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NCT00198939
In this R01 study, a randomized clinical trial is proposed to evaluate the efficacy of a drug abuse prevention intervention for indicated middle school youth that coordinates family and teen-based components. The Family Management Intervention is comprised of a parent-focused curriculum to foster parenting skills followed by brief family therapy to foster adaptive family communication and age-appropriate roles. The Teen Achievement Intervention is comprised of a clinician-delivered learning strategy curriculum to foster academic achievement followed by a similar yet peer-facilitated curriculum to foster self-efficacy and prosocial peer networks. In the first study aim, we seek to evaluate the separate and possibly synergistic effects of the Family Management and Teen Achievement components on post intervention drug use, problem behavior, psychological distress, and academic achievement of indicated youth. Innovative analytic strategies are subsequently used to elucidate mediated pathways by which the interventions might reduce drug involvement and problem behavior by promoting changes in targeted skills and behavior change processes. The possibility of effect-modification also is considered, with a focus on neurocognitive, internalizing/externalizing, and demographic factors, in an effort to discern why interventions work for some youth but not others. This application revision has sought to address well-taken concerns cited by the reviewers while maintaining proposal strengths. In response to a key limitation, this revision includes further specification of anticipated relationships between neurocognitive variables, skill acquisition levels, and prevention intervention outcomes among indicated youth. Study hypotheses on specific neurocognitive effects are informed by empirical findings and the clinical experience of investigative team members specializing in neuropsychology. If successful, this project should improve prevention practices by identifying malleable behavior change processes fostered by effective interventions. Improving our understanding of how individual characteristics of indicated youth, such as neurocognitive deficits or externalizing problems, influence the development of skills during interventions and subsequent outcomes may also help to improve existing prevention interventions. The significance of the proposed study is underscored further by the substantial size of the targeted population of indicated youth, and the range of morbidities and mortality that often result when early warning signs of drug abuse are not addressed.
NCT00164372
The purpose of this study is to test whether a six-session behavioral intervention for HIV and HCV seronegative injection drug users is effective in reducing sexual and injection risk behaviors that could lead to primary HIV and HCV infection.
NCT00063635
The purpose of this study is to determine if therapeutic modification of insulin resistance or oxidative stress leads to improvement in serum or histologic indicators of liver injury or quality of life.
NCT00181077
To compare hypertonic saline to Lactated Ringer's solution and assess whether one speeds up the process of getting rid of extra body water faster in women with preeclampsia.
NCT00003805
RATIONALE: Antibiotic therapy may prevent the development of infection in patients with hematologic cancer and the persistent fever caused by a low white blood cell count. It is not yet known which regimen of antibiotics is most effective in preventing infection in these patients. PURPOSE: Randomized phase III trial to study the effectiveness of piperacillin-tazobactam with or without vancomycin in reducing fever in patients who have leukemia, lymphoma, or Hodgkin's disease.
NCT00832832
This research is being done to determine if closing your eyelids after you take your glaucoma drops makes them more effective in lowering your eye pressure, and to determine if closing your eyelids for 5 minutes is better than closing them for one minute
NCT00949585
Chronic kidney disease is associated with high blood pressure, heart disease, and strokes. Potassium lowers blood pressure and may help prevent heart disease and strokes in the general population, but has not been well-studied in people with kidney disease. This study will look at the benefits and safety of two levels of potassium intake in patients with kidney disease. We expect that a higher level of potassium intake safely lowers blood pressure compared to a lower level of potassium intake. We hope that this and other research projects will help us to learn more so that guidelines can be created for potassium intake in patients with chronic kidney disease
NCT00938236
This trial is a longterm follow up of a phase III study of inhaled cyclosporine for the prevention of chronic rejection in lung transplant recipients.
NCT00990964
The purpose of the study is to assess lead implant success and complication rate using the Medtronic Attain Family of left-heart leads and delivery catheters.
NCT00796744
The purpose of this study is to assess if the experimental drug, DSC127, is safe, how well it can be tolerated, and how different doses effect the healing of the chronic foot ulcers in diabetic subjects.
NCT01687764
The objective of this project is to test the combination of active or placebo Attentional Bias Modification Treatment (ABMT) to either Cognitive Behavioral Group Therapy (CBGT) or Psychoeducational Control Intervention (PCI) for anxiety disorders in children.
NCT00134602
The purpose of the study is to develop and evaluate an intervention to promote adherence to HIV medications among children 5-12 years of age. It compares changes in antiretroviral (ARV) adherence between the EIG (enhanced intervention group) and an MIG (minimal intervention group) from baseline to 4 months post-intervention. Secondary outcomes include examining whether improvement in adherence to a medication regimen is associated with improved health outcomes (i.e., viral load, CD4 counts, etc.); identifying and evaluating predictors and/or mediators of adherence; studying the feasibility of electronic recording in measuring adherence in an HIV-infected pediatric population; and evaluating the relationship between the amount of intervention received (i.e., number of hours/number of sessions) and changes in adherence.
NCT00651118
The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)
NCT00189904
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations.
NCT00604214
The purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated) treatment provides significant mortality reduction improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock. This study will also assess the effectiveness of drotrecogin alfa (activated) in reducing 28-day mortality in patients with septic shock and concomitant severe protein C deficiency.
NCT00337493
This study will determine which, if any, allelic variants of mycophenolic acid (MPA) metabolizing enzymes, drug transporters and drug targets are associated with the observed variation in pharmacokinetic and pharmacodynamic outcomes observed with CellCept usage. Patients participating in study ML17225 will be eligible for this pharmacogenetic investigation, and will have one additional blood sample taken during the study. The anticipated time on study treatment in study ML17225 is 1-2 years, and the target sample size is 500+ individuals.
NCT00506415
The purpose of this study was to support the optimal use of rivastigmine patch in long-term treatment of Alzheimer's Disease in patients demonstrating functional and cognitive decline at the target maintenance dose of rivastigmine patch 10 cm\^2.
NCT01229137
Assessment of sensor parameter in patients with heart failure.
NCT01247818
PH-10 is an aqueous hydrogel formulation of rose bengal disodium (RB) for topical administration to the skin, and is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. This multicenter phase 2 study of subjects randomized sequentially by center to one of four treatment cohorts will assess efficacy and safety of topical PH-10 applied once daily to areas of mild to moderate plaque psoriasis.
NCT00820196
Venous leg ulcers are a common, costly and debilitating condition, with few effective treatments. Compression bandaging helps healing, but more than four out of every ten leg ulcers remain unhealed after three months. New treatments to help heal venous ulcers are urgently needed. Initial studies with a new drug product candidate called Nexagon® (developed by CoDa Therapeutics, Inc.) have shown improvements in healing when applied topically to a wound. Further research will be undertaken to assess the safety and activity of Nexagon® when applied to venous leg ulcers in humans, and to obtain further information on the most appropriate dose or doses to apply. A proposed randomised controlled trial aims to further evaluate Nexagon® by randomly allocating (e.g., by the toss of a coin) 90 people with venous leg ulcers to Nexagon® (one of two different doses) or a vehicle (substance containing no medication) to be applied to their ulcer three times over four weeks. Participants will be followed up for 12 weeks to evaluate ulcer healing.
