Is there a positive effect of participation on a clinical trial for patients with advanced non-small cell lung cancer?

BACKGROUND: There is general belief that patients who enrolled on a clinical trial have better outcomes compared to those who are treated outside of a trial. We analyzed if there was a 'trial effect' for patients with advanced non-small cell lung cancer (NSCLC) treated with chemotherapy. MATERIALS AND METHODS: A retrospective analysis of cohorts of patients with advanced NSCLC who received chemotherapy inside and outside of a clinical trial were analyzed for response rates (RR), progression free survival (PFS), overall survival (OS), 1 and 2 year survival. RESULTS: There were 194 patients who received chemotherapy of which, 54 were on a clinical trial and 140 outside of it. For the whole group, the RR, median PFS, OS, one and two-year survivals were 35.4%, six months (range, 2-70), seven months (range, 2-72), 29.8% and 9.7% respectively. The differences in RR and PFS of patients who were treated inside and outside of a clinical trial were not significant (P=0.6164, 0.0881). The differences in median OS and one-year survivals between the groups were significant (P=0.0052, 0.022). For the whole group, patients who received II line chemotherapy had better OS (P< or = 0.0001). More patients in the trial group received II line chemotherapy (P=0.0004).The difference in the median OS between the groups continued to be significant even after patients who received II line chemotherapy were censored (P=0.0437). CONCLUSION: Patients with advanced NSCLC who were treated inside of a clinical trial had better OS compared to those who were treated outside of it.

Fusogenic peptide as diagnostic marker for detection of flaviviruses.

BACKGROUND: Dengue, Japanese encephalitis, West Nile encephalitis, yellow fever are the common flaviviral diseases associated with high morbidity and mortality. The initial symptoms of most of the flaviviral infections are similar to each other as well as to some other viral diseases. Making clinical diagnosis, therefore, becomes a challenging task for the clinician. Several studies have been reported on using detection of serum antibodies against flavivirus for the diagnosis of specific flaviviral disease; no field-based pan-flavi virus detection system is available, which can be used in low-endemicity areas for differentiation of flaviviral disease from other viral diseases. AIM: To identify a conserved amino acid sequence among all flaviviruses and evaluate the antibody formed against the conserved peptide to develop pan-flavivirus detection system. MATERIALS AND METHODS: In the present study we have compared amino acid sequences of several flaviviruses and identified a conserved amino acid sequence lying in domain II of envelope protein. RESULTS: A peptide having the conserved amino acid sequence was used to generate polyclonal antibodies and these antibodies were used to detect several flaviviruses. Anti-peptide polyclonal antibodies selectively recognized flaviviruses and did not detect non-flaviviruses. Anti-peptide antibodies detected presence of virus in serum spiked with pure virus preparations. CONCLUSION: The study offers a rationale for development of pan-flavivirus capture assay suitable for low endemic areas.

Transcatheter closure of a large coronary artery fistula with Amplatzer duct occluder: a new approach.

We report a new retrograde approach for the successful closure of a large right coronary artery fistula in a 27-year-old man using the Amplatzer duct occluder. The device was deployed through a coronary angioplasty-guiding catheter that had been advanced through the aorta and the dilated right coronary artery into the fistula. This method simplified the procedure by eliminating the need for making a femoral artery-to-femoral vein wire loop.

Massive rectal bleeding due to jejunal and colonic tuberculosis.

A case of massive rectal bleeding due to colonic tuberculosis in advanced pregnancy with intrauterine foetal death is reported. Patient was treated with resection of the left colon and left transverse end colostomy with closure of the rectal stump. Hysterotomy for the removal of the dead foetus was performed. The patient improved in health with antitubercular treatment. The colorectal anastomosis was performed after 4 months. Massive rectal bleeding in intestinal tuberculosis, though rare should be kept in mind.

Recovery positive exercise stress test: an indication for coronary artery disease.

The significance of ST depression occurring during exercise treadmill stress test has been well established. However, at times there may be no ST segment changes during exercise with changes occurring during the recovery phase. Out of the 1234 patients who underwent exercise stress test, 17 patients had ST segment changes confined to recovery phase. Coronary angiography performed in these 17 patients showed 11 patients had significant coronary artery disease (CAD), with nine patients having triple vessel disease and 2 having double vessel disease. Analysis showed there was no significant difference in the two groups of CAD and no CAD with respect to sex ratio, mean duration of exercise, maximal heart rate and double product achieved. Conclusion: Although, patients with recovery positive stress test may have normal coronary angiography, a large number of patients (64.7%) in our study had significant CAD. Hence, such patients should be subjected to another noninvasive test such as thallium perfusion scan or coronary angiography.

Sion thrombolysis trial--randomised trial of intravenous thrombolysis & primary percutaneous transluminal coronary angioplasty for acute myocardial infarction [AMI]--feasibility phase data of angioplasty limb.

Reperfusion in acute myocardial Infarction [AMI] can be realised by thrombolytic therapy or percutaneous transluminal coronary angioplasty [PTCA] has theoretical advantage but hardly any randomised trials have been published till recently to compare the two modalities. We started the STAT trial with this objective. Patients of AMI were randomised to thrombolytic therapy or PTCA. In the present article we present the phase I data of the PTCA limb. The procedural success rate was 100% with no procedural mortality. In-hospital mortality was 10% [Anterior Infarction 0%, Inferior infarction 20%]. Recurrence of angina occurred in 10% patients. Direct PTCA to left anterior descending artery appeared to be more rewarding than PTCA to right coronary artery.

Percutaneous transluminal coronary angioplasty (PTCA) in unstable angina.

We performed percutaneous transluminal coronary angioplasty in 33 highly selected patients of unstable angina, a majority of whom were initially stabilized by medical therapy. All these patients had single vessel disease with type A lesion. The initial success rate was 91% with recurrence of 17% at the end of 1 year.

Acute accidental exposure to chlorine fumes--a study of 82 cases.

Eighty-two patients were hospitalized following an accidental exposure to chlorine. All patients presented with dyspnoea and cough. The other symptoms included irritation of throat (53.6%), irritation of eyes (42.3%), headache (29.2%), abdominal pain (26.8%), vomiting (24.3%) and giddiness (9.7%). All of them had bronchospasm and 5 (6%) had cyanosis at the onset. An x-ray of the chest revealed patchy infiltrates in 3 (3.85%) and hilar congestion in 2 (2.44%). Pulmonary function tests showed an obstructive pattern in 27.4%, restrictive in 3.25% and mixed in 53.2%. Pulmonary functions were normal in 16.1% of the patients. Bronchoscopy revealed tracheobronchial mucosal congestion in all cases, hemorrhagic spots in 35.7%, erosions and ulcers in 12.5%. All patients were treated with oxygen, aminophylline, hydrocortisone and antibiotics. Haematemesis (n = 1) and pulmonary oedema (n = 2) developed 12 hours after the admission. Two other patients developed pneumonia 48 hours later. All patients recovered satisfactorily. On follow-up 16 patients had no sequelae after one year. Pulmonary functions were normal in 5 patients after 3 years of follow-up.

Coronary arteriographic findings soon after non Q wave myocardial infarction.

We performed early coronary arteriography in 27 patients (23 males, 4 females) having non Q wave MI. Infarct related vessel (IRV) was totally blocked in 25.9%, whereas 66.7% had severe residual stenosis (greater than or equal to 70%). Left main was involved in 7.5%, and at least 2 major coronary arteries were involved in 51.8%. Visible collaterals were seen in 11%. We feel, as compared to transmural MI, where total occlusion of IRV is common, the higher incidence of subtotal occlusion of IRV with severe residual stenosis, poor collaterals and significant involvement of at least one other major coronary artery may be responsible for observation of early recurrent ischemic episodes in non Q wave MI.