All clinical trials

Purpose: Multiple formulations and brands of botulinum toxin exist on the market today. Only OnabotulinumtoxinA (BOTOX®) is currently FDA approved for treatment of overactive bladder. IncobotulinumtoxinA (XEOMIN®) is a similar formulation of botulinum toxin A that has similar dosing and safety profile at onabotulinumtoxinA. OnabotulinumtoxinA is the most expensive formulation on the market. Compare the efficacy of incobotulinumtoxinA (Xeomin®, Merz Pharmaceuticals) to onabotulinumtoxinA (Botox®, Allergan) for treatment of OAB. Study design: A single-blinded, randomized non-inferiority trial of IncobotulinumtoxinA (Xeomin®, Merz Pharmaceuticals) to OnabotulinumtoxinA (Botox®, Allergan) in treatment of OAB. Target Population: The study findings will be applicable to all women 18 years of age or older with OAB symptoms associated with urinary urgency incontinence. Procedure: All patients that presents to urogynecology clinic at Walter Reed National Medical Military Center will be screened for inclusion and exclusion criteria. Patients that meet criteria will be offered to participate in the study. After enrollment patient will complete demographics data sheet, 24 hours bladder diary, OAB-q SF, PGI-S, PISQ-IR. Patients will be randomized by the principal investigator and the allocated treatment will be reveled by the treating provider to the treating provider only. Patient will have a follow up at 2-6 weeks and 6-9 months after procedure. During the follow up appointments patient will be asked to fill out 24-hour voiding diary, OAB-q SF, PGI-I, PGI-S, and PISQ-IR surveys.

Neuroinflammation is a significant component of Alzheimer disease (AD). Our group recently demonstrated that regulatory T cells (Tregs) have a compromised phenotype and reduced suppressive function in AD patients, skewing the immune system toward a proinflammatory status and potentially contributing to disease progression. Low dose interleukin-2 (IL-2) is now viewed as a promising immunoregulatory drug with the capacity to selectively expand and restore functional Tregs. This study is a phase II, randomized, double-blind, placebo-controlled study to assess low dose IL-2 therapy in AD patients. Up to 40 Alzheimer's disease patients in the mild- to moderate clinical dementia stages (MMSE scores: 12-26) will be randomized to five-day-courses of subcutaneous IL-2 or placebo for a total of 6 months. We will evaluate the safety and tolerability of IL-2 treatment and the possible effects of IL-2 treatment on peripheral and central inflammation. The expected time participants will be in the study is 30 weeks.

Children with cerebral palsy (CP), Gross Motor Functional Classification Scale (GMFCS) I-II will be recruited to participate in a home based physical activity intervention for 12 weeks. Demographic data will be collected, and validated surveys assessing baseline activity level and quality of life will be administered. Participants will have an exercise program assigned and will be given a logbook to record their exercise adherence. They will be randomized to one of the two arms: Augment Reality (AR) app or control group. The AR app group will have exercises administered through the AR app. The Control group will do an at-home program using handouts. At the end of the program, participants will complete final surveys and activity tests. The control group will have access to the AR component after the 12 week period.

This randomized controlled trials study aims, first, to determine the effectiveness of a nurse-led PNE program designed by a multidisciplinary team, compared with an active control group on pain intensity, fibromyalgia (FM) severity, pain catastrophizing, and cognitive performance in patients with FM. Second, to determine the mediator role of pain catastrophizing in the effects of PNE on outcomes of interest. Third, to explore PNE-induced changes to the brain circuitry using QEEG in patients with FM.

The researchers are doing this study to find out if the study drug, enzalutamide, alone or combined with the study drug, mifepristone, is effective in treating advanced or metastatic androgen receptor-positive (AR+) triple negative breast cancer (TNBC) or estrogen receptor-low breast cancer (ER-low BC), and whether these study treatments work as well as standard chemotherapy with carboplatin, paclitaxel, capecitabine, or eribulin.

This Phase 1 clinical trial will assess the safety, tolerability and pharmacokinetics (PK) of a solid capsule form of NTP42:KVA4 in male and female healthy volunteers. In a randomised, 3-way cross-over study, the Trial will involve 3 dose sessions where all volunteers will receive 3 single doses of NTP42:KVA4. In two of the dose sessions, volunteers will be fasted where, in one, they will be given the NTP42:KVA4 capsule and, in another, they will be given NTP42:KVA4 in oral liquid form. To test the effect of food on drug absorption (PK), the volunteers will also be given the NTP42:KVA4 capsule after eating a full breakfast.

To determine the safety and tolerability of adding durvalumab to mFOLFIRINOX prior to surgery in patients with resectable or borderline resectable pancreatic adenocarcinoma.

This trial is a multicenter, single-arm, open design designed to evaluate the safety and tolerability of Autologous Tumor Infiltrating Lymphocyte Injection in the treatment of patients with advanced solid tumors, as well as pharmacokinetic profiling and efficacy. The trial consists of two phases: dose-escalation and dose-expansion.

This study is to assess the efficacy and tolerability of an oral supplement in mild to moderate acne in adult females.

This study will evaluate the safety and efficacy of NK510 in the treatment of relapsed and refractory advanced NSCLC.NK510 will be administered in combination with PD-1 blockade. Patients are required to undergo a biopsy for confirmation of tumor PD-L1 expression,and EGFR,ROS1,ALK gene must be negative. The safety and efficacy of this treatment will be evaluated.