There are about 5567 clinical studies being (or have been) conducted in India. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This a prospective observational study in Chronic Liver Disease patients admitted or seen in OPD, Department of Hepatology, Institute of Liver and Biliary Sciences, India. The study will be conducted in a period of three months starting September 2016 in sample size of 80 . A detailed proforma including history and examination and routine blood investigations will be noted. The patients will undergo close follow up at 0, 7, 15, 30, 45, 60, 90 days and similar activities will be repeated at every visit.
Development of a new mass spectrometry-based biomarker for the ear-ly and sensitive diagnosis of the Creatine Deficiency Syndromes from dry-blood-spot sample
The study will be conducted in the Department of Hepatology, Institute of Liver & Biliary Sciences, New Delhi. As a part of this study history will be taken and clinical examination will be done. Subjects will be screened for diagnosis of NASH (Non Alcoholic Steatohepatitis) cirrhosis. If subjects are found to have NASH (Non Alcoholic Steatohepatitis) cirrhosis, they will be chosen to receive stool from healthy donor, which is voluntarily donated by a healthy donor related or unrelated to the subjects and the stool will be prepared using standard guidelines. The prepared sample of stool, about 50 ml will be instilled into proximal small intestine by way of a thin and soft tube inserted through nose. This administration of sample, 50 ml daily will occur once a month every month for 6 months. The liver function parameters will be assessed and thereafter at 1 month and 3 months & subjects will be clinically assessed for improvement or worsening.
Development of a new mass spectrometry-based biomarker for the early and sensitive diagnosis of Cystinosis disease from the blood
Development of a new mass spectrography-based biomarker for the early and sensitive diagnosis of Fabry disease from the blood
The patients will be randomized into two groups 1. Endoscopic Variceal Ligation with Non Selective Beta Blocker 2. Placebo with Endoscopic Variceal Ligation
International, multicenter, observational, longitudinal study to identify biomarker/s for the development of a new MS-based biomarker for the early and sensitive diagnosis of Transthyretin-Related Familial Amyloidotic Polyneuropathy from blood and number of correctly identified patients with Transthyretin-Related Familial Amyloidotic Polyneuropathy
Development of a new MS-based biomarker for the early and sensitive diagnosis of Gilbert disease from blood
Chronic liver diseases of differing etiologies are among the leading causes of morbidity and mortality worldwide [1]. Chronic liver disease progresses through different pathological stages that vary from mild hepatic inflammation without fibrosis to advanced hepatic fibrosis and cirrhosis [2]. Assessment of the stage of liver disease is important for diagnosis, treatment, and follow-up both during treatment and after cessation of treatment. A liver biopsy is the oldest and most accurate method used to evaluate liver histology and the progression of chronic liver disease. Furthermore, different histological scoring systems have been developed and modified [3]. A liver biopsy is considered the gold standard for assessing liver histology [4]. During the pathological progression of liver fibrosis, excessive amounts of extracellular matrix build up; furthermore, serum levels of various biomarkers change, in addition to the appearance of new biomarkers in the serum during the different stages of fibrosis [2, 5]. Recently many noninvasive markers (NIMs) for assessing liver fibrosis have been developed, and they are frequently used in clinical practice. They have been validated in different studies, and some were found to be highly accurate in the assessment of liver fibrosis compared with liver biopsies [6-7], which have always been used as the standard reference method for evaluating the accuracy of noninvasive methods. There are limited studies documenting the cost effectiveness of non invasive markers over invasive technique. Most people with chronic Hepatitis B or C are unaware of their infection, putting them at serious risk of developing cirrhosis or liver cancer which are life threatening. Similarly patients with non alcoholic fatty liver diseases are unaware about fibrosis in liver. About 20-50% of persistent infection ends up into fibrosis and finally cirrhosis. Invasive and non invasive diagnostic methods are widely used to detect the fibrosis. Clinicians use different drugs and combinations to treat HBV and HCV infections. However, there is scarcity of a longitudinal prospective study to assess the cost effectiveness of these diagnostic measures. We planned to conduct a retrospective followed by prospective cohort study among all cases that underwent biopsy in ILBS or GB Pant Hospital since 2000 till Dec 2020 with HBV infection, HCV infection, or non alcoholic fatty liver disease. For retrospective cohort study, we will collect data from hospital information system for all patients with HBV infection, HCV infection, or non alcoholic fatty liver disease, who underwent biopsy during the period of 2000-Dec 2015. The new patients with HBV infection, HCV infection, or non alcoholic fatty liver disease who will undergo biopsy during the period Jan 2016- Dec 2020 will serve as a cohort for prospective design. We will collect socio-demographic data, clinical data, family history, personal history, medical history, anthropometry, biochemical and radiological data from each patient. We will also be conducting a cost effective analysis for various non invasive markers against biopsy as a gold standard in predicting fibrosis, both for retrospective and prospective cohorts. For prospective cohort study, after evaluation of baseline biopsy results, the cases with metavir fibrosis score (F0-3) will be followed for a period of 5 years to document incidence of development and progression of fibrosis. No additional investigation or test will be asked to the patient for the study. We will also develop a predicting model for development and progression of fibrosis.
The purpose of this study is to evaluate the safety of abiraterone acetate in Indian participants with metastatic, castration-resistant prostate cancer who have been prescribed abiraterone acetate as per locally approved prescribing information.