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.
Stomach cancer is the second most common cause of cancer-related deaths in India. Curative surgery offers the only chance of improving survival in this cancer. In patients whose cancer has not spread to other parts of the body (beyond the stomach and lymph nodes around it), removal of stomach (gastrectomy) with lymph nodes around the stomach and along the major vessels supplying blood to the stomach (D2 lymphadenectomy) is regarded as current standard of care at Tata Memorial Centre. However, the extent of lymphadenectomy is controversial. Some studies have suggested that removing more lymph nodes, even around the major vessels of the abdomen (aorta and inferior vena cava) may not only help to accurately determine the disease spread, but may also confer an additional survival benefit. Removing more lymph nodes around the major vessels may increase the risk of morbidity to the patient. In the last 5-6 years, stomach cancer specialists around the world have resorted to giving half the cycles of chemotherapy to the patient before the surgery (neoadjuvant chemotherapy), and the other half after the surgery in what is called 'perioperative chemotherapy'. This has been shown to lead to more patients surviving to 5 years, than before. The investigators feel that perioperative chemotherapy with D2 lymphadenectomy may constitute the best care for our patients with stomach cancer such that no further removal of lymph nodes beyond is required. However, the investigators have no evidence in literature to support this hypothesis. The investigators have thus designed this trial based on which we propose that there exists no difference between a D2 lymphadenectomy and a D3 lymphadenectomy following neoadjuvant chemotherapy for non-metastatic, locally advanced but resectable gastric cancer. The data will enable the development of clear management guidelines for lymph node dissection in stomach cancer.
Despite intense research efforts and clinical trials, there is still no effective treatment that can prolong the survival of patients with IPF. Conventional therapeutic approach includes combination of corticosteroids, anti-oxidants, immunodepressants and immune modulatory anti-fibrotic agents to be discontinued 20 days before screening. The only, so far, therapeutic approach that has been proven effective in terms of prolonging patient's survival is lung transplantation. Nonetheless, not all the patients with IPF are eligible for lung transplantation; there is a significant proportion of these patients that finally succumb while waiting in a lung transplantation list. Therefore, there is critical need for more effective and reliable therapeutic modalities5. Adult Stem Cells (ASCs) seem to represent one of these. Therefore, it is conceivable to assume that adult-stem cells can be easily and safely be applied as a novel therapeutic agent in chronic and fatal lung diseases, including chronic obstructive pulmonary disease (COPD) and IPF. Therefore, there is an urgent need to provide a safe, effective and affordable treatment option for IPF patients. New diagnostic, prognostic and therapeutic strategies need to be developed to reduce the burden of IPF. Given the present lack of appropriate treatment adjunctive in the therapy of IPF, adipose derived stromal vascular fraction provides new opportunities for development of the same. MSCs are having anti-fibrotic activity and hence may be excellent source to tackle pulmonary fibrosis and hence could be explored for their therapeutic potential for treating Idiopathic pulmonary fibrosis. MSC's also display membrane-bound and insoluble secreted molecules involved with cell attachment to neighbouring cells and to the extra cellular matrix.18 This cell surface configuration may enable mesenchymal stem cells to home from bloodstream to mesenchymal tissue.14 As limited clinical information is available about use of SVF and MSC in the IPF patients hence this Open Label, Prospective, Randomized multi center comparative study has been undertaken to explore the tolerability & effectiveness of SVF in one treatment arm and MSC in second treatment arm in IPF patients. Adipose derived stromal vascular fraction and Mesenchymal Stem Cells has been found in preclinical studies to be safe and effective
AIM: To develop and standardize a cost effective methodology or algorithm for mRNA E6/E7 for HPV genotypes 16, 18, 31, 33 and 45 as compared to commercially available assays which can be incorporated to triage excess false positives from primary screening for cervical cancers Objectives: 1. Development and standardization of methodology /algorithm for mRNA E6/E7 testing for HPV genotypes 16, 18, 31, 33 and 45 using Real-time RT-PCR, in cervical samples. 2. To compare the test performance of this HPV E6/E7 mRNA assay to HPV DNA by HC 2 as secondary screening test, with the reference standard of colposcopy with biopsy, to triage women found positive in primary screening by VIA , in a population based screening for cancer of cervix. 3. To determine number of false positives in the primary screening test after testing VIA positives with a known high specificity secondary screening test (HPV-DNA HC II ) compared to HPV E6/E7 mRNA testing. Study Population: Women in the age group of 30-65 years, who test positive on primary cervical screening test VIA will be enrolled for the proposed diagnostic tests along with reference standard of colposcopy with guided biopsy. Methodology: Women in the age group of 30-65 years undergoing routine cervical cancer screening through hospital ( Preventive Oncology screening clinic) and community based screening programs with abnormal test result using the primary cervical cancer screening test VIA will be recruited in the study. The primary screening test VIA will be administered by application of 5% Acetic Acid to the cervix and visualizing the cervix with the help of a halogen focus lamp. VIA will be considered to be positive if definite acetowhite lesions are visualized close to the squamocolumnar junction.
Zari workers in Mumbai city will be assessed for tobacco consumption habit. They will be divided into 3 arms as - 1) First arm will get Medium intensity tobacco cessation intervention 2) Second arm will get low intensity tobacco cessation intervention 3) Control arm. At the end of 12 months of intervention quit rates will be compared.
This study is planned to evaluate if linagliptin can improve insulin sensitivity in patients with type 2 diabetes mellitus. In addition, the effect of linagliptin on pancreatic function will be studied.
A large number of children in developing countries lack access to known effective interventions. Almost 9 million die each year before reaching their fifth birthday, and over 200 million children who survive fail to achieve their full growth or developmental potential, trapping them in a cycle of continuing disadvantage. The goal of "SPRING", Sustainable Programme Incorporating Nutrition and Games, is to develop an innovative approach to close this access gap, in two of the worst affected countries India and Pakistan, using community based agents. Extensive formative research will be carried out to help ensure that the content and approach of the "SPRING" intervention is feasible, acceptable and appropriately targeted. Findings will be reviewed at an intervention development workshop with local and international stakeholders and experts, and the agreed intervention piloted with a few community based agents and their supervisors. Cluster randomised controlled trials will be carried out in each setting to evaluate the impact of "SPRING" on child growth, development and survival. The programme will include process and economic evaluations to provide information on the total cost of the intervention and its cost effectiveness, as well as development of a framework with lessons learned for implementing "SPRING" in other settings.
The health benefits of exercise have been widely described, the most notable of which is an increase in cardiorespiratory fitness.Cardiorespiratory fitness has been identified as the strongest independent predictor of both all cause and cardiovascular disease mortality in nearly every population in which it has been examined. Statins, a class of hydroxymethylglutaryl-coenzyme A reductase inhibitors that lower low-density lipoprotein cholesterol, are commonly prescribed to patients with the metabolic syndrome. Statins are widely prescribed in combination with exercise to lower risk of cardiovascular disease morbidity and mortality. Every 1 millimole per liter reduction in LDL is associated with a 10-20% reduction in risk of cardiovascular events and all-cause mortality , while every 1 MET (3.5 milliters of oxygen per kilogram of body weight per minute) increase in fitness is associated with an 18% reduction in cardiovascular disease mortality and an 11-50% reduction in all-cause mortality. Although the mechanisms are poorly understood, some statins have been shown to reduce skeletal muscle mitochondrial content and oxidative capacity in humans . The muscle is a special potential target for the vitamin D endocrine system. Myopathy is well recognized in patients with severe vitamin D deficiency. This myopathy can be rapidly and impressively corrected by the appropriate vitamin D therapy. The beneficial effect of vitamin D supplementation of severely deficient but otherwise healthy adults on muscle weakness, has been reported by improved mitochondrial function. Despite the potential public health implications, studies examining the benefits and risks of combining statins and exercise in humans are limited. Moreover, Vitamin D may play a role in statin mediated changes in exercise adaptations.This study is being done to look for effect of simvastatin on exercise mediated cardiorespiratory fitness and the effect of vitamin D supplementation in these settings.
The aim of this study is to compare efficacy of POEM and pneumatic dilatation in treatment of achalasia cardia.
Hypothesis:Sleep Disorders are very common during pregnancy but the their exact role in causation of pregnancy related disorders is yet to be determined. OSA can complicate pregnancy given the risk factors of weight gain, upper displacement of the diaphragm, and hormonal-induced hyperaemia of the nasopharyngeal passages. SDB confers the risk of hypertensive disorders of pregnancy and is associated with adverse maternal and foetal outcomes. The study would involve pregnant females which would be prospectively followed in pregnancy and post partum to know the prevalence of sleep disorders in pregnancy. Diagnosis of sleep disorders would be confirmed by overnight polysomnography and ambulatory blood pressure monitoring. Pregnancy outcomes, both maternal and fetal would be recorded and its relation with sleep disorders in pregnancy would be analysed.
Childhood chronic vasculitis describes a group of rare life-threatening diseases that have in common inflammation of blood vessels in vital organs such as kidneys, lungs and brain. Most knowledge about them comes from adult patients. Severe disease requires aggressive life-saving treatments with steroids and some cancer drugs which can themselves cause damage, and increase risks of cancer and severe infections. Conversely, milder disease can be treated with less toxic drugs. Different classification and "scoring tools" are used to define the types and severity of vasculitis and to measure damage caused by disease or drugs. These in turn help direct how aggressively to treat a patient and to measure outcome. None of these tools however have been assessed in children and the best balance of disease and treatment risks against outcome for children is not known. Although causes of these diseases in children and adults are probably the same, the effects of the disease and the response (good and bad) to drugs will differ in growing children. Because specialists may see only one new child with vasculitis each year, obtaining enough information to learn about childhood vasculitis requires cooperation. We will use an international web-based registry to which doctors from 50 or more centers can contribute patient data. We will determine the features which help better classify and diagnose children compared to adults. Through the web we will collect and analyze information on patients similarly classified and "scored" so that most successful treatments can be identified. Children with vasculitis are less likely to have diseases associated with aging, alcohol and smoking etc., and therefore may be a better group in whom to study the underlying biology of vasculitis. We will use this opportunity and collect spit, blood and tissue from registry patients for laboratory study with an aim to find biomarkers to better classify, define and direct optimal treatment and outcomes.