About 1,060,105 results

Natural History and Development of Spondyloarthritis

Aug 4th, 2022 - The purpose of this protocol is to study the natural history of spondyloarthritis (SpA) in children and adults. Spondyloarthritis encompasses a spectrum of immune-mediated inflammatory diseases that exhibit overlapping features, but differ from other types of inflammatory arthritis in genetic predisposition, pathogenesis, and outcome. Ankylosing spondylitis (AS), the most common form of SpA, fr...

A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens

Jul 15th, 2022 - The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected...

A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delive...

Aug 5th, 2022 - Study GR41675 is a Multicenter, Randomized Study in Participants with Diabetic Retinopathy (DR) Without Center-Involved Diabetic Macular Edema (CI-DME) to Evaluate the Efficacy, Safety of the Port Delivery System with Ranibizumab (PDS) Relative to the Comparator Arm

The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes

Aug 5th, 2022 - The Specific Aims of the first phase of the study are as follows: Aim 1. To determine the feasibility of performing a randomized trial comparing two major types of bariatric surgery, Laparoscopic Roux en Y Gastric Bypass (RNY) and Laparoscopic Adjustable Gastric Banding (GB) versus a lifestyle weight loss intervention (LWLI) induced by diet and increased physical activity in moderately obese pa...

Cognitive Task Development and Implementation for Functional MRI Studies

Aug 5th, 2022 - Objective: Drugs of abuse have cognitive and affective effects that may contribute to the inception and maintenance of their use. In order to measure these effects, psychological tests suitable for use both in and outside the fMRI scanner need to be developed and validated. Thus, the objective of this protocol is to allow for the development, assessment and refinement of cognitive and affective...

Screening Protocol for the Evaluation of Potential Research Subjects

Aug 5th, 2022 - This protocol describes the screening process used by the National Institute on Drug Abuse (NIDA IRP) to assess potential research participants' eligibility for entering protocols of the NIDA/IRP. Through its clinical research protocols, the IRP attempts to: elucidate the nature of drug abuse and addiction; determine the potential use of new therapies, both pharmacological and psychosocial; and...

Characterization of Phenotypic and Genotypic Regressors for Imaging

Aug 5th, 2022 - Objective: To determine genetic variants as well as behavioral measures across different study group populations. Results of these will be used as regressors to help explain inter-individual differences in data collected across IRP protocols. Study Population: The study population will include 1) healthy non-smoking, participants with no substance use disorders 2) healthy individuals with nicot...

Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury

Aug 5th, 2022 - Care partners of persons with traumatic brain injury (TBI) are often faced with considerable physical and emotional stress resulting from their caregiver role. The researchers hypothesize that the care partners who receive the intervention will show improvements in caregiver strain and mental health.

Corticotrophin-releasing Hormone (CRH) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing s Disease

Aug 5th, 2022 - This study is designed as a single institution trial. The study utilizes safe and clinically-validated tools for preoperative workup of patients with small pituitary tumors. CRH stimulation and 18F-FDG uptake in PET imaging will be used to detect MRI-negative pituitary adenomas in patients with Cushing s disease. Patients who have MRI-negative pituitary microadenomas will undergo 18F-FDG PET-im...

Identification of Relevant Biological, Imaging, Mobility and Clinical Markers for Clinical Research in Sarcopenia

Aug 5th, 2022 - This trial is part of a Research Program partly funded by a grant from the Walloon region entitled "Development of Markers of Sarcopenia Using an Integrated Approach : From Cell to Human". Consistent with the above-mentioned observation, there is not only one biological marker that perfectly matches the sarcopenia criteria but there is a range of complementary biomarkers - including but not lim...

Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE

Aug 5th, 2022 - This is a prospective trial to determine if contrast enhanced ultrasound (CEUS) is non-inferior to CT or MRI in patients with hepatocellular carcinoma (HCC) following transcatheter arterial chemoembolization(TACE) treatments. All patients will receive standard of care CT/MRI and will also get a contrast ultrasound to directly compare. Timepoint 0- Our proposed study population includes subjects...

Placenta Development Study

Aug 5th, 2022 - The primary purpose of this study is to understand the epigenetic signaling events in placental trophoblast development.

Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy

Aug 5th, 2022 - Phase 2, open label, randomized, multicenter study in subjects with cGVHD who have previously been treated with at least 2 prior lines of systemic therapy. Approximately 166 subjects with active cGVHD will be randomized (1:1) to receive treatment with one of two belumosudil (formerly known as KD025) regimens: Arm A: belumosudil 200 mg QD Arm B: belumosudil 200 mg BID With Amendment 2, the sampl...

Henan STEMI Registry

Aug 5th, 2022 - Henan institute of cardiovascular epidemiology is responsible for design, data quality control and statistical analysis. Data are collected using a uniformed questionnaire by trained staff at each hospital. Sample size estimation: Based on Henan retrospective observational cohort of STEMI patients, in-hospital mortality in secondary and tertiary hospitals were 5.6% and 6.0%, respectively. To ac...

Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer

Aug 5th, 2022 - PRIMARY OBJECTIVE: I. To evaluate overall survival (OS) in each of the 2 experimental arms (Arms A and B) to control (Arm C). SECONDARY OBJECTIVES: I. To evaluate progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for Arm C versus each of Arms A and B. II. To evaluate best objective response rates per RECIST 1.1 for Arm C versus each of Arms A and B. I...

Nivolumab and Ipilimumab in Treating Patients With Rare Tumors

Aug 5th, 2022 - PRIMARY OBJECTIVES: I. To evaluate the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy. II. To evaluate the overall response rate (ORR) in patients with gestational trophoblastic tumors treated with ipilimumab plus nivolumab combinat...

Testing Pembrolizumab Versus Observation in Patients With Merkel Cell Carcinoma After Surgery, STAMP Study

Aug 5th, 2022 - PRIMARY OBJECTIVE: I. To compare recurrence free survival (RFS) and overall survival (OS) as co-primary endpoints across the two arms. SECONDARY OBJECTIVES: I. To evaluate adverse events. II. To evaluate distant metastasis free survival (DMFS). III. To evaluate the impact of radiation on clinical outcomes (OS, RFS, DMFS). OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive ...

Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV

Aug 5th, 2022 - Behavioral interventions for chronic pain among people living with HIV (PLWH) are an understudied area, with great potential to improve pain and function. Chronic pain is an important comorbidity that affects between 30% and 85% of PLWH and is associated with greater odds of functional impairment, increased emergency room utilization, suboptimal retention in HIV care, and failure to achieve vir...

The SNAP Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Neuropathic Post-Amputation Pain

Aug 5th, 2022 - The purpose of this study is to determine if pain can be relieved by delivering small amounts of electricity (called "electrical stimulation") to the nerves in an individual's amputated leg.This study will involve the use of a Peripheral Nerve Stimulation (PNS) System that is made by SPR Therapeutics (the sponsor of the study). The PNS System was cleared by the FDA for up to 60 days of use for ...

Foods Within a Meal and Food Liking Study

Aug 5th, 2022 - All participants will be asked to come to HEAL for 1, 60-minute screening session and 4, 30-minute meal sessions, with no more than two meal sessions occurring per week between the hours of 11:00am and 7:00pm. For each participant, each meal session will need to occur within the same two-hr time frame (i.e., all meal sessions occurring between 11am and 1pm). During the first session interested ...