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NCT ID: NCT00978133 Terminated - Wound Clinical Trials

Study of DERMABOND ProPen in Closure of Colectomy Wounds

Start date: May 2006
Phase: Phase 2
Study type: Interventional

2-octylcyanoacrylate (2-OCA) has been used extensively in clinical practice in trauma, plastic surgery, orthopaedic surgery, emergency medicine and paediatrics. Most studies on 2-OCA to date have focused on closure of short wounds, and only one has included closure of abdominal wounds in the context of general surgery. Here, the investigators will look at the results of closure of abdominal wounds in patients undergoing elective colectomies with 2-OCA, which is commercially available to us, versus closure with skin staples, which is the current standard technique of skin closure employed in the Department of Colorectal Surgery, Singapore General Hospital. The primary objective was to measure effectiveness of 2-OCA in 2 respects - the adequacy of wound healing and cosmesis, and the incidence of superficial wound infection.

NCT ID: NCT00977405 Terminated - Clinical trials for Superficial Surgical Site Infection

Collagen-Gentamicin Implant in the Treatment of Contaminated Surgical Abdominal Wounds

Start date: September 2009
Phase: Phase 2
Study type: Interventional

The investigators' hypothesis is that placement of CollatampG in the subcutaneous layer of contaminated abdominal wounds is effective prophylaxis for superficial surgical site infection (SSI). CollatampG is composed of highly purified type 1 collagen obtained from bovine tendon, which acts as a vehicle for the aminoglycoside antibiotic, gentamicin. This implant provides a high concentration of local gentamicin at the surgical wound to decrease the local microorganism load. It has been shown that if a surgical site is contaminated with > 10 to the power of 5 microorganisms per gram of tissue, the risk of infection is markedly increased. When a gastrointestinal organ is the source of pathogens, gram-negative bacilli (e.g., E. coli) are typical isolates, which are susceptible to gentamicin. Therefore, a high local concentration of gentamicin at the contaminated surgical wound provided by the CollatampG implant may prevent the local bacterial load from reaching levels high enough to cause a clinical infection.

NCT ID: NCT00977015 Completed - Healthy Clinical Trials

Study To Estimate The Time Course Of PF-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers

Start date: September 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the time course of PF-04764793 concentration in the blood following dosing by oral inhalation from dry powder inhalers.

NCT ID: NCT00973258 Completed - Clinical trials for Pre-Frail or Frail State

Randomized Controlled Trial of Community-based Nutritional, Physical and Cognitive Training Intervention Programmes for At Risk Frail Elderly

FIT
Start date: December 2009
Phase: Phase 3
Study type: Interventional

The aims of this proposed community-based randomized controlled trial are to evaluate the effectiveness of nutritional, physical exercise and cognitive training interventions for at-risk and frail elderly, to elucidate the biological determinants and changes associated with frailty, and to develop, evaluate and demonstrate the feasibility of screening instruments for frailty.

NCT ID: NCT00971282 Completed - Healthy Skin Clinical Trials

Adjunctive Usage of a Moisturizing Lotion (Cetaphil® Moisturizing Lotion) to Limit the Skin Irritation Linked to the Set-Up of a Treatment by Topical Retinoid (Differin® Gel 0,1%) in Healthy Subjects of Chinese Origins

Start date: December 2008
Phase: Phase 4
Study type: Interventional

This is a single-center study, randomized, Investigator/Evaluator-blinded bilateral (split-face) comparison. The objective: To assess the benefit of the concomitant use of a Moisturizing Lotion in reducing the skin irritation induced by a adapalen gel treatment in Chinese Subjects.

NCT ID: NCT00968591 Completed - Clinical trials for Hepatic Insufficiency

Pharmacokinetics of Everolimus in Subjects With Hepatic Insufficiency

Start date: November 2009
Phase: Phase 1
Study type: Interventional

This clinical pharmacology research study will assess the safety and pharmacokinetics of the drug everolimus in patients with impaired hepatic function as compared to healthy volunteers.

NCT ID: NCT00962975 Completed - Clinical trials for Hepatitis B, Chronic

A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies

Start date: September 2009
Phase: Phase 1
Study type: Interventional

In this open-label multicenter study the long-term effect of Pegasys monotherapy on pharmacodynamic HBV-related markers will be investigated in patients with chronic hepatitis B. Eligible patients will have completed treatment on another donor protocol (e.g. PP22512) and will receive Pegasys at an appropriate dose based on the standard of care (180mcg sc once weekly) for up to 48 weeks. Target sample size is <100.

NCT ID: NCT00962871 Completed - Clinical trials for Hepatitis B, Chronic

A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both

Start date: August 2009
Phase: Phase 1
Study type: Interventional

This open-label, randomized, parallel-arm study will assess the early immunologic response in treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment with Pegasys or tenofovir or Pegasys plus tenofovir. Patients will be randomized to one of 4 cohorts to receive either Pegasys (360mcg subcutaneously weekly) or tenofovir (300mg orally daily) or both or no treatment for 2 weeks. After 2 weeks on study treatment, patients may opt to receive standard of care treatment with Pegasys. Target sample size is <50.

NCT ID: NCT00958555 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study of Predictive and Prognostic Markers in Patients With Non-small Cell Lung Cancer

Start date: April 2009
Phase: N/A
Study type: Observational

1. To establish a retrospective compilation of clinical, histopathological, treatment and follow-up (clinic pathological) data of previous non-small cell lung cancer (NSCLC) cases. 2. To establish a prospective collection of clinic pathological information from NSCLC patients with corresponding blood and tissue samples 3. To discover and validate molecular biomarkers of survival and treatment outcome in NSCLC One of the current difficulties in the management of lung cancer is the decision to treat and the type of treatment to select. Thus there is a need for additional prognostic (indicative of disease aggressiveness) and predictive (indicative of likely response to treatment) markers for lung cancer. To conduct a successful prognostic and predictive marker program, several factors are required, including: a comprehensive database linking clinical, histopathological, treatment and outcome characteristics of each case, a collection of samples linked to the database that is suitable for the testing of candidate markers, and a multi-disciplinary, interdepartmental level of expertise in the management of lung cancer. Objective 1: A review of the case records will be conducted to extract clinical, treatment and follow-up data Objective 2: Patients aged 21 years or more with newly diagnosed, untreated non-small cell lung cancer shall be approached for consent. Patients will be identified through the pathology records, and from the study investigators' clinic. After subject consent, baseline characteristics will be obtained. Follow up data on therapies received and toxicities encountered will be obtained. Tumor samples will be obtained only from patients with NSCLC undergoing surgery as part of routine clinical care. The surgical specimen will be sent to Pathology to verify the adequacy of the diagnostic sample as per usual practice. Blood will be collected at the baseline (or prior to any anti-cancer treatment) and will be sampled again at the time of relapse or disease progression. Collection will entail drawing 7ml blood into a Vacutainer CPT tube (Becton Dickinson, USA), centrifugation, extraction of a separated layer of mononuclear cells (MNC), labeling followed by storage below -80oC. The frequency of blood drawn will be about 1-5 times (7-35mls total). The number of times depends on whether the lung cancer relapses and in the advanced stage, how often the lung cancer relapses after treatment. DNA and RNA will be extracted by CSIS and stored in freezer space there. Stored samples will be used for investigation of prognostic and predictive markers of outcome and for discovery of novel molecular alterations Objective 3: Biomarker analysis of tumor and blood. Blood will be enriched for circulating tumor cells (CTC) using previously optimized methods (11) and DNA will be extracted from CTC and tumor using the Tri-Reagent (Molecular Research Center, Cincinatti, OH). DNA will be extracted from tumor, CTC and mononucleated cells and tested for somatic lung mutations by sequencing (2). Germline DNA will be analysed for genes linked to genetic risk for NSCLC and, for treatment toxicities, for genes related to NSCLC chemotherapy metabolic pathways. Tissue microarray (TMA) is a high-throughput method of analysing large numbers of formalin-fixed, paraffin-embedded tumor at a minimal cost and effort. To analyse the expression of proteins of putative relevance to EGFR function, cell proliferation, angiogenesis, apoptosis, metastasis, and hormonal, TMA will be utilised. PTEN and C/EBPa will also be analysed.

NCT ID: NCT00957086 Active, not recruiting - Clinical trials for Carcinoma, Squamous Cell of Head and Neck

Study of Post-Op Adjuvant Concurrent Chemo-RT With or Without Nimotuzumab for Head & Neck Cancer

Start date: August 13, 2009
Phase: Phase 3
Study type: Interventional

The aim of the study is to improve the loco-regional control rate and overall survival of locally advanced head and neck squamous carcinoma (HNSCC). The investigators hypothesize that the addition of nimotuzumab (a recombinant humanized murine immune antibody that blocks both epidermal growth factor (EGF) and transforming growth factor (TGF)) to the current gold standard of concurrent chemoradiotherapy (CCRT) (7)(8), an adjuvant setting in patients after resection of their locally advanced HNSCC will confer therapeutic advantage.