Baltimore, MD Paid Clinical Trials

The need to obtain human tissue for methods development and disease correlation is frequent in Biomedical Research Center laboratories. This protocol is designed to create the opportunity to obtain such tissue samples including: blood, urine, saliva, sweat, feces, hair and nail clippings, nasal scraping, muscle, fat, skin and taste buds. It may also include samples taken during a surgical procedure, including: fluid from around the spinal column, heart, lungs and abdomen; fat, muscle, connective tissue and organs (liver, bladder, heart, kidney and skin). Information derived from such studies is for research purposes only and is not provided to the participants or their health care provider. Samples will be coded (no names) and identifying information linking the participant to the sample will be maintained in a secure location by the P.I. and Study Coordinator. Participants will be 18 years or older and have been identified by the investigator and/or physician to have a condition of interest for exploratory studies related to the participant s illness or other feature that offers the possibility of creating information that leads to scientifically useful and important studies. Participants could also be healthy volunteers, willing to provide their samples. These samples could be requested by an investigator to be used as age, gender, race and/or ethnicity-matched controls or to calibrate or compare and contrast across lab equipment. Participants will be excluded if obtaining the sample would be over and above usual clinical care, would result in excessive blood loss, or the individual is unable to provide informed consent. The expected outcome is to provide investigators with the opportunity to obtain tissues of interest for laboratory evaluation.... Read Less

This phase II trial studies how well nab-paclitaxel, durvalumab, and tremelimumab with or without personalized synthetic long peptide vaccine (neoantigen vaccine) works in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as nab-paclitaxel, 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. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether giving nab-paclitaxel, durvalumab, and tremelimumab with or without neoantigen vaccine will work better in treating patients with triple negative breast cancer. Read Less

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke. Read Less

This phase I/Ib trial tests the safety and best dose of ipatasertib in combination with the usual treatment approach using chemotherapy together with radiation therapy ("chemo-radiation") in patients with head and neck cancer. Ipatasertib is in a class of medications called protein kinase B (AKT) inhibitors. It may stop the growth of tumor cells and may kill them. Cisplatin which is a chemotherapy used in this trial is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Radiation therapy uses high energy to kill tumor cells and shrink tumors. Giving ipatasertib in combination with chemo-radiation may be better than chemo-radiation alone in treating patients with advanced head and neck cancer. Read Less

This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment. Read Less

Snoring is a common problem caused by vibration of tissues in the throat region during sleep. Although snoring is sometimes dismissed as a minor nuisance rather than a medical disorder, several studies indicate that snoring can disrupt sleep quality of the snorer, as well as the snorer's bed partner. Snoring also might lead to problems such as dry mouth, bad breath, dental problems, and even cardiovascular disease. Current treatments for snoring include lifestyle modifications such as weight loss, side-sleeping, and avoidance of evening alcohol intake. In some cases, invasive surgeries, dental devices, or even CPAP are recommended for snoring. These interventions have mixed effectiveness and may be difficult to use. It may be possible to treat snoring by fostering nasal breathing, while avoiding mouth-breathing during sleep. Breathing through the mouth reduces the airway diameter and contributes to snoring. Several studies show that nasal breathing can reduce snoring volume and improve airflow. Recent studies have shown that covering the mouth during sleep with adhesive patches or tape can improve snoring volume without adverse effects. However, these studies were performed in a small number of patients and did not fully measure the impact of the intervention on sleep quality, sleep architecture, or the experience of the bed partner, who is often the overlooked "victim" of the snoring. In this interventional study, the investigators will examine the safety and efficacy of mouth tape for snoring, focusing on subjective and objective snoring/breathing metrics of both the snorer and bed partner. Snoring is sometimes also a sign of obstructive sleep apnea (OSA). If OSA is ruled out with a sleep study, patients are considered to have "simple" snoring. When OSA is mild (apnea hypopnea index 15), treatments can include the same interventions as snoring (e.g. weight loss, avoidance of alcohol, side-sleeping) or can be more aggressively treated with devices such as continuous positive airway pressure (CPAP). CPAP may be challenging to use, expensive, and associated with side effects such as mouth dryness and skin irritation. Alternative, inexpensive, and well-tolerated interventions are needed for mild OSA. For this reason, the investigators include patients with snoring and mild OSA in this study. Read Less

This phase I/II trial studies how well tiragolumab and atezolizumab works when given to children and adults with SMARCB1 or SMARCA4 deficient tumors that have either come back (relapsed) or do not respond to therapy (refractory). SMARCB1 or SMARCA4 deficiency means that tumor cells are missing the SMARCB1 and SMARCA4 genes, seen with some aggressive cancers that are typically hard to treat. Immunotherapy with monoclonal antibodies, such as tiragolumab and atezolizumab, 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

VETERANS ONLY. Chronic low back pain (cLBP) is common. Most Americans will have at least one episode of low back pain in their lifetimes. Approximately 50% of all US Veterans have chronic pain, and CLBP is the most common type of pain in this population. This study will use a sequential randomized, pragmatic, 2-step comparative effectiveness study design. The main goal is to identify the best approach for treating cLBP using commonly recommended non-surgical and non-pharmacological options. The first step compares continued care and active monitoring (CCAM) to internet-based pain self-management (Pain EASE) and an enhanced physical therapy intervention that combines Pain EASE with tailored exercise and physical activity. Patients who do not have a significant decrease in pain interference (a functional outcome) in Step 1 and those desiring additional treatment will be randomized in Step 2 to yoga, spinal manipulation therapy (SMT), or therapist-delivered cognitive behavioral therapy (CBT). Participants proceeding to randomization in Step 2 will be allowed to exclude up to one of the three Step 2 treatments based on their preferences. The investigators' primary hypothesis for the first treatment step is that an enhanced physical therapy intervention that combines pain self-management education with a tailored exercise program will reduce pain interference greater than internet-based pain self-management alone or CCAM in Veterans with cLBP. The primary outcome is change in pain interference at 3 months, measured using the Brief Pain Inventory (BPI) pain interference subscale. Study participants will be followed for one year after initiation of their final study treatments to assess the durability of treatment effects. The study plans to randomize 2529 patients across 20 centers. Read Less

The objective of this study is to determine the effect of low caffeine green tea extract containing 45% epigallocatechin gallate (EGCG) on fibroids and subsequent pregnancy and live births in women seeking fertility treatment. The population will consist of 50 women desirous of conceiving, ages ≥18 to ≤40 years (at time of consent), and known to have class 2-6 fibroids, according to the FIGO staging system. Read Less

This phase II ComboMATCH treatment trial tests how well AMG 510 (sotorasib) with or without panitumumab works in treating patients with KRAS G12C mutant solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Sotorasib is in a class of medications called KRAS inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells. Panitumumab is in a class of medications called monoclonal antibodies. It works by slowing or stopping the growth of cancer cells. Giving combination panitumumab and sotorasib may kill more tumor cells in patients with advanced solid tumors with KRAS G12C mutation. Read Less

This study will evaluate the individual and interactive effects of oral cannabis and alcohol on subjective and behavioral measures of impairment. Read Less

This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Read Less