Clinical trials

The main objective of the proposed research study is to determine in men and women with spinal cord injury/disease and neurogenic bladder whether the dose of coupled gentamicin \& Lactobacillus rhamnosus GG affects the recolonization of the bladder, and whether the rate of success differs by sex. Secondary objectives include determining whether that recolonization lasts 7, 14, or 28 days; and safety of the coupled gentamicin \& Lactobacillus instillations.

Young adult cancer survivors (YACS) commonly experience chronic insomnia due to many factors such as cancer related symptoms, effects of anti-cancer therapies, co-morbid mood disorders, and/or other psychosocial and economic stressors. Cognitive behavioral therapy for insomnia (CBT-I) is the gold standard for insomnia management but remains challenging to deliver to patients due to limited numbers of trained therapists, inconvenient scheduling availability, or prohibitive therapy costs. To address this critical gap in young adult cancer survivorship, the investigators propose to develop and test efficacy of the More Sleep Hours Electronic Education Program (More SHEEP), a novel system of smart speaker, smart lighting, and specialized Wi-Fi router that delivers AI-driven CBT-I to patients at home.

This multi-centered, randomized controlled trial will evaluate the safety and efficacy of home use of the novel Reia System (RS), which includes the Reia pessary and applicator, compared to standard pessary care (Gellhorn or ring with/without support without knob) among women with stage II-IV pelvic organ prolapse (POP). A total of 200 participants will be recruited among pessary naïve patients who are symptomatic and choose a vaginal pessary for management of their POP from study sites specializing in Urogynecology and Reconstructive Pelvic Surgery (URPS). Participants will be assigned via 1:1 randomization using computer generated numbers in permutated groups of variable block sizes to either the intervention (the Reia System, RS) or standard pessary care (SPC) stratified by site. Participation in this trial will involve a total of four visits over six months. The primary outcome measure will be satisfaction measured at the six-month time point. Secondary outcomes will include validated surveys to assess quality of life, number of self-management events, ease/difficulty of pessary insertion/removal, importance of ability to self-manage pessary, and adverse events. Specific Aims Aim 1: To compare satisfaction with pessary use and management between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 2: To assess successful fitting, number of refitting visits, number of self-management events and continued pessary use over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 3: To compare ease/difficulty of pessary use and importance of ability to self-manage, as well as quality of life over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 4: To measure rates of adverse events and risk factors for adverse events over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.

Background: While left ventricular assist device (LVAD) therapy improves survival in patients with advanced heart failure (AHF), unique LVAD-related burdens may impact health-related quality of life (HRQoL). Palliative care specialists are key members of the multidisciplinary care team for patients with long-term-LVAD (LT-LVAD), offering specialized, comprehensive, holistic care. Problem: A seminal study of palliative care in patients with heart failure (PAL-HF trial) demonstrated that outpatient palliative care improved HRQoL, depression, anxiety, and spiritual well-being compared to usual care. The impact of longitudinal palliative care on HRQoL in LT-LVAD patients is unknown. Objective: The investigators aim to conduct the first study examining a palliative care intervention to improve HRQoL among LT- LVAD recipients (patients who have lived with LT-LVAD for at least six months and are not heart transplant candidates) at two centers (MedStar Health and Inova) in the Mid-Atlantic Region. Given the demographics of the study institutions, the investigators anticipate a socioeconomically and racially diverse cohort of patients with subgroups who may disproportionately experience LVAD-related burdens relative to benefits. Aims: The first aim is to assess baseline measures of HRQoL in LT-LVAD patients to understand differences in HRQoL across subgroups and multiple, understudied domains. The second aim is to test the feasibility and acceptability of a randomized, unblinded pilot study of a palliative care interdisciplinary intervention in this population. Significance: Results of this study will inform the development of a large randomized controlled trial to test the effectiveness of palliative care intervention in improving HRQoL in LT-LVAD patients. If results are positive, this will revolutionize the post-LVAD treatment paradigm, by making palliative care integration the standard of care for longitudinal LT-LVAD patient management.

People with type 1 or type 2 diabetes often use insulin pumps to manage their blood sugar during pregnancy. These pumps can help keep blood sugar in a healthy range. However, when people come to the hospital to give birth, they are often asked to stop using their insulin pump and switch to insulin given through an IV. This change can be stressful and may make blood sugar harder to control during labor. There is not enough research to know if it is safe and practical for people to keep using their insulin pump while in labor. The goal of this study is to learn whether it is safe, practical, and acceptable for pregnant people with diabetes to continue using their insulin pump during labor. The study will also look at how this approach compares to standard care, which uses IV insulin. This is a small pilot study. About 30 pregnant people with type 1 or type 2 diabetes will take part. All participants already use an insulin pump and receive care through the MedStar Diabetes in Pregnancy Program. Participants will be allowed to continue using their own insulin pump during labor, following a hospital safety plan. Their outcomes will be compared to similar patients from the past who used IV insulin during labor. The main focus of the study is to see how often people can safely stay on their insulin pump during labor and how well this approach fits into hospital care. The study will also collect information about blood sugar levels during labor and health outcomes for newborns, such as low blood sugar, breathing problems, or need for care in the neonatal intensive care unit. These outcomes are being studied to help plan future research. After delivery, participants will be asked to share their experience. This includes how satisfied they were with their diabetes care during labor, how much control they felt over their care, and how difficult or easy the treatment was to manage. Nurses and doctors will also provide feedback about caring for patients who use insulin pumps during labor. Participants will continue to check their blood sugar using continuous glucose monitoring, with fingerstick checks when needed. If any safety concerns arise, such as blood sugar levels that are too high or too low, participants will switch to standard IV insulin. This study is not meant to prove that one method is better than another. Instead, it will help researchers decide whether a larger study should be done in the future. The long-term goal is to improve diabetes care during labor and support safe, patient-centered options for people with diabetes and their babies.

The goal of this observational qualitative study is to learn about the experiences and perspectives of patients with neurogenic lower urinary tract dysfunction (NLUTD) and their caregivers regarding different types of intravesical instillations used for urinary health. The study aims to understand the perceived benefits, challenges, and opportunities related to Lactobacillus-only, gentamicin-only, and combined gentamicin-Lactobacillus instillations. The main question this study seeks to answer is: 1\. Determine patient and caregivers' preferences, and overall experiences regarding intravesical therapeutics for urinary symptoms and UTI Researchers will compare responses from four groups: participants who have used Lactobacillus-only instillations, gentamicin-only instillations, combined gentamicin-Lactobacillus instillations, and caregivers who have experience supporting instillations. Participants will take part in a one-hour semi-structured interview and may be contacted for brief follow-up discussions to clarify findings. Interviews will be audio-recorded, transcribed, and analyzed using qualitative data software to identify themes related to treatment preferences and acceptability.

Evaluate the diagnostic journey, patient experience, and disparities in the treatment of Spinal Muscular Atrophy (SMA) in the MedStar Health System.

This is a prospective randomized control trial comparing two collared and collarless femoral implants used in primary total hip arthroplasty. The specific aims of this trial are to: SA1: Prospectively assess clinical outcomes in patients undergoing primary total hip arthroplasty with a collared versus collarless femoral stem of the same design. SA2: Evaluate serial radiographs to quantify differences in subsidence between collared and collarless implant groups. SA3: Report and compare incidence rates of intraoperative and postoperative periprosthetic fractures and aseptic loosening following primary total hip arthroplasty with use of either a collared or collarless stem. Hypothesis: The addition of a collar to the same designed triple-taper primary hip stem will lead to a reduction in subsidence and incidence of perioperative and periprosthetic femur fractures.

While chronic cancer pain affecting as many as 75% of patients is typically addressed using pharmacologic interventions, experts and patients alike support maximizing any relevant non-pharmacologic interventions as well, such as cognitive behavioral therapy. Virtual reality, a novel technology that can temporarily immerse users in a calm, pleasant environment, has been increasingly shown to facilitate improvement in different acute and chronic pain syndromes by providing distraction from pain and lowering pain sensation. To address the significant needs of patients living with chronic cancer pain, we aim to develop and pilot test a prototype device that will leverage cognitive behavioral therapy principles to deliver a novel virtual reality pain therapy. The investigators will do this through the following steps: Step 1. Develop and refine a CBT-assisted VR prototype for patients with chronic cancer pain (VR-CAN). Step 2. Conduct a randomized controlled trial to examine the feasibility, acceptability, usability, safety, and initial clinical impact of the developed VR-CAN prototype compared to a tablet-based two-dimensional video control group. Step 3. Collect and evaluate qualitative post-intervention data on VR-CAN participants' preferences, thoughts, and feelings about the VR-CAN technology and protocol to optimize for a future, larger, fully powered randomized controlled trial.

Patients living with cancer commonly have chronic pain due to the disease or to cancer treatments. Virtual reality, a new technology that immerses the user in pleasant, diverting, and exciting virtual environments, may lower chronic cancer pain to improve quality of life and complement need for pain medications like opioids. The investigators aim to learn from patients about the experience of cancer pain, develop a virtual reality prototype specific to cancer pain management, and test the feasibility and acceptability of this technology to improve the cancer pain experience.

The goal of this clinical trial is to determine whether Lactobacillus crispatus strains isolated from the lower urinary tracts of adult women can be used as an antibiotic-sparing treatment for urinary symptoms and urinary tract infection (UTI) among adults with neurogenic lower urinary tract dysfunction (NLUTD). The main question\[s\] it aims to answer are: 1. To identify soluble bactericidal compounds produced by urinary isolates of L. crispatus that kill uropathogenic E. coli (UPEC). 2. To determine if intravesical instillation of L. crispatus is safe and well tolerated in adults with NLUTD due to SCI who use intermittent catheterization (IC). If there is a comparison group: Researchers will compare L. Crispatus to standard care saline to see if there is a difference in urinary symptoms and urinary microbiome. Participants will be asked to complete daily symptom surveys, complete 2 bladder instillations, and collect, freeze, and return 14 urine samples.

Single-center, open label, prospective study conducted at Medstar Georgetown Headache Center. Men and woman ≥ 18 years old that are diagnosed with migraine with or without aura for at least 1 year, who report a reliable migraine trigger. Acceptable triggers for the study will include exercise, alcohol (less than one drink per day for woman and less than two drinks per day for men), air travel that lasts no more than 12 hours, sexual activity, fasting that lasts no more than 24 hours, stress or stress let-down headache.

The APPROVE trial is a multi-centered, randomized controlled trial designed to assess differences in symptom improvement, quality of life, bladder symptoms, satisfaction with treatment and continued treatment efficacy in women with overactive bladder (OAB) randomized to a prescription digital therapeutic (PDTx) app called RiSolve compared to standard behavioral education (handouts).

In this prospective, randomized, split-body control trial, we aim to compare complications, patient-reported outcomes, and cost differentials following reduction mammaplasty with prophylactic closed incision negative pressure wound therapy versus standard adhesive dressing.

The objectives of the proposed research among this population are: 1) to define clinically meaningful change (i.e. differentiating states of health and illness) with respect to urinary symptoms, urine inflammation, cultivable bacteria, and the urine ecosystem; and 2) to determine the optimal intravesical Lactobacillus RhamnosusGG (LGG®) dose to be used to reduce urinary symptoms in a future clinical trial.

This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI).

This study aims to examine the clinical profile/anatomical characteristics and natural history of patients who subsequently fail screening for transcatheter mitral valve intervention (TMVI).

This study uses a procedure called chromopertubation to look at how fibroids and fibroid surgery affect the fallopian tubes. Specifically, this study will test if the fallopian tubes are occluded or patent (open) before and after surgically removing fibroids. Chromopertubation is a commonly performed and well-established procedure that is done during laparoscopic surgery to determine if the fallopian tubes are open or blocked. It includes inserting a dilute solution of saline with a small amount of medical-grade blue dye (called methylene blue) into the uterine cavity to see if it spills out of the fallopian tubes. Chromopertubation is considered a safe procedure - the main risk is an allergic reaction to the dye, which is very rare. The minimum amount of methylene blue dye will be used to further reduce risks of a reaction. Open fallopian tubes are necessary to become pregnant without the use of IVF. While it is known that some conditions can affect the functioning of the fallopian tubes, there is a lack of research about how fibroids affect the tubes. It is also not known how much about how the process of removing fibroids may affect the fallopian tubes. The investigators hypothesize that tubal occlusion will be observed in patients with fibroids and that the frequency of tubal occlusion will change after myomectomy compared to pre-myomectomy. This study will be conducted entirely during planned surgery for laparoscopic myomectomy. Chromopertubation will be performed at the beginning and again at the end of the surgery. This is expected to take less than 10 minutes in total. The results of the chromopertubation as well as background medical information will be recorded and the characteristics of the fibroids (size, number, and location) will be compared to the presence or abscence of tubal occlusion as determined by chromopertubation.

This study is being done to test if paraffin wax can be used to improve the range of motion and function for scars across joints when used in combination with scar rehabilitation therapy sessions. For those randomized to receive it, the paraffin wax will be used alongside the participants' exercise therapy treatments. Currently, treatments that are used in addition to rehabilitation therapy for increasing range of motion across joints in the burn population are limited. By getting more information about how paraffin wax may or may not work, patients in the future that have scars may be able to be helped.

The goal of this randomized controlled trial is to determine whether the use of a novel vibrating pelvic floor therapeutic device ("Kiwi") improves sexual function in sexually active women aged 18 and older with genito-pelvic pain and penetration disorder (GPPPD) more effectively than traditional vaginal dilators. The main questions it aims to answer are: 1. Does the use of the Kiwi device lead to higher sexual function scores compared to traditional vaginal dilators 2. Does the Kiwi device improve sexual distress, pain, and overall symptom severity more effectively than traditional vaginal dilators? Researchers will compare the Kiwi vibrating device to traditional cylindrical vaginal dilators to assess whether the Kiwi device results in greater improvements in sexual function and symptom relief. Participants will: * Be randomly assigned to use either the Kiwi device or traditional vaginal dilators. * Use the assigned device three times per week for 15 minutes per session over four weeks. * Complete surveys before and after the study, including assessments of sexual function, pain, and overall improvement.

There are vulnerabilities in post-discharge care transition for patients after undergoing resection of malignant gastrointestinal tumors. This study aims to investigate the possibility of utilizing Voice-Assisted Remote Symptom Monitoring System (VARSMS) to alleviate some of these challenges.

REVIVE TAVR is an acronym for the Randomized Evaluation of Valve-In-Valve versus Explantation for failed TAVR. This is a prospective, multicenter, global randomized trial investigating the safety and efficacy of reintervention for transcatheter heart valve (THV) failure by comparing redo-TAVR (TAV-in-TAV) with TAVR surgical explantation (TAVR-explant) in subjects who are suitable for both options in a real-world clinical setting

The goal of this study is to evaluate the HandMATE device's effectiveness in the rehabilitation of stroke patients and asses if the HandMATE application is received well by stroke survivors. Participants will use the HandMate device in clinic and in the home. They will also complete clinical upper extremity assessments.

This study is being done to demonstrate the effectiveness of Regenerative Peripheral Nerve Interfaces (RPNI) surgery in treating symptomatic neuromas of the hand and digits following amputation compared to standard of care using a Prospective, Observational Trial

This is a prospective, randomized crossover study. The objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves exercise tolerance during the 6-minute walk test. The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa.