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Само по покана

Inpatient Monitoring of Unfractionated Heparin

Blood Clot Thrombosis

Unfractionated heparin (UFH) is the most widely used intravenous (IV) anticoagulant for treating and preventing thromboembolic disease (e.g., blood clots ). UFH must be closely monitored and adjusted in the hospital. There are two assays used to monitor UFH: 1) the activated partial thromboplastin time (PTT) and 2) the chromogenic anti-factor Xa assay (anti-Xa). This study aims to compare PTT and anti-Xa methods for monitoring UFH in a pragmatic, randomized controlled trial to determine which helps patients reach a therapeutic anticoagulation range faster.

Начало: 26.06.2024 Край: 01.07.2026 Възраст: от 18 г.

United States Vanderbilt University Medical Center NCT06329921

Само по покана

Fine-tuned Physical Training to Improve Quality of Life in Older Individuals

Frail Elderly Elderly Aging Aging Frailty +1

The overall aim of this project, which is based upon the interdisciplinary expertise of four research groups within the University of Rome Foro Italico, in the macro-areas of psychology, bioengineering, physiology, and internal medicine, is to improve the overall health and well-being of community-dwelling frail older adults, who are often suffering from non-communicable diseases, by means of an integration of innovative cognitive and resistance-core training. Forty-five frail or pre-frail community-dwelling older adults aged ≥65 years will be randomly assigned to three 8-week intervention groups: A) resistance training; B) resistance-core training; C) cognitive-resistance-core training. Comparison between groups C and B will show the effects of an innovative cognitive-motor dual-task training method, which will incorporate principles of modern psychotherapeutic approaches to boost physical training, and to improve cognitive, emotional, and mood disturbances in older ages. Comparison between groups B and A will focus on the motor component of the intervention, showing the effects of adding specific core-exercises to a traditional resistance training program on muscle strength, power, and the ability to safely carry out functional abilities of daily life. As outcomes, clinical and psychological scales, cognitive tasks, and their underlying cortical mechanisms will be measured. In addition, state-of-art physiological and biomechanical methods will be used to study human kinematics, muscle synergies, and cortico-muscular coherence furthering some important neurophysiological mechanisms of motor control underlying the execution of functional tasks. The results of this project, therefore, will be of great relevance for the advancement of training-exercise methodology as well as unravelling central and peripheral mechanisms underlying frailty with the final goal of improving the quality of life in older individuals.

Начало: 12.04.2024 Край: 01.07.2026 Възраст: от 65 г.

Italy University of Rome Foro Italico NCT07546734

Само по покана

The Effect of Neonatal Care Education Given to Primiparous Mothers in the Last Trimester on Mothers' Self-Efficacy Perception, Prenatal and Maternal Bonding in the Early Postpartum Period

Primiparous Pregnant Women in the Last Trimester

This study was conducted using a pre-test-post-test randomized controlled experimental design to investigate the effects of neonatal care education given to primiparous mothers in the last trimester on their self-efficacy perception, prenatal and maternal bonding in the early postpartum period. The study population consisted of pregnant women in the last trimester who applied to the Antenatal School of Kars Harakani State Hospital between November 2024 and November 2026. The study sample consisted of a total of 76 pregnant women, divided into an intervention group (n: 38) and a control group (n: 38). Data were collected using the "Personal Information Form", "General Self-Efficacy Scale", "Prenatal Attachment Inventory", and "Maternal Attachment Scale". The intervention group received training on newborn care. In the first phase of the study, a pre-test was administered to both the intervention and control groups. Following the pre-test, Newborn Care Training was conducted face-to-face with pregnant women in the experimental group in two 20-minute sessions, totaling 40 minutes, after which the pregnant women were given an educational booklet. After this training session, reinforcement training was conducted twice by telephone at one-week intervals, and their questions were answered. After the pre-test, at 36 weeks of gestation, both the intervention and control groups were contacted by telephone and the "General Self-Efficacy Scale" and "Prenatal Attachment Inventory" were administered as post-tests. Six weeks after delivery, the maternal attachment scale was administered to both the intervention and control groups.

Начало: 01.04.2024 Край: 31.12.2027 Възраст: 18–35 г.

Turkey (Türkiye) Kafkas University NCT07547579

Само по покана

Determination of the Effect of Using Virtual Glasses on Pain and Anxiety During IUD Application

Women Health

This randomized controlled experimental study aimed to determine the effect of using virtual glasses during IUD application on pain and anxiety. The hypotheses of the study were determined as follows. H1-a: Using virtual glasses during IUD application affects the level of pain. H1-b: Using virtual glasses during IUD application affects the level of anxiety.

Начало: 31.03.2024 Край: 31.08.2026 Възраст: 18–49 г.

Turkey (Türkiye) Inonu University NCT07545850

Само по покана

Exercise Strategies in Parkinson's Disease

Parkinson Disease

The goal of this clinical trial is to learn about exercise and physical activity people with Parkinson's Disease. The main questions it aims to answer are: 1) learn about the physical activity and exercise behaviors of people with Parkinson's Disease over the course of a year and 2) compare 3 exercise guidance strategies aimed to impact exercise behavior: standard care, written exercise guidance from neurologist and/or physical therapy. During the course of the study: 1. Participants will use activity trackers and a mobile phone application to monitor their exercise participation. 2. At the same time, the research team will be working with the participant's medical teams at Northwestern Medicine and University of Chicago Medical Center to improve the way that they deliver exercise guidance using verbal instructions and encouragement, written exercise guidance, and/or physical therapy.

Начало: 01.03.2024 Край: 31.05.2028 Възраст: 18–89 г.

United States Shirley Ryan AbilityLab NCT06104397

Само по покана

Guerbet Liver Fibrosis

Metabolic Dysfunction-associated Steatotic Liver Disease

The goal of this study is to assess the value of liver dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and texture analysis post gadopiclenol for liver fibrosis staging, in comparison with MR elastography, T1 mapping, ultrasound elastography and blood tests in 50 initial patients with metabolic dysfunction-associated steatohepatitis (MASH).

Начало: 28.02.2024 Край: 01.10.2026 Възраст: 18–89 г.

United States Icahn School of Medicine at Mount Sinai NCT06703450

Само по покана

Feasibility of Improving Glycemia With Heat Therapy to Prevent AD

Healthy Aging Alzheimer Disease Metabolic Disease

The investigators will determine if heat therapy can improve blood (Aim 1) and brain (Aim 2) glucose metabolism in cognitively healthy older adults (65+) who are at risk for AD. The investigators will also examine the degree to which changes in blood and brain glucose metabolism track together and explore several additional potential mechanisms that are critical to understanding the brain benefits of heat therapy (Aim 3). These aims will provide a comprehensive understanding of the impact of heat therapy on whole body metabolic function and brain health.

Начало: 27.02.2024 Край: 31.03.2028 Възраст: от 65 г.

United States University of Kansas Medical Center NCT06023407

Само по покана Фаза 4

Laparoscopic TAP Block During Robotic Assisted Laparoscopic Radical Prostatectomy for Improvement in Postoperative Pain

Prostate Cancer

Determine the impact of a laparoscopic-guided transversus abdominis plane (TAP) block timing (at initiation or conclusion of procedure) on the postoperative pain experience in patients following robot assisted laparoscopic radical prostatectomy (RALP).

Начало: 19.02.2024 Край: 01.08.2029 Възраст: от 18 г.

United States Corewell Health East NCT05753046

Само по покана

Efficacy of Vitamin B1 in Familial Adenomatous Polyposis Patients.

Familial Adenomatous Polyposis (FAP)

This study aimed to investigate the efficacy of vitamin B1 in patients with familial adenomatous polyposis, and to determine the inhibitory effect of vitamin B1 on the size and number of colorectal adenomas by administering oral vitamin B1 therapy for 1 year and colonoscopy follow-up every 3 months

Начало: 08.01.2024 Край: 01.12.2028 Възраст: 18–80 г.

China Shanghai Zhongshan Hospital NCT06649825

Само по покана

EFFECTIVENESS OF CARBOHYDRATE LOADING IN LOWERING PERIOPERATIVE INSULIN RESISTANCE IN PEDIATRIC PATIENTS UNDERGOING SURGERY

Insulin Resistance

It is a double blinded randomized controlled trial interventional study, examining the effect of carb loading given prior to surgery on preventing post operative insulin resistance in pediatric patients undergoing elective surgery

Начало: 01.01.2024 Край: 01.06.2026 Възраст: 2–16 г.

Indonesia Gadjah Mada University NCT07545538

Само по покана

A Long Term Follow-Up Study for Subjects Who Have Received Q-Cells

Transverse Myelitis

This study is an observational study designed to obtain information on the long-term safety, tolerability, and continued activity of Q-Cells®. The study will follow the participants who previously received Q-Cells® for 10 years. The goal of this observational study is to learn about the long term effects of Q-Cells® in people with transverse myelitis. The main objectives the study is to evaluate the safety of patients who have received Q-Cells®. The secondary goal of the study is to get data about the long-term activity of Q-Cells® over a period of 10 years. Patients will complete exams, lab tests, imaging, and questionnaires to monitor their safety.

Начало: 12.12.2023 Край: 01.12.2035

United States University of Texas Southwestern Medical Center NCT06163508

Само по покана Фаза 3

Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion.

Non-Small-Cell Lung Cancer

Efficacy and safety evaluation of PLB1004 in patients with locally advanced/metastatic non-squamous NSCLCharboring EGFR exon 20 insertion.

Начало: 01.12.2023 Край: 30.06.2030 Възраст: от 18 г.

China Avistone Biotechnology Co., Ltd. NCT06281964

Само по покана

Community Health Worker Based Intervention to Improve Palliative Care

Cancer End Stage Cancer Malignancy Advanced Cancer

The study aims to find out if community health worker (CHW) support will improve palliative care outcomes in African American patients with advanced cancer, by comparing the quality of life of patients who are receiving standard care to those whose standard care is supplemented with CHW support.

Начало: 02.11.2023 Край: 01.09.2027 Възраст: от 18 г.

United States Wake Forest University Health Sciences NCT05407844

Само по покана Фаза 3

A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

Subacute Cutaneous Lupus Erythematosus Chronic Cutaneous Lupus Erythematosus

In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue. The study will enroll only those participants who have completed treatment with litifilimab in the parent study, 230LE301. The main objective of the study is to learn more about the long-term safety of litifilimab. The main question researchers want to answer is: \- How many participants have adverse events and serious adverse events after taking litifilimab? Adverse events are unwanted health problems that may or may not be caused by the study drug. Researchers will also learn more about the effect of litifilimab on CLE. They will do this by measuring the symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI). Researchers will look at how litifilimab and CLE affect the quality of life of participants using a group of questionnaires. They will also look at how litifilimab affects laboratory tests and how participants' immune systems respond to litifilimab. The study will be done as follows: * The last visit of parent study 230LE301 will be the first visit of study 230LE305. * All participants will receive litifilimab as an injection under the skin once every 4 weeks. Both researchers and participants will know the dose and identity of the study drug. * Globally, the treatment period will last up to 104 weeks, or 2 years. For participants in the United States, the treatment period may last up to 260 weeks, or 5 years * There will be a follow-up safety period that lasts up to 24 weeks. * Globally, participants will have up to 27 study visits during the treatment period. In the US, participants will have up to 66 study visits. * Globally, the total study duration for participants will be up to 128 weeks. In the US, the total study duration will be up to 284 weeks .

Начало: 03.10.2023 Край: 11.12.2029 Възраст: от 18 г.

Argentina, Brazil, Bulgaria +22 Biogen NCT06044337

Само по покана Фаза 2/3

An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007

Mucopolysaccharidosis II

This is a multiregional open-label extension (OLE) to assess the safety, tolerability, and efficacy of long-term treatment with tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant intravenous (IV) enzyme replacement therapy (ERT) for Hunter syndrome (MPS II). Participants who complete at least through the Week 49 visit in Study DNLI-E-0002 and do not discontinue study intervention early and participants who complete Study DNLI-E-0007 will be enrolled in this OLE. All participants will receive DNL310 for up to 5 years from the time of entry in this OLE. Participants, site staff, and the Sponsor will remain blinded to the original treatment assignment for participants entering this OLE from Study DNLI-E-0007.

Начало: 20.09.2023 Край: 01.06.2027 Възраст: до 18 г.

Argentina, Belgium, Canada +10 Denali Therapeutics Inc. NCT06075537

Само по покана

Genomic Sequencing for Evaluation of Fetal Structural Anomalies

Fetal Structural Anomalies

This study follows an observational prospective cohort design. Women with fetal structural anomalies are routinely offered diagnostic testing with chorionic villus sampling or amniocentesis, with analysis for chromosomal analysis using karyotype or microarray analysis. Women in whom such testing does not explain the fetal phenotype, or in whom a genetic disease is strongly suggested based on the phenotype or a pattern of recurrent anomalies, will be offered exome sequencing (ES) and/or genome sequencing (GS) through the UCSF CLIA certified Genomic Medicine Laboratory. In advance of study enrollment, patients have been counseled regarding the structural anomalies in the fetus and offered pregnancy termination. The sequencing results for on-going pregnancies have a turnaround time of 2-4 weeks, and in the majority of cases are available after decisions have been made regarding continuation or termination of pregnancy. Patients who decline diagnostic testing but who have a prenatally identified anomaly may be offered the option of testing on umbilical cord blood at delivery or on the placenta or other products of conception after a stillbirth or pregnancy termination. The project is exploratory in nature, with the ultimate goal of contributing to a growing body of phenotypic data and understanding how providers and patients utilize genomic (either exome or genome) sequencing results during pregnancy.

Начало: 18.09.2023 Край: 15.07.2030 Възраст: 18–64 г.

United States University of California, San Francisco NCT06054230

Само по покана Фаза 3

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy

Myositis Active Idiopathic Inflammatory Myopathy Dermatomyositis Polymyositis +2

The main purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with Idiopathic Inflammatory Myopathy (IIM) who previously participated in ARGX-113-2007. The study consists of a treatment period where participants will receive efgartigimod PH20 SC for up to 51 months. The treatment period will be followed by a treatment-free safety follow-up period of 56 days.

Начало: 12.09.2023 Край: 01.09.2028 Възраст: от 18 г.

Argentina, Austria, Belgium +26 argenx NCT05979441

Само по покана

Magnetic Stimulation as a Treatment for Stress Urinary Incontinence

Stress Urinary Incontinence

The goal of this clinical trial is to determine the efficacy of electromagnetic stimulation treatment of the pelvic floor muscles in adult females with stress urinary incontinence.

Начало: 01.09.2023 Край: 31.07.2028 Възраст: от 18 г.

Canada Sunnybrook Health Sciences Centre NCT05952258

Само по покана

The Nightlight Falls Prevention Study

Aging Alzheimer Disease Dementia Alzheimers Dementia of Alzheimer Type +1

This project will test the effectiveness of a novel intervention consisting of unobtrusive, low-intensity, horizontal and vertical lights that outline the bathroom or entry way doorframe in residents' rooms and provide visual cues to promote postural stability. Specifically, this pragmatic crossover trial will enroll 335 assisted living residents with dementia and follow them for one year, comparing the incidence of nighttime falls during the lighting condition to the incidence of falls during the control condition; secondarily, it will determine whether and to what extent the intervention effect is modified by resident- and environmental-level risk factors, and satisfaction with the lighting system.

Начало: 28.07.2023 Край: 31.12.2027 Възраст: от 18 г.

United States University of North Carolina, Chapel Hill NCT05973448

Само по покана

taVNS During Multi-site HRV Measurement: Reliability & Agreement Study

Autonomic Nervous System (ANS) Functioning and Mood State Heart Rate Variability (HRV) Blood Pressure Monitoring Transcutaneous Electric Nerve Stimulation +1

This study examines the reliability and agreement of autonomic nervous system measurements obtained from different anatomical sites during transcutaneous auricular vagus nerve stimulation (taVNS). taVNS is a non-invasive electrical stimulation delivered to the ear using a small stimulator. Healthy volunteers aged 18-40 years will participate in one laboratory session. Heart rate and heart rate variability will be recorded from the chest (reference), finger, and arm. Blood pressure and pulse will also be measured. Data will be collected in three standardized periods: T0 (5-minute resting baseline), T1 (10 minutes during taVNS), and T2 (5-minute recovery). The main goal is to determine how closely finger- and arm-based measurements match the chest reference and how consistent these measurements are across the study periods. Participation is voluntary, and participants may withdraw at any time. Expected risks are minimal and may include temporary tingling or mild discomfort at the ear and, rarely, lightheadedness. No direct medical benefit is expected, but the findings may help improve how autonomic responses are monitored during taVNS in future research.

Начало: 20.03.2023 Край: 05.05.2026 Възраст: 18–40 г.

Turkey (Türkiye) SEFA HAKTAN HATIK NCT07548723

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