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NCT ID: NCT01525732 Completed - Achalasia Clinical Trials

Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Esophageal Motility Disorders

POEM
Start date: June 2010
Phase: N/A
Study type: Interventional

Spastic esophageal motility disorders induced significant symptoms including dysphagia, retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel approach to perform myotomy through the esophagus with long submucosal tunnel. This study aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques from animal study to clinical practice in human.

NCT ID: NCT01524432 Completed - Tinea Pedis Clinical Trials

Hygienic Socks With Antifungal Agent-loaded Microcapsules for Patients With Tinea Pedis

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

This is a study of hygienic socks with antifungal agent-loaded microcapsules for subjects with interdigital type tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 2 week treatment period and a 4 week follow-up evaluation.

NCT ID: NCT01523470 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Withdrawal of Non-invasive Ventilation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Acute Hypercapnic Respiratory Failure

Start date: November 2010
Phase: Phase 3
Study type: Interventional

The investigators design a pilot randomised, single-centred, controlled trial to compare different withdrawal methods of Non-invasive ventilation. Our study aims at comparing stepwise withdrawal of Non-invasive ventilation versus immediate withdrawal of Non-invasive ventilation. The primary endpoint is to compare the rate of success between two withdrawal methods. The investigators define success as no recurrence of acute hypercapnic respiratory failure or restitution of Non-invasive ventilation within 48 hours after NIV is stopped. The secondary endpoints include time to recurrence of acute hypercapnic respiratory failure measured from the time of randomisation, the total days of Non-invasive ventilation use and the days of hospitalisation. Results from this trial will inform design of future randomised trial in this area.

NCT ID: NCT01520909 Completed - Clinical trials for Idiopathic Thrombocytopenic Purpura

Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body.

PETIT2
Start date: March 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the efficacy, safety and tolerability of eltrombopag in children with previously treated chronic immune thrombocytopenia who are between 1 and 17 years of age. This is a 2 part study. In part 1, patients will be randomized to receive either eltrombopag or placebo for 13 weeks. All patients who complete part 1 will enter part 2. In part 2, all patients will receive 24 weeks of eltrombopag.

NCT ID: NCT01514110 Completed - Gastric Cancer Clinical Trials

Gastric Cancer RAD001 Study

Start date: January 23, 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of RAD001, as well as to assess tumor response and overall survival.

NCT ID: NCT01508884 Completed - Chronic Illness Clinical Trials

Intradermal Trivalent Influenza Vaccine With Imiquimod

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

Despite the WHO International Health Regulations Emergency Committee declared an end to the 2009 H1N1 pandemic globally, the emergence of the novel 2009 H1N1 virus in March 2009 has affected more than 214 countries with at least 18000 deaths [1]. Patients with chronic underlying illness and extreme of ages are at risk of developing severe disease and complications [2-3]. Resistance to oseltamivir has also been reported [4]. Therefore, vaccination with the 2010/2011 trivalent influenza vaccine (TIV) with the 2009 H1N1-like virus incorporated will be the best protection against the influenza infection, especially among the at risk population. Recent study on dose sparing seasonal influenza vaccine delivered via a novel intradermal microneedle has demonstrated good immunogenic responses similar to full-dose intramuscular vaccination [6]. Poor immunogenicity of the H1N1 2009 component of the trivalent influenza has been reported [7]. Study has also suggested the combined intradermal vaccination with local stimulation of dermal antigen presenting cells by applying imiquimod cream (Aldara) to the injection site, which activate antigen presenting cells (APC) through the toll-like receptor 7 (TLR7) may produce better immunogenicity [8]. Imiquimod cream is currently registered for the treatment of warts and basal cell carcinoma. Scientific evidence has demonstrated that after treatment with imiquimod, the antigen is processed and presented to cells of the adaptive immune system leading to clearance of the virus and subsequent clearance of the lesions [9]. In addition to functional maturation, imiquimod induces migration of dendritic cells from the dermis to draining lymph nodes [10,11]. Subcutaneous administration of imiquimod as vaccine adjuvant simultaneously with the antigen of interest, has shown to induce enhanced responses towards the administered antigen [12]. We therefore performed a prospective, double blind, randomized controlled study to compare the safety and immunogenicity between intradermal 2011/2012 TIV immunization with pretreatment of imiquimod cream and conventional full dose intramuscular 2011/2012 TIV immunization with pretreatment of aqueous cream as control.

NCT ID: NCT01507649 Completed - Clinical trials for Postnatal Depression

Effect of a Telephone-based Intervention on Postnatal Depression

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

Purpose: To evaluate the effectiveness of a telephone-based intervention using cognitive-behavioral approach in preventing postnatal depression and improving quality of life in first-time Chinese mothers. Hypothesis: Women who receive the telephone-based cognitive-behavioral intervention will have a lower level of depressive symptoms (primary outcome) and a higher level of quality of life at 6 weeks and 6 months postpartum than those who receive the usual postpartum care. Design and subjects: Randomized controlled trial is used. A sample of postpartum women with high risk of postnatal depression (EPDS > 9, n = 498) will be randomly assigned to either the experimental (n = 249) or the control groups (n = 249). The experimental group receives the intervention and the control group receives usual postpartum care. Study instruments: EPDS and Medical Outcomes Study Short Form Health Survey (SF-12). Interventions: The intervention is based on the cognitive-behavioral approach. It consists of five, 30-minutes sessions delivered weekly from postpartum week one to week five via telephone. Main outcome measures and analysis: Outcomes on postnatal depression and quality of life will be measured by EPDS and SF-12, respectively, at 6 weeks and 6 months postpartum. A repeated-measures multivariate analysis of variance will be used to compare differences between two groups.

NCT ID: NCT01507168 Completed - Clinical trials for Carcinoma, Hepatocellular

A Study of GC33 (RO5137382) in Patients With Advanced or Metastatic Hepatocellular Carcinoma

Start date: February 2, 2012
Phase: Phase 2
Study type: Interventional

This randomized, placebo-controlled, multicenter study will evaluate the efficacy and safety of GC33 (RO5137382) in previously treated patients with unresectable advanced or metastatic hepatocellular carcinoma. Participants will be stratified according to the level of GPC-3 expression in tumors and randomized to receive either GC33 (1600 mg intravenously) or placebo on Days 1 and 8 of Cycle 1 and every 2 weeks thereafter. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

NCT ID: NCT01506856 Completed - Clinical trials for Fallopian Tube Cancer

Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial

iPocc
Start date: May 2010
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is: Phase A: To confirm the feasibility of paclitaxel administered by intravenous (IV) infusion weekly plus concurrent carboplatin administered by intraperitoneal (IP) injection once every 3 weeks (dd-TCip therapy). Phase B: To compare the efficacy and safety of the following two treatment regimens as first-line chemotherapy in women with epithelial ovarian, Fallopian tube or primary peritoneal cancer.

NCT ID: NCT01502397 Completed - Clinical trials for Exposure to Hepatitis B Virus

Risk of Hepatitis B Reactivation in Patients With Prior HBV Exposure Undergoing Rituximab-containing Chemotherapy: A Prospective Study

Start date: December 2011
Phase:
Study type: Observational

The purpose of this study is to determine whether preemptive nucleoside analogue therapy or regular virologic monitoring is the preferred method in management patients with prior exposure to hepatitis B vius (HBV) and undergoing rituximab-containing chemotherapy.