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NCT03893825
The primary objective of the study is to evaluate the long-term safety and tolerability of TV-46000. The primary safety and tolerability endpoint is the frequency of all adverse events, including serious adverse events. For new participants, the total duration of participant participation in the study is planned to be up to 80 weeks (including a screening period of up to 4 weeks, a 12-week oral conversion/stabilization stage \[Stage 1\], a 56-week double-blind maintenance stage \[Stage 2\], and a follow-up period \[8 weeks\]). For roll-over participants, the total duration of participant participation in the study is planned to be up to 64 weeks (including up to 56 weeks in the maintenance stage \[Stage 2\] and a follow-up period \[8 weeks\]). Participants who started Stage 2 who relapse or meet 1 or more of the withdrawal criteria should be invited to perform the Early Termination visit as soon as possible within 4 weeks of the last injection. Participants who withdraw from the study before completing the 56-week maintenance stage will have follow-up procedures and assessments performed at their follow-up visits. During the follow-up period, participants will be treated according to the investigator's judgment. All participants will be treated with active drug.
NCT01412905
Objective: To test the accuracy of a referral system for diabetic eye disease conducted by a trained screener using a digital camera, a mobile medical unit and a centralized image-storing software in underserved, ethnically diverse neighborhoods in San Diego. Methods and Research Design: Retinal screening exams were offered at 8 community health centers for 1229 individuals, ages 16-80 years with diabetes throughout San Diego County over 18 months. Images were captured with a special digital camera, securely transferred to a software system and read independently by a trained technician and retinal specialist. An analysis was conducted to evaluate who had severe eye disease and how accurate the reading of the technician were compared to the expert ophthalmologist readings. The investigators would like to demonstrate that telemedicine retinal screening utilizing a mobile medical unit with a trained technician in high-risk, ethnically diverse populations can accurately detect positive and negative disease. This may be a model to increase access to retinal examination in order to meet current guidelines and can allow more efficient use of the retinal specialist to evaluate and treat disease leading to a more cost efficient method of care.
NCT02506244
The purpose of this study is to investigate whether it is possible to identify a high-risk cohort suitable for screening for asymptomatic atrial fibrillation using claims data, and then engage those individuals in a mobile health technology-enabled home monitoring program in order to document previously undiagnosed atrial fibrillation, and provide clinical evidence of an outcomes benefit associated with this early detection.
NCT00660673
The primary objective of this study is to provide continued access to levodopa-carbidopa intestinal gel (LCIG), to participants who have already participated in an open-label efficacy and safety study with the same treatment (Study S187.3.003 \[NCT00360568\] or Study S187.3.004 \[NCT00335153\]).
NCT01081912
The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain.
NCT03811912
This study will evaluate the efficacy and tolerability of once-daily versus twice-daily dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata.
NCT01879319
The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in a home-use setting using either an automated mini-doser (AMD) or autoinjector/pen (AI/pen).
NCT00062816
The purposes of this Phase 1/2 study are to examine the safety, tolerability, and antiviral activity of ISIS 14803, when given in combination with peginterferon alfa and ribavirin, to patients who either failed to have at least a 100-fold HCV reduction at Week 12 of standard therapy or still have detectable HCV at Week 24.
NCT02703272
The purpose of this study is to confirm that the pharmacokinetics of ibrutinib in pediatric participants is consistent with that in adults (part 1) and to assess efficacy (event-free survival \[EFS\]) of ibrutinib in combination with rituximab, ifosfamide, carboplatin, and etoposide (RICE) or rituximab, vincristine, ifosfamide, carboplatin, and idarubicin (RVICI) background therapy compared to RICE or RVICI background therapy alone (part 2).
NCT03208985
This study is designed to assess whether consumers select and use ella® (ulipristal acetate 30mg), an emergency contraceptive, in a manner consistent with the OTC package directions in an OTC-like setting.
NCT02081248
The study has two parts: (1) Randomized Study to evaluate the effectiveness of ETRIC, and (2) Evaluation Study to understand barriers to implementation of ETRIC.
NCT03090737
A study to evaluate the safety of Nivolumab in participants with advanced or metastatic non-small cell lung cancer
NCT03134833
The focus of this study (Engaging Seronegative Youth to Optimize HIV Prevention Continuum) - will be to stop HIV-related risk acts and to encourage youth at high risk for HIV to adopt antiretroviral medications as treatment and prevention (either pre exposure prophylaxis (PrEP) or post exposure prophylaxis) among gay, bisexual and transgender and/or homeless youth with contact with the criminal justice system in the HIV epicenters of Los Angeles and New Orleans. A cohort of 1500 youth at the highest risk of seroconverting over 24 months will be identified. The goal will be to optimize the HIV Prevention Continuum over 24 months. The proposed randomized controlled trial (RCT) aims to compare youth outcomes when randomized to one of four automated and person-mediated social media delivered intervention conditions: 1) Automated Messaging and Monitoring Intervention (AMMI) only (n=900) consisting of daily motivational, instructional, and referral text-messaging (SMS), and brief, weekly SMS monitoring surveys of outcomes; 2) Peer Support through social media plus AMMI (n=200) via private online discussion boards; 3) Coaching plus AMMI (n=200) to provide service linkages, eligibility support, appointment coordination and follow-up, communication with healthcare providers, and brief motivational and strengths-based counseling for linkage and retention to prevention, mental health, and substance abuse services; and, 4) Coaching plus Peer Support and AMMI (n=200).
NCT02657889
This Phase 1/2 study will evaluate the safety and efficacy of combination treatment with niraparib and pembrolizumab (MK-3475) in patients with advanced or metastatic triple-negative breast cancer or recurrent ovarian cancer. (KEYNOTE-162)
NCT04527328
This study will evaluate the tolerability, feasibility, and efficacy of the AKST1210 column in subjects with end-stage renal disease with cognitive impairment (ESRD-CI) undergoing hemodialysis 3 times per week.
NCT01362595
This study will determine the safety and possibility of giving the amino acid, leucine, in patients with Diamond Blackfan anemia(DBA)who are on dependent on red blood cell transfusions. The leucine is expected to produce a response in patients with DBA to the point where red blood cell production is increased. Red cell transfusions can then be less frequent or possibly discontinued. The investigators will study the side effects, if any, of giving leucine to DBA patients. Leucine levels of leucine will be obtained at baseline and during the study. The drug leucine will be provided in capsule form and taken 3 times a day for a total of 9 months.
NCT03833128
The purpose of this Phase 1b study is to assess REN001 safety in subjects with fatty acid oxidation disorders.
NCT03241186
This is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered Day 1 of a 21-day cycle in Cycles 1-4 and then nivolumab 480 mg will be administered Day 1 of a 28-day cycle for Cycles 5-15 (maximum of 15) or until disease recurrence or intolerance before completion of 15 cycles.
NCT01998633
HLH, HLH-related disorders, Chronic Granulomatous (CGD), HIGM1, Immune dysregulation, polyendocrinopathy, enteropathy, and X-linked inheritance (IPEX) and severe LAD-I represent primary immune disorders that are typically fatal without Hematopoietic Cell Transplant (HCT). However, transplant is often complicated by inflammation, infection and other co-morbidities. In addition, these disorders have been shown to be cured with partial chimerism, making them an ideal target for the use of reduced intensity approaches, where a portion of patients may not achieve full donor chimerism, but instead achieve stable mixed chimerism. Reduced-intensity conditioning strategies have demonstrated improved survival with decreased Treatment Related Mortality (TRM) in institutional series for patients with HLH (Cooper et al., 2006; Marsh et al., 2010; Marsh et al., 2011). However, graft loss and unstable chimerism remain challenges. An institutional case series from Cincinnati Children's Hospital demonstrated full or high-level chimerism and improved durable engraftment using intermediate (Day -14) timing alemtuzumab (Marsh et al., 2013b). This study aims to test the efficacy of the Intermediate RIC strategy in a prospective multi-center study including HLH as well as other primary immunodeficiencies where allogeneic transplant with RIC has been shown to be feasible and stable chimerism is curative.
NCT05387642
This is a 2-part clinical trial to evaluate the safety, tolerability, pharmacokinetics, and efficacy of PRAX-114 in participants with essential tremor (ET). Part A is a randomized, double-blind, placebo-controlled, three-period, three-sequence, crossover design where participants will receive a single dose of 10 mg PRAX-114, 20 mg PRAX-114, and matching placebo. Part B is an open-label design where participants from Part A, after washout and confirmation of eligibility may elect to participate in Part B where all participants will receive 10 mg once every morning (QAM) for the first 14 days. Based on investigator judgement of the safety and tolerability, the dose for Days 15 to 28 could be increased to 20 mg QAM.