16 Clinical Trials for Various Conditions
Psychological treatments are effective, but take a long time and can be burdensome. Therefore, avenues to optimize behavioral treatments are needed. Despite important advancements, neuroscience has had a limited effect on psychotherapy development. Therefore, one paradigm shift would be to develop neuroscience informed behavioral treatments. The investigators identified from the literature a problem that affects several mental disorders (emotion dysregulation) and a neural circuit that underlies this important concern. They found that this circuit is dysfunctional in those with psychopathology but can be changed with treatment. The goal is in one session to train this brain network to operate more efficiently and to test the short and long term effects of this intervention. The investigators plan to engage this brain network using a traditional psychotherapy strategy (cognitive restructuring) and to enhance learning using repetitive transcranial magnetic stimulation (rTMS), a neuromodulation technique through which magnetic stimulation enhances the electrical activity in brain areas close to the scalp. The study team proposed two studies to examine this novel approach, In one of the studies 83 participants were enrolled and 47 eligible participants were divided into 3 groups. All participants were trained in emotion regulation by first being asked to remember an event where they experienced a negative emotion and then being instructed either to think differently about the event, or to wait. Participants simultaneously underwent either active (left or right side of brain) or sham rTMS. In a second study 65 participants were enrolled, and 31 were assigned to either active left or sham rTMS guided using neuroimaging results. Across both studies, the investigators measured regulation in the lab and during a-week long naturalistic assessment. Participants in the second study returned for a follow up neuroimaging visit at the end of this week. Participants returned for a one moth follow up assessment and to rate feasibility, acceptability, and provide feedback. This proof of concept set of studies demonstrated feasibility and preliminary efficacy for this approach, which opens new frontiers for neuroscience informed treatment development.
This study will analyze the germline and somatic mutations underlying the development of ADPKD in order to better understand the genetic mechanism responsible for the cystic transformation. Once identified, these mutations could help us understand better the mechanism leading to the development of this disease and may explain at least in part the phenotypic variability.
The purpose of the study is to assess the tolerability and efficacy of dextromethorphan in combination with fluoxetine for symptom relief in OCD and related disorders.
The present study is a randomized clinical trial of an emotional awareness and expression intervention (EAET) and a mindfulness meditation intervention (MMT) for Wayne State University students with anxiety and somatic symptoms. Each of these treatments will be compared to a wait list control condition and to one another to evaluate how well the treatments improve physical and psychological symptoms, stress, and interpersonal functioning of 120 Wayne State University students at 4-week and 8-weeks post-randomization. This research is intended to provide an evidence-based approach to working with emotions to improve both anxiety and somatic symptoms in young adults and will illuminate how EAET compares to the commonly used mindfulness training. It is hypothesized that both active interventions will be superior to no treatment, and differences between the two treatments will be explored.
This study is a randomized controlled pilot trial using a hybrid type 1 effectiveness-implementation design to evaluate the feasibility, acceptability, and preliminary effectiveness of a brief cognitive-behavioral intervention delivered by medical assistants in a primary care setting. The trial compares clinical outcomes of participants assigned to the intervention condition to those of participants assigned to a usual care condition. The clinical outcome is change on a self-report measure of health anxiety. Assessments occur at baseline, four weeks, and 12 weeks post-treatment. The study will also measure engagement with the intervention and assess feasibility and acceptability of the intervention in terms of fidelity of trained study therapists and ratings of the intervention by participants. The usual care condition consists of a referral to a mental health provider. The intervention is comprised of four sessions of individually administered cognitive-behavioral therapy addressing health anxiety. Treatment focuses on building motivation for change, psychoeducation about health anxiety, cognitive restructuring, and situational and interoceptive exposure. The study will recruit from three primary care clinics within the Dartmouth-Hitchcock Health system. The study will also assess facilitators and barriers to implementation using qualitative analyses of interview responses provided by the medical assistants delivering the intervention, primary care providers, and clinic administrators at the study sites.
The goals of this observational study are to test the reliability of a new, standardized physical examination method to identify motion problems within joints or groups of joints among adult asymptomatic volunteers and in patients hospitalized with stroke or stroke-like episodes (e.g., transient ischemic attack, TIA). The main questions this investigation aims to answer are: * Can different, independent providers reliability quantify motion pattern problems using a systematic approach called, The Functional Pathology of the Musculoskeletal System (FPMSS) model? * Are there differences in joint(s) motion patterns among asymptomatic volunteers, patients with TIA (people with brain disease without new neurologic disability), and recent ischemic stroke (patients with new stroke-related-disability, e.g., paralysis)? * Is there an association between joint(s) motion impairment severity and stroke survivor outcomes? Participants (asymptomatic and those with stroke) will undergo a set of repeated paired, musculoskeletal physical exams by independent providers blinded to each other's assessments and patient information. Researchers will compare the severity, location, and quantity of joint(s) motion impairment between these three groups with the physical examination methodology (FPMSS). Clinical information (e.g., test results, diagnoses, brain imaging, medical history) will be collected from patients admitted for TIA and stroke. Enrolled participants with recent stroke will complete a survey three months after hospitalization to determine their self-perceived quality-of-life.
Background: Allogeneic hematopoietic stem cell transplant involves taking blood stem cells from a donor and giving them to a recipient. The transplants are used to treat certain diseases and cancers. Researchers want to see if the transplant can treat VEXAS Syndrome. Objective: To see if stem cell transplants can be successfully performed in people with VEXAS and even improve the disease. Eligibility: People ages 18-75 who have VEXAS Syndrome that has caused significant health problems and standard treatment either has not worked or is not available. Design: Participants will be screened with: Physical exam Medical review Blood and urine tests Heart and lung function tests Bone marrow biopsy Participants will have a chest x-ray. They will have an imaging scan of the head, chest, abdomen, pelvis, and sinus. They will have a bone density scan. They will have a dental exam and eye exam. They will meet with specialists. They will repeat some screening tests. Participants will be admitted to the NIH hospital. They have a central venous catheter put into a vein in the chest or neck. They will receive drugs to prepare their bone marrow for the transplant. They may have total body irradiation. They will receive the donor stem cells through the catheter. They will get other drugs to prevent complications and infections. After discharge, they must stay in the DC area for 3 months for weekly study visits. Participants will have study visits 30, 60, 100, 180, 210, 240, 300, and 360 days later. After that, they will have yearly visits for 2 years and then be contacted yearly by phone....
Background: - PIK3CA-related overgrowth spectrum (PROS) is caused by changes in the PIK3CA gene. This gene makes a protein that communicates with other proteins in the body to cause cells to grow. Alterations in PIK3CA change the chemical signals in the body and cause overgrowth in fatty, vascular and other tissues. Sirolimus is a drug that reduces the signals sent by one of the proteins in this chemical signaling pathway. Researchers want to learn whether the drug sirolimus can reduce or stabilize some of the overgrowth that patients with PROS experience. Objectives: - To measure how the overgrowth of patients with PROS changes over time and whether taking a drug called sirolimus can reduce or stabilize a person s overgrowth. Eligibility: - People ages 3 to 65 years old with a confirmed mutation or alteration of the PIK3CA gene in the person s affected tissues (a somatic mutation). Design: * Participants will be screened with medical history and genetic counseling. * First 6 months: Participants will have their overgrowth monitored. * Next 6 months: Participants will take sirolimus once or twice a day. * Participants will have to visit the clinic several times, and stay in the area for 4 to 5 days each time. * Participants will have a one month-long visit to the clinic. * During clinic visits, participants will have: * Blood and urine tests. * Photographs of their physical features. * Scans, including an MRI and DEXA, and possibly x-rays and CT scans. * For the MRI and CT scans, participants will lie in a machine that takes pictures of their body. * The DEXA involves a small amount of radiation. * They may have: * Non-invasive heart function tests. * Lung function tests. * Participants will have several blood and urine tests between visits. * Participants will complete surveys and keep a diary of their treatment and side effects. * Participants may visit other health specialists or undergo other tests based on side effects. * One month after stopping the study drug, participants will have 1 clinic visit.
The purpose of this study is to correlate the link between palpatory findings of somatic dysfunction and gastrointestinal endoscopic evidence of changes in mucosa. The investigators' hypothesis is that there is a direct connection between somatic palpatory changes and intestinal mucosal changes via a somatovisceral/viscerosomatic mechanism.
The purpose of this study is to determine if osteopathic manipulative treatment (OMT) is effective for persons with emphysema as a component of their chronic obstructive pulmonary disease.
The goal of this study is to test the feasibility and acceptability of providing an experiential assessment interview that targets emotional and stressful experiences in primary care. In this randomized, controlled trial, the investigators will compare an interview condition to a wait-list control condition. The investigators hypothesize that helping individuals first identify the links between their stress and symptoms will likely increase their awareness and endorsement of the link between stress and physical symptoms, including a willingness to engage in stress management techniques. It is also expected that helping raise an individual's awareness about their symptoms, followed by an experience and expression of unexpressed emotions is likely to influence their physical symptoms and psychological status.
This study will examine the feasibility of virtual Tai Chi Easy training for registered nurses and see if participation results in changes in symptoms of transition shock, healthcare-related psychological traumatic stress, burnout, somatic symptoms, and intention to quit. Participants will do virtual Tai Chi Easy for 2 hours per week and practice on their own for 40 minutes per week. The study will last six weeks. Surveys will be completed in REDCap before, during, and after the intervention.
This is an exploratory natural history protocol that will enroll patients with known genetic diseases, such as VEXAS syndrome, or as yet undiagnosed disorders of inflammation with the goal of improving our understanding of disease processes. Blood, saliva, hair, nail, or buccal samples may be collected for genetic analysis, blood samples will be obtained for immunologic and other functional studies, and a small number of subjects may undergo skin biopsy.
This is a phase II, open-label, prospective study of T cell receptor alpha/beta depletion (α/β TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies
Part 1 (Completed Enrollment) - The purpose of the first part of the study was to evaluate the safety of different doses and dosing regimens of oral rucaparib administered daily to patients with solid tumors. Part 2A (Completed Enrollment) and Part 2B (Completed Enrollment) - The purpose of the second part of the study is to determine the safety and clinical activity of the RP2D of oral rucaparib administered daily to patients with a known deleterious BRCA mutation (germline or somatic). Part 3 (Completed Enrollment) - The purpose of the third part of the study is to further evaluate PK of higher dose strength tablets at the RP2D in patients with any advanced solid tumor, inclusive of lymphoma, with evidence of a BRCA mutation (germline or somatic).
The aim of this clinical trial is to investigate the efficacy (by monitoring overall improvement of EB symptoms) and safety (by monitoring adverse events) of three doses of allo-APZ2-EB administered intravenously to patients with recessive dystrophic epidermolysis bullosa (RDEB).