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NCT00113165
This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of partial seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.
NCT00097799
This study was designed to provide early access to and evaluate the safety of TPV/r in PI-experienced patients with HIV-1 infection.
NCT01537679
The purpose of this study is to determine whether meditation will reduce stress and depressive of adult caregivers of a person with dementia.
NCT01778153
The purpose of this study is to compare the Equinox Personal Coaching exercise training method to self-directed exercise training in helping subjects become more fit. Men between 30 and 44 years of age who exercise on a regular basis and are interested in receiving Equinox personal training will be invited to participate. The investigators will enroll 36 subjects at University of California, Los Angeles (UCLA), the only site. The hypothesis of this study is that subjects randomized to the Personal Coaching Method will result in significantly greater lean mass accrual than those randomized to self-directed training over the 12 weeks of the study. Subjects will have 2 Baseline visits over 1 week, then be randomized to receive either Coached training or self-training, which they will do for 12 weeks, then complete two End of Study visits over the final week. Visits 1 and 3 include questionnaires, skinfold fat/lean body mass measurements, and strength and aerobic performance tests, and will take place at Equinox. Visits 2 and 4 include a DEXA scan and ECG, which will take place at UCLA.
NCT01641146
HIV continues to spread among Black men who have sex with men (MSM), but few interventions target high-risk Black men who have sex with men and women (MSMW). Black MSMW with histories of childhood sexual abuse (CSA) may be an especially vulnerable population for: a) high-risk sexual behaviors; b) negative psychological sequelae (e.g., depressive or posttraumatic stress disorder (PTSD) symptoms); and c) neurobiological abnormalities in cardiovascular, neuroendocrine and/or immune systems (e.g., cortisol and norepinephrine), and HIV/AIDS progression. The purpose of this study was to test an HIV risk reduction intervention, guided by the Social Learning Theory, the Ecological Model, and the concept of allostatic load, a composite of the cumulative effects of stress on biological systems including psychoneuroimmunologic markers. The investigators tested the 6-session Enhanced Sexual Health Intervention for Men (ES-HIM) on 88 non-gay identifying HIV-positive Black MSMW with histories of CSA. The outcomes were to reduce high-risk sexual behaviors (i.e., unprotected anal and vaginal sex and number of sex partners) and negative psychological symptoms of depression and PTSD. Links between these outcomes and biomarkers of stress were also explored. Randomization to either the ES-HIM or a health promotion control group occurred with study participants assessed at baseline, post, 3- and 6-months.
NCT00651495
Chronic diseases are the primary cause of morbidity and mortality for older Americans. Active patient participation in treatment decision-making has the potential to significantly improve outcomes in chronic disease care, but interventions to increase participation remain underused. Some studies have found that older individuals are less interested in participating in clinical decision-making, but other studies find that exposing patients to decision aids (PtDAs) increases their desire to take an active role in making decisions with their physicians. The present study targets hard-to-reach seniors by showing decision aids focused on chronic disease management in senior centers. Decision aids will be made available in two senior centers through a lending library and by conducting group screenings of the decision aids followed by moderated discussion of the content with participants. A randomized encouragement design will be used to test the effectiveness of a modest financial incentive on increasing seniors' participation in group screenings. The investigators will evaluate the effects of the intervention on seniors' decision-making role preferences, attitudes, perceived social norms and self efficacy for asking questions of their physician, health-related quality of life, physical activity, and changes in prescribed treatment regimens and self-care.
NCT01158508
Rupture of brain aneurysms is a common cause of death and disability, accounting for as many as 10% of stroke cases in the United States. While much of the resulting injury to the nervous system is caused by the initial bleeding from the aneurysm, many of these patients develop cerebral vasospasm, pathological constriction of the blood vessels supplying the brain, several days following hemorrhage. As many as a third of patients can suffer a resulting neurological deficit and stroke, presumably caused by the decreased blood flow to the brain (ischemia). This delayed brain injury accounts for a significant percentage of poor outcomes following aneurysm rupture. Studies have shown that remote ischemia to many organs can precondition other tissues (including the brain) to be more tolerant to decreases in blood flow. This "remote ischemic preconditioning" has the promise of protecting the brain from ischemic injury. Whereas in other forms of stroke the onset of ischemia cannot be predicted in the general population, following aneurysm rupture the investigators know which patients are likely to develop vasospasm and when. Therefore, ischemic preconditioning following aneurysm rupture may help prevent some of the ischemic injury caused by vasospasm. Remote ischemic preconditioning by transient limb ischemia (produced by inflation of a blood pressure cuff on the arm or leg) has been shown to minimize injury to other organs, most notably the heart. Remote ischemic preconditioning of the brain following aneurysm rupture has not yet been investigated.
NCT01505140
Walnuts as a whole food contain polyunsaturated fatty acids, anti-oxidants, and other nutrients essential to sperm development and function. This randomized controlled trial sought to determine if a Western style diet supplemented with walnuts would improve sperm quality as a predictor of male fertility.
NCT00458198
This study will determine the effectiveness of integrated behavior therapy in treating children with selective mutism.
NCT01421667
This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression and response in DLBCL (Part C).
NCT01896297
The goal of this study is to assess dabigatran pharmacokinetics in NVAF subjects with severe renal impairment defined as creatinine clearance between 15 and 30 mL/min calculated by Cockcroft-Gault formula. The dabigatran etexilate dose of 75 mg BID was approved by the FDA for NVAF patients with severe renal impairment (CrCl 15-30 mL/min) , based on pharmacokinetic modeling and simulation.
NCT02603770
The objective of this study is to compare laboratory tests profiles of a botanic drug XueZhiKang (XZK) 300 mg capsules versus a marketed drug Lovastatin 20 mg tablets in healthy male volunteers between 18 and 50 years of age.
NCT02117414
The purpose of the Evera MRI™ study is to confirm safety and efficacy of the Evera MRI ICD (Implantable cardioverter-defibrillator) System in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans without positioning restrictions (MRI scans may occur anywhere on the body).
NCT00517829
The purpose of this research study is to find out what effects (good and bad) docetaxel, oxaliplatin, and cetuximab have on gastric or GEJ cancer.
NCT00573183
The purpose of this study is to determine whether a combined group and individual 12-Step facilitative (TSF) intervention, Stimulant Abuser Groups to Engage in 12 -Step (STAGE-12), improves substance -related outcomes.
NCT02473510
This prospective annual release study is designed to evaluate the safety of 3 new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2015-2016 influenza season
NCT01220739
To assess the safety and preliminary efficacy of combining intravenous rt-PA with transcranial laser therapy (TLT) with the NeuroThera® Laser System (referred to hereafter as NTS) in subjects treated for acute ischemic stroke. Treatment with IV rt-PA must begin within 3 hours of symptom onset, and the initiation of TLT procedure must be feasible for each subject within 6 hours of stroke onset. The NeuroThera® Laser System is an investigational device that provides noninvasive transcranial laser therapy to subjects diagnosed with acute ischemic stroke. The wavelength of the laser light is in the infrared zone of the electromagnetic spectrum and is invisible to the naked eye.
NCT00163358
The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.
NCT00933205
The purpose of this Open Label Safety Study is to provide access to and evaluate the safety and tolerability of TPV/r in treatment-experienced patients with advanced HIV-1 infection who have failed at least two PI-containing regimens, and have limited treatment options.
NCT00163436
The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. Ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks).