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Showing 1-20 of 273 trials
NCT07646652
The goal of the study is to assess if learning one's Lewy Body Dementia (LBD) biomarker test result impacts longitudinal psychosocial and behavioral responses and to identify factors that moderate and mediate these outcomes.
NCT07029581
Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.
NCT06938932
This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of high temperature exposure and the underlying mechanisms.
NCT07578597
Background Bariatric surgery (BS) is an efficient treatment of severe obesity and diseases like female infertility. Almost half of the population having BS are women of reproductive age, and BMI above 35 kg/m2 and infertility even serve as eligibility for surgery. BS improves fertility, however with risk of adverse effects on maternal glucose regulation and fetal growth. Objective We hypothesize that pregnant women with BS have a higher frequency of both hypo- and hyperglycemia causing abnormal fetal growth, and that Roux-en-Y gastric bypass (RYGB) results in higher risk of hypoglycemia and larger glucose variability than sleeve gastrectomy (SG). Methods In this prospective, multicenter study, we will include 225 pregnant BMI, age, and parity-matched women from four obstetric departments: 75 with RYGB, 75 with SG and 75 without BS. Data include continuous glucose monitoring, activity tracking, blood sampling, questionnaires, and fetal growth. Discussion Knowledge on prevalence, clinical significance and treatment of maternal glucose excursions and fetal growth in pregnancy following BS are lacking. This study will help clinicians improve the care of pregnant women with BS and to guide women of reproductive age considering BS.
NCT04940936
A Patient Decision Aid (PtDA) is developed during a workshop in close collaboration with selected patients. The PtDA is subsequently used in the consultation between patient and physician to facilitate their shared decision on the dose of stereotactic body radiation therapy (SBRT) for lung tumors located less than 1 cm from the thoracic wall. Hypothesis: The use of a PtDA will increase the extent of Shared Decision Making (SDM) during the consultation and result in patients being more directly involved in the planning of their treatment.
NCT04728633
This phase II trial studies the effect of transarterial chemoembolization in treating patients with uveal melanoma that has spread to the liver (liver metastases). Transarterial chemoembolization involves the injection of a blocking agent (gelatin sponge, ethiodized oil) and a chemotherapy agent (carmustine) directly into the artery in the liver to treat liver cancers. Chemotherapy drugs, such as carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. transarterial chemoembolization with carmustine in combination with ethiodized oil and gelatin sponge may help cause the tumors in the liver to shrink or disappear.
NCT01354002
The aims of this protocol are: to collect and store diseased and normal tissue and body fluid samples from new and returning patients at St. Jude Children's Research Hospital (SJCRH), affiliated sites and collaborating institutions; to collect and store samples from relatives of SJCRH patients; to collect and store retrospective and prospective pertinent corresponding clinical and laboratory data on disease characterization, treatment, and outcome; and to serve as a source of human biological samples and corresponding laboratory and clinical data.
NCT00017914
This study will evaluate subjects with adult- and childhood-onset myositis to learn more about their cause and the immune system changes and medical problems associated with them. Myositis is an inflammatory muscle disease that can damage muscles and other organs, resulting in significant disability. Children or adults with polymyositis or dermatomyositis or a related condition may be evaluated under this study. Healthy children or adults will also be enrolled as "controls," for comparison of test results. All patients will undergo a complete history (including completing some questionnaires) and physical examination, review of medical records, and blood and urine tests. Patients may then choose to participate in an additional 1- to 5-day evaluation, which will include some or all of the following diagnostic, treatment or research procedures: 1. Standardized muscle strength testing, range of motion of joints and walking (gait) analysis by a physiotherapist; completion of a questionnaire regarding ability to perform daily tasks 2. Skin assessment, possibly including photographs of lesions and a skin biopsy (removal of a small skin sample under local anesthetic) 3. Magnetic resonance imaging (scans that use magnetic fields to visualize tissues) of leg muscles 4. Swallowing studies, including a physical examination and questionnaire on swallowing ability, studies of tongue strength, and ultrasound imaging during swallowing, and possibly, a modified barium swallow 5. Voice and speech assessment, possibly including computerized voice analysis and laryngoscopy-analysis of the larynx (voice box) using a small rigid scope with a camera placed in the mouth to view and record vocal cord function 6. Pulmonary function tests (measurement of air moved into and out of the lungs, using a breathing machine) to evaluate lung function and, possibly, chest X-ray 7. Electrocardiogram (measurement of the electrical activity of the heart) and, possibly, echocardiogram (ultrasound imaging of the heart) 8. Endocrine evaluation 9. Eye examination, in patients with vision loss or other eye symptoms 10. Nutrition assessment to evaluate muscle mass and muscle wasting, including tape measurements or bioelectric impedance testing, a painless procedure in which wires are attached to the extremities with a sticky paste. 11. Muscle ultrasound. 12. Electromyography (record of the electrical activity of muscles) 13. Muscle or skin biopsy (removal of a small piece of muscle tissue for microscopic examination) All patients may have only a one-time evaluation or may return for one follow-up evaluations (either the 1-day or 3- to 5-day evaluation) over a 1-year period. Healthy children will undergo a medical history and brief physical examination; blood and urine tests; speech and swallowing studies including questionnaires and physical examination, tongue strength, and ultrasound study; and bioelectric impedance testing. Children 8 to 18 years old may also have exercise testing....
NCT07548515
This study aims to address the gap by investigating the correlation between body composition and metabolism in adult and older Filipino endurance and strength athletes. It seeks to offer significant insights that can guide age- and sport-specific training programs, nutritional strategies, and health interventions adapted to the requirements of Filipino athletes. The results may help enhance the wider discussion on fostering healthy aging and athletic longevity in the Philippines.
NCT07545473
Hyperspectral retinal imaging is a non-invasive imaging modality in which a series of images of the retina are captured using light of different wavelengths. The resulting "hypercube" of data provides a wealth of information about the retinal structure. Our group has developed evidence supporting a role for this technology in the detection of retinal amyloid beta in Alzheimer's disease. We are undertaking further studies to establish the role of this method in the assessment of people with dementia, or those at risk of Alzheimer's disease. In addition, we wish to test whether the approach may have value in other forms of dementia or neurodegenerative disease such as Parkinson's disease, Lewy-Body dementia or vascular dementia.
NCT07542041
The goal of this clinical study is to evaluate whether the NEO-Match® test, based on ARTIDIS nanomechanical profiling technology, can help predict treatment outcomes and improve clinical decision-making in patients with suspected pancreatic cancer undergoing biopsy. The main questions this study aims to answer are: * Can the NEO-Match® test predict how patients respond to neoadjuvant (pre-surgical) treatment for pancreatic cancer? * How well does the NEO-Match® test detect malignant pancreatic lesions compared to standard histopathological assessment? This is a prospective, single-arm study. Researchers will compare results from the NEO-Match® test with standard clinical outcomes, imaging findings, and pathology results to evaluate its predictive and diagnostic performance. Participants will: * Undergo a standard-of-care pancreatic biopsy or surgical procedure * Provide an additional biopsy sample for research analysis using the ARTIDIS ART-1 device * Continue to receive standard treatment and care, which is not influenced by the study * Have clinical data, imaging results, and treatment outcomes collected * Be followed every 3 months for up to 2 years The study does not involve experimental treatment or changes to standard medical care. The information collected may help improve future diagnosis, prognosis, and treatment selection for patients with pancreatic cancer.
NCT07527156
This study will evaluate the feasibility and safety of achieving therapeutic concentrations of beta-hydroxybutyrate using continuous infusion of D-beta-hydroxybutyrate monoester administered via a nasogastric tube in patients with acutely decompensated heart failure with reduced left ventricular ejection fraction.
NCT07509606
Chronic obstructive pulmonary disease (COPD) is an irreversible disorder characterized by persistent airflow limitation and increased lung compliance. It leads to dyspnea, skeletal muscle dysfunction, impaired functional capacity, and reduced quality of life. Physical inactivity is considered a major contributor to symptom deterioration, the development of a vicious cycle, and ultimately increased mortality. According to the American College of Sports Medicine (ACSM), the American Thoracic Society (ATS), and the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR), pulmonary rehabilitation should include aerobic and resistance exercise for at least 20 minutes per session, performed three to five times per week for a minimum of 12 weeks. Exercise intensity should be progressively increased to exceed 60% of peak oxygen uptake (VO₂peak), and patients are encouraged to maintain long-term exercise habits. However, there is still no consensus regarding the optimal initial intensity, progression strategy, and exercise duration. Previous studies have demonstrated that whole-body vibration (WBV) can improve lower extremity muscle strength, functional capacity, and quality of life in patients with COPD. However, its effects on lung function and the optimal training dose remain unclear. In addition, COPD also affects respiratory muscles, upper extremity strength and flexibility, as well as cardiac autonomic function. Therefore, the aim of this study is to investigate the effects of different WBV frequencies on lung function, respiratory muscle function, upper extremity strength and flexibility, and cardiac autonomic function, in order to determine the optimal training dose.
NCT07111663
This is an observational study in individuals with isolated (or primary) dystonia that involves more than one body region. The purpose of the study is to collect detailed information to help your physician and other researchers understand how dystonia impacts your and other patients' lives and how the disease changes over time. The study may also help researchers better understand the clinical scales that are commonly used to evaluate dystonia symptoms and how they affect various areas of life such as well-being, pain, relationships and social interactions, and progress over time. Because this is an observational study, you will not receive any interventional treatment in the study.
NCT07426094
Patients with prostate cancer and pelvic lymph node involvement (cN1M0) identified on PSMA PET imaging represent a biologically aggressive yet potentially curable disease population. Contemporary management relies on multimodality treatment combining definitive radiotherapy to the prostate and pelvic lymph nodes with long-term androgen deprivation therapy (ADT), often intensified with androgen receptor pathway inhibitors. Despite these advances, a substantial proportion of patients still develop distant metastatic disease, highlighting the need to optimize local-regional treatment strategies in the era of molecular imaging. The introduction of PSMA PET has fundamentally altered staging accuracy in prostate cancer, enabling earlier and more precise detection of pelvic nodal disease. However, most existing evidence guiding radiotherapy dose prescription in node-positive prostate cancer originates from the pre-PSMA era. As a result, it remains unclear how best to integrate prostate-directed and nodal-directed dose escalation strategies when disease extent is defined by modern molecular imaging. In particular, it is unknown whether long-term disease control is primarily driven by durable intraprostatic tumor eradication, by aggressive treatment of involved lymph nodes, or by a combination of both. PRO-BOOST-N is a prospective, multicenter, randomized phase II/III clinical trial designed to address this critical evidence gap. The trial evaluates prostate-first versus combined prostate and nodal dose escalation strategies in patients with PSMA PET-staged node-positive (cN1M0) prostate cancer treated within a standardized ultrahypofractionated whole-pelvis radiotherapy framework. All enrolled patients indicated for definitive treatment undergo mandatory baseline PSMA PET/CT to confirm pelvic lymph node involvement and exclude distant metastatic disease. All patients receive a uniform radiotherapy backbone consisting of ultrahypofractionated whole-pelvis radiotherapy delivered in five fractions, combined with long-term ADT. Use of androgen receptor pathway inhibitors is permitted and encouraged according to contemporary clinical practice and local availability, ensuring the relevance of the trial to real-world treatment settings. Using a 2×2 factorial randomized design, PRO-BOOST-N evaluates two independent treatment factors. The primary randomized comparison assesses whether ablative prostate dose escalation improves oncologic outcomes compared with contemporary SBRT-based definitive prostate radiotherapy without additional boost. Prostate dose escalation may be delivered using one of three protocol-defined modalities-high-dose-rate brachytherapy, low-dose-rate brachytherapy, or single-fraction SBRT-according to institutional expertise. This comparison directly tests the hypothesis that durable intraprostatic disease control is the dominant determinant of long-term systemic disease suppression in node-positive prostate cancer. The key secondary, hierarchically tested comparison evaluates the role of nodal dose escalation by comparing two predefined dose levels delivered to PSMA PET-positive pelvic lymph nodes. These dose levels reflect intermediate versus higher nodal boost strategies based on biologically effective dose concepts specific to prostate cancer radiobiology. To ensure patient safety and protocol feasibility, organ-at-risk-driven nodal dose de-escalation is permitted within the higher-dose arm, without altering randomization assignment. The primary endpoint of the trial is metastasis-free survival. Secondary endpoints include overall survival, radiographic progression-free survival assessed primarily using PSMA PET imaging, intraprostatic and regional nodal control, time to castration-resistant prostate cancer, time to next systemic therapy, treatment-related toxicity graded according to CTCAE version 5.0, and patient-reported outcomes assessing urinary, bowel, sexual, and global quality of life. By prospectively and hierarchically evaluating prostate and nodal dose escalation strategies within a modern PSMA PET-guided and ultrahypofractionated radiotherapy platform, PRO-BOOST-N aims to define the optimal radiotherapy intensification approach for patients with node-positive prostate cancer. The results of this study are expected to directly inform clinical practice, guideline development, and future treatment individualization in the PSMA PET era.
NCT06738160
Introduction: Immunotherapy in combination with chemotherapy have been recommended as the first-line treatment of driver-negative advanced non-small cell lung cancer (NSCLC), but the efficacy is worse in NSCLC patients with bone metastases due to the immunosuppressive microenvironment. Studies have shown that not only the nuclear factor kappa-B ligand (RANKL) inhibitors but also Stereotactic Body Radiation Therapy (SBRT) play a significant role in improving the tumor immune microenvironment. Therefore, narlumosbart，a monoclonal antibody (mAb) targeting RANKL，in combination with SBRT may have synergistic effects and improve efficacy of immunotherapy and chemotherapy in driver-negative advanced NSCLC patients with bone metastases. Methods: This single-arm, single-center phase II clinical trial will enroll NSCLC patients with bone metastases who have not received any systemic therapy. Patients will receive narlumosbart and bone target lesion SBRT in combination with first-line treatment immunotherapy and chemotherapy after screening eligible subjects. Narlumosbart, 120mg/time, subcutaneous injection, is administered every 4 weeks. For the treatment of SBRT for bone metastases, the dose of 24Gy/3F is used for spinal metastases, and 30Gy/5F or 35Gy/5F is used for non-spinal lesions. Chemotherapy combined with immune checkpoint inhibitor therapy was used in accordance with the guidelines. The primary endpoint is to assess the objective response rate of NSCLC patients with bone metastases from narlumosbart combined with SBRT and first-line chemotherapy and immunotherapy. The secondary endpoints include progression-free survival, overall survival and safety. Sample size calculation used the Simon Two-Stage method. 9 patients will be enrolled in the first stage. If ≥ 2 patients achieve CR/PR, the second stage of enrollment will be performed. If only 2 patients \< achieve CR/PR, the trial will be terminated. In the second phase, 15 patients will be enrolled. 27 subjects will be enrolled in this project, considering the dropout rate of 10%. Wangjun Yan AND Zhengfei Zhu are the Co-Principal Investigators of this study.
NCT06389032
Lewy Body Dementia (LBD) is the second most common form of degenerative dementia, affecting at least 2.4 million US adults, and the overwhelming majority of persons living with LBD (PLBD) are cared for by family caregivers. LBD caregiver strain: 1) exceeds that of non-LBD dementia caregivers; 2) worsens caregiver physical and mental health; and 3) increases the risk of PLBD hospitalization and institutionalization. LBD progression is complicated by combined motor, cognitive, and neuropsychiatric decline, and is punctuated by falls, infections, dehydration, and neuropsychiatric symptoms leading to acute healthcare utilization. Although family caregivers are uniquely positioned to identify and manage these challenges, which may avert emergency department visits and reduce morbidity, many caregivers lack the knowledge, skills, confidence, resources, and support to do so. The study team aims to 1) quantify the impact of PERSEVERE on caregiver knowledge, attitudes, mastery, and strain; 2) identify the intervention and mentor factors determining implementation fidelity; and 3) test the effects of PERSEVERE on PLBD quality of life and healthcare utilization. This will be accomplished in an NIH Behavioral Model Stage II national, randomized, attention-controlled, 12-week trial of PERSEVERE in 502 LBD caregivers in partnership with the Lewy Body Dementia Association, Parkinson's Foundation, and LBD Caregiver Advisors. The study team will match intervention arm caregivers with a trained peer mentor who will coach them through a modular, theory-based curriculum on LBD knowledge and social support. Attention-control participants will receive weekly, curated links to educational materials. The study team will identify immediate and delayed intervention effects, including mediators of strain at 12 weeks, and caregiver strain and PLBD outcomes at nine months. Implementation fidelity and PLBD healthcare utilization will be tracked biweekly. Qualitative methods will explore the intervention- and mentor-specific factors predicting fidelity, mentee outcomes, and retention. Remote recruitment, mentoring, and community engagement strategies will maximize accessibility and inclusion of underrepresented caregiver groups. Results will illuminate the extent to which leveraging prior LBD caregivers as expert interventionists can improve current caregiver outcomes, and in turn, PLBD outcomes. These results will inform future adaptation and dissemination of this model for other conditions.
NCT07478861
This study will aim to evaluate the effects of whole-body vibration training (WBVT) on body composition, muscle strength (hand grip strength), and physical performance \[gait speed (GS), 5-time chair stand test (5CST), and short physical performance battery (SPPB), pain intensity, triglycerides in older people with knee OA and sarcopenic obesity in a group of Men compared to group of females.
NCT06096506
The purpose of this study is to assess the effect of an adapted virtual Culinary Medicine (CM) curriculum on dietary behaviors, nutrition knowledge, and cooking skills and behaviors on outcomes such as HbA1c levels, Body Mass Index, Blood Pressure, HDL, LDL, and Triglycerides, as well as to determine the feasibility and reproducibility of virtual synchronous CM classes.
NCT06528067
The aim of this study is to test how acceptable and feasible a new eating intervention is in people with overweight and binge eating. This intervention combines mindful eating with motivational interviewing to target binge eating. The main questions this clinical trial aims to answer are: How well do participants accept the new intervention (acceptability)? Is the intervention practical and easy to implement (feasibility)? In this trial researchers will compare the new eating intervention (motivational interviewing for mindful eating + digital meditation) to an active control (digital meditation) to see if the intervention can help reduce binge eating. Participants will: 1. Take online questionnaires at four different time points 2. Provide body composition and samples to measure glucose levels 3. Meditate for at least 10 minutes a day 4. If assigned to the Mindful Motivation group, 8 weeks of brief counseling