Baltimore, MD Paid Clinical Trials

This study is a 3-group, parallel design, randomized controlled trial (RCT) in approximately 258 adults with obesity that will investigate whether a 16-week behavioral weight loss treatment and a 52-week stepped-care digital health intervention can improve the maintenance of a ≥ 5% weight loss. 16-week run-in (Phase 1). To qualify for randomization, participants must lose ≥ 5% of initial weight in the 16-week run-in. This loss will be achieved with the provision of weekly-group lifestyle counseling, which includes a partial meal replacement diet. 52-week randomized trial of 3 weight loss maintenance strategies (Phase 2): Participants who have achieved ≥ 5% weight loss during Phase 1 will be randomly assigned to 1 of 3 groups: 1. Participants in the Usual Care group will be emailed monthly educational modules with information on maintaining weight loss. 2. Participants in the SELF group will receive a wireless "smart" body weight scale and a wearable physical activity tracker, and daily text messages with tailored feedback to assist in weight loss maintenance. 3. Participants in the STEP group will be enrolled in an intervention that consists of 4 steps that are progressive and based on response to treatment. After 13 weeks at each step, participants who do not maintain a ≥5% weight loss or regain 2 percentage points of weight from the participants randomization value will move to a higher intensity step. Participants who maintain weight loss will stay at the same step. Read Less

Background: Puberty is a normal part of life. Many big changes occur in all parts of the body as a child matures into an adult. Researchers in this study want to find out more about how the brain changes during puberty. Objective: To study changes that occur in the brain before, during, and after puberty. Eligibility: Healthy children aged 9 to 14 years. Design: Participants will have 2 clinic visits. Each visit will last up to 4 hours. In the first visit, participants will be screened: They will have a physical exam with blood tests. They will complete a mental health questionnaire on a computer. They will undergo a mock magnetic resonance imaging (MRI) scan. Participants will be made comfortable as they lie on the table and slide into the big tube. They will learn what it feels and sounds like to lie still inside a real MRI. At the second visit, participants will have more tests: They will have a physical exam with blood tests. This time the doctor will check for their stage of puberty. The doctor will look at and touch their genitals and breasts. They will have a real MRI exam. An x-ray will be taken of their hand and wrist. This will show how their bones are maturing. They will have a DEXA scan. They will lie on a table while a machine uses x-rays to measure the makeup of their bodies, including bone, muscle, and fat. They will have a 3D body scan. They will wear tight clothes and a shower cap. They will stand on a platform while sensors take pictures of their body. Read Less

A Phase 2b/3 multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and tolerability of MN-166 given to ALS participants for 12 months followed by a 6-month open-label extension phase. Read Less

The overriding objective of DREAM is to conduct a prospective longitudinal (36 months) observational clinical study to investigate the incidence, etiology, and pathophysiology of diabetes mellitus (DM) following acute pancreatitis (AP). Read Less

The study is a non-interventional evaluation of participants with SCLC who will receive diagnostic and (where possible) post-progression tumor tissue profiling, alongside plasma ctDNA biomarker profiling in addition to their standard of care therapy and disease surveillance. Read Less

The LINKED- HEARTS Program is a multi-level project that intervenes at the practice level by linking home blood pressure monitoring (HBPM) with a telemonitoring platform (Sphygmo). The program incorporates team-based care by including community health workers (CHWs) and pharmacists to improve the outcomes of multiple chronic conditions (reduced blood pressure (BP), lower blood sugar, and improved kidney function). The LINKED-HEARTS Program will recruit a total of 600 adults with uncontrolled hypertension (BP ≥ 140/90 mm Hg) AND either type 2 diabetes or chronic kidney disease (CKD) across 16 community health centers or primary care practices serving high-risk adults. This cluster-randomized trial consists of two arms: (1) enhanced "usual care arm," wherein patients will be provided with Omron 10 series home BP monitors and will be managed by the patients' primary care clinicians as usual; and (2) the "intervention arm" which will integrate HBPM telemonitoring, a CHW intervention and provider-level interventions into the usual clinical care to improve BP control and provide support for self-management of chronic conditions. The study pharmacist will conduct telehealth, use the Sphygmo app and the Pharmacist Patient Care Process to collaborate with other providers to optimize pharmacologic therapy to improve hypertension outcomes and with payors to ensure consistent access to drug therapy. Read Less

This phase I trial studies the side effects of nivolumab before and after surgery in treating children and young adults with high grade glioma that has come back (recurrent) or is increasing in scope or severity (progressive). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Read Less

A randomized, parallel group, active comparator-controlled trial to evaluate the non-inferiority or superiority of Cryopreserved Platelets with Liquid Stored Platelets in controlling blood loss in patients undergoing Cardiopulmonary Bypass Surgery. Read Less

This study will propose and evaluate a standardized LeFort osteotomy anesthetic protocol for pediatric patients at Johns Hopkins Hospital. There are two cohorts to this study: a prospective cohort who will receive the study anesthesia protocol and a historical cohort that received standard of care. The investigators hope this will help to minimize unnecessary postoperative pain management, inpatient stay, and long-term morbidity and mortality in these patients. Read Less

A pilot injection-setting targeted peer-driven intervention to reduce HIV and hepatitis C virus transmission and overdose risk behaviors among people who inject drugs (PWID). Read Less

The Coronavirus Disease 2019 (COVID-19) pandemic has resulted in catastrophic infections and fatalities across the nation. Many older Veterans with comorbidities are especially vulnerable to complications and poor recovery. This award will investigate the effect of a novel, home-based, supervised, group exercise tele-rehabilitation in Veterans recovered from COVID-19 on cardiopulmonary and physical function. Read Less

Patients that undergo decompressive craniectomy are at risk of delayed changes in brain function known as "Sunken Flap Syndrome" or "Syndrome of the Trephined." The goal of this clinical trial is to see if placing a prosthetic over patients' skull defects can prevent "Sunken Flap Syndrome." The main questions are: 1. Can placing a prosthetic device over patients' skull defects prevent Sunken Flap Syndrome? 2. Can placing a prosthetic device over patients' skull defects decrease healthcare costs? 3. Can placing a prosthetic device over patients' skull defects improve recovery and return of brain function after decompressive craniectomy? Patients that experience traumatic brain injuries, brain bleeds, and large strokes can build up high levels of pressure in the skull. When this pressure can't be controlled with medications, a life-saving surgery called a decompressive hemicraniectomy (DC) is often performed. In this surgery, a large portion of the patient's skull is removed to decrease pressure on the brain and decrease permanent damage. After this surgery, many patients experience sinking of the brain in the skull as the pressure inside the head improves. The skull normally protects the brain from the outside environment. When large parts of the skull are removed, the brain is not able to regulate itself normally. This can lead to a number of problems, such as headaches, weakness, seizures, and even coma and permanent brain damage. This is referred to as "Sunken Flap Syndrome" (SFS) or "Syndrome of the Trephined" (SoT). After 3-6 months, patients can have the missing skull surgically repaired, which improves and sometimes fixes SFS, but the damage is sometimes too severe to be reversed. There are reports of patients with SFS treated with custom-made prosthetics that cover the missing piece of skull. In this study, the researchers want to see if wearing a custom-made prosthetic can prevent patients from experiencing SFS. Patients will also receive additional non-invasive measurement to see if the prosthetic can improve brain function and recovery. Finally, the researchers want to know if the prosthetic is cost-effective by decreasing the frequency that patients see doctors or receive care to treat SFS. Patients or the patient's medical decision makers will be asked if the patient wants to participate in the study after DC. If the patient or decision maker agrees to participate, the patient will be also asked if the patient wants to wear the prosthetic. The prosthetic is made of a common material used in other facial prosthetics. Patients that agree to wear the prosthetic will have a custom plate made for the participant. All patients will receive the same post-operative care and appointments whether or not the prosthetic is worn. The participant will go to the normally scheduled post-operative doctor's appointments at 2 and 4 weeks after initial DC surgery. Patient's that agree to wear the prosthetic will receive it at the 4-week post-DC appointment. The participant will then be asked to wear it as much as possible, but to let the researchers know if the participant experiences any pain, itching, discomfort or other problems. All patients will also be seen by the patient's physician before and after and after skull repair. At all appointments, patients will receive non-invasive testing of brain function. Recovery and rate of SFS will be compared between patients that do and do not wear the prosthetic. Participants will: * Go to the normally scheduled 2 and 4 week post-DC appointments * Go to the normally scheduled pre- and post-skull repair appointments * Receive additional non-invasive brain health testing at each appointment Participants that agree to wear a prosthetic will: * Receive the custom prosthetic at the 4-week post-DC appointment * Wear the prosthetic as much as possible, including at night * Take a brief survey about the prosthetic at the post-skull repair appointment Read Less