Baltimore, MD Paid Clinical Trials

The purpose of this study is to determine whether the combination of subcutaneous DRP-104 in combination with intravenous Durvalumab is safe and yields a clinically compelling antitumor activity measured as based on objective response rate (ORR, assessed by RECIST 1.1). Secondary objectives include progression-free survival (PFS) and overall survival (OS). Read Less

Men with localized, intermediate risk prostate cancer will be randomized to undergo either radical prostatectomy or the TULSA procedure, with a follow-up of 10 years in this multi-centered randomized control trial. This study will determine whether the TULSA procedure is as effective and more safe compared to radical prostatectomy. Read Less

This is a Phase 2, randomized, double-blind, placebo-controlled, adaptive, multicenter study to evaluate the efficacy, safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of OATD-01 in the treatment of subjects with active pulmonary sarcoidosis. Read Less

The goal of this observational study is to learn about lung structure and function in a group of 1000 healthy people aged 25 to 35. The main questions it aims to answer are whether people's bodies, environment, and general lung health are associated with: * the structure of the participants lungs' airways, * the structure of blood vessels in the participants lungs and heart, and * the participants lungs' ability to exchange gases. Participants will take four different lung function tests to measure lung function, including: * air movement in the lungs (oscillometry) * lung size (slow vital capacity (SVC) and functional residual capacity (FRC) * gas transfer in the lungs (diffusing capacity for carbon monoxide (DLCO). Read Less

This study is a 16-week intent-to-treat randomized controlled trial (RCT) with 120 suicidal juvenile justice (JJ)-involved transition-age (TA) youth (age 15-21 years) and a primary caregiver (dyads). Dyads will be randomly assigned to iKinnect2.0 (n=60 dyads) or Life360 (control app) plus an electronic suicide resources brochure (n=60 dyads). This design will test iKinnect2.0's new features for suicide prevention against TA youth awareness of and access to high-quality suicide prevention resources, while simultaneously testing features relating to conduct problems and parent management against parents knowing the TA youth's whereabouts in real-time and controlling for dyad member engagement in technology (Life360). Participants will be assessed at baseline, 4, 8 and 16 weeks. Primary youth-reported outcomes relating to suicide risk include: Suicidal behaviors (ideation, planning, attempts), non-suicidal self-injurious behaviors, self-efficacy in coping with distress, and use of imminent distress coping strategies (behavioral skills, use of crisis stabilization plan). Youth will also report on their criminal behavior. Primary caregiver-reported outcome variables relating to youth suicide include: Self-efficacy in applying family-based suicide-prevention strategies and reported use of those strategies; caregivers will also report on their own functioning (efficacy/confidence in parenting skills, life stress), TA youth functioning (internalizing and externalizing symptoms), parental management behaviors (expectation clarity, parental monitoring, discipline effectiveness/consistency, use of rewards), and parent-youth relationship quality (communication, conflict, support). App satisfaction and use of technology outcomes (i.e., degree of app usage, features used) will be examined and reported descriptively. Read Less

The goal of this clinical trial is to test the safety and effectiveness of a single dose of RABI-767 given by endoscopic ultrasound (EUS) guided peripancreatic injection in participants with predicted severe acute pancreatitis. The main question the study aims to answer is: • Is a single-dose of RABI-767 given by EUS-guided peripancreatic injection safe in patients with predicted severe acute pancreatitis. The study also aims to answer: • Is a single-dose of RABI-767 given by EUS-guided peripancreatic injection effective in treating patients with predicted severe acute pancreatitis. Study participants will be randomly assigned (like the flip of a coin) to receive a single dose of RABI-767 plus supportive care or supportive care only. The study sponsor will compare safety and efficacy data collected from participants who receive RABI-767 to participants who receive supportive care only to test if RABI-767 is safe and effective. Read Less

The study is comparing the effect on weight of providing home-delivered whole-food, plant-based meals versus standard, general nutritional counseling to men with prostate cancer on androgen-deprivation therapy (ADT). Read Less

The central scientific premise of the proposed study is that sleep disruption (SD) will influence individuals' subjective response to blinded medication administration. The investigators further believe these responses will vary among patients who have chronic low back pain (CLBP) vs. healthy controls, and that sex will moderate effects. The proposed study evaluates whether CLBP patients' subjective responses to study medication administration are altered by SD. The investigators focus on two outcome domains: abuse liability (i.e., drug liking and valuation) and response to pain testing. The investigators propose a mixed between-within randomized crossover human-laboratory experiment that investigates placebo-controlled effects of study medication on 1) abuse liability metrics (Drug Liking and Monetary Valuation) and 2) response to laboratory-evoked standardized pain measures, after one night of uninterrupted sleep (US) and again after one night of SD. The investigators will recruit both CLBP patients(\*) and healthy controls (N = 60). (\*) We originally aimed to accrue 60 subjects with CLBP. However, we have been granted approval by the National Institute on Drug Abuse (NIDA) to reduce expectations for the target N for the CLBP cohort. We are no longer expected to recruit N=60 CLBP participants; this is a COVID-19 modification, and we are not required to re-do a power analysis. Read Less

Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). In the United States, more people with CF and low lung function die each year than undergo lung transplant. More than half of people with CF who die without a lung transplant were never referred for consideration. Patient preference not to undergo lung transplant may account for 25-40% of decisions to defer referral. Rates of death without transplant are higher for people with CF who are members of marginalized communities, including those with Black race, Hispanic ethnicity, or low socioeconomic status. Increasing awareness of lung transplant among people with CF, and promoting understanding of the risks and benefits of transplant, can potentially reduce the number of people with CF who die without a lung transplant. The CF Foundation (CFF) lung transplant referral guidelines were developed to optimize the timing of referral for lung transplant. These guidelines recommend annual conversations with people with CF once their forced expiratory volume in one second (FEV1) is \<50% predicted. Considering lung transplant as a treatment option before it is medically needed will allow more time to learn about lung transplant and address any barriers to lung transplant that may exist. Investigators are interested in understanding how people with CF use lung transplant educational resources and how one prepares for having discussions and/or making decisions about lung transplant as a treatment option for advanced CF. The purpose of this study is to test whether a research website improves patient preparedness for discussions about lung transplant. Investigators also aim to understand whether there are unique factors that affect people with CF from communities with decreased access to transplant ("communities of concern"). Study involvement will span 6 months and study activities will involve the following: * Four Zoom research sessions (15-30 minutes each) * Survey assessments * Access to a research website that contains educational resources about lung transplant * Audio recording of a routine CF clinic visit to determine if and how lung transplant is discussed between a participant and his/her/their CF doctor Read Less

The brachial plexus is a network of nerves that exit the spinal cord from the C5-T1 nerve roots and provide all motor and sensory function to the arm from the shoulder to the fingers. Injury to the brachial plexus due to traction forces during labor and/or delivery causing the nerves to stretch or tear occurs in 0.9 out of 1000 live births. As many as 30% of infants with brachial plexus birth injury (BPBI) have paralysis or weakness in one arm resulting in lifelong impairment in arm function with joint contractures, the shortening of tendons, ligaments and muscles, leading to reduced range of motion (ROM), being a common complication and major source of disability. A primary goal of early management of BPBI is to use passive range of motion (PROM) (stretching) to improve and/or maintaining shoulder ROM due to the known risk of shoulder contracture within the first year of life. Infants who develop contractures face challenges in overall sensory-motor development and are less able to participate in meaningful occupations and activities of daily living due to limited upper extremity ROM. They are also at risk for subsequent surgeries throughout their lives. Occupational therapy practitioners (OTPs) and physicians who specialize in treating infants with BPBI recommend caregivers to perform PROM at every diaper change, which is every 1-3 hours in the first months of life, and every 4-6 hours by age one. A survey study by one of the investigators on this proposed project found that 85% of OTPs who specialize in BPBI make this recommendation for performing PROM at every diaper change; however, there is no research to support this frequency to prevent or decrease contractures. Clinical observations suggest that infants who receive consistent daily PROM seem to avoid development of shoulder contractures while those who receive no or infrequent PROM seem to develop early and significant contractures. In a retrospective pilot study we found that children whose parents consistently performed PROM two times daily starting before age two months were less likely to develop shoulder contractures than children whose parents were inconsistent in performing PROM. These findings, along with our clinical observations suggest that frequency of PROM might be less important than consistency. In order to assess the efficacy of different levels of frequency (e.g., at every diaper change vs. two times per day), it is imperative to identify methods that support caregivers in performing PROM every day. Therefore, the proposed study will pilot a caregiver training method which, if successful in facilitating daily adherence, will be used as part of a larger planned study that will compare differences in recommended frequencies of stretching. In a survey study and scoping literature review performed by one of the co-investigators on this project, caregiver adherence to home therapy recommendations was found to be facilitated by confidence in the training they received and by their confidence in ability to carry-out recommendations; lack of confidence in performing the home therapy recommendations was found to be a common barrier. Therefore, the objective of the proposed work is to assess the efficacy of a pilot training protocol for caregivers of infants with BPBI. Our central hypothesis is that the pilot training protocol will improve caregiver efficacy and increase their confidence in performing the recommended PROM/stretching procedure, thus facilitating adherence which we hope to later demonstrate will decrease the risk of shoulder contracture in infants with BPBI. The significance of this work is that it will evaluate and provide evidence for the use of the pilot training protocol so that this training protocol can later be used in a larger study on the efficacy of different frequencies of PROM to reduce the development of shoulder contracture in infants with BPBI, and thus contribute to developing evidenced-based standards of care for this population. The objectives of this clinical trial are to: 1. determine whether caregivers who receive a pilot training protocol for performing PROM demonstrate improved efficacy in performing PROM compared to caregivers who receive standard training 2. determine whether caregivers who receive a pilot training protocol for performing PROM demonstrate improved self-confidence in performing PROM compared to caregivers who receive standard training 3. determine whether caregivers who receive a pilot training protocol for performing PROM report better daily adherence to daily PROM compared to caregivers who receive standard training Read Less

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-Hodgkin's lymphomas. Read Less

Vitrectomy to remove an epiretinal membrane (ERM) is one of the most common procedures performed by retinal surgeons. Patients who present with significant macular changes on optical coherence tomography (OCT) but relatively good vision are often advised to defer surgery until vision declines to 20/40 or worse. However, it is unknown if delaying surgery, which allows the foveal architecture to remain compromised and potentially to deteriorate, results in worse visual acuity outcomes than if surgery is performed earlier. In addition, there is a need to better understand predictors of outcomes when surgery is performed and predictors of progression when surgery is deferred. Finally, one of the most common presenting symptoms from an ERM is distortion or metamorphopsia. There are several objective measures of metamorphopsia but none have ever been employed to evaluate ERMs in a randomized clinical trial (RCT) and their usefulness is unknown. The purposes of this study are to better understand the optimal timing of surgery to produce the best visual result, to better understand predictors of outcomes in those who undergo surgery and predictors of progression in those whose are observed, and to better characterize and evaluate the usefulness of metamorphopsia and reading speed measures. Read Less