There are about 5618 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.
A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.
The purpose of the study is to assess the efficacy and safety of darolutamide in combination with standard androgen deprivation therapy (ADT) in patients with metastatic hormone sensitive prostate cancer.
The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone receptor-positive (ER-positive), human epidermal growth factor 2-negative (HER2-negative) advanced/metastatic breast cancer. INFORMATION FOR TRIAL PARTICIPANTS In this trial, the researchers will look at how well camizestrant with palbociclib works, compared with anastrozole with palbociclib, in participants with breast cancer that has either spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of standard endocrine treatment. Participants in this trial will have breast cancer that has ER proteins but does not have overexpression of HER2 protein.
Primary Objective: - To evaluate the efficacy of treatment with dupilumab to reduce sinus opacification in a population with allergic fungal rhinosinusitis (AFRS) Secondary Objectives: - To evaluate the efficacy of treatment with dupilumab to reduce sinus opacification in a population with allergic fungal rhinosinusitis (AFRS) at Week 24 - To assess the efficacy of dupilumab to reduce the need for rescue treatments - To evaluate the efficacy of treatment with dupilumab in improving symptoms in AFRS - To evaluate the efficacy of dupilumab to reduce nasal polyp formation in participants with AFRS - To evaluate the efficacy of dupilumab in improving overall symptom severity and quality of life in AFRS - To evaluate the efficacy of dupilumab in improving sense of smell in participants with AFRS - To explore the effect of dupilumab as assessed by three-Dimensional CT volumetric measurement of the paranasal sinuses - To evaluate the safety and tolerability of dupilumab when administered to participants with AFRS - To evaluate the pharmacokinetics (PK) of dupilumab in participants with AFRS - To characterize the effect of dupilumab on total IgE and specific IgE - To assess immunogenicity to dupilumab in participants with AFRS
Approximately 216 patients with acute pancreatitis and accompanying SIRS will be randomized at approximately 30 sites. Patients will be randomly assigned to either Auxora at one of three dose levels or one of three placebo volumes to maintain the double-blind. Study drug infusions will occur every 24 hours for three consecutive days for a total of three infusions. Patients will remain hospitalized as per standard of care and once discharged will be asked to complete a daily meal diary and return for a Day 30 safety assessment. It is recommended that patients randomized in the study should not be discharged from the hospital until solid food is tolerated, abdominal pain has resolved or been adequately controlled, and there is no clinical evidence of infection necessitating continued hospitalization.
Background: Recent reports increasingly recognize neurological manifestations in COVID-19 patients. However, the full spectrum of the disease and risk factors are not well understood. Aim: To describe the full spectrum of neurological manifestations in COVID-19 and assess the clinical characteristics, risks and prognostic factors. Outcomes: Identification of COVID-19 associated neurological disease is the primary outcome while requirement for admission to critical care unit, mortality, length of hospital stay, quality of life, and neurological disability are the secondary outcomes. Participants: Patients above Age more than 18 years enrolled based on new-onset acute neurological disease and COVID19 positive will serve as cases while patient with confirmed COVID-19 without neurological manifestation will serve as controls. Design and Procedures: The study is prospective case control in design and is divided into three phases in India, Brazil and Malawi ; the first phase will address role of hypoxia in causation of neurological diseases, the second phase will compare characteristics of patients hospitalized with COVID-19 with and without neurological disease and the third phase will assess the long-term follow up (at 3 months and 9 months) of cases.
The study drug, fixed dose combination of acarbose and metformin, have already been approved to take together as a treatment for type 2 diabetes (T2D). Sometimes, researchers continue studying a treatment after it has been approved to learn more about how doctors decide which treatment to give to patients. In this study, the researchers want to learn more about how acarbose and metformin work when taken together and if the patients have any medical problems. The study will include patients with T2D that was diagnosed in the last 3 to 6 months. These patients will also have recently started treatment with acarbose and metformin. The study will include about 2,000 men and women in India who are at least 18 years old. All of the patients will take fixed dose combination of acarbose and metformin tablets based on their doctor's instructions. They will then visit their study site 4 times over 6 months. At these visits, their doctors will ask them questions about how they are feeling and what medications they are taking. If require, the doctors will take blood samples to measure the patients' blood sugar levels as per routine practice. The doctors will also do physical examinations and check the patients' overall health.
The primary and general objective of this protocol as the current standard of care is to improve the quality of radiotherapy for HNC patients. This will ultimately be achieved by optimizing locoregional tumour control and overall survival and by reducing radiation-induced side effects. It will also allow the assessment of the effects of newly introduced radiation technology (e.g. proton therapy) for this particular group of patients. The clinical introduction of this standard follow-up program (SFP) will allow for a systematic and broad scale quality improvement cycle for HNC patients treated with radiotherapy.
The investigators will conduct an embedded mixed methods study in which the primary approach is a randomized controlled trial (RCT), and the secondary or embedded approach is a descriptive qualitative study. The aim of the RCT is to assess the impact of presbyopic correction on workplace productivity and retention in the textile industry in a low middle-income country. Additional qualitative data will be collected to enhance understanding of factors linked to reasons why enrolled sew-ers left their job during the study. Participants will be textile workers aged 30 years and above with uncorrected presbyopia who are employed by Shahi Exports Private Limited in Karnataka, India.
The goal of this study is to improve HCV care continuum outcomes for people who inject drugs (PWID), reduce potential onward transmission to others and improve HIV outcomes among those who are HIV/HCV coinfected. The study will evaluate whether HCV treatment outcomes (sustained virologic response, treatment completion, adherence) and post treatment outcomes (HCV reinfection, HIV viral suppression) in HCV mono- and HIV/HCV co-infected PWID can be optimized by tailoring treatment support in 7 PWID-focused integrated HIV/HCV prevention and treatment centers in India.