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## Relationship Between Repetitive Negative Thinking and CBT Outcomes - NCT ID: NCT06370559 - Study ID: 339042 - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2024-02-01 - Lead Sponsor: South London and Maudsley NHS Foundation Trust ### Study Description 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. ### Conditions - Anxiety Disorders - Obsessive-Compulsive Disorder - Post-traumatic Stress Disorder - Social Anxiety Disorder - Specific Phobia - Panic Disorder - Body Dysmorphic Disorders ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Change in Repetitive Ruminative Thinking Questionnaire score - Change in disorder-specific measure score Secondary Outcomes ### Location - Facility: Centre for Anxiety Disorders and Trauma, London, N/A, SE5 8AZ, United Kingdom @@
## Cardiac Response to Strength Training in Hypertensive Individuals - NCT ID: NCT06370546 - Study ID: 229/2022 - Status: RECRUITING - Start Date: 2023-03-20 - Completion Date: 2024-07-20 - Lead Sponsor: Universidad Católica del Maule ### Study Description This study aims to determine the acute and chronic effects of high and low-intensity strength training on cardiac autonomic control in hypertensive subjects ### Conditions - Physical Exercise - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Low intensity - high intensity ### Outcomes Primary Outcomes - Heart rate variability - Blood pressure systolic - Blood pressure diastolic - Blood pressure mean - Heart Rate Secondary Outcomes ### Location - Facility: Universidad Católica del Maule, Talca, Maule, 3469001, Chile @@
## Healthy Gestational Weight Gain Programme - NCT ID: NCT06370533 - Study ID: HGWG-pro - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-01-31 - Lead Sponsor: Peking University ### Study Description 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. ### Conditions - Gestational Weight Gain - Overweight and Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - behavioral interventions ### Outcomes Primary Outcomes - Total gestational weight gain - Gestational weight gain before OGTT screening Secondary Outcomes - Weekly rate of gestational weight gain between study clinical assessments - Proportion of women who exceed the Chinese reference/2009 IOM guidelines for total gestational weight gain - Proportion of women who exceed the Chinese reference/2009 IOM guidelines for appropriate weekly rate of GWG in second and third trimester - Proportion of women who exceed the Chinese reference/2009 IOM guidelines for appropriate weekly rate of GWG before OGTT screening - Rate of Gestational Diabetes Mellitus diagnosed according to International Association of Diabetes and Pregnancy Study Group (IADPSG) criteria - Rate of Preeclampsia/Gestational hypertension - Rate of Cesarean Section - Absolute/Mean Infant birth weight - Rate of Macrosomia - Absolute/Mean Apgar scores at 1 min or 5 min ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Screening Emotions in Adolescents at the Hospital for mTBI - NCT ID: NCT06370520 - Study ID: 123 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-12 - Lead Sponsor: University of California, Davis ### Study Description 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. ### Conditions - Brain Injury Traumatic Mild - Brain Injuries - Brain Injuries, Acute - Head Injury With Intracranial Hemorrhage - Head Injury Trauma - Brain Injury Traumatic Focal With Loss of Consciousness - Skull Fractures - Diffuse Axonal Injury - Intracranial Hemorrhages - Head Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Validated Questionnaires - Questionnaires - Clinician / Medical Record Variables ### Outcomes Primary Outcomes - New or worsening depression or anxiety - Unmet mental health care needs in patients with new or worsening depression or anxiety Secondary Outcomes - Decline in quality of life - Persistent mTBI symptoms - New deficits in emotional/behavioral functioning or hyperactivity/inattention - Parent Perception of Unmet Mental Health Needs ### Location - Facility: University of California, Davis Medical Center, Sacramento, California, 95817, United States @@
## Monitoring of Lung Ventilation Through Electrical Impedance Tomography During Pediatric Surgery - NCT ID: NCT06370507 - Study ID: UPO2# - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-07-31 - Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita ### Study Description 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. ### Conditions - Ventilator Lung - Surgery - Pediatric ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Electrical impedance tomography assessment of ventilation distribution in course of sedation/general anesthesia for pediatric surgery ### Outcomes Primary Outcomes - Ventilation distribution Secondary Outcomes - Intraoperative ventilatory respiratory mechanics - Postoperative pulmonary complications - Intraoperative oxygenation - Intraoperative hemodynamics ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Testing New Models of Diabetes Self-Management to Improve Population Health - NCT ID: NCT06370494 - Study ID: IRB2020-0956D - Status: COMPLETED - Start Date: 2019-02-01 - Completion Date: 2022-03-31 - Lead Sponsor: Texas A&M University ### Study Description 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. ### Conditions - Diabetes Mellitus, Type 2 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Living Healthier with Diabetes ### Outcomes Primary Outcomes - A1C -Change in HbA1c between baseline, 3 months, and 6 months is the primary outcome. Secondary Outcomes - Diabetes Knowledge: Knowledge of diabetes will be measured by the simplified version of the Revised Diabetes Knowledge Scale (True/False version). - Diabetes Self Care - Diabetes Care Confidence - Diabetes care distress - A1C ### Location - Facility: Texas A&M Health, College Station, Texas, 77843-1266, United States @@
## HIV, Equity, and Addiction Training (HEAT) Program - NCT ID: NCT06370481 - Study ID: IRB-300012349 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2029-12 - Lead Sponsor: University of Alabama at Birmingham ### Study Description 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. ### Conditions - Substance Use Disorders - Hiv - Opioid Use Disorder - Stimulant Use (Diagnosis) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Telemedicine - Standard of care ### Outcomes Primary Outcomes - Percent of participants who have a follow-up healthcare visit Secondary Outcomes ### Location - Facility: University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States @@
## The Epidemiological and Intrinsic Characteristics of Chronic Rhinitis - NCT ID: NCT06370468 - Study ID: 2024-CR-China - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-08-01 - Lead Sponsor: Zheng Liu ENT ### Study Description 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. ### Conditions - Chronic Rhinitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Epidemiological investigation ### Outcomes Primary Outcomes - The prevalence and distribution patterns of chronic rhinitis within the Chinese population - The clinical features and endotype of chronic rhinitis Secondary Outcomes ### Location - Facility: Tongji Hosptial affiliated to Tongji Medical college of Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China @@
## Comparison of Septal Advancement Flap and Columellar Strut Effect on Nasal Tip - NCT ID: NCT06370455 - Study ID: 36264MS429/11/23 - Status: RECRUITING - Start Date: 2024-01-23 - Completion Date: 2025-04-20 - Lead Sponsor: Tanta University ### Study Description 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 ### Conditions - Rhinoplasty ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - comparison of septal advancement flap effect on nasal tip in primary rhinoplasty to columellar strut technique ### Outcomes Primary Outcomes - subjective assessment using Rhinoplasty Outcome Evaluation Questionnaire - measuring the degree of tip projection and rotation preoperative and postoperative Secondary Outcomes ### Location - Facility: Otorhinolaryngology department -Tanta University Hospitals, Tanta, N/A, N/A, Egypt @@
## Intranasal Dexmedetomidine vs. Standard of Care for Emergency Department (ED) Procedural Sedation in the Older Adult - NCT ID: NCT06370442 - Study ID: 2137695 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-09-01 - Lead Sponsor: State University of New York - Upstate Medical University ### Study Description 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). ### Conditions - Altered Mental Status ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Dexmedetomidine - Lorazepam - Haloperidol ### Outcomes Primary Outcomes - Sedation Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Online Exercises for Premenstrual Syndrome on Couple's Stress and Family Function - NCT ID: NCT06370429 - Study ID: 8743432956-050.99-621064 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-12-30 - Lead Sponsor: Suleyman Demirel University ### Study Description 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. ### Conditions - Premenstrual Syndrome - Exercises - Stress Level - Family Characteristics ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Progressive Relaxation Exercises, randomized pretest-posttest ### Outcomes Primary Outcomes - Premenstrual Syndrome Scale - Family Assessment Scale - Perceived Stress Scale Secondary Outcomes ### Location - Facility: Suleyman Demirel University, Isparta, N/A, 32500, Turkey @@
## the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib - NCT ID: NCT06370416 - Study ID: HSKY002 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-12-31 - Lead Sponsor: Henan Cancer Hospital ### Study Description 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. ### Conditions - Non-small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Trilaciclib ### Outcomes Primary Outcomes - The incidence of grade ≥ 3 neutropenia during chemotherapy treatment Secondary Outcomes - The incidence of grade 4 neutropenia during chemotherapy treatment - The incidence of grade 3 or grade 4 thrombocytopenia - The incidence of grade 3 or 4 anemia during chemotherapy treatment ### Location - Facility: Henan Tumor Hospital, Zhengzhou, Henan, 450000, China @@
## Effects of Head and Neck Cooling and Heating on Fatigue in Multiple Sclerosis and Healthy Men - NCT ID: NCT06370403 - Study ID: LithuanianSportsU-21 - Status: COMPLETED - Start Date: 2014-02-04 - Completion Date: 2017-01-08 - Lead Sponsor: Lithuanian Sports University ### Study Description 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. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Cooling of the head and neck - Heating of the head and neck ### Outcomes Primary Outcomes - Body weight (kg) - Body fat (%) - Body free fat mass (kg) - Body mass index (kg/m2) - Change in muscle temperature (°C) - Change in plasma cortisol (nmol/L) concentrations - Change in plasma dopamine (nmol/L) concentrations - Change in plasma prolactin (ng/mL) concentrations - Change in subjective rating of perceived exertion - Change in muscle activity (mV) - Change in muscle activity (Hz) - Change in voluntary torque (Nm) - Change in involuntary torque (Nm) - Change in muscle contraction and relaxation (ms) - Change in central activation ratio (percent) - Change in constant error - Change in absolute error Secondary Outcomes - Height (m) ### Location - Facility: Lithuanian Sports University, Kaunas, N/A, LT 44221, Lithuania @@
## Community-based Group Rehabilitation Program for Stroke Patients With Dysphagia - NCT ID: NCT06370390 - Study ID: community - stroke dysphagia - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-06 - Lead Sponsor: Copka Sonpashan ### Study Description 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. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - swallowing function training ### Outcomes Primary Outcomes - Standardized Swallowing Assessment Scale Secondary Outcomes - Time consumed in eating - Penetration-Aspiration Scale - 15-item Geriatric Depression Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Nurses' Adherence to Professional Nursing Code of Ethics and Quality of Nursing Care Satisfaction - NCT ID: NCT06370377 - Study ID: 0305899 - Status: COMPLETED - Start Date: 2022-12-01 - Completion Date: 2023-02-28 - Lead Sponsor: Matrouh University ### Study Description 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. ### Conditions - Professional Role - Nurse's Role - Ethics, Narrative - Satisfaction, Patient ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - the Egyptian code of ethical practice ### Outcomes Primary Outcomes - Questionnaire to measure source of nurses' knowledge about Egyptian code of ethics - Observational checklist to measure - Questionnaire to measure patient satisfaction with the quality of nursing care Secondary Outcomes ### Location - Facility: Faculty of Nursing, Matrouh University, Mersa Matruh, N/A, 002, Egypt @@
## Nurses' Practice of Safe Blood Transfusion in Surgical and Critical Care Units - NCT ID: NCT06370364 - Study ID: 25 - Status: COMPLETED - Start Date: 2020-12-01 - Completion Date: 2021-04-30 - Lead Sponsor: Matrouh University ### Study Description 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 ### Conditions - Practice Nurse's Scope - Blood Transfusion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Nurses' Practice of Safe Blood Transfusion ### Outcomes Primary Outcomes - Questionnaire to measure factors affecting safe blood transfusion - observational checklist to measure nurses' practice of safe blood transfusion Secondary Outcomes ### Location - Facility: Faculty of Nursing, Matrouh University, Mersa Matruh, N/A, 002, Egypt @@
## A Phase I/II Clinical Trial With SENS-501 in Children Suffering From Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations - NCT ID: NCT06370351 - Study ID: SENS-501-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2031-04 - Lead Sponsor: Sensorion ### Study Description 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. ### Conditions - OTOF Gene Mutation - DFNB9 - Congenital Deafness - Hearing Disorders - Ear Diseases - Otorhinolaryngologic Diseases - Deafness - Hearing Loss, Sensorineural ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - SENS-501 administration ### Outcomes Primary Outcomes - Safety and tolerability of SENS-501 - Efficacy of SENS-501 assessed by ABR Secondary Outcomes - Safety and tolerability of SENS-501 - Efficacy of SENS-501 assessed by ABR - Efficacy of SENS-501 assessed by PTA - Clinical performance of the administration system - Safety of the administration system - Usability of the administration system ### Location - Facility: Hopital Necker Enfants Malades, Paris, N/A, 75015, France @@
## Cardiothoracic Critical Care as Subspecialty and Its Core Competencies - NCT ID: NCT06370338 - Study ID: 2024B0101 - Status: RECRUITING - Start Date: 2024-04-11 - Completion Date: 2025-04-30 - Lead Sponsor: Ohio State University ### Study Description 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. ### Conditions - Consensus Development ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Delphi Questionnaire ### Outcomes Primary Outcomes - Degree of consensus on the curriculum for training cardiothoracic critical care by first evaluating the need for the field Secondary Outcomes - Degree of consensus on defining training core competencies, goals, and milestones. - Degree of consensus on the definitions of "Scholarship", "Patient", "Safety", "Quality" ### Location - Facility: The Ohio State University Wexner Medical Center, Columbus, Ohio, 43210, United States @@
## Neuromuscular Electrical Stimulation in Foot and Ankle Surgery - NCT ID: NCT06370325 - Study ID: 23-00987 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-08 - Lead Sponsor: NYU Langone Health ### Study Description 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. ### Conditions - Ankle Fractures ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - VPOD Wireless Tens Unit - Physical Therapy - Biodex ### Outcomes Primary Outcomes - Isometric Strength of Gastrocnemius Muscle - Isometric Strength of Gastrocnemius Muscle - Isometric Strength of Gastrocnemius Muscle - Bilateral Calf Circumference - Bilateral Calf Circumference - Bilateral Calf Circumference Secondary Outcomes - Lower Extremity Functional Scale (LEFS) Questionnaire Score - Lower Extremity Functional Scale (LEFS) Questionnaire Score - Lower Extremity Functional Scale (LEFS) Questionnaire Score - Sit-to-Stand Test - Sit-to-Stand Test - Sit-to-Stand Test - 2 Minute Walk Test - 2 Minute Walk Test - 2 Minute Walk Test - Stair Climb Test - Stair Climb Test - Stair Climb Test ### Location - Facility: NYU Langone Health, New York, New York, 10016, United States @@
## Analysis of Articular Biomarkers From Osteoarthritic Thumb Basal Joints - NCT ID: NCT06370312 - Study ID: 2023-07921-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-04-30 - Lead Sponsor: Region Skane ### Study Description 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. ### Conditions - Osteoarthritis Thumb - Osteoarthritis, Knee - Metabolic Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Trapeziectomy ### Outcomes Primary Outcomes - Serum cholesterol levels Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Screening of Multidrug Resistant Bacteria, and the Clinical Implication for the Patient - NCT ID: NCT06370299 - Study ID: 2023-06402-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-06 - Lead Sponsor: Region Skane ### Study Description 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. ### Conditions - Multi-antibiotic Resistance ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - (exposure of) MDR carriage ### Outcomes Primary Outcomes - 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. - The ratio of the probability of death in patients who are screening positive to the probability of death in patients who are screening negative. - 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. Secondary Outcomes - prevalence of positive screening results - prevalence of MDR in clinical samples - time to first occurrence of phenotypically same MDR as in screening - prevalence of MDR in clinical samples in patients with negative screening results ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Acute Concurrent Exercise on Inhibitory Control: An Event-related Potential Study - NCT ID: NCT06370286 - Study ID: PACNL_rueihongli_CE_IC - Status: COMPLETED - Start Date: 2021-02-15 - Completion Date: 2022-02-15 - Lead Sponsor: National Taiwan Normal University ### Study Description 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? ### Conditions - Exercise - Cognition ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - concurrent exercise (CE) - aerobic exercise (AE) ### Outcomes Primary Outcomes - Inhibitory control Secondary Outcomes - Blood lactate ### Location - Facility: Department of Physical Education and Sport Sciences, National Taiwan Normal University, Taipei, N/A, 106, Taiwan @@
## Thromboprophylaxis in Lower Limb Immobilisation - NCT ID: NCT06370273 - Study ID: 1009305 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-02 - Lead Sponsor: Queen Mary University of London ### Study Description 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. ### Conditions - Thrombosis - Injury Leg ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Rivaroxaban - Apixaban - Enoxaparin Injectable Solution - Tinzaparin Injectable Solution - Dalteparin Injectable Solution - Fondaparinux Injectable Product ### Outcomes Primary Outcomes - Composite of net clinical benefit comprising clinical VTE event, major bleeding, and cause-specific mortality Secondary Outcomes - Symptomatic VTE event occurrence - Major bleeding occurrence - Cause-specific mortality occurrence - Adverse and Serious adverse events - Medication adherence - Health utility (EQ-5D-5L) - Patient satisfaction regarding the burdens and benefits of anticoagulation - Hospital readmission/reattendance - Health and social care resource use - Patient longer term outcome VTE and bleeding data ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Assessing the Efficacy of a Hydrogen Peroxide Gel for Oral Wound Healing and Oral Hygiene - NCT ID: NCT06370260 - Study ID: INTM-PMCF-UNIGEL - Status: COMPLETED - Start Date: 2023-05-02 - Completion Date: 2023-12-27 - Lead Sponsor: National and Kapodistrian University of Athens ### Study Description 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. ### Conditions - Wound Heal - Postoperative Pain - Biopsy Wound - Wound; Mouth - Quality of Life - Dental Plaque - Gingival Inflammation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Hydrogen Carbamide/Peroxide Gel - Placebo Gel ### Outcomes Primary Outcomes - Assessment of wound healing based on Percentage Healing Index on day 14 - Assessment of wound healing based on Percentage Healing Index on day 7 Secondary Outcomes - Postoperative symptoms (pain, eating and speech difficulty) during the first week (at home) - Postoperative symptoms (pain, eating and speech difficulty) on day 7 - Postoperative symptoms (pain, eating and speech difficulty) on day 14 - Wound healing based on clinical signs - Oral Hygiene - Dental Plaque: Sextant Plaque Index - Oral Hygiene - Gingival Inflammation: Sextant Gingival Index - Oral Health Related Quality of Life ### Location - Facility: Department of Oral Medicine & Pathology and Hospital Dentistry, School of Dentistry, Athens, Attiki, 11527, Greece @@
## First-time Usage of SGLT2 Inhibitors in Type 2 Diabetic Patients Who Are Fasting During Ramadan: Safety and Efficacy - NCT ID: NCT06370247 - Study ID: Soh-Med-23-04-07PD. - Status: COMPLETED - Start Date: 2023-04-25 - Completion Date: 2023-09-25 - Lead Sponsor: Sohag University ### Study Description 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). ### Conditions - SGLT2 Inhibitors, First Time Use - Type2 Diabetes - Fasting in Ramadan ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - HbA1c, serum creatinine, eGFR urine analysis and serum electrolyte Na and K ### Outcomes Primary Outcomes - blood glucose level monitoring - safety of SGLT2 inhibitors usage during ramadan Secondary Outcomes ### Location - Facility: Sohag Faculty of Medicine, Sohag, N/A, N/A, Egypt @@
## The Prediction Model of NAC Response for Breast Cancer Based on The Parametric Dynamics Features. - NCT ID: NCT06370234 - Study ID: 201412166MINA - Status: COMPLETED - Start Date: 2015-04-21 - Completion Date: 2020-03-03 - Lead Sponsor: National Taiwan University Hospital ### Study Description 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. ### Conditions - Breast Cancer - Chemotherapy Effect - Diffusion Weighted MRI - PET Imaging - Multiparametric Magnetic Resonance Imaging ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Whole body 18F-FDG Positron Emission Tomography ### Outcomes Primary Outcomes - Model Prediction power of pathological complete response(pCR) - Comparison of models in prediction of pathological complete response(pCR) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Psoriatic Arthritis on Female Sexual Dysfunction - NCT ID: NCT06370221 - Study ID: psoriatic Arthritis - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2024-12-30 - Lead Sponsor: Egymedicalpedia ### Study Description Psoriasis is one of the most common immunemediated chronic inflammatory skin disorders. ### Conditions - Psoriatic Arthritis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - The effect of psoriatic Arthritis ### Outcomes Primary Outcomes - Evaluation of female sexual function Secondary Outcomes ### Location - Facility: Qena Hospital, Qinā, N/A, N/A, Egypt @@
## Prophylactic Effect of Probiotic Streptococcus Salivarius K12 Against Recurrent Streptococcus Pyogenes Pharyngotonsillitis Infection in Pediatrics - NCT ID: NCT06370208 - Study ID: LUMHS/B12/Temp/13.04.2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-31 - Lead Sponsor: Liaquat University of Medical & Health Sciences ### Study Description 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. ### Conditions - Streptococcus Pyogenes Pharyngotonsillitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Probiotic Bactoblis® (Streptococcus salivarius K12) ### Outcomes Primary Outcomes - Recurrence of Streptococcus pyogenes pharyngotonsillitis infection - Probiotic safety and tolerability Secondary Outcomes - Protection against viral infection - Protection against Acute Otitis Media infection - Protection against respiratory infection - Protection against Rhinitis - Protection against flu - Protection against Enteritis - Protection against Stomatitis ### Location - Facility: Liaquat University of Medical and Health Sciences, Jamshoro, N/A, 76090, Pakistan @@
## Effect of Stellate Ganglion Block on Drooling in Parkinson's Syndrome - NCT ID: NCT06370195 - Study ID: SGB-Liuxian - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: Babujinaya Cela ### Study Description 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. ### Conditions - Parkinson's Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Comprehensive rehabilitation - Stellate ganglion block - Lidocaine hydrochloride - Placebo injection ### Outcomes Primary Outcomes - Drooling amount Secondary Outcomes - Modified Barthel Index - Patient Health Questionnaire-9 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA5 Device - NCT ID: NCT06370182 - Study ID: ANA2401 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2026-03 - Lead Sponsor: Anaconda Biomed S.L. ### Study Description 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. ### Conditions - Acute Ischemic Stroke From Large Vessel Occlusion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ANA Funnel Catheter - Control ### Outcomes Primary Outcomes - 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. - Rate of symptomatic intracranial hemorrhage (sICH), attributable to the device or procedure. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## EUS Guided Coil Embolization for Primary Prophylaxis of Gastric Varices - NCT ID: NCT06370169 - Study ID: ROSC 1 - Status: RECRUITING - Start Date: 2022-08-01 - Completion Date: 2024-08-10 - Lead Sponsor: Asian Institute of Gastroenterology, India ### Study Description 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. ### Conditions - Gastric Varices Bleeding ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Endoscopic ultrasound placement of Coil and glue ### Outcomes Primary Outcomes - The outcome will measure number of patient had achieved complete obliteration of varices Secondary Outcomes - Number of patient needed re intervention - Number of patient needed had bleeding following intervention like immediate (with in 5 days) or later (5-90 days) ### Location - Facility: Asian institute of Gastroenterology, Hyderabad, Telangana, 500082, India @@
## Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients - NCT ID: NCT06370156 - Study ID: TWEAK in plaque psoriasis - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-06-10 - Lead Sponsor: Egymedicalpedia ### Study Description 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 ### Conditions - Plaque Psoriasis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Adalimumab ### Outcomes Primary Outcomes - Treatment of psoriasis vulgaris and psoriatic arthritis Secondary Outcomes - Evaluation of serum TWEAK ### Location - Facility: South Valley Hospitals, Qinā, N/A, N/A, Egypt @@
## A Study Collecting Health Information to Understand and Prevent Gastric Cancer - NCT ID: NCT06370143 - Study ID: 24-083 - Status: RECRUITING - Start Date: 2024-04-11 - Completion Date: 2036-04-11 - Lead Sponsor: Memorial Sloan Kettering Cancer Center ### Study Description 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. ### Conditions - Gastric Atrophy - Gastric Intestinal Metaplasia - Dysplasia - Gastric Adenocarcinoma - Gastric Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaire ### Outcomes Primary Outcomes - Creation of participant registry Secondary Outcomes ### Location - Facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, 07920, United States @@
## Different Dose of Esketamine Inhibiting Response to Laryngeal Mask Airway Insertion - NCT ID: NCT06370130 - Study ID: AerospaceCH - Status: COMPLETED - Start Date: 2022-05-01 - Completion Date: 2023-03-10 - Lead Sponsor: Aerospace Center Hospital ### Study Description 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. ### Conditions - Anesthesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Esketamine 0.2mg/kg - Esketamine 0.3mg/kg ### Outcomes Primary Outcomes - Record of the patient response during LMA placement - Overall condition of LMA placement - Record related indicators - Record related indicators - Record related indicators - Record related indicators - Record of additional doses of propofol and the adverse reactions of positive patients during the induction process (hypotension, bradycardia and apnoea, etc.) Secondary Outcomes ### Location - Facility: Liang-Yuan Lu, Beijing, Beijing, 100049, China @@
## The Effects of Three Different Nonpharmacological Methods Used During Vascular Access in Children on Pain and Anxiety - NCT ID: NCT06370117 - Study ID: Aydın Adnan Menderes - Status: COMPLETED - Start Date: 2023-02-01 - Completion Date: 2023-12-30 - Lead Sponsor: Aydin Adnan Menderes University ### Study Description 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. ### Conditions - Pain - Anxiety - Nurse's Role ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Buzzy - Music video listening - Buzzy+ Music video listening ### Outcomes Primary Outcomes - Wong-Baker Facial Expression Rating Scale Secondary Outcomes - Children's Fear and Anxiety Scale ### Location - Facility: Bircan Kahraman Berberoğlu, Aydın, AYDIN-efeler, 0900, Turkey @@
## Treating Suicidality Remotely - NCT ID: NCT06370104 - Study ID: NL85041.018.23 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2028-04-25 - Lead Sponsor: 113 Suicide Prevention ### Study Description 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. ### Conditions - Suicide Attempt ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Brief Cognitive Behavioral Therapy for Suicide Prevention - Living under control ### Outcomes Primary Outcomes - Number of suicide attempts Secondary Outcomes - Severity of suicidal ideation - Severity of suicidal Thoughts and Behaviors Composite - Treatment satisfaction - Adverse effects - Co-occuring mental health issues - Quality of life ### Location - Facility: 113 Suicide Prevention, Amsterdam, Zuid-Holland, 1105BP, Netherlands @@
## Effect of Xylitol-based Chewing Gums, Sugar-free and Sugared, on Salivary Flow and pH in Young Adults - NCT ID: NCT06370091 - Study ID: PICVII19-41 - Status: RECRUITING - Start Date: 2023-12-12 - Completion Date: 2024-07-31 - Lead Sponsor: Universidad Católica de Cuenca ### Study Description 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. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Gum of Xylitol - Gum of sugar free - Gum of sugar - Paraffin wax ### Outcomes Primary Outcomes - G1: Gum of xilytol - G2: Gum of sugar free - G3: Gum of sugar - G4: Parafinn wax Secondary Outcomes ### Location - Facility: Miriam Lima, Cuenca, Azuay, 010101, Ecuador @@
## Effect of Early Administration of Albumin 20% Versus Crystalloid - NCT ID: NCT06370078 - Study ID: Ahmed Helal - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-11-15 - Lead Sponsor: Egymedicalpedia ### Study Description 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. ### Conditions - Septic Shock ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Albumin Human ### Outcomes Primary Outcomes - Recovery from shock Secondary Outcomes ### Location - Facility: Assuit University hospitals, Assiut, N/A, N/A, Egypt @@
## Serplulimab Combined With Bevacizumab Biosimilar and HAIC in Advanced Hepatocellular Carcinoma (HCC) Patients - NCT ID: NCT06370065 - Study ID: HLX10IIT70-TJ - Status: RECRUITING - Start Date: 2023-04-27 - Completion Date: 2024-12-31 - Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital ### Study Description Evaluation of the efficacy and safety of Serplulimab combined with bevacizumab biosimilar and HAIC in Advanced Hepatocellular Carcinoma (HCC) patients ### Conditions - Advanced Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - HAIC+Serplulimab（HLX10）+ Bevacizumab Biosimilar（HLX04） ### Outcomes Primary Outcomes - ORR Secondary Outcomes - PFS - OS ### Location - Facility: Tianjin Cancer Hospital Airport Hospital, Tianjin, Tianjin, N/A, China @@
## Pathophysiological Basis of Hidradenitis Suppurativa - NCT ID: NCT06370052 - Study ID: CHCRI-DJ-HS - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-31 - Lead Sponsor: Clinical Hospital Center Rijeka ### Study Description 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. ### Conditions - Hidradenitis Suppurativa ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - excision ### Outcomes Primary Outcomes - The pathohistological changes Secondary Outcomes - The expression of cytokines - The correlation of the clinical Hurley classification and pathohistological changes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of INV-102 Ophthalmic Solution in Adults With Moderate to Severe Dry Eye Disease - NCT ID: NCT06370039 - Study ID: INV-102-CS-003 - Status: RECRUITING - Start Date: 2024-03-27 - Completion Date: 2024-08 - Lead Sponsor: Invirsa, Inc. ### Study Description 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. ### Conditions - Dry Eye Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - INV-102 - Vehicle ### Outcomes Primary Outcomes - Change from Baseline in corneal fluorescein staining total score on the National Eye Institute (NEI)/Industry scale Secondary Outcomes - Percentage of eyes with complete clearing of central corneal fluorescein staining ### Location - Facility: iuvo BioScience, Rush, New York, 14543, United States @@
## KSD-101 Therapy for Standard Treatment Failed EBV-associated Nasopharyngeal Carcinoma: an Exploratory Clinical Trial - NCT ID: NCT06370026 - Study ID: KSD-101-CR004 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-31 - Lead Sponsor: Sun Yat-sen University ### Study Description 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. ### Conditions - Nasopharyngeal Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - KSD-101 ### Outcomes Primary Outcomes - The incidence Adverse events (Safety endpoint) Secondary Outcomes - EBV-DNA load - Objective response rate (ORR) - Disease control rate (DCR) - Duration of response (DOR) - Progression-free survival (PFS) - Overall survival (OS) - Levels of EBV-specific CD8+ T cells - Levels of B cells - Levels of NK cells - According to EORTC QLQ-C30 - According to EQ-5D-5L - According to EORTC QLQ-H&N35 - According to ECOG fitness status ### Location - Facility: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China @@
## Rollover Study to Provide Continued Access to TT-00420 (Tinengotinib) for Subjects With Advanced Solid Tumors - NCT ID: NCT06370013 - Study ID: TT00420US14 - Status: AVAILABLE - Start Date: N/A - Completion Date: N/A - Lead Sponsor: TransThera Sciences (Nanjing), Inc. ### Study Description 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 ### Conditions - Advanced Solid Tumors - Cholangiocarcinoma ### Study Design - Type: EXPANDED_ACCESS - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tinengotinib ### Outcomes Primary Outcomes Secondary Outcomes ### Location - Facility: University of Chicago Medical Center, Chicago, Illinois, 60637, United States @@
## Oral Azacitidine in Transplant-Eligible Patients With Acute Myeloid Leukemia (AML) Suffering From Health-Inequality - NCT ID: NCT06370000 - Study ID: MCC-23-20817 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2028-10-31 - Lead Sponsor: Virginia Commonwealth University ### Study Description 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 ### Conditions - Acute Myeloid Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Oral Azacitidine ### Outcomes Primary Outcomes - 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 Secondary Outcomes - Overall survival (OS) - Leukemia Free Survival (LFS) 3 months after beginning of treatment and at relapse, completion of treatment or removal from study - Measure rates of measurable residual disease (MRD) negativity ### Location - Facility: Virginia Commonwealth University, Richmond, Virginia, 23298, United States @@
## Visual Performance of Dailies Total1 Multifocal and Acuvue Oasys Max 1-Day Multifocal in Presbyopic Lens Wearers - NCT ID: NCT06369987 - Study ID: 46238 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-10 - Lead Sponsor: University of Waterloo ### Study Description 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. ### Conditions - Presbyopia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Deleficon A (multifocal) - Senofilcon A (multifocal) ### Outcomes Primary Outcomes - High contrast visual acuity (logMAR) at 6m - High contrast visual acuity (logMAR) at 40cm Secondary Outcomes ### Location - Facility: Centre for Ocular Research & Education (CORE), Waterloo, Ontario, N2L 3G1, Canada @@
## Single Participant Study of an Experimental ASO Treatment for TUBB4A-related Leukodystrophy - NCT ID: NCT06369974 - Study ID: 2024P000386 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-06 - Lead Sponsor: Massachusetts General Hospital ### Study Description This research project entails delivery of a personalized antisense oligonucleotide (ASO) drug designed for a single pediatric participant with TUBB4A associated leukodystrophy. ### Conditions - Genetic Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Antisense oligonucleotide treatment (ASO) ### Outcomes Primary Outcomes - Neurological assessments Secondary Outcomes - Feeding and swallow evaluation - Safety and tolerability ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Correlation Between the Analgesic Effect of Fentanyl Transdermal Patches and Nutritional Status in Cancer Pain Patients - NCT ID: NCT06369961 - Study ID: TDFCANCERPAIN20230101 - Status: COMPLETED - Start Date: 2023-03-01 - Completion Date: 2023-12-31 - Lead Sponsor: Chongqing University Cancer Hospital ### Study Description 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. ### Conditions - Cancer Pain - Nutrition Disorders ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - transdermal fentanyl ### Outcomes Primary Outcomes - 11-point numeric rating scale (NRS) after TDF treatment - the occasions that breakthrough pain attacks per day after TDF treatment - The dose adjustment of TDF - The kinds of other analgesics combined with TDF Secondary Outcomes - Adverse effects ### Location - Facility: Chao Li, Chongqing, N/A, 400030, China @@
## Quality Of Recovery After Pericapsular Nerve Group (PENG) Block For Hip Hemiarthroplasty Under Spinal Anesthesia - NCT ID: NCT06369948 - Study ID: M703 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-09-01 - Lead Sponsor: Fayoum University Hospital ### Study Description 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. ### Conditions - Hip Hemiarthroplasty ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pericapsular Nerve Group (PENG) Block - elective hip hemiarthroplasty without receiving a PENG block. - bupivacaine 0.5% injection ### Outcomes Primary Outcomes - Total opioid consumption post operative Secondary Outcomes - 2) a Visual Analogue Scale (VAS) ranging from zero (no pain) to 10 (severe pain) for dynamic and static pain - 3) Time to first opioid use - 4) Ability to perform physiotherapy - 5) Opioid-related side effects. - 6) Total length stay of hospital - 7) Complications of local anesthetic toxicity ### Location - Facility: Fayoum University Hospital, Madīnat Al Fayyūm, Fayoum Governorate, 63514, Egypt @@
## A Real World Study of Equecabtagene Autoleucel in Subjects With Relapsed and Refractory Multiple Myeloma. - NCT ID: NCT06369935 - Study ID: 20240407 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-20 - Completion Date: 2027-08-20 - Lead Sponsor: Peking University People's Hospital ### Study Description 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 ### Conditions - Relapsed/Refractory Multiple Myeloma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Equecabtagene Autoleucel ### Outcomes Primary Outcomes - Best Overall Response Rate， BOR Secondary Outcomes - PFS rate of 6 month - OS rate of 6 month - Time to Response， TTR - Time to Complete Response， TTCR - Adverse Event， AE ### Location - Facility: Peking University People's Hospital, Beijing, N/A, N/A, China @@
## TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence. - NCT ID: NCT06369922 - Study ID: STUDY00009315 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2026-06-01 - Lead Sponsor: University of Rochester ### Study Description 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. ### Conditions - Stress Incontinence Female - Urinary Incontinence - Urinary Incontinence,Stress - Pain - Pain Acute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TENS - Control TENS ### Outcomes Primary Outcomes - Mean pain measured by Visual Analog Scale (VAS) - Mean pain measured by Visual Analog Scale (VAS) - Mean pain measured by Visual Analog Scale (VAS) Secondary Outcomes - Mean pain measured by Likert scale - Mean pain measured by Likert scale - Mean pain measured by Likert scale - Number of participants with side effects - Mean satisfaction with the procedure - TENS or NO TENS ### Location - Facility: Pelvic Health and Continence Specialties, Rochester, New York, 14623, United States @@
## Study on AI-assisted Multimodal Diagnosis System of Autoimmune Pancreatitis - NCT ID: NCT06369909 - Study ID: K5507 - Status: RECRUITING - Start Date: 2024-01-31 - Completion Date: 2026-01-31 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description 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. ### Conditions - Autoimmune Pancreatitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - EUS-FNA ### Outcomes Primary Outcomes - Tfh level in blood - Microbiota composition measured by 16S rRNA sequencing - AI-EUS differentiation - Cytokine level in blood Secondary Outcomes ### Location - Facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, 100730, China @@
## Digital Single-operator Cholangioscopy and Intraductal Ultrasound for Nonicteric Biliary Strictures - NCT ID: NCT06369896 - Study ID: SpyIDUSForNonictericStricture - Status: NOT_YET_RECRUITING - Start Date: 2024-05-05 - Completion Date: 2026-12-25 - Lead Sponsor: Soonchunhyang University Hospital ### Study Description 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. ### Conditions - Cholangiocarcinoma - Biliary Stricture ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - diagnostic accuracy of SOC Secondary Outcomes - Diagnostic accuracy of IDUS - Technical success of SOC - Technical success of IDUS - Adverse event ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## How Often and What Type of Deformity is Detected in All Spine Radiographs? - NCT ID: NCT06369883 - Study ID: 2022/41 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-08-30 - Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital ### Study Description 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. ### Conditions - Scoliosis - Kyphosis - Radiography ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Spine radiography ### Outcomes Primary Outcomes - Who should have full spine radiographs? Secondary Outcomes - We aimed to determine the frequency of kyphosis, types and percentages of scoliosis detected on the radiographs. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Interpectoral-pectoserratus Plane Block for Minimally Invasive Aortic Valve Replacement Via Right Anterior Minithoracotomy - NCT ID: NCT06369870 - Study ID: PAINCARE - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2027-12 - Lead Sponsor: Algemeen Ziekenhuis Maria Middelares ### Study Description 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. ### Conditions - Analgesic Effect ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Levobupivacaine Hydrochloride 0.25 % Injectable Solution - Sodium chloride 0.9% ### Outcomes Primary Outcomes - Cumulative opioid consumption Secondary Outcomes - Number of episodes of postoperative pain - Time to need for rescue medication - Number of patients with respiratory complications - PaCO2 levels - Postsurgical Quality of Recovery measured by the Quality of Recovery questionnaire - Number of episodes of postoperative nausea and vomiting - Time to extubation - Number of hours spent in the Intensive Care Unit - Hospitalization duration - Quality of life measured by the 5 level version of the EuroQoL-5 Dimension questionnaire - Days alive and at home - Vital status (whether the patient is alive or dead) ### Location - Facility: Bart Vaes, Gent, Oost-Vlaanderen, 9000, Belgium @@
## Pectopexy for Apical Prolapse Management - NCT ID: NCT06369857 - Study ID: PPY - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-08 - Lead Sponsor: Assiut University ### Study Description 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 ### Conditions - Pelvic Organ Prolapse ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Pectopexy ### Outcomes Primary Outcomes - Pelvic Organ Prolapse Quantification stage Secondary Outcomes - Urinary Symptoms questionnaire - Bladder neck measurements using Transperineal US ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pressure Injury Education Intervention for Pediatric Intensive Care Nurses: A Randomized Controlled Trial - NCT ID: NCT06369844 - Study ID: 1.2023-440 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-01 - Completion Date: 2024-04-30 - Lead Sponsor: Ankara Yildirim Beyazıt University ### Study Description 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. ### Conditions - Pressure Injury Prevention ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Pressure injury education ### Outcomes Primary Outcomes - Stop Pressure Injuries" Education Evaluation Survey Secondary Outcomes ### Location - Facility: Ankara yıldırım Beyazıt Üniversitesi, Ankara, N/A, N/A, Turkey @@
## HER2 Targeted Molecular Imaging in mBC Using 68Ga-ABS011 - NCT ID: NCT06369831 - Study ID: ABS011-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2025-06 - Lead Sponsor: ABSCINT NV/SA ### Study Description 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). ### Conditions - Metastatic Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - 68Ga-NOTA-ABSCINT-HER2 PET/CT ### Outcomes Primary Outcomes - positive, negative, and overall diagnostic agreement between 68Ga-ABS011 PET/CT and the standard of care IHC (and ISH) HER2 status test. Secondary Outcomes - Safety of 68Ga-ABS011. - Change in treatment management - reliability of whole body 68Ga-ABS011 PET/CT compared to HER2-targeted treatment response (Early tumor shrinkage) - reliability of whole body 68Ga-ABS011 PET/CT compared to HER2-targeted treatment response (metabolic response) - Tumor heterogeneity ### Location - Facility: OLV Aalst, Aalst, East-Flanders, 9300, Belgium @@
## Correlation of Cardiac Output Determined by Echocardiography and Indirect Calorimetry in Critically Ill Patients in Cardiogenic Shock on Extracorporeal Circulatory Life Support - NCT ID: NCT06369818 - Study ID: AnIt23-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-02 - Lead Sponsor: Universität Münster ### Study Description 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. ### Conditions - Cardiogenic Shock ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Correlation of t two methods of determining cardiac output (determined by transthoracic echocardiography and determined by indirect calorimetry Secondary Outcomes ### Location - Facility: University Hospital Münster, Münster, N/A, 48149, Germany @@
## EVALUATION OF BLOOD BIOMARKER-BASED DIAGNOSTIC AID IN OUTPATIENTS SUFFERING FROM DEPRESSION - NCT ID: NCT06369805 - Study ID: 2021-00731 - Status: COMPLETED - Start Date: 2021-06-02 - Completion Date: 2022-11-17 - Lead Sponsor: Les Toises - Psychiatry and Psychotherapy Center ### Study Description 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. ### Conditions - Depressive Disorder - Bipolar Disorder - Bipolar Depression ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - there is no intervention ### Outcomes Primary Outcomes - Psychiatric symptomatology Secondary Outcomes ### Location - Facility: Les Toises - Psychiatry and Psychotherapy Center, Lausanne, N/A, 1005, Switzerland @@
## PROSPECTIVE EVALUATION OF BLOOD BIOMARKERS AS AN AID TO DIAGNOSTIC AND TREATMENT IN DRUG-NAIVE PATIENTS WITH DEPRESSION - NCT ID: NCT06369792 - Study ID: 2020-00266 - Status: RECRUITING - Start Date: 2020-10-20 - Completion Date: 2024-12-31 - Lead Sponsor: Les Toises - Psychiatry and Psychotherapy Center ### Study Description 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. ### Conditions - Depressive Disorder - Bipolar Disorder - Bipolar Depression ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - psychiatric symptomatology - EDIT-B profiling Secondary Outcomes ### Location - Facility: Les Toises - Psychiatry and Psychotherapy Center, Lausanne, N/A, 1005, Switzerland @@
## Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Direct Restorative Treatment - NCT ID: NCT06369779 - Study ID: OTCS 36406866 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2030-12 - Lead Sponsor: Ivoclar Vivadent AG ### Study Description 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. ### Conditions - Class I or II Cavities in Premolars or Molars ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - TM Fill and TM Flow ### Outcomes Primary Outcomes - Postoperative hypersensitivity Secondary Outcomes - 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 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## REtinal Markers In Neuroinflammatory Diseases ("REMIND") - NCT ID: NCT06369766 - Study ID: 2023-02144; ko23Papadopoulou4 - Status: RECRUITING - Start Date: 2024-01-31 - Completion Date: 2029-02 - Lead Sponsor: University Hospital, Basel, Switzerland ### Study Description 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. ### Conditions - Multiple Sclerosis - Neuroinflammatory Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Optical coherence tomography (OCT) - Static retinal vessel analyzer - Dynamic retinal vessel analyzer - Laser speckle flowgraphy system - Questionnaire ### Outcomes Primary Outcomes - Occurence of Progression Independent of Relapse Activity (PIRA) - Neuroaxonal loss in the retina (as marker of neurodegeneration in the CNS) - Neuroinflammation in the retina - Fixation instability (as marker of global neuronal dysfunction in the CNS) - Structural changes of the retinal vessels (as marker of systemic microvascular health) - (For a subgroup of participants) Functional/perfusional changes of the retinal vessels Secondary Outcomes - Relative value of retinal markers for the prediction of PIRA compared to or combined with other biomarkers of neuroaxonal damage - Comparison of the examined retinal markers of Multiple Sclerosis patients with Healthy Controls and with patients with other neuroinflammatory diseases of the CNS - The relationship between neuroaxonal loss, functional deficits and vascular changes in Multiple Sclerosis ### Location - Facility: University Hospital Basel, Department of Neurology, Basel, N/A, 4031, Switzerland @@
## Visible Abdominal Distension - NCT ID: NCT06369753 - Study ID: PR(AG)459/2023B - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2025-07 - Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute ### Study Description 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. ### Conditions - Irritable Bowel Syndrome - Dyspepsia - Functional Bloating ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Biofeedback - Placebo ### Outcomes Primary Outcomes - Visible abdominal distension Secondary Outcomes - Sensation of abdominal pressure/fullness - Sensation of abdominal discomfort/pain ### Location - Facility: Hospital Universitari Vall d'Hebron, Barcelona, N/A, 08035, Spain @@
## Case and Use Scenario Study to Gain Knowledge on the User Needs for a Medical Device for Hemophilia A Monitoring - NCT ID: NCT06369740 - Study ID: ENZ20-2024-INDIANAPOLIS - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2024-06-04 - Lead Sponsor: Enzyre B.V. ### Study Description 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. ### Conditions - Hemophilia A ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Case scenarios - questionnaire - Case scenarios - Focus groups - Use scenarios - Usability test - Use scenarios - interview ### Outcomes Primary Outcomes - Current management of Hemophilia A coagulation lab testing - Potential case scenarios for a point of care in-vitro diagnostic device for hemophilia A - Usability issues of the current POC in-vitro diagnostic device prototypes Secondary Outcomes - User preferences for the point of care in-vitro diagnostic device - Problems with current Hemophilia A coagulation monitoring - Potential benefits of a POC device for home use, near-patient use or in clinic use ### Location - Facility: Indiana Hemophilia & Thrombosis Center, Indianapolis, Indiana, 46260, United States @@
## Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design - NCT ID: NCT06369727 - Study ID: MOB015B-VI - Status: COMPLETED - Start Date: 2017-10-15 - Completion Date: 2018-02-15 - Lead Sponsor: Moberg Pharma AB ### Study Description 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 ### Conditions - Erythema ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - MOB015B - MOB015B vehicle - Negative irritant solution of 0.9% saline ### Outcomes Primary Outcomes - To determine the potential of MOB015B to induce sensitization by repeated topical application to the healthy skin of humans under controlled conditions. - To assess safety Secondary Outcomes ### Location - Facility: TKL Research, Inc, Fair Lawn, New Jersey, 07410, United States @@
## Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of ADHD in Children. - NCT ID: NCT06369714 - Study ID: CHEC2023-296 - Status: RECRUITING - Start Date: 2023-02-24 - Completion Date: 2025-02-24 - Lead Sponsor: Lei Lei, MD ### Study Description 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. ### Conditions - Attention Deficit Disorder With Hyperactivity - Executive Function Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Concerta - Digital therapeutics ### Outcomes Primary Outcomes - Swanson, Nolan, and Pelham IV Rating Scale Secondary Outcomes - Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for ADHD - Questionnaire-Children with Difficulties - Behavior Rating Inventory of Executive Function - Continuous Performance Test - Digital Cancellation Test ### Location - Facility: Changzheng Hospital, Naval Medical University, Shanghai, Shanghai, 200003, China @@
## Effects Compressive Tissue Flossing on Lateral Elbow Tendinopathy in US Service Members - NCT ID: NCT06369701 - Study ID: C.2024.019 - Status: RECRUITING - Start Date: 2024-02-13 - Completion Date: 2024-06 - Lead Sponsor: Brooke Army Medical Center ### Study Description 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. ### Conditions - Lateral Elbow Tendinopathy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Compressive tissue floss band ### Outcomes Primary Outcomes - Patient's report of pain on the Defense and Veteran's Pain Rating Scale - Patient-Rated Tennis Elbow Evaluation - Maximal grip strength in the affected upper extremity Secondary Outcomes ### Location - Facility: Brooke Army Medical Center, Fort Sam Houston, Texas, 78234, United States @@
## IDEAL SKIIN CARES Bundle to Prevent Pressure Injury - NCT ID: NCT06369688 - Study ID: Baqiyatallah University - Status: NOT_YET_RECRUITING - Start Date: 2025-10-01 - Completion Date: 2027-10-01 - Lead Sponsor: Baqiyatallah Medical Sciences University ### Study Description 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. ### Conditions - Pressure Ulcer - Pressure Injury - Bed Sore - Pressure Sore - Decubitus Sore - Decubitus Ulcer - Skin Ulcer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - IDEAL SKIIN CARES bundles - IDEAL SKIIN CARES bundles workshop - Respiratory care workshop ### Outcomes Primary Outcomes - Incidence of hospital-acquired pressure injury (HAPI) Secondary Outcomes - Pressure Injury Stage - Patient participation in care - Healthcare costs - Self-report Patient participation in care ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design - NCT ID: NCT06369675 - Study ID: MOB015B-V - Status: COMPLETED - Start Date: 2017-10-19 - Completion Date: 2017-11-14 - Lead Sponsor: Moberg Pharma AB ### Study Description 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 ### Conditions - Erythema ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - MOB015B - 0.2% SLS - 0.9% Saline - MOB015B vehicle ### Outcomes Primary Outcomes - To determine the potential of MOB015B to cause skin irritation after repeated topical application to the healthy skin of humans under controlled conditions. - To assess safety Secondary Outcomes ### Location - Facility: TKL Research, Inc, Fair Lawn, New Jersey, 07410, United States @@
## CD155 Expression in Acute Myeloid Leukemia - NCT ID: NCT06369662 - Study ID: SECI-CD155 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-07-01 - Completion Date: 2024-08-30 - Lead Sponsor: Assiut University ### Study Description 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. ### Conditions - Acute Myeloid Leukemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Flow cytometric immunophenotyping - Complete blood count - Bone marrow aspiration - Cytogenetic testing - FLT3-ITD using High resolution melting curve (HRM) analysis ### Outcomes Primary Outcomes - CD155 expression level in AML patients Secondary Outcomes ### Location - Facility: South Egypt Cancer Institute, Assiut University, Assiut, N/A, 71111, Egypt @@
## Coolsense and Buzzy Use on Pain Score and Anxiety Level During Insulin Injection Application - NCT ID: NCT06369649 - Study ID: COOLSENSE-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-12-31 - Lead Sponsor: Ankara Yildirim Beyazıt University ### Study Description 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? ### Conditions - Injection Fear - Injection Site Coldness - Pain - Type 1 Diabetes Mellitus - Pediatric Disease - Nurse's Role ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Coolsense and Buzzy ### Outcomes Primary Outcomes - Faces Pain Scale- Revised (FPS-R) - Children's Fear Scale (CFS) - Heart rate - Oxygen saturation - Respiratory rate - Blood pressure Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of El-Ganzouri Risk Index and Airway Ultrasonographic Evaluation in Thyroid Surgery - NCT ID: NCT06369636 - Study ID: myucesu - Status: COMPLETED - Start Date: 2023-06-01 - Completion Date: 2024-01-28 - Lead Sponsor: Ankara City Hospital Bilkent ### Study Description 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. ### Conditions - Thyroid Surgery - Difficult Intubation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Thyroid Surgery ### Outcomes Primary Outcomes - Compare EGRI and airway ultrasonographic parameters Secondary Outcomes - Find which is the best test predicts difficult intubation - Finding the incidence of difficult intubation in thyroid surgery ### Location - Facility: Ankara Bilkent City Hospital, Ankara, Çankaya, 06800, Turkey @@
## Monetary Incentive Delay Task for Probing Reward-related Neural Processes - NCT ID: NCT06369623 - Study ID: IRB2023-00466 - Status: RECRUITING - Start Date: 2024-04-06 - Completion Date: 2028-11-30 - Lead Sponsor: Stony Brook University ### Study Description 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. ### Conditions - Adolescent Development ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Monetary Incentive Delay Task ### Outcomes Primary Outcomes - Functional Brain Activation from Monetary Incentive Delay Task Secondary Outcomes ### Location - Facility: Stony Brook Medicine, Stony Brook, New York, 11794, United States @@
## Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment Prostate Cancer - NCT ID: NCT06369610 - Study ID: GMROA2256 - Status: RECRUITING - Start Date: 2024-04-22 - Completion Date: 2027-04-22 - Lead Sponsor: Mayo Clinic ### Study Description 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. ### Conditions - Oligometastatic Prostate Carcinoma - Prostate Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Abiraterone Acetate - Biospecimen Collection - Computed Tomography - Gonadotropin-releasing Hormone Analog - Magnetic Resonance Imaging - Positron Emission Tomography - Questionnaire Administration - Radiation Therapy ### Outcomes Primary Outcomes - Hormonal domain scores Secondary Outcomes ### Location - Facility: Mayo Clinic in Arizona, Scottsdale, Arizona, 85259, United States @@
## A Randomized Controlled Trial of the Safety and Efficacy of Robotic Telesurgery Versus Laparoscopic Surgery - NCT ID: NCT06369597 - Study ID: Robot2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-03-31 - Lead Sponsor: Sun Yat-sen University ### Study Description 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. ### Conditions - Liver Cancer - Renal Cancer - Rectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Robotic telesurgery - Laparoscopic surgery ### Outcomes Primary Outcomes - Surgical complication Secondary Outcomes - Surgical time (min) - Intraoperative blood loss (mL) - Postoperative hospitalization days - Physician satisfaction - Remote metrics ### Location - Facility: First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, 510080, China @@
## Prone Position During ECMO in Pediatric Patients With Severe ARDS - NCT ID: NCT06369584 - Study ID: PEPAD - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-07-01 - Lead Sponsor: Seventh Medical Center of PLA General Hospital ### Study Description 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. ### Conditions - Pediatric Acute Respiratory Distress Syndrome - Extracorporeal Membrane Oxygenation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - prone position ### Outcomes Primary Outcomes - Mortality Secondary Outcomes - Failure of supine position - ECMO successful weaning rate - Total duration of ECMO Support - Number of ECMO-free days - Duration of mechanical ventilation days after ECMO successful weaning. - Duration of Pediatric Intensive Care Unit (PICU) stay. - Duration of hospitalization - Incidence of brain injury before discharge - Number of days with organ failure - Number of days alive without organ failure - Number of ventilator assist pneumonia, bacteriemia, and cannula infection episodes - Number of days with hemodynamic support with catecholamines - Number of days without hemodynamic support with catecholamines ### Location - Facility: seventh medical center of Chinese PLA General Hospital, Beijing, Beijing, 100700, China @@
## Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet - NCT ID: NCT06369571 - Study ID: IRB00439268 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2027-12 - Lead Sponsor: Johns Hopkins University ### Study Description 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. ### Conditions - Epilepsy - Dyslipidemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Atorvastatin 10mg - Modification of dietary fat composition ### Outcomes Primary Outcomes - Diet adherence as assessed by 3 day food records - Statin Adherence - LDL Change - Change in weekly seizure frequency - Seizure severity questionnaire score Secondary Outcomes - Frequency of adverse events - Blood ketone change ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Plyometric Exercise Training in Athletes With Chronic Low Back Pain - NCT ID: NCT06369558 - Study ID: BiruniUniversi - Status: COMPLETED - Start Date: 2024-01-01 - Completion Date: 2024-04-04 - Lead Sponsor: Ugur Cavlak ### Study Description 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. ### Conditions - Low Back Pain, Mechanical ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PLYOMETRIC TRAINING - CLASSIC PHYSIOTHERAPY PROGRAM ### Outcomes Primary Outcomes - VISUAL ANALOG SCALE - OSWESTRY DISABILITY INDEX - SIT AND REACH TEST - VERTICAL JUMP TEST - FLAMINGO BALANCE TEST - SHUTTLE RUNNİNG (20 MİN.) - MANUAL MUSCLE STRENGTH TEST Secondary Outcomes ### Location - Facility: Faculty of Health Sciences in Biruni University, İ̇stanbul, Zeytinburnu, 34010, Turkey @@
## Chronic Pelvic Pain Syndrome in Males - NCT ID: NCT06369545 - Study ID: BiruniUniver - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-08-15 - Lead Sponsor: Biruni University ### Study Description 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. ### Conditions - Pelvic Pain Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - EXERCISE - TENS - ESWT ### Outcomes Primary Outcomes - VISUAL ANALOUGE SCALE - National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) - ALGOMETER Secondary Outcomes - Hospital Anxiety and Depression Scale- HAD - Nottingham Health Profile-NHP - Digital Muscle Testing - Flexibility Measurements - ROM Assessments - Lasegue Test ### Location - Facility: Faculty of Health Sciences in Biruni University, İ̇stanbul, Zeytinburnu, 34010, Turkey @@
## Combination of Neurostimulation and Psychotherapy to Stop Worrying - NCT ID: NCT06369532 - Study ID: ONZ-2023-0460 - Status: RECRUITING - Start Date: 2024-03-06 - Completion Date: 2027-02-20 - Lead Sponsor: University Hospital, Ghent ### Study Description 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. ### Conditions - Active tDCS - Sham tDCS ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Active tDCS - Sham tDCS ### Outcomes Primary Outcomes - the therapeutic effect of the combination therapy for repetitive negative thinking - the consolidation effect of tDCS on CBT Secondary Outcomes - Change of neuroimaging data ### Location - Facility: University Hospital Ghent, Ghent, East-Flanders, 9000, Belgium @@
## Optimization of Management for Sporadic Bilateral Renal Cell Carcinoma - NCT ID: NCT06369519 - Study ID: 2023#17-23 - Status: COMPLETED - Start Date: 2000-01-01 - Completion Date: 2020-12-31 - Lead Sponsor: Peking University First Hospital ### Study Description 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. ### Conditions - Kidney Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Surgery treatment or local tumor destruction. ### Outcomes Primary Outcomes - Overall survival (OS) Secondary Outcomes - Cancer-specific survival (CSS) ### Location - Facility: Peking University First Hospital, Beijing, Beijing, 100034, China @@
## Evaluation of Gingival Thickness Measurement at Different Anatomical Landmarks - NCT ID: NCT06369506 - Study ID: PYO.DIS.1904 Protocol ID:4467 - Status: COMPLETED - Start Date: 2022-09-10 - Completion Date: 2023-12-17 - Lead Sponsor: Ondokuz Mayıs University ### Study Description 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. ### Conditions - Gingival Thickness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - GTmeasurement ### Outcomes Primary Outcomes - 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). - Examining the agreement of GT measurements at three different points in 50 patients, 1195 teeth, using Kappa analysis. Secondary Outcomes ### Location - Facility: Ondokuz Mayis University Faculty of Dentistry Department of Periodontology, Samsun, N/A, 55000, Turkey @@
## Examining The Relationship Between Gingival Thickness and Tooth and Gingival Parameters - NCT ID: NCT06369493 - Study ID: OMUKAEK: 2022/210 - Status: COMPLETED - Start Date: 2022-09-01 - Completion Date: 2023-12-18 - Lead Sponsor: Ondokuz Mayıs University ### Study Description This study aims to assess whether there is a valid correlation between the identified multiple clinical and morphometric parameters and the gingival thickness. ### Conditions - Gingival Thickness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - 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. - 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. - Examining the effect of age and gender of 50 participants on the gingival thickness measured in mm using binary logistic regression analysis. Secondary Outcomes ### Location - Facility: Ondokuz Mayis University Faculty of Dentistry Department of Periodonthology, Samsun, N/A, 55200, Turkey @@
## Prognostic Factors for Survival in Patients With Cholangiocarcinoma - NCT ID: NCT06369480 - Study ID: Journal-nr.: R-23057752 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-08-31 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description 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. ### Conditions - Cholangiocarcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Resection/Ablation of tumor - Palliative chemotherapy - Neoadjuvant chemotherapy - Stereotatic radiotherapy - Best supportive care ### Outcomes Primary Outcomes - Aim I - Aim II Secondary Outcomes ### Location - Facility: Rigshospitalet, Copenhagen, N/A, 2100, Denmark @@
## Short-Term Linvoseltamab Treatment, on Top of Chronic Dupilumab Treatment, for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy - NCT ID: NCT06369467 - Study ID: R5458-668-ALG-2219 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-12 - Completion Date: 2026-04-24 - Lead Sponsor: Regeneron Pharmaceuticals ### Study Description 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 ### Conditions - Food Allergy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - linvoseltamab - dupilumab ### Outcomes Primary Outcomes - Incidence of treatment-emergent adverse events (TEAEs) - Severity of TEAEs - Incidence of adverse event of special interest (AESIs) - Severity of AESIs - Incidence of serious adverse events (SAEs) - Severity of SAEs Secondary Outcomes - Absolute change in the serum concentration of total IgE over time - Percent change in the serum concentration of total IgE over time - Time to reach unquantifiable total serum IgE concentration - Time to reach baseline level and/or the lower limit of the normal ranges of serum IgG - Time to reach baseline level and/or the lower limit of the normal ranges of serum immunoglobulin M (IgM) - Time to reach baseline level and/or the lower limit of the normal ranges of serum immunoglobulin A (IgA) - Incidence of participants with unquantifiable concentrations of serum total IgE - Absolute change in the serum concentration of food allergen-specific IgE - Percent change in the serum concentration of food allergen-specific IgE - Time to reach unquantifiable food allergen-specific serum IgE levels ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## 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 - NCT ID: NCT06369454 - Study ID: B7981090 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-08-03 - Lead Sponsor: Pfizer ### Study Description 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. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Ritlecitinib ### Outcomes Primary Outcomes - Site of capsule disintegration and MR microsphere dispersion - Gastric emptying time - Small intestine residence/transit time - Colon arrival time - Colon (ascending, transverse, descending) residence/transit time - Total transit time Secondary Outcomes - Maximum plasma concentration (Cmax) - Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) - Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) - Time for Cmax (Tmax) - Terminal half-life (t1/2) - Frequency of adverse events - Frequency of abnormal clinical laboratory tests - Frequency of abnormal vital signs - Frequency of abnormal 12-lead ECG ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Collection of Biological Specimens and Associated Health Information - NCT ID: NCT06369441 - Study ID: Ovation-23-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2034-04 - Lead Sponsor: Ovation.io, Inc. ### Study Description 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. ### Conditions - Cancer - Other Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Biorepository Secondary Outcomes ### Location - Facility: Ovation.io, Portland, Maine, 04101, United States @@
## Patient Characteristics, Treatment Patterns, and Healthcare Resource Utilization of Metastatic Melanoma Patients - NCT ID: NCT06369428 - Study ID: CDRB436BFI02 - Status: COMPLETED - Start Date: 2021-06-23 - Completion Date: 2023-04-13 - Lead Sponsor: Novartis ### Study Description 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. ### Conditions - Metastatic Melanoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Mean Age-standardized Annual Incidence of Metastatic Melanoma in 2014-2021 - Point Prevalence per 100,000 Population - Mean Age of Patients at Index Date per Hospital District - Mean Length of Follow-up at Index Date per Hospital District - Gender at Index Date per Hospital District - Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per Hospital District - Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per Hospital District - Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per Hospital District - Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per Hospital District - Number of Patients with Negative BRAF Status at Index Date per Hospital District - Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per Hospital District - Number of Patients by Number of Metastatic Organs at Index Date per Hospital District - Number of Patients by Location of Metastases at Index Date per Hospital District - Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per Hospital District - Number of Patients by Most Prevalent (greater than 5%) Baseline Comorbidities per First-line Medication Secondary Outcomes - Overall Survival (OS) - Time to Next Treatment (TTNT) of the First-line (1L) by Type of Treatment - Duration of Treatment (DoT) - Mean Age at Index Date per First-line (1L) Medication - Length of Follow-up at Index Date per 1L Medication - Time to Treatment at Index Date per 1L Medication - Gender at Index Date per 1L Medication - Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per 1L Medication - Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per 1L Medication - Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per 1L Medication - Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per 1L Medication - Number of Patients with Negative BRAF Status at Index Date per 1L Medication - Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per 1L Medication - Number of Patients by Number of Metastatic Organs at Index Date per 1L Medication - Number of Patients by Location of Metastases at Index Date per 1L Medication - Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per 1L Medication - Number of Patients that Received Radiotherapy During 1L Treatment - Number of Patients Switched from Immuno-oncology (IO) 1L Treatment to Targeted Therapy (TT) Second-line (2L) Treatment - Number of Patients Switched from IO 1L Treatment to Chemotherapy (Chemo) 2L Treatment - Number of Patients Switched from TT 1L Treatment to IO 2L Treatment - Number of Patients Switched from TT 1L Treatment to Chemo 2L Treatment - Number of Patients Switched from Chemo 1L Treatment to IO 2L Treatment - Number of Patients Switched from Chemo 1L Treatment to TT 2L Treatment - Number of Patients Switched from IO 2L Treatment to TT Third-line (3L) Treatment - Number of Patients Switched from IO 2L Treatment to Chemo 3L Treatment - Number of Patients Switched from TT 2L Treatment to IO 3L Treatment - Number of Patients Switched from TT 2L Treatment to Chemo 3L Treatment - Number of Patients Switched from Chemo 2L Treatment to IO 3L Treatment - Number of Patients Switched from Chemo 2L Treatment to TT 3L Treatment - Number of Healthcare Contacts and Associated Costs per Patient Year - Number of Healthcare Contacts and Associated Costs per Patient - Number of Healthcare Contacts and Associated Total Costs ### Location - Facility: Novartis, Basel, N/A, 4056, Switzerland @@
## Health of Babies Born From IVF Versus IVM at 5 Years Old - NCT ID: NCT06369415 - Study ID: 04/24/DD-BVMD - Status: RECRUITING - Start Date: 2024-04-16 - Completion Date: 2026-03-30 - Lead Sponsor: Mỹ Đức Hospital ### Study Description 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. ### Conditions - Infertility - IVF - IVM - Development, Child ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 and behavioural screening according to Strength and Difficulties Questionnaires (SDQ's) ### Outcomes Primary Outcomes - Normal ASQ-3 score rate. - Normal SDQ score rate. - Normal weight rate Secondary Outcomes - Thinness rate - Overweight rate - Obesity rate - Score of Communication (ASQ-3 questionnaire) - Score of Gross motor (ASQ-3 questionnaire) - Score of Fine motor (ASQ-3 questionnaire) - Score of Problem solving (ASQ-3 questionnaire) - Score of Personal-Social (ASQ-3 questionnaire) - Score of Emotional symptoms (SDQ questionnaire) - Score of Conduct problems (SDQ questionnaire) - Score of hyperactivity/inattention (SDQ questionnaire) - Score of peer relationship problems (SDQ questionnaire) - Score of prosocial behavior (SDQ questionnaire) - The total difficulties score. ### Location - Facility: Mỹ Đức Hospital, Ho Chi Minh City, Tan Binh, N/A, Vietnam @@
## Cognitive Impairment and Cerebral Haemodynamics in Individuals With Symptomatic Peripheral Arterial Disease - NCT ID: NCT06369402 - Study ID: 0963 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-02 - Lead Sponsor: University of Leicester ### Study Description 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. ### Conditions - Peripheral Arterial Disease - Cognitive Impairment ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cerebral haemodynamic testing using transcranial Doppler - Ankle-brachial pressure index - Six-minute walk test ### Outcomes Primary Outcomes - Peak % change of CBv from baseline Secondary Outcomes - Autoregulation index (Tieck's model) - Absolute score achieved on the Addenboook's cognitive examination (III) - Digit span forward and backward scores ### Location - Facility: Glenfield Hospital Leicester, Leicester, Leicestershire, LE3 9QP, United Kingdom @@
## Real-life Management of Patients Eligible for CAR-T Cell Therapy - NCT ID: NCT06369389 - Study ID: RC31/23-0417 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2034-12-31 - Lead Sponsor: University Hospital, Toulouse ### Study Description 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. ### Conditions - Hemopathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Patients eligible for CAR-T treatment ### Outcomes Primary Outcomes - Overall survival of patients with hemopathy eligible for CAR-T cell therapy Secondary Outcomes - 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 - Evaluate the time taken to treat patients with CAR-T cells ### Location - Facility: CHU de Toulouse, Toulouse, CHU De Toulouse, 31059, France @@
## Electrodiagnostic Approach for Pectoral Nerve Conduction Studies - NCT ID: NCT06369376 - Study ID: ONZ-2022-0072 - Status: COMPLETED - Start Date: 2023-06-30 - Completion Date: 2024-04-12 - Lead Sponsor: University Hospital, Ghent ### Study Description 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. ### Conditions - New Nerve Conduction Protocol for Pectoral Nerve ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - New nerve conduction protocol ### Outcomes Primary Outcomes - Latency - Amplitude Secondary Outcomes ### Location - Facility: UZ Gent, Gent, Oost-Vlaanderen, 9000, Belgium @@
## Estrogen Deficiency on Cardiovascular Risk - NCT ID: NCT06369363 - Study ID: STUDY000024245 - Status: NOT_YET_RECRUITING - Start Date: 2025-09 - Completion Date: 2027-11 - Lead Sponsor: Milton S. Hershey Medical Center ### Study Description 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. ### Conditions - Postmenopausal Symptoms - Cardiovascular Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Placebo - Estradiol ### Outcomes Primary Outcomes - Red blood cell flux - Mean arterial pressure (mmHg) - baseline plasma TNF-α concentration (pg/ml) - One week post-intervention plasma TNF-α concentration (pg/ml) - baseline plasma IL-1β concentration (pg/ml) - One week post-intervention plasma IL-1β concentration (pg/ml) - baseline plasma IL-6 concentration (pg/ml) - One week post-intervention plasma IL-6 concentration (pg/ml) Secondary Outcomes - baseline plasma estrogen (pg/ml) - One week post-intervention plasma estrogen (pg/ml) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion - NCT ID: NCT06369350 - Study ID: STUDY000020217 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2025-09 - Lead Sponsor: Milton S. Hershey Medical Center ### Study Description 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. ### Conditions - Ischemia Reperfusion Injury - Peripheral Artery Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Vitamin B6 25 MG - Vitamin B6 50 MG - Vitamin B6 100 MG - Placebo ### Outcomes Primary Outcomes - baseline blood pressure in mmHg - Second visit blood pressure in mmHg - baseline heart Rate in beats per minute - Second visit heart Rate in beats per minute - baseline muscle sympathetic nerve activity in burst/min - Second visit muscle sympathetic nerve activity in burst/min - baseline walking time in minutes - Second visit walking time in minutes Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ultrasound Study of the Submentonian Musculature and Its Relationship in Dysphagia - NCT ID: NCT06369337 - Study ID: 014-24 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-06 - Lead Sponsor: Universidad Europea de Madrid ### Study Description 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 ### Conditions - Dysphagia, Oropharyngeal - Deglutition Disorders - Mechanical Ventilation Complication ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ultrasound ### Outcomes Primary Outcomes - Thickness of the submental muscles - Hyolaryngeal displacement Secondary Outcomes - Muscle strength - Functional Status - Swallowing function - Swallowing function - Swallowing function ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy of Pain Neuroscience Education and Physiotherapy in Patients Diagnosed With Spondyloarthritis - NCT ID: NCT06369324 - Study ID: 05 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-04-11 - Lead Sponsor: Universidad de Extremadura ### Study Description 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. ### Conditions - Spondyloarthropathies - Ankylosing Spondylitis - Exercise Therapy - Physical Therapy Modalities - Pain Management ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pain education - Exercise supervised by external focus - Therapy by means of electrical stimulation (electro-massage) ### Outcomes Primary Outcomes - Numeric Pain Rating Scale (NPRS) - Cervical and Lumbar Joint Position Sense Error - Cervical Range of Motion (CRoM) - Pressure Pain Threshold (PPT) - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) - Bath Ankylosing Spondylitis Motility Index (BASMI) - Bath Ankylosing Spondylitis Functional Index (BASFI). - Kinesophobia - Catastrophizing Pain - Fear-Avoidance Beliefs Questionnaire (FABQ) Secondary Outcomes ### Location - Facility: Faculty of Medicine and Health Sciences, Badajoz, N/A, 06006, Spain @@
## [Trial of device that is not approved or cleared by the U.S. FDA] - NCT ID: NCT06369311 - Study ID: 2000037345 - Status: WITHHELD - Start Date: N/A - Completion Date: N/A - Lead Sponsor: [Redacted] ### Study Description No description available. ### Conditions - No conditions listed. ### Study Design - Type: N/A - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of JK07 in Patients With Chronic Heart Failure - NCT ID: NCT06369298 - Study ID: JK07.2.01 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2026-06-30 - Lead Sponsor: Salubris Biotherapeutics Inc ### Study Description 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. ### Conditions - Heart Failure With Reduced Ejection Fraction - Heart Failure With Preserved Ejection Fraction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - JK07 - Placebo ### Outcomes Primary Outcomes - Safety - Cohort 1 - Efficacy - Cohort 1 - Safety - Cohort 2 Secondary Outcomes ### Location - Facility: Southern California Heart Specialists, Pasadena, California, 91105, United States @@
## A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer - NCT ID: NCT06369285 - Study ID: PUMA-ALI-1201 - Status: NOT_YET_RECRUITING - Start Date: 2024-12-31 - Completion Date: 2028-12-31 - Lead Sponsor: Puma Biotechnology, Inc. ### Study Description 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. ### Conditions - Hormone Receptor Positive HER-2 Negative Breast Cancer - Metastatic Breast Cancer - Recurrent Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Alisertib - Endocrine therapy ### Outcomes Primary Outcomes - Objective Response Rate (ORR) Within Dose Subgroup - Duration of Response (DOR) Within Dose Subgroup - Disease Control Rate (DCR) Within Dose Subgroup - Progression Free Survival (PFS) Within Dose Subgroup - Overall Survival (OS) Within Dose Subgroup - Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the Enrolled Population Secondary Outcomes - Objective Response Rate (ORR) Within Biomarker-Defined Subgroup - Duration of Response (DOR) Within Biomarker-Defined Subgroup - Disease Control Rate (DCR) Within Biomarker-Defined Subgroup - Progression Free Survival (PFS) Within Biomarker-Defined Subgroup - Overall Survival (OS) Within Biomarker-Defined Subgroup ### Location - Facility: Mayo Clinic, Rochester, Minnesota, 55905, United States @@
## Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy - NCT ID: NCT06369272 - Study ID: mRNA-1273-P919 - Status: COMPLETED - Start Date: 2023-03-01 - Completion Date: 2023-10-20 - Lead Sponsor: ModernaTX, Inc. ### Study Description 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. ### Conditions - Maternal Outcomes - Infant Outcomes - Pregnancy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of MCMs - Number of Adverse Neonatal and Infant Outcomes - Number of Participants with Hypertensive Disorders - Number of Stillbirths, Preterm Births, and Medically Attended Spontaneous Abortions Secondary Outcomes - Demographics: Participant Region of Residence - Demographics: Age at LMP - Demographics: Number of Overweight or Obese Participants - Demographics: Duration of Health Plan Enrolment Prior to Pregnancy - Demographics: Calendar Date of the Pregnancy Outcome - Demographics: Participant Race and Ethnicity - Demographics: Participant Socio-economic Status - Healthcare Utilization: Number of Office Visits, Emergency Department Visits, and Hospitalizations - Healthcare Utilization: Number of Distinct Medications Used ### Location - Facility: Carelon Research, Newton, Massachusetts, 02458, United States @@