California Paid Clinical Trials

The goal of this clinical trial is to learn if ABX-002 added to an existing antidepressant treatment will benefit depression symptoms in adults with moderate to severe major depressive disorder who have had an inadequate response to their antidepressant. This is a double-blind, placebo-controlled, 2-arm, parallel-group, Phase 2 study, randomized 1:1 (ABX-002: placebo). The study will include the following stages: 1. Screening, Treatment, and Follow-Up ; approximately 35 days 2. 42-day Treatment Period 3. 2-week post dose Safety Follow-up Period Read Less

The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of tinlarebant in subjects with Stargardt Disease Read Less

Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-106. Read Less

More than 10% of the US population have obstructive sleep apnea (OSA). Standard of care is therapy with CPAP (continuous positive airway pressure) which virtually eliminates OSA. However, most patients use CPAP only for part of the night (4-5hours) and about 50% patients discontinue CPAP long-term. Alternative therapies are limited, thus many OSA patients remain at risk of OSA sequelae (e.g. sleepiness, memory issues, high blood pressure, etc.). Importantly, different patients get OSA for different reasons, and recent data show that some of the underlying causes of OSA ("endotypes") such as having a low arousal threshold (i.e. waking up easily) are associated with lower CPAP adherence. Using a randomized controlled trial design, this will be the first study using a targeted intervention to manipulate the underlying OSA causes (i.e., giving a safe hypnotic to patients with OSA to increase the arousal threshold) to test the hypothesis that endotype-targeted therapy increases CPAP-adherence in patients who have low but continued CPAP usage. Ultimately, this strategy may improve the care and outcomes of millions of undertreated OSA patients. Read Less

This Phase 3, multicenter, double-masked, parallel-group, placebo-controlled, randomized, fixed-dose clinical study is designed to evaluate the efficacy and safety of tinlarebant (LBS-008) in subjects diagnosed with GA. Read Less

This is a multi-arm, randomized controlled, pilot study which will recruit cancer patients who have been seen by a UCSF Cancer Center-affiliated clinical department to evaluate the efficacy of "CareConnect". This is the first study to assess the efficacy CareConnect, a combination of the Ask-Advise-Connect (AAC) with an Interactive Voice Response (IVR) delivering cancer-targeted educational messages to support referral to smoking cessation resources for patients with cancer. Read Less

Constipation affects 12-19% of Americans. Pelvic floor dyssynergia is considered to play an important role in constipation but the underlying mechanisms are not well understood in individual patients. The investigators have developed a novel device named Fecobionics that provide detailed mapping of physiological parameters during defecation. The aim of the study is to use Fecobionics to assess anorectal function in dyssynergia patients and monitor and predict the outcome of the biofeedback therapy. Read Less

Obstructive sleep apnea (OSA) is a severe type of snoring causing people to choke in their sleep. It affects millions of Americans, causing many health problems. For example, patients with OSA often feel very sleepy and are at risk of falling asleep while driving. OSA also causes elevated blood pressure increasing the risk for heart attacks and strokes. Patients with OSA are often treated with a face-mask that helps them breath at night but can be difficult to tolerate. In fact, about half the patients eventually stop using this mask. Because there are few other treatments (and no drug therapy), many OSA patients are still untreated. Of note, especially young adults (i.e. 18 to 50 years old) benefit from treating their OSA, but they are also less likely to use the mask. Acetazolamide (a mild diuretic drug) has been used for over 50 years to treat many different conditions and is well tolerated. Recent data suggest, that acetazolamide may help OSA patients to not choke in their sleep and lower their blood pressure. Especially young adults with OSA are likely to respond well to this drug. Further, its low cost (66¢/day) and once- daily dosing may be particularly attractive for young OSA patients unable or unwilling to wear a mask each night. But previous studies had many limitations and did not focus on young adults. The goal of this study is to test if acetazolamide can improve sleep apnea and cardiovascular health in young adults with OSA (18-50 years old), and how it does that. Thus, we will treat 46 young OSA patients with acetazolamide or placebo for 2 weeks each. The order in which participants receive the drug or placebo will be randomized. At the end of each 2 week period we will assess OSA severity and cardiovascular health. Thus, this study will help assess acetazolamide's potential value for OSA treatment, and may also help to identify patients who are most likely to respond to acetazolamide (including select individuals \>50 years of age). Ultimately, this work promises a drug therapy option for millions of OSA patients who are unable to tolerate current treatments. Read Less

The goal of this randomized intervention study is to learn about effective health literacy teaching methods in Justice Involved Adults (JIA). Researchers will compare coach-guided health literacy or self-study design to see if there is a difference in the access and use of healthcare in this population. The main questions it aims to answer are: * Will this improve access and use of heath services? * Will this improve health insurance coverage and long term use of health services? Participants will: * Meet with a health coach and service navigator during 12 sessions or meet with service navigator and complete online training over 12 weeks. * Complete surveys at different time (6months, 1 year) Read Less

Transthyretin cardiac amyloidosis (ATTR-CA) is a relentlessly progressive disease that can progress to end stage heart failure, at which point recently approved transthyretin production silencing or structure stabilizing therapies provide no clinical benefit. For well-selected individuals, heart transplantation is an excellent therapeutic option to improve survival. Historically, concomitant liver transplantation has been used to halt the progression of non-cardiac transthyretin amyloidosis (ATTR) manifestations, especially for individuals with TTR genotypes associated with significant neuropathy. However, despite this, patients continue to experience progressive non-cardiac manifestations, particularly gastrointestinal and neuropathic, which can have a substantial influence on post-heart transplantation morbidity. Concomitant liver transplantation is also associated with substantial morbidity and its future therapeutic role is questionable with recently established therapies for ATTR. Therefore, there is a clear unmet need to determine the utility and safety of ATTR targeted therapies for patients with recent heart transplantation for end-stage ATTR-CA. The central hypothesis of this proposal is that in patients who have received a heart transplantation for end-stage ATTR-CA, tafamidis therapy will be efficacious and well-tolerated. We aim to determine the safety and efficacy of tafamidis in stable patients who have undergone heart or combined heart/liver transplantation for ATTR (wild-type or variant) cardiac amyloidosis. The proposed study will be a single-arm intervention clinical trial with tafamidis. Because of the efficacy of tafamidis for both variant ATTR-CA and wild-type ATTR-CA, there is no clinical equipoise for an inactive-comparator placebo arm. The primary endpoint of this study will be serial change in plasma transthyretin (TTR) levels from baseline to 12 months at 3-month intervals. The secondary endpoints of this study will include serial changes in neuropathy assessments, modified body mass indices, incident transplant-specific adverse events, and pharmacokinetics of tafamidis. Observations from this study will establish the role of tafamidis use for the management of ATTR in patients after transplantation for end-stage ATTR-CA. Read Less

The objective is to determine the length-tension properties of the anal sphincters using Fecobionics in normal subjects and FI patients during anal distension and during simulated evacuation. Fecobionics has the consistency and shape of normal stool and can record pressures, cross-sectional area, orientation and viscoelastic properties of the anorectum and can map the geometric profiles during evacuation, and thereby provides multi-dimensional measurements of pressures, deformability, and topographic changes. Fecobionics combines several existing tests to provide novel insight into anorectal function. The purpose for the development was to overcome the technological controversies and disagreement between various tests and unphysiological test conditions. The aim was to imitate defecation as much as possible to the natural process. Fecobionics was developed to simulate stool and to provide the driving pressure and resulting deformations of stool along with a measure of an objective anorectal angle during defecation in a single examination. Fecobionics makes it possible to describe objectively, without disturbing the defecation process, the opening characteristics and pressure signatures during initial entry into the relaxing anal canal. The overall goal is to provide mechanistic understanding of defecation in health and defecatory disorders. It exceeds previous attempts to make artificial stool for evaluation of defecation (BET and FECOM) and integrates other technologies as well. It was designed to have a consistency and deformability of Type 4 (range type 3-5) on the Bristol stool form scale. The range from types 3-5 is found in 70% of normal subjects. A major novelty is that Fecobionics measures pressures in axial direction; i.e., in the flow direction. Read Less

The incidence of moderate to severe congenital heart disease (CHD) in the United States is estimated to be 6 per 1000 live-born full term infants. Recent advances in pediatric cardiology, surgery and critical care have significantly improved the survival rates of patients with CHD leading to an increase in prevalence in both children and adults. Children with CHD significant enough to require cardiac surgery frequently also undergo non-cardiac surgical procedures. Analysis of the Pediatric Health Information System database between 2004 and 2012 demonstrated that 41% of children who had undergone surgery to correct CHD in the first year of life also underwent at least one non-cardiac surgery by age 5. With this increased demand for non-cardiac procedures, anesthesiologists, pediatricians and other healthcare providers will encounter patients with repaired or unrepaired CHD and other cardiac diseases in their practice. However, the information provided by national databases lack granularity and the information from single institutional data is limited. This project aims to address this knowledge gap in quantifying the risk for cardiac patients coming for noncardiac procedures and identify the health care resource utilization and system to best care for this patient population. To conduct this study, we will create a multi-institutional collaboration between large and small centers to create a unique dataset spanning all the different variables that need to be considered in risk prediction for these patients including patient variables, hospital setting, and providers. The aggregate multiinstitutional data set may be used for benchmarking for national quality improvement efforts. Read Less