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protocolSection identificationModule nctId: NCT06370559, orgStudyIdInfo id: 339042, briefTitle: Relationship Between Repetitive Negative Thinking and CBT Outcomes, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: South London and Maudsley NHS Foundation Trust, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about the role of repetitive negative thinking (measured by the RTQ) in adult populations from an anxiety disorders and trauma clinic.The main questions it aims to answer are:* Whether the repetitive negative thinking can be used to predict i. initial symptom severity, and ii. therapy outcome (measured by change in scores on disorder specific measures).* Whether change in RTQ mediates change in outcome Participants are sent weekly questionnaires that measure their progress. Within these questionnaires are the RTQ and other disorder-specific measures that we will be analysing.Researchers may also compare clients with different disorders to see the accuracy the RTQ can predict treatment outcomes for each disorder., conditionsModule conditions: Anxiety Disorders, conditions: Obsessive-Compulsive Disorder, conditions: Post-traumatic Stress Disorder, conditions: Social Anxiety Disorder, conditions: Specific Phobia, conditions: Panic Disorder, conditions: Body Dysmorphic Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 320, type: ACTUAL, outcomesModule primaryOutcomes measure: Change in Repetitive Ruminative Thinking Questionnaire score, primaryOutcomes measure: Change in disorder-specific measure score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre for Anxiety Disorders and Trauma, city: London, zip: SE5 8AZ, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False |
protocolSection identificationModule nctId: NCT06370546, orgStudyIdInfo id: 229/2022, briefTitle: Cardiac Response to Strength Training in Hypertensive Individuals, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-20, primaryCompletionDateStruct date: 2024-07-20, completionDateStruct date: 2024-07-20, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Universidad Católica del Maule, class: OTHER, descriptionModule briefSummary: This study aims to determine the acute and chronic effects of high and low-intensity strength training on cardiac autonomic control in hypertensive subjects, conditionsModule conditions: Physical Exercise, conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized clinical trial, single blinded., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Low intensity, interventions name: high intensity, outcomesModule primaryOutcomes measure: Heart rate variability, primaryOutcomes measure: Blood pressure systolic, primaryOutcomes measure: Blood pressure diastolic, primaryOutcomes measure: Blood pressure mean, primaryOutcomes measure: Heart Rate, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Universidad Católica del Maule, status: RECRUITING, city: Talca, state: Maule, zip: 3469001, country: Chile, contacts name: Luis Benavides Roca, PhD(c), role: CONTACT, phone: +5699926 8137, email: [email protected], contacts name: Luis Benavides Roca, PhD(c), role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -35.4264, lon: -71.65542, hasResults: False |
protocolSection identificationModule nctId: NCT06370533, orgStudyIdInfo id: HGWG-pro, briefTitle: Healthy Gestational Weight Gain Programme, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Peking University, class: OTHER, collaborators name: W.F. Maternal and Child Health Hospital, descriptionModule briefSummary: This study aims to evaluate the efficacy of a multi-component lifestyle interventions during pregnancy on promoting appropriate gestational weight gain, preventing GDM, and improving pregnancy, delivery, and neonatal outcomes among overweight or obese pregnant women. The intervention strategies are developed based on the transtheoretical model and mobile health (via WeChat Public Account in smartphone), and will be conducted online and offline. This study will recruit and follow-up 200 overweight or obese singleton pregnant women (pre-pregnancy BMI≥24 kg/m2) during the first trimester of pregnancy from Weifang maternal and Child Health Center, Shandong Province, China. The 200 overweight or obese pregnant women will be randomly allocated at a 1:1 ratio to either the intervention or control group, stratified by the categorical variables of age, BMI and parity. Participants in the control group will be provided usual prenatal care. The lifestyle intervention will last for approximately 6 months (from 10-14 weeks to 32-36 weeks of gestation). Follow-up timepoints included 10-14 weeks of gestation,24-28 weeks of gestation,32-36 weeks of gestation. The interventions are composed of health education related to gestational weight gain and healthy lifestyles, diet modification, active physical activity, regular individual in-person and telephone sessions, diet behavior monitoring, physical activity monitoring, and weight monitoring with Huawei smart watch. The hypothesis is that lifestyle interventions based on the transtheoretical model and mobile health will result in more appropriate gestational weight gain and lower risk of adverse pregnancy outcomes compared with usual care., conditionsModule conditions: Gestational Weight Gain, conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: behavioral interventions, outcomesModule primaryOutcomes measure: Total gestational weight gain, primaryOutcomes measure: Gestational weight gain before OGTT screening, secondaryOutcomes measure: Weekly rate of gestational weight gain between study clinical assessments, secondaryOutcomes measure: Proportion of women who exceed the Chinese reference/2009 IOM guidelines for total gestational weight gain, secondaryOutcomes measure: Proportion of women who exceed the Chinese reference/2009 IOM guidelines for appropriate weekly rate of GWG in second and third trimester, secondaryOutcomes measure: Proportion of women who exceed the Chinese reference/2009 IOM guidelines for appropriate weekly rate of GWG before OGTT screening, secondaryOutcomes measure: Rate of Gestational Diabetes Mellitus diagnosed according to International Association of Diabetes and Pregnancy Study Group (IADPSG) criteria, secondaryOutcomes measure: Rate of Preeclampsia/Gestational hypertension, secondaryOutcomes measure: Rate of Cesarean Section, secondaryOutcomes measure: Absolute/Mean Infant birth weight, secondaryOutcomes measure: Rate of Macrosomia, secondaryOutcomes measure: Absolute/Mean Apgar scores at 1 min or 5 min, otherOutcomes measure: Change of Blood pressure, otherOutcomes measure: Change of body fat percentage (%), otherOutcomes measure: Change of fat free mass (kg), otherOutcomes measure: Change of muscle mass (kg), otherOutcomes measure: Change of handgrip strength (kg), otherOutcomes measure: Change of Attitude and knowledge, otherOutcomes measure: Change of dietary intake, otherOutcomes measure: Change of physical activity, otherOutcomes measure: Change of sleep quality, otherOutcomes measure: Change of Quality of life (12-Item Short Form Survey, SF-12), otherOutcomes measure: Incidence of depression, otherOutcomes measure: Incidence of anxiety, otherOutcomes measure: The Change of Self-efficacy score (General Self-Efficacy Scale, GSES), otherOutcomes measure: The stage of change related to gestational weight control behavior, otherOutcomes measure: Rate of Postpartum weight retention, otherOutcomes measure: Absolute/mean offspring weight in kilograms, otherOutcomes measure: Absolute/mean offspring height in centimetres, otherOutcomes measure: Absolute/mean offspring head circumference, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06370520, orgStudyIdInfo id: 123, briefTitle: Screening Emotions in Adolescents at the Hospital for mTBI, acronym: SEARCH-mTBI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-09, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of California, Davis, class: OTHER, collaborators name: Pediatric Emergency Care Applied Research Network, descriptionModule briefSummary: The goal of this observational study is to develop and validate a clinical tool to predict which adolescents aged 11 to less than 18 years of age with mild traumatic brain injury (mTBI) are at an increased risk for developing significant new or worsening mental health conditions.The main aims the study wish to answer are:* Does the adolescent have new or worsening depression or anxiety defined as a change from their previous medical history using self-reported questionnaires at either one or three months post-injury?* Does the adolescent have unmet mental health care needs, defined as not receiving any mental or behavior health care in patients with new or worsening anxiety or depression as defined by the self reported questionnaires?Participants will be enrolled after being diagnosed in the emergency department (ED) with an mTBI. During the ED visit, the child's parent/caregiver and the adolescent will complete several questionnaires related to mental health which include tools to measure anxiety and depression. Participants will be asked to complete these questionnaires again at 1 month and 3 months post enrollment., conditionsModule conditions: Brain Injury Traumatic Mild, conditions: Brain Injuries, conditions: Brain Injuries, Acute, conditions: Head Injury With Intracranial Hemorrhage, conditions: Head Injury Trauma, conditions: Brain Injury Traumatic Focal With Loss of Consciousness, conditions: Skull Fractures, conditions: Diffuse Axonal Injury, conditions: Intracranial Hemorrhages, conditions: Head Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2592, type: ESTIMATED, armsInterventionsModule interventions name: Validated Questionnaires, interventions name: Questionnaires, interventions name: Clinician / Medical Record Variables, outcomesModule primaryOutcomes measure: New or worsening depression or anxiety, primaryOutcomes measure: Unmet mental health care needs in patients with new or worsening depression or anxiety, secondaryOutcomes measure: Decline in quality of life, secondaryOutcomes measure: Persistent mTBI symptoms, secondaryOutcomes measure: New deficits in emotional/behavioral functioning or hyperactivity/inattention, secondaryOutcomes measure: Parent Perception of Unmet Mental Health Needs, eligibilityModule sex: ALL, minimumAge: 11 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of California, Davis Medical Center, city: Sacramento, state: California, zip: 95817, country: United States, contacts name: Maria Marois, PhD, MPH, role: CONTACT, phone: 916-734-0373, email: [email protected], contacts name: Kyle Pimenta, BAS, role: CONTACT, phone: 916-734-8847, email: [email protected], contacts name: Daniel K Nishijima, MD, MAS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.58157, lon: -121.4944, locations facility: Children's Hospital of Philadelphia, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Daniel Corwin, MD, role: CONTACT, phone: 215-327-2306, email: [email protected], contacts name: Melissa Godfrey, MPH, role: CONTACT, phone: 302-598-2134, email: [email protected], contacts name: Kristy Arbogast, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Hasbro Children's Hospital and Brown University, city: Providence, state: Rhode Island, zip: 02903, country: United States, contacts name: Mark Zonfrillo, MD, role: CONTACT, phone: 401-606-3532, email: [email protected], contacts name: Mhina Johnbaptiste, MPH, role: CONTACT, phone: 954-591-1222, email: [email protected], contacts name: Mark Zonfrillo, MD, MSCE, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.82399, lon: -71.41283, locations facility: University of Texas Southwestern Medical Center, city: Dallas, state: Texas, zip: 75390, country: United States, contacts name: Mohamed Badawy, MD, role: CONTACT, phone: 214-456-7106, email: [email protected], contacts name: Aja Bayo, MSc, role: CONTACT, phone: 214-457-1793, email: [email protected], contacts name: Mohamad Badawy, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Baylor College of Medicine, Texas Children's Hospital, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Andrea Cruz, MD, MPH, role: CONTACT, phone: 832-824-5582, email: [email protected], contacts name: Victor Gonzalez, MD, role: CONTACT, phone: 832-824-5977, email: [email protected], contacts name: Andrea Cruz, MD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: The Medical College of Wisconsin, Inc., city: Milwaukee, state: Wisconsin, zip: 53226, country: United States, contacts name: Danny G Thomas, MD, MPH, role: CONTACT, phone: 414-266-2625, email: [email protected], contacts name: Najia Ali, role: CONTACT, phone: 414-266-2767, email: [email protected], contacts name: Danny G Thomas, MD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.0389, lon: -87.90647, hasResults: False |
protocolSection identificationModule nctId: NCT06370507, orgStudyIdInfo id: UPO2#, briefTitle: Monitoring of Lung Ventilation Through Electrical Impedance Tomography During Pediatric Surgery, acronym: VentiPed, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliero Universitaria Maggiore della Carita, class: OTHER, descriptionModule briefSummary: Given the scarcity of studies aimed at assessing the effect of anesthesia and m ventilation on the distribution of lung ventilation in pediatric patients undergoing surgery, with the exclusion of thoracic surgery, the present prospective observational study would shed the light on ventilation practice in pediatric anesthesia for surgery. This study wold fill the actual gap allowing the evaluation, through electrical impedance tomography (EIT) of the distribution of lung ventilation across the different phases of anesthesia for pediatric surgery. These insights could contribute to improve clinical practice and research in the management of ventilation in pediatric patients undergoing anesthesia for surgery., conditionsModule conditions: Ventilator Lung, conditions: Surgery, conditions: Pediatric, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: Electrical impedance tomography assessment of ventilation distribution in course of sedation/general anesthesia for pediatric surgery, outcomesModule primaryOutcomes measure: Ventilation distribution, secondaryOutcomes measure: Intraoperative ventilatory respiratory mechanics, secondaryOutcomes measure: Postoperative pulmonary complications, secondaryOutcomes measure: Intraoperative oxygenation, secondaryOutcomes measure: Intraoperative hemodynamics, eligibilityModule sex: ALL, minimumAge: 0 Days, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06370494, orgStudyIdInfo id: IRB2020-0956D, briefTitle: Testing New Models of Diabetes Self-Management to Improve Population Health, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-02-01, primaryCompletionDateStruct date: 2022-03-31, completionDateStruct date: 2022-03-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Texas A&M University, class: OTHER, collaborators name: Blue Cross Blue Shield, descriptionModule briefSummary: Aim 1.1 To understand if diabetes self-management education and support (DSMES) improves diabetes-related outcomes among those with Type 2 diabetes living in Texas.Aim 1.2 To examine how rurality affects study participation, engagement in, and effectiveness of different education interventions.These aims are based on a randomized controlled trial of different evidence-based diabetes self-management interventions., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: A randomized controlled trial (RCT) was conducted to assess the outcomes associated with different technological intervention approaches. This 3-arm RCT assessed independent and combined interventions:, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 191, type: ACTUAL, armsInterventionsModule interventions name: Living Healthier with Diabetes, outcomesModule primaryOutcomes measure: A1C -Change in HbA1c between baseline, 3 months, and 6 months is the primary outcome., secondaryOutcomes measure: Diabetes Knowledge: Knowledge of diabetes will be measured by the simplified version of the Revised Diabetes Knowledge Scale (True/False version)., secondaryOutcomes measure: Diabetes Self Care, secondaryOutcomes measure: Diabetes Care Confidence, secondaryOutcomes measure: Diabetes care distress, secondaryOutcomes measure: A1C, eligibilityModule sex: ALL, minimumAge: 25 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Texas A&M Health, city: College Station, state: Texas, zip: 77843-1266, country: United States, geoPoint lat: 30.62798, lon: -96.33441, hasResults: False |
protocolSection identificationModule nctId: NCT06370481, orgStudyIdInfo id: IRB-300012349, briefTitle: HIV, Equity, and Addiction Training (HEAT) Program, acronym: HEAT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2029-06, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, descriptionModule briefSummary: This project is a pilot study to determine the feasibility and acceptability of a telemedicine intervention for substance use disorder service delivery in diverse people living with HIV in Alabama., conditionsModule conditions: Substance Use Disorders, conditions: Hiv, conditions: Opioid Use Disorder, conditions: Stimulant Use (Diagnosis), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Telemedicine, interventions name: Standard of care, outcomesModule primaryOutcomes measure: Percent of participants who have a follow-up healthcare visit, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: Tyler O'Rear, role: CONTACT, phone: 205-721-5735, email: [email protected], contacts name: Ellen F Eaton, MD, MSPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False |
protocolSection identificationModule nctId: NCT06370468, orgStudyIdInfo id: 2024-CR-China, briefTitle: The Epidemiological and Intrinsic Characteristics of Chronic Rhinitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-08-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Zheng Liu ENT, class: OTHER, collaborators name: Peking Union Medical College, collaborators name: Hainan People's Hospital, collaborators name: Shandong Second Provincial General Hospital, collaborators name: First Affiliated Hospital of Chongqing Medical University, collaborators name: First Affiliated Hospital of Xinjiang Medical University, descriptionModule briefSummary: Chronic rhinitis affects 10-40% of China's population, or over 300 million people, and can lead to respiratory and psychological issues. Despite treatment progress, 30% of patients have poor outcomes, likely due to the disease's complexity and a lack of new treatment targets. The incidence is rising, but there's a lack of nationwide studies on its variations. This study addresses this through a multicentric survey to create a national database on chronic rhinitis, including epidemiological, clinical, and biological data. The goal is to understand chronic rhinitis's causes and risks, improve treatments, and develop preventive strategies. The study will survey 30,000 patients across China, using questionnaires and nasal exams, and preserve biological samples in a biobank for detailed analysis. This will lay the groundwork for understanding the disease's mechanisms, developing new diagnostics, and tailoring prevention and treatment approaches for different forms of chronic rhinitis., conditionsModule conditions: Chronic Rhinitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 150000, type: ESTIMATED, armsInterventionsModule interventions name: Epidemiological investigation, outcomesModule primaryOutcomes measure: The prevalence and distribution patterns of chronic rhinitis within the Chinese population, primaryOutcomes measure: The clinical features and endotype of chronic rhinitis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongji Hosptial affiliated to Tongji Medical college of Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430030, country: China, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False |
protocolSection identificationModule nctId: NCT06370455, orgStudyIdInfo id: 36264MS429/11/23, briefTitle: Comparison of Septal Advancement Flap and Columellar Strut Effect on Nasal Tip, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-23, primaryCompletionDateStruct date: 2025-02-23, completionDateStruct date: 2025-04-20, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: The aim of the study to compare and evaluate the effect of septal advancement flap in preserving and reshaping the nasal tip with columellar strut graft, conditionsModule conditions: Rhinoplasty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: comparison of septal advancement flap effect on nasal tip in primary rhinoplasty to columellar strut technique, outcomesModule primaryOutcomes measure: subjective assessment using Rhinoplasty Outcome Evaluation Questionnaire, primaryOutcomes measure: measuring the degree of tip projection and rotation preoperative and postoperative, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Otorhinolaryngology department -Tanta University Hospitals, status: RECRUITING, city: Tanta, country: Egypt, contacts name: Mohamed Elsayed Elkady, MD, role: CONTACT, phone: 01004582738, phoneExt: +2, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False |
protocolSection identificationModule nctId: NCT06370442, orgStudyIdInfo id: 2137695, briefTitle: Intranasal Dexmedetomidine vs. Standard of Care for Emergency Department (ED) Procedural Sedation in the Older Adult, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: State University of New York - Upstate Medical University, class: OTHER, descriptionModule briefSummary: The purpose of the study is to determine if intranasal dexmedetomidine could be an alternative to the current standard of care (injectable benzodiazepines or antipsychotics) for sedation prior to computerized tomography (CT) or magnetic resonance imaging (MRI) in those greater than or equal to 65 years of age (older adults) that are seen in the Emergency Department (ED)., conditionsModule conditions: Altered Mental Status, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine, interventions name: Lorazepam, interventions name: Haloperidol, outcomesModule primaryOutcomes measure: Sedation, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06370429, orgStudyIdInfo id: 8743432956-050.99-621064, briefTitle: Effect of Online Exercises for Premenstrual Syndrome on Couple's Stress and Family Function, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Suleyman Demirel University, class: OTHER, descriptionModule briefSummary: Universe of Research The universe of the research; It will consist of women and their spouses with premenstrual syndrome complaints who use social media.3.6. Sample of the Research The number of samples of the study was composed of a total of 60 (Intervention = 30, Control = 30) participants.Criteria for inclusion in the study:* Being married and living with his wife* Being between the ages of 18-45,* The woman's ability to use a mobile phone and/or computer to receive online* The woman and her husband must be literate* The woman does not have a hearing problem that would prevent her from understanding the voice recording, 9. Scoring 110 or above on the Premenstrual Syndrome Scale 10. Having regular menstrual cycles for the last six months, 13. Having no other medical disease in the last six months, 14. Participant who does not use oral contraceptives, 16. Not pregnant or breastfeeding, 17. No history of cancer. 18. Those who do not use medical drugs to reduce premenstrual syndrome 19. Those who do not use herbal medicine to reduce premenstrual syndrome 20. Do not practice exercise, yoga, etc. to reduce premenstrual syndrome.Exclusion criteria from the study:1. He or his spouse fills out the research survey forms incompletely,2. Pregnancy occurs,3. Receiving breathing exercise consultancy from another consultant during the study periodData Collection Method and Duration Descriptive Characteristics Data Form, Perceived Stress Scale (PSS) and Family Assessment Scale will be applied to the sampled women and their spouses. Data collection will continue until the calculated sample number is reached., conditionsModule conditions: Premenstrual Syndrome, conditions: Exercises, conditions: Stress Level, conditions: Family Characteristics, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The sample was divided into intervention and control groups, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Progressive Relaxation Exercises, randomized pretest-posttest, outcomesModule primaryOutcomes measure: Premenstrual Syndrome Scale, primaryOutcomes measure: Family Assessment Scale, primaryOutcomes measure: Perceived Stress Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Suleyman Demirel University, city: Isparta, zip: 32500, country: Turkey, geoPoint lat: 37.76444, lon: 30.55222, hasResults: False |
protocolSection identificationModule nctId: NCT06370416, orgStudyIdInfo id: HSKY002, briefTitle: the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Henan Cancer Hospital, class: OTHER_GOV, collaborators name: Jiangsu Simcere Pharmaceutical Co., Ltd., descriptionModule briefSummary: This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of tralazili before chemotherapy in patients with NSCLC.After pathological diagnosis of non-small cell lung cancer(NSCLC), 40 eligible subjects who met the inclusion criteria were screened and given a treatment regimen of trilaciclib before chemotherapy, after signing informed consent., conditionsModule conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Trilaciclib, outcomesModule primaryOutcomes measure: The incidence of grade ≥ 3 neutropenia during chemotherapy treatment, secondaryOutcomes measure: The incidence of grade 4 neutropenia during chemotherapy treatment, secondaryOutcomes measure: The incidence of grade 3 or grade 4 thrombocytopenia, secondaryOutcomes measure: The incidence of grade 3 or 4 anemia during chemotherapy treatment, otherOutcomes measure: Objective relief rate, otherOutcomes measure: Disease control rate, otherOutcomes measure: Progression free survival, otherOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Henan Tumor Hospital, city: Zhengzhou, state: Henan, zip: 450000, country: China, geoPoint lat: 34.75778, lon: 113.64861, hasResults: False |
protocolSection identificationModule nctId: NCT06370403, orgStudyIdInfo id: LithuanianSportsU-21, briefTitle: Effects of Head and Neck Cooling and Heating on Fatigue in Multiple Sclerosis and Healthy Men, statusModule overallStatus: COMPLETED, startDateStruct date: 2014-02-04, primaryCompletionDateStruct date: 2016-03-01, completionDateStruct date: 2017-01-08, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Lithuanian Sports University, class: OTHER, descriptionModule briefSummary: Local head and neck cooling strategies can help reduce multiple sclerosis-related fatigue, while heating can exacerbate heat-related fatigue. However, no study has detailed the peripheral and central responses to head and neck cooling (at 18°C) and heating (at 43 ± 1°C next to the scalp and neck skin) during fatiguing isometric exercise in non-challenging ambient temperature in multiple sclerosis and healthy male subjects. In addition, there is a lack of data describing the effects of head and neck cooling/heating and strenuous exercise on blood markers, muscle temperature, motor accuracy, and rate of perceived exertion. The investigators hypothesized that: (i) men with multiple sclerosis would be more affected by central and peripheral fatigue compared to healthy subjects; (ii) local cooling will result in greater central fatigue but will be associated with greater peripheral fatigue, whereas heating will result in greater central and peripheral fatigue in multiple sclerosis men; (iv) local cooling and heating will have a greater effect on the release of stress hormones, rate of perceived exertion and motor accuracy compared to the control condition in both multiple sclerosis and healthy groups., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: NONE, maskingDescription: The researchers who analyzed the venous blood samples were blinded., enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Cooling of the head and neck, interventions name: Heating of the head and neck, outcomesModule primaryOutcomes measure: Body weight (kg), primaryOutcomes measure: Body fat (%), primaryOutcomes measure: Body free fat mass (kg), primaryOutcomes measure: Body mass index (kg/m2), primaryOutcomes measure: Change in muscle temperature (°C), primaryOutcomes measure: Change in plasma cortisol (nmol/L) concentrations, primaryOutcomes measure: Change in plasma dopamine (nmol/L) concentrations, primaryOutcomes measure: Change in plasma prolactin (ng/mL) concentrations, primaryOutcomes measure: Change in subjective rating of perceived exertion, primaryOutcomes measure: Change in muscle activity (mV), primaryOutcomes measure: Change in muscle activity (Hz), primaryOutcomes measure: Change in voluntary torque (Nm), primaryOutcomes measure: Change in involuntary torque (Nm), primaryOutcomes measure: Change in muscle contraction and relaxation (ms), primaryOutcomes measure: Change in central activation ratio (percent), primaryOutcomes measure: Change in constant error, primaryOutcomes measure: Change in absolute error, secondaryOutcomes measure: Height (m), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Lithuanian Sports University, city: Kaunas, zip: LT 44221, country: Lithuania, geoPoint lat: 54.90272, lon: 23.90961, hasResults: False |
protocolSection identificationModule nctId: NCT06370390, orgStudyIdInfo id: community - stroke dysphagia, briefTitle: Community-based Group Rehabilitation Program for Stroke Patients With Dysphagia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: Community-based exercise programs have demonstrated potential for implementation in older adults; however, it remains imperative to ascertain whether this strategy will yield comparable benefit in stroke patients with dysphagia.Participants were randomly assigned to either the intervention group or the control group. Patients in the intervention group received swallowing function training in community public spaces for 5 days every week for four-week period (60 minutes per day). Patients in the control group received no intervention. Penetration-Aspiration Scale and Standardized Swallowing Assessment (SSA), depressive symptoms (Geriatric Depression Scale-15), and meal duration were assessed before and after all the treatment., conditionsModule conditions: Stroke, 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: swallowing function training, outcomesModule primaryOutcomes measure: Standardized Swallowing Assessment Scale, secondaryOutcomes measure: Time consumed in eating, secondaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: 15-item Geriatric Depression Scale, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06370377, orgStudyIdInfo id: 0305899, briefTitle: Nurses' Adherence to Professional Nursing Code of Ethics and Quality of Nursing Care Satisfaction, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-01, primaryCompletionDateStruct date: 2023-02-28, completionDateStruct date: 2023-02-28, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Matrouh University, class: OTHER, descriptionModule briefSummary: Nursing code of ethics is an essential part of nursing professional practice. Nurses' adherence to a code of ethics is an important pillar of improving their performance, providing good nursing care and achieving patient satisfaction., conditionsModule conditions: Professional Role, conditions: Nurse's Role, conditions: Ethics, Narrative, conditions: Satisfaction, Patient, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 400, type: ACTUAL, armsInterventionsModule interventions name: the Egyptian code of ethical practice, outcomesModule primaryOutcomes measure: Questionnaire to measure source of nurses' knowledge about Egyptian code of ethics, primaryOutcomes measure: Observational checklist to measure, primaryOutcomes measure: Questionnaire to measure patient satisfaction with the quality of nursing care, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Nursing, Matrouh University, city: Mersa Matruh, zip: 002, country: Egypt, geoPoint lat: 31.3529, lon: 27.23725, hasResults: False |
protocolSection identificationModule nctId: NCT06370364, orgStudyIdInfo id: 25, briefTitle: Nurses' Practice of Safe Blood Transfusion in Surgical and Critical Care Units, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-12-01, primaryCompletionDateStruct date: 2021-04-30, completionDateStruct date: 2021-04-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Matrouh University, class: OTHER, descriptionModule briefSummary: Blood transfusions are an important part of nursing procedure. Nurses play a key role in safely administering blood products to patients in surgical and critical care unit, conditionsModule conditions: Practice Nurse's Scope, conditions: Blood Transfusion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 350, type: ACTUAL, armsInterventionsModule interventions name: Nurses' Practice of Safe Blood Transfusion, outcomesModule primaryOutcomes measure: Questionnaire to measure factors affecting safe blood transfusion, primaryOutcomes measure: observational checklist to measure nurses' practice of safe blood transfusion, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Nursing, Matrouh University, city: Mersa Matruh, zip: 002, country: Egypt, geoPoint lat: 31.3529, lon: 27.23725, hasResults: False |
protocolSection identificationModule nctId: NCT06370351, orgStudyIdInfo id: SENS-501-101, secondaryIdInfos id: 2023-504466-28-00, type: CTIS, briefTitle: A Phase I/II Clinical Trial With SENS-501 in Children Suffering From Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations, acronym: AUDIOGENE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2031-04, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Sensorion, class: INDUSTRY, descriptionModule briefSummary: This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene., conditionsModule conditions: OTOF Gene Mutation, conditions: DFNB9, conditions: Congenital Deafness, conditions: Hearing Disorders, conditions: Ear Diseases, conditions: Otorhinolaryngologic Diseases, conditions: Deafness, conditions: Hearing Loss, Sensorineural, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: SENS-501 administration, outcomesModule primaryOutcomes measure: Safety and tolerability of SENS-501, primaryOutcomes measure: Efficacy of SENS-501 assessed by ABR, secondaryOutcomes measure: Safety and tolerability of SENS-501, secondaryOutcomes measure: Efficacy of SENS-501 assessed by ABR, secondaryOutcomes measure: Efficacy of SENS-501 assessed by PTA, secondaryOutcomes measure: Clinical performance of the administration system, secondaryOutcomes measure: Safety of the administration system, secondaryOutcomes measure: Usability of the administration system, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 31 Months, stdAges: CHILD, contactsLocationsModule locations facility: Hopital Necker Enfants Malades, city: Paris, zip: 75015, country: France, contacts name: Natalie LOUNDON, Pr, role: CONTACT, phone: +33(0)171396782, email: [email protected], contacts name: Natalie LOUNDON, Pr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False |
protocolSection identificationModule nctId: NCT06370338, orgStudyIdInfo id: 2024B0101, briefTitle: Cardiothoracic Critical Care as Subspecialty and Its Core Competencies, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, descriptionModule briefSummary: The aim of this study is to develop a consensus on the curriculum for training cardiothoracic critical care by first evaluating the need for the field, based on a Delphi consensus among a panel of experts in this field., conditionsModule conditions: Consensus Development, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Delphi Questionnaire, outcomesModule primaryOutcomes measure: Degree of consensus on the curriculum for training cardiothoracic critical care by first evaluating the need for the field, secondaryOutcomes measure: Degree of consensus on defining training core competencies, goals, and milestones., secondaryOutcomes measure: Degree of consensus on the definitions of "Scholarship", "Patient", "Safety", "Quality", eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Ohio State University Wexner Medical Center, status: RECRUITING, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Alberto Uribe, MD, role: CONTACT, phone: 614-293-3559, email: [email protected], contacts name: Jeremy Reeves, BA, role: CONTACT, phone: 6148067569, email: [email protected], geoPoint lat: 39.96118, lon: -82.99879, hasResults: False |
protocolSection identificationModule nctId: NCT06370325, orgStudyIdInfo id: 23-00987, briefTitle: Neuromuscular Electrical Stimulation in Foot and Ankle Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, descriptionModule briefSummary: This is a pilot randomized controlled trial, wherein the intervention group will undergo NMES five days a week beginning three weeks postoperative and lasting for ten weeks. Both the control and intervention groups will start standard physical therapy six weeks postoperative. Primary outcome measure will be the isometric strength of the gastrocnemius muscle. The secondary outcomes will comprise subjective clinical evaluations (using the Lower Extremity Functional Scale \[LEFS\]), functional assessments such as the sit-to-stand test, 2-minute walk test, stair climb test and objective clinical evaluation using contralateral comparison of calf circumference., conditionsModule conditions: Ankle Fractures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: VPOD Wireless Tens Unit, interventions name: Physical Therapy, interventions name: Biodex, outcomesModule primaryOutcomes measure: Isometric Strength of Gastrocnemius Muscle, primaryOutcomes measure: Isometric Strength of Gastrocnemius Muscle, primaryOutcomes measure: Isometric Strength of Gastrocnemius Muscle, primaryOutcomes measure: Bilateral Calf Circumference, primaryOutcomes measure: Bilateral Calf Circumference, primaryOutcomes measure: Bilateral Calf Circumference, secondaryOutcomes measure: Lower Extremity Functional Scale (LEFS) Questionnaire Score, secondaryOutcomes measure: Lower Extremity Functional Scale (LEFS) Questionnaire Score, secondaryOutcomes measure: Lower Extremity Functional Scale (LEFS) Questionnaire Score, secondaryOutcomes measure: Sit-to-Stand Test, secondaryOutcomes measure: Sit-to-Stand Test, secondaryOutcomes measure: Sit-to-Stand Test, secondaryOutcomes measure: 2 Minute Walk Test, secondaryOutcomes measure: 2 Minute Walk Test, secondaryOutcomes measure: 2 Minute Walk Test, secondaryOutcomes measure: Stair Climb Test, secondaryOutcomes measure: Stair Climb Test, secondaryOutcomes measure: Stair Climb Test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False |
protocolSection identificationModule nctId: NCT06370312, orgStudyIdInfo id: 2023-07921-01, briefTitle: Analysis of Articular Biomarkers From Osteoarthritic Thumb Basal Joints, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Region Skane, class: OTHER, descriptionModule briefSummary: The study project aims at examining molecular markers in synovial fluid, bone and articular cartilage from osteoarthritic thumb basal joints. The degradation of extracellular matrix (ECM) proteins in thumb basal joints will be evaluated in association to the metabolic profile of the patient, but we also aim to compare the ECM degradation and inflammatory profiles with articular cartilage degradation ECM profile from knee joints with osteoarthritis. A third aim is to evaluate associations between patient-reported hand function, pain, strength and range of thumb motion to analyses of synovial fluid., conditionsModule conditions: Osteoarthritis Thumb, conditions: Osteoarthritis, Knee, conditions: Metabolic Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Trapeziectomy, outcomesModule primaryOutcomes measure: Serum cholesterol levels, eligibilityModule sex: ALL, minimumAge: 25 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06370299, orgStudyIdInfo id: 2023-06402-01, briefTitle: Screening of Multidrug Resistant Bacteria, and the Clinical Implication for the Patient, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Region Skane, class: OTHER, collaborators name: Lund University, descriptionModule briefSummary: The goal of this observational study is to evaluate the screening for multidrug resistant bacteria in patients admitted to hospitals in Scania. The main questions it aims to answer are:* admission rates after screening* 30-day and one-year mortality after screening Participants will be evaluated for positive screening results with following multidrug resistant gram negative bacilli: ESBL producing Enterobacterales, Carbapenemase producing Enterobacterales, Carbapenem resistant P.aeruginosa and carbapenem resistant Acinetobacter baumannii. Researchers will compare patients with positive and negative screening results to see, if the relative risks in the two groups differ in admission rates and mortality., conditionsModule conditions: Multi-antibiotic Resistance, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule interventions name: (exposure of) MDR carriage, outcomesModule primaryOutcomes measure: The ratio of the probability of all-cause admission in patients who are screening positive to the probability of all-cause admission in patients who are screening negative., primaryOutcomes measure: The ratio of the probability of death in patients who are screening positive to the probability of death in patients who are screening negative., primaryOutcomes measure: The ratio of the probability of antibiotic use in patients who are screening positive to the probability of antibiotic use in patients who are screening negative., secondaryOutcomes measure: prevalence of positive screening results, secondaryOutcomes measure: prevalence of MDR in clinical samples, secondaryOutcomes measure: time to first occurrence of phenotypically same MDR as in screening, secondaryOutcomes measure: prevalence of MDR in clinical samples in patients with negative screening results, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06370286, orgStudyIdInfo id: PACNL_rueihongli_CE_IC, briefTitle: The Effect of Acute Concurrent Exercise on Inhibitory Control: An Event-related Potential Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-02-15, primaryCompletionDateStruct date: 2021-08-15, completionDateStruct date: 2022-02-15, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: National Taiwan Normal University, class: OTHER, descriptionModule briefSummary: The present study aimed to determine the effects of acute concurrent exercise on inhibitory control via behavioral and event-related potential approaches and to examine its potential mediational role on lactate among younger adults. The main questions it aims to answer are: (1) Does acute concurrent exercise improve inhibitory control via behavioral and event-related potential approaches? (2) Does lactate play a potential mediational role in the effect of acute concurrent exercise on inhibitory control?, conditionsModule conditions: Exercise, conditions: Cognition, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants were randomly assigned to either a concurrent exercise (CE), aerobic exercise (AE), or control (CON) group. Participants in the CE group engaged in 12-minutes of AE (40%-59% of heart rate reserve \[HRR\]) coupled with 13-minutes of resistance exercise (1 set, with 75% of 10-repetition maximum, and 12 repetitions of 8 movements). The AE group participated in 25 minutes of AE (40%-59% HRR). Prior to and following exercise onset, participants in both the CE and AE groups completed a 5-minute warm-up and cool-down. Participants in the CON group read books for 35 minutes. Lactate concentrations were measured at timepoint of 0-, 17-, and 30-minutes relative to the treatment onset. Response time (RT) and accuracy in the Stroop test, as well as P3 amplitudes, were assessed before and after the treatment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 78, type: ACTUAL, armsInterventionsModule interventions name: concurrent exercise (CE), interventions name: aerobic exercise (AE), outcomesModule primaryOutcomes measure: Inhibitory control, secondaryOutcomes measure: Blood lactate, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Physical Education and Sport Sciences, National Taiwan Normal University, city: Taipei, zip: 106, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False |
protocolSection identificationModule nctId: NCT06370273, orgStudyIdInfo id: 1009305, briefTitle: Thromboprophylaxis in Lower Limb Immobilisation, acronym: TiLLI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-02, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Queen Mary University of London, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to find out the clinical and cost effectiveness of Thromboprophylaxis in participants who have been placed in a plaster cast or splint after injury.The main questions it aims to answer are:* whether giving tablets to people at high risks of clots after a leg injury is as good as injections (standard care)* whether giving any medication after a leg injury is better than standard care (advice only) for people at low risk of clots.Participants will be assessed to be high risk (TiLLI High) or low risk (TiLLI Low). People who are at high risk of clots will have either tablets or injections to reduce their risk. People at low risk will receive tablets, injections or no medication.Drug treatments will be provided for the duration of immobilisation or up to 42 days (whichever is earlier), in accordance with current NICE guidelines. The participants will be followed up for 90 days following randomisation., conditionsModule conditions: Thrombosis, conditions: Injury Leg, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A pragmatic, open-label, linked pair of randomised controlled trials with common outcomes and parallel economic analysis each with internal pilot phases, conducted across 30 NHS sites, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Open-label study. Trial Statistician and Health Economist to be blinded for analysis, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 10044, type: ESTIMATED, armsInterventionsModule interventions name: Rivaroxaban, interventions name: Apixaban, interventions name: Enoxaparin Injectable Solution, interventions name: Tinzaparin Injectable Solution, interventions name: Dalteparin Injectable Solution, interventions name: Fondaparinux Injectable Product, outcomesModule primaryOutcomes measure: Composite of net clinical benefit comprising clinical VTE event, major bleeding, and cause-specific mortality, secondaryOutcomes measure: Symptomatic VTE event occurrence, secondaryOutcomes measure: Major bleeding occurrence, secondaryOutcomes measure: Cause-specific mortality occurrence, secondaryOutcomes measure: Adverse and Serious adverse events, secondaryOutcomes measure: Medication adherence, secondaryOutcomes measure: Health utility (EQ-5D-5L), secondaryOutcomes measure: Patient satisfaction regarding the burdens and benefits of anticoagulation, secondaryOutcomes measure: Hospital readmission/reattendance, secondaryOutcomes measure: Health and social care resource use, secondaryOutcomes measure: Patient longer term outcome VTE and bleeding data, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06370260, orgStudyIdInfo id: INTM-PMCF-UNIGEL, secondaryIdInfos id: 571/13.02.2023, type: OTHER, domain: INTERMED S.A, briefTitle: Assessing the Efficacy of a Hydrogen Peroxide Gel for Oral Wound Healing and Oral Hygiene, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-02, primaryCompletionDateStruct date: 2023-12-27, completionDateStruct date: 2023-12-27, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: National and Kapodistrian University of Athens, class: OTHER, collaborators name: Ioulia And Irene Tseti Pharmaceutical Laboratories S.A., descriptionModule briefSummary: This study aims to assess the effectiveness and safety of a hydrogen carbamide/peroxide gel, called UNISEPT® ORAL GEL, in promoting oral wound healing, alleviating postoperative symptoms, and enhancing oral hygiene.Study participants will include individuals with any suspicious lesion in their gums or the roof of their mouth. They will undergo a procedure to remove a small piece of tissue for testing (biopsy) in order to confirm the diagnosis.This is a standardized diagnostic procedure that involves the use of a punch, which is a plastic handpiece with a cylindrical cutting blade. Subsequently, the wound heals naturally without the need for sutures.Researchers are comparing this gel with a placebo (a look-and-taste-alike substance that contains no active ingredients) to see if it is helpful with healing of wounds in the mouth and associated symptoms, improving oral hygiene. Participants randomly get the hydrogen carbamide/peroxide gel or the placebo one to use for 14 days after the biopsy. The researchers will not know which one they are providing as the gel tubes will be identical.Oral wound healing, postoperative symptoms (such as pain, eating and speech difficulties), oral hygiene (dental plaque and gingival inflammation) and quality of life are assessed during a 14-day period after the biopsy. Participants are required to visit the clinic three times, one for the initial biopsy, one at 7 days and one at 14 days after the biopsy. They are asked to fill in some questionnaires, while certain procedures (taking a photo the site of the biopsy) and assessments (like evaluating the dental plaque and gingival inflammation) take place. During the first week they, also, keep a diary of their symptoms, as instructed., conditionsModule conditions: Wound Heal, conditions: Postoperative Pain, conditions: Biopsy Wound, conditions: Wound; Mouth, conditions: Quality of Life, conditions: Dental Plaque, conditions: Gingival Inflammation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This trial is designed as a prospective, randomized, placebo-controlled, triple blinded, with two parallel groups and an equal allocation ratio in all groups. In this study, the intervention consists of delivery of a hydrogen carbamide/peroxide gel or placebo gel, made by the same manufacturer., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ACTUAL, armsInterventionsModule interventions name: Hydrogen Carbamide/Peroxide Gel, interventions name: Placebo Gel, outcomesModule primaryOutcomes measure: Assessment of wound healing based on Percentage Healing Index on day 14, primaryOutcomes measure: Assessment of wound healing based on Percentage Healing Index on day 7, secondaryOutcomes measure: Postoperative symptoms (pain, eating and speech difficulty) during the first week (at home), secondaryOutcomes measure: Postoperative symptoms (pain, eating and speech difficulty) on day 7, secondaryOutcomes measure: Postoperative symptoms (pain, eating and speech difficulty) on day 14, secondaryOutcomes measure: Wound healing based on clinical signs, secondaryOutcomes measure: Oral Hygiene - Dental Plaque: Sextant Plaque Index, secondaryOutcomes measure: Oral Hygiene - Gingival Inflammation: Sextant Gingival Index, secondaryOutcomes measure: Oral Health Related Quality of Life, otherOutcomes measure: Adverse Events, otherOutcomes measure: Participant's comments and satisfaction regarding the provided treatment/use of the products, otherOutcomes measure: Compliance, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Oral Medicine & Pathology and Hospital Dentistry, School of Dentistry, city: Athens, state: Attiki, zip: 11527, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, hasResults: False |
protocolSection identificationModule nctId: NCT06370247, orgStudyIdInfo id: Soh-Med-23-04-07PD., briefTitle: First-time Usage of SGLT2 Inhibitors in Type 2 Diabetic Patients Who Are Fasting During Ramadan: Safety and Efficacy, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-25, primaryCompletionDateStruct date: 2023-06-25, completionDateStruct date: 2023-09-25, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: All healthy Muslim adults are required to observe the Ramadan fast, which is one of Islam's five pillars. People with Type 2 Diabetes Mellitus frequently fast throughout Ramadan (T2DM).Although fasting during Ramadan is said to have positive effects on diabetes patients, such as a reduction in excess body weight and an improvement in lipid profile it can be linked to a slight increased risk for metabolic complications that need immediate attention, such as hypoglycemia and hyperglycemia, dehydration, and diabetic ketoacidosis (DKA The number of diabetics worldwide was projected to reach 537 million in 2021. Studies have shown that there are a rising number of people in this category, and by 2045, there will be 738 million people worldwide who have diabetes. Almost 150 million Muslims worldwide have diabetes, and this number is progressively rising. Research estimates that 118 million of these Muslims who have diabetes fast throughout Ramadan, underscoring the need of choosing the best treatment strategy at this time. Almost two-thirds of all Muslims with T2DMfast throughout the month of Ramadan, according to studies from CREED, Epidemiology of Diabetes, and Ramadan.According to this, the most recent study showed that 86% of patients with T2DMreported a fast for at least 2 weeks.Patient education, which should cover information on risks, lifestyle modifications, glucose monitoring, diet, exercise, and medication, is a crucial component of managing diabetes during Ramadan.Several studies have demonstrated the effectiveness and safety of sodium glucose cotransporter 2 inhibitors (SGLT2 I) in T2DM patients who are fasting throughout Ramadan. In individuals with T2DM, SGLT2 inhibitors have shown to reduce cardiovascular events and slow the course of renal disease.In the literature published so far, SGLT2i has shown lower rates of hypoglycemia and hypovolemia during fasting as compared to sulphonylureas (SU)., conditionsModule conditions: SGLT2 Inhibitors, First Time Use, conditions: Type2 Diabetes, conditions: Fasting in Ramadan, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: HbA1c, serum creatinine, eGFR urine analysis and serum electrolyte Na and K, outcomesModule primaryOutcomes measure: blood glucose level monitoring, primaryOutcomes measure: safety of SGLT2 inhibitors usage during ramadan, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sohag Faculty of Medicine, city: Sohag, country: Egypt, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False |
protocolSection identificationModule nctId: NCT06370234, orgStudyIdInfo id: 201412166MINA, briefTitle: The Prediction Model of NAC Response for Breast Cancer Based on The Parametric Dynamics Features., statusModule overallStatus: COMPLETED, startDateStruct date: 2015-04-21, primaryCompletionDateStruct date: 2019-06-30, completionDateStruct date: 2020-03-03, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, collaborators name: Ministry of Science and Technology, Taiwan, descriptionModule briefSummary: The main purpose of this study is to develop a computer-aided prediction model for NAC treatment response. Based on the heterogeneity of internal parametric tumor composition commonly observed, this study will utilize the histologic characteristics and treatment response to investigate the image features as input data for predicting treatment response using Deep Learning technology. Using this technique, preoperative treatment evaluation may be facilitated by tumor heterogeneity analysis from developed dynamic radiomics, and the possibility of personal medicine can be realized not far ahead. In the first two years of this study using images from DCE-MRI, PET/CT and QDS-IR, we plan to develop the image processing algorithms, including segmenting breast and tumor region, extracting image feature which reflects angiogenic properties and permeability of tumor, which are highly correlated with NAC treatment response. During the third year of the project, the morphology and texture features from first two years can be combined for PET/MRI and prediction model can be achieved in accordance with the features extracted from dynamic features extraction using longitudinal images of PET/MRI., conditionsModule conditions: Breast Cancer, conditions: Chemotherapy Effect, conditions: Diffusion Weighted MRI, conditions: PET Imaging, conditions: Multiparametric Magnetic Resonance Imaging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Whole body 18F-FDG Positron Emission Tomography, outcomesModule primaryOutcomes measure: Model Prediction power of pathological complete response(pCR), primaryOutcomes measure: Comparison of models in prediction of pathological complete response(pCR), eligibilityModule sex: FEMALE, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06370221, orgStudyIdInfo id: psoriatic Arthritis, briefTitle: The Effect of Psoriatic Arthritis on Female Sexual Dysfunction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-12-20, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Egymedicalpedia, class: INDUSTRY, descriptionModule briefSummary: Psoriasis is one of the most common immunemediated chronic inflammatory skin disorders., conditionsModule conditions: Psoriatic Arthritis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: The effect of psoriatic Arthritis, outcomesModule primaryOutcomes measure: Evaluation of female sexual function, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Qena Hospital, city: Qinā, country: Egypt, contacts name: Eisa Hegazy, Assist.Prof, role: CONTACT, phone: 01094337795, email: [email protected], geoPoint lat: 26.16418, lon: 32.72671, hasResults: False |
protocolSection identificationModule nctId: NCT06370208, orgStudyIdInfo id: LUMHS/B12/Temp/13.04.2024, briefTitle: Prophylactic Effect of Probiotic Streptococcus Salivarius K12 Against Recurrent Streptococcus Pyogenes Pharyngotonsillitis Infection in Pediatrics, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Liaquat University of Medical & Health Sciences, class: OTHER, descriptionModule briefSummary: Recurrent Streptococcus pyogenes pharyngotonsillitis infection in children presents a significant health concern, characterized by frequent episodes of sore throat, fever, and swollen tonsils. These recurrent infections can lead to missed school days, discomfort, and potential complications if left untreated. Current treatment typically involves antibiotics to eradicate the bacterial infection. However, drawbacks exist with this approach, including the risk of antibiotic resistance, disruption of the gut microbiota, and potential adverse effects such as gastrointestinal upset or allergic reactions. Moreover, antibiotics do not prevent future episodes and may contribute to recurrent infections by disrupting the balance of the throat microbiome. Therefore, there is a growing interest in alternative approaches such as probiotics, which aim to support the body's natural defenses and restore microbial balance in the throat and oral cavity., conditionsModule conditions: Streptococcus Pyogenes Pharyngotonsillitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Probiotic Bactoblis® (Streptococcus salivarius K12), outcomesModule primaryOutcomes measure: Recurrence of Streptococcus pyogenes pharyngotonsillitis infection, primaryOutcomes measure: Probiotic safety and tolerability, secondaryOutcomes measure: Protection against viral infection, secondaryOutcomes measure: Protection against Acute Otitis Media infection, secondaryOutcomes measure: Protection against respiratory infection, secondaryOutcomes measure: Protection against Rhinitis, secondaryOutcomes measure: Protection against flu, secondaryOutcomes measure: Protection against Enteritis, secondaryOutcomes measure: Protection against Stomatitis, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Liaquat University of Medical and Health Sciences, city: Jamshoro, zip: 76090, country: Pakistan, contacts name: Dr. Ikram Ujjan, MBBS, PhD, role: CONTACT, phone: 03000506955, email: [email protected], geoPoint lat: 25.43773, lon: 68.28522, hasResults: False |
protocolSection identificationModule nctId: NCT06370195, orgStudyIdInfo id: SGB-Liuxian, briefTitle: Effect of Stellate Ganglion Block on Drooling in Parkinson's Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Babujinaya Cela, class: OTHER_GOV, descriptionModule briefSummary: This is a randomized controlled study, including dysphagic patients with Parkinson's syndrome who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, Functional Oral Intake Scale, Drooling amount, depression are assessed., conditionsModule conditions: Parkinson's Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Comprehensive rehabilitation, interventions name: Stellate ganglion block, interventions name: Lidocaine hydrochloride, interventions name: Placebo injection, outcomesModule primaryOutcomes measure: Drooling amount, secondaryOutcomes measure: Modified Barthel Index, secondaryOutcomes measure: Patient Health Questionnaire-9, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06370182, orgStudyIdInfo id: ANA2401, briefTitle: Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA5 Device, acronym: ATHENA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Anaconda Biomed S.L., class: INDUSTRY, descriptionModule briefSummary: The objective of this study is to assess the safety and effectiveness of mechanical thrombectomy using the ANA funnel catheter to treat people with acute ischemic stroke within 24 hours of symptom onset. The device facilitates the placement of other devices such as stent retrievers and intravascular catheters during the procedure., conditionsModule conditions: Acute Ischemic Stroke From Large Vessel Occlusion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: ANA Funnel Catheter, interventions name: Control, outcomesModule primaryOutcomes measure: Proportion of subjects with "near-complete" reperfusion after one thrombectomy pass (FPE, eTICI 2c-3, extended Thrombolysis in Cerebral Infarction scale) in the target vessel after one reperfusion attempt., primaryOutcomes measure: Rate of symptomatic intracranial hemorrhage (sICH), attributable to the device or procedure., eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06370169, orgStudyIdInfo id: ROSC 1, briefTitle: EUS Guided Coil Embolization for Primary Prophylaxis of Gastric Varices, acronym: EUS, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-01, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-08-10, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Asian Institute of Gastroenterology, India, class: OTHER, descriptionModule briefSummary: The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue. Our study will evaluate the efficacy of EUS guided coil as primary prophylaxis for high-risk gastric varices. All procedures will be performed with patient under deep sedation or general anaesthesia under the supervision of an anaesthesiologist., conditionsModule conditions: Gastric Varices Bleeding, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopic ultrasound placement of Coil and glue, outcomesModule primaryOutcomes measure: The outcome will measure number of patient had achieved complete obliteration of varices, secondaryOutcomes measure: Number of patient needed re intervention, secondaryOutcomes measure: Number of patient needed had bleeding following intervention like immediate (with in 5 days) or later (5-90 days), eligibilityModule sex: ALL, minimumAge: 18 Months, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Asian institute of Gastroenterology, status: RECRUITING, city: Hyderabad, state: Telangana, zip: 500082, country: India, contacts name: Jahangeer Dr Basha, MD DM, role: CONTACT, phone: 04023378888, email: [email protected], contacts name: Sandeep Dr Nath, MD, role: CONTACT, phone: 04023378888, email: [email protected], geoPoint lat: 17.38405, lon: 78.45636, hasResults: False |
protocolSection identificationModule nctId: NCT06370156, orgStudyIdInfo id: TWEAK in plaque psoriasis, briefTitle: Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-10, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Egymedicalpedia, class: INDUSTRY, descriptionModule briefSummary: Psoriasis vulgaris is associated with significant comorbidity including depression, increased risk of cardiovascular events, diminished quality of life, as well as overall increased mortality.Moreover, concomitant psoriatic arthritis is present in up to 40% of psoriasis patients or will develop in the future.To enhance quality of life and potentially lower the risk of concomitant disease in psoriasis patients, effective treatment of this immune-mediated systemic inflammatory disease is required, conditionsModule conditions: Plaque Psoriasis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Adalimumab, outcomesModule primaryOutcomes measure: Treatment of psoriasis vulgaris and psoriatic arthritis, secondaryOutcomes measure: Evaluation of serum TWEAK, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: South Valley Hospitals, city: Qinā, country: Egypt, contacts name: Eisa Mohamed Hegazy, Professor, role: CONTACT, phone: +201094337795, email: [email protected], geoPoint lat: 26.16418, lon: 32.72671, hasResults: False |
protocolSection identificationModule nctId: NCT06370143, orgStudyIdInfo id: 24-083, briefTitle: A Study Collecting Health Information to Understand and Prevent Gastric Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2036-04-11, completionDateStruct date: 2036-04-11, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Memorial Sloan Kettering Cancer Center, class: OTHER, descriptionModule briefSummary: The purpose of this study is to create a registry of participants with precursor lesions for gastric cancer, including gastric atrophy, intestinal metaplasia, and dysplasia. Normal controls and individuals with gastric cancer for comparison of baseline characteristics will also be enrolled., conditionsModule conditions: Gastric Atrophy, conditions: Gastric Intestinal Metaplasia, conditions: Dysplasia, conditions: Gastric Adenocarcinoma, conditions: Gastric Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3200, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaire, outcomesModule primaryOutcomes measure: Creation of participant registry, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), status: RECRUITING, city: Basking Ridge, state: New Jersey, zip: 07920, country: United States, contacts name: Monika Laszkowska, MD, role: CONTACT, phone: 212-639-6857, geoPoint lat: 40.70621, lon: -74.54932, locations facility: Memorial Sloan Kettering Monmouth (All Protocol Activities), status: RECRUITING, city: Middletown, state: New Jersey, zip: 07748, country: United States, contacts name: Monika Laszkowska, MD, role: CONTACT, phone: 212-639-6857, 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: Monika Laszkowska, MD, role: CONTACT, phone: 212-639-6857, geoPoint lat: 41.04676, lon: -74.02292, locations facility: Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity), status: RECRUITING, city: Commack, state: New York, zip: 11725, country: United States, contacts name: Monika Laszkowska, PhD, role: CONTACT, phone: 212-639-6857, 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: Monika Laszkowska, MD, role: CONTACT, phone: 212-639-6857, geoPoint lat: 40.96899, lon: -73.71263, locations facility: Memorial Sloan Kettering Cancer Center (All protocol activites), status: RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: Monika Laszkowska, MD, role: CONTACT, phone: 212-639-6857, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Memorial Sloan Kettering Nassau (Limited Protocol Activites), status: RECRUITING, city: Rockville Centre, state: New York, zip: 11553, country: United States, contacts name: Monika Laszkowska, MD, role: CONTACT, phone: 212-639-6857, geoPoint lat: 40.65871, lon: -73.64124, hasResults: False |
protocolSection identificationModule nctId: NCT06370130, orgStudyIdInfo id: AerospaceCH, briefTitle: Different Dose of Esketamine Inhibiting Response to Laryngeal Mask Airway Insertion, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-01, primaryCompletionDateStruct date: 2022-12-20, completionDateStruct date: 2023-03-10, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Aerospace Center Hospital, class: OTHER, descriptionModule briefSummary: Objective To prospectively determine the median effective dose (ED50) of propofol for inhibiting a response to laryngeal mask airway (LMA) insertion when combined with different doses of esketamine in female patients.Methods Fifty-eight female patients (aged 20-60, ASAⅠ-Ⅱ) scheduled for elective hysteroscopy were enrolled and randomly divided into two groups, one administered 0.2 mg/kg of esketamine (K1 group, n = 28) and the other 0.3 mg/kg of esketamine (K2 group, n = 30). The two groups received the corresponding doses of esketamine intravenously, followed by an intravenous injection of propofol (injection time was 30 s). The initial dose of propofol was 2 mg/kg, and the dose ratio of propofol in the adjacent patients was 0.9. If there was a positive reaction to LMA insertion, the dose ratio in the next patient was increased by one gradient, and if not, the dose ratio was decreased by one gradient. The median effective dose (ED50), 95% effective dose (ED95) and 95% confidence interval (95%CI) of propofol for inhibiting a response to LMA insertion in the two esketamine groups were calculated using a probit analysis., conditionsModule conditions: Anesthesia, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 58, type: ACTUAL, armsInterventionsModule interventions name: Esketamine 0.2mg/kg, interventions name: Esketamine 0.3mg/kg, outcomesModule primaryOutcomes measure: Record of the patient response during LMA placement, primaryOutcomes measure: Overall condition of LMA placement, primaryOutcomes measure: Record related indicators, primaryOutcomes measure: Record related indicators, primaryOutcomes measure: Record related indicators, primaryOutcomes measure: Record related indicators, primaryOutcomes measure: Record of additional doses of propofol and the adverse reactions of positive patients during the induction process (hypotension, bradycardia and apnoea, etc.), eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Liang-Yuan Lu, city: Beijing, state: Beijing, zip: 100049, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06370117, orgStudyIdInfo id: Aydın Adnan Menderes, briefTitle: The Effects of Three Different Nonpharmacological Methods Used During Vascular Access in Children on Pain and Anxiety, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2023-10-30, completionDateStruct date: 2023-12-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Aydin Adnan Menderes University, class: OTHER, descriptionModule briefSummary: The research was conducted to evaluate the effects of three different non-pharmacological methods (playing a music video, buzzy application, listening to a music video + buzzy application) on the pain and anxiety levels of children in the 4-12 age group during vascular access.H0.1. Playing music (music video) during the vascular access procedure has no effect on children's pain and anxiety levels.H0.2. Applying buzzy during the vascular access procedure has no effect on children's pain and anxiety levels.H0.3. Listening to a music video + applying buzzy during the vascular access procedure has no effect on children's pain and anxiety levels., conditionsModule conditions: Pain, conditions: Anxiety, conditions: Nurse's Role, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: It is a randomized controlled experimental study., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 126, type: ACTUAL, armsInterventionsModule interventions name: Buzzy, interventions name: Music video listening, interventions name: Buzzy+ Music video listening, outcomesModule primaryOutcomes measure: Wong-Baker Facial Expression Rating Scale, secondaryOutcomes measure: Children's Fear and Anxiety Scale, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Bircan Kahraman Berberoğlu, city: Aydın, state: AYDIN-efeler, zip: 0900, country: Turkey, geoPoint lat: 37.84501, lon: 27.83963, hasResults: False |
protocolSection identificationModule nctId: NCT06370104, orgStudyIdInfo id: NL85041.018.23, briefTitle: Treating Suicidality Remotely, acronym: TREASURE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2028-04-25, completionDateStruct date: 2028-04-25, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: 113 Suicide Prevention, class: OTHER, collaborators name: Amsterdam UMC, descriptionModule briefSummary: Background: Practical and psychological barriers make it difficult for people with Suicidal Thoughts and Behaviors (STBs) to get professional help. Online interventions have the potential to overcome many of these barriers, but the online interventions to date have produced small or short-lived effects and have only been found to reduce suicidal thoughts, not behaviors. This is a crucial limitation, since previous studies have shown that interventions that reduce suicidal thoughts often do not prevent suicide attempts, and vice versa.Methods: A fully remote randomized controlled trial will be conducted in which 364 participants of 16 years and older will be recruited through the website of a suicide prevention helpline in the Netherlands and randomized with an allocation ratio of 1:1 to either Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT-SP) or a semi-guided online self-help course that has previously been found superior to waitlist in reducing suicidal thoughts. The primary outcome of the study is the number of suicide attempts, measured with the Columbia Suicide Severity Rating Scale. Secondary outcomes are self-reported suicidal ideation, healthcare utilization, treatment satisfaction, adverse effects, and quality of life. All outcomes will be assessed at baseline, immediately after the treatment and at 18 months follow-up.Discussion: If remote BCBT-SP proves effective, the findings of this study will add to the evidence base of BCBT-SP as one of very few psychological interventions with replicated effectiveness in preventing suicide attempts and provide the first evidence to date that remote interventions cannot only reduce suicidal thoughts, but also prevent suicidal behavior., conditionsModule conditions: Suicide Attempt, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel randomized controlled trial with a 1:1 allocation ratio., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Participants are not blind to the treatment condition, but are unaware which is the experimental condition and which the control condition., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 364, type: ESTIMATED, armsInterventionsModule interventions name: Brief Cognitive Behavioral Therapy for Suicide Prevention, interventions name: Living under control, outcomesModule primaryOutcomes measure: Number of suicide attempts, secondaryOutcomes measure: Severity of suicidal ideation, secondaryOutcomes measure: Severity of suicidal Thoughts and Behaviors Composite, secondaryOutcomes measure: Treatment satisfaction, secondaryOutcomes measure: Adverse effects, secondaryOutcomes measure: Co-occuring mental health issues, secondaryOutcomes measure: Quality of life, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 113 Suicide Prevention, city: Amsterdam, state: Zuid-Holland, zip: 1105BP, country: Netherlands, contacts name: Wilco Janssen, MSc, role: CONTACT, phone: 020 3 113 883, email: [email protected], contacts name: Saskia Mérelle, PhD, role: CONTACT, phone: 020 3 113 883, email: [email protected], geoPoint lat: 52.37403, lon: 4.88969, hasResults: False |
protocolSection identificationModule nctId: NCT06370091, orgStudyIdInfo id: PICVII19-41, briefTitle: Effect of Xylitol-based Chewing Gums, Sugar-free and Sugared, on Salivary Flow and pH in Young Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-12, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Universidad Católica de Cuenca, class: OTHER, descriptionModule briefSummary: This study was planned to evaluate the effects of xylitol-based chewing gums, sugar-free and sugared, on salivary flow and pH in young adults., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: It will be an experimental study through a double-blind parallel randomized controlled trial.All saliva samples will be collected using the spitting method. Each participant will provide a basal saliva sample for 5 minutes. Participants must meet the following inclusion criteria: having at least 20 teeth, providing written informed consent, and being willing to comply with the study procedures. The exclusion criteria will include individuals with systemic, infectious, or inflammatory diseases or those taking medications, antibiotics, or fluoride in the last month; regular consumers of products and mouthwashes containing xylitol or sorbitol, with abnormal salivary flow (\<1 ml/min), pregnant women or those on contraceptive pill treatment, or with abnormal dietary habits; subjects with periodontal disease or presence of dental caries, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: Participants who meet the selection criteria will be probabilistically assigned using simple random sampling through a lottery system. An urn will be used to draw colors corresponding to a type of chewing gum, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Gum of Xylitol, interventions name: Gum of sugar free, interventions name: Gum of sugar, interventions name: Paraffin wax, outcomesModule primaryOutcomes measure: G1: Gum of xilytol, primaryOutcomes measure: G2: Gum of sugar free, primaryOutcomes measure: G3: Gum of sugar, primaryOutcomes measure: G4: Parafinn wax, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Miriam Lima, status: RECRUITING, city: Cuenca, state: Azuay, zip: 010101, country: Ecuador, contacts name: Miriam Lima, Ph D, role: CONTACT, phone: 0999975073, email: [email protected], geoPoint lat: -2.90055, lon: -79.00453, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-12-12, uploadDate: 2024-04-13T10:26, filename: Prot_000.pdf, size: 1132158, hasResults: False |
protocolSection identificationModule nctId: NCT06370078, orgStudyIdInfo id: Ahmed Helal, briefTitle: Effect of Early Administration of Albumin 20% Versus Crystalloid, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2025-11-15, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Egymedicalpedia, class: INDUSTRY, descriptionModule briefSummary: Sepsis and septic shock are global health problems, leading to a high mortality rate. They are often associated with extremely low blood pressure and multiple organ dysfunctions, which are the main causes of death in critically ill patients. Fluid resuscitation is one of the most critical treatments for patients with sepsis and septic shock.An early administration of an appropriate fluid to patients is considered the most effective way to increase blood pressure, improve tissue perfusion, and save their lives. Crystalloid fluids are a subset of intravenous solutions composed of mineral salts and other small, water-soluble molecules, including normal, isotonic or hypertonic saline, and various buffered solutions., conditionsModule conditions: Septic Shock, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Albumin Human, outcomesModule primaryOutcomes measure: Recovery from shock, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Assuit University hospitals, city: Assiut, country: Egypt, contacts name: Ahmed Abdelhamed Helal Mohamed, MSc, role: CONTACT, phone: +201140415513, email: [email protected], contacts name: Amany Hassan Abdelwahab, Assist.Prof., role: CONTACT, phone: +201004610623, email: [email protected], contacts name: Noha Yahia Mohamed, Lecturer, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False |
protocolSection identificationModule nctId: NCT06370065, orgStudyIdInfo id: HLX10IIT70-TJ, briefTitle: Serplulimab Combined With Bevacizumab Biosimilar and HAIC in Advanced Hepatocellular Carcinoma (HCC) Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-27, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Tianjin Medical University Cancer Institute and Hospital, class: OTHER, descriptionModule briefSummary: Evaluation of the efficacy and safety of Serplulimab combined with bevacizumab biosimilar and HAIC in Advanced Hepatocellular Carcinoma (HCC) patients, conditionsModule conditions: Advanced Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: HAIC+Serplulimab（HLX10）+ Bevacizumab Biosimilar（HLX04）, outcomesModule primaryOutcomes measure: ORR, secondaryOutcomes measure: PFS, secondaryOutcomes measure: OS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tianjin Cancer Hospital Airport Hospital, status: RECRUITING, city: Tianjin, state: Tianjin, country: China, contacts name: Huikai Li, MD, role: CONTACT, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False |
protocolSection identificationModule nctId: NCT06370052, orgStudyIdInfo id: CHCRI-DJ-HS, briefTitle: Pathophysiological Basis of Hidradenitis Suppurativa, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Clinical Hospital Center Rijeka, class: OTHER, descriptionModule briefSummary: HS is a chronic inflammatory disease manifested by recurrent inflammatory nodules, abscesses and tunnels under the skin. This disease is characterized by an inflammatory process that takes place in hair follicles, sebaceous glands and surrounding tissue. Because of its frequent recurrence and chronicity, it represents a major public health problem and there is a need for better diagnosis and new and more effective drugs. This research can be a part of realizing the stated needs., conditionsModule conditions: Hidradenitis Suppurativa, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: excision, outcomesModule primaryOutcomes measure: The pathohistological changes, secondaryOutcomes measure: The expression of cytokines, secondaryOutcomes measure: The correlation of the clinical Hurley classification and pathohistological changes, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06370039, orgStudyIdInfo id: INV-102-CS-003, briefTitle: Study of INV-102 Ophthalmic Solution in Adults With Moderate to Severe Dry Eye Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Invirsa, Inc., class: INDUSTRY, descriptionModule briefSummary: Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during 4-week repeat dosing in subjects with moderate to severe dry eye disease., conditionsModule conditions: Dry Eye Disease, 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: 110, type: ESTIMATED, armsInterventionsModule interventions name: INV-102, interventions name: Vehicle, outcomesModule primaryOutcomes measure: Change from Baseline in corneal fluorescein staining total score on the National Eye Institute (NEI)/Industry scale, secondaryOutcomes measure: Percentage of eyes with complete clearing of central corneal fluorescein staining, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 74 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: iuvo BioScience, status: RECRUITING, city: Rush, state: New York, zip: 14543, country: United States, geoPoint lat: 42.9959, lon: -77.64556, hasResults: False |
protocolSection identificationModule nctId: NCT06370026, orgStudyIdInfo id: KSD-101-CR004, briefTitle: KSD-101 Therapy for Standard Treatment Failed EBV-associated Nasopharyngeal Carcinoma: an Exploratory Clinical Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, collaborators name: Kousai Bio Co., Ltd., descriptionModule briefSummary: The main purpse of this study is to evaluate the safety of KSD-101 in patients with EBV-associated Nasopharyngeal Carcinoma,to evaluate the initial clinical outcomes and evaluate the immune response to KSD-101 for the treatment in Patients with EBV-associated Nasopharyngeal Carcinoma., conditionsModule conditions: Nasopharyngeal Carcinoma, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: KSD-101, outcomesModule primaryOutcomes measure: The incidence Adverse events (Safety endpoint), secondaryOutcomes measure: EBV-DNA load, secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Levels of EBV-specific CD8+ T cells, secondaryOutcomes measure: Levels of B cells, secondaryOutcomes measure: Levels of NK cells, secondaryOutcomes measure: According to EORTC QLQ-C30, secondaryOutcomes measure: According to EQ-5D-5L, secondaryOutcomes measure: According to EORTC QLQ-H&N35, secondaryOutcomes measure: According to ECOG fitness status, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, city: Guangzhou, state: Guangdong, zip: 510060, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06370013, orgStudyIdInfo id: TT00420US14, briefTitle: Rollover Study to Provide Continued Access to TT-00420 (Tinengotinib) for Subjects With Advanced Solid Tumors, statusModule overallStatus: AVAILABLE, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: TransThera Sciences (Nanjing), Inc., class: INDUSTRY, descriptionModule briefSummary: This study is an open-label, multicenter study for Continued Characterization of Safety and Tolerability of TT-00420 (tinengotinib) Tablet Monotherapy in Adult Patients with Advanced Solid Tumors, conditionsModule conditions: Advanced Solid Tumors, conditions: Cholangiocarcinoma, designModule studyType: EXPANDED_ACCESS, armsInterventionsModule interventions name: Tinengotinib, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Chicago Medical Center, status: AVAILABLE, city: Chicago, state: Illinois, zip: 60637, country: United States, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Roswell Park Comprehensive Cancer Center, status: AVAILABLE, city: Buffalo, state: New York, zip: 14203, country: United States, geoPoint lat: 42.88645, lon: -78.87837, locations facility: Sarah Cannon Research Institute, status: AVAILABLE, city: Nashville, state: Tennessee, zip: 37203, country: United States, geoPoint lat: 36.16589, lon: -86.78444, locations facility: MD Anderson Cancer Center, status: AVAILABLE, city: Houston, state: Texas, zip: 77030, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: UW Carbone Cancer Center, status: AVAILABLE, city: Madison, state: Wisconsin, zip: 53705, country: United States, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False |
protocolSection identificationModule nctId: NCT06370000, orgStudyIdInfo id: MCC-23-20817, secondaryIdInfos id: HM20029540, type: OTHER, domain: Virginia Commonwealth University, briefTitle: Oral Azacitidine in Transplant-Eligible Patients With Acute Myeloid Leukemia (AML) Suffering From Health-Inequality, acronym: REMAIN1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-10-31, completionDateStruct date: 2028-10-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Virginia Commonwealth University, class: OTHER, descriptionModule briefSummary: Test feasibility of an oral maintenance strategy for transplant eligible AML patients in first CR who are medically underserved or have a disadvantage in the CDC SDOH domains, conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Oral Azacitidine, outcomesModule primaryOutcomes measure: Rate of completion of at least 4 cycles an oral maintenance strategy for transplant eligible AML patients in CR who are medically underserved or have a disadvantage in the CDC SDOH domains, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Leukemia Free Survival (LFS) 3 months after beginning of treatment and at relapse, completion of treatment or removal from study, secondaryOutcomes measure: Measure rates of measurable residual disease (MRD) negativity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Virginia Commonwealth University, city: Richmond, state: Virginia, zip: 23298, country: United States, contacts name: Kristin Lantis, MSN, RN, role: CONTACT, phone: 804-828-2177, email: [email protected], contacts name: Massey Heme Malig Team, role: CONTACT, email: [email protected], contacts name: Keri Maher, DO, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.55376, lon: -77.46026, hasResults: False |
protocolSection identificationModule nctId: NCT06369987, orgStudyIdInfo id: 46238, briefTitle: Visual Performance of Dailies Total1 Multifocal and Acuvue Oasys Max 1-Day Multifocal in Presbyopic Lens Wearers, acronym: GIRAFFE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Waterloo, class: OTHER, collaborators name: Alcon Research, descriptionModule briefSummary: The purpose of this study is to measure the logMAR visual acuity when presbyopic soft lens wearers are fit with Dailies Total1 Multifocal and ACUVUE OASYS MAX 1-DAY Multifocal., conditionsModule conditions: Presbyopia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Deleficon A (multifocal), interventions name: Senofilcon A (multifocal), outcomesModule primaryOutcomes measure: High contrast visual acuity (logMAR) at 6m, primaryOutcomes measure: High contrast visual acuity (logMAR) at 40cm, eligibilityModule sex: ALL, minimumAge: 42 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre for Ocular Research & Education (CORE), city: Waterloo, state: Ontario, zip: N2L 3G1, country: Canada, contacts name: Jill Woods, MSc, MCOptom, role: CONTACT, phone: 519-888-4567, phoneExt: 36746, email: [email protected], contacts name: Lyndon Jones, PhD, FCOptom, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.4668, lon: -80.51639, hasResults: False |
protocolSection identificationModule nctId: NCT06369974, orgStudyIdInfo id: 2024P000386, briefTitle: Single Participant Study of an Experimental ASO Treatment for TUBB4A-related Leukodystrophy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: n-Lorem Foundation, descriptionModule briefSummary: This research project entails delivery of a personalized antisense oligonucleotide (ASO) drug designed for a single pediatric participant with TUBB4A associated leukodystrophy., conditionsModule conditions: Genetic Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single participant interventional study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Open label study, enrollmentInfo count: 1, type: ESTIMATED, armsInterventionsModule interventions name: Antisense oligonucleotide treatment (ASO), outcomesModule primaryOutcomes measure: Neurological assessments, secondaryOutcomes measure: Feeding and swallow evaluation, secondaryOutcomes measure: Safety and tolerability, eligibilityModule sex: ALL, minimumAge: 4 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06369961, orgStudyIdInfo id: TDFCANCERPAIN20230101, briefTitle: Correlation Between the Analgesic Effect of Fentanyl Transdermal Patches and Nutritional Status in Cancer Pain Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2023-07-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Chongqing University Cancer Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to investigate the correlation and quantitative relationship between the analgesic effect of fentanyl transdermal patches in cancer pain patients and their nutritional status., conditionsModule conditions: Cancer Pain, conditions: Nutrition Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 151, type: ACTUAL, armsInterventionsModule interventions name: transdermal fentanyl, outcomesModule primaryOutcomes measure: 11-point numeric rating scale (NRS) after TDF treatment, primaryOutcomes measure: the occasions that breakthrough pain attacks per day after TDF treatment, primaryOutcomes measure: The dose adjustment of TDF, primaryOutcomes measure: The kinds of other analgesics combined with TDF, secondaryOutcomes measure: Adverse effects, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chao Li, city: Chongqing, zip: 400030, country: China, geoPoint lat: 29.56278, lon: 106.55278, hasResults: False |
protocolSection identificationModule nctId: NCT06369948, orgStudyIdInfo id: M703, briefTitle: Quality Of Recovery After Pericapsular Nerve Group (PENG) Block For Hip Hemiarthroplasty Under Spinal Anesthesia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Fayoum University Hospital, class: OTHER, descriptionModule briefSummary: Patients undergoing hip hemiarthroplasty can benefit significantly from regional anesthesia in terms of pain management and recovery . There is a wide range of regional anesthetic techniques. The most common in this anatomical region and those with the greatest published research are fascia iliac block, lumbar plexus block, and femoral nerve block . Alternative methods include lateral femoral cutaneous nerve and selective obturator nerve infiltration blocks. Novel techniques, including local infiltration analgesia and quadratus lumborum block, have been reported.While femoral nerve and lumbar plexus blocks are two common opioid-sparing regional anesthetic procedures that are successful, they come with a risk of undesired lower limb muscle weakness . On the other hand, the fascia iliac block does not always offer sufficient pain relief following hip surgery. The important landmarks targeted on the hip joint branches from the femoral nerve and the auxiliary obturator nerve may now be identified thanks to a recent anatomical study on hip innervation .This led to the discovery of a novel localized anesthetic treatment termed pericapsular nerve group block (PENG), which blocks these nerves to target the hip's anterior capsule. The PENG block has been suggested as a successful motor-sparing block for hip hemiarthroplasty . The objective of the current study is to evaluate the efficacy of the pericapsular nerve group block (PENG) for the reduction of opioid consumption and management of postoperative pain after hip hemiarthroplasty., conditionsModule conditions: Hip Hemiarthroplasty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: We will include 60 patients who will undergoe elective hip hemiarthroplasty. Patients will be divided into two groups randomized by computer generated random numbers that will be placed in separate opaque envelopes that will be opened by study investigators just before the block.Pericapsular Nerve Group (PENG) Block (P group) includes 30 patients who will receive a PENG block.Control group (C group) includes 30 patients who will not receive a PENG block., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Patients will be divided into two groups randomized by computer generated random numbers that will be placed in separate opaque envelopes that will be opened by study investigators just before the block., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Pericapsular Nerve Group (PENG) Block, interventions name: elective hip hemiarthroplasty without receiving a PENG block., interventions name: bupivacaine 0.5% injection, outcomesModule primaryOutcomes measure: Total opioid consumption post operative, secondaryOutcomes measure: 2) a Visual Analogue Scale (VAS) ranging from zero (no pain) to 10 (severe pain) for dynamic and static pain, secondaryOutcomes measure: 3) Time to first opioid use, secondaryOutcomes measure: 4) Ability to perform physiotherapy, secondaryOutcomes measure: 5) Opioid-related side effects., secondaryOutcomes measure: 6) Total length stay of hospital, secondaryOutcomes measure: 7) Complications of local anesthetic toxicity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fayoum University Hospital, status: RECRUITING, city: Madīnat Al Fayyūm, state: Fayoum Governorate, zip: 63514, country: Egypt, contacts name: Atef Mohamed Sayed, MS.C, role: CONTACT, phone: 01003973883, email: [email protected], geoPoint lat: 29.31667, lon: 30.83333, hasResults: False |
protocolSection identificationModule nctId: NCT06369935, orgStudyIdInfo id: 20240407, briefTitle: A Real World Study of Equecabtagene Autoleucel in Subjects With Relapsed and Refractory Multiple Myeloma., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-20, primaryCompletionDateStruct date: 2026-08-20, completionDateStruct date: 2027-08-20, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Peking University People's Hospital, class: OTHER, descriptionModule briefSummary: This study is a multicenter, observational, single-arm real world study. The purpose of this study is to describe demographic and disease characteristics, treatment patterns, and clinical outcomes in the real-world setting among participants in China with relapsed/refractory multiple myeloma (RRMM) who have been treated with Equecabtagene Autoleucel. This study will use both prospective and retrospective data, conditionsModule conditions: Relapsed/Refractory Multiple Myeloma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 260, type: ESTIMATED, armsInterventionsModule interventions name: Equecabtagene Autoleucel, outcomesModule primaryOutcomes measure: Best Overall Response Rate， BOR, secondaryOutcomes measure: PFS rate of 6 month, secondaryOutcomes measure: OS rate of 6 month, secondaryOutcomes measure: Time to Response， TTR, secondaryOutcomes measure: Time to Complete Response， TTCR, secondaryOutcomes measure: Adverse Event， AE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University People's Hospital, city: Beijing, country: China, contacts name: Yang Liu, role: CONTACT, phone: +8613716926210, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06369922, orgStudyIdInfo id: STUDY00009315, briefTitle: TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence., acronym: TENSUB, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University of Rochester, class: OTHER, descriptionModule briefSummary: This will be a double-blind randomized control trial in women with stress urinary incontinence who are undergoing an outpatient transurethral bulking procedure for stress urinary incontinence. Subjects will be identified by the University of Rochester urologists and urogynecologists participating in the study who currently oversee stress incontinence care. Subjects will be randomized into two groups. One group will be undergoing the cystoscopy with transcutaneous electrical nerve stimulation (TENS) for analgesia, and the second group will have the cystoscopy with placebo TENS., conditionsModule conditions: Stress Incontinence Female, conditions: Urinary Incontinence, conditions: Urinary Incontinence,Stress, conditions: Pain, conditions: Pain Acute, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: TENS, interventions name: Control TENS, outcomesModule primaryOutcomes measure: Mean pain measured by Visual Analog Scale (VAS), primaryOutcomes measure: Mean pain measured by Visual Analog Scale (VAS), primaryOutcomes measure: Mean pain measured by Visual Analog Scale (VAS), secondaryOutcomes measure: Mean pain measured by Likert scale, secondaryOutcomes measure: Mean pain measured by Likert scale, secondaryOutcomes measure: Mean pain measured by Likert scale, secondaryOutcomes measure: Number of participants with side effects, secondaryOutcomes measure: Mean satisfaction with the procedure, secondaryOutcomes measure: TENS or NO TENS, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pelvic Health and Continence Specialties, city: Rochester, state: New York, zip: 14623, country: United States, contacts name: Jared M Floch, DO, MS, role: CONTACT, phone: 585-895-9301, email: [email protected], contacts name: Diego Hernandez-Aranda, MD, role: CONTACT, phone: (585) 487-3400, email: [email protected], contacts name: Jared M Floch, DO, MS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.15478, lon: -77.61556, hasResults: False |
protocolSection identificationModule nctId: NCT06369909, orgStudyIdInfo id: K5507, briefTitle: Study on AI-assisted Multimodal Diagnosis System of Autoimmune Pancreatitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, collaborators name: Tianjin Medical University General Hospital, collaborators name: The Second Hospital of Hebei Medical University, descriptionModule briefSummary: The existing comprehensive diagnostic system for autoimmune pancreatitis (AIP) is complex, with multidimensional clinical information including morphological changes and a lack of specific biomarkers. Endoscopic ultrasound (EUS) can provide all the elements for morphological diagnosis of AIP, but the long learning curve and large observer differences make it difficult to popularize and promote. The cooperation units of the three regions in this project have found in the early stage that Klebsiella pneumoniae (KP) induced follicular helper T cells (Tfh) activation is an important mechanism of AIP, but the identification of pathogenic components of the strain and clinical validation need to be explored. We have established a national multicenter AIP queue in the early stage and extracted EUS audio-visual features to establish a scoring model, but intelligent assistance is still needed to improve efficiency. Therefore, we plan to integrate gut microbiota, Tfh activation markers, and EUS imaging features to establish an AI assisted multimodal diagnostic system for AIP. This study will collaborate across multiple centers to identify and validate the components that induce Tfh activation in KP bacterial cells, to extract EUS pancreatic ultrasound features and optimize artificial intelligence assisted diagnostic algorithms, and to establish and validate an artificial intelligence assisted multimodal diagnostic system based on clinical information, biomarkers, and EUS. The aim of this study is to provide new diagnosis and treatment evaluation methods for AIP with high accuracy, convenience, and easy promotion for clinical practice., conditionsModule conditions: Autoimmune Pancreatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: EUS-FNA, outcomesModule primaryOutcomes measure: Tfh level in blood, primaryOutcomes measure: Microbiota composition measured by 16S rRNA sequencing, primaryOutcomes measure: AI-EUS differentiation, primaryOutcomes measure: Cytokine level in blood, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, status: RECRUITING, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Mai Li, role: CONTACT, phone: 13683296860, email: [email protected], contacts name: Xi Wu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06369896, orgStudyIdInfo id: SpyIDUSForNonictericStricture, briefTitle: Digital Single-operator Cholangioscopy and Intraductal Ultrasound for Nonicteric Biliary Strictures, acronym: Spy+IDUS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-05, primaryCompletionDateStruct date: 2025-12-25, completionDateStruct date: 2026-12-25, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Soonchunhyang University Hospital, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of indeterminate biliary stricture., conditionsModule conditions: Cholangiocarcinoma, conditions: Biliary Stricture, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: diagnostic accuracy of SOC, secondaryOutcomes measure: Diagnostic accuracy of IDUS, secondaryOutcomes measure: Technical success of SOC, secondaryOutcomes measure: Technical success of IDUS, secondaryOutcomes measure: Adverse event, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06369883, orgStudyIdInfo id: 2022/41, briefTitle: How Often and What Type of Deformity is Detected in All Spine Radiographs?, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital, class: OTHER_GOV, descriptionModule briefSummary: The study will be done retrospectively.The aim of this study is to retrospectively examine the spinal pathologies of patients with a prediagnosis of spinal deformity and for whom spinal radiography is requested and to evaluate the clinical features of these patients., conditionsModule conditions: Scoliosis, conditions: Kyphosis, conditions: Radiography, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 632, type: ESTIMATED, armsInterventionsModule interventions name: Spine radiography, outcomesModule primaryOutcomes measure: Who should have full spine radiographs?, secondaryOutcomes measure: We aimed to determine the frequency of kyphosis, types and percentages of scoliosis detected on the radiographs., eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06369870, orgStudyIdInfo id: PAINCARE, briefTitle: Interpectoral-pectoserratus Plane Block for Minimally Invasive Aortic Valve Replacement Via Right Anterior Minithoracotomy, acronym: PAINCARE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2027-11, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Algemeen Ziekenhuis Maria Middelares, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the analgesic effect of locoregional anaesthesia, specifically the interpectoral pectoserratus plane (IPP-PSP) block, in comparison to a placebo (sham block) after Aortic Valve Replacement via Right Anterior Minithoracotomy (AVR-RAT). The main question the trial aims to answer is: Can the IPP-PSP block effectively reduce opioid consumption within the first 48 hours after AVR-RAT surgery? The purpose is to understand the impact of the IPP-PSP block on postoperative pain. Therefore, the aim is to investigate the influence of the IPP-PSP block on the amount of pain medication administered during the patients' first 48 hours after surgery.Participants, who are scheduled for AVR-RAT surgery, will be randomly assigned to receive either the IPP-PSP block or the sham block. Researchers will compare opioid consumption among other outcomes, including differences in pain scores, incidence of nausea and vomiting, quality of recovery, quality of life, and the length of hospital stay between the two groups.Patients will be monitored during their hospitalization, and a follow-up phone call will be conducted 30 days after surgery., conditionsModule conditions: Analgesic Effect, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The trial is designed as a single-center, prospective, double-blind, randomized controlled superiority trial. Patients will be randomly assigned to either the IPP-PSP block group or the sham block group (placebo)., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Neither the participant, anesthesiologist, study nurse, surgeon, nor the doctors and nurses in the Intensive Care Unit will know the participant's group assignment., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: Levobupivacaine Hydrochloride 0.25 % Injectable Solution, interventions name: Sodium chloride 0.9%, outcomesModule primaryOutcomes measure: Cumulative opioid consumption, secondaryOutcomes measure: Number of episodes of postoperative pain, secondaryOutcomes measure: Time to need for rescue medication, secondaryOutcomes measure: Number of patients with respiratory complications, secondaryOutcomes measure: PaCO2 levels, secondaryOutcomes measure: Postsurgical Quality of Recovery measured by the Quality of Recovery questionnaire, secondaryOutcomes measure: Number of episodes of postoperative nausea and vomiting, secondaryOutcomes measure: Time to extubation, secondaryOutcomes measure: Number of hours spent in the Intensive Care Unit, secondaryOutcomes measure: Hospitalization duration, secondaryOutcomes measure: Quality of life measured by the 5 level version of the EuroQoL-5 Dimension questionnaire, secondaryOutcomes measure: Days alive and at home, secondaryOutcomes measure: Vital status (whether the patient is alive or dead), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bart Vaes, city: Gent, state: Oost-Vlaanderen, zip: 9000, country: Belgium, contacts name: Bart Vaes, MD, role: CONTACT, phone: +3292461700, email: [email protected], contacts name: Steffi Ryckaert, MSc, role: CONTACT, phone: +3292461910, email: [email protected], geoPoint lat: 51.05, lon: 3.71667, hasResults: False |
protocolSection identificationModule nctId: NCT06369857, orgStudyIdInfo id: PPY, briefTitle: Pectopexy for Apical Prolapse Management, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: This study was designed to evaluate the efficacy of pectopexy for treatment of apical pelvic organ prolapse at follow up at 12 months. Investigator also evaluates complications, improvement of symptoms, quality-of-life outcomes and patient satisfaction with surgery.Assessment of restoration of normal pelvic anatomy and lower urinary tract symptoms using transperineal ultrasound, conditionsModule conditions: Pelvic Organ Prolapse, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Case series study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Pectopexy, outcomesModule primaryOutcomes measure: Pelvic Organ Prolapse Quantification stage, secondaryOutcomes measure: Urinary Symptoms questionnaire, secondaryOutcomes measure: Bladder neck measurements using Transperineal US, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06369844, orgStudyIdInfo id: 1.2023-440, briefTitle: Pressure Injury Education Intervention for Pediatric Intensive Care Nurses: A Randomized Controlled Trial, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-04-03, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Ankara Yildirim Beyazıt University, class: OTHER, collaborators name: Ankara City Hospital Bilkent, descriptionModule briefSummary: The purpose of this observational study is to find out the impact of pressure injury education on the knowledge level of pediatric intensive care nurses and the likelihood of pediatric pressure injury occurrence. The main questions it aims to answer are:* Does pressure injury education increase nurses knowledge level on pediatric pressure injuries?* Does the rate of pediatric pressure injuries decrease after the education?The researcher will compare nurses working in two separate pediatric intensive care units where similar patients are treated to see if planned education on pressure injuries affects nurses knowledge level and the rate of pediatric pressure injuries.* Volunteer nurses participating in the study will answer pressure injury survey questions prepared by the researcher.* Nurses in the intervention group will attend planned education sessions provided by the researcher.* Two weeks after the completion of the education sessions, all nurses in the intervention and control groups who wish to continue participating in the study will answer the pressure injury survey questions prepared by the researcher again., conditionsModule conditions: Pressure Injury Prevention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study design will be two-group and pretest-posttest design., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Pressure injury education, outcomesModule primaryOutcomes measure: Stop Pressure Injuries" Education Evaluation Survey, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara yıldırım Beyazıt Üniversitesi, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06369831, orgStudyIdInfo id: ABS011-1, secondaryIdInfos id: 2024-511419-22-00, type: CTIS, briefTitle: HER2 Targeted Molecular Imaging in mBC Using 68Ga-ABS011, acronym: HERMIA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: ABSCINT NV/SA, class: INDUSTRY, descriptionModule briefSummary: This phase II study aims to confirm the diagnostic performance and accuracy of 68Ga-ABS011 PET/CT in determining the HER2 expression status, and to evaluate 68Ga-ABS011's ability to drive changes in therapeutic treatment. 68Ga-ABS011 will be compared to the current standard of care (SOCa) diagnostic methods including immunohistochemistry (IHC), in situ hybridization (ISH) and imaging tools used for treatment response follow-up including Fluorodeoxyglucose F-18 (18F-FDG) positron emitted tomography (PET) and contrast enhanced computed tomography (ceCT)., conditionsModule conditions: Metastatic Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Interventional, prospective, single arm radio-diagnostic study. Driven by number of biopsied lesions (and not by number of patients), primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: 68Ga-NOTA-ABSCINT-HER2 PET/CT, outcomesModule primaryOutcomes measure: positive, negative, and overall diagnostic agreement between 68Ga-ABS011 PET/CT and the standard of care IHC (and ISH) HER2 status test., secondaryOutcomes measure: Safety of 68Ga-ABS011., secondaryOutcomes measure: Change in treatment management, secondaryOutcomes measure: reliability of whole body 68Ga-ABS011 PET/CT compared to HER2-targeted treatment response (Early tumor shrinkage), secondaryOutcomes measure: reliability of whole body 68Ga-ABS011 PET/CT compared to HER2-targeted treatment response (metabolic response), secondaryOutcomes measure: Tumor heterogeneity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: OLV Aalst, city: Aalst, state: East-Flanders, zip: 9300, country: Belgium, contacts name: G. Huygh, Dr., role: CONTACT, geoPoint lat: 50.93604, lon: 4.0355, locations facility: AZ Delta, city: Brussels, zip: 1070, country: Belgium, contacts name: C. Closset, Dr., role: CONTACT, geoPoint lat: 50.85045, lon: 4.34878, locations facility: Cliniques Universitaires Saint-Luc, city: Brussels, zip: 1070, country: Belgium, contacts name: F. Duhoux, Prof., role: CONTACT, geoPoint lat: 50.85045, lon: 4.34878, locations facility: Free University Brussels (VUB), city: Brussels, zip: 1070, country: Belgium, contacts name: C. Fontaine, Dr., role: CONTACT, geoPoint lat: 50.85045, lon: 4.34878, locations facility: Institut Jules Bordet, city: Brussels, zip: 1070, country: Belgium, contacts name: E. De Azambuja, Prof., role: CONTACT, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False |
protocolSection identificationModule nctId: NCT06369818, orgStudyIdInfo id: AnIt23-02, briefTitle: Correlation of Cardiac Output Determined by Echocardiography and Indirect Calorimetry in Critically Ill Patients in Cardiogenic Shock on Extracorporeal Circulatory Life Support, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Universität Münster, class: OTHER, descriptionModule briefSummary: This observational study investigates whether the daily measured trend of cardiac output as evaluated by indirect calorimetry correlates with the same evaluated by transthoracic echocardiography., conditionsModule conditions: Cardiogenic Shock, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Correlation of t two methods of determining cardiac output (determined by transthoracic echocardiography and determined by indirect calorimetry, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Münster, city: Münster, zip: 48149, country: Germany, contacts name: Thilo von Groote, MD, role: CONTACT, phone: +49-251-47255, geoPoint lat: 51.96236, lon: 7.62571, hasResults: False |
protocolSection identificationModule nctId: NCT06369805, orgStudyIdInfo id: 2021-00731, briefTitle: EVALUATION OF BLOOD BIOMARKER-BASED DIAGNOSTIC AID IN OUTPATIENTS SUFFERING FROM DEPRESSION, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-06-02, primaryCompletionDateStruct date: 2022-11-17, completionDateStruct date: 2022-11-17, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Les Toises - Psychiatry and Psychotherapy Center, class: OTHER, descriptionModule briefSummary: This is an observational (non-interventional) study, carried out in an outpatient setting, which involves a blood sampling. The primary objective of this study is to confirm the association between the EDIT-B® editing signature and early unipolar or bipolar differentiation. Results of this research may provide an aid to early diagnosis and guide clinical practice towards individualized treatment., conditionsModule conditions: Depressive Disorder, conditions: Bipolar Disorder, conditions: Bipolar Depression, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 307, type: ACTUAL, armsInterventionsModule interventions name: there is no intervention, outcomesModule primaryOutcomes measure: Psychiatric symptomatology, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Les Toises - Psychiatry and Psychotherapy Center, city: Lausanne, zip: 1005, country: Switzerland, geoPoint lat: 46.516, lon: 6.63282, hasResults: False |
protocolSection identificationModule nctId: NCT06369792, orgStudyIdInfo id: 2020-00266, briefTitle: PROSPECTIVE EVALUATION OF BLOOD BIOMARKERS AS AN AID TO DIAGNOSTIC AND TREATMENT IN DRUG-NAIVE PATIENTS WITH DEPRESSION, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-10-20, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Les Toises - Psychiatry and Psychotherapy Center, class: OTHER, descriptionModule briefSummary: This is an observational (non-interventional) prospective study, carried out in drug-naïve outpatients who start a treatment with escitalopram, fluoxetine, sertraline or quetiapine. Five blood samples are collected (i.e. before initiating the drug, and then after 1, 2, 4 and 8 weeks of treatment). It does not affect the choice or the treatment dose. The primary objective of this study is to measure the association between the EDIT-B® editing signature and response to pharmacological treatment in drug-naïve patients. Results of this research could provide an aid to early diagnosis, optimize pharmacological treatment and guide clinical practice towards individualized treatment., conditionsModule conditions: Depressive Disorder, conditions: Bipolar Disorder, conditions: Bipolar Depression, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: psychiatric symptomatology, primaryOutcomes measure: EDIT-B profiling, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Les Toises - Psychiatry and Psychotherapy Center, status: RECRUITING, city: Lausanne, zip: 1005, country: Switzerland, contacts name: Aurélie Reymond-Delacrétaz, PhD, role: CONTACT, phone: +41584580580, email: [email protected], geoPoint lat: 46.516, lon: 6.63282, hasResults: False |
protocolSection identificationModule nctId: NCT06369779, orgStudyIdInfo id: OTCS 36406866, briefTitle: Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Direct Restorative Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2030-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Ivoclar Vivadent AG, class: INDUSTRY, descriptionModule briefSummary: The overall objective of this clinical investigation is to evaluate the clinical safety and performance of the new flowable composite TM Flow and the new sculptable composite TM Fill for restoration of class I and class II cavities. The fillings are assessed according to selected FDI criteria at baseline (7-10 days after placement of filling) and after 1, 6, 12, 24, 36 and 60 months., conditionsModule conditions: Class I or II Cavities in Premolars or Molars, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 65, type: ESTIMATED, armsInterventionsModule interventions name: TM Fill and TM Flow, outcomesModule primaryOutcomes measure: Postoperative hypersensitivity, secondaryOutcomes measure: evaluation of functional (e.g. fracture of the material and retention), biological (e.g. caries at restoration margins) and aesthetic (e.g. color match) properties of the restorations, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06369766, orgStudyIdInfo id: 2023-02144; ko23Papadopoulou4, briefTitle: REtinal Markers In Neuroinflammatory Diseases ("REMIND"), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2029-02, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University Hospital, Basel, Switzerland, class: OTHER, collaborators name: University of Basel, descriptionModule briefSummary: The goal of this observational study, including patients with Multiple Sclerosis, patients with other neuroinflammatory diseases and healthy controls, is to determine the predictive value of retinal markers in predicting disease progression. Participants complete a questionnaire and undergo various non-invasive retinal routine clinical examinations., conditionsModule conditions: Multiple Sclerosis, conditions: Neuroinflammatory Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Optical coherence tomography (OCT), interventions name: Static retinal vessel analyzer, interventions name: Dynamic retinal vessel analyzer, interventions name: Laser speckle flowgraphy system, interventions name: Questionnaire, outcomesModule primaryOutcomes measure: Occurence of Progression Independent of Relapse Activity (PIRA), primaryOutcomes measure: Neuroaxonal loss in the retina (as marker of neurodegeneration in the CNS), primaryOutcomes measure: Neuroinflammation in the retina, primaryOutcomes measure: Fixation instability (as marker of global neuronal dysfunction in the CNS), primaryOutcomes measure: Structural changes of the retinal vessels (as marker of systemic microvascular health), primaryOutcomes measure: (For a subgroup of participants) Functional/perfusional changes of the retinal vessels, secondaryOutcomes measure: Relative value of retinal markers for the prediction of PIRA compared to or combined with other biomarkers of neuroaxonal damage, secondaryOutcomes measure: Comparison of the examined retinal markers of Multiple Sclerosis patients with Healthy Controls and with patients with other neuroinflammatory diseases of the CNS, secondaryOutcomes measure: The relationship between neuroaxonal loss, functional deficits and vascular changes in Multiple Sclerosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Basel, Department of Neurology, status: RECRUITING, city: Basel, zip: 4031, country: Switzerland, contacts name: Athina Papadopoulou, PD Dr. med., role: CONTACT, phone: +41 61 32 85704, email: [email protected], contacts name: Athina Papadopoulou, PD Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.55839, lon: 7.57327, hasResults: False |
protocolSection identificationModule nctId: NCT06369753, orgStudyIdInfo id: PR(AG)459/2023B, briefTitle: Visible Abdominal Distension, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Hospital Universitari Vall d'Hebron Research Institute, class: OTHER, descriptionModule briefSummary: Background. Abdominal distention is produced by an abnormal somatic postural tone. The authors developed an original biofeedback technique. In a randomized, placebo-controlled trial the authors demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical.Aim. To prove the efficacy of a noninstrumental biofeedback technique, transmitted by a standard training program, for the treatment of abdominal distension in different centers.Selection criteria. Episodes of visible abdominal distension. Intervention. Patients will be randomized into biofeedback and placebo groups. Three sessions of either biofeedback or placebo intervention will be performed during the first 3 weeks of the intervention period.Biofeedback: Patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. In each center one operator will receive a standard training on how to deliver the noninstrumental biofeedback treatment. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.Placebo: Sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period., conditionsModule conditions: Irritable Bowel Syndrome, conditions: Dyspepsia, conditions: Functional Bloating, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Biofeedback, interventions name: Placebo, outcomesModule primaryOutcomes measure: Visible abdominal distension, secondaryOutcomes measure: Sensation of abdominal pressure/fullness, secondaryOutcomes measure: Sensation of abdominal discomfort/pain, otherOutcomes measure: Follow-up after biofeedback, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitari Vall d'Hebron, city: Barcelona, zip: 08035, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False |
protocolSection identificationModule nctId: NCT06369740, orgStudyIdInfo id: ENZ20-2024-INDIANAPOLIS, briefTitle: Case and Use Scenario Study to Gain Knowledge on the User Needs for a Medical Device for Hemophilia A Monitoring, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-06-04, completionDateStruct date: 2024-06-04, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Enzyre B.V., class: INDUSTRY, collaborators name: Indiana Hemophilia & Thrombosis Center, descriptionModule briefSummary: This observational study consists of two parts.In part one, case scenario focus groups with hemophilia A patients and healthcare providers (HCPs) will be held. This parts aims to identify potential use scenarios of a point of care (POC) in vitro medical for patients with hemophilia A. The main questions it aims to answer are:* How is coagulation lab testing for patients with hemophilia A currently organized?* What is the interest and what are desired alternatives of a POC in-vitro diagnostic medical device for patients with hemophilia A?Part two of the study consists of a use scenario study in which patients with hemophilia A and HCPs will evaluate two types of non-functional mock-ups of a POC in vitro medical device. The main goal of this part is to evaluate the usability of the current prototypes of the POC device., conditionsModule conditions: Hemophilia A, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: Case scenarios - questionnaire, interventions name: Case scenarios - Focus groups, interventions name: Use scenarios - Usability test, interventions name: Use scenarios - interview, outcomesModule primaryOutcomes measure: Current management of Hemophilia A coagulation lab testing, primaryOutcomes measure: Potential case scenarios for a point of care in-vitro diagnostic device for hemophilia A, primaryOutcomes measure: Usability issues of the current POC in-vitro diagnostic device prototypes, secondaryOutcomes measure: User preferences for the point of care in-vitro diagnostic device, secondaryOutcomes measure: Problems with current Hemophilia A coagulation monitoring, secondaryOutcomes measure: Potential benefits of a POC device for home use, near-patient use or in clinic use, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Indiana Hemophilia & Thrombosis Center, city: Indianapolis, state: Indiana, zip: 46260, country: United States, geoPoint lat: 39.76838, lon: -86.15804, hasResults: False |
protocolSection identificationModule nctId: NCT06369727, orgStudyIdInfo id: MOB015B-VI, briefTitle: Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design, acronym: RIPT, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-10-15, primaryCompletionDateStruct date: 2018-02-15, completionDateStruct date: 2018-02-15, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Moberg Pharma AB, class: INDUSTRY, descriptionModule briefSummary: A Randomized, Controlled Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design To evaluate the sensitization potential, conditionsModule conditions: Erythema, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: NA- Safety study, enrollmentInfo count: 250, type: ACTUAL, armsInterventionsModule interventions name: MOB015B, interventions name: MOB015B vehicle, interventions name: Negative irritant solution of 0.9% saline, outcomesModule primaryOutcomes measure: To determine the potential of MOB015B to induce sensitization by repeated topical application to the healthy skin of humans under controlled conditions., primaryOutcomes measure: To assess safety, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: TKL Research, Inc, city: Fair Lawn, state: New Jersey, zip: 07410, country: United States, geoPoint lat: 40.94038, lon: -74.13181, hasResults: False |
protocolSection identificationModule nctId: NCT06369714, orgStudyIdInfo id: CHEC2023-296, briefTitle: Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of ADHD in Children., acronym: ADHD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-24, primaryCompletionDateStruct date: 2025-02-24, completionDateStruct date: 2025-02-24, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Lei Lei, MD, class: OTHER, descriptionModule briefSummary: A multi-center, randomized controlled trial is being conducted to investigate the efficacy of a novel digital therapeutics (DTx) program that utilizes a cross-training approach between neurofeedback training and executive function training for pediatric patients (aged 6-12) diagnosed with ADHD. This gamified interactive program is designed to improve attention deficits and executive function impairments in pediatric patients with ADHD. It is delivered through an engaging iPad game in a home-based treatment format. Patients will be randomly assigned to one of three groups: medication alone, digital therapeutics alone, or a combination of both interventions. Subjects will undergo 30 treatment sessions over the 8-week period, with each session lasting 30 minutes. Investigators will reassess symptoms of ADHD, executive functions, and objective measures of attention at the end of the treatment. Additionally, questionnaires will be distributed to parents to gather their insights and feedback on the treatment approach. This innovative digital therapeutics approach is expected to improve ADHD symptoms individually and enhance therapeutic outcomes when used alongside conventional drug treatment regimens., conditionsModule conditions: Attention Deficit Disorder With Hyperactivity, conditions: Executive Function Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Concerta, interventions name: Digital therapeutics, outcomesModule primaryOutcomes measure: Swanson, Nolan, and Pelham IV Rating Scale, secondaryOutcomes measure: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for ADHD, secondaryOutcomes measure: Questionnaire-Children with Difficulties, secondaryOutcomes measure: Behavior Rating Inventory of Executive Function, secondaryOutcomes measure: Continuous Performance Test, secondaryOutcomes measure: Digital Cancellation Test, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Changzheng Hospital, Naval Medical University, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200003, country: China, contacts name: Yujiao Wang, MBBS, role: CONTACT, phone: 15021500051, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, locations facility: Changhai Hospital, Naval Medical University, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200433, country: China, contacts name: Yuanhao Cai, MBBS, role: CONTACT, phone: 15001969690, email: [email protected], contacts name: Yuanhao Cai, MBBS, role: SUB_INVESTIGATOR, contacts name: Lei Lei, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06369701, orgStudyIdInfo id: C.2024.019, briefTitle: Effects Compressive Tissue Flossing on Lateral Elbow Tendinopathy in US Service Members, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Brooke Army Medical Center, class: FED, descriptionModule briefSummary: The purpose of this research study will be to assess the effects of a compressive tissue flossing (CTF) program on the symptoms of lateral elbow tendinopathy in United States service members. Dependent variables will be the Defense and Veteran's Pain Rating Scale (DVPRS), decrease their Patient-Rated Tennis Elbow Evaluation (PRTEE) score, increase their maximal grip strength in the affected upper extremity (UE). Measurements will be taken at baseline, immediately after the first CTF intervention, and at the 1-week follow-up, for a total of 3 measurements., conditionsModule conditions: Lateral Elbow Tendinopathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Within-subjects repeated measures design, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Compressive tissue floss band, outcomesModule primaryOutcomes measure: Patient's report of pain on the Defense and Veteran's Pain Rating Scale, primaryOutcomes measure: Patient-Rated Tennis Elbow Evaluation, primaryOutcomes measure: Maximal grip strength in the affected upper extremity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brooke Army Medical Center, status: RECRUITING, city: Fort Sam Houston, state: Texas, zip: 78234, country: United States, contacts name: Carly R Cooper, PhD, role: CONTACT, phone: 210-808-2240, email: [email protected], contacts name: Brian T Gregg, PhD, role: CONTACT, phone: (210) 808-2269, email: [email protected], contacts name: John E Elam, DSc Fellow, role: PRINCIPAL_INVESTIGATOR, contacts name: Carly R Cooper, PhD, role: SUB_INVESTIGATOR, contacts name: Katelyn A Culley, DSc Fellow, role: SUB_INVESTIGATOR, contacts name: Tara A Haugen, DSc Fellow, role: SUB_INVESTIGATOR, geoPoint lat: 29.45746, lon: -98.4472, hasResults: False |
protocolSection identificationModule nctId: NCT06369688, orgStudyIdInfo id: Baqiyatallah University, briefTitle: IDEAL SKIIN CARES Bundle to Prevent Pressure Injury, acronym: IdealSkinCares, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-10-01, primaryCompletionDateStruct date: 2026-10-01, completionDateStruct date: 2027-10-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Baqiyatallah Medical Sciences University, class: OTHER, collaborators name: Tehran University of Medical Sciences, collaborators name: Hamadan University of Medical Science, collaborators name: Tabriz University of Medical Sciences, descriptionModule briefSummary: The study will be a multi-center, triple-blinded, cluster randomized controlled trial (c-RCT) conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group, where patients will receive training in relevant pressure injury care bundles, and the placebo group, where patients will receive training in an irrelevant topic like respiratory care. Both intervention and placebo groups will receive specialized pressure injury prevention (PIP) care bundle from trained wound specialist nurses (WSNs). The third arm will be the control group comprising patients who do not undergo any training course and will receive only routine standard care for PIP care bundle. The aim of c-RCT will be to compare the incidence of hospital-acquired pressure injury (HAPI) in the three study groups and to provide detailed evidence on the effect of the developed pressure injury care bundle, administered by WSNs on the development of HAPI in trained hospitalized patients, as opposed to those receiving routine standard care for PIP care bundle without training., conditionsModule conditions: Pressure Ulcer, conditions: Pressure Injury, conditions: Bed Sore, conditions: Pressure Sore, conditions: Decubitus Sore, conditions: Decubitus Ulcer, conditions: Skin Ulcer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: C-RCT will be conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group and the placebo group. The third arm will be the control group., primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: In this placebo-controlled trial, patients will be blinded to their group allocations. Additionally, WSNs, who are trained for delivering special PIP care bundles, as well as nursing staff who are responsible for measuring wounds and collecting data, and data analyst, will also be blinded., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1620, type: ESTIMATED, armsInterventionsModule interventions name: IDEAL SKIIN CARES bundles, interventions name: IDEAL SKIIN CARES bundles workshop, interventions name: Respiratory care workshop, outcomesModule primaryOutcomes measure: Incidence of hospital-acquired pressure injury (HAPI), secondaryOutcomes measure: Pressure Injury Stage, secondaryOutcomes measure: Patient participation in care, secondaryOutcomes measure: Healthcare costs, secondaryOutcomes measure: Self-report Patient participation in care, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06369675, orgStudyIdInfo id: MOB015B-V, briefTitle: Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design, acronym: CIPT, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-10-19, primaryCompletionDateStruct date: 2017-11-14, completionDateStruct date: 2017-11-14, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Moberg Pharma AB, class: INDUSTRY, descriptionModule briefSummary: A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design To evaluate the irritation potential of MOB015B on normal skin. Single center, randomized, controlled, evaluator blinded, within-subject comparison study, conditionsModule conditions: Erythema, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ACTUAL, armsInterventionsModule interventions name: MOB015B, interventions name: 0.2% SLS, interventions name: 0.9% Saline, interventions name: MOB015B vehicle, outcomesModule primaryOutcomes measure: To determine the potential of MOB015B to cause skin irritation after repeated topical application to the healthy skin of humans under controlled conditions., primaryOutcomes measure: To assess safety, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: TKL Research, Inc, city: Fair Lawn, state: New Jersey, zip: 07410, country: United States, geoPoint lat: 40.94038, lon: -74.13181, hasResults: False |
protocolSection identificationModule nctId: NCT06369662, orgStudyIdInfo id: SECI-CD155, secondaryIdInfos id: SECI-IRB-IORG0006563-545, type: OTHER, domain: Scientific Research Unit, briefTitle: CD155 Expression in Acute Myeloid Leukemia, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy. It is the most common form of acute leukemia among adults. In the United States, an estimated 19,940 people will be diagnosed with AML in 2020.CD155 expression was associated with an unfavorable prognosis in solid tumors such as colon cancer, breast cancer, lung adenocarcinoma, pancreatic cancer, melanoma, and glioblastoma, as it correlated with tumor migration, development of metastases, tissue and lymph node invasion, relapse, and poorer survival., conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 93, type: ACTUAL, armsInterventionsModule interventions name: Flow cytometric immunophenotyping, interventions name: Complete blood count, interventions name: Bone marrow aspiration, interventions name: Cytogenetic testing, interventions name: FLT3-ITD using High resolution melting curve (HRM) analysis, outcomesModule primaryOutcomes measure: CD155 expression level in AML patients, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: South Egypt Cancer Institute, Assiut University, city: Assiut, zip: 71111, country: Egypt, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False |
protocolSection identificationModule nctId: NCT06369649, orgStudyIdInfo id: COOLSENSE-1, briefTitle: Coolsense and Buzzy Use on Pain Score and Anxiety Level During Insulin Injection Application, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Ankara Yildirim Beyazıt University, class: OTHER, descriptionModule briefSummary: This study aims to determine the effect of using Coolsense, which is created using the proven effect of cold application during insulin injection, and Buzzy, which is a combination of vibration and cold application, in reducing pain and anxiety in children diagnosed with Type 1 diabetes mellitus.This randomized controlled clinical study is planned to be conducted between 05.2024-12.2025 with 147 participants between the ages of 6-12. Participants will be divided into three groups according to the randomization method: buzzy group (n = 49), coolsense group (n = 49) and control group (n = 49). Participants in the Coolsense group will receive a cold application using the coolsense device for 5 seconds before the injection. Participants in the Buzzy group will be subjected to vibration and cold application 30-60 seconds before the procedure. Participants in the control group will continue the clinic's standard procedure. Changes in participants' pain score and fear level, heart rate, blood pressure, respiratory rate and oxygen saturation will be measured at three time points: immediately before and after the procedure. Data descriptive information form, application registration form, Facial Expressions Pain Scale (FPS-R) and Child Fear Scale (CFS) will be used. The collected data will be analyzed using SPSS 15 software. The main questions it aims to answer:* Does buzzy and coolsense application have an effect the pain score of children during the insülin injection?* Does buzzy and coolsense application have an effect the fear score of children during the insülin injection?* Does buzzy and coolsense application have an effect the heart rate of children during the insülin injection?* Does buzzy and coolsense application have an effect the oxygen saturation of children during the insülin injection?* Does buzzy and coolsense application have an effect the blood pressure of children during the insülin injection?* Does buzzy and coolsense application have an effect the respiratory rate of children during the insülin injection?, conditionsModule conditions: Injection Fear, conditions: Injection Site Coldness, conditions: Pain, conditions: Type 1 Diabetes Mellitus, conditions: Pediatric Disease, conditions: Nurse's Role, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Single blinding (participants) will be used in the research and the researchers will not have information about the other group.While applying both scales, care will be taken to ensure that children, parents and observers do not see each other's evaluations and are not influenced by each other. In this way, the child, parent and independent observer will score blindly before and after the procedure., whoMasked: PARTICIPANT, enrollmentInfo count: 147, type: ESTIMATED, armsInterventionsModule interventions name: Coolsense and Buzzy, outcomesModule primaryOutcomes measure: Faces Pain Scale- Revised (FPS-R), primaryOutcomes measure: Children's Fear Scale (CFS), primaryOutcomes measure: Heart rate, primaryOutcomes measure: Oxygen saturation, primaryOutcomes measure: Respiratory rate, primaryOutcomes measure: Blood pressure, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06369636, orgStudyIdInfo id: myucesu, briefTitle: Comparison of El-Ganzouri Risk Index and Airway Ultrasonographic Evaluation in Thyroid Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2023-10-31, completionDateStruct date: 2024-01-28, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: The primary purpose of this prospective observational study was to compare these tests used to predict difficult intubation in patients undergoing thyroid surgery. Secondarily; By comparing these tests, we aim to find the test that best predicts difficult intubation and to determine the incidence of difficult intubation in patients who will undergo thyroid surgery., conditionsModule conditions: Thyroid Surgery, conditions: Difficult Intubation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule interventions name: Thyroid Surgery, outcomesModule primaryOutcomes measure: Compare EGRI and airway ultrasonographic parameters, secondaryOutcomes measure: Find which is the best test predicts difficult intubation, secondaryOutcomes measure: Finding the incidence of difficult intubation in thyroid surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Bilkent City Hospital, city: Ankara, state: Çankaya, zip: 06800, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06369623, orgStudyIdInfo id: IRB2023-00466, briefTitle: Monetary Incentive Delay Task for Probing Reward-related Neural Processes, acronym: MID, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-06, primaryCompletionDateStruct date: 2028-11-30, completionDateStruct date: 2028-11-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Stony Brook University, class: OTHER, descriptionModule briefSummary: 150 males and 150 females ages 14-17 years-old will be enrolled in an observational, longitudinal study. There are three planned in-person visits: a baseline assessment, an 18-month follow-up, and a 36-month follow-up. The in-person visits will include assessment of substance use and other individual differences (e.g., reward function, psychiatric history), neuromelanin-sensitive MRI, as well as functional brain activation collected while the participant is at rest (resting-state fMRI) and while the participant completes a Monetary Incentive Delay task. Subjects will also be asked to complete past 90-day substance use assessments remotely every 90 days for 36 months., conditionsModule conditions: Adolescent Development, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Monetary Incentive Delay Task, outcomesModule primaryOutcomes measure: Functional Brain Activation from Monetary Incentive Delay Task, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Stony Brook Medicine, status: RECRUITING, city: Stony Brook, state: New York, zip: 11794, country: United States, contacts name: Greg Perlman, PhD, role: CONTACT, phone: 631-638-1922, email: [email protected], contacts name: Roman Kotov, PhD, role: CONTACT, contacts name: Greg Perlman, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.92565, lon: -73.14094, hasResults: False |
protocolSection identificationModule nctId: NCT06369610, orgStudyIdInfo id: GMROA2256, secondaryIdInfos id: NCI-2024-03020, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 22-012591, type: OTHER, domain: Mayo Clinic Institutional Review Board, secondaryIdInfos id: GMROA2256, type: OTHER, domain: Mayo Clinic in Arizona, briefTitle: Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment Prostate Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2027-04-22, completionDateStruct date: 2027-04-22, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This phase II trial tests how well risk based de-escalated hormone therapy (i.e., fewer treatments) with radiation works in treating patients with prostate cancer. Androgen deprivation therapy (ADT), such as gonadotropin-releasing hormone analogs (LHRH) and abiraterone acetate (Zytiga), lower the amount of the male hormone, testosterone, made by the body. This may help kill or stop the growth of tumor cells that need testosterone to grow. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Research has shown that long-term ADT is beneficial for patients with high-risk prostate cancer. However, there are few studies that determine ADT treatment based on risk factors. Giving risk based de-escalated ADT with radiation therapy may be as effective as giving more ADT in treating high-risk prostate cancer., conditionsModule conditions: Oligometastatic Prostate Carcinoma, conditions: Prostate Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Abiraterone Acetate, interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Gonadotropin-releasing Hormone Analog, interventions name: Magnetic Resonance Imaging, interventions name: Positron Emission Tomography, interventions name: Questionnaire Administration, interventions name: Radiation Therapy, outcomesModule primaryOutcomes measure: Hormonal domain scores, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Arizona, status: RECRUITING, city: Scottsdale, state: Arizona, zip: 85259, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: [email protected], contacts name: Carlos E. Vargas, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.50921, lon: -111.89903, hasResults: False |
protocolSection identificationModule nctId: NCT06369597, orgStudyIdInfo id: Robot2024, briefTitle: A Randomized Controlled Trial of the Safety and Efficacy of Robotic Telesurgery Versus Laparoscopic Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: This is a randomized controlled trial that will be preceded by a safety trial focusing on the safety and efficacy of robotic telesurgery. The hypothesis is that robotic telesurgery has a non-inferior primary endpoint event rate to local laparoscopic surgery., conditionsModule conditions: Liver Cancer, conditions: Renal Cancer, conditions: Rectal Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 177, type: ESTIMATED, armsInterventionsModule interventions name: Robotic telesurgery, interventions name: Laparoscopic surgery, outcomesModule primaryOutcomes measure: Surgical complication, secondaryOutcomes measure: Surgical time (min), secondaryOutcomes measure: Intraoperative blood loss (mL), secondaryOutcomes measure: Postoperative hospitalization days, secondaryOutcomes measure: Physician satisfaction, secondaryOutcomes measure: Remote metrics, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Affiliated Hospital, Sun Yat-Sen University, city: Guangzhou, state: Guangdong, zip: 510080, country: China, contacts name: Kuang Ming, PhD, role: CONTACT, phone: 008687755766, phoneExt: 8576, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06369584, orgStudyIdInfo id: PEPAD, briefTitle: Prone Position During ECMO in Pediatric Patients With Severe ARDS, acronym: PEPAD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Seventh Medical Center of PLA General Hospital, class: OTHER, collaborators name: Gansu Provincial Maternal and Child Health Care Hospital, collaborators name: Xian Children's Hospital, collaborators name: Henan Provincial People's Hospital, collaborators name: People's Hospital of Guangxi, collaborators name: Guangdong Provincial People's Hospital, descriptionModule briefSummary: In 2023, the second Pediatric Acute Lung Injury Consensus Conference (PALICC-2) updated the diagnostic and management guidelines for Pediatric Acute Respiratory Distress Syndrome (PARDS). The guidelines do not provide sufficient evidence-based recommendations on whether prone positioning ventilation is necessary for severe PARDS patients. However, the effectiveness of Extracorporeal Membrane Oxygenation (ECMO) in treating severe PARDS has been fluctuating around 70% according to recent data from Extracorporeal Life Support Organization (ELSO).In 2018, the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) study group conducted a retrospective analysis and concluded that ECMO does not significantly improve survival rates for severe PARDS. However, this retrospective study mainly focused on data from North America, with significant variations in annual ECMO support cases among different centers, which may introduce bias. With advancements in ECMO technology and materials, ECMO has become safer and easier to operate. In recent years, pediatric ECMO support technology has rapidly grown in mainland China and is increasingly being widely used domestically to rescue more children promptly.ECMO can also serve as a salvage measure for severely ARDS children who have failed conventional mechanical ventilation treatment. When optimizing ventilator parameters (titrating positive end expiratory pressure (PEEP) levels, neuromuscular blockers, prone positioning), strict fluid management alone cannot maintain satisfactory oxygenation (P/F\<80mmHg or Oxygen Index (OI) \>40 for over 4 hours or OI \>20 for over 24 hours), initiating ECMO can achieve lung-protective ventilation strategies with ultra-low tidal volumes to minimize ventilator-associated lung injury., conditionsModule conditions: Pediatric Acute Respiratory Distress Syndrome, conditions: Extracorporeal Membrane Oxygenation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 7, type: ESTIMATED, armsInterventionsModule interventions name: prone position, outcomesModule primaryOutcomes measure: Mortality, secondaryOutcomes measure: Failure of supine position, secondaryOutcomes measure: ECMO successful weaning rate, secondaryOutcomes measure: Total duration of ECMO Support, secondaryOutcomes measure: Number of ECMO-free days, secondaryOutcomes measure: Duration of mechanical ventilation days after ECMO successful weaning., secondaryOutcomes measure: Duration of Pediatric Intensive Care Unit (PICU) stay., secondaryOutcomes measure: Duration of hospitalization, secondaryOutcomes measure: Incidence of brain injury before discharge, secondaryOutcomes measure: Number of days with organ failure, secondaryOutcomes measure: Number of days alive without organ failure, secondaryOutcomes measure: Number of ventilator assist pneumonia, bacteriemia, and cannula infection episodes, secondaryOutcomes measure: Number of days with hemodynamic support with catecholamines, secondaryOutcomes measure: Number of days without hemodynamic support with catecholamines, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: seventh medical center of Chinese PLA General Hospital, city: Beijing, state: Beijing, zip: 100700, country: China, contacts name: Xiaoyang Hong, M.D., role: CONTACT, phone: 13311057633, email: [email protected], contacts name: Zhe Zhao, role: CONTACT, phone: 18500179885, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, locations facility: Gansu Provincial Maternal and Child Health Care Hospital, city: Lanzhou, state: Gansu, zip: 730050, country: China, contacts name: Weikai Wang, M.D., role: CONTACT, phone: 0931-5188650, email: [email protected], geoPoint lat: 36.05701, lon: 103.83987, locations facility: The Second School of Clinical Medicine, Southern Medical University, city: Guangzhou, state: Guangdong, country: China, contacts name: Yuxiong Guo, M.D., role: CONTACT, phone: 13423661583, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, locations facility: The People's Hospital of Guangxi Zhuang Autonomous Region, city: Nanning, state: Guangxi, country: China, contacts name: Hanwu Huang, M.D., role: CONTACT, phone: 15107710327, email: [email protected], geoPoint lat: 22.81667, lon: 108.31667, locations facility: Henan Children's Hospital, city: Zhengzhou, state: Henan, zip: 450014, country: China, contacts name: Feng Wang, M.D., role: CONTACT, phone: 0371-85515892, email: [email protected], geoPoint lat: 34.75778, lon: 113.64861, locations facility: Henan Provincial People's Hospital, city: Zhengzhou, state: Henan, zip: 463599, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Xi'an Children's Hospital, city: Xi'an, state: Shaanxi, zip: 710002, country: China, contacts name: Yi Wang, M.D., role: CONTACT, phone: 18591953652, email: [email protected], geoPoint lat: 34.25833, lon: 108.92861, hasResults: False |
protocolSection identificationModule nctId: NCT06369571, orgStudyIdInfo id: IRB00439268, briefTitle: Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: American Heart Association, descriptionModule briefSummary: Ketogenic diet therapies (KDTs) emphasize high fat and very low carbohydrate intake and help to control seizures in adults who fail to respond to medications. However, KDT use can lead to increased cholesterol levels in some adults with epilepsy (AWE). Treatments that can reverse elevations in cholesterol observed with long-term KDT use without compromising diet adherence and seizure control are needed. The proposed study will explore the feasibility and safety of diet modification and statin use to lower cholesterol in this population. Study findings will help guide doctors utilizing KDTs in adults with epilepsy on how to approach managing elevations in cholesterol., conditionsModule conditions: Epilepsy, conditions: Dyslipidemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Atorvastatin 10mg, interventions name: Modification of dietary fat composition, outcomesModule primaryOutcomes measure: Diet adherence as assessed by 3 day food records, primaryOutcomes measure: Statin Adherence, primaryOutcomes measure: LDL Change, primaryOutcomes measure: Change in weekly seizure frequency, primaryOutcomes measure: Seizure severity questionnaire score, secondaryOutcomes measure: Frequency of adverse events, secondaryOutcomes measure: Blood ketone change, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06369558, orgStudyIdInfo id: BiruniUniversi, briefTitle: Plyometric Exercise Training in Athletes With Chronic Low Back Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-04-04, completionDateStruct date: 2024-04-04, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Ugur Cavlak, class: OTHER, collaborators name: Biruni University, descriptionModule briefSummary: The aim of this study is to examine the effectiveness of plyometric exercise training in the athletes with chronic low back pain. 32 professional volunteer athletes participated in the study., conditionsModule conditions: Low Back Pain, Mechanical, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: PLYOMETRIC TRAINING, interventions name: CLASSIC PHYSIOTHERAPY PROGRAM, outcomesModule primaryOutcomes measure: VISUAL ANALOG SCALE, primaryOutcomes measure: OSWESTRY DISABILITY INDEX, primaryOutcomes measure: SIT AND REACH TEST, primaryOutcomes measure: VERTICAL JUMP TEST, primaryOutcomes measure: FLAMINGO BALANCE TEST, primaryOutcomes measure: SHUTTLE RUNNİNG (20 MİN.), primaryOutcomes measure: MANUAL MUSCLE STRENGTH TEST, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Health Sciences in Biruni University, city: İ̇stanbul, state: Zeytinburnu, zip: 34010, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06369545, orgStudyIdInfo id: BiruniUniver, briefTitle: Chronic Pelvic Pain Syndrome in Males, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-04-04, completionDateStruct date: 2024-08-15, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Biruni University, class: OTHER, descriptionModule briefSummary: The aim of this study is to evaluate the effectiveness of ESWT (Extracorporeal Shock Wave Therapy) and TENS (Transcutaneous Electrical Nerve Stimulation) in individuals diagnosed with chronic pelvic pain syndrome and treated with medication. The study was organized as a randomized controlled trial. The sample size is 30 patients suffering from chronic pelvic pain syndrome., conditionsModule conditions: Pelvic Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controled Trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: EXERCISE, interventions name: TENS, interventions name: ESWT, outcomesModule primaryOutcomes measure: VISUAL ANALOUGE SCALE, primaryOutcomes measure: National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), primaryOutcomes measure: ALGOMETER, secondaryOutcomes measure: Hospital Anxiety and Depression Scale- HAD, secondaryOutcomes measure: Nottingham Health Profile-NHP, secondaryOutcomes measure: Digital Muscle Testing, secondaryOutcomes measure: Flexibility Measurements, secondaryOutcomes measure: ROM Assessments, secondaryOutcomes measure: Lasegue Test, eligibilityModule sex: MALE, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Health Sciences in Biruni University, status: RECRUITING, city: İ̇stanbul, state: Zeytinburnu, zip: 34010, country: Turkey, contacts name: UGUR CAVLAK, Prof., PhD., role: CONTACT, phone: 00905324519644, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06369532, orgStudyIdInfo id: ONZ-2023-0460, briefTitle: Combination of Neurostimulation and Psychotherapy to Stop Worrying, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-06, primaryCompletionDateStruct date: 2026-02-20, completionDateStruct date: 2027-02-20, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University Hospital, Ghent, class: OTHER, descriptionModule briefSummary: This study aims to investigate whether the combination of transcranial Direct Current Stimulation (tDCS) and cognitive-behavioral therapy (CBT) is more effective for treating repetitive negative thinking (RNT) in patients with the symptom of high rumination. High ruminators will be included (Group1, active tDCS-CBT group; Group2, sham tDCS-CBT group). All patients will receive active or sham tDCS., conditionsModule conditions: Active tDCS, conditions: Sham tDCS, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Participants will be allocated into two groups randomly (using a code). The psychotherapist, the study managers and the patients will not be aware of treatment allocation., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 85, type: ESTIMATED, armsInterventionsModule interventions name: Active tDCS, interventions name: Sham tDCS, outcomesModule primaryOutcomes measure: the therapeutic effect of the combination therapy for repetitive negative thinking, primaryOutcomes measure: the consolidation effect of tDCS on CBT, secondaryOutcomes measure: Change of neuroimaging data, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Ghent, status: RECRUITING, city: Ghent, state: East-Flanders, zip: 9000, country: Belgium, contacts name: Chris Baeken, Prof., role: CONTACT, contacts name: Josefien Dedoncker, M.Sc., role: CONTACT, geoPoint lat: 51.05, lon: 3.71667, hasResults: False |
protocolSection identificationModule nctId: NCT06369519, orgStudyIdInfo id: 2023#17-23, briefTitle: Optimization of Management for Sporadic Bilateral Renal Cell Carcinoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2000-01-01, primaryCompletionDateStruct date: 2020-12-31, completionDateStruct date: 2020-12-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Peking University First Hospital, class: OTHER, descriptionModule briefSummary: Sporadic bilateral renal cell carcinoma (BRCC) is a rare situation of RCC. The treatment for BRCC is controversial and there is a lack of authoritative guidelines about the management of BRCC. The goal of this cohort study is to identify prognostic factors, construct predictive nomograms, and optimize management for sporadic BRCC patients. The main questions it aims to answer are:What are the factors influencing the prognosis of BRCC patients? What's the appropriate treatment for BRCC patients?Researchers will analysis the prognostic factors and compare the prognosis of BRCC patients receiving different treatments., conditionsModule conditions: Kidney Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3677, type: ACTUAL, armsInterventionsModule interventions name: Surgery treatment or local tumor destruction., outcomesModule primaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Cancer-specific survival (CSS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University First Hospital, city: Beijing, state: Beijing, zip: 100034, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06369506, orgStudyIdInfo id: PYO.DIS.1904 Protocol ID:4467, briefTitle: Evaluation of Gingival Thickness Measurement at Different Anatomical Landmarks, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-10, primaryCompletionDateStruct date: 2023-08-05, completionDateStruct date: 2023-12-17, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Ondokuz Mayıs University, class: OTHER, descriptionModule briefSummary: In this study, the point at which gingival thickness (GT) should be measured was investigated. Measurements were made from three different points. It was classified as thin and thick in two ways, according to the average of these three different points and the point corresponding to the base of the gingival groove, which is frequently used in the literature. And these two classifications were compared., conditionsModule conditions: Gingival Thickness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants were divided into two different classifications: "thin" and "thick". The first classification was made by measuring the GT of the point corresponding to the base of the gingival sulcus. GT was defined as thin if ≤1 mm, and thick if \>1 mm. In the second classification, GT was measured from three different points. And according to the average GT of three points, they were equally classified as "thin" and "thick"., primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: GTmeasurement, outcomesModule primaryOutcomes measure: Examining the sensitivities and sensitivities of two different gingival phenotype classifications based on three-point average GT measurement and single-point measurement using Receiver Operating Characteristic Analysis (ROC)., primaryOutcomes measure: Examining the agreement of GT measurements at three different points in 50 patients, 1195 teeth, using Kappa analysis., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ondokuz Mayis University Faculty of Dentistry Department of Periodontology, city: Samsun, zip: 55000, country: Turkey, geoPoint lat: 41.27976, lon: 36.3361, hasResults: False |
protocolSection identificationModule nctId: NCT06369493, orgStudyIdInfo id: OMUKAEK: 2022/210, briefTitle: Examining The Relationship Between Gingival Thickness and Tooth and Gingival Parameters, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2023-12-01, completionDateStruct date: 2023-12-18, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Ondokuz Mayıs University, class: OTHER, descriptionModule briefSummary: This study aims to assess whether there is a valid correlation between the identified multiple clinical and morphometric parameters and the gingival thickness., conditionsModule conditions: Gingival Thickness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Evaluation of the correlation between KGW, CW, CL PH parameters of GT measured in "mm" with a digital caliper with 0.001 mm precision in 1200 teeth in 50 participants using Spearman correlation analysis., primaryOutcomes measure: Evaluation of the effect of GT on keratinized gingival width, measured in "mm" by digital caliper with a precision of 0.001 mm, both by binary logistic regression analysis of 50 participants., primaryOutcomes measure: Examining the effect of age and gender of 50 participants on the gingival thickness measured in mm using binary logistic regression analysis., otherOutcomes measure: Evaluation of researcher reliability by ICC (Intra-Class Correlation Coefficient) in 10 participants in 2 weeks, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ondokuz Mayis University Faculty of Dentistry Department of Periodonthology, city: Samsun, zip: 55200, country: Turkey, geoPoint lat: 41.27976, lon: 36.3361, hasResults: False |
protocolSection identificationModule nctId: NCT06369480, orgStudyIdInfo id: Journal-nr.: R-23057752, briefTitle: Prognostic Factors for Survival in Patients With Cholangiocarcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: The objective of this retrospective study is to determine the survival rates of CCA patients based on different therapeutic approaches. Additionally, we aim to investigate the risk factors associated with poor survival within a cohort of patients treated over a seven-year period across four Danish hospitals. We anticipate that our findings could provide additional evidence for clinical decision-making, improve patient outcomes, and contribute to the knowledge in the field., conditionsModule conditions: Cholangiocarcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Resection/Ablation of tumor, interventions name: Palliative chemotherapy, interventions name: Neoadjuvant chemotherapy, interventions name: Stereotatic radiotherapy, interventions name: Best supportive care, outcomesModule primaryOutcomes measure: Aim I, primaryOutcomes measure: Aim II, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rigshospitalet, status: RECRUITING, city: Copenhagen, zip: 2100, country: Denmark, contacts name: Hans-Christian Pommergaard, MD DMSc PhD, role: CONTACT, email: [email protected], geoPoint lat: 55.67594, lon: 12.56553, hasResults: False |
protocolSection identificationModule nctId: NCT06369467, orgStudyIdInfo id: R5458-668-ALG-2219, secondaryIdInfos id: 2024-511032-27-00, type: REGISTRY, domain: EU CT Number, briefTitle: Short-Term Linvoseltamab Treatment, on Top of Chronic Dupilumab Treatment, for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2026-04-24, completionDateStruct date: 2026-04-24, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Regeneron Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This study is researching an experimental drug called linvoseltamab when combined with another drug called dupilumab. The study is focused on patients who have IgE-mediated food allergy. If the patient has an allergy, the immune system overreacts to an allergen (eg, certain foods such as peanuts, milk, shellfish) by producing antibodies called IgE. IgE antibodies are released by cells such as plasma cells. These antibodies and allergen bind to other cells that release chemicals, causing an allergic reaction. The aim of the study is to see how safe and tolerable linvoseltamab is when combined with dupilumab.The study is looking at several other research questions, including:* What side effects may happen from taking the study drugs* Whether linvoseltamab when combined with dupilumab has an effect on other types of antibodies in the blood at different times* How much study drug(s) is in the blood at different times, conditionsModule conditions: Food Allergy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: linvoseltamab, interventions name: dupilumab, outcomesModule primaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs), primaryOutcomes measure: Severity of TEAEs, primaryOutcomes measure: Incidence of adverse event of special interest (AESIs), primaryOutcomes measure: Severity of AESIs, primaryOutcomes measure: Incidence of serious adverse events (SAEs), primaryOutcomes measure: Severity of SAEs, secondaryOutcomes measure: Absolute change in the serum concentration of total IgE over time, secondaryOutcomes measure: Percent change in the serum concentration of total IgE over time, secondaryOutcomes measure: Time to reach unquantifiable total serum IgE concentration, secondaryOutcomes measure: Time to reach baseline level and/or the lower limit of the normal ranges of serum IgG, secondaryOutcomes measure: Time to reach baseline level and/or the lower limit of the normal ranges of serum immunoglobulin M (IgM), secondaryOutcomes measure: Time to reach baseline level and/or the lower limit of the normal ranges of serum immunoglobulin A (IgA), secondaryOutcomes measure: Incidence of participants with unquantifiable concentrations of serum total IgE, secondaryOutcomes measure: Absolute change in the serum concentration of food allergen-specific IgE, secondaryOutcomes measure: Percent change in the serum concentration of food allergen-specific IgE, secondaryOutcomes measure: Time to reach unquantifiable food allergen-specific serum IgE levels, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06369454, orgStudyIdInfo id: B7981090, briefTitle: A Study to Learn About How Different Forms of the Study Medicine Called Ritlecitinib Pass the Intestines of Healthy Male Adults When Taken With or Without Food, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-08-03, completionDateStruct date: 2024-08-03, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Pfizer, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to learn about how different forms of the study medicine called ritlecitinib pass the intestines of healthy male adults when taken with or without food.This study is seeking healthy participants who have:* Aged 18 years or older;* male who are healthy as determined by medical assessment;* BMI of 16-32 kg/m2, and a total body weight \>45 kg (99 lb).All participants in this study will receive a ritlecitinib oral dose in two different forms (solution without food, capsule with or without food).The study will take up to 3 months, including the screening period and follow-up phone call. Participants will have to stay at the study clinic for at least 11 days. There will be 3 periods in total, and a washout period of at least 3 days between dosings in Period 1 and Period 2, and at least 7 days between dosings in Period 2 and Period 3 for this study. On day 1 of each period, participants will take one form of Riltecitinib without food for the first two periods and with food for the last period. Participants will have blood samples taken both before and after taking ritlecitinib. A follow-up phone call will be made at 28 to 35 days after the last study period., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Ritlecitinib, outcomesModule primaryOutcomes measure: Site of capsule disintegration and MR microsphere dispersion, primaryOutcomes measure: Gastric emptying time, primaryOutcomes measure: Small intestine residence/transit time, primaryOutcomes measure: Colon arrival time, primaryOutcomes measure: Colon (ascending, transverse, descending) residence/transit time, primaryOutcomes measure: Total transit time, secondaryOutcomes measure: Maximum plasma concentration (Cmax), secondaryOutcomes measure: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf), secondaryOutcomes measure: Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast), secondaryOutcomes measure: Time for Cmax (Tmax), secondaryOutcomes measure: Terminal half-life (t1/2), secondaryOutcomes measure: Frequency of adverse events, secondaryOutcomes measure: Frequency of abnormal clinical laboratory tests, secondaryOutcomes measure: Frequency of abnormal vital signs, secondaryOutcomes measure: Frequency of abnormal 12-lead ECG, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06369441, orgStudyIdInfo id: Ovation-23-001, briefTitle: Collection of Biological Specimens and Associated Health Information, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2034-04, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Ovation.io, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to collect blood samples from a large number of individuals with cancer to create a database for researchers to use in future studies. Researchers may use this database to discover new ways to detect and treat cancer and other diseases. Future studies may use stored blood samples to discover how genes affect health and disease., conditionsModule conditions: Cancer, conditions: Other Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Biorepository, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ovation.io, city: Portland, state: Maine, zip: 04101, country: United States, contacts name: Stephanie Balcaitis, role: CONTACT, phone: 617-795-4947, phoneExt: 2, email: [email protected], contacts name: Ed Stepanski, PhD, role: CONTACT, email: [email protected], contacts name: Pauline Gee, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.66147, lon: -70.25533, hasResults: False |
protocolSection identificationModule nctId: NCT06369428, orgStudyIdInfo id: CDRB436BFI02, briefTitle: Patient Characteristics, Treatment Patterns, and Healthcare Resource Utilization of Metastatic Melanoma Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-06-23, primaryCompletionDateStruct date: 2023-04-13, completionDateStruct date: 2023-04-13, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Novartis, class: INDUSTRY, descriptionModule briefSummary: This was a retrospective, non-interventional, registry study based on secondary electronic medical record (EMR) data collected in Helsinki and Uusimaa hospital district (HUS data lake), hospital district of Southwest Finland (VSSHP data lake) and Pirkanmaa hospital district (PSHP data lake) as a part of their routine clinical practice. Social Insurance Institution of Finland (SII; reimbursed drug purchases) was utilized in this study to complement the medication data. The metastatic melanoma patients were stratified by first-line treatment and by hospital district., conditionsModule conditions: Metastatic Melanoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1795, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Mean Age-standardized Annual Incidence of Metastatic Melanoma in 2014-2021, primaryOutcomes measure: Point Prevalence per 100,000 Population, primaryOutcomes measure: Mean Age of Patients at Index Date per Hospital District, primaryOutcomes measure: Mean Length of Follow-up at Index Date per Hospital District, primaryOutcomes measure: Gender at Index Date per Hospital District, primaryOutcomes measure: Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per Hospital District, primaryOutcomes measure: Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per Hospital District, primaryOutcomes measure: Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per Hospital District, primaryOutcomes measure: Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per Hospital District, primaryOutcomes measure: Number of Patients with Negative BRAF Status at Index Date per Hospital District, primaryOutcomes measure: Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per Hospital District, primaryOutcomes measure: Number of Patients by Number of Metastatic Organs at Index Date per Hospital District, primaryOutcomes measure: Number of Patients by Location of Metastases at Index Date per Hospital District, primaryOutcomes measure: Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per Hospital District, primaryOutcomes measure: Number of Patients by Most Prevalent (greater than 5%) Baseline Comorbidities per First-line Medication, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Time to Next Treatment (TTNT) of the First-line (1L) by Type of Treatment, secondaryOutcomes measure: Duration of Treatment (DoT), secondaryOutcomes measure: Mean Age at Index Date per First-line (1L) Medication, secondaryOutcomes measure: Length of Follow-up at Index Date per 1L Medication, secondaryOutcomes measure: Time to Treatment at Index Date per 1L Medication, secondaryOutcomes measure: Gender at Index Date per 1L Medication, secondaryOutcomes measure: Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per 1L Medication, secondaryOutcomes measure: Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per 1L Medication, secondaryOutcomes measure: Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per 1L Medication, secondaryOutcomes measure: Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per 1L Medication, secondaryOutcomes measure: Number of Patients with Negative BRAF Status at Index Date per 1L Medication, secondaryOutcomes measure: Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per 1L Medication, secondaryOutcomes measure: Number of Patients by Number of Metastatic Organs at Index Date per 1L Medication, secondaryOutcomes measure: Number of Patients by Location of Metastases at Index Date per 1L Medication, secondaryOutcomes measure: Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per 1L Medication, secondaryOutcomes measure: Number of Patients that Received Radiotherapy During 1L Treatment, secondaryOutcomes measure: Number of Patients Switched from Immuno-oncology (IO) 1L Treatment to Targeted Therapy (TT) Second-line (2L) Treatment, secondaryOutcomes measure: Number of Patients Switched from IO 1L Treatment to Chemotherapy (Chemo) 2L Treatment, secondaryOutcomes measure: Number of Patients Switched from TT 1L Treatment to IO 2L Treatment, secondaryOutcomes measure: Number of Patients Switched from TT 1L Treatment to Chemo 2L Treatment, secondaryOutcomes measure: Number of Patients Switched from Chemo 1L Treatment to IO 2L Treatment, secondaryOutcomes measure: Number of Patients Switched from Chemo 1L Treatment to TT 2L Treatment, secondaryOutcomes measure: Number of Patients Switched from IO 2L Treatment to TT Third-line (3L) Treatment, secondaryOutcomes measure: Number of Patients Switched from IO 2L Treatment to Chemo 3L Treatment, secondaryOutcomes measure: Number of Patients Switched from TT 2L Treatment to IO 3L Treatment, secondaryOutcomes measure: Number of Patients Switched from TT 2L Treatment to Chemo 3L Treatment, secondaryOutcomes measure: Number of Patients Switched from Chemo 2L Treatment to IO 3L Treatment, secondaryOutcomes measure: Number of Patients Switched from Chemo 2L Treatment to TT 3L Treatment, secondaryOutcomes measure: Number of Healthcare Contacts and Associated Costs per Patient Year, secondaryOutcomes measure: Number of Healthcare Contacts and Associated Costs per Patient, secondaryOutcomes measure: Number of Healthcare Contacts and Associated Total Costs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Novartis, city: Basel, zip: 4056, country: Switzerland, geoPoint lat: 47.55839, lon: 7.57327, hasResults: False |
protocolSection identificationModule nctId: NCT06369415, orgStudyIdInfo id: 04/24/DD-BVMD, briefTitle: Health of Babies Born From IVF Versus IVM at 5 Years Old, acronym: FM-BABIES-5Y, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-03-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Mỹ Đức Hospital, class: OTHER, descriptionModule briefSummary: The investigators conduct a long-term follow-up at five years on offspring born from our randomized controlled trial (RCT) to investigate whether or not there is any difference in developmental outcomes in children born after capacitation IVM (CAPA IVM) compared with conventional IVF in order to give strong evidence about the safety of IVM in women with high antral follicle count., conditionsModule conditions: Infertility, conditions: IVF, conditions: IVM, conditions: Development, Child, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 231, type: ESTIMATED, armsInterventionsModule interventions name: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 and behavioural screening according to Strength and Difficulties Questionnaires (SDQ's), outcomesModule primaryOutcomes measure: Normal ASQ-3 score rate., primaryOutcomes measure: Normal SDQ score rate., primaryOutcomes measure: Normal weight rate, secondaryOutcomes measure: Thinness rate, secondaryOutcomes measure: Overweight rate, secondaryOutcomes measure: Obesity rate, secondaryOutcomes measure: Score of Communication (ASQ-3 questionnaire), secondaryOutcomes measure: Score of Gross motor (ASQ-3 questionnaire), secondaryOutcomes measure: Score of Fine motor (ASQ-3 questionnaire), secondaryOutcomes measure: Score of Problem solving (ASQ-3 questionnaire), secondaryOutcomes measure: Score of Personal-Social (ASQ-3 questionnaire), secondaryOutcomes measure: Score of Emotional symptoms (SDQ questionnaire), secondaryOutcomes measure: Score of Conduct problems (SDQ questionnaire), secondaryOutcomes measure: Score of hyperactivity/inattention (SDQ questionnaire), secondaryOutcomes measure: Score of peer relationship problems (SDQ questionnaire), secondaryOutcomes measure: Score of prosocial behavior (SDQ questionnaire), secondaryOutcomes measure: The total difficulties score., eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule locations facility: Mỹ Đức Hospital, status: RECRUITING, city: Ho Chi Minh City, state: Tan Binh, country: Vietnam, contacts name: Tuong M Ho, MD, MCE, role: CONTACT, phone: +84903633377, email: [email protected], geoPoint lat: 10.82302, lon: 106.62965, hasResults: False |
protocolSection identificationModule nctId: NCT06369402, orgStudyIdInfo id: 0963, briefTitle: Cognitive Impairment and Cerebral Haemodynamics in Individuals With Symptomatic Peripheral Arterial Disease, acronym: CInCH PAD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Leicester, class: OTHER, collaborators name: University Hospitals, Leicester, descriptionModule briefSummary: Background:Arterial disease of the legs causes symptoms such as pain when walking and may ultimately lead to a leg amputation. Many older people with arterial disease of the legs also have problems with their thinking and memory. Blood flow in the brain may be altered in these people and may be a cause for memory and thinking problems.Aim:The aim of this project is to investigate whether people with arterial disease of the legs have altered blood flow in the brain causing problems with memory and thinking.Research plan:Twenty people with arterial disease of the legs causing pain while walking and twenty healthy people will have a series of non-invasive assessments. Arterial disease in the legs will be measured using ankle blood pressures before and after walking. Blood flow in the brain will be measured using ultrasound whilst performing memory and thinking tests. Results will be compared between the people with arterial disease in the legs and the healthy people to see if there are any differences in blood flow to the brain and memory and thinking.Benefits to society:This project will help determine if there is a link between arterial disease of the legs and memory and thinking problems caused by altered blood flow in the brain. It will enable future research in people with cognitive impairment caused by altered blood supply to the brain and to prevent confusion and further memory and thinking problems in people undergoing surgery for arterial disease of the legs., conditionsModule conditions: Peripheral Arterial Disease, conditions: Cognitive Impairment, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Cerebral haemodynamic testing using transcranial Doppler, interventions name: Ankle-brachial pressure index, interventions name: Six-minute walk test, outcomesModule primaryOutcomes measure: Peak % change of CBv from baseline, secondaryOutcomes measure: Autoregulation index (Tieck's model), secondaryOutcomes measure: Absolute score achieved on the Addenboook's cognitive examination (III), secondaryOutcomes measure: Digit span forward and backward scores, otherOutcomes measure: Claudication distance, otherOutcomes measure: Maximal walking distance, otherOutcomes measure: Ankle-brachial pressure index, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Glenfield Hospital Leicester, city: Leicester, state: Leicestershire, zip: LE3 9QP, country: United Kingdom, geoPoint lat: 52.6386, lon: -1.13169, hasResults: False |
protocolSection identificationModule nctId: NCT06369389, orgStudyIdInfo id: RC31/23-0417, briefTitle: Real-life Management of Patients Eligible for CAR-T Cell Therapy, acronym: CARAVAGE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2033-12-31, completionDateStruct date: 2034-12-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University Hospital, Toulouse, class: OTHER, collaborators name: Ligue contre le cancer, France, collaborators name: Janssen, LP, descriptionModule briefSummary: Adoptive immunotherapy using CAR-T cells is now one of the Advanced Therapy Medicines routinely used for relapsed or refractory lymphoid hemopathies. In 2023, in France, 5 types of CAR-T cells have marketing authorization for 6 different indications. However, these marketing authorizations are based on clinical trials involving a limited number of selected patients. Real-life data are essential for assessing the post-authorization use of these innovative treatments. The French national DESCAR-T registry, promoted by LYSARC and in which Toulouse University Hospital plays an active role, is an international reference for this real-life evaluation. It does not, however, allow precise evaluation of patient-centered indicators and care pathways.With the increasing number of indications and candidate patients, Toulouse University Hospital, the only healthcare facility authorized in the Western Occitanie region to administer CAR-T cells, is faced with growing hospital needs and longer treatment times. In 2023, this has necessitated the implementation of new ambulatory and inter-facility care pathways in collaboration with the referral centers of the Onco-Occitanie Ouest regional cancer network. The selection of patients for CAR-T cell treatment is based on objective clinical criteria linked to the pathology (histology, morphological localization, size and kinetics of the tumor mass) and the patient (physiological age, performance index, comorbidities, patient choice). Because of their innovative nature, in a difficult psychological and physical context for the patient (refractory disease), CAR-T cell care pathways also need to be evaluated in terms of their "quality of life" dimension. The impact of non-biological determinants (also described as social and territorial inequalities in health) such as place of residence and distance from healthcare provision, marital, economic and social status, has never been explored on the accessibility and progress of the CAR-T cell treatment pathway.The creation of a registry of patients eligible for CAR-T cells at Toulouse University Hospital will enable these lines of research to be explored on the scale of a region with a population of 3 million., conditionsModule conditions: Hemopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 550, type: ESTIMATED, armsInterventionsModule interventions name: Patients eligible for CAR-T treatment, outcomesModule primaryOutcomes measure: Overall survival of patients with hemopathy eligible for CAR-T cell therapy, secondaryOutcomes measure: Compare progression-free survival and overall survival of patients according to care pathway and type of hemopathy, and investigate clinical and socioeconomic factors associated with better survival, secondaryOutcomes measure: Evaluate the time taken to treat patients with CAR-T cells, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Toulouse, city: Toulouse, state: CHU De Toulouse, zip: 31059, country: France, contacts name: Pierre BORIES, MD, role: CONTACT, phone: 0531156415, phoneExt: 33, email: [email protected], contacts name: Sandra DE BARROS, role: CONTACT, phone: 0561145982, email: [email protected], geoPoint lat: 43.60426, lon: 1.44367, hasResults: False |
protocolSection identificationModule nctId: NCT06369376, orgStudyIdInfo id: ONZ-2022-0072, briefTitle: Electrodiagnostic Approach for Pectoral Nerve Conduction Studies, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-30, primaryCompletionDateStruct date: 2023-11-29, completionDateStruct date: 2024-04-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University Hospital, Ghent, class: OTHER, descriptionModule briefSummary: Anatomical studies have challenged traditional perceptions of the pectoral nerve structure, revealing a network of three branches rather than the previously accepted medial and lateral branches. This study aims to explore the implications of this updated anatomy on nerve conduction studies of the pectoral nerve and proposes a modified nerve conduction study protocol to enhance diagnostic accuracy.A study on 25 volunteers was conducted, examining the three parts of the pectoral nerve. Electrode placement followed a detailed methodology ensuring precise data collection. The nerve conduction study was performed bilaterally, exploring latency and amplitude while addressing inter-observer variability and demographic influences., conditionsModule conditions: New Nerve Conduction Protocol for Pectoral Nerve, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ACTUAL, armsInterventionsModule interventions name: New nerve conduction protocol, outcomesModule primaryOutcomes measure: Latency, primaryOutcomes measure: Amplitude, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 68 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZ Gent, city: Gent, state: Oost-Vlaanderen, zip: 9000, country: Belgium, geoPoint lat: 51.05, lon: 3.71667, hasResults: False |
protocolSection identificationModule nctId: NCT06369363, orgStudyIdInfo id: STUDY000024245, briefTitle: Estrogen Deficiency on Cardiovascular Risk, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-09, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2027-11, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Milton S. Hershey Medical Center, class: OTHER, descriptionModule briefSummary: To explore how estrogen deficiency impacts the blood pressure (BP) and sympathetic nerve activity (SNA), and how it impacts the production of the key pro-inflammatory mediators such as Tumor necrosis factor α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6). It is hypothesized that estrogen deficiency increases BP, SNA and the pathway activities of the key pro-inflammatory mediators. Those effects are impacted through the downregulation of the estrogen receptor., conditionsModule conditions: Postmenopausal Symptoms, conditions: Cardiovascular Diseases, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: Estradiol, outcomesModule primaryOutcomes measure: Red blood cell flux, primaryOutcomes measure: Mean arterial pressure (mmHg), primaryOutcomes measure: baseline plasma TNF-α concentration (pg/ml), primaryOutcomes measure: One week post-intervention plasma TNF-α concentration (pg/ml), primaryOutcomes measure: baseline plasma IL-1β concentration (pg/ml), primaryOutcomes measure: One week post-intervention plasma IL-1β concentration (pg/ml), primaryOutcomes measure: baseline plasma IL-6 concentration (pg/ml), primaryOutcomes measure: One week post-intervention plasma IL-6 concentration (pg/ml), secondaryOutcomes measure: baseline plasma estrogen (pg/ml), secondaryOutcomes measure: One week post-intervention plasma estrogen (pg/ml), eligibilityModule sex: FEMALE, minimumAge: 54 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06369350, orgStudyIdInfo id: STUDY000020217, secondaryIdInfos id: 940567, type: OTHER_GRANT, domain: American Heart Association, briefTitle: Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Milton S. Hershey Medical Center, class: OTHER, collaborators name: American Heart Association, descriptionModule briefSummary: In this study, we are trying to see if vitamin B6 can minimize the amplified blood pressure response to exercise following ischemia-reperfusion injury. We are interested in a protein called P2X3, of which function can be blocked by vitamin B6, in the neurons of our nervous system. It is very important for blood pressure regulation. We would like to see if the P2X3 plays a role in patients' rising blood pressure during exercise. The results of the proposed studies will provide a base for those two potential economic and non-invasive inventions to improve the overall health and well-being of PAD patients., conditionsModule conditions: Ischemia Reperfusion Injury, conditions: Peripheral Artery Disease, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Vitamin B6 25 MG, interventions name: Vitamin B6 50 MG, interventions name: Vitamin B6 100 MG, interventions name: Placebo, outcomesModule primaryOutcomes measure: baseline blood pressure in mmHg, primaryOutcomes measure: Second visit blood pressure in mmHg, primaryOutcomes measure: baseline heart Rate in beats per minute, primaryOutcomes measure: Second visit heart Rate in beats per minute, primaryOutcomes measure: baseline muscle sympathetic nerve activity in burst/min, primaryOutcomes measure: Second visit muscle sympathetic nerve activity in burst/min, primaryOutcomes measure: baseline walking time in minutes, primaryOutcomes measure: Second visit walking time in minutes, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06369337, orgStudyIdInfo id: 014-24, briefTitle: Ultrasound Study of the Submentonian Musculature and Its Relationship in Dysphagia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Universidad Europea de Madrid, class: OTHER, collaborators name: Hospital Universitario Ramon y Cajal, descriptionModule briefSummary: Acquired dysphagia is one of the most frequent complications suffered by patients in intensive care units (ICU) after orotracheal extubation. Ultrasound has proven to be a useful method in the morphological and kinematic exploration of the main swallowing structures. AIM: to evaluate, through ultrasound procedures, the evolution of the morphology of the tongue and muscles of the floor of the mouth and the hyolaryngeal kinematics in patients intubated \>48h and to correlate these measurements with the possible development of acquired dysphagia. The incidence of dysphagia and ICU acquired weakness (ICUAW) in subjects with \>48h of intubation and the relative risk factors associated with baseline characteristics and clinical variables will be described. METHODOLOGY: Design: Single-center cohort study (Ramón y Cajal University Hospital). Participants: subjects \>18 years old, admitted to an intensive care unit (ICU), with \>48 hours of orotracheal intubation who meet eligibility criteria. Outcomes: the study of socio-demographic and clinical variables related to ICU admission will be included. The physical function variables will be analyzed through the Medical Research Council (MRC) and Functional Status Score (FSS), as well as swallowing function variables through the Volume-Viscosity Swallow (VVS-T) and Functional Oral Intake Scale scales. (FOIS) and Gugging Swallowing Screen (GUSS). Measurements will be made of the thickness and echogenicity of the submental and tongue muscles, as well as hyolaryngeal kinematics, conditionsModule conditions: Dysphagia, Oropharyngeal, conditions: Deglutition Disorders, conditions: Mechanical Ventilation Complication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound, outcomesModule primaryOutcomes measure: Thickness of the submental muscles, primaryOutcomes measure: Hyolaryngeal displacement, secondaryOutcomes measure: Muscle strength, secondaryOutcomes measure: Functional Status, secondaryOutcomes measure: Swallowing function, secondaryOutcomes measure: Swallowing function, secondaryOutcomes measure: Swallowing function, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06369324, orgStudyIdInfo id: 05, briefTitle: Efficacy of Pain Neuroscience Education and Physiotherapy in Patients Diagnosed With Spondyloarthritis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-04-11, completionDateStruct date: 2024-04-11, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Universidad de Extremadura, class: OTHER, descriptionModule briefSummary: Spondyloarthritis, notably ankylosing spondylitis (AS), represents a chronic rheumatic condition typified by persistent back pain and stiffness. It constitutes a substantial portion of diagnoses within rheumatology units and exhibits a higher prevalence among males. Diagnosis relies upon comprehensive clinical evaluation, including patient history, physical examination, and adjunctive radiological assessments, with genetic predisposition, particularly the presence of the HLA-B27 antigen, playing a significant role.Management strategies encompass a multidisciplinary approach, with physiotherapy emerging as a cornerstone therapeutic modality. Various exercise interventions, particularly those supervised by trained professionals, demonstrate efficacy in improving pain, stiffness, and overall functional capacity. Furthermore, patient education plays a pivotal role in enhancing treatment adherence and optimizing outcomes by aligning patient expectations with therapeutic goals.The evolving landscape of spondyloarthritis management underscores the necessity of further research into multimodal treatment approaches, particularly in integrating novel interventions such as electrophysical agents. By elucidating the mechanisms of action and exploring their synergistic effects, clinicians can refine treatment protocols and ultimately enhance the quality of care provided to individuals living with spondyloarthritis., conditionsModule conditions: Spondyloarthropathies, conditions: Ankylosing Spondylitis, conditions: Exercise Therapy, conditions: Physical Therapy Modalities, conditions: Pain Management, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Pain education, interventions name: Exercise supervised by external focus, interventions name: Therapy by means of electrical stimulation (electro-massage), outcomesModule primaryOutcomes measure: Numeric Pain Rating Scale (NPRS), primaryOutcomes measure: Cervical and Lumbar Joint Position Sense Error, primaryOutcomes measure: Cervical Range of Motion (CRoM), primaryOutcomes measure: Pressure Pain Threshold (PPT), primaryOutcomes measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), primaryOutcomes measure: Bath Ankylosing Spondylitis Motility Index (BASMI), primaryOutcomes measure: Bath Ankylosing Spondylitis Functional Index (BASFI)., primaryOutcomes measure: Kinesophobia, primaryOutcomes measure: Catastrophizing Pain, primaryOutcomes measure: Fear-Avoidance Beliefs Questionnaire (FABQ), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine and Health Sciences, status: RECRUITING, city: Badajoz, zip: 06006, country: Spain, contacts name: Carlos Fernández-Morales, MSc, role: CONTACT, geoPoint lat: 38.87789, lon: -6.97061, hasResults: False |
protocolSection identificationModule nctId: NCT06369311, orgStudyIdInfo id: 2000037345, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False |
protocolSection identificationModule nctId: NCT06369298, orgStudyIdInfo id: JK07.2.01, briefTitle: Study of JK07 in Patients With Chronic Heart Failure, acronym: RENEU-HF, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Salubris Biotherapeutics Inc, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and efficacy of JK07 in participants aged 18-85 with heart failure.There will be 2 cohorts in this study:Cohort 1: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) of ≤ 40%.Cohort 2: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) \> 40% and ≤ 65%.Participants in both cohorts will be randomized into either low dose JK07, high dose JK07 or placebo. Participants will have a 2:1 chance of receiving JK07 versus placebo., conditionsModule conditions: Heart Failure With Reduced Ejection Fraction, conditions: Heart Failure With Preserved Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 282, type: ESTIMATED, armsInterventionsModule interventions name: JK07, interventions name: Placebo, outcomesModule primaryOutcomes measure: Safety - Cohort 1, primaryOutcomes measure: Efficacy - Cohort 1, primaryOutcomes measure: Safety - Cohort 2, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Southern California Heart Specialists, status: RECRUITING, city: Pasadena, state: California, zip: 91105, country: United States, contacts name: Gregory Giesler, role: CONTACT, geoPoint lat: 34.14778, lon: -118.14452, locations facility: New Generation of Medical Research, status: RECRUITING, city: Hialeah, state: Florida, zip: 33016, country: United States, contacts name: Karelia Ruiz, role: CONTACT, geoPoint lat: 25.8576, lon: -80.27811, locations facility: Louisiana Heart Center, status: RECRUITING, city: Covington, state: Louisiana, zip: 70433, country: United States, contacts name: Bruce Iteld, MD, role: CONTACT, geoPoint lat: 30.47549, lon: -90.10042, locations facility: Cardiology and Vascular Associates, status: RECRUITING, city: Bloomfield Hills, state: Michigan, zip: 48304, country: United States, contacts name: Kirit Patel, role: CONTACT, geoPoint lat: 42.58364, lon: -83.24549, locations facility: St. Louis Heart and Vascular Cardiology, status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63136, country: United States, contacts name: Harvey Serota, role: CONTACT, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Southwest Family Medicine, status: RECRUITING, city: Dallas, state: Texas, zip: 75235, country: United States, contacts name: Chriistte Dharma, role: CONTACT, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False |
protocolSection identificationModule nctId: NCT06369285, orgStudyIdInfo id: PUMA-ALI-1201, secondaryIdInfos id: 2024-511497-79-00, type: CTIS, briefTitle: A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer, acronym: ALISCA-Breast1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-12-31, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Puma Biotechnology, Inc., class: INDUSTRY, descriptionModule briefSummary: PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy., conditionsModule conditions: Hormone Receptor Positive HER-2 Negative Breast Cancer, conditions: Metastatic Breast Cancer, conditions: Recurrent Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Alisertib, interventions name: Endocrine therapy, outcomesModule primaryOutcomes measure: Objective Response Rate (ORR) Within Dose Subgroup, primaryOutcomes measure: Duration of Response (DOR) Within Dose Subgroup, primaryOutcomes measure: Disease Control Rate (DCR) Within Dose Subgroup, primaryOutcomes measure: Progression Free Survival (PFS) Within Dose Subgroup, primaryOutcomes measure: Overall Survival (OS) Within Dose Subgroup, primaryOutcomes measure: Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the Enrolled Population, secondaryOutcomes measure: Objective Response Rate (ORR) Within Biomarker-Defined Subgroup, secondaryOutcomes measure: Duration of Response (DOR) Within Biomarker-Defined Subgroup, secondaryOutcomes measure: Disease Control Rate (DCR) Within Biomarker-Defined Subgroup, secondaryOutcomes measure: Progression Free Survival (PFS) Within Biomarker-Defined Subgroup, secondaryOutcomes measure: Overall Survival (OS) Within Biomarker-Defined Subgroup, 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, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False |
protocolSection identificationModule nctId: NCT06369272, orgStudyIdInfo id: mRNA-1273-P919, briefTitle: Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2023-10-20, completionDateStruct date: 2023-10-20, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: ModernaTX, Inc., class: INDUSTRY, descriptionModule briefSummary: The primary objectives of this study are:In infants of women exposed to SPIKEVAX during pregnancy, to assess:* If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of major congenital malformations (MCMs).* If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of adverse neonatal and infant outcomes, specifically neonatal encephalopathy, small for gestational age, respiratory distress in the newborn, and incidence of hospitalization due to infections including coronavirus disease 2019 (COVID-19).* In women exposed to SPIKEVAX during pregnancy, to assess whether exposure to SPIKEVAX is associated with an increased prevalence of hypertensive disorders \[e.g., pre-eclampsia, eclampsia, and gestational hypertension\] gestational diabetes, and post-partum hemorrhage; and* To assess whether exposure to SPIKEVAX during pregnancy is associated with an increased incidence of stillbirth, preterm birth, and medically attended spontaneous abortion., conditionsModule conditions: Maternal Outcomes, conditions: Infant Outcomes, conditions: Pregnancy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1192, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Number of MCMs, primaryOutcomes measure: Number of Adverse Neonatal and Infant Outcomes, primaryOutcomes measure: Number of Participants with Hypertensive Disorders, primaryOutcomes measure: Number of Stillbirths, Preterm Births, and Medically Attended Spontaneous Abortions, secondaryOutcomes measure: Demographics: Participant Region of Residence, secondaryOutcomes measure: Demographics: Age at LMP, secondaryOutcomes measure: Demographics: Number of Overweight or Obese Participants, secondaryOutcomes measure: Demographics: Duration of Health Plan Enrolment Prior to Pregnancy, secondaryOutcomes measure: Demographics: Calendar Date of the Pregnancy Outcome, secondaryOutcomes measure: Demographics: Participant Race and Ethnicity, secondaryOutcomes measure: Demographics: Participant Socio-economic Status, secondaryOutcomes measure: Healthcare Utilization: Number of Office Visits, Emergency Department Visits, and Hospitalizations, secondaryOutcomes measure: Healthcare Utilization: Number of Distinct Medications Used, eligibilityModule sex: FEMALE, minimumAge: 13 Years, maximumAge: 49 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Carelon Research, city: Newton, state: Massachusetts, zip: 02458, country: United States, geoPoint lat: 42.33704, lon: -71.20922, hasResults: False |
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