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NCT ID: NCT03195920 Recruiting - Urinary Stone Clinical Trials

Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease

Start date: June 2017
Phase: N/A
Study type: Interventional

This is a single arm, single center study to assess the safety and efficacy of a form of extracorporeal lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones.

NCT ID: NCT03191786 Not yet recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study of Atezolizumab Compared With Chemotherapy in Treatment Naïve Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Containing Therapy

Start date: September 1, 2017
Phase: Phase 3
Study type: Interventional

This Phase III, global, multicenter, open-label, randomized, controlled study will evaluate the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 [anti-PD-L1] antibody) compared with a single agent chemotherapy regimen by investigator choice (vinorelbine or gemcitabine) in treatment-naïve participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are deemed unsuitable for platinum-containing therapy due to poor performance status (Eastern Cooperative Oncology Group [ECOG] performance status of 2-3).

NCT ID: NCT03190330 Not yet recruiting - Clinical trials for Leukemia, Lymphocytic, Chronic, B-Cell

A Study to Assess Safety of ImbruvicaTM in Indian Participants With Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy or Chronic Lymphocytic Leukemia With 17p Deletion

Start date: July 5, 2017
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to evaluate the post-marketing safety of ImbruvicaTM (ibrutinib capsule 140 milligram [mg]) under actual conditions of use, and to understand the incidence of adverse events (AEs) (serious and non-serious AEs).

NCT ID: NCT03188770 Not yet recruiting - Clinical trials for Mechanical Ventilation

Practice of Ventilation in Middle-Income Countries

PRoVENT-iMIC
Start date: October 2017
Phase: N/A
Study type: Observational

The purpose of this international, multicenter service review is to describe and compare ventilation management in patients at risk of acute respiratory distress syndrome (ARDS) versus patients not at risk and patients with established ARDS, and to ascertain whether certain ventilator settings and ventilation parameters are associated with pulmonary complications or development of ARDS after start of ventilation in patients in intensive care units (ICUs) in Asian countries. Participating centers will include adult patients undergoing mechanical ventilation in the ICU during a 28-day period. Patients' data will be collected during the first 7 days in the ICU, or until ICU discharge. Follow up is until ICU discharge. The primary outcome includes two main ventilator settings, i.e., tidal volume and the level of positive end-expiratory pressure. Secondary endpoints are development of ARDS in patients without ARDS at the onset of mechanical ventilation, worsening of ARDS in patients with ARDS at the onset of mechanical ventilation, pulmonary infection, other pulmonary complications, need for tracheostomy, duration of ventilation, length of ICU stay and ICU mortality.

NCT ID: NCT03187158 Enrolling by invitation - Metabolic Syndrome Clinical Trials

Factors Affecting Early Adult Lung Function

FEAL
Start date: July 15, 2017
Phase: N/A
Study type: Observational

Attainment of peak healthy lung function during the 18-26 yr window is a strong determinant of the rate of lung function decline during the later years of life. The attainment of a healthy peak lung function is mediated by pre and peri natal exposures ( in utero environment and nutrition) and exposure to environmental toxicants and nutrition during childhood and early adulthood. Towards this Indian birth cohorts, having collected comprehensive data on maternal nutrition and anthropometry can provide invaluable insight into the factors affecting lung function growth and their effect sizes in the Indian population. Therefore, in this observational study, the Investigator will be collecting data on lung function, current nutritional and environmental exposures and linking it to pre and peri natal data of the same participants in order to understand lung function growth and the reasons for an early decline in the Indian population, using a life course approach.

NCT ID: NCT03184909 Not yet recruiting - Cognitive Change Clinical Trials

Tulsi Consumption and Its Effects on Cognition, Stress and Anxiety

Start date: August 15, 2017
Phase: N/A
Study type: Interventional

Tulsi and its effects on facilitative cognitive enhancement through lowering levels of stress and anxiety. A randomised placebo-controlled clinical trial.

NCT ID: NCT03176238 Active, not recruiting - Clinical trials for Post Menopausal Breast Cancer

Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

EVEREXES
Start date: March 29, 2013
Phase: Phase 3
Study type: Interventional

The present international, multi-center, open-label, single-arm study aims at collecting clinical safety, tolerability and efficacy data with the use of everolimus combined with exemestane in the Novartis Oncology Emerging Growth Market (EGM) countries for the treatment of post-menopausal women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer after documented recurrence or progression following a non-steroidal aromatase inhibitor (NSAI) therapy.

NCT ID: NCT03172780 Recruiting - Clinical trials for Osteoarthritis, Knee

A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee"

Start date: May 24, 2017
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, three-arm, placebo controlled, bioequivalence study with clinical endpoint has been designed to establish clinical equivalence and safety of Mylan's diclofenac gel in the symptomatic treatment of steoarthritis of knee compared to Voltaren® gel and to establish superiority in efficacy of both compared to a placebo (vehicle) gel. Male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of osteoarthritis of the knee according to the American College of Rheumatology (ACR) criteria Total study duration for the clinical part will be around 56 days that includes screening period of 28 days and treatment period of 4 weeks.

NCT ID: NCT03171324 Recruiting - Iron-deficiency Clinical Trials

to Assess the Effect of Early vs Routine Iron Supplementation on Iron Store and Growth in Term Infants

Start date: March 1, 2017
Phase: Phase 4
Study type: Interventional

Term infants (Small for Gestational Age and Appropriate for Gestational Age) would be randomized to receive oral iron supplementation from 6 weeks and 6 months. Growth in terms of Occipitofrontal circumference, length and weight would be monitored at 6 weeks, 6 months and 1 year of age. Hemoglobin, RBC (Red blood corpuscles) indices and ferritin would be monitored at 6 months and 1 year of age.

NCT ID: NCT03170765 Enrolling by invitation - MEASLES DISEASE Clinical Trials

Randomized Controlled Trial of Measles Vaccination Schedule

Start date: March 14, 2017
Phase: N/A
Study type: Interventional

Measles is a preventable infectious viral disease. Since 1985, India has been administering a single dose of measles vaccine to all infants at 9 months of age. This age was chosen to balance the disappearance of maternal (transplacental) antibodies with the increasing risk of developing measles. Thus infants are expected to get protection against measles by acquired maternal measles antibodies derived trans-placentally from the mother for the first 9 months of life. Thereafter vaccine-induced antibodies are expected to protect infants. Seroconversion after measles vaccination does not take place as long as maternal measles antibodies persist in the infant. However, it is widely recognized that a substantial proportion of measles infection (10 to 15%) can occur among infants before the age of measles vaccination. Further, two small cohort studies done in our institution confirm that the majority of infants lose maternal antibodies by six months of age, making them susceptible to measles.This argues strongly for anticipating measles vaccination to an earlier age. However, such early vaccination has the risk that residual maternal antibodies (even if insufficient to protect infants) can neutralize the antigen in the vaccine, rendering vaccination ineffective. Therefore, a careful balance has to be chosen so that low levels of circulating maternal antibodies do not interfere with infants' response to vaccination. However, there is no prospective study in Indian infants to determine the seroconversion and sero-protection rate of earlier vaccination. This study has following aims and objectives: 1. To study the level of measles specific immunoglobulin G (IgG) antibodies in a cohort of term infants followed from birth to 9 months of age; and the pattern of antibody decline in them. 2. To compare the levels of antibodies in infants at these time points and correlate the levels with the antibody level in the respective mothers at the time of delivery. 3. To compare the efficacy and safety of three different measles vaccination schedules in a cohort of term infants viz (i) vaccination at 9 months of age (current practice), (ii) vaccination at 7.5 months and 9 months of age, and (iii) vaccination at 6 months and 9 months of age.