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NCT ID: NCT01643785 Terminated - Clinical trials for Helicobacter Pylori Infection

Additive Effect of Endonase on Eradication Rate of Second Line Therapy for HP Infection

Start date: June 2012
Phase: N/A
Study type: Interventional

Endonase, a kind of protease, is known to cause both extensive degradation of mucins and a reduction in mucus viscosity. As part of the search for more effective forms of therapy against H. pylori when it colonizes not only the surface of the surface mucosal cells but also the surface mucous gel layer covering the mucosal surface of the stomach. The investigators decided to investigate whether or not endonase might have additive effect of pronase on the efficacy of the second-line eradication therapy against Helicobacter pylori.

NCT ID: NCT01623427 Terminated - Clinical trials for Post-laparoscopy Umbilical Port-site Wound Infection

The AVATAR Trial: Applying VAcuum To Accomplish Reduced Wound Infections

AVATAR
Start date: August 2012
Phase: N/A
Study type: Interventional

Postoperative pain and time taken to return to normal activities after laparoscopic surgery are significantly shorter. Wound infections still occur and contribute to prolonged hospital stays and morbidity. Typically, port incision sites are covered with a standard dressing (approximating strips and a gauze). Although the umbilical wound infection rate in laparoscopic surgery is considered to be low, a recent study by Muensterer and Keijzer showed that the umbilical wound infection rate after single incision laparoscopic appendectomy in children is approximately 7%. In the same retrospective study, the investigators demonstrated that a simple low cost vacuum dressing can significantly reduce the infection rate. The aim of this prospective randomized controlled trial is to determine if the simple vacuum dressing is superior to a standard dressing in reducing laparoscopic postoperative umbilical wound infections. All patients under 17 years of age undergoing a laparoscopic operation in the Children's Hospital will be randomized to a standard postoperative dressing or a standard postoperative dressing with vacuum applied to it. The vacuum will be applied with a 22g needle on a 10ml syringe passed percutaneously from outside the dressing into the gauze and the air around the gauze is evacuated. The umbilical wounds will be evaluated 8-10 days postoperatively in the clinical research unit of the Manitoba Institute of Child Heath according to a standardized and validated wound evaluation tool from the Canadian Center for Disease Control. Primary outcome measure in this study is postoperative wound infection. A sample size calculation using the retrospective data demonstrated that the investigators need 275 patients in each group for the Chi-squared test to have an 80% chance of detecting a difference in wound infection rate of 6% at the 5% level of significance. Based on the annual number of laparoscopic operations in the Children's Hospital (around 400) the investigators anticipate completing the inclusion of patients within a two-year period.

NCT ID: NCT01588249 Terminated - Cough Clinical Trials

A Novel Formulation of Pasteurized Maple Cough Syrup Compared With Placebo on Nocturnal Cough and Sleep Quality in Infants With Upper Respiratory Infection

Start date: April 2012
Phase: N/A
Study type: Interventional

Cough is a frequent symptom in children and infants and is one of the most common reasons parents visit a healthcare provider for their child. The US Food and Drug Administration has issued a warning that over-the-counter cough and cold medicines including antihistamines, decongestants, anti-tussives, and expectorants should not be administered to children younger than 2 years of age due not only to lack of proven efficacy, but also because of important safety concerns. A product that has been used in alternative medicine for cough is maple syrup. Although no studies have formally evaluated the use of maple syrup for nocturnal cough associated with URI, the demulcent effect of maple syrup may provide some relief from cough in children. A novel formulation of pasteurized maple cough syrup, when compared to placebo, should provide superior relief on nocturnal cough and the sleep difficulty associated with URI in children under 12 months and sleep difficulty of their parent/caregiver.

NCT ID: NCT01586325 Terminated - Clinical trials for Chronic Hepatitis C Infection

A Study of the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of JNJ-47910382 at Different Doses and Dose Regimens in Asian Genotype-1, Chronic, HCV-Infected Patients

Start date: May 25, 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (how a drug is absorbed and distributed in the body), and intrinsic antiviral activity of JNJ-47910382 after 5 consecutive days of administration in chronic, hepatitis C virus (HCV)-genotype-1-infected patients at different doses and dose regimens.

NCT ID: NCT01562769 Terminated - Clinical trials for Patients Hospitalized in Infectious Disease

Interest of Contact Precautions for Preventing Micro-organisms Acquisition in Patients Hospitalized in Infectious Disease Unit of University-affiliated Hospital in Rennes

ISOL/STAND
Start date: March 2012
Phase: N/A
Study type: Observational

Application of isolation (=contact precautions) in hospitalized patients is recommended when patient is colonized (or infected) by micro-organism known for its outbreak capacity or high pathogenicity. It allows the reinforcement of universal precautions (=standard precautions) in order to control patient-to-patient micro-organisms transmission. Recently, the efficacy of this measure is questioned and its impact on patient care seems deleterious. In a particular context of Infectious Disease Unit, where standard precautions are handled (favorable architecture and appropriate practice for hand hygiene), assessment of contact precautions to reduce the incidence of acquired bacteria during hospitalization would be of interest. The investigators design a non-inferiority comparative study to measure the colonization pressure in patients hospitalized in two different parts of the department: one unit only with standard precautions applied (intervention) and one unit with contact precautions (control) as current routine care.

NCT ID: NCT01560468 Terminated - Clinical trials for Hepatitis C Infection

Study of Hepatitis C Virus (HCV) Entry Inhibitor in Liver Transplant Recipients With HCV Infection

Start date: March 2012
Phase: Phase 1
Study type: Interventional

This study will test the safety and tolerability of HCV Entry Inhibitor ITX 5061 in Liver Transplant Recipients with Hepatitis C infection. The investigators hypothesize that ITX 5061 oral monotherapy will be safe in adults during and after liver transplantation and that therapy will also inhibit HCV infection of newly transplanted livers in adults with prior HCV infection.

NCT ID: NCT01540279 Terminated - Clinical trials for Wound Infection, Surgical

Clinical Outcome in View of Surgical Site Infection (SSI) With Antibacterial Skin Sutures

Start date: July 2011
Phase: N/A
Study type: Observational

Background: Poor wound healing and the development of surgical site infection (SSI) continue to occur and remain a significant cause of disability among operated patients. In spite of the substantial advances in our understanding of the epidemiology, pathogenesis and prevention it remains one of the most common complications in conventional abdominal surgery with an incidence in the literature between 4% and 17%. As it is known that surgical sutures potentiate the development of wound infection the search for an ideal suture material, suitable for all purposes has been pursued by surgeons for decades. Hypothesis: In line with in-vitro results the investigators hypothesize that the use of antibacterial skin sutures with triclosan poliglecaprone 25 reduces the rate of SSI after open abdominal surgery Methods: To prevent microbial colonization of suture material in operative wounds and therefore to prevent SSI, triclosan-coated poliglecaprone 25 suture materials with antibacterial activity will be tested against un-coated suture material for skin closure after open abdominal surgery of 200 patients. The study is planed as a single center, randomized controlled trial. After ethical approval the patients will be consecutively enrolled from 2011 to 2012 in the Department of Visceral Surgery, University Hospital Basel, Switzerland. The patients will be followed for 30 days (day 3,7 and 30) to detect and document wound complications. Wound complications will be classified according to Center for Disease Control and Prevention Standard guidelines. Data will be collected and the rate of SSI will be analysed in both groups. Expected value of the proposed project: If the investigators can confirm the proposed hypothesis in our study this could be a promising and feasible approach to lower SSI after open abdominal surgery and might be also used in other surgical fields. By lowering the rate of SSI the investigators might offer a new and cost saving procedure to the surgical community.

NCT ID: NCT01515020 Terminated - Clinical trials for Nosocomial Infection

Daptomycin Versus Vancomycin in the Treatment of Nosocomial or Healthcare-associated MRSA Bacteremia

DAVASAB
Start date: May 2012
Phase: Phase 3
Study type: Interventional

Hypothesis: The use of daptomycin to treat nosocomial or healthcare-associated bacteremia due to methicillin-resistant S. aureus (MRSA) would increase the proportion of patients whose blood cultures are sterilized after 72 hours by 15% relative to vancomycin and would improve treatment safety. Hypothesis: for MRSA nosocomial or healthcare related bacteriemia treatment, the use of daptomycin versus vancomycin would increase by 15% the proportion of patients with sterilized blood cultures at 72 hours and would increase the treatment safety. Primary objective: To study the efficacy of daptomycin compared to vancomycin on the sterilization of blood cultures after 72 hours of therapy.

NCT ID: NCT01483872 Terminated - Clinical trials for Infection; Dialysis Catheter

Use of a Novel Catheter Lock Solution For Treatment of Hemodialysis Catheter Infections

Start date: March 2012
Phase: Phase 3
Study type: Interventional

Aim: To conduct a randomized, double-blinded, controlled phase II trial to investigate the use of a catheter lock solution consisting of N-acetylcysteine, tigecycline and heparin, in addition to systemic antibiotics, for the treatment of hemodialysis catheter-associated bacteremia via a catheter-salvage strategy. The investigators plan to randomize 102 patients with hemodialysis catheter-associated bacteremia to one of two treatment arms. All patients will receive systemic antibiotics for treatment of their infection. Additionally, patients randomized to the interventional arm will also receive a catheter lock solution consisting of N-acetylcysteine, tigecycline and heparin for 2 weeks with the aim of salvaging the catheter. The control arm will receive only an anticoagulant solution as a catheter lock which is standard of care - this can be either heparin or citrate (depending on what agent is standard of care for a particular patient). The main outcome of interest is successful treatment which is defined as a resolution of the current episode of bacteremia as well as lack of recurrent bacteremia within 90 days of follow-up.

NCT ID: NCT01465516 Terminated - Clinical trials for Hepatitis C Infection

Treating Hispanic Patients Diagnosed With Hepatitis C Using Boceprevir

Start date: November 2011
Phase: N/A
Study type: Observational

Hypothesis Response guided therapy improves significantly the overall SVR in Hispanics compared to historical control. There is no difference in SVR between patients with an undetectable HCV RNA at week 8 and week 28 who received a 4 week lead-in of PR plus 24 weeks of PR+BOC based treatment and patients with detectable HCV RNA at week 8 and undetectable HCV RNA at week 24 who received a lead-in of PR plus 32 weeks PR+BOC followed by based therapy and 12 weeks of PR.