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Discover 23,284 clinical trials near Maryland. Find research studies in your area.
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NCT04376684
OSCAR (Otilimab in Severe COVID-19 Related Disease) is a multi-center, double-blind, randomized, placebo-controlled trial to assess the efficacy and safety of otilimab for the treatment of severe pulmonary COVID-19 related disease. The study is being conducted in 2 parts (Part 1 and Part 2). Otilimab is a human monoclonal anti-granulocyte macrophage colony stimulating factor (GM-CSF) antibody that has not previously been tested in participants with severe pulmonary COVID-19 related disease in Part 1. The aim of this study is to evaluate the benefit-risk of a single infusion of otilimab in the treatment of hospitalized participants with severe COVID-19 related pulmonary disease with new onset hypoxia requiring significant oxygen support or requiring early invasive mechanical ventilation (less than or equal to \[\<=\] 48 hours before dosing). Participants will be randomized to receive a single intravenous (IV) infusion of otilimab or placebo, in addition to standard of care.
NCT01621568
Background: \- Sunitinib is drug that is approved for treating various types of cancers, including kidney cancers. However, it has not been approved to treat cancers of the thymus. Sunitinib works by blocking proteins that are responsible for cell division and growth. Some of these proteins can be found on thymus cancer cells. Researchers want to see if sunitinib can be used to treat advanced thymus cancer. It will be given to people who have had at least one earlier chemotherapy treatment containing platinum. Objectives: \- To see if sunitinib is a safe and effective treatment for advanced thymus cancer that has not responded to earlier treatments. Eligibility: * Individuals at least 18 years of age who have advanced thymus cancer that has not responded to earlier treatments. * At least one previous cancer treatment must have been chemotherapy treatment containing platinum. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies and tumor biopsies will be used to check the severity of the cancer. * Participants will take sunitinib tablets once a day, in the morning. They will take the tablets daily for 4 weeks, followed by 2 weeks of rest with no sunitinib. This 6-week period is called a cycle. * Treatment will be monitored with frequent blood tests and imaging studies. * Treatment cycles may be repeated as long as the tumor does not continue to grow and there are no severe side effects....
NCT05778877
This Phase 1/2 study will evaluate the safety and pharmacodynamics (PD) of SEL-302, which consists of the gene transfer vector MMA-101 following administration of an immunomodulatory SEL-110 agent in pediatric subjects with Methylmalonyl-CoA Mutase (MMUT) MMA.
NCT02675270
The goal of this study is to remediate word-finding problems in patients who have Primary Progressive Aphasia (PPA) or Alzheimer's Disease and to delay the further progression of word-finding impairment. The current approach is novel in that it contains a prophylaxis component in which the investigators attempt to strengthen neural connections that remain functional, making them more resistant to degradation as the disease progresses. While the study is specific in its targeting of word-finding problems, a successful outcome would bode well for other studies aimed at prevention or reversal of declining cognitive functions in dementia. One set of participants with PPA will receive practice with picture naming in two conditions: viewing the picture and repeating the name; and viewing the picture with its written name, plus reading and writing the name. Another set of participants with PPA or Alzheimer's Disease will be trained in two different conditions: learning about the word's semantic features (meaning); and learning about the word's lexical features (letters and sounds). Naming of pictures trained in each of these conditions will be compared, at three time intervals post-training, with naming of pictures tested before the study but never trained. It is predicted that the pairing of the picture with its written name, combined with the motor task of writing the name, will result in a greater ability to name the picture at a later date than simple practice viewing the picture and repeating the name. Furthermore, it is predicted that participants who have difficulty understanding concepts will be more likely to respond to semantic treatment, while participants who have difficulty connecting words with concepts will be more likely to respond to lexical treatment.
NCT04228978
The PROVE Trial is a randomized clinical trial that will determine whether a weight loss intervention combined with walking exercise achieves greater improvement or less decline in six-minute walk distance at 12 month follow-up than walking exercise alone in people with PAD and BMI\>25 kg/m2. The intervention uses a Group Mediated Cognitive Behavioral framework, connective mobile technology, remote monitoring by a coach, and a calorie restricted Dietary Approaches to Stop Hypertension (DASH)-derived Optimal Macronutrient Intake Trial for Heart Health (OMNIHeart) diet. 212 participants with PAD and BMI \> 25 kg/m2 will be randomized to one of two groups: weight loss + exercise (WL+EX) vs. exercise alone (EX). Participants will be randomized at Northwestern, Tulane University, and University of Minnesota. Our primary outcome is change in six-minute walk distance at 12-month follow-up. Secondary outcomes are change in 6-minute walk distance at 6-month follow-up and change in exercise adherence, physical activity, patient-reported walking ability (measured by the Walking Impairment Questionnaire (WIQ) distance score), and mobility (measured by the Patient-Reported Outcomes Measurement Information System \[PROMIS\] mobility questionnaire) at 12-month follow-up. Tertiary outcomes are perceived exertional effort (measured by the Borg scale at the end of the 6-minute walk at 12-month follow-up), and diet quality. Exploratory outcomes consist of change in the short physical performance battery (SPPB), the WIQ stair climbing and walking speed scores, and calf muscle biopsy measures at 12-month follow-up. Study investigators will perform calf muscle biopsies in 50 participants to compare changes in mitochondrial biogenesis and activity, capillary density, and inflammation between WL+EX vs. EX.
NCT03484182
This is an online study that involves assessment and training of arm function at home. Stroke is the leading cause of disability worldwide. Of the annual incidence of stroke (\~750,000) in the USA about 60% fail to recover arm and hand use contributing to reduced quality of life for survivors and caregivers. How can therapists facilitate the rehabilitation of individuals with arm movement deficits and increase their quality of life over a long time period? It is known that principles of treatment including repetition, feedback, challenge and progression are important for producing recovery. The ability for patients to train at home and manage their own rehabilitation duration, intensity and progression, via effective self-management strategies, is vital. What is needed is an effective, easy to use, low cost system that self-motivates patients to intensively practice their therapy exercises at home while maintaining elements of repetition, feedback, challenge and progression. In this proposal the investigators intend to adapt just such a "web-based system" originally designed in the UK. The first version of the system has shown preliminary efficacy and feasibility in a small pilot study in UK. The investigators will adapt the system for use in the USA, with the assistance of consultants from the UK. The purpose of this study is to investigate the efficacy and feasibility of using a free, easy to use, interactive web-based upper extremity stroke rehab program on individuals with stroke who have been discharged from outpatient rehabilitation. The goal is to compare the home use of the web-based stroke rehab program with that of written exercises in a randomized controlled trial. The aims/objectives are to (1) adapt the existing system for use in America including adding bilateral activities and then to assess (2) motor function immediately before and after six weeks intervention and after 12 weeks follow up in order to support the efficacy of using this web-based intervention; (3) behavioral changes in motivation and self-efficacy at the same time points to understand the relationship between behavioral and motor function changes; (4) perceptions of patients and caregivers of the web-based program to understand feasibility and barriers to home use; and (5) perceptions of therapists to understand feasibility and barriers to clinic use.
NCT03124160
This will be a multi-site, participant-blinded, randomized clinical trial. The investigators will randomize 1000 eligible participants in a 4:1 ratio to two different copper IUDs: 800 to Mona Lisa NT Cu380 Mini and 200 to ParaGard.
NCT05582707
This is an exploratory single-center prospective study of 20 subjects with primary basal ganglia ICH who will receive early MIPS in combination with perioperative pioglitazone treatment. Outcomes will be compared to matched subjects with basal ganglia ICH who undergo MIPS alone as part of the ENRICH trial. This study will take approximately two years to complete.
NCT04978337
The purpose of this study is to evaluate the efficacy of rilematovir compared to placebo with respect to the time to resolution of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) symptoms.
NCT04265261
The study's main purpose is to asses the safety, tolerability, and effect of oral administration of RG7774 on the severity of diabetic retinopathy (DR) in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) and good vision.
NCT05004337
The purpose of this study is to collect blood samples from women carrying a vanishing twin pregnancy to further develop Natera's non-invasive prenatal screening test to provide information about possible chromosomal conditions for the living twin
NCT04308395
This is a multicenter, open label extension study evaluating the safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult subjects with Gorlin syndrome.
NCT04877990
The purpose of this study is to evaluate the long-term safety and efficacy of Deucravacitinib in participants who have previously been enrolled in a Deucravacitinib Phase 2 study for moderate to severe Crohn's disease or moderate to severe Ulcerative Colitis.
NCT04754542
The Main Hypothesis of this extension trial is that among those who have successfully discontinued their DMT as part of the DISCOMS trial (i.e. did not have a new MS relapse or brain MRI lesion) and remain off DMT after DISCOMS are at no greater risk of new or worsened MS disease activity compared to those who successfully continued their DMT as part of DISCOMS and remain on DMT, each assessed at least one year after termination of the primary DISCOMS study.
NCT03828747
This Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the clinical efficacy, safety, pharmacokinetics, and pharmacodynamics of semorinemab in patients with moderate AD. The study consists of a screening period, a double-blind treatment period, an optional open-label extension (OLE) period, and a safety follow-up period. There may be up to two study cohorts.
NCT00807612
This is a global, multicenter, 2-part, open-label phase 1b and single-arm phase 2 study designed to evaluate the safety and efficacy of AMG 479 in combination with paclitaxel and carboplatin for the first-line treatment of advanced squamous non-small cell lung carcinoma.
NCT05227118
The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of MK-8189 in participants with Alzheimer's Disease (AD) with or without symptoms of agitation-aggression and/or psychosis.
NCT05559476
The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when co-administered with the high dose quadrivalent influenza (FLU HD) vaccine in adults aged 65 years and above compared to separate administration of the vaccines.
NCT04672460
This will be a Phase 1, open label, 2-sequence, crossover study to establish the BE of the current commercial formulation (Generation 3.1 talazoparib capsules) to the proposed talazoparib liquid-filled soft gelatin capsule (soft gel capsule) formulation after multiple dosing under fasting conditions in participants with advanced solid tumors. In addition, the effect of food on the PK of the proposed talazoparib soft gel capsule formulation will be evaluated in fixed sequence after the 2 BE assessment periods.
NCT04988867
To investigate the safety and tolerability of long-term treatment with oral trofinetide in girls with Rett syndrome
