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Discover 14,679 clinical trials near San Diego, California. Find research studies in your area.
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NCT02730351
This is a multicenter, randomized, double-blind, double-dummy, crossover study with two 2-week treatment periods separated by a 2-week wash-out period. Subjects will participate in up to eight study visits and have a follow up phone call approximately a week after the last clinic visit. Visits 1, 2, 3, 5 and 6 are evening visits that will be conducted between 5PM and 11PM. Visit 4 and Visit 7 are also evening visits that will begin between 5PM and 11PM and continue over a period of approximately 24 hours. Subjects will be required to attend three clinic visits during this 24-hour period. An exercise challenge (using a treadmill) will be conducted at Visit 2, Visit 3 and Visit 6 (after 23 hours of the first treatment dose in each Treatment Period); and at 12 and 23 hours post evening dose at Visits 4 and 7. Spirometry will be conducted at specified visits and prior to and after each exercise challenge. Subjects with symptomatic allergic rhinitis at Visit 1 (screening) may be treated for up to four weeks with intranasal corticosteroids followed by a repeat screening visit to determine eligibility prior to entry into the study. Eligible subjects at visit 1 will complete a 4-week single blind run-in on FP 250 microgram (mcg) twice daily (BID), followed by 2-week double-blind Treatment Period 1 on randomized treatment, a 2-week single blind washout period on FP 250 mcg BID, 2-week double-blind Treatment Period 2 receiving the alternative treatment, and follow-up contact approximately 7-days after completing Treatment Period 2. The total duration of study participation is approximately 11 weeks; and up to 15 weeks for subjects with Symptomatic Allergic Rhinitis. The primary objective of the study is to evaluate the protective effect of fluticasone furoate/vilanterol (FF/VI) 100/25 mcg once-daily compared with fluticasone propionate (FP) 250 mcg twice-daily against exercise-induced bronchoconstriction in adolescent and adult subjects aged 12 to 50 with persistent asthma. ELLIPTA, ACCUHALER, and DISKUS are registered trademarks of the GlaxoSmithKline group of companies.
NCT02566278
The investigators hypothesis is that upper airway collapsibility (Pcrit) in patients with obstructive sleep apnea (OSA) can be measured using equipment found in the clinical sleep laboratory and these Pcrit measurements obtained using clinical sleep laboratory equipment is comparable to those obtained using research equipment. OSA is a common disease characterized by repetitive collapse of the upper airway during sleep, leading to hypoxemia and arousals, and which has important neurocognitive and cardiovascular consequences. The single most important factor in the development of OSA is upper airway collapsibility: those with a more collapsible upper airway tend to have OSA while those with a stiffer upper airway do not. The gold standard treatment for OSA is continuous positive airway pressure (CPAP), which acts by stenting open the collapsible airway. Upper airway collapsibility can be measured during sleep by changing the CPAP level and assessing the change in inspiratory flow through the upper airway. Although technically feasible, these measurements are typically only undertaken in research laboratories with specialized equipment. The purpose of this study is to measure upper airway collapsibility using clinically available (i.e. equipment found in a clinical sleep laboratory) equipment only. If successful, upper airway collapsibility could be routinely measured in clinical practice, which could help inform treatment decisions and help individualize therapy for OSA.
NCT02699138
Obstructive sleep apnea (OSA) has traditionally been attributed only to a collapsible upper airway. However, it is increasingly recognized that multiple additional non-anatomical mechanisms contribute to the disease. Higher rates of OSA in patients with post-traumatic stress disorder (PTSD) than in those without PTSD have been reported however the mechanism behind this increased prevalence has not been investigated. Our hypothesis is that patients with PTSD have a predisposition to OSA due to a lower respiratory arousal threshold (wake up too easily) than patients without PTSD. The goal of this project will be to study and compare the ArTH in patients with PTSD and those without. In addition, we plan to see whether medications can be used to increase the arousal threshold and treat OSA in patients with PTSD.
NCT02512419
The aim of this study is to build upon our tailored print intervention by developing new text-delivered intervention materials to complement our print-based physical activity (PA) intervention. In Phase 1 we will conduct 6 focus groups with Mexican and Mexican American (MA) men to determine content, frequency, and types of text messages desired, and to identify cultural themes to incorporate into existing and new materials. Themes from the focus groups and sample text messages will be presented to a confirmatory focus group panel. Phase 2 will be a 6-month pilot randomized controlled trial with Mexican and MA men (N=60) to test the text-enhanced, Spanish language, individually tailored PA intervention vs. publicly available, Spanish language health education materials, including information on PA, diet, and stress management. This will be followed by post-intervention qualitative interviews to solicit suggestions for improvements to help further refine the program. The proposed pilot will support a future R01 to establish the efficacy of this multi-media, multi-level PA intervention for Mexican and MA men.
NCT02508259
This study is designed to test the safety and efficacy of a single, intravenous dose of suramin in autism spectrum disorders (ASD).
NCT01754038
This registry will perform prospective surveillance of participants attending collaborating Integrative Medicine clinic sites for clinical services. All decisions about medication use, treatments, visit frequency, assessment of tolerance, and other aspects of patient management will be left to the clinical providers' discretion. We will attempt to follow the participants in the PRIMIER Registry for up to 2 years. Essential data elements that capture patient-reported outcomes and measures of clinical activity will be obtained at approximately 2-month intervals for the first 6 months, then every 6 months through the end of year 2.
NCT02159365
To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible and safe.
NCT00910910
The purpose of this study is to determine the safety and efficacy of lenalidomide as a first line therapy in treating patients with B-cell Chronic Lymphocytic Leukemia. This study will compare the effects (good and bad) of lenalidomide with chlorambucil.
NCT03814733
Based on the pharmacological class of rapastinel, this study will be conducted to evaluate the participant's driving performance after single IV doses of rapastinel as compared with single oral doses of alprazolam, a benzodiazepine that demonstrates driving impairment, and placebo in healthy participants.
NCT01282424
The primary objective will be to assess the overall response rate and to evaluate the efficacy and safety of idelalisib (IDELA; GS-1101) in participants with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg taken twice per day. Treatment with idelalisib can continue in compliant participants as long as the study is still ongoing and the participants appear to be benefiting from treatment with acceptable safety.
NCT00058058
RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may improve the ability to detect cancer in the unaffected breast of women recently diagnosed with unilateral breast cancer. PURPOSE: Diagnostic trial to determine the effectiveness of MRI in evaluating the unaffected breast of women recently diagnosed with unilateral breast cancer.
NCT03239223
This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.
NCT03676231
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, pharmacokinetics, and pharmacodynamics of 12 weeks' administration of SGM-1019 in subjects with fibrosis stage 1-3 (F1-F3) NASH.
NCT02210273
The SUCCESS Trial is designed to determine whether the Solace Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.
NCT02023697
This study will assess different doses and regimens of radium-223 dichloride on the incidence of symptomatic skeletal events. Eligible subjects must have castration resistant prostate cancer with 2 or more skeletal metastases documented within 8 weeks of randomization. Subjects will be randomized to one of 3 treatment arms in a 1:1:1 fashion: a standard regimen of radium-223 dichloride of 50 kBq/kg (55 kBq/kg after implementation of NIST update) injections every month for 6 months, a high dose regimen of 80 kBq/kg (88 kBq/kg after implementation of NIST update)injections every month for 6 months or an extended duration regimen of 50 kBq/kg (55 kBq/kg after implementation of NIST update) injections every month for 12 months. Following the treatment phase, subjects will be followed up every 12 weeks for a minimum of 2 years, at which point they will enter a long term follow-up period during which they are seen every 6 months for up to 7 years after the last dose of radium dichloride. Symptomatic skeletal event and safety endpoints will be assessed at each clinic visit. Pain and analgesic use data will be collected every 4 weeks through Week 48. Additionally, radiological assessments including MRI/CT of the abdomen and pelvis and chest CT, as well as technetium-99 bone scans will be performed at Weeks 8, 16, and 24 and continue every 12 weeks thereafter until disease progression is documented in either the bone or in soft tissue. Radiological imaging will be evaluated by blinded central review.
NCT01832610
Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation.
NCT01131260
The purpose of this research is to test a new instrument, called a fetal STAN monitor, that may be used during labor to monitor the electrical activity of the baby's heart. This new instrument is designed to help the doctor determine how well the baby is doing during labor. It will be used along with the existing electronic fetal monitor used to measure the baby's heart rate and the mother's contractions during birth. The specific purpose of this research study is to see if this new instrument (fetal STAN monitor) will have an impact on newborn health.
NCT01636882
This is an extended use study for patients who have received 10 doses of CAVATAK™ in the VLA 007 trial. There may be patients who have benefitted from the study drug and who might benefit from further treatment. In order to accommodate those patients further treatment to complete 48 weeks of CVA21 intratumoral injections will be made available.
NCT02926209
This will be a prospective multi-center, multi-national comparative non-blinded clinical investigation. Each subject will undergo back-to-back tandem colonoscopies with the Aer-O-Scope Colonoscope System and a conventional colonoscope since this is a tandem colonoscopy study, each subject will serve as their own control. The 1st procedure will be randomized, half to Aer-O-Scope Colonoscope System and half to conventional colonoscope. The same investigator will perform both procedures on each subject. All pathologies found will be either removed or tattooed. Unmarked pathologies found on second pass will represent those missed during the 1st pass, thus making the subject and the control one and the same. Tattooed pathologies that can be removed endoscopically will be removed in an additional colonoscopy. This may occur if a large polyp cannot be removed for any reason with the Aer-O-Scope, but can be removed with conventional colonoscopy.
NCT03267264
This is a multi-site, prospective, open-label, randomized, 2 period cross over study comparing the subjects' current 32G pen needle (four groups of pen needles) to the BD Nucleus pen needle. The study will consist of two 15 day periods ( in which the subject will use each pen needle \[BD Nucleus pen needle or subject's current pen needle, order randomized\] for injection. At the end of the last study period, each subject will be asked to evaluate his or her perceptions using a 150mm relative VAS scale.
