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NCT ID: NCT00679666 Withdrawn - Corneal Ectasia Clinical Trials

Corneal Crosslinking in Keratoconus and Corneal Ectasia

CXL
Start date: April 2008
Phase: Phase 2/Phase 3
Study type: Interventional

Prospective, randomized, single site to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes progressive keratoconus or corneal ectasia.

NCT ID: NCT00677183 Withdrawn - Clinical trials for Non-Alcoholic Steatohepatitis

Development of Biomarker for Development of Non-Alcoholic Steatohepatitis (NASH) in Children

NASH
Start date: May 2008
Phase: N/A
Study type: Observational

The purpose of this study is to document how often specific genotypes known to be associated with adult-onset NASH (Non-Alcoholic Steatohepatitis) occur in a pediatric cohort and investigate whether these genotypes are associated with increased susceptibility to NASH.

NCT ID: NCT00676559 Withdrawn - Clinical trials for Diabetic Macular Edema

Combined aPproach to Treatment Using Ranibizumab and Efalizumab for Diabetic Macular Edema Study: The CAPTURE DME Study

CAPTURE
Start date: April 2008
Phase: Phase 1
Study type: Interventional

This study looks to continue the study of anti-vegf therapy in patients with macular edema, and compare it to an anti-inflammatory therapy and a combined Anti-vegf and anti-inflammatory.

NCT ID: NCT00675532 Withdrawn - Drug Dependence Clinical Trials

Testing a Primary Care Model for the Treatment of Opioid Dependence Using Long-acting Injectable Naltrexone (Vivitrol).

Start date: May 2011
Phase: N/A
Study type: Interventional

In opioid dependent patients treated with long-acting injectable naltrexone (Vivitrol ®), we will compare the efficacy of a primary care model of counseling (Condition 1) versus individualized cognitive-behavioral psychotherapy (Condition 2) for the treatment of opioid dependence. Treatment will last 12 weeks, and participants will be given 380mg of naltrexone per injection (3 injections in total; each lasting 4 weeks). Primary outcomes will be 1) percent of opioid negative urines and 2) treatment compliance as measured by attendance and time in treatment. Secondary outcomes are opiate craving, opiate withdrawal symptoms, perceived stress scores, severity of addiction problems, and patient satisfaction. Findings will elucidate whether injectable, long-acting naltrexone would be safe and effective in a primary care setting where medication would be administered in the absence of traditional cognitive-behavioral psychotherapy and indicate whether cognitive-behavioral psychotherapy adds to treatment effects above and beyond primary care counseling. If positive, this small controlled study will provide effect size estimates for a larger trial to assess Vivitrol ® in a primary care setting.

NCT ID: NCT00672464 Withdrawn - Schizophrenia Clinical Trials

Cardio Risk of Acute Schizophrenia Olanzapine Duke

CRASOD
Start date: April 2008
Phase: Phase 4
Study type: Interventional

Primary Objective: To compare added metformin and/or added simvastatin versus no intervention in reducing or eliminating increased cardiovascular risk (as estimated by elevation in non-HDL cholesterol levels) during the treatment of schizophrenia with olanzapine. Secondary Objective(s): To compare added metformin and/or added simvastatin versus no intervention in reducing or eliminating increased cardiovascular risk (as estimated by elevation in triglyceride levels) during the treatment of schizophrenia with olanzapine. To compare added metformin and/or added simvastatin versus no intervention in reducing or eliminating increased cardiovascular risk (as estimated by C-reactive protein levels) during the treatment of schizophrenia with olanzapine

NCT ID: NCT00671983 Withdrawn - Obesity Clinical Trials

The Effect of Obstructive Sleep Apnea on Medical Outcomes After Gastric Bypass Surgery

Start date: March 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Obstructive sleep apnea (OSA) is a syndrome characterized by repetitive episodes of airway obstruction during sleep, which result in low oxygen level in the blood and bad sleep quality. Both of these effects are implicated in medical, neurological and cognitive disorders in subjects with OSA. The purpose of this study is to examine how OSA affects medical and neurobehavioral outcomes after gastric bypass surgery for weight loss in morbidly obese patients.

NCT ID: NCT00671541 Withdrawn - Chronic Sinusitis Clinical Trials

Nasospore Stent For Use in Enodscopic Sinus Surgery

Start date: March 2006
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate a stenting material called Nasopore. This is a synthetic material approved by FDA for use as a stent in postoperative sinus surgery patients. This study will compare the Nasopore stent to other approved stenting materials.

NCT ID: NCT00671463 Withdrawn - Pancreatic Cancer Clinical Trials

Pancreatic Stent to Prevent Leak After Distal Pancreatectomy

LEAPS
Start date: April 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate an intervention to prevent complications after pancreas surgery. The goal is to determine if placing a stent into the pancreatic duct before surgery will decrease or prevent leaking from the pancreatic duct after surgery. Leaks are common after pancreas surgery and can result in serious problems and post-operative pain. The study will compare two groups. One group will have the stent before surgery, and the other group will have standard pancreas surgery, no endoscopy, and no stent.

NCT ID: NCT00670150 Withdrawn - Clinical trials for Acute Promyelocytic Leukemia

New Retinoid Agent Combined With Arsenic Trioxide for Untreated Acute Promyelocytic Leukemia

Start date: May 2010
Phase: Phase 2
Study type: Interventional

The safety and efficacy of combining NRX 195183 with arsenic trioxide in treating untreated APL will be assessed.

NCT ID: NCT00669799 Withdrawn - Rhinosinusitis Clinical Trials

Topical Antibiotic Use In Chronic Rhinosinusitis A Double-Blinded, Randomized, Placebo Controlled Study

Start date: March 2008
Phase: N/A
Study type: Interventional

Chronic rhinosinusitis is a pervasive and costly disease. Recent estimates describe over 20 million Americans suffering from this diagnosis at a cost of over $4.3 billion per year. Primary intervention consists of oral antibiotics and nasal steroid sprays. A role for antifungal irrigation has also been proposed. Topical antibiotics are used by some physicians, but there are few reports in the published literature describing their use and establishing or refuting their efficacy. Sykes in 1986 performed a randomized, prospective, double-blinded study with 50 patients using topical nasal sprays with dexamethasone, tramazoline, and neomycin; dexamethasone and tramazoline without antimicrobial; and placebo. Both of the treatment groups showed improvement over placebo, but in those groups there was no significant difference in response rates between those patients receiving neomycin and those who did not. There were no adverse events reported. In the same year, Cuenant et al. reported success with neomycin-tixocortol irrigations in the treatment of chronic rhinosinusitis. Scheinberg and Otsuji and Vaughn and Carvalho describe their use of various nebulized antimicrobials (including aminoglycosides) in patients with recurrent sinusitis. Both are uncontrolled, retrospective studies showing improvement in symptom scores. Neither study reported any major side effects. Leonard and Bolger describe a case report and review their success with the use of topical Ceftazidime in 50 patients. Only one patient reported stinging sensation during administration. They reported no problems with antibiotic resistance. Studies by Davidson et al. , and Moss and King describe the use of topical antibiotics for sinusitis in patients with cystic fibrosis. They report improvement in sinusitis symptoms and reduction of need for revision sinus surgery in patients treated with surgery followed by topical intranasal tobramycin. They report no significant side effects. Dudley described the use of topical gentamicin in a case report of a patient with atrophic rhinitis. The patient had resolution of her complaints without any adverse symptoms. He also describes a study by Thornell showing success with streptomycin nasal sprays and reports work by Rubinstein demonstrating safe administration of gentamicin into the nose without absorption by the nasal mucosa. On balance, the literature describes topical antibiotics as a safe, but variably efficacious treatment for chronic rhinosinusitis. There is a paucity of prospective, randomized, blinded, and controlled studies. The purpose of this protocol is to describe a scientifically rigorous study of the use of broad spectrum antibiotic nasal sprays for chronic sinusitis. The patient population for this study will consist of patients who have a history of multiple sinus infections each year that require treatment with antibiotics. The patients in this study will have had recurrent infections despite prior medical and surgical intervention. They will fulfill the criteria for chronic rhinosinusitis without nasal polyposis. Treatment will include conventional treatment with oral antibiotics and a topical nasal steroid. In addition, patients will be randomized to receive either topical antibiotics or a vehicle placebo. The study will follow patients for a three month period. Patients will be monitored for improvement in radiographic findings and quality of life when compared to a randomized and double-blinded placebo group. The patient population identified for inclusion in this study will also be evaluated for allergy and humoral and innate immunodeficiency. Nasal lavage will be obtained from the study population and pre and post-treatment comparisons will be performed.