016, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: The First Affiliated hospital of Zhengzhou University, status: RECRUITING, city: Zhengzhou, state: Henan, zip: 450052, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: The Central Hospital of Wuhan, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430014, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Union Hospital Tongji Medical College Huazhong University of science and Technology, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430022, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Wuhan No 1 Hospital, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430022, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430030, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Wuhan Third Hospital-Tongren Hospital Of Wuhan University, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430060, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Hunan Provincial Peoples Hospital, status: RECRUITING, city: Changsha, state: Hunan, zip: 410005, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Changshu No1 Peoples Hospital, status: RECRUITING, city: Changshu, state: Jiangsu, zip: 215500, country: China, geoPoint lat: 29.44395, lon: 118.88005, locations facility: Changshu NO2 Peoples Hospital, status: RECRUITING, city: Changshu, state: Jiangsu, zip: 215523, country: China, geoPoint lat: 29.44395, lon: 118.88005, locations facility: Nantong First Peoples Hospital, status: RECRUITING, city: Nantong, state: Jiangsu, zip: 226000, country: China, geoPoint lat: 32.03028, lon: 120.87472, locations facility: The first peoples hospital of Kunshan, status: RECRUITING, city: Suzhou, state: Jiangsu, zip: 215300, country: China, geoPoint lat: 31.30408, lon: 120.59538, locations facility: Wuxi Peoples Hospital, status: RECRUITING, city: Wuxi, state: Jiangsu, zip: 214023, country: China, geoPoint lat: 31.56887, lon: 120.28857, locations facility: The Affiliated Hospital of Xuzhou Medical University, status: RECRUITING, city: Xuzhou, state: Jiangsu, zip: 221006, country: China, geoPoint lat: 34.18045, lon: 117.15707, locations facility: Jiangxi Provincial People Hospital, status: RECRUITING, city: Nanchang, state: Jiangxi, zip: 330006, country: China, geoPoint lat: 28.68396, lon: 115.85306, locations facility: The first affiliated Hospital of Nanchang University, status: RECRUITING, city: Nanchang, state: Jiangxi, zip: 330006, country: China, geoPoint lat: 28.68396, lon: 115.85306, locations facility: The First Hospital of Nanchang, status: RECRUITING, city: Nanchang, state: Jiangxi, zip: 330008, country: China, geoPoint lat: 28.68396, lon: 115.85306, locations facility: The Second Hospital of Jilin University, status: RECRUITING, city: Changchun, state: Jilin, zip: 13041, country: China, geoPoint lat: 43.88, lon: 125.32278, locations facility: Dalian Municipal Central Hospital Affiliated Of Dalian Medical University, status: RECRUITING, city: Dalian, state: Liaoning, zip: 116000, country: China, geoPoint lat: 38.91222, lon: 121.60222, locations facility: The First Affiliated Hospital of Dalian Medical University, status: RECRUITING, city: Dalian, state: Liaoning, zip: 116000, country: China, geoPoint lat: 38.91222, lon: 121.60222, locations facility: The Second Hospital of Dalian Medical University, status: RECRUITING, city: Dalian, state: Liaoning, zip: 116027, country: China, geoPoint lat: 38.91222, lon: 121.60222, locations facility: The First Affiliated Hospital of Jinzhou Medical University, status: RECRUITING, city: Jinzhou, state: Liaoning, zip: 121000, country: China, geoPoint lat: 41.10778, lon: 121.14167, locations facility: General Hospital of Northern Theater Command, status: RECRUITING, city: Shenyang, state: Liaoning, zip: 110016, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: The Forth Affiliated Hospital of China Medical University, status: RECRUITING, city: Shenyang, state: Liaoning, zip: 110032, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Tangdu Hospital,Air Force Military Medical University, status: RECRUITING, city: Xi'an, state: Shaanxi, zip: 710038, country: China, geoPoint lat: 34.25833, lon: 108.92861, locations facility: Shaanxi Provincial Peoples Hospital, status: RECRUITING, city: Xi'an, state: Shaanxi, zip: 710068, country: China, geoPoint lat: 34.25833, lon: 108.92861, locations facility: Qilu Hospital of Shandong University, status: RECRUITING, city: Jinan, state: Shandong, zip: 250012, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Jinan Central Hospital, status: RECRUITING, city: Jinan, state: Shandong, zip: 250013, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Shandong Qianfoshan Hospital, status: RECRUITING, city: Jinan, state: Shandong, zip: 250014, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Shandong Provincial Hospital, status: RECRUITING, city: Jinan, state: Shandong, zip: 250021, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Affiliated hospital of Jining Medical University, status: RECRUITING, city: Jining, state: Shandong, zip: 272009, country: China, geoPoint lat: 35.405, lon: 116.58139, locations facility: Zibo central Hospital, status: RECRUITING, city: Zibo, state: Shandong, zip: 255030, country: China, geoPoint lat: 36.79056, lon: 118.06333, locations facility: Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200092, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: The Second Hospital of Shanxi Medical University, status: RECRUITING, city: Taiyuan, state: Shanxi, zip: 030001, country: China, geoPoint lat: 37.86944, lon: 112.56028, locations facility: The First Affiliated Hospital of Xi An Jiaotong University, status: RECRUITING, city: XI An, state: Shanxi, zip: 710061, country: China, locations facility: Chengdu First Peoples Hospital, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610041, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Chengdu Third Peoples Hospital, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 61031, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Tianjin Peoples Hospital, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300120, country: China, geoPoint lat: 39.14222, lon: 117.17667, locations facility: Tianjin Chest Hospital, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300222, country: China, geoPoint lat: 39.14222, lon: 117.17667, locations facility: The First Affiliated Hospital of Xinjiang Medical University, status: RECRUITING, city: Urumqi, state: Xinjiang, zip: 830054, country: China, geoPoint lat: 43.80096, lon: 87.60046, locations facility: Yanan Hospital of Kunming City, status: RECRUITING, city: Kunming, state: Yunnan, zip: 473009, country: China, geoPoint lat: 25.03889, lon: 102.71833, locations facility: First Affiliated Hospital of Kunming Medical University, status: RECRUITING, city: Kunming, state: Yunnan, zip: 650032, country: China, geoPoint lat: 25.03889, lon: 102.71833, locations facility: Yunnan First Peoples Hospital, status: RECRUITING, city: Kunming, state: Yunnan, zip: 650032, country: China, geoPoint lat: 25.03889, lon: 102.71833, locations facility: Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310016, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: the First Peoples Hospital of Xiaoshan District Hangzhou, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 311201, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Huzhou Central Hospital, status: RECRUITING, city: Huzhou, state: Zhejiang, zip: 310005, country: China, geoPoint lat: 30.8703, lon: 120.0933, locations facility: The First Peoples Hospital of Huzhou, status: RECRUITING, city: Huzhou, state: Zhejiang, zip: 313000, country: China, geoPoint lat: 30.8703, lon: 120.0933, locations facility: Jiaxing Second Hospital, status: RECRUITING, city: Jiaxing, state: Zhejiang, zip: 314000, country: China, geoPoint lat: 30.7522, lon: 120.75, locations facility: The first affiliated hospital of Ningbo university, status: RECRUITING, city: Ningbo, state: Zhejiang, zip: 315010, country: China, geoPoint lat: 29.87819, lon: 121.54945, locations facility: Ningbo medical center lihuili hospital, status: RECRUITING, city: Ningbo, state: Zhejiang, zip: 315046, country: China, geoPoint lat: 29.87819, lon: 121.54945, locations facility: Shaoxing Second Hospital, status: RECRUITING, city: Shaoxing, state: Zhejiang, zip: 312000, country: China, geoPoint lat: 30.00237, lon: 120.57864, locations facility: Beijing Anzhen Hospital, Capital Medical University, status: RECRUITING, city: Beijing, zip: 100029, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Tongji Hospital of Tongji University, status: RECRUITING, city: Shanghai, zip: 200065, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06295666, orgStudyIdInfo id: 26.12.2018/901, briefTitle: Gingival Crevicular Fluid (GCF) Bactericidal Permeability Protein (BPI) and Interleukin (IL)-1 Beta, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-02-19, primaryCompletionDateStruct date: 2019-11-25, completionDateStruct date: 2020-01-20, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Akdeniz University, class: OTHER, descriptionModule briefSummary: Objective: The aim of this study is to determine the amounts of BPI (Bactericidal permeability protein) and interleukin-1beta (IL-1β) in gingival fluid samples obtained from individuals with periodontally healthy and periodontal disease, to compare these amounts between study groups, and to evaluate their relationship with clinical parameters. In cases where clinical parameters increase, IL-1β amounts also increase significantly. The amount of IL-1β in individuals with periodontal disease is significantly higher compared to healthy individuals. There is positive correlation between BPI and clinical parameters. The amount of BPI in individuals with periodontal disease is significantly higher than in healthy individuals. More studies are needed to better understand the importance and therapeutic effect of BPI in periodontitis, conditionsModule conditions: Periodontitis, conditions: Gingival Crevicular Fluid, conditions: Interleukin 1-beta, conditions: Bactericidal Permeability Protein, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Gingival Crevicular Fluid Bactericidal Permeability Increasing Protein levels in periodonitis, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Akdeniz Üniversitesi Diş Hekimliği Fakültesi, city: Antalya, country: Turkey, geoPoint lat: 36.90812, lon: 30.69556, hasResults: False |
protocolSection identificationModule nctId: NCT06295653, orgStudyIdInfo id: 7-23, briefTitle: Subepithelial Connective Tissue Graft Versus Amniotic Chorion Membrane for Peri-implant Mucosal Thickness Enhancement, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: The objective of this study will be to assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amnion Chorion Membrane placed simultaneously with dental implant placement., conditionsModule conditions: Dental Implant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 26, type: ESTIMATED, armsInterventionsModule interventions name: implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane, outcomesModule primaryOutcomes measure: measure changes in periimplant mucosal thickness, secondaryOutcomes measure: mid-buccal keratinized mucosal width, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculity of Dentistry Tanta University, city: Tanta, state: Elgarbia, zip: 6620012, country: Egypt, contacts name: Faten a Seddiq, Faculty Dean, role: CONTACT, phone: 3335631, phoneExt: +20, email: [email protected], contacts name: ahmed a abdelsayed, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.78847, lon: 31.00192, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-03-03, uploadDate: 2024-03-03T10:57, filename: Prot_SAP_000.pdf, size: 472866, hasResults: False |
protocolSection identificationModule nctId: NCT06295640, orgStudyIdInfo id: 300/2022, briefTitle: Relative Contribution of Brain Insulin Action for Postprandial Metabolism, acronym: BrainInsPPM, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University of Ulm, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to clarify (i) the contribution of brain insulin action on regulation of systemic metabolism, (ii) sex-specific differences in the central regulation and (iii) the influence of the menstrual cycle in women.Therefore, participants will undergo oral glucose tolerance tests combined with a double tracer dilution technique. This approach will be compared between days with insulin delivery to the brain as nasal spray and days with placebo spray., conditionsModule conditions: Glucose Metabolism Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomized, controlled, cross-over design for men. Randomized, controlled, 2x2 factorial cross-over design for women taking the menstrual cycle phase into account., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Oral glucose tolerance test with double-tracer dilution and intranasal insulin spray, interventions name: Oral glucose tolerance test with double-tracer dilution and intranasal placebo spray, outcomesModule primaryOutcomes measure: Endogenous glucose production, primaryOutcomes measure: Rate of glucose disappearance, secondaryOutcomes measure: Proglucagon cleavage products, secondaryOutcomes measure: Glucose tolerance, secondaryOutcomes measure: Whole-body insulin sensitivity, secondaryOutcomes measure: Insulin secretion, secondaryOutcomes measure: Post-absorptive energy expenditure, secondaryOutcomes measure: Sex differences, secondaryOutcomes measure: Menstrual cycle effects, secondaryOutcomes measure: Autonomic nervous system activity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Universityhospital Ulm, status: RECRUITING, city: Ulm, zip: 89081, country: Germany, contacts name: Julia Hummel, Phd, role: CONTACT, phone: +4973150044744, email: [email protected], contacts name: Rebecca Spies, MD, role: CONTACT, email: [email protected], geoPoint lat: 48.39841, lon: 9.99155, hasResults: False |
protocolSection identificationModule nctId: NCT06295627, orgStudyIdInfo id: SYSKY-2024-115-01, briefTitle: The Analysis of Factors Causing Indwelling Urinary Catheter-related Infections in ICU Patients and Their Nursing Strategies, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-30, primaryCompletionDateStruct date: 2023-09-30, completionDateStruct date: 2024-01-15, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: To explore the analysis of factors causing indwelling urinary catheter-related infections in ICU patients and their nursing strategies, and to provide reference for clinical nursing work. 291 patients with indwelling urinary catheters in the second area of ICU of our hospital from January 1, 2023 to September 30, 2023 were selected as research subjects. They were divided into infection group and non-infection group according to the presence or absence of urinary tract infection. Non-infection group The first group consisted of patients without urinary tract infection (278 cases), and the infection group consisted of patients with urinary tract infection (13 cases). A retrospective analysis method was used to analyze the causes of catheter-related urinary tract infection and the infecting bacteria of the two groups of patients. A single factor analysis was performed on various factors and other related factors, and corresponding nursing strategies were summarized and proposed., conditionsModule conditions: Catheter-associated Urinary Tract Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 291, type: ACTUAL, armsInterventionsModule interventions name: There were no interventions in retrospective analysis, outcomesModule primaryOutcomes measure: How many patients in the infected group and how many patients in the non-infected group had bladder irrigation, primaryOutcomes measure: How many patients in the infected group and how many patients in the non-infected group were given enema, primaryOutcomes measure: How many times the indwelling catheter was changed in patients in the infected group and patients in the non-infected group respectively, primaryOutcomes measure: How many patients in the infected group and the non-infected group had co-diabetes, eligibilityModule sex: ALL, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-Sen Memorial Hospital, city: Canton, state: Guangdong, zip: 510030, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06295614, orgStudyIdInfo id: SPARKL, briefTitle: Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease, acronym: SPARKL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2029-04-01, completionDateStruct date: 2029-04-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Ecole Polytechnique Fédérale de Lausanne, class: OTHER, descriptionModule briefSummary: The purpose of this clinical trial is to assess the preliminary safety and efficacy of the ARC-IM spinal cord stimulation therapy in alleviating locomotor deficits in individuals with Parkinson's disease. The ARC-IM Therapy employs epidural electrical stimulation (EES) to modulate leg muscle recruitment, with the aim of improving mobility deficits. The ultimate goal is to enhance the quality of life of people with Parkinson's disease., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single-site, single-arm, non-blinded, non-randomized, interventional, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: ARC-IM System implantation, outcomesModule primaryOutcomes measure: Occurrence of serious adverse events and adverse events that are deemed related or possibly related to the study procedures or to the investigational system., secondaryOutcomes measure: 10-meter walk test, secondaryOutcomes measure: 6-minute walk test, secondaryOutcomes measure: Timed up and Go and its cognitive version, secondaryOutcomes measure: Freezing of gait circuit, secondaryOutcomes measure: Kinematic analysis, secondaryOutcomes measure: Muscle analysis, secondaryOutcomes measure: Mini Balance Evaluation Systems Test (mini-BESTest), secondaryOutcomes measure: Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, secondaryOutcomes measure: King's Parkinson's disease Pain Scale (KPPS), secondaryOutcomes measure: The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IA & IV Part I, II & IV., secondaryOutcomes measure: Parkinson's Disease Questionnaire-39 (PDQ-39), secondaryOutcomes measure: Activities specific Balance Confidence Questionnaire (ABC-Q), secondaryOutcomes measure: The Freezing of Gait Questionnaire (FOG-Q), secondaryOutcomes measure: Home-use kinematic monitoring, secondaryOutcomes measure: Daily falls tracking, secondaryOutcomes measure: Satisfaction questionnaire, secondaryOutcomes measure: User Evaluation of Satisfaction with technology (QUEST 2.0), secondaryOutcomes measure: System Usability Scale (SUS), otherOutcomes measure: Nerve conduction studies (NCS), otherOutcomes measure: Somato-sensory evoked potential (SSEP), otherOutcomes measure: Cortical signal recording, otherOutcomes measure: Kinematic analysis in different therapeutic conditions, otherOutcomes measure: Muscle analysis in different therapeutic conditions, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier Universitaire Vaudois (CHUV), status: RECRUITING, city: Lausanne, state: Vaud, zip: 1011, country: Switzerland, contacts name: Jocelyne Dr Bloch, Prof. Dr., role: CONTACT, geoPoint lat: 46.516, lon: 6.63282, hasResults: False |
protocolSection identificationModule nctId: NCT06295601, orgStudyIdInfo id: 2024/5591, briefTitle: Telerehabilitation Based Motor Imagery and Action Observation Training in Multiple Sclerosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-02-15, completionDateStruct date: 2025-08-15, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, descriptionModule briefSummary: This study aims to investigate the effects of the treatment combination consisting of motor imagery and action observation therapy on balance, functional mobility, lower extremity muscle strength, fatigue and quality of life., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Traditional rehabilitation, interventions name: Action observation therapy and motor imagery, outcomesModule primaryOutcomes measure: Berg Balance Scale, primaryOutcomes measure: Berg Balance Scale, primaryOutcomes measure: Muscle strength and functional mobility, primaryOutcomes measure: Muscle strength and functional mobility, secondaryOutcomes measure: Fatigue Severity Scale, secondaryOutcomes measure: Fatigue Severity Scale, secondaryOutcomes measure: Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire, secondaryOutcomes measure: Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06295588, orgStudyIdInfo id: STUDY00009135, secondaryIdInfos id: T32CA102618, type: NIH, link: https://reporter.nih.gov/quickSearch/T32CA102618, briefTitle: Clinical Trial of the Seaweed Supplement Fucoidan in Survivors of Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-15, completionDateStruct date: 2025-04-15, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Rochester, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: To determine the feasibility of an 8-week fucoidan supplement intervention for patients with fatigue post-cancer treatment and assess changes in fatigue, frailty, and inflammation., conditionsModule conditions: Fatigue, conditions: Inflammation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Fucoidan extracted from F. Vesiculosus, interventions name: Fucoidan extracted from U. Pinnatifida, outcomesModule primaryOutcomes measure: percentage of participants who are randomized to the study out of all participants approached, primaryOutcomes measure: percentage of participants who start the intervention who go on to complete the 8-week or 16-week intervention, primaryOutcomes measure: percentage of participants who take at least 80% of the fucoidan pills during the study, secondaryOutcomes measure: mean change in Brief Fatigue Inventory, secondaryOutcomes measure: mean change in plasma viscosity in blood, secondaryOutcomes measure: mean change in erythrocyte sedimentation rate in blood, secondaryOutcomes measure: mean change in thyroid stimulating hormone in blood, secondaryOutcomes measure: mean change in C-reactive protein in blood, secondaryOutcomes measure: mean change in leptin in blood, secondaryOutcomes measure: mean change in D Dimer in blood, secondaryOutcomes measure: mean change in TNF alpha in blood, secondaryOutcomes measure: mean change in neopterin in blood, secondaryOutcomes measure: mean change in lactase dehydrogenase in blood, secondaryOutcomes measure: mean change in procalcitonin in blood, secondaryOutcomes measure: mean change in frailty using a modified Fried's Frailty questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Rochester Medical Center, city: Rochester, state: New York, zip: 14642, country: United States, geoPoint lat: 43.15478, lon: -77.61556, hasResults: False |
protocolSection identificationModule nctId: NCT06295575, orgStudyIdInfo id: ZZhang, briefTitle: Effect of Probiotics on Patients With Congenital Heart Disease Following Cardiopulmonary Bypass, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-06-01, primaryCompletionDateStruct date: 2022-07-01, completionDateStruct date: 2022-07-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Nanjing Children's Hospital, class: OTHER, descriptionModule briefSummary: A randomized, controlled study including infants with non-cyanosis congenital heart disease (CHD) in need of surgical correction involving cardiopulmonary bypass (CPB) was established. Infants aged 1 month to 1 years were enrolled between June 2021 and July 2022. The patients in treatment group were supplied with probiotics consisting of Bifidobacterium infantis and Lactobacillus perioperatively and patients in control group were provided with placebo. Data concerning patients' clinical outcome such as diarrhea were collected. Blood samples were collected for measurement of fatty acid binding protein 2 (FABP2), diamine oxidase (DAO), d-lactic acid (D-LA) and C-reactive protein (CRP). Stool samples were collected to investigate the changes of intestinal flora., conditionsModule conditions: Congenital Heart Disease, conditions: Intestinal Disease, conditions: Dysbiosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: probiotics containing Bifidobacterium infantis and Lactobacillus, interventions name: placebos containing lactose, outcomesModule primaryOutcomes measure: incidence of morbidity, primaryOutcomes measure: gastrointestinal functional recovery indicators, primaryOutcomes measure: biomarkers, primaryOutcomes measure: microbiome, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 1 Year, stdAges: CHILD, contactsLocationsModule locations facility: Children's Hospital of Nanjing Medical University, city: Nanjing, state: Jiangsu, zip: 210093, country: China, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False |
protocolSection identificationModule nctId: NCT06295562, orgStudyIdInfo id: CMUH112-REC3-201, briefTitle: Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: China Medical University Hospital, class: OTHER, descriptionModule briefSummary: This study will recruit 66 patients with obstructive sleep apnea, comprising 33 men and 33 women, who have been referred to the sleep center by their doctors for polysomnograms (PSG). The subjects will undergo two overnight sleep PSG sessions at the sleep center. The interval between the two examinations will be at least 7 days, during which they will receive both a placebo and medication conditions, administered 1 hour before bedtime. The study drugs will include: (1) atomoxetine 80 mg and oxybutynin 5 mg; or (2) venlafaxine 37.5 mg; or (3) atomoxetine 80 mg and trazodone 100 mg. Endotypic traits will be estimated using the Phenotyping Using Polysomnography method. The primary outcome is the change in apnea-hypopnea index, and secondary outcomes include endotypic traits and sleep parameters., conditionsModule conditions: Obstructive Sleep Apnea of Adult, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Atomoxetine 80mg combined with oxybutynin 5mg, interventions name: Venlafaxine 37.5mg, interventions name: Atomoxetine 80mg combined with trazodone 100mg, interventions name: Placebo, outcomesModule primaryOutcomes measure: Physiological parameter, secondaryOutcomes measure: Endotypic traits, otherOutcomes measure: Sleep quality, otherOutcomes measure: Waking sleepiness, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06295549, orgStudyIdInfo id: LB2304-0001, briefTitle: Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, collaborators name: Nanjing Legend Biotech Co., descriptionModule briefSummary: A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39P, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma, conditionsModule conditions: Relapsed and Refractory B-cell Non-Hodgkin Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: LUCAR-G39P cells product, outcomesModule primaryOutcomes measure: Incidence, severity and type of TEAEs, primaryOutcomes measure: Pharmacokinetics in peripheral blood, primaryOutcomes measure: Pharmacokinetics in bone marrow, primaryOutcomes measure: The recommended Phase II dose (RP2D) for this cell therapy, secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Time to Response (TTR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Immunogenicity assessment of LUCAR-G39P cells, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, status: RECRUITING, city: Nanjin, state: Jiangsu, zip: 210029, country: China, contacts name: Huayuan Zhu, PhD，MD, role: CONTACT, phone: 86 25 68306034, email: [email protected], contacts name: Yeqin Sha, MD, role: CONTACT, email: [email protected], hasResults: False |
protocolSection identificationModule nctId: NCT06295536, orgStudyIdInfo id: WS10363, briefTitle: Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Essilor International, class: INDUSTRY, descriptionModule briefSummary: The objective is to compare the refractive parameters of the photorefraction prototype device without cycloplegia with the refractive parameters of reference device, an autorefractometer with and without cycloplegia., conditionsModule conditions: Ametropia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 115, type: ESTIMATED, armsInterventionsModule interventions name: Comparator device, Closed-field autorefractometer, outcomesModule primaryOutcomes measure: Objective refractive error, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 13 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06295523, orgStudyIdInfo id: STU_2019_1759_COPD, briefTitle: Heat Waves and the Elderly With COPD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Texas Southwestern Medical Center, class: OTHER, collaborators name: American Heart Association, descriptionModule briefSummary: The purpose of this study is to investigate thermoregulatory responses in older individuals with COPD., conditionsModule conditions: COPD, conditions: Aging, conditions: Hyperthermia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Water Spray, interventions name: Control, outcomesModule primaryOutcomes measure: Core body temperature, primaryOutcomes measure: Forced expiratory volume (FEV1), primaryOutcomes measure: Forced vital capacity (FVC), primaryOutcomes measure: FEV1/FVC ratio, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Texas Health Presbyterian Hospital Dallas, status: RECRUITING, city: Dallas, state: Texas, zip: 75231, country: United States, contacts name: Whitley Atkins, PhD, role: CONTACT, contacts name: Courtney Kirby, BS RN, role: CONTACT, phone: 214-345-6502, contacts name: Craig Crandall, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False |
protocolSection identificationModule nctId: NCT06295510, orgStudyIdInfo id: CDUTCM20240223, briefTitle: Observational Study of the Association Between Food Intake and Endometrial Polyps, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: qinxiu zhang, class: OTHER, descriptionModule briefSummary: There are currently no studies evaluating the association between diet and the incidence of endometrial polyps. We aim to evaluate the association to provide more recommendations for the early prevention of endometrial polyps., conditionsModule conditions: Diet Habit, conditions: Endometrial Polyp, conditions: Women, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: No interventions., outcomesModule primaryOutcomes measure: Hormonal dietary intake, primaryOutcomes measure: Comparison of daily living habits, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06295497, orgStudyIdInfo id: LC-SHIELD, briefTitle: Lung Cancer Screening by Artificial Intelligence Device, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: Lung cancer screening is currently not recommended in non-smokers due to paucity of evidence. Emerging evidence suggests that first-degree family history is a strong risk factor for lung cancer in Asian non-smokers. In Asia, lack of resource is a major challenge in successful implementation of lung cancer screening. Artificial intelligence (AI) is a promising tool to overcome this resource. In this study, we aim to study the clinical utility and demonstrate the feasibility of using an AI assisted programme for lung cancer screening in Asian non-smokers with a positive family history. This is a single-arm non-randomized lung cancer screening study. 1000 non-smokers, age 50 to 75 year old, with a first-degree family history of lung cancer, will be enrolled. Participants will undergo low does computed tomography (LDCT) of thorax and blood taking at enrolment. LDCT films will be interpreted by AI softwares for presence of lung nodules. Participants with lung nodules will be further investigated and followed up according to the risk of malignancy. The primary endpoint is the prevalence of early-staged lung cancer detected by first-round LDCT thorax in this population., conditionsModule conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Lung-SIGHT, outcomesModule primaryOutcomes measure: The prevalence of early-staged lung cancer detected by first-round LDCT thorax (T0) in a high-risk non-smoker population, secondaryOutcomes measure: Sensitivity of AI-assisted programme in lung nodule detection and monitoring compared to radiologist assessment, secondaryOutcomes measure: Rate of invasive workup and incidence of associated complications., secondaryOutcomes measure: Prevalence of lung cancer detected by second-round LDCT (T1) in patients with negative first-round LDCT, secondaryOutcomes measure: Diagnostic accuracy and discrimination ability of plasma-based fragmentomic assay in detection of lung cancer via assessment of sensitivity, specificity, positive predictive value and negative predictive value, secondaryOutcomes measure: To determine the quality adjusted life years (QALYs) gained through screening, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Clinical Oncology, Prince of Wales Hospital, city: Hong Kong, country: Hong Kong, contacts name: Molly SC LI, MBBS, MRCP, role: CONTACT, phone: 3505 2166, email: [email protected], geoPoint lat: 22.27832, lon: 114.17469, hasResults: False |
protocolSection identificationModule nctId: NCT06295484, orgStudyIdInfo id: 5136, briefTitle: Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-08-21, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Sunnybrook Health Sciences Centre, class: OTHER, descriptionModule briefSummary: Background:In premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to collapse. This support commonly done by CPAP and Non-Invasive Positive Pressure Ventilation (NIPPV) therapy by giving some pressure and oxygen to their lungs through an interface placed on their noses. Both (CPAP and NIPPV) can be used as a support modality for respiratory distress syndrome, apnea of prematurity, and providing breathing support after extubation from the full mechanical breathing support.The CPAP supports the baby's immature lungs by delivering constant pressure to keep their lungs and breathing well supported. Whereas the NIPPV will use constant pressure in the background (similar to CPAP), and on top, it will give extra intermittent puffs at regular intervals to support the baby's breathing. The NIPPV is the most common choice by the clinicians when the traditional CPAP is no longer effective, to avoid the full mechanical breathing support and to protect the developing lungs.Studies suggested that NIPPV is better than the traditional CPAP in reducing the need of the baby to need full mechanical breathing support. This might be because the investigators tend to use lower pressures with CPAP (5-8 cmH2O) compared to relatively higher pressures with NIPPV. More recently, clinicians showed the safety of using equivalent higher CPAP pressures (\>9 cmH2O) to what the investigators use in the NIPPV in preterm babies.One way to measure the support that the investigators are giving to the patient with the different devices is to measure the diaphragm activity, which the investigators call the Edi signal, using a special feeding catheter and a specific machine to measure it. The catheter is placed and used as a routine feeding tube but has sensors at the end to measure this Edi signal. One opening of the tube will be connected to a computer to record the Edi signals. The other opening of the tube will be used for feeding., conditionsModule conditions: Preterm Birth, conditions: Premature Lungs, conditions: Respiratory Distress Syndrome in Premature Infant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The baby will be assigned to first go on traditional CPAP, NIPPV, or high CPAP, stay for 2 hours, switch to one of the other methods for 2 hours and then spend 2 hours supported by the remaining method. We will continue to record the Edi signals during the 3 methods.Study duration will be 6 hours from the time of catheter insertion to fit into feeding and handling plans. Upon completion or termination of the study protocol, your baby will be put back to the originally prescribed breathing support.Routine monitoring for oxygen saturation, heart rate, and respiratory rate will be continued as per the standard of practice in the NICU., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Alternating traditional CPAP, NIPPV, and high CPAP, outcomesModule primaryOutcomes measure: The differences in Electrical Activity of the Diaphragm measured in MicroVoltage (Edi minimum) between: 1. Traditional CPAP versus NIPPV. 2. NIPPV versus CPAP (equivalent pressures in cmH2O)., secondaryOutcomes measure: 1. Neural respiratory rate per minute, secondaryOutcomes measure: 2. Edi peak measured in MicroVoltage, secondaryOutcomes measure: 3. The difference in transcutaneous pCO2 in mmHg, secondaryOutcomes measure: 4. The difference in oxygen requirements in percent (i.e, 21%), eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 8 Months, stdAges: CHILD, contactsLocationsModule locations facility: Sunnybrook Health Sciences Center, status: RECRUITING, city: Toronto, state: Ontario, zip: M4N 3M5, country: Canada, contacts name: Maher Shahroor, MD, role: CONTACT, phone: (416) 480-6100, phoneExt: 687939, email: [email protected], geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06295471, orgStudyIdInfo id: 2024P000112, briefTitle: A Comparative Clinical Study to Assess Pain Score and Wound Healing Following Fractional Ablation With a DFG Laser and CO2 Laser, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, descriptionModule briefSummary: This research study aims assess whether the Difference Frequency Generation (DFG) laser could be a better alternative to the CO2 laser in terms of reduced side effects and patient downtime., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 23, type: ESTIMATED, armsInterventionsModule interventions name: DFG Laser, interventions name: CO2 Laser, interventions name: Optical coherence tomography (OCT), outcomesModule primaryOutcomes measure: Visual Analog Scale (VAS) pain score, primaryOutcomes measure: Wound healing time, secondaryOutcomes measure: Vessel density via OCT imaging, secondaryOutcomes measure: Vessel length via OCT imaging, secondaryOutcomes measure: Vessel thickness via OCT imaging, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MGH Clinical Unit for Research Trials & Outcomes in Skin, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Alicia Van Cott, MSN, role: CONTACT, phone: 617-726-4454, email: [email protected], contacts name: Abigail Carlson, BS, role: CONTACT, phone: 617-726-4454, email: [email protected], geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06295458, orgStudyIdInfo id: STUDY00006945, briefTitle: Gamma Sensory Flicker for Parkinson's Disease Patients With Freezing of Gait, acronym: Flicker w FOG, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Emory University, class: OTHER, collaborators name: Parkinson's Foundation, descriptionModule briefSummary: The purpose of the study is to examine the safety of special eyewear and earphones that emit a visual and auditory stimulus in the gamma range (gamma flicker) in patients with Parkinson's disease for 1 hour per day and to assess the effects this stimulus has on reducing a walking problem referred to as freezing of gait (FOG) as well as on a specific spinal fluid chemical marker, amyloid.Based on previous animal studies this gamma stimulus has the potential as a novel, non-invasive, non-pharmacological approach, to remove amyloid from the brain. The investigators have found in a prior study, that amyloid levels are high in the spinal fluid of Parkinson's patients with FOG.Parkinson's disease (PD) patients often experience a complex gait disorder known as Freezing of Gait (FOG). FOG is characterized by brief arrests of stepping when initiating gait, turning, and walking straight and patients describe it as their feet being "glued" to the floor. FOG in Parkinson's disease (PD) is a considerable public health burden worldwide. It is a poorly understood gait symptom that has potentially grave consequences as FOG is intermittent and unpredictable in nature, a leading cause of falls with injury, and results in loss of independence.FOG is generally found to be associated with cognitive decline, particularly executive dysfunction which, in turn, has been associated with higher spinal fluid amyloid (Aβ42) levels in PD., conditionsModule conditions: Gait Disorders, Neurologic, conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: GammaSense Stimulation System, interventions name: Control Group, outcomesModule primaryOutcomes measure: Number of participants with Adverse events, primaryOutcomes measure: Number of participants compliant with the study procedures, secondaryOutcomes measure: Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scale in participants with PD, secondaryOutcomes measure: Change in the freezing of gait severity in participants with PD., secondaryOutcomes measure: Change in subjective changes in FOG., otherOutcomes measure: Change in the effects of driving gamma on cerebrospinal fluid (CSF) amyloid levels in patients with PD-FOG, otherOutcomes measure: Change in the effects of driving gamma on cerebrospinal fluid (CSF) inflammatory markers levels in patients with PD-FOG, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emory Movement Disorders Center, city: Atlanta, state: Georgia, zip: 30329, country: United States, geoPoint lat: 33.749, lon: -84.38798, hasResults: False |
protocolSection identificationModule nctId: NCT06295445, orgStudyIdInfo id: Cardiopulmonary Ultrasound, briefTitle: Impact of Integrated Cardiopulmonary Ultrasound on Clinical Outcome of Shocked Patients in Intensive Care Unit, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2023-09-01, completionDateStruct date: 2023-09-15, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Egymedicalpedia, class: INDUSTRY, descriptionModule briefSummary: Shock is one of the most common conditions in the intensive care unit (ICU) affecting one-third of critically ill patients. It reduces oxygen and nutrition's perfusion to the solid organs and is closely associated with increased mortality. Most literature has described how hemodynamic monitoring could provide an effective way to identify underlying pathophysiological processes and guide appropriate therapy in shock patients., conditionsModule conditions: Shock, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 108, type: ACTUAL, armsInterventionsModule interventions name: care cardio-pulmonary ultrasound, interventions name: treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management, outcomesModule primaryOutcomes measure: Mortality rate, primaryOutcomes measure: Number of mortalities, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Al-Azhar University hospitals, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06295432, orgStudyIdInfo id: DZ2022E0001, briefTitle: A Phase II Clinical Trial of DZD9008 in Combination With AZD4205 in Standard Treatment Failed NSCLC Patients With EGFR Mutations (WU-KONG21), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Dizal Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: DZD9008 in combination with AZD4205 for the treatment of patients with advanced NSCLC with EGFR mutations who have progressed after standard treatment. The purpose of this study is to assess the safety and efficacy of this combination therapy., conditionsModule conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: DZD9008+AZD4205, outcomesModule primaryOutcomes measure: Part A: incidence of DLT, ≥grade 3 TEAEs and SAEs; Part B: incidence of ≥grade 3 TEAEs as assessed by CTCAE, incidence of SAEs., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guangdong Provincial People'S Hospital, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Zhen Wang, role: CONTACT, phone: 020-83827812, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06295419, orgStudyIdInfo id: Igdir182, briefTitle: The Effect of Dual Task on Manual Ability Performance in Children With Cerebral Palsy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Igdir University, class: OTHER, descriptionModule briefSummary: The aim of the study is to investigate the effect of dual task conditions on manual dexterity performance in young people and children with CP between the ages of 7-18 and to compare it with their peers.Evaluations to be made in the study (children with CP) and control (typically developing peers) groups:* Demographic information, Gross Motor Function Level (GMFCS), Manual Skills Classification System (MACS) and dominant extremity will be noted and the evaluation will begin by applying the Abilhand Kids questionnaire.* Firstly, the child's performance on a single cognitive task will be evaluated in a supported sitting position on a chair. The cognitive task will be the n-back task (counting down task) to be applied in accordance with the level of the child or young person.* Using the Visual Analogue Scale (VAS), participants will be asked to score the difficulty of the cognitive task as a number between 0 and 10.* In order to evaluate the single motor performance of manual skills, the 9-Hole Test will be applied and the times will be recorded by asking to write a given paragraph.* Dual task evaluations will be administered by giving a simultaneous cognitive task while administering the 9-Hole Test and writing a paragraph.* In order to reveal the dual-task cost (DTC), dual-task performance will be subtracted from single-task performance and the difference will be calculated in seconds.* The Body Control Measurement Scale will be applied for body evaluation purposes.As a result of this study, the changes in manual dexterity and cognitive performance in dual-task conditions in children and adolescents with CP will be revealed. Additionally, changes in this performance in dual-task situations will be compared with a control group of typically developing children., conditionsModule conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: dual task, interventions name: single task, outcomesModule primaryOutcomes measure: Abilhand Kids, primaryOutcomes measure: cognitive task (single task), primaryOutcomes measure: motor performance of manual skills (writing a paragraph) (single task), primaryOutcomes measure: motor performance of manual skills (single task), primaryOutcomes measure: motor performance of manual skills (dual task), primaryOutcomes measure: motor performance of manual skills (writing a paragraph) (dual task), primaryOutcomes measure: The Body Control Measurement Scale, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06295406, orgStudyIdInfo id: 21C310, briefTitle: Reading Ability in Childhood Obesity, acronym: Lettura_evOB, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: There is some evidence about the negative impact of overweight and obesity on reading ability, with negative consequences on quality of life and school success.In this neuropsychological research, the relationship between the characteristics of reading abilities in individuals with obesity (age range between 11 and 16 years) and the skills of motor coordination, postural stability, manual dexterity, including graphomotor skills, and estimation of time is investigated according to the cerebellar deficit theory., conditionsModule conditions: Obesity, Childhood, conditions: Obesity, Adolescent, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Neuropsychological assessment, outcomesModule primaryOutcomes measure: Raw score at the neuropsychological assessment, eligibilityModule sex: ALL, minimumAge: 11 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe, status: RECRUITING, city: Piancavallo, state: VCO, zip: 28824, country: Italy, contacts name: Federica Scarpina, PhD, role: CONTACT, phone: +39032351, phoneExt: 4003, email: [email protected], hasResults: False |
protocolSection identificationModule nctId: NCT06295393, orgStudyIdInfo id: 20-0229-CCMC, briefTitle: Renin Angiotensin Aldosterone System In Septic Kids, acronym: RISK, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-24, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Northwell Health, class: OTHER, descriptionModule briefSummary: Prospective observational cohort study; pediatric sepsis vs. healthy pediatric subjects and pediatric sepsis with acute kidney injury (AKI) vs without AKI.Blood samples and renal ultrasound will be collected on sequential days for septic subject and one time for the healthy patients.Enzyme-linked immunosorbent assays (ELISA) with be run on serum plasma to compare the renin-angiotensin-aldosterone system (RAAS) between groups., conditionsModule conditions: Sepsis, conditions: Acute Kidney Injury Due to Sepsis, conditions: Acute Kidney Injury (Nontraumatic), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Difference in serum renin in sepsis, secondaryOutcomes measure: Aberrations in the renin angiotensin aldosterone system (RAAS) in sepsis associated acute kidney injury, secondaryOutcomes measure: Septic induced kidney injury will be associated with alterations in renal blood flow, secondaryOutcomes measure: Aberrations in the renin angiotensin aldosterone system (RAAS) in sepsis versus healthy patients, secondaryOutcomes measure: Changes in the components of the RAAS over the first three days in sepsis, secondaryOutcomes measure: Changes in renal blood flow on Ultrasound in Sepsis, secondaryOutcomes measure: Renal blood flow and RAAS in sepsis, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Cohen Children's Medical Center, status: RECRUITING, city: New Hyde Park, state: New York, zip: 11004, country: United States, contacts name: Grace Fisler, MD, role: CONTACT, email: [email protected], contacts name: Shannon A Moriarty, role: CONTACT, phone: 631-834-0984, email: [email protected], geoPoint lat: 40.7351, lon: -73.68791, hasResults: False |
protocolSection identificationModule nctId: NCT06295380, orgStudyIdInfo id: CarenAmp, briefTitle: Virtual Reality Rehabilitation to Promote Motor Recovery in Amputees, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: IRCCS Centro Neurolesi "Bonino-Pulejo", class: OTHER, descriptionModule briefSummary: Interventional, non-pharmacological crossover study aimed at identify statistically significant differences in postural stability and spatio-temporal gait cycle parameters in patients with lower limb amputation by means of taskoriented rehabilitation training and multisensory feedback generated by an immersive RV environment, aiming at the enhancement of use-dependent brain plasticity. These changes will be compared between the two groups examined, respectively experimental (Caren virtual training phase plus conventional physiotherapy phase) and control (conventional physiotherapy phase plus Caren virtual training phase)., conditionsModule conditions: Lower Limb Amputation Knee, conditions: Injuries, conditions: Biomechanical Lesion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Virtual environment practiced on the Caren, interventions name: Conventional physiotherapy, outcomesModule primaryOutcomes measure: Kinematic data, primaryOutcomes measure: Kinetic data, primaryOutcomes measure: Electromyography, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Centro Neurolesi, city: Messina, state: Sicily, zip: 98124, country: Italy, contacts name: Rocco Salvatore Calabrò, MD, role: CONTACT, phone: 09060128179, phoneExt: +39, email: [email protected], geoPoint lat: 38.19394, lon: 15.55256, hasResults: False |
protocolSection identificationModule nctId: NCT06295367, orgStudyIdInfo id: EAQ222CD, secondaryIdInfos id: NCI-2023-09944, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: EAQ222CD, type: OTHER, domain: ECOG-ACRIN Cancer Research Group, secondaryIdInfos id: ECOG-ACRIN-EAQ222CD, type: OTHER, domain: DCP, secondaryIdInfos id: EAQ222CD, type: OTHER, domain: CTEP, secondaryIdInfos id: R01CA272680, type: NIH, link: https://reporter.nih.gov/quickSearch/R01CA272680, secondaryIdInfos id: UG1CA189828, type: NIH, link: https://reporter.nih.gov/quickSearch/UG1CA189828, briefTitle: Cost Communication and Financial Navigation in Cancer Patients (COSTCOM), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2029-02-01, completionDateStruct date: 2029-08-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: ECOG-ACRIN Cancer Research Group, class: NETWORK, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This clinical trial evaluates the effect of Cost Communication and Financial Navigation (CostCOM) intervention on adherence to care and financial burden in cancer patients. Many cancer patients experience financial hardship due to high medical out of pocket costs (OOPC), changes in employment, income and insurance. Financial hardship can lead to a delay or a stop in cancer care, and is linked to poor quality of life. Financial navigation programs, such as CostCOM, provide financial counseling, education and connections to appropriate resources to reduce financial barriers to healthcare and minimize financial stress and burden. CostCOM may improve adherence to care and decrease financial burden in patients with cancer., conditionsModule conditions: Malignant Solid Neoplasm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 760, type: ESTIMATED, armsInterventionsModule interventions name: Best Practice, interventions name: Financial Navigation, interventions name: Interview, interventions name: Survey Administration, outcomesModule primaryOutcomes measure: Cost-related cancer care non-adherence, secondaryOutcomes measure: Rate of Material Financial Hardship, secondaryOutcomes measure: Patient-reported financial worry, secondaryOutcomes measure: Patient-reported Quality of life - mental and physical health, secondaryOutcomes measure: Patient-reported satisfaction with care at 12 months, otherOutcomes measure: Out of pocket cost (OOPC) accuracy, otherOutcomes measure: Proportion of study patient participants that are of minority racial/ethnic background, and with public insurance will be measured and compared with that of practice patient population., otherOutcomes measure: Patient reported satisfaction with intervention, otherOutcomes measure: Receipt of financial navigation via internal practice or external resources, otherOutcomes measure: Evaluate longitudinal changes in Cost-related cancer care non-adherence, material hardship, financial worry, quality of life and satisfaction with care, otherOutcomes measure: longitudinal changes in cost-related cancer care non-adherence, otherOutcomes measure: longitudinal changes in cost-related cancer care material hardship, otherOutcomes measure: longitudinal changes in cost-related cancer care financial worry, otherOutcomes measure: longitudinal changes in cost-related cancer care quality of life, otherOutcomes measure: longitudinal changes in cost-related cancer care satisfaction with care, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mercy Hospital Fort Smith, status: RECRUITING, city: Fort Smith, state: Arkansas, zip: 72903, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 800-378-9373, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.38592, lon: -94.39855, locations facility: CARTI Cancer Center, status: RECRUITING, city: Little Rock, state: Arkansas, zip: 72205, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 501-906-4199, email: [email protected], contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.74648, lon: -92.28959, locations facility: Saint Anthony's Health, status: RECRUITING, city: Alton, state: Illinois, zip: 62002, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 618-463-5623, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.8906, lon: -90.18428, locations facility: Saint Mary's Hospital, status: RECRUITING, city: Centralia, state: Illinois, zip: 62801, country: United States, contacts name: Site Public Contact, role: CONTACT, email: [email protected], contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.52505, lon: -89.1334, locations facility: Good Samaritan Regional Health Center, status: RECRUITING, city: Mount Vernon, state: Illinois, zip: 62864, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 618-242-4600, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.31727, lon: -88.90312, locations facility: Central Care Cancer Center - Garden City, status: RECRUITING, city: Garden City, state: Kansas, zip: 67846, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 913-948-5588, email: [email protected], contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.97169, lon: -100.87266, locations facility: Central Care Cancer Center - Great Bend, status: RECRUITING, city: Great Bend, state: Kansas, zip: 67530, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 913-948-5588, email: [email protected], contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.36446, lon: -98.76481, locations facility: Saint Louis Cancer and Breast Institute-Ballwin, status: RECRUITING, city: Ballwin, state: Missouri, zip: 63011, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 314-251-7058, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.59505, lon: -90.54623, locations facility: Central Care Cancer Center - Bolivar, status: RECRUITING, city: Bolivar, state: Missouri, zip: 65613, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 913-948-5588, email: [email protected], contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.61448, lon: -93.41047, locations facility: Cox Cancer Center Branson, status: RECRUITING, city: Branson, state: Missouri, zip: 65616, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 417-269-4520, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.64367, lon: -93.21851, locations facility: Freeman Health System, status: RECRUITING, city: Joplin, state: Missouri, zip: 64804, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 417-347-4030, email: [email protected], contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.08423, lon: -94.51328, locations facility: Mercy Hospital Joplin, status: RECRUITING, city: Joplin, state: Missouri, zip: 64804, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 417-556-3074, email: [email protected], contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.08423, lon: -94.51328, locations facility: Lake Regional Hospital, status: RECRUITING, city: Osage Beach, state: Missouri, zip: 65065, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 573-302-2768, email: [email protected], contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.12956, lon: -92.65277, locations facility: Delbert Day Cancer Institute at PCRMC, status: RECRUITING, city: Rolla, state: Missouri, zip: 65401, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 573-458-7504, email: [email protected], contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.95143, lon: -91.77127, locations facility: Mercy Clinic-Rolla-Cancer and Hematology, status: RECRUITING, city: Rolla, state: Missouri, zip: 65401, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 573-458-6379, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.95143, lon: -91.77127, locations facility: Heartland Regional Medical Center, status: RECRUITING, city: Saint Joseph, state: Missouri, zip: 64506, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 816-271-7937, email: [email protected], contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.76861, lon: -94.84663, locations facility: Saint Louis Cancer and Breast Institute-South City, status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63109, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 314-353-1870, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Mercy Hospital South, status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63128, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 314-525-6042, email: [email protected], contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Mercy Hospital Saint Louis, status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63141, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 314-251-7066, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Mercy Hospital Springfield, status: RECRUITING, city: Springfield, state: Missouri, zip: 65804, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 417-269-4520, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.21533, lon: -93.29824, locations facility: CoxHealth South Hospital, status: RECRUITING, city: Springfield, state: Missouri, zip: 65807, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 417-269-4520, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.21533, lon: -93.29824, locations facility: Mercy Hospital Washington, status: RECRUITING, city: Washington, state: Missouri, zip: 63090, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 636-390-1600, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.55811, lon: -91.01209, locations facility: Strecker Cancer Center-Belpre, status: RECRUITING, city: Belpre, state: Ohio, zip: 45714, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 800-523-3977, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.27396, lon: -81.5729, locations facility: Adena Regional Medical Center, status: RECRUITING, city: Chillicothe, state: Ohio, zip: 45601, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 877-779-7585, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.33312, lon: -82.9824, locations facility: Mount Carmel East Hospital, status: RECRUITING, city: Columbus, state: Ohio, zip: 43213, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2118, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, locations facility: The Mark H Zangmeister Center, status: RECRUITING, city: Columbus, state: Ohio, zip: 43219, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2118, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Mount Carmel Health Center West, status: RECRUITING, city: Columbus, state: Ohio, zip: 43222, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-234-5433, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Central Ohio Breast and Endocrine Surgery, status: RECRUITING, city: Gahanna, state: Ohio, zip: 43230, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2745, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.01923, lon: -82.87934, locations facility: Mount Carmel Grove City Hospital, status: RECRUITING, city: Grove City, state: Ohio, zip: 43123, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 877-779-7585, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.88145, lon: -83.09296, locations facility: Zangmeister Center Grove City, status: RECRUITING, city: Grove City, state: Ohio, zip: 43123, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2745, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.88145, lon: -83.09296, locations facility: Fairfield Medical Center, status: RECRUITING, city: Lancaster, state: Ohio, zip: 43130, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 740-687-8863, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.71368, lon: -82.59933, locations facility: Saint Rita's Medical Center, status: RECRUITING, city: Lima, state: Ohio, zip: 45801, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 419-226-9617, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.74255, lon: -84.10523, locations facility: Marietta Memorial Hospital, status: RECRUITING, city: Marietta, state: Ohio, zip: 45750, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 800-523-3977, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.41535, lon: -81.45484, locations facility: Memorial Hospital, status: RECRUITING, city: Marysville, state: Ohio, zip: 43040, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2118, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.23645, lon: -83.36714, locations facility: Knox Community Hospital, status: RECRUITING, city: Mount Vernon, state: Ohio, zip: 43050, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 740-393-9000, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.3934, lon: -82.48572, locations facility: Mount Carmel New Albany Surgical Hospital, status: RECRUITING, city: New Albany, state: Ohio, zip: 43054, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2745, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.08117, lon: -82.80879, locations facility: Licking Memorial Hospital, status: RECRUITING, city: Newark, state: Ohio, zip: 43055, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 740-348-4000, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.05812, lon: -82.40126, locations facility: Newark Radiation Oncology, status: RECRUITING, city: Newark, state: Ohio, zip: 43055, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2118, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.05812, lon: -82.40126, locations facility: Mercy Health Perrysburg Cancer Center, status: RECRUITING, city: Perrysburg, state: Ohio, zip: 43551, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2118, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.557, lon: -83.62716, locations facility: Southern Ohio Medical Center, status: RECRUITING, city: Portsmouth, state: Ohio, zip: 45662, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2118, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.73174, lon: -82.99767, locations facility: Springfield Regional Cancer Center, status: RECRUITING, city: Springfield, state: Ohio, zip: 45504, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 937-528-2900, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.92423, lon: -83.80882, locations facility: Springfield Regional Medical Center, status: RECRUITING, city: Springfield, state: Ohio, zip: 45505, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 937-528-2900, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.92423, lon: -83.80882, locations facility: Saint Vincent Mercy Medical Center, status: RECRUITING, city: Toledo, state: Ohio, zip: 43608, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2118, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.66394, lon: -83.55521, locations facility: Mercy Health - Saint Anne Hospital, status: RECRUITING, city: Toledo, state: Ohio, zip: 43623, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2118, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.66394, lon: -83.55521, locations facility: Saint Ann's Hospital, status: RECRUITING, city: Westerville, state: Ohio, zip: 43081, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-234-5433, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.12617, lon: -82.92907, locations facility: Clinton Memorial Hospital, status: RECRUITING, city: Wilmington, state: Ohio, zip: 45177, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 937-283-2273, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.44534, lon: -83.82854, locations facility: Genesis Healthcare System Cancer Care Center, status: RECRUITING, city: Zanesville, state: Ohio, zip: 43701, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 740-454-5232, email: [email protected], contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.94035, lon: -82.01319, locations facility: Mercy Hospital Oklahoma City, status: RECRUITING, city: Oklahoma City, state: Oklahoma, zip: 73120, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 405-752-3402, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.46756, lon: -97.51643, hasResults: False |
protocolSection identificationModule nctId: NCT06295354, orgStudyIdInfo id: 2024-17062, briefTitle: Early Variations in Immune Aging, acronym: EVIA-NL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Radboud University Medical Center, class: OTHER, descriptionModule briefSummary: Background:Despite an increase in lifespan over the last decades, our healthspan lags behind. In our aging population, it is pressing that we prevent age-related morbidities and associated burden on the health care system. Instead of investigating aging in already aged populations, the currently proposed study aims to elucidate the process of immune aging in relation to biological aging, demographic and lifestyle factors in young and midlife adults, and to identify early biomarkers and pathways associated with fast versus slow immune aging and aging endotypes.Study design:A single-center, observational prospective cohort study in the Netherlands. Participants from priorly established cohorts will be invited to join the EVIA-study. We will obtain demographic and basic clinical data and biological samples (blood and stool) at baseline and after three years, with a short, yearly online questionnaire in between., conditionsModule conditions: Aging, conditions: Aging Well, conditions: Immuno Aging, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, we just study 'aging', outcomesModule primaryOutcomes measure: Immunological function, primaryOutcomes measure: Immunological Aging Score, primaryOutcomes measure: Biological Aging Score, primaryOutcomes measure: Metagenomics, primaryOutcomes measure: Genetics and epigenetics, primaryOutcomes measure: Clinical events, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06295341, orgStudyIdInfo id: 01C312, briefTitle: Short Stature and Psychological Well-being, acronym: PSICOSHORT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-10, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: The first aim of the present study is to evaluate the psychological impact of the condition of short stature (family) in a sample of Italian children, comparing them with subjects of normal stature, measuring their levels of psychological well-being, psychological distress, quality of health-related life and any behavioral issues. The secondary objective is to study the psychological impact evaluated with the tests described below (see methods section) in children with GH deficiency and the effects of replacement therapy (6 months) with GH from recombinant DNA., conditionsModule conditions: Short Stature, conditions: Short; Stature, Psychosocial, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Recombinant human growth hormone (only for children with growth hormone deficiency), outcomesModule primaryOutcomes measure: Psychological well-being through the Psychological Well-Being Scales (PWB), primaryOutcomes measure: Psychological distress through the Depression Anxiety Stress Scale (DASS-21), primaryOutcomes measure: Quality of life through the Quality of Life in Short Stature Youth (QoLISSY),, primaryOutcomes measure: Skills and problems through the Strengths and Difficulties Questionnaire (SDQ), secondaryOutcomes measure: Behavioral problems through the Child Behaviour Checklist for Children (CBCL), eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: Istituto Auxologico Italiano, status: RECRUITING, city: Milano, zip: 20145, country: Italy, contacts name: Alessandro Sartorio, MD, role: CONTACT, phone: +390261911, phoneExt: 2426, email: [email protected], geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06295328, orgStudyIdInfo id: NL 72439.018.19, briefTitle: From Fungus to Virus, Investigating the Safety and Efficacy of Terbinafine in Chronic Hepatitis B Patients, acronym: HepBTer, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-04-13, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), class: OTHER, descriptionModule briefSummary: Rationale: Currently, there is no curative therapy available for patients that are chronically infected with the hepatitis B virus (HBV). Especially the presence of a viral reservoir of stable episomal, covalently closed circular DNA (cccDNA) in the nucleus of infected hepatocytes poses a great challenge for the development of curative therapies. HBV cccDNA acts as the template for production of viral proteins and HBV genomes. In a preclinical study, terbinafine (an antifungal agent) was identified as a potent and specific suppressor of HBx-mediated cccDNA transcription. HBx is an accessory viral protein of HBV which has been proven to be essential for HBV replication and enhances replication at the transcriptional level in vivo. The suppression of cccDNA transcription results in a strong reduction of the production of viral genomes (RNA and DNA) as well as viral proteins. This will allow recovery of the immune system, increase viral clearance and prevent replenishment of the cccDNA pool in the hepatocyte, all contributing to cure chronic hepatitis B (CHB).Objective: to provide proof of concept for the inhibition of HBx mediated cccDNA transcription by terbinafine, both as monotherapy and add-on therapy next to tenofovir. Secondary outcomes will be the safety and tolerability of terbinafine in this specific group.Study design: This pilot study is a stratified, single center, randomized, double-blinded, placebo-controlled, dose-ascending proof of concept clinical trial.Study population: patients chronically infected with the hepatitis B virus with a normal liver function and no signs of liver damage, who do not use any antiviral medication (group A, n=16) or are treated with tenofovir \> 6 months (group B, n=16).Intervention: Patients will be randomly allocated to daily oral treatment with terbinafine or a matched placebo, either as monotherapy (group A) or as add-on therapy to tenofovir (group B).Main study parameters/endpoints: Primary outcomes: decline in level of serum HBsAg \>0.32log10 IU/mL in both groups A and B and decline in serum HBV DNA \>0.86log10 in group A at the end of study treatment (week 10 vs baseline). Secondary outcomes: 1) Safety and tolerability of terbinafine as mono- or combination therapy; 2) level of serum HBsAg and HBV DNA at 3 months follow-up; 3) decline of HBsAg levels over time (all visits); 4) HBV RNA, large HBsAg (LHBs) HBcrAg levels, and HBeAg status at baseline and end of study 4).Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients participating in this study will undergo physical examinations and blood sample collections (13 samples and in total 467.5 mL). They will also be asked to fill in the HBQOL and EQ5D5L quality of life questionnaires and a medicine diary. In total there will be 13 visits in the hospital of which 7 will be for blood collection only. Terbinafine can induce liver damage 1 of 50,000 to 120,000 prescriptions (LiverTox), a weekly safety laboratory control is implemented in the visits to detect possible liver toxicity in an early stage and prevent liver damage., conditionsModule conditions: Chronic Hepatitis b, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Phase 1b study with two parallel treatment arms and placebo controls., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Terbinafine, interventions name: Placebo, interventions name: Tenofovir, outcomesModule primaryOutcomes measure: Change in level of serum HBsAG, primaryOutcomes measure: Change in serum HBV DNA, secondaryOutcomes measure: Safety of terbinafine, secondaryOutcomes measure: Tolerability of terbinafine, secondaryOutcomes measure: Serum levels of HBsAG, secondaryOutcomes measure: Serum levels of HBV DNA, secondaryOutcomes measure: Serum levels of HBV RNA, secondaryOutcomes measure: Serum levels of HBcrAg, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Amsterdam UMC, status: RECRUITING, city: Amsterdam, state: Noord-Holland, zip: 1105AZ, country: Netherlands, contacts name: M.W. Peters, RN, role: CONTACT, phone: +31207320393, email: [email protected], contacts name: D.J. van Doorn, MD, role: SUB_INVESTIGATOR, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False |
protocolSection identificationModule nctId: NCT06295315, orgStudyIdInfo id: 01C310, briefTitle: Evaluation of the Psychological Profile of Adult Patients With Prader-Willi Syndrome, acronym: PROPSICOPWS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-21, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: The primary aim of the present study is to investigate the psychological profile of adult patients with PWS and the fatigue experienced by family members. Specifically, the level of psychological well-being, the subjective perception of life quality, and the main characteristics present in terms of psychopathological functioning of subjects with PWS will be investigated. These variables will be investigated in order to detect their presence and the main bonds of interaction, either between them or with other socio-demographic data, in a sample of adults with PWS. At the same time, the presence of psychological distress, levels of well-being quality of life, and coping strategies in family members and caregivers of individuals with PWS will be investigated., conditionsModule conditions: Prader-Willi Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 36, type: ESTIMATED, outcomesModule primaryOutcomes measure: Psychological well-being through the Psychological General Well-Being Index (PGWBI), primaryOutcomes measure: Perception of life quality through the 36-Item Short Form Survey (SF-36), primaryOutcomes measure: Mental distress through the Symptom Checklist-90-R (SCL-90-R), secondaryOutcomes measure: Psychological distress through the Depression, Anxiety, and Stress Scale (DASS-21), secondaryOutcomes measure: Coping strategies through Coping Orientation to Problem Experienced (COPE-new Italian version)., secondaryOutcomes measure: Hyperphagia of subjects with PWS through the Hyperphagia Questionnaire (HQ), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano IRCCS, site Piancavallo, status: RECRUITING, city: Oggebbio, state: Verbania, zip: 28824, country: Italy, contacts name: Alessandro Sartorio, MD, role: CONTACT, phone: +390261911, phoneExt: 2426, email: [email protected], geoPoint lat: 45.99088, lon: 8.64663, hasResults: False |
protocolSection identificationModule nctId: NCT06295302, orgStudyIdInfo id: RFCU-IIa-202308, briefTitle: A Study to Explore the Efficacy and Safety of HWH486 in Adults With Chronic Spontaneous Urticaria, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-13, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Hubei Biological Medicine Industrial Technology Institute Co., Ltd., class: OTHER, descriptionModule briefSummary: This is a multicenter, randomized, double-bind and placebo-controlled phase IIa dose-finding study to assess the safety and efficacy of HWH486 in adults with chronic spontaneous urticaria (CSU). In addition, the pharmacokinetic characteristics will also be investigated., conditionsModule conditions: Chronic Spontaneous Urticaria, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: HWH486, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in Urticaria Activity Score (UAS) over a 7-day period (UAS7), secondaryOutcomes measure: Change in Hive Severity Score (HSS) over a 7-day period (HSS7), secondaryOutcomes measure: Change in Itch Severity Score (ISS) over a 7-day period (ISS7), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West China Hospital,Sichuan University, status: RECRUITING, city: Chengdu, state: Sichuan, country: China, contacts name: Bioethics Committee of West China Hospital, role: CONTACT, phone: +86 28 8512 3237, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False |
protocolSection identificationModule nctId: NCT06295289, orgStudyIdInfo id: ZRKY-2023-04, briefTitle: Hybrid Closed-loop Insulin Delivery System in Perioperative Diabetic Patients: an Open-label, Randomized Controlled Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-16, primaryCompletionDateStruct date: 2024-10-04, completionDateStruct date: 2024-12-04, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Huazhong University of Science and Technology, class: OTHER, descriptionModule briefSummary: Perioperative management of glucose levels remains challenging. The purpose of the study is to compare the hybrid closed-loop insulin delivery system with the standard insulin therapy ( insulin pump with CGM, insulin dose controlled by physicians) in controlling glucose levels among patients in the perioperative period., conditionsModule conditions: Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Hybrid Closed-loop Insulin Delivery System, interventions name: Insulin pump, outcomesModule primaryOutcomes measure: TIR, secondaryOutcomes measure: TAR, secondaryOutcomes measure: TBR, secondaryOutcomes measure: MBG, otherOutcomes measure: postoperative infection, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Xuefeng Yu, role: CONTACT, phone: 02783662883, email: [email protected], geoPoint lat: 30.58333, lon: 114.26667, hasResults: False |
protocolSection identificationModule nctId: NCT06295276, orgStudyIdInfo id: HSOsnabruck, briefTitle: Effect of Teletherapy-supported Training on Nursing Students, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Hochschule Osnabruck, class: OTHER, descriptionModule briefSummary: Design: This study is a pilot randomized controlled trial (RCT) with two-arm parallel groups, the gold standard for determining treatment efficacy. The flowchart (see appendix) provides an overview of the study design. Participants are randomized and stratified by age into intervention group and waiting list group.The intervention is teletherapy-supported muscular training for 20 minutes 4 times a week.The duration of the intervention is six weeks in total. At the beginning Neck Disability Index (NDI), Oswestry Disability Index (ODI), Short-Form-36 (SF36), and the Numerical rating Scale (NRS) are collected. After six weeks, the same outcome measures and the global rating scale, conditionsModule conditions: Low Back Pain, conditions: Neck Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel comparative randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Allocation concealment:The results of the allocation sequence are placed in sequentially numbered, opaque, and sealed envelopes by an independent researcher to ensure confidentiality., enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: teletherapy-guided exercise programme, interventions name: Waiting list/control intervention, outcomesModule primaryOutcomes measure: Neck Disability Index (NDI), primaryOutcomes measure: Oswestry Disability Index (ODI), primaryOutcomes measure: NRS Numeric rating scale for pain, secondaryOutcomes measure: Short-Form: SF 36-Quality of life, secondaryOutcomes measure: Global rating scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Diakonie Pflege Schule, status: RECRUITING, city: Osnabrück, state: Niedersachsen, zip: 49078, country: Germany, contacts name: Roland Simon, BScPTc, role: CONTACT, phone: 05068932755, email: [email protected], geoPoint lat: 52.27264, lon: 8.0498, hasResults: False |
protocolSection identificationModule nctId: NCT06295263, orgStudyIdInfo id: KYLL-202203-028-1, briefTitle: Application of AI Technology for the Diagnosis and Treatment of Geriatric Diseases, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2026-06-28, completionDateStruct date: 2026-06-29, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, collaborators name: Shandong University, descriptionModule briefSummary: 1) Characteristics of handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers in patients with Alzheimer's disease.(2) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), imaging, EEG, and other relevant markers in patients with Parkinson's disease.(3) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers in patients with other neurological disorders.(4) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), images, EEG and other relevant markers in elderly patients., conditionsModule conditions: Parkinson Disease, conditions: Alzheimer Disease, conditions: Nervous System Diseases, conditions: Geriatric Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 460, type: ESTIMATED, armsInterventionsModule interventions name: Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers, outcomesModule primaryOutcomes measure: Handwriting, primaryOutcomes measure: gait, primaryOutcomes measure: speech, primaryOutcomes measure: eye movements, primaryOutcomes measure: biological samples (blood, urine, stool, saliva, etc.), primaryOutcomes measure: images, primaryOutcomes measure: EEG, primaryOutcomes measure: other relevant markers, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 100 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Qilu Hospital of Shandong University, status: RECRUITING, city: Jinan, state: Shandong, zip: 250012, country: China, contacts name: Wenjing Jiang, role: CONTACT, phone: 18560082210, email: [email protected], geoPoint lat: 36.66833, lon: 116.99722, hasResults: False |
protocolSection identificationModule nctId: NCT06295250, orgStudyIdInfo id: STUDY00001114, secondaryIdInfos id: 7R01MH127577, type: NIH, link: https://reporter.nih.gov/quickSearch/7R01MH127577, briefTitle: ASHA Bangladesh--Integrated Intervention to Address Poverty and Depression, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2027-12-30, completionDateStruct date: 2027-12-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Massachusetts, Worcester, class: OTHER, collaborators name: International Centre for Diarrhoeal Disease Research, Bangladesh, collaborators name: Georgetown University, collaborators name: National Institute of Mental Health (NIMH), collaborators name: Albert Einstein College of Medicine, descriptionModule briefSummary: The goal of this randomized controlled trial is to compare the impact of an integrated intervention combining poverty alleviation and depression treatment to depression treatment alone, in low income rural Bangladeshi women with depression. The main question\[s\] it aims to answer are: 1) whether adding poverty alleviation to depression treatment in an integrated intervention improves depression outcomes at 24 months, as assessed by depressive symptoms and by the presence or absence of relapse; and 2) whether adding poverty alleviation to depression treatment improves implementation outcomes including treatment uptake and retention. Participants in both arms will participate in interviews at 6,12,18 and 24 months., conditionsModule conditions: Depression, conditions: Economic Vulnerability, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Interventionists and outcome assessors will not be informed regarding the study design and research question., whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 660, type: ESTIMATED, armsInterventionsModule interventions name: Manualized Group Based Psychotherapy, interventions name: Poverty Alleviation, outcomesModule primaryOutcomes measure: Change in Depressive symptoms at 24 Months, primaryOutcomes measure: Change in Depressive symptoms at intermediate timepoints, primaryOutcomes measure: 24 Month Relapse, secondaryOutcomes measure: Economic vulnerability, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Function, secondaryOutcomes measure: European Quality of Life Five Dimensions Five Level scale, secondaryOutcomes measure: Tension Scale, otherOutcomes measure: Implementation Outcomes--Adoption, otherOutcomes measure: Implementation Outcomes--Feasibility, otherOutcomes measure: Implementation outcomes--fidelity, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: International Centre for Diarrhoeal Disease Research, city: Dhaka, country: Bangladesh, contacts name: Fahmida Tofail, MBBS, PhD, role: CONTACT, email: [email protected], geoPoint lat: 23.7104, lon: 90.40744, hasResults: False |
protocolSection identificationModule nctId: NCT06295237, orgStudyIdInfo id: i-Sync, briefTitle: Automatic Adjustment for Asynchronies During Mechanical Ventilation, acronym: i-Sync, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-02-15, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Hospital San Carlos, Madrid, class: OTHER, collaborators name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, descriptionModule briefSummary: Asynchronies between the patient and the artificial ventilator are a frequent problem. They may cause altered sleep, ventilator-induced lung injury, prolong length of ICU stay, cause neuro-psycologic complications and increase mortality. Although reducing their incidence through ventilator setting adjustments is possible, they frequently go undetected and it also requires that attendings remain at the bedside to repeatedly modify ventilator parameters. Ventilator systems may detect and automatically adjust parameters of mechanical ventilation. This would avoid delays in detection and adjustment if the intensivist is not immediately available. The investigators intend to study an automatic detection and adjustment tool which is incorporated in the ventilator software., conditionsModule conditions: Mechanical Ventilation Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Two 2-hour periods: 1) "off mode" consisting of a control period with optimized ventilator parameters and 2) "on mode" with an active automated detection and adjustment for asynchronies. The starting first period is randomized., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Anonymized evaluation, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Intellisync+, outcomesModule primaryOutcomes measure: Duration of asyncronies, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Clinico San Carlos, status: RECRUITING, city: Madrid, zip: 28040, country: Spain, contacts name: Miguel Sanchez-Garcia, MD, role: CONTACT, phone: +34658762739, email: [email protected], contacts name: Paloma Gonzalez-Arenas, MD, role: CONTACT, phone: +34 670 57 66 45, email: [email protected], contacts name: David Janeiro Lumbreras, MD, role: SUB_INVESTIGATOR, contacts name: Fernando Suarez-Sipmann, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: José Antonio Sánchez-Giralt, MD, role: SUB_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False |
protocolSection identificationModule nctId: NCT06295224, orgStudyIdInfo id: GOKAEK-2024/02.19, briefTitle: Retrospective Evaluation of Effect of Anterior Iliac Block, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-03-10, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Kocaeli University, class: OTHER, descriptionModule briefSummary: In this study, the investigators aimed to evaluate the effect of ultrasound-guided anterior iliac block which was performed preoperatively. Anterior iliac bone harvesting is associated with severe postoperative pain. As several fascial plane blocks were defined to provide analgesia, their effects are debatable and requires high volumes of local anesthetic considering the regional anesthesia technique used for the main surgical procedure., conditionsModule conditions: Regional Anesthesia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Morphine consumption, secondaryOutcomes measure: NRS score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kocaeli Universty, status: RECRUITING, city: Kocaeli, country: Turkey, contacts name: Hadi Ufuk Yörükoğlu, role: CONTACT, email: [email protected], geoPoint lat: 39.62497, lon: 27.51145, hasResults: False |
protocolSection identificationModule nctId: NCT06295211, orgStudyIdInfo id: FEDII_HL_PR/R-Bv-Bs, briefTitle: Brentuximab Vedotin Combined With Bendamustine Supercharge, a Low-toxicity and Efficient Salvage Regimen for Primary Refractory or First-relapsed Classic Hodgkin Lymphoma: Long-term Results of a Retrospective Monocenter Study., acronym: HL_PR/R-B, statusModule overallStatus: COMPLETED, startDateStruct date: 2013-09-01, primaryCompletionDateStruct date: 2023-09-01, completionDateStruct date: 2024-02-22, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Federico II University, class: OTHER, descriptionModule briefSummary: This is a retrospective, monocenter and non-interventional study. Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023., conditionsModule conditions: Hodgkin Lymphoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: observational, outcomesModule primaryOutcomes measure: Overall survival, secondaryOutcomes measure: Progression overall survival, secondaryOutcomes measure: Response to treatment, secondaryOutcomes measure: Incidence of treatment emergent adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06295198, orgStudyIdInfo id: OPMM-Ankle Instability, briefTitle: The Effect of Different Talocrural Joint Mobilization Techniques in Lateral Ankle Sprain, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-30, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Bahçeşehir University, class: OTHER, descriptionModule briefSummary: Decreased ankle dorsiflexion range of motion (DFROM) has been identified among the factors that increase the risk of lateral ankle sprain (LAS) in basketball players. Restoring the DFROM is important in restoring reduced functional abilities and reducing the risk of re-injury. There is evidence that talocrural joint mobilization improves DFROM, but studies investigating the effectiveness of different mobilization techniques are needed. Our study aims to investigate the effects of single-session Mulligan and Maitland talocrural joint mobilization methods on dorsiflexion joint range of motion, jumping performance, and kinesiophobia in elite basketball players., conditionsModule conditions: Ankle Sprains, conditions: Ankle Injuries, conditions: Kinesiophobia, conditions: Jumping From Height, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants with lateral ankle sprains will be randomized to the Mulligan and Maithland groups, and their evaluations and treatments will be completed., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: After evaluations, the groups determined as a result of randomization via a website were placed in opaque envelopes. The participant is randomized to one of the Mulligan or Maitland groups by selecting an envelope., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Single lep drop jump test, outcomesModule primaryOutcomes measure: Single-leg drop jump test, secondaryOutcomes measure: Weight-bearing lunge test, secondaryOutcomes measure: Tampa kinesiophobia scale, secondaryOutcomes measure: Fear Avoidance Belief Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Bahcesehir University, status: RECRUITING, city: Besiktas, state: Istanbul, zip: 34353, country: Turkey, contacts name: Pelin Pişirici, PT, PhD, role: CONTACT, phone: 05055016076, email: [email protected], contacts name: Ozlem Feyzioglu, PT, PhD, role: CONTACT, phone: 05353529794, email: [email protected], hasResults: False |
protocolSection identificationModule nctId: NCT06295185, orgStudyIdInfo id: AJOUIRB-IV-2024-097, briefTitle: Digital Therapeutic Workplace Technology as a Employee Management Tool and Employee's Mental Health Care, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Ajou University School of Medicine, class: OTHER, descriptionModule briefSummary: The purpose of the study is to determine whether a digital healthcare app for employee's mental health can effectively improve the mental health of Hisbeans's employees and the managerial performance of Hisbeans, which is represented as a 'social enterprise'., conditionsModule conditions: Depression, conditions: Mental Health Issue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: application MARO, interventions name: Sham application, outcomesModule primaryOutcomes measure: Change in network on the Standard Name Generator Approach scale, primaryOutcomes measure: Change in depression symptoms severity on the Patient Health Questionnaire-9, secondaryOutcomes measure: Change in social capital on the Social Capital Scale, secondaryOutcomes measure: Change in perceived workload on the Perceived Workload Scale, secondaryOutcomes measure: Change in job self-efficacy on the Job Self-Efficacy Scale, secondaryOutcomes measure: Change in sense of meaningfulness for job on the Sense of Meaningfulness for Job Scale, secondaryOutcomes measure: Change in work orientation toward his or her job on the Work Orientation Scale, secondaryOutcomes measure: Change in sense of psychological safety on the Perception of Psychological Safety Scale of Company Employees, secondaryOutcomes measure: Change in firm performance on the Company weekly sales records, secondaryOutcomes measure: Change in amsenteeism/leaves on the absenteeism/leave scales for employees with severe mental disabilities, secondaryOutcomes measure: Change in stress regulation skill on the Emotional/Cognitive/Behavioral State Questionnaire, secondaryOutcomes measure: Change in anxiety symptoms severity on the General Anxiety Disorder-7items scale, secondaryOutcomes measure: Change in perceived stress level on the Perceived Stress Scale, secondaryOutcomes measure: Change in social functioning on Social Adaptation Self Rating Scale, secondaryOutcomes measure: Change in positive psychological capital on Korean version of Positive Psychological Capital Scale, secondaryOutcomes measure: Change in Organizational Companionship on Organizational Culture Inventory, secondaryOutcomes measure: Change in individual's social network on Lubben Social Network Scale-18, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06295172, orgStudyIdInfo id: LF15_NLF_301, briefTitle: A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Samyang Biopharmaceuticals Corporation, class: INDUSTRY, descriptionModule briefSummary: The objective of this clinical trial is to verify the safety and efficacy of Lafullen15 in the temporary improvement of nasolabial Folds, conditionsModule conditions: Nasolabial Folds, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A Randomized, Evaluator-blind, Matched pairs, Prospective, Non inferiority, Confirmatory Study, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 73, type: ESTIMATED, armsInterventionsModule interventions name: Lafullen15, interventions name: Lafullen, outcomesModule primaryOutcomes measure: Changes in WSRS at 12 months after the last application of the clinical trial medical device compared to the baseline evaluated by an independent evaluator, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06295159, orgStudyIdInfo id: MCC-22574, briefTitle: Biomarker Driven Patient Selection Neoadjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: H. Lee Moffitt Cancer Center and Research Institute, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine if neoadjuvant (treatment before surgery) immunotherapy treatment based on tumor biomarkers results in better participant outcomes. Immunotherapy is the treatment of disease by using a person's own immune system., conditionsModule conditions: Melanoma Stage III, conditions: Melanoma Stage IV, conditions: Advanced Melanoma, conditions: Melanoma, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Nivolumab, interventions name: Nivolumab + Relatlimab, interventions name: Ipilimumab, outcomesModule primaryOutcomes measure: Pathologic Major Response (pMR), secondaryOutcomes measure: Preoperative Radiologic Response Rate, secondaryOutcomes measure: Complete Pathologic Response Rate (pCR), secondaryOutcomes measure: Partial Pathologic Response Rate (pPR), secondaryOutcomes measure: Non-Response Pathologic Response Rate (pNR), secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Moffitt Cancer Center, status: RECRUITING, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: Justin Martin, role: CONTACT, phone: 813-745-7544, email: [email protected], contacts name: Ahmad Tarhini, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.94752, lon: -82.45843, hasResults: False |
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