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.
Informed consent obtained from the patient or the patient's legal surrogate. The window for randomization and initiation of study drug infusion is 2 days from day of Admission. All further time points are relative to the day of randomization. Patients will be randomized (1:1) to receive either recombinant human GM-CSF or placebo. Using randomized block design of 10 each generated by computer and provided in sequential, sealed, opaque envelopes. Subjects will be stratified based on Child status. Patients who fulfil the inclusion criteria will receive either slow IV infusion of GM CSF (Sargamostatim-250mcg/M2) over 4 hour and inhalation of same dose by micronebulizer for 7 days OR Placebo(saline infusion and saline nebulization). Standard medical care will be given in both limbs.
- Study population:Person with HBeAg negative CHB on TDF/ETV for more than 1 year - Study design:Prospective,Interventional (single arm study) - Sample size: All the patients fulfilling the inclusion criteria will be included in first 6 months and subsequently followed up for 2 years - Intervention: Peg IFN 2b 1.5mcg/kg once every week for 48 weeks - Monitoring and assessment: LFT,HBV DNA and HbsAg at baseline, 4 weeks, 12 weeks,24 weeks,48 weeks ,72 weeks and 96 weeks, CBC every month and Thyroid function Test every 3rd month - Adverse effects: The most frequently reported side effects of IFN-based therapy are flu-like symptoms, headache, fatigue, myalgia, alopecia, and local reaction at the injection site. Peg-IFN have myelosuppressive effects; however, neutropenia\1000/mm3 and thrombocytopenia \500,000/ mm3 are not common unless patients already have cirrhosis
This Phase 3, 2-arm, randomized, active comparator-controlled, open-label, multicenter study will compare the efficacy and health-related quality of life (HR-QoL) and assess the safety of selinexor plus bortezomib (Velcade) plus low-dose dexamethasone (SVd) versus bortezomib plus low-dose dexamethasone (Vd) in adult patients with RRMM who have received 1 to 3 prior anti-multiple myeloma (MM) regimens. Crossover from the Vd Arm to a treatment that includes selinexor (i.e., SVdX or SdX) will be allowed at the point of IRC-confirmed objective disease progression per the IMWG criteria for patients in the Vd Arm.
Study population: Patients attending the Out Patient Department and admitted to Institute of Liver and Biliary Sciences. Study design: Prospective randomized controlled trial Study period: One year- January 2017- December 2018 Sample size: 130 (65 cases in each group) Intervention: The subjects will be given Fecal Microbiota Transplantation through a NJ tube placed after admission to the hospital. Participants will be administered the processed fecal microbiota sample collected from a related or unrelated healthy donor for a period of 7 days. Monitoring and assessment: The recipient will be monitored every day after Fecal Microbiota Transplantation therapy. The recipient will undergo physical examination, complete blood counts, at baseline and a chest X ray, serum procalcitonin, CRP and Tumor Necrosis Factor alpha levels, Liver Function Tests, Kidney Function Tests, International Normalized Ratio and arterial ammonia, at day 0,4,7,14,28,90,180,270 and 365 from the start of therapy. Microbiota analysis of the donors will be done at baseline and the recipients will be done on day 0,7,28,90 & 180.
Study Design: Open labeled randomized controlled trial. The study will be conducted on patients attending outpatient or admitted to admitted to Department of Hepatology from January 2017 to December 2018 at ILBS, New Delhi
Due to early diagnosis (<20yrs of age) of Type 1 Diabetes, patients face longer duration of disease and greater glycemic exposure which makes them more vulnerable towards chronic complications. The aim of this study is to investigate the prevalence and incidence of micro and macro-vascular, pulmonary complications and patterns of growth failure in approximately 500 Type 1 Diabetes patients enrolled at Diabetes Unit, King Edward Memorial Hospital Research Centre. Then follow up of 100 participants who are above 15 years of age at baseline will be done after 2 years to document incidence and progression of complications. This will contribute in assessing the public health burden of complications of Type 1 Diabetes. Factors associated with prevalence of complications will be investigated. This risk factor analysis could aid in further modifying current prevention and treatment recommendations of these complications. Results of this study could modify current clinical practice.
Patients with chronic myeloid leukemia (CML) are conventionally put on life long therapy with tyrosine kinase inhibitor drugs (Imatinib mesylate in India). Patients who achieve a deep molecular response which has been sustained for at least three years, can be taken off the drug therapy. Thereafter a close monitoring is required to monitor their disease relapse. In case there is evidence of disease recurrence on highly sensitive molecular assays, their drug therapy is restarted. The study aims to identify proportion of patients who can be kept off drug therapy in a state of sustained molecular remission.
Study assessing the efficacy and safety of alpelisib plus fulvestrant or letrozole, based on prior endocrine therapy, in patients with hormone receptor (HR) positive, HER2-negative advanced breast cancer (aBC), harboring PIK3CA mutations, who have progressed on or after prior treatments.
A phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to crizotinib alone in prolonging the progression-free survival in advanced ALK-positive NSCLC patients who are treatment naïve and to compare lorlatinib to crizotinib with respect to overall survival in the same population
The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA).