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.
This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib for HER2-positive metastatic breast cancer (MBC). Patients were treated until disease progression, unmanageable toxicity, or study termination. Once disease progression was reported, all patients were followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.
At Tata Memorial Hospital 50% of the patients present in the locally advanced stage which is technically unresectable, or that is beyond the realm of a potentially curative surgical resection. The evaluation of treatment approaches for these tumors is hampered by the absence of any substantial randomized studies and the heterogeneous nature of the tumors at presentation. The management of these tumors has changed over the years, there is emphasis on neoadjuvant chemoradiation therapy, trying to convert a tumor that is initially unresectable to one that is potentially curable by surgery. But only 70-80% of the patients are able to complete this treatment without any significant treatment breaks. Dose escalated treatment with radiotherapy in locally advanced and unresectable rectal cancers have been tried in many small series with good results and lesser toxicity. Comparison outcome between the two arms will indicate the relative efficacy and toxicity of neoadjuvant concurrent chemoradiation vs boosted radiotherapy alone in downstaging of advanced cancers.
The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated
Obstructive Sleep Apnea (OSA) is a condition in which a person stops breathing for several seconds at a time due to relaxation of the throat muscles. This can occur many times during sleep. It is known to cause sleepiness and poor concentration during the day. Research indicates that OSA may be a modifiable risk factor for cardiovascular disease due to its association with hypertension, stroke, heart attack and sudden death. The standard therapy for symptomatic OSA is continuous positive airway pressure (CPAP). CPAP has been shown to effectively reduce snoring, obstructive episodes and daytime sleepiness and to modestly reduce blood pressure and other risk factors for cardiovascular disease. The overall aim of SAVE is to determine if CPAP can reduce the risk of heart attack, stroke or heart failure for people with OSA.
A Phase II, Open Label, Multi-Center, Proof-Of-Concept Study determing whether treatment with HDV-Interferon (HDV-IFN), by oral or subcutaneous (injection) routes, and ribavirin results in similar efficacy [Rapid Virologic Response (RVR)] and safety as the reported efficacy and safety with pegylated alpha-interferon-2a and ribavirin (historical control) in patients with chronic hepatitis C (treatment naïve by oral route and non-responders by SC route respectively).
This is an international multi-center trial that will enroll patients with locally advanced, unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose tumors have amplification of the ErbB2 (HER2) gene. The trial will investigate whether lapatinib, when added to the chemotherapy regimen, capecitabine plus oxaliplatin (CapeOx), extends the time to progression and overall survival. Tumor ErbB2 (HER2) status must be known before trial entry. CapeOx is administered to all patients, and patients will be randomly assigned to receive either lapatinib or placebo.
A feasibility study to compare the test characteristics of three different oral cancer screening techniques performed by trained primary health care workers:1)Unaided Visual Inspection, 2)VelScope Assisted Examination, and 3) Examination after application of Toluidine Blue dye.
Head & Neck squamous cell carcinomas are the commonest cancers afflicting the developing countries. Traditionally surgery or radiotherapy alone in the early stages and surgery with postoperative radiotherapy in advanced stages have been the mainstay of treatment. Of late there has been a paradigm shift in the management of these cancers, particularly those of the oropharynx and laryngopharynx, where chemoradiation has been advocated as part of organ preservation protocol with good outcomes. Conventional radiotherapy involves the use of 2 or 3 field technique with or without compensators to encompass the volume at risk to radical doses of 66-70 Gy typically needed to sterilize gross disease. This strategy however is associated with considerable acute morbidity (mucositis, dysphagia, dermatitis) and debilitating late toxicity (xerostomia). Three dimensional conformal radiation therapy (3D-CRT) and intensity modulated radiation therapy (IMRT) have the potential to improve the dose distribution, with increased doses to the target volumes and reduced doses to surrounding normal structures, thereby improving the therapeutic ratio.
We hypothesize through this randomized, placebo-controlled adjuvant study, that Aspirin in patients with dukes C or high risk dukes B colorectal cancer (ASCOLT) can improve survival in this patient population over placebo control. If indeed found to be beneficial, because aspirin is cheap and easy to administer, it will positively impact the lives of many individuals in Asia and globally. STUDY OBJECTIVE To assess the effectiveness of Aspirin against placebo control in patients with dukes C or high risk dukes B colorectal cancer in terms of Disease Free Survival (DFS) and Overall Survival (OS) Primary endpoints - DFS among all eligible subjects (high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer patient sub-groups); - DFS among patients with colon cancer (high-risk Dukes B and Dukes C colon cancer). Secondary endpoints - Overall survival (OS) over 5 years - DFS and OS in - Chinese, Malay, Indian and other ethnic groups - Resected high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer sub-groups, individually - Compliant versus non-compliant subjects - PIK3CA mutated tumors (where samples are available)
A therapeutic as well as preventive role of probiotics has been suggested from results of different studies using different probiotics that have been tested, usually lactic acid producing bacteria such as lactobacillus, bifidobacterium and streptococcus species. The supplementation of probiotics to infants may also have a prophylactic effect against acute diarrhoeal diseases. In the present proposal, we plan to examine if daily intake of a probiotic beverage, which includes 15 billion probiotic Lactobacilli, has a beneficial role in protecting children from infectious diarrhea in Kolkata. OBJECTIVES Primary objectives: 1. To assess the impact of probiotics in the prevention of acute diarrhoeal diseases in children 2. To assess the impact of probiotics on nutrition and growth of the children Secondary Objectives: 1. Reduction in duration, frequency of diarrhoea 2. Identification of pathogens causing diarrhoea 3. Examination of faecal microflora STUDY DESIGN It will be a double blind randomized controlled field trial involving 4000 children aged between 1 and 5 years in an urban slum of Kolkata, India. The 4000 children will be identified through demographic survey. The study will be double blinded where the study arm will receive Probiotic drink, which includes 15 billion probiotic Lactobacilli, one bottle (65ml) daily (under supervision of a Health Worker) for 12 weeks and the control arm will receive a similar drink without the lactobacilli (Nutrient drink) daily for 12 weeks. Randomization will be done in a ratio of 1:1, i.e., the study arm and control arm will include 2000 children each. All the children under the study will be visited daily by a health worker who will supervise intake of Probiotic drink or Nutrient drink by the children. All the children will be followed up daily for 24weeks for identification of acute diarrhoea cases.