All clinical trials

Chronic pain is very common among primary care Veterans and can seriously impact overall patient functioning and well-being. Currently, behavioral treatments for pain management are not often provided in primary care because they are designed to be delivered in specialty care settings, such as chronic pain clinics. To address this gap in care, the proposed study will test if Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) is an effective treatment. Therefore, the first objective of the proposed study is to conduct a randomized controlled trial of Brief CBT-CP compared to primary care treatment as usual to assess treatment effectiveness by examining changes in pain-related physical activity interference, psychological distress, pain intensity, and other related outcomes. 178 eligible participants will be randomized into either Brief CBT-CP and primary care treatment as usual or primary care treatment as usual only. Eligible Veterans will include those with chronic musculoskeletal pain and pain-related functional impairment identified from primary care. Participants assigned to Brief CBT-CP will receive six sessions of treatment in 30-minute appointments. This intervention will include education and goal setting, activities and pacing, relaxation skills, cognitive coping, and relapse prevention. Assessments will include validated self-report measures that will take place at pre-treatment (baseline), mid-treatment, post-treatment, and at 6-month follow-up. The second objective of this study is examine the mechanisms by which Brief CBT-CP leads to improvement in patient outcomes. Statistical analysis will reveal if changes pain self-efficacy (i.e., perceived ability to manage pain or engage in usual activities despite being in pain) and catastrophizing (i.e., unhelpful, negative though patterns about pain and pain management) lead to improvements in patient functioning. The third objective of this study will be to explore perceptions of Brief CBT-CP among patients who experience significant improvement in outcomes compared to those who did not experience improvement. Participants will include up to 40 patients who were treated with Brief CBT-CP. Participants will be interviewed about key components of the treatment and their perception of effectiveness. Interview data will be compared to the results of statistical analysis to help understand the mechanisms by which Brief CBT-CP is effective or identify areas for improvement. Results of this study will provide information needed to determine if Brief CBT-CP should be widely disseminated across VA primary care clinics.

The primary objective of the proposed Stage IA/IB study is to establish feasibility of an integrated cognitive-behavioral intervention for reducing SUD and PTSD symptoms among women who experienced a sexual assault within the past six weeks. The intervention will be tested in an open label trial to make final modifications to evaluate feasibility, acceptability, and preliminary efficacy of the five to six week integrated intervention with standardized repeated measures during a one-month follow-up.

The purpose of this study is to test the efficacy and safety of Anlotinib in combination with STUPP regimen for MGMT promoter nonmethylated glioblastoma.

IHBDH-GTHA-2020 is an open- label, non- randomized study to evaluate the safety, tolerability and kinetics of a single intravenous infusion of GS001 in hemophilia A subjects with <1 IU/dl residual FVIII levels.

Fibromyalgia is serious chronic pain condition which is often accompanied by sleep disturbances, fatigue and disability and reduced quality of life. There is no cure and treatments are based on reliving symptoms and maintaining function. The currently available medical treatments are not helping many patients, and many get side-effects. Medical cannabis is sought after among patients and many use this medication un-licenced, although it is not properly documented if it works or is safe. Therefore, it is necessary to investigate the effects and safety of medical cannabis in a properly designed randomized trial. The aim of the study is to investigate if cannabidiol (CBD) can improve pain, sleep, function and quality of life in patients with fibromyalgia. The study will include 200 patients, who will receive either cannabidiol or placebo over a period of 24 weeks. Participants will be closely looked after for improvements in their condition and for potential side-effects to ensure safety.

This phase I trial studies the effects and best dose of ONC206 alone or in combination with radiation therapy in treating patients with diffuse midline gliomas that is newly diagnosed or has come back (recurrent) or other recurrent primary malignant CNS tumors. ONC206 is a recently discovered compound that may stop cancer cells from growing. This drug has been shown in laboratory experiments to kill brain tumor cells by causing a so called "stress response" in tumor cells. This stress response causes cancer cells to die, but without affecting normal cells. ONC206 alone or in combination with radiation therapy may be effective in treating newly diagnosed or recurrent diffuse midline gliomas and other recurrent primary malignant CNS tumors.

This is an interventional study to assess the safety, PK, and efficacy of HST5040 in 12 subjects - 6 with Methylmalonic Acidemia (MMA) and 6 with Propionic Acidemia (PA). The study consists of 3 parts: Part A: Open-label, within-subject, dose escalation study in PA and MMA subjects ≥ 2 years old to identify a safe and pharmacologically active (optimal) dose of HST5040 for use in Part B. Subjects will continue in a Part A open-label extension until all subjects complete Part A and the optimal dose of HST5040 is identified for use in Part B. Part B: 6-month, randomized, double-blind, placebo-controlled, 2-period crossover in the same subjects from Part A to evaluate safety and efficacy of the optimal dose of HST5040 in addition to standard of care (SoC). Part C: open-label long-term extension study in PA and MMA subjects ≥ 2 years old (N = approximately 12, 6 each) to evaluate the long-term safety and efficacy of the optimal dose of HST5040. This study will determine whether HST5040 can improve levels of disease-associated toxins that accumulate in patients with PA and MMA.

Gout is secondary to urate crystal deposition after chronic elevation of serum urate level (SUL). Long-term lowering SUL below 360 µmol/L allows dissolution of deposited crystals and disease cure. There is currently a paradoxical observation: while urate-lowering therapy (ULT) is available and efficient there is an increase of gout prevalence and severity. The apparent failure of ULT in gout management is due to several causes including unadjusted dosage, no SUL verification, irregular follow-up and low treatment compliance. In contrast, a nurse-led treat-to-target (T2T) strategy with regular adaptations of ULT until reaching SUL target allows gout cure in more than 90% of patients. We hypothesize that an electronic messaging-led T2T strategy will allow obtaining similar results. The aim of this study is to demonstrate that email-led T2T strategy during ULT is superior to usual care.

An open-label, three-centers, controlled, randomized, and crossover study containing 14 days of baseline period with standard of care (SOC) therapy followed by two-sessions of 4-weeks home study phase with Diabeloop closed-loop (CL) system comparing the declaration of meals and the non-declaration of meals.

The study will compare the impact FIRST (a transdiagnostic treatment built upon five empirically supported principles of change) versus usual care outpatient psychotherapy on youths' mental health outcomes and a candidate mechanism of change: regulation of negative emotions.