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NCT ID: NCT01957618 Enrolling by invitation - Clinical trials for Hepatitis B Virus-Related Hepatocellular Carcinoma

The Follow-up Study of Chronic Hepatitis B Patients With Liver Cirrhosis Receiving Anti-HBV Therapy

CTEAM
Start date: October 2011
Phase: N/A
Study type: Observational

Hepatitis B virus (HBV) infection is a global health problem, especially in the endemic area like Taiwan, where there are more than 3 million chronic hepatitis B carriers. Patients with chronic HBV infection are at increased risk of developing cirrhosis, which may have disastrous complications, including hepatic decompensation, and hepatocellular carcinoma (HCC). The liver cirrhosis related complications accounts for the 8th leading cause of deaths in Taiwan; whereas, the HCC is the 2nd leading cause of deaths among all cancers. Therefore, it is prudent to develop strategies to prevent or halt the progression of liver cirrhosis. For HBV patients who have already had cirrhosis, the main treatment objective is to reduce their risk of complications. A large-scale multicenter clinical trial showed that viral suppression using lamivudine in patients with advanced fibrosis effectively decreases the risk of HCC and liver-related complications. This study highlights the importance to treat HBV-related cirrhosis patients; however, several issues remain to be addressed. The first issue is that this clinical trial only enrolled patients with positive HBeAg or HBV-DNA level >1.4 x105 IU/mL. However, the current recommended threshold for cirrhotic patients to start anti-viral treatment is 2000 IU/mL. Whether anti-HBV therapy benefits cirrhotic patients in this level is still unclear. Second, lamivudine was used in this clinical trial; however, the high resistant rate of lamivudine during treatment probably lowers its protective effect against HCC. Whether a more potent anti-HBV agent with extremely low resistance profile, entecavir, is more beneficial to HBV-related cirrhotic patients is also unclear. The Bureau of National Health Institute launched the reimbursement program for anti-HBV therapy since 2003 and extended this program to cirrhotic patients with HBV DNA level > 2000 IU/mL for long-term use since Aug, 2010. Taking this advantage, we may explore the above-mentioned clinical questions more easily. To address these issues, we will first retrospectively collect a cohort of HBV-related cirrhosis patients. All the patients will be enrolled from the time before oral anti-HBV therapy is widely used. We will determine their baseline serum HBV-DNA levels using the stored sera and enrolled those with baseline HBV-DNA levels higher than 2000 IU/mL as our historical controls. Second, we will enroll a retrospective cohort of HBV-related cirrhotic patients from 2008 who had HBV-DNA levels higher than 2000 IU/mL and received indefinite therapy of entecavir. By comparing these two cohorts, we will be able to clarify whether indefinite viral suppression by entecavir is beneficial for the cirrhotic patients. With comprehensive analysis, we wish to document that re-setting the risk level of HBV DNA from 140,000 IU/mL to 2,000 IU/mL is more beneficial for HBV-related cirrhotic patients and long-term entecavir does lower the risk of HCC further. These lines of evidence will assist in delivering appropriate and more aggressive treatment for these high-risk patients.

NCT ID: NCT01950884 Enrolling by invitation - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

Lifestyle Versus Ezetimibe Plus Lifestyle in Patients With Non-alcoholic Steatohepatitis

Start date: October 2013
Phase: Phase 4
Study type: Interventional

- NAFLD (Non-alcoholic fatty liver disease) has become the most common cause of liver disease in Western countries (hepatic manifestation of insulin resistance); - NAFLD represents a cardiovascular risk factor; - Lifestyle modification(weight loss)is the effective medical treatment recommended for NASH (Non-alcoholic Steatohepatitis); - Ezetimibe could represent a novel safe treatment for NAFLD (Patel 2006. Here the investigators propose a Randomized Controlled Pilot Trial to evaluate the addictive effect of ezetimibe on liver histology, biochemical and sonographic parameters in a small (n.40) number of NASH patients randomized for 12 months in two arms: lifestyle vs lifestyle+ezetimibe.

NCT ID: NCT01898780 Enrolling by invitation - Clinical trials for Patients Who Undergo Pancreatoduodenectomy

Horizontal Mattress vs. Interrupted Suture in Surgical Techniques of Pancreaticojejunostomy

Start date: June 2013
Phase: Phase 3
Study type: Interventional

The aim of this study is to verify that the frequency of pancreatic fistula (ISGPF grade B and C) in horizontal mattress suture are lower than in interrupted suture during pancreaticojejunostomy in pancreatoduodenectomy by randomized clinical trial.

NCT ID: NCT01883518 Enrolling by invitation - Sarcoma Clinical Trials

Autologous Dendritic Cell Vaccine in Patients With Soft Tissue Sarcoma

ADCVCTAST
Start date: June 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to achieving a six-month progression free survival (PFS) of patients receiving autologous dendritic cell vaccine (ADKV) loaded with allogeneic tumor lysate expression of cancer-testis antigens (CTA) in patients with soft tissue sarcomas

NCT ID: NCT01882335 Enrolling by invitation - Malnutrition Clinical Trials

Saving Brain in Uganda and Burkina Faso

Start date: April 2013
Phase: N/A
Study type: Interventional

The study will estimate the effect of peer-counseling for exclusive breast feeding (EBF) in the first 6 months of life on cognition and other determinants of human capital formation including behavioral and emotional status; school readiness and attainment; health status; fine and gross motor skills; physical growth; and household economic status.

NCT ID: NCT01852370 Enrolling by invitation - Clinical trials for Wiskott-Aldrich Syndrome

Sequential Cadaveric Lung and Bone Marrow Transplant for Immune Deficiency Diseases

BOLT+BMT
Start date: June 20, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether bilateral orthotopic lung transplantation (BOLT) followed by cadaveric partially-matched hematopoietic stem cell transplantation (HSCT) is safe and effective for patients aged 5-45 years with primary immunodeficiency (PID) and end-stage lung disease.

NCT ID: NCT01822470 Enrolling by invitation - Clinical trials for Functional Dyspepsia

Small Intestinal Bacterial Overgrowth: A Prospective Registry

SIBO
Start date: January 2013
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to investigate the prevalence of small intestinal bacterial overgrowth (SIBO) in patients who will be undergoing an enteroscopy as an outpatient procedure with symptoms of functional dyspepsia. In addition, the investigators would like to identify the types of bacteria that are present in the small intestines in patients with SIBO and compare two different diagnostic tools: microbiologic culture and DNA sequencing of bacteria. The aim is to compare the microbiota between patients with and without the clinical complications of SIBO

NCT ID: NCT01818843 Enrolling by invitation - Clinical trials for Miscellaneous Disorders in the Fetus or Newborn

The Safety and Adverse Reaction Study of Neonatal to Inhaled Carbon Monoxide

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

Based on the study about carbon monoxide in human inflammatory and other beneficial physiological function , now we'll be going to research its application in neonates .Phase 1 Study as a foundation for the further test is, the safety and Adverse reaction study of newborn to inhaled CO

NCT ID: NCT01814579 Enrolling by invitation - Clinical trials for Disease (or Disorder); Gynecological

Vaginal Cuff Closure Time Using Unidirectional Barbed Suture in Robotic Hysterectomy

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

This study is designed to determine if using the V-Loc Wound Closure System expedites operative time in robotic hysterectomy.

NCT ID: NCT01814306 Enrolling by invitation - Clinical trials for Inadequate or Impaired Breathing Pattern or Ventilation

Supreme LMA and Proseal LMA in Prone Anesthetized Patient

SPLMA
Start date: October 2011
Phase: N/A
Study type: Interventional

There is no significant difference about success rate of two devices.