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.
The study is a randomised control trial to assess the visual and clinical outcomes of collagen cross linking in fungal keratitis. Fungal keratitis is a major cause of corneal blindness in India and the therapeutic options available are minimal to handle the advanced complications and sequalae caused by the disease.The antimicrobial and tissue remodeling role of corneal cross linking was demonstrated by several studies earlier,we anted to specifically assess the role of corneal cross linking in non resolving fungal keratitis in prevention of perforation and enhancement of healing process.
Objective: To compare intraocular pressure lowering effect of combined sclerotomy ab interno with phacoemulsification and phacoemulsification alone, in primary or secondary open angle glaucoma patients. Study design: Prospective, randomized, case- control interventional surgical trial
This is an open label, multicenter, non-comparative, phase IV study of panitumumab monotherapy in Indian subjects with previously treated, wild-type Kirsten rat sarcoma viral oncogene homolog (KRAS) and wild-type Neuroblastoma rat sarcoma viral (v-ras) oncogene homolog (NRAS), metastatic colorectal cancer. This study is designed to fulfil the requirement of the Indian regulatory authority to characterize the safety and tolerability of panitumumab when administered to Indian subjects with wild-type KRAS and wild-type NRAS metastatic colorectal cancer. Approximately 58 Indian subjects with previously treated wild-type KRAS and wild-type NRAS, metastatic colorectal cancer will be enrolled in order to achieve the target enrollment of 50 evaluable subjects who have received at least one dose of panitumumab. Subjects will receive panitumumab 6 milligram/kilogram (mg/kg) intravenously every 14 days until disease progression, intolerability, withdrawal of consent, or death. All subjects will be followed at 4 weeks and 8 weeks after the last administration of panitumumab, unless the treatment was discontinued due to withdrawal of consent or death of the subject.
Non Alcoholic Fatty Liver Disease (NAFLD) is considered as the component of metabolic syndrome. The prevalence of the same has been increasing rapidly in India, along with an increase in the prevalence of diabetes and obesity. Insulin resistance is the key underlying pathogenetic mechanism of NAFLD. NAFLD accounts for significant morbidity and mortality and the therapeutic options are limited. Insulin sensitizing drugs are used in the management of NAFLD.
To compare the efficacy of acapella and expiration against open glottis (ELTGOL) technique in promoting airway clearance of chronic obstructive pulmonary disease (COPD) patients
Methotrexate (MTX) is considered the 'gold-standard' drug for the treatment of severe psoriasis. Health-related quality of life (HRQOL) is impaired in patients with psoriasis, more so if disease is severe.
In India, majority of our patients have advanced hepatocellular carcinoma (HCC) at presentation and hence are unsuitable for the available curative treatment options. In such patients the treatment options are mainly palliative. Transarterial chemoembolization (TACE), transarterial chemotherapy (TAC) and various forms of oral chemotherapy are the only available options currently. Many patients have more advanced disease with the involvement of branches of portal vein. This further limits the therapeutic options. According to Barcelona Clinic Liver Cancer (BCLC) staging, involvement of portal vein precludes any standard form of therapy. TAC and oral chemotherapy has been tried in this group of patients by few researchers. Which treatment (TAC or oral chemotherapy) would be better suitable for advanced stage (BCLC C) needs to be explored. However, there are no randomized controlled trials (RCT's) available. TAC is the procedure for treating patients of HCC with portal vein invasion where only the chemotherapeutic drugs are injected into the feeding vessels of the tumor with no subsequent embolization of the feeding vessels. In order to select a modality which would produce better outcomes in advanced HCC patients (BCLC C), this study was planned.
A multicenter, open-label Phase 2b study of selinexor (KPT-330) in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have no therapeutic options of demonstrated clinical benefit.
Aim/ Objective: Study consists of 2 separate and distinct entities A. Evaluation of the efficacy of 2% cyclosporine in preventing graft rejection in primary grafts w/o high risk characteristics study 1 (PKP study) B. Evaluation of the efficacy of 2% cyclosporine in preventing graft rejection in therapeutic keratoplasty- study 2(TKP study) Materials & Methods: In both arms Patients requiring keratoplasty, above the age of 18 whom satisfactorily meet The inclusion criteria are different for each study Eligible candidates will be enrolled after signing an Informed Consent form Patients will be randomized into one of 2 groups - Only on topical steroids group A - On topical steroids + 2% cyclosporine Group B Study design: Prospective, randomized non-blinded study at a single centre. Methodology In both arms 1. Schedule of topical steroid administration : 6 times for 2 weeks; 5 times for 2 weeks; 4 times for a month; 3 times for a month, and, subsequently twice-a-day until 1 year is completed Systemic steroids may be administered in the initial 2 weeks at the discretion of the investigators. (For all patients with fungal keratitis topical steroids can preferrably be administered only after 2 weeks post keratoplasty.) Until then voveran ophtha may be used 3. Patients randomized to receive 2% cyclosporine will receive the same 3 times a day for 2years 4. All patients will be followed for a minimum period of 2 years 5. Follow up schedule - at 1 week, 2 weeks, 1 month, 2 months, 3 months, then every 3 months until 2 years are completed 6. All episodes of graft rejection will be treated as per accepted norms and the patient will no longer follow the standardized protocol for steroid administration
Various preclinical animal studies have shown the potential of stem cells in re-vascularising ischemic limbs and promoting collateral vessel formation. SVF have the potential to facilitate the formation of new blood vessels and skeletal muscle. Early pilot clinical studies indicate that stem-cell transplantation is feasible and may have beneficial effects in CLI. Injury or inflammation is a prerequisite for the participation of circulating stem cells to home and differentiate on to this microenvironment. The increased vascular permeability and expression of adhesion proteins like integrin assist in stem cell homing. The migratory capacity of stem cells is dependent on natural growth factors such as vascular endothelial growth factor (VEGF), Stromal cell derived factor (SDFI) and stem cell factor (SCF). The expression of VEGF, SDFI and SCF is highly unregulated in the hypoxic muscular tissue and is responsible for the recruitment of the stem cells to assist in the repair mechanism and consequent improvement in limb function. In addition to the above regenerating potential of SVF, they have several advantages; they can be easily isolated without further culturing it. Most importantly SVF have shown to have significantly highest expression of pluripotent markers similar to that of human embryonic stem cells and yet they are non-tumorogenic and safe. MSCs are having angiogenic activity and hence may be excellent source to develop neo-vasculature and hence could be explored for their therapeutic potential for treating Critical Limb Ischemia. MSC's also display membrane-bound and insoluble secreted molecules involved with cell attachment to neighbouring cells and to the extra cellular matrix19 Adipose derived Stromal vascular fraction and Mesenchymal Stem Cells has been found in preclinical studies to be safe and effective. The current Phase I/II study of adipose derived stromal vascular fraction and Mesenchymal stem cells is conducted with the broad objective of establishing safety and efficacy.