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Discover 14,679 clinical trials near San Diego, California. Find research studies in your area.
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NCT03276936
The primary objective is to show that open-label extended treatment with FMX103 1.5%, for up to an additional 40 weeks, is safe and well tolerated.
NCT03852316
This is a multi-center study with a minimum of three sites in the United States. The study will enroll approximately 1750 female subjects, 14 years of age and older, and will have a study duration of approximately 9 months after enrollment of the first subject. Female subjects seen at the participating sites for any reason will be evaluated for enrollment in this study. All subjects will be managed per standard of care as applicable. Subjects who are enrolled in the study will perform self-collection of a vaginal swab to be tested by Click device and allow the health care provider (HCP) to collect three additional vaginal swabs to be tested by recognized FDA-cleared comparator methods. Subjects will complete the study in a single visit. The primary objective is to assess the performance of the Click device for detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) in self-collected vaginal specimens as compared to Patient Infected Status (PIS) determined by three approved comparator assays using vaginal specimens collected by a qualified HCP in support of obtaining FDA clearance. and a Clinical Laboratory Improvement Amendments (CLIA) Waiver.
NCT01978938
This is a phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy and safety of eravacycline compared with levofloxacin in participants with complicated urinary tract infections (cUTI).
NCT03557242
100 subjects in the each of the treatment arms of the study (total 200 treatment arm subjects) and up to 100 subjects in the registry arm of the study.
NCT03712124
This study evaluates CNSA-001 (sepiapterin) in the treatment of women with moderate to severe diabetic gastroparesis. Participants will be randomized in a ratio of 1:1 to receive CNSA-001 20 (milligrams) mg/kilogram (kg)/day or placebo. All participants will receive the standard of care for diabetic gastroparesis.
NCT03626012
The primary objective of this study is to evaluate the safety and tolerability of BIIB078 in adults with C9ORF72-Amyotrophic Lateral Sclerosis (ALS). The secondary objectives of this study are to evaluate the pharmacokinetic profile of BIIB078 and to evaluate the effects of BIIB078 on clinical function. As the first-in-human study, the study enrolls a small number of participants in each cohort. Every participant in a cohort is treated with the same dose or placebo. The study is designed to evaluate and confirm the safety of each dose before enrolling and exposing new participants to a higher dose in the next cohort.
NCT03730480
This study will collect lay user ("subjects") and healthcare professional information on the performance of two different blood glucose monitors, the CONTOUR NEXT and the CONTOUR TV3, in people with and without diabetes. Each subject will use both meters, at different times and in different order, using a fingerstick(s) to collect meter samples. Meter results will be compared to standardized test system to assess the accuracy of the meters' results. Additionally, a blood sample will be drawn from the subject's arm by a trained healthcare professional for testing on both BGMS. Subjects will also be asked to complete a questionnaire to rate their experience using the meters and to evaluate the meter's Instructions for Use. After all testing and the first questionnaire have been completed, the study staff will demonstrate only to subjects with diabetes several features of the meters that would not necessarily be experienced during the meter testing. These subjects will then answer questions about the features in a second questionnaire.
NCT02815280
This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.
NCT02424019
This study will assess the safety in patients treated with ILUVIEN, with primary focus on IOP.
NCT05179525
This is an Open-Label, One-Sequence Study to Evaluate the Steady- State Comparative Bioavailability of Intramuscular Risperidone ISM® and EU Risperdal® (Sourced From Germany).
NCT03268005
The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe). Fast-acting insulin aspart will be tested to see how well it works and if it is safe. Participants will get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is decided by chance. Both medicines will be taken together with insulin degludec. Participants will need to take 1 injection 4 times every day (all insulins will be provided in pens). The study will last for about 8 months (34 weeks).
NCT01265784
This is a Phase 2, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of two dose regimens of TP-434 compared with ertapenem in the treatment of adult community-acquired complicated intra-abdominal infections (cIAIs).
NCT01147666
The primary objective of this study is to evaluate the efficacy and safety of roxadustat in participants with end-stage renal disease (ESRD) on maintenance hemodialysis (HD) therapy, previously treated with intravenous (IV) epoetin alfa.
NCT03168438
This trial will evaluate safety, tolerability, and efficacy of letetresgene autoleucel (GSK3377794) with or without pembrolizumab in participants with relapsed and refractory multiple myeloma.
NCT02778204
This study aimed to evaluate the safety, tolerability, and pharmacokinetics of maraviroc in infants at risk for mother-to-child HIV transmission, and to determine an appropriate dose of maraviroc during the first six weeks of life.
NCT04039503
The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowering medications. The study will last approximately 47 weeks and may include about 23 visits.
NCT00688376
The purpose of this study is to evaluate the efficacy, safety and tolerability of donepezil in children with persistent attention impairment that is present at least 12 months after the completion of cancer treatment.
NCT03559699
Study AG348-C-007 was a multicenter study designed to evaluate the efficacy and safety of treatment with AG-348 in a minimum of 20, with up to 40, participants with pyruvate kinase (PK) deficiency, who were regularly receiving blood transfusions. The study was composed of two parts. During Part 1, Dose Optimization Period, participants started on a dose of 5 mg AG-348 administered twice daily. Over the course of Part 1 each participant's dose of AG-348 was sequentially increased to 20 mg twice a day, followed by 50 mg twice a day depending on their tolerance. During Part 2, Fixed-Dose Period, participants received AG-348 at their optimized dose from Part 1.
NCT05185232
Congenital heart defects (CHDs) are a heterogeneous group of rare diseases of varying severity, each diagnosis with its unique set of co-morbidities. In addition to the heterogeneity, perhaps the greatest challenge to conducting comparative effectiveness research in CHD patients are the poor rates of successful transition from pediatric to adult centered cardiology care and high rates of gaps in recommend care for adults with CHD. This study will use PCORnet to examine the effects of gaps in recommended care (cardiology visits) on patient prioritized outcomes for adults with non-complex and complex subtypes of CHD. This system will be established through 14 (12 recruiting) PCORnet affiliated institutions and linkage to the Congenital Heart Initiative registry (https://chi.eurekaplatform.org), the first patient powered registry for adults with CHD. This registry launched in December 2020, and is IRB approved at Children's National Hospital (IRB# Pro00014697). Funded by PCORI, this project will recruit patients at the 12 PCORnet affiliated institutions and will invite them to contribute their health records data and then join the established Congenital Heart Initiative. By enrolling patients and linking their PCORnet (health record) data into an existing adult congenital heart disease (ACHD) specific registry, future interventions to reduce gaps in care based on study findings can be rapidly implemented in real-world settings through the strong partnerships established with key CHD stakeholders.
NCT01956110
This trial investigates the effects of FE 999049 compared to GONAL-F.
