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.
Prospective randomized controlled trial to be conducted in the Respiratory Intensive Care Unit (RICU) of Post Graduate Institute of Medical Education And Research (PGIMER),Chandigarh. The study is approved by the Institute Ethics committee. In view of lack of previous outcome data in such patients, all patients requiring RICU admission for acute respiratory distress syndrome(ARDS) between January 2010 and June 2011 are being enrolled in this pilot study. The patients meeting the aforementioned criteria will randomly assigned to ventilation with assist control mode ventilation (ACMV group) as per the ARDSnet strategy or adaptive support ventilation (ASV group). Being the first RCT of its type, patients will be first stabilized on ACMV for 1 hour to determine the adequate minute ventilation. The randomization sequence will be computer generated. The assignments will placed in sealed opaque envelopes and each patient's assignment was made on admission to the RICU by the attending physician. Blinding of treatment is not possible. All patients will be ventilated only by Galileo Gold ventilators (Hamilton medical systems, Bonaduz, Switzerland). Patients randomized to the ACMV group will be ventilated according to low tidal volume strategy of 6ml/kg with Fio2/PEEP as per ARDSnet table to achieve a saturation between 88-95% with the lowest possible Fio2 to maintain plateau pressures < 30 cms H2o and PH > 7.3 with option to reduce tidal volume to 4 ml/kg and increase respiratory rate to 35/ min to achieve the above said goals11.These patients will be weaned as per standard protocol of spontaneous breathing trial of 30 minutes once they are recognized eligible as per statement of the sixth International consensus conference on weaning.
During colonoscopy, the colonoscopist employs various maneuvers, including changing the patient's posture to left-lateral decubitus or supine, to achieve complete colonoscopic examination. Posture change has also been reported to increase the success rate of ileal intubation. However, there has been no randomized trial which has shown that a particular posture of the patient increases the success rate of ileoscopy. The present study will be carried out to determine the impact of the patient's posture (left lateral vs supine position) on success rate of ileal intubation.
Carcinoma of the esophagus is the among the most common cancers in Indian population. While adenocarcinoma is more common in western countries, in India squamous cell carcinoma is the more frequent form. Surgery is the standard treatment in resectable lesions, but survival is poor. Adjuvant and neoadjuvant treatment therapy is used with an aim to improve the results. Though few randomized trials have addressed the issue of neoadjuvant chemoradiotherapy, the methodology was inhomogeneous and the populations studied were different. The investigators will be conducting a randomized controlled trial in patients with squamous cell carcinoma of the esophagus. Preoperative chemoradiation followed by surgery will be compared with surgery alone.
Estimation of liver volume is important for live donor liver transplant as well as extended liver resections. Computed tomography (CT) volumetry which is currently a gold standard for liver volumetry , is a time consuming process. A quicker method to estimate liver volume is essential. The aim of the present study is to try and formulate an equation based on patients height, weight etc to estimate liver volume.
Currently available investigating modalities like CT scans, MRI etc although have a high accuracy in staging of gastrointestinal(GI) tract malignancies, are not correct in all cases . The aim of this study is to assess the role of intraoperative ultrasound as a modality to increase the staging accuracy of GI tract malignancies
To study the effects of rapid escalation of Cabergoline in comparison to conventional dosing in macroprolactinomas. Rapid escalation of cabergoline may help in earlier normalization of prolactin and shrinkage of tumor mass, and thus decrease the cumulative dose of cabergoline altogether.
CPAP, the standard treatment for Obstructive sleep apnea syndrome (OSAS) that reduces sleep fragmentations and neurocognitive deficit in OSAS may also have a key role in reduction of cardiovascular, mortality risks in the same patients.
Chronic peripheral and splanchnic vasodilatation are the hallmark hemodynamic abnormality in cirrhosis and contribute to the pathogenesis of portal hypertension. Alterations in intestinal motility and bacterial overgrowth in gut may predispose to the development of bacteraemia and endotoxaemia in cirrhotic patients which play a role in the hyperdynamic circulatory syndrome of cirrhosis. Probiotic therapy is aimed at changing the make-up of the indigenous microflora by administering specific strains of non-pathogenic and potentially beneficial microflora. In this study, the investigators hypothesize that a modification in the composition of the endogenous digestive microflora by oral bacteriotherapy with high potency probiotic preparations could be a safe way to regulate the portal pressure. As there is a relative paucity in effective pharmacological treatment for portal hypertension, these novel and innovative therapy might provide important alternative or adjunct therapy to beta blockers in the clinical management of patients with portal hypertension. Aims and objectives To study in patients with cirrhosis and large varices whether probiotics and/or norfloxacin given for 2 months : 1. achieve a reduction in HVPG 2. alter the endotoxin and cytokine levels, and improve systemic inflammatory responses 3. well tolerated. Inclusion criteria: Consecutive patients of cirrhosis with portal hypertension who fulfill the following criteria: 1. Diagnosed cases of cirrhosis (by clinical, biochemical and radiological criteria with or without liver biopsy) 2. No history of upper GI bleeding in the past 3. Endoscopically documented large esophageal varices Exclusion criteria 1. history of gastrointestinal bleeding 2. patients who have received beta blockers for portal hypertension in the past 6 weeks. 3. hepatic encephalopathy 4. ongoing bacterial infection, 5. Spontaneous bacterial peritonitis 6. active alcoholism or illicit drug abuse 7. alcoholic hepatitis 8. Treatment with antibiotics in the preceding 2 weeks. 9. presence of hepatocellular carcinoma, 10. portal vein thrombosis 11. serum creatinine>1.5 mg/dL, 12. treatment with vasoactive drugs in the past 6 weeks, 13. history of arterial hypertension, congestive heart failure or arterial occlusive disease, and 14. Refusal to participate. 15. Active smokers. Study plan: Ethical approval will be obtained prior to study initiation. Patients presenting to Department of Gastroenterology, GB Pant Hospital will be recruited in the study. Patients will be evaluated regarding the eligibility for the study. After being found eligible for the study, if the patient agrees to participate in the study, a signed informed consent will be obtained. Baseline HVPG will be measured in all patients and then they will be randomized into 3 groups:. 1. Group 1: Beta blockers + placebo 2. Group 2: Beta blockers + Norfloxacin (400mg BD) 3. Group 3: Beta blockers + probiotics. (one sachet of VSL#3 BD) 30 patients will be enrolled into each group. The treatment will be continued for 2 months. The study design is a randomized double-blinded placebo controlled trial. Once patients have been enrolled, they will undergo baseline investigations. Blood will be drawn from both peripheral and hepatic veins and sent for routine parameters, pro-inflammatory cytokines (IL-1b, IL-6, IL-10, TNF-α, endotoxins, NO2 and NO3 levels, PRA, BNP). Samples will be stored at -70 ºC. Baseline vitals will be recorded. Patients will be called at the end of 1 month for assessment of compliance and then at the end of the study (2 months) to repeat the HVPG and the same parameters as at the time of enrollment End Points: 1. Primary a. Change in HVPG levels as compared with baseline, to define responder (≥20% reduction in HVPG or ≤ 12 mm Hg). 2. Secondary 1. Change in digestive flora 2. Reduction in serum and hepatic endotoxin and cytokine levels 3. Assessment of improvement in the renal parameters and Systemic inflammatory response syndrome 4. Improvement in the markers of oxidative injury 5. Adverse effects
Radiotherapy is the most appropriate treatment for postoperative recurrent carcinoma cervix. However it is technically difficult to deliver adequate doses of RT due to presence of small intestines in the radiation area; thus disease control rates are poor and complication rates are high with conventional radiotherapy. Use of IMRT and brachytherapy for these cases allows for increasing dose to the tumor while sparing normal structures. It is expected that the use of a combination of IMRT & brachytherapy will achieve higher disease control rates and decrease the complication rates.
The primary purpose of this population-based study is to quantify and understand the trends in pregnancy outcomes in defined low-resource geographic areas over time, in order to provide population-based data on stillbirths, neonatal and maternal mortality.