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NCT ID: NCT00854230 Withdrawn - HIV Infections Clinical Trials

Pharmacotherapy for HIV Infected Patients With Alcohol Problems

Start date: January 2009
Phase: Phase 4
Study type: Interventional

This is a randomized double blind clinical trial to test the effect of Naltrexone on HIV infected heavy drinkers. The study will select 40 HIV positive patients who meet criteria for heavy drinking. Treatments include Naltrexone (25-100mg)and placebo. Patients will be treated, followed up, and assessed for a duration of 12 weeks. The investigators associated hypotheses Hypothesis 1: Naltrexone will reduce the frequency of heavy drinking. Hypothesis 2: Naltrexone will lead to maintenance or improvement in CD4 lymphocyte count and decreased HIV RNA levels. Hypothesis 3: Naltrexone will lead to a reduction in sexual risk behaviors. Hypothesis 4: Naltrexone will lead to improved adherence to HAART. Hypothesis 5 (Exploratory): Naltrexone will be well-tolerated with minimal side effects and patients will exhibit good treatment retention.

NCT ID: NCT00844155 Withdrawn - Clinical trials for Influenza A Virus Infection

Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir in the Intensive Care Unit

Start date: March 2009
Phase: N/A
Study type: Interventional

This proposed pharmacokinetic study will test the hypothesis that in critically ill patients with respiratory failure requiring mechanical ventilation such as might be anticipated to be needed to treat patients with severe influenza pneumonia, oseltamivir administered enterally via nasogastric tube, with and without concomitant food or alimentation, will have similar oral bioavailability to that observed in ambulatory adults ill with influenza in whom oseltamivir therapy 75 mg BID is efficacious and well tolerated. Additionally, this experiment will test the hypothesis that increasing the dose (150 mg), with and without concomitant enteral feeding, will show a proportionate increase in bioavailability. Relative oral bioavailability will be assessed from plasma concentration vs. time over 12 hrs and urinary recovery of drug from 0 to 48 hrs after administration.

NCT ID: NCT00795470 Withdrawn - Clinical trials for Urinary Tract Infections

Factorial Trial of Antimicrobial Therapy and/or Catheter Change for Catheter Urinary Tract Infections.

CAUTION
Start date: January 2012
Phase: Phase 3
Study type: Interventional

Urinary tract infection (UTI) is a common infection in patients in the intensive care unit (ICU) that increases length of stay but not mortality. It is not known whether antibiotic treatment will alter outcomes. Our previous studies have documented wide practice variations exist amongst doctors, including prescribing antibiotics to asymptomatic patients. Therefore, the merits of various ways to manage the infection require further studies to minimize the potential for over-prescribing of antibiotics, a practice that can increase the development of resistant bacteria. The objective of this pilot study is to determine the feasibility of conducting a larger definitive study that will determine the effect of catheter change and/or systemic antibiotics as compared to no interventions on outcomes and resource utilization in ICU patients with UTI. Patients will be randomized to receive no treatment, antibiotics alone, urine catheter change alone, and both catheter change and antibiotics. Their clinical outcomes will be assessed. Results from the pilot trial will provide information about whether it is feasible to conduct the larger definitive trial. Results of the definitive study will provide guidance to clinicians on how to manage a frequent clinical problem and optimize antibiotic usage.

NCT ID: NCT00789464 Withdrawn - Clinical trials for Recurrent Urinary Tract Infection

Probiotics for Girls With Recurring Urinary Tract Infections

Start date: n/a
Phase: Phase 2
Study type: Interventional

Probiotics are dietary supplements containing potentially beneficial bacterial strains such as Lactobacillus. The safety of oral administration of probiotics has been demonstrated in hundreds of studies using adults over the last 30 years. Very few studies have been conducted with children. UTI in girls occur when virulent bacteria migrate from the rectum and colonize the vagina and peri-urethral mucosa, thus gaining access to the bladder. This study will randomize girls to ARM A (probiotics + placebo) and ARM B (antibiotics + placebo) to determine if UTIs are decreased when the probiotics are given.

NCT ID: NCT00765401 Withdrawn - Cystic Fibrosis Clinical Trials

An Investigation of the Association Between Helicobacter Pylori Infection and Abdominal Pain in Cystic Fibrosis Patients

Start date: November 2008
Phase: N/A
Study type: Observational

Cystic fibrosis (CF) is the most common lethal autosomal recessive disease among Caucasians. While the pulmonary disease in CF receives most of the attention, gastrointestinal diseases occur in >95% of CF individuals and can contribute to significant morbidity, mortality and a decreased quality of life. The abdominal pain in CF is usual chronic in nature, and the etiology is not usually found, despite medical testing for standard causes of abdominal pain. Helicobacter pylori (Hp) is increasingly being recognized as the etiology of peptic ulcer disease and other upper and lower gastrointestinal tract diseases.1 The role that Hp plays in CF abdominal pain has not been elucidated. Our long-term goal is to understand relationship between chronic HP infection and abdominal pain in pediatric CF patients. The specific objective of this proposal is to utilize current state-of-the-art testing for HP to determine the prevalence of Hp in our CF patients age 5 and older. The central hypothesis is that Cystic fibrosis subjects with significant abdominal pain will have an increased incidence of Helicobacter pylori as determined by the urea breath test and stool antigen test. The rationale for the proposed research is that once we elucidate a causal relationship between CF patients with abdominal pain and Hp, we can begin treatment of this infection to improve quality of life.

NCT ID: NCT00765141 Withdrawn - Infection Clinical Trials

A Multi-Center Protocol for Obtaining and Storing Human Samples for Immediate or Future Microbial, Immune, or Host Microbe Scientific Study

Start date: June 2008
Phase: N/A
Study type: Observational

The intent of this protocol is to salvage human-related material that is normally destined for destruction, so it can be used in infection-related scientific studies.

NCT ID: NCT00754299 Withdrawn - Infection Clinical Trials

Smoking Cessation in Nonunion, Malunion, Osseous Infection

nicotine
Start date: October 2010
Phase:
Study type: Observational

The Study Investigators have seen high rates of tobacco cessation success combining Chantix with the risk of no surgery, should tobacco use continue. Once patients achieve tobacco cessation and undergo surgery, the investigators have seen high rates of union and/or infection resolution. The investigators are looking to document and publish these observations. To date, no studies have been published that have examined the effects of this type of protocol on short and long-term tobacco cessation. The investigators want to examine and report the outcome of Hershey Medical Center's Orthopaedic Trauma Division's protocol for two endpoints: 1) pre-op tobacco cessation and 2) duration of tobacco cessation. This protocol involves counseling, Chantix, and a 'no-surgery' risk. Patients will be followed postoperatively for success and duration of tobacco cessation, as well as for fracture union and/or infection eradication.

NCT ID: NCT00712413 Withdrawn - Clinical trials for Helicobacter Pylori Infection

Safety, Efficacy of Pylera BID Dosing in Eradication of H. Pylori

Start date: August 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of Pylera when given twice a day. Pylera approved treatment schedule is 3 pills taken 4 times daily, in addition to omeprazole given twice daily. In this trial, subjects with confirmed Helicobacter Pylori infection will receive Pylera treatment and omeprazole twice daily.

NCT ID: NCT00700362 Withdrawn - Diabetes Mellitus Clinical Trials

Insulin Infusion and Infectious Diabetic Foot Ulcers (IIIFU)

Start date: December 2011
Phase:
Study type: Observational

Normoglycemia is important for the outcome of surgical and medical conditions. Insulin infusions have been studied to achieve normoglycemia during these circumstances and have proved to be useful. Insulin given by subcutaneous injections has longer duration compared to intravenous given insulin which makes it more difficult to control. The hypothesis behind the trial is the concept that insulin infusion is more effective in reaching normoglycemia in diabetic subjects during foot ulcer infection and surgical wound infection. - The study evaluates a target controlled insulin infusion or conventional therapy as antidiabetic treatment during foot ulcer infection and surgical wound infection. - Secondary efficacy parameter will be hospital stay, laboratories for inflammation and oxidative stress.

NCT ID: NCT00672672 Withdrawn - Infection Clinical Trials

Autologous Platelet Gel in Wound Healing of Coronary Artery Bypass Grafting (CABG) Patients

Start date: January 13, 2009
Phase: N/A
Study type: Interventional

This study will determine if autologous platelet gel (APG) on sternal incision and conduit sites will improve wound healing and decrease infection in coronary artery bypass grafting surgery patients.