PubMed Health⌕ Search

Biomedical subjects

S R Mehta

Publications and source records attributed to S R Mehta.

70 records · Page 4Linked to original sources
PubMedDate not supplied

Safety outcomes in meta-analyses of phase 2 vs phase 3 randomized trials: Intracranial hemorrhage in trials of bolus thrombolytic therapy.

CONTEXT: Recent studies have reported disagreement between meta-analysis of small trials and subsequent large trials addressing the same question. However, disagreement for uncommon but serious adverse safety outcomes has not been examined. OBJECTIVE: To explore disagreement for serious adverse safety (intracranial hemorrhage [ICH]) and efficacy outcomes between meta-analysis of phase 2 (small) vs meta-analysis of phase 3 (large) randomized controlled trials comparing the efficacy of bolus thrombolytic therapy with infusion for acute myocardial infarction (AMI). DATA SOURCES: Electronic databases (MEDLINE, Cochrane Database of Clinical Trials) between January 1980 and December 1999 using the search terms thrombolysis, thrombolytic therapy, and myocardial infarction; conference proceedings; and reference lists. STUDY SELECTION: Fifteen randomized trials comparing thrombolytic agents administered by bolus injection with standard infusion therapy in patients with AMI. DATA EXTRACTION: Data on ICH, other causes of stroke, total mortality, and reinfarction were independently extracted from each study by 2 observers. DATA SYNTHESIS: Meta-analysis of 9 phase 2 trials (n = 3956) revealed a lower risk of ICH with bolus thrombolytic therapy (odds ratio [OR], 0.53; 95% confidence interval [CI], 0.27-1.01), which was not statistically significant. Meta-analysis of 6 phase 3 trials (n = 62 673) indicated a significant increase in risk of ICH (OR, 1.25; 95% CI, 1.06-1.49). These results were significantly different (P =.01). There was no disagreement for efficacy outcomes. Phase 2 trials included younger and heavier patients with lower baseline blood pressures, and were more often open-label. Subgroup analyses suggested that each of these factors was associated with a lower estimate of risk of ICH with bolus agents. CONCLUSIONS: Our results suggest that when therapeutic interventions are associated with a potential for uncommon but serious adverse safety outcomes, there may be differences between small phase 2 and large phase 3 trials that result in their disagreement for safety but not necessarily efficacy outcomes. Further investigation of the frequency and causes of disagreement between small and large trials for safety outcomes is warranted.

Clinical Trials, Phase II as Topic↗
PubMedDate not supplied

Falciparum malaria.

We analysed cases of hematologically proved cases of Plasmodium falciparum malaria encountered from July 1984 to Dec 1985 in a military hospital. The age range was 3 days to 10 years. Majority presented with classical symptom of fever (92.7%). Others presented with gastrointestinal (7.3%), hepatic (4.5%), central nervous system (7.3%) and respiratory (3.6%) symptoms. Anemia was found in 36.4%. Hepatosplenomegaly was present in majority of the cases. The rare findings were polyarthritis, rash, urticaria and cerebellar features. All cases responded to chloroquine or quinine. No resistance to drugs was found and there was no mortality.

Animals↗
PubMedDate not supplied

Diagnostic significance of pleural fluid eosinophilia during initial thoracocentesis.

A prospective study of pleural fluid eosinophilia (PFE) during initial thoracocentesis in 162 patients of pleural effusion was undertaken to determine its value in establishing an etiological diagnosis. Eighteen of the 162 cases showed pleural fluid eosinophilia (PFE), twelve could not be labelled with any definitive etiology even after extensive investigations, four belonged to the para-pneumonic group and resolved with treatment. Of the 32 patients with malignancy, PFE was seen in a single case of pleural mesothelioma. None of the patients with tuberculosis, empyema, systemic lupus erythematosus or amoebiasis had PFE. These findings suggest that PFE seen at initial thoracocentesis favours a benign diagnosis, with a rare chance of malignancy. Tuberculosis is unlikely in such patients.

Biopsy, Needle↗
PubMedDate not supplied

Cardiovascular system in leprosy.

Involvement of cardiovascular system (CVS) in 50 multibacillary (MB) and 20 paucibacillary (PB) cases of leprosy was evaluated. 20 age and sex matched controls were also studied. In addition to detailed clinical examination and resting electro-cardiogram, Master's two step exercise test (DMT) was also carried out to find out the occult and asymptomatic cardiac involvement. We have not found any significant symptomatic or electrocardiographic evidence of CVS involvement in various groups of leprosy.

Adult↗