All Clinical Trials

Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements is performed using a bioprosthesis1. Durability of surgical bioprostheses varies based on the patient's age at the moment of implantation, type and size etc2. TAVI has become the preferred treatment for degenerated aortic bioprostheses in elderly patients3. The median time since index surgical aortic valve replacement (SAVR) and for bioprosthetic valve degeneration is typically 8 - 10 years4-6. TAVI in this setting has proven to have equally favorable results as in native aortic valves7. Balloon expandable8 and self-expanding9 transcatheter heart valves (THV) can be used in a degenerated bioprosthesis and each have specific assets and limitations. TAVI in a failed bioprosthesis can cause coronary obstruction, THV migration, paravalvular leakage and prosthesis patient mismatch. The SAPIEN-3 / Ultra and EVOLUT R/Pro are the 2 most commonly used THV platforms in contemporary clinical practice including treatment of failing surgical aortic bioprostheses. Objective: To compare TAVI with EVOLUT R/Pro vs. SAPIEN-3 / Ultra in terms of device success. Study design: International multi-center randomized study with 1:1 randomization to TAVI with SAPIEN-3 / Ultra or Evolut R/Pro. Study population: 440 patients with a failing surgical aortic bioprosthesis (aortic stenosis with or without aortic regurgitation) and selected for transfemoral TAVI by heart-team consensus. Investigational intervention: Transfemoral TAVI with SAPIEN-3 / Ultra or Evolut R/PRO Main study parameters/endpoints: 1. Primary endpoint is device success at 30 days Defined by * Absence of procedural mortality AND * Correct positioning of a single prosthetic heart valve into the proper anatomical location AND * Intended performance of the prosthetic heart valve (no severe prosthesis- patient mismatch and mean aortic valve gradient \< 20 mmHg or peak velocity \< 3 m/s, AND no moderate or severe prosthetic valve regurgitation). Severe prosthesis patient mismatch is defined by effective orifice area (EOAi) ≤0.65 cm2/m2 2. Safety endpoint at 1 year defined by the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems. Read Less

Horizon Outreach has developed the Horizon Eagle Fatherhood Program (HEFP). HEFP includes a program/services aspect, but also includes a rigorous evaluation component, featuring a randomized control trial (RCT) research design. The evaluation will determine the effect of the Horizon Eagle Fatherhood Program with fathers aged 18 and up in Houston, Texas. Specifically, the research is examining the effects of the program relative to: (1) improvement in healthy relationship and marriage skills, (2) improvement in parenting skills, (3) improvement in conflict resolution and anger management skills, and (4) improvement in financial management skills and progress toward greater economic stability. Program participants will be randomly assigned to either the intervention group or the control group. Participants assigned to the intervention group will receive the program now. Participants assigned to the control group will have an opportunity to receive the program later. All participants (intervention and control) will complete a pretest questionnaire. Intervention participants will then participate in the Horizon Eagle Fatherhood program. This is an intensive 40-hour classroom-based program taught by project staff. Both intervention and control participants will receive case management services. Following completion of the program by the intervention participants, all participants will complete a posttest questionnaire. After completion of the posttest, all participants will have an opportunity to participate in a workforce training program. Six months following posttest, all participants will complete a third questionnaire. In addition, a selected number of participants will participate in focus groups. After completing the six-month follow-up questionnaire, participants from the control group may participate in the 40 hours of classroom instruction, should they choose to do so. This RCT research design component of the Horizon Eagle Fatherhood Program began in June of the second project year. Prior to the start of the RCT, a pilot/readiness project with no control group was conducted. This was followed by a short-term pilot of the RCT. Read Less

The study evaluates the effect of theophylline in 100 subjects with Pseudohypoparathyroidism. Read Less

This is an investigator-initiated study that is in the funding range for a grant from the NIH. This study is testing the possibility that non-invasive brain stimulation (ESSTim) would be superior to sham in the treatment of pain secondary to diabetic neuropathy. Read Less

Bardet-Biedl Syndrome (BBS) is a rare genetic disorder associated with a vast array of symptoms. The features of BBS are highly variable, even between siblings, making long-term follow-up and centralization of information vital to better understanding this complex disease and designing effective treatments. Marshfield Clinic has developed the Clinical Registry Investigating Bardet-Biedl Syndrome (CRIBBS) to gather comprehensive health information from patients diagnosed with BBS in a single repository. This information will be used to inform patients, families, and physicians about the complex features of BBS and will serve as a platform for researchers to develop effective and targeted treatment strategies for patients with BBS. CRIBBS is a web-based, confidential database and the privacy of patients enrolled in the registry will always be respected. Information maintained in the database will be identifiable only by an assigned study identification number, not by name. The registry strictly complies with HIPAA regulations. CRIBBS participants may be contacted periodically with information regarding clinical trials or research studies, but participation is entirely voluntary. CRIBBS will bring together complex genetic and clinical information from BBS patients to accelerate research into effective treatments, attract additional researchers, and make it easier for researchers to identify patients and find funding for innovative studies. Read Less

Investigators will determine the long-lasting effects of post-acute rehabilitation after traumatic brain injury and stroke. Investigators will also evaluate if the beneficial effects of rehabilitation continue after discharge from a rehabilitative program. Read Less

A first-in-human study using BIO-106 as a single agent and in combination with pembrolizumab in advanced cancers. Read Less

Study Description: This protocol will be utilized for the creation and management of a repository of coded clinical data on patients with Telomere Biology Disorders (TBDs) submitted by researchers from CCCTAA member institutions. Objective: The primary objective of this study is to develop a shared database (repository) of coded clinical research data, managed by NCI, to facilitate collaborative research across CCCTAA member institutions. Read Less

This is a multi-center randomized controlled evaluator-masked trial designed to compare metagenomic deep sequencing (MDS) versus standard of care testing for improvement of outcomes for intraocular infections. Patients with presumed intraocular infections who meet the eligibility criteria will be randomized to receive MDS testing results or not to receive MDS testing results. All patients will receive standard-of-care testing to guide management. Enrolled patients will be followed at week 2, week 3-6 (randomization visit), and at 4 weeks after the randomization visit. The proportions of patients who received the appropriate therapy and the proportions of patients with improved outcome will be compared between arms. Patient quality of life, MDS performance, and the provider certainly of belief will be collected. Read Less

Our goal is to enhance repeated exposure to acute intermittent hypoxia (rAIH)/training-induced aftereffects on upper and lower limb function recovery in humans with chronic spinal cord injury (SCI). Read Less

Moms will call and agencies will determine if she is eligible based on basic criteria. If she is eligible, the agency will send her an intake application link to complete, which includes a consent form. After completing the survey, if she is still eligible, she will be placed on a waitlist for services. When a bed becomes available in an individual agency, the agency will call two moms at the top of the waitlist, conduct in-person interviews to confirm eligibility and good fit. They will use a computer to randomly assign one to treatment and one to control. Agency will let moms know of their status and will allow the treatment mom to move in. Moms in treatment and control will be surveyed approximately one year post the mother's reported due date of the child. Read Less

Endoscopic retrograde cholangiopancreatography and endoscopic ultrasound are increasingly being used to manage complex disease of the bile duct, pancreas and cancer. Gastroenterology patients at the Los Angeles County Hospital presents a unique and diverse patient population. Our aim is to study the biochemical, radiographic, and clinical predictors of bile duct stones. Exploratory aims include the study of the management of cholangitis, bile leaks, GI cancer diagnosis and management, and the management of pancreaticobiliary problems in the underserved. All patients managed by EUS or ERCP at the LA County \& USC University Hospitals will be enrolled in the databaseThe timing, clinical presentation, and objective details of patient presentation are recorded prospectively. Additionally the results of the subsequent ERCP and EUS procedures. Subsequent, clinical course and pathology will also be recorded. Read Less