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L Jeyaseelan

Publications and source records attributed to L Jeyaseelan.

At least 19 recordsLinked to original sources

Pre-trial evaluation of the potential for unblinding in drug trials: a prototype example.

Blinding is an important design feature of randomised trials that may reduce bias in the results, compared to the situation where blinding is not possible or is not maintained. The literature provides some guidance for the evaluation of blinding in ongoing or completed studies, but the question of pre-trial assessment of the potential for unblinding has not been addressed. This paper describes the design and analysis of a prototype experiment for the pre-trial assessment of blinding in a drug trial. This work was motivated by a trial using antibiotic therapy, in which the investigators were concerned about the possibility of subjects being able to differentiate active medication from placebo, and thus become unblinded to their treatment assignment. A small experiment was mounted in which participants had to divide a random mixture of tablets into two groups. Statistical methods were developed to calculate the probability of a given number of similar tablets being classified into the same group by chance, with a modification to allow for some participants having constrained their responses to have equal numbers of tablets in each group. Differentiation of tablets by taste (the initial concern of the investigators) was not statistically different from chance. A smaller set of data on differentiation by appearance (a possibility not originally considered) had borderline statistical significance. After reviewing all these results, the investigators decided to proceed with the study without modifying the tablets, in part because subjects in the study would be unlikely to compare the two types of medication side-by-side. Our results suggest that blinding might sometimes be compromised in unexpected ways. Whenever possible, we suggest that similar and larger such experiments be carried out before the trial to assess whether blinding might be compromised. The methods proposed here could easily be adapted to evaluate the results of such experiments.

Anti-Bacterial Agents↗

Segmental colonoscopic biopsies in the differentiation of ileocolic tuberculosis from Crohn's disease.

BACKGROUND AND AIM: The differentiation between Crohn's disease (CD) and tuberculosis (TB) of the intestine can be difficult in areas where both diseases occur. The present study examined histological criteria that would enable the diagnosis in mucosal biopsies. METHODS: Colonoscopic biopsies from 33 patients with TB and 31 patients with CD were examined for several specific histological features and their distribution. RESULTS: The salient distinguishing features of TB were granulomas larger than 400 microm in maximum dimension, more than four sites of granulomatous inflammation per site, cessation, a band of epithelioid histiocytes in ulcer bases and location of granulomas in the caecum. The salient features of CD were granulomas not showing any of the above features, focally enhanced colitis, pericryptal granulomatous inflammation, and the presence of architectural alteration/activity/chronic inflammation/deep ulceration at sites that did not show granulomatous response in the same or adjacent segments. Although granulomas in CD were distributed throughout the colon, they were more frequent in the rectosigmoid than in TB. All biopsies from endoscopically abnormal sites did not show distinguishing features of TB or CD, emphasizing the need for multiple biopsies. There was an accrual in the number of diagnoses made with increasing numbers of biopsies from rectum to ileum. CONCLUSIONS: Histology of mucosal biopsies can aid in the differentiation of TB from CD, but multiple biopsies from different colonic segments are important for complete evaluation.

Adult↗

Predictors of mortality in mechanically ventilated patients.

OBJECTIVES: There are scarce data from India validating scoring systems used to predict outcome in patients requiring mechanical ventilation. This study prospectively compared the organ system failure (OSF), the acute physiology and chronic health evaluation (APACHE) II, and the APACHE III, scores on patients requiring mechanical ventilation in the medical intensive care unit, to predict outcome. METHODS: 200 consecutive patients requiring mechanical ventilation in a medical intensive care unit were recruited. OSF, APACHE II, and APCHE III scores were calculated at admission and daily for one week or until discharge in all patients. Other variables recorded include age, sex, diagnosis, oxygen therapy before ventilation, complications on ventilation, duration in hospital before ventilation, duration of ventilation, type of respiratory failure, alveolar arterial oxygen gradient, P/F ratio, use of tracheostomy, time on ventilator before tracheostomy, muscle relaxant used, fluid balance, inotrope support. Logistic regression analysis and area under the curve were computed to determine which variables independently predict outcome. RESULTS: Of the 200 patients, at discharge 143 patients (71.5%) had died. The factors that independently predicted outcome among these patients on mechanical ventilation were the type of respiratory failure (type I) OR = 2.7 (p = 0.02), the use of inotropes OR 2.4 (p = 0.04), and the APACHE II score OR = 1.8 (p = 0.008) for every five point increase in APACHE II score. CONCLUSIONS: Type 1 respiratory failure, the use of inotropes, and the APACHE II score measured at admission are significant independent predictors of mortality in the patients on mechanical ventilation.

APACHE↗

Community prevalence of hepatitis B infection and modes of transmission in Tamil Nadu, India.

BACKGROUND AND OBJECTIVE: There have been very few community based studies on prevalence of hepatitis B virus (HBV) infection in India. We undertook this study to determine the prevalence of HBV infection in a southern State of India, Tamil Nadu and to describe the important factors related to transmission of the virus in the community. METHODS: Analysis of stored blood samples from a representative population of Tamil Nadu from an earlier community cluster survey on sexually transmitted diseases (STD) prevalence using proportionate to population size (PPS) technique was done. Serum markers of HBV viz., hapatitis B surface antigen (HBsAg), hepatitis B e antigen (HBe Ag) and antibody to surface antigen (anti-HBs) were performed. RESULTS: 1981 subjects were screened in the study. HBsAg prevalence was 5.7 per cent (CI 4.6- 6.8) with 23.5 per cent (25/106) of these having positive HBe-antigen. Community seroprevalence (HbsAg + anti-HBs) of hepatitis B infection was 27.4 per cent (CI: 25.3-29.5) with the highest prevalence of 32.7 per cent (CI: 30.2-35.2) noted in the 15-20 yr age group. Significant independent association (OR 1.4; P=0.006) was detected with family history of exposure to HBV infection by logistic modeling. Other risk factors noted to have significant association were use of disposable needles during injection (OR 0.5; P=0.02) in men, smoking (OR 3; P=0.04) and use of condom (OR 0.6; P=0.08) in women. INTERPRETATION AND CONCLUSION: This community based study shows a high prevalence of hepatitis B infection in the state of Tamil Nadu with the highest prevalence being in the younger (15-20 yr) age group. High prevalence rate in childhood with e-antigenemia seen in 23.5 per cent of HBsAg positive subjects suggest childhood transmission. Poor injection practices and high-risk sexual behavior were found to be additional risk factors for transmission of the disease in the community.

Adolescent↗

Biochemical and clinical profile after organophosphorus poisoning--a placebo-controlled trial using pralidoxime.

BACKGROUND: Organophosphorus (OP) compounds are the most common suicidal poison in developing countries and mortality continues to be high. METHODS: A study was done to see butyryl cholinesterase (BuChE) profile after OP poisoning in pralidoxime (P2AM) and placebo treated cases. Highest recommended dose of P2AM was used to study the reactivation of cholinesterase. Clinical outcomes like, correlation of BuChE and severity of poisoning, mortality and complications like Type I and II paralysis, need for ventilation and ICU stay were also studied. RESULTS: Twenty one cases of moderate and severe poisoning with OP compounds were included in the study. Mean BuChE levels came up gradually over 6-7 days, some taking up to two weeks. There was no. difference between the treatment and placebo groups. BuChE levels did not correlate with severity of poisoning nor did it correlate with Type I or II paralysis, need for ventilation, ICU stay or mortality. CONCLUSIONS: Treatment with P2AM does not make any difference in BuChE reactivation or complications of moderate and severe OP poisoning. We have not been using P2AM for OP poisoning in our medical ICU with good patient outcomes.

Antidotes↗

World studies of abuse in the family environment--risk factors for physical intimate partner violence.

OBJECTIVES: To identify risk factors for physical intimate partner violence against women in Chile, India, Egypt and the Philippines. DESIGN: Population-based household survey. SETTINGS: Selected urban communities in Temuco, Chile; ISmailia, Egypt; Lucknow, Trivandrum and Vellore in India and Metro Manila, Philippines. PARTICIPANTS: Women aged 15-49 years of age who care for at least one child younger than 18 years of age. The number of participants was 442 in Chile, 631 in Egypt, 506 in Lucknow, 700 in Trivandrum, 716 in Vellore and 1000 in the Philippines. MAIN OUTCOME MEASURE: Risk of and protective factors against lifetime physical IPV. RESULTS: Significant associations were found between several risk factors like regular alcohol consumption of the husband/partner, past witnessing of father beating mother, the woman's poor mental health and poor family work status, with any lifetime physical IPV. Woman's poor mental health and witnessing father beat mother were statistically significant only in a few sites. Poor family work status, differences in employment between husband and wife and experiencing harsh physical punishment during childhood, were not found to be statistically significant across all sites. Protective factors, like higher levels of husband's and wife's education, were only found to be significantly associated with any lifetime physical IPV in Trivandrum, India. Social support was not significantly associated with any lifetime physical IPV across all sites. CONCLUSIONS: These large population-based household surveys have provided empirical evidence of the widespread nature of domestic violence and the relative commonality of risk factors across sites.

Adolescent↗

Chlamydia trachomatis genital infection in apparently healthy adult population of Tamil Nadu, India: a population-based study.

Since the epidemiology of Chlamydia trachomatis infection in apparently healthy population has not been studied in India, a population-based study was conducted in the state of Tamil Nadu, India in order to analyse the prevalence of genital chlamydial infections in the community and to implement control programmes. A representative sample was taken from three randomly selected districts by using the 'probability proportional to size' cluster survey method. Households were the basic units of clusters. Adults aged 15-45 years, pre-identified from the selected households were enrolled during the medical camps conducted for a major study on community prevalence of sexually transmitted diseases in Tamil Nadu. Blood and urine samples collected from the study subjects were tested by enzyme-linked immunosorbent assay (ELISA) for anti-chlamydial IgM antibodies and by the commercial Amplicor polymerase chain reaction (PCR) test for chlamydial DNA. The prevalence of anti-C. trachomatis antibodies determined by IgM-ELISA was 2.4% (95% CI 1.6%-3.2%). The prevalence of genital chlamydial infection determined by PCR was 1.1% (95% CI 0.5%-1.7%). Majority of the detected infections (68.8%) were asymptomatic. This is the first Indian report on the prevalence of genital chlamydial infections in the general population. It is concluded that this study provides evidence for a substantial burden of approximately 10 million asymptomatic genital chlamydial infection cases in the sexually active age groups in the general population of India.

Adolescent↗

Genital syndromes and syndromic management of vaginal discharge in a community setting.

The objective of the study was to determine the community prevalence of genital syndromes in women and evaluate the syndromic management of vaginal discharge in this setting. A representative sample for the state of Tamilnadu was chosen using probability proportional to size cluster technique. Thirty clusters were selected from three districts. Demographic, sexual behaviour, risk factors, clinical and laboratory data were collected from the selected population using a structured questionnaire. Direct smear examination for Trichomonas vaginalis, culture for Neisseria gonorrhoeae and Haemophilus ducreyi, serological tests for syphilis (RPR and TPHA), hepatitis B (Hbs Ag ELISA), IgM and IgG antibodies to HSV2 (Novum diagnostics, Germany) and PCR test for detection of C. trachomatis from urine were done. There were 1157 women in the selected population. On examination, vaginal discharge was the most common genital syndrome (38.4%). The sensitivity, specificity, positive and negative predictive value of vaginal discharge as a marker for STD in women was found to be 43.3%, 61.6%, 10.7% and 91.1%, respectively. We concluded that treatment on the basis of syndromic management would result in over-treatment of 90% of women with vaginal discharge.

Adult↗

Effect of potassium channel modulators on toxicity of Cleistanthus collinus.

The study was conducted to determine the effects of boiled extract of Cleistanthus collinus on rats by observing ECG changes and electrolyte levels in serum and urine. Influence of minoxidil and glibenclamide on Cleistanthus collinus induced toxicity was determined. ED50 for arrhythmia, changes in contractility and heart rate were recorded using the isolated frog heart. Cleistanthus at low doses caused transient tachycardia and increase in contractility and at high dose caused arrhythmia and cardiac arrest in rat. LD50 was found to be 1690 mg/kg. Minoxidil potentiated cardiac toxicity, whereas glibenclamide did not produce any significant change. High concentration of potassium in Cleistanthus extract hindered comparison of its levels. There was excretion of sodium even in the presence of hyponatraemia. Cleistanthus at low dose caused transient tachycardia and increase in contractility and at high dose caused arrhythmia and cardiac arrest in isolated frog heart. ED50 for arrhythmia was found to be 1406 mg/kg. Acute toxicity was mainly due to depressive cardiac activity of Cleistanthus. It also caused renal failure. Potassium channel modulators did not have important role in acute cardiac toxicity treatment. Probably in chronic toxicity, electrolyte level changes are involved and potassium channel modulators might have a role.

Animals↗

Fine needle aspiration in chronic tonsillitis: reliable and valid diagnostic test.

Fine needle aspiration (FNA) of the tonsil as a diagnostic tool in evaluating the microflora in chronic tonsillitis has not been popularized. A prospective study of 30 patients with chronic tonsillitis undergoing tonsillectomy was undertaken. FNA of the tonsil core was done under local/general anaesthesia. The reliability of the culture by FNA of the tonsil core was then validated with the reference (gold) standard which is the dissected tonsil core. The sensitivity of FNA culture as compared to core culture was 100 per cent and 93 per cent under general and local anaesthesia respectively. The positive predictive value of FNA culture as compared to core culture was 92 per cent and 82 per cent for general and local anaesthesia respectively. These factors indicate that FNA of the tonsil core is reliable and valid. It can safely be performed as an out-patient procedure under local anaesthesia. This is reported for the first time. Identifying the bacterial organism within the infected tonsil for appropriate antibiotic therapy could revolutionize the management of chronic tonsillitis.

Adolescent↗

Oxidative damage in intermediate syndrome of acute organophosphorous poisoning.

BACKGROUND & OBJECTIVES: The main cause of morbidity due to organophosphate poisoning is intermediate syndrome (Type II paralysis) that can occur 48-72 h after poisoning. Mechanisms that underlie the intermediate syndrome are not known. This study investigates the role of oxidative damage to muscles as a possible mechanism underlying the development of the intermediate syndrome. METHODS: Nineteen patients with acute organophosphate poisoning were evaluated from admission to discharge from intensive care for the severity of poisoning and the development and duration of the intermediate syndrome. Blood cholinesterases and parameters of oxidative stress were studied daily and their temporal profiles analysed according to the severity of poisoning and the development and duration of the intermediate syndrome. RESULTS: Fifteen patients had severe poisoning and 16 developed intermediate syndrome. There was a positive association between the severity of poisoning and the occurrence of intermediate syndrome. There was no association between the organophosphate ingested and the development of intermediate syndrome. Erythrocyte membrane acetylcholinesterase and serum butyrylcholinesterase levels at admission and over the course of poisoning were significantly (P < 0.001) reduced in patients compared to controls. There were significantly (P < 0.05) higher levels of lipid peroxidation, conjugated dienes and protein thiols in erythrocyte membranes of patients who developed the intermediate syndrome compared to healthy controls, in patients who developed intermediate syndrome compared to those who did not and in patients with long compared to short duration intermediate syndrome. INTERPRETATION & CONCLUSION: In acute organophosphate poisoning, severe and prolonged acetylcholinesterase inhibition is associated with oxidative stress, detected in erythrocyte membranes, that occurs early in the course of poisoning and may contribute to the development and severity of intermediate syndrome.

Acetylcholinesterase↗

Problems of classification of Henoch Schonlein purpura: an Indian perspective.

A 2-year prospective study was carried out in which 71 patients with primary cutaneous vasculitis were classified using the American College of Rheumatology (ACR) classification and the Chapel Hill Consensus Conference (CHCC) recommendations for Henoch Schonlein purpura (HSP). The sensitivity of the ACR criteria was 64.8% and that of the CHCC definition 31%. When the ACR criteria were combined with results of direct immunofluorescence (DIF) the sensitivity was 78.9%. The concordance between the two systems was low as only 12 patients fulfilled criteria for both classifications. Although the ACR criteria were found to be more useful in the classification of HSP our data suggest that they need to be modified to include adults with disease. The age at onset of disease was higher than that in the west. Seventy per cent of patients identified by either classification were > 20 years of age. The prevalence of gut involvement, microhaematuria and proteinuria was < 25% in both groups. The sensitivity of histopathology on the other hand was 80.4% and was not influenced by the duration of the lesion. The DIF test was a useful adjunct to histopathology if it was done within 48 h as the yield of a positive test was significantly higher in this group as compared to the patients who had the test done later.

Adolescent↗

Effect of controlled hypercapnia on cerebrospinal fluid pressure and operating conditions during transsphenoidal operations for pituitary macroadenoma.

Controlled hypercapnia was assessed for its effectiveness in raising cerebrospinal fluid pressure to enable descent of the suprasellar portion of pituitary macroadenomas during transsphenoidal surgery. The result was compared in a randomized, single blind trial with intermittent boluses of saline injected intrathecally. Intrathecal pressures were monitored in both groups. Twenty-seven of 29 patients in the study group and 25 of 28 patients in the control group reached the target pressure of 20 mm Hg. The mean ETCO2 at the time of maximum pressure was 42.34 +/- 4.75 mm Hg in the study group and 29.81 +/- 2.61 mm Hg in the control group, (P< .001). Mean arterial carbon dioxide was 46.90 +/- 6.55 and 31.42 +/- 4.87 mm Hg, respectively. Surgeons blinded to the technique assessed the descent of the tumor. The operating conditions were judged by the surgeons to be satisfactory for 20 patients in the study group and 17 patients in the control group. Both techniques were equally effective in raising intracranial pressure and in providing descent of the suprasellar component of the tumor. No untoward side effects occurred while using either technique. The authors conclude that controlled hypercapnia is effective in producing descent of the suprasellar portion of a pituitary adenoma.

Adenoma↗

Neuroparalysis and oxime efficacy in organophosphate poisoning: a study of butyrylcholinesterase.

The temporal profile of butyrylcholinesterase (BuChE) and in vitro pralidoxime-reactivated BuChE was studied in a cohort of 25 organophosphate-poisoned patients to examine their relationship to the development of intermediate syndrome and to understand reasons for lack of efficacy of oxime treatment. The clinical severity of poisoning (assessed by the Namba Scale) correlated significantly with the severity of intermediate syndrome. BuChE activity increased significantly over time and showed significant relationship to muscle power. The temporal profile of the enzyme was correlated to the clinical severity of poisoning. Reactivation potentials of BuChE (the difference between oxime-reactivated and -unreactivated enzyme activity) declined significantly with time after organophosphate ingestion. The reactivation potential of the enzyme at admission decreased significantly with increasing severity of poisoning and was lower in patients who developed intermediate syndrome. Patients who received oxime prior to hospitalization had a higher rate of intermediate syndrome and lower levels of BuChE at admission than those who had not. The study suggests that (i) BuChE reflects the clinical course of poisoning, confirming earlier studies; (ii) intermediate syndrome may be associated with a persistent inhibition of BuChE; and (iii) the lack of oxime efficacy in our patients maybe due to their severity of poisoning and the timing of oxime treatment.

Adult↗

Quantitative analysis of CD1a (T6) positive Langerhans cells in human tonsil epithelium.

Fifty-one human palatine tonsils of both sexes and 4-54 years of age were studied for quantitative analysis of Langerhans cells in the epithelium using CD1a (T6), which is a specific immunological marker for Langerhans cells and indeterminate cells. Cryo-sections were stained using the avidin biotin peroxidase method. Using light microscopy, CD1a-positive dark brown cells with dendritic processes were identified as Langerhans cells, which were located in the epithelium, subepithelial tissue, follicles and interfollicular areas. The Langerhans cells were counted only in the tonsil epithelium per zone of 1.1 mm length of basement membrane. For each biopsy, 25 such zones were studied. The mean number (SEM) of Langerhans cells per zone of tonsil epithelium was found to be 37 (+/- 0.5). In the male, it was 36 (+/- 0.7) but in the female, it was 38 (+/- 0.2). In different age subgroups, the mean number (SEM) varied between 40 (+/- 1.7) and 14 (+/- 1.1). In the age subgroups of 11-15, 16-20, and 21-25 years, the mean number showed significant sex differences. Since the 11-15, 16-20, and 21-25 age subgroups in the female showed an increased number of Langerhans cells, it is concluded that the immunological role of the palatine tonsils is increased during puberty and adolescence. In the female, there was a negative correlation (r = -0.196, p < 0.01) between age subgroups and mean numbers, but in the male there was no correlation (r = 0.008). Overall, in all the 51 biopsies together, there was a negative correlation (r = -0.017, p < 0.01) and significant (p < 0.001) sex and age differences.

Adolescent↗

Evaluation of uroprotective efficacy of amifostine against cyclophosphamide induced hemorrhagic cystitis.

The role of amifostine in the prevention of cyclophosphamide-induced hemorrhagic cystitis (HC) was evaluated in the rat model. Urinary bladders from control rats that received no drugs (group I) were compared with those from rats receiving cyclophosphamide alone at a dose of 150 mg/kg (group II), and two other groups receiving amifostine at 100 mg/kg (group III) and 200 mg/kg (group IV), 15 min prior to cyclophosphamide. Bladders were assessed macroscopically and histologically at 24 h and after 7 days. All the animals that received cyclophosphamide alone developed severe HC. On the basis of the scores of macroscopic and histologic changes, animals that received amifostine showed excellent uroprotection. Only 2/6 rats in group III and 1/6 rats in group IV developed mild HC at 24 h. None of the rats in either of these groups showed any evidence of HC at 7 days. It is concluded that amifostine protects the urothelium against cyclophosphamide-induced HC.

Amifostine↗

Survey of physical abuse during pregnancy GMCH, Nagpur, India.

INTRODUCTION: Domestic violence is a major health concern for women globally. Violence may commence or escalate during pregnancy and may be more frequent than obstetric complications e.g. preeclampsia or gestational diabetes for which they are routinely screened. No literature is available on abuse during pregnancy from India. OBJECTIVE: To assess the frequency and severity of physical abuse during pregnancy and its association with entry to antenatal care and to identify lifetime risk factors. STUDY DESIGN: Cross sectional study. STUDY SETTING: Secondary and tertiary care public hospital. PARTICIPANTS: Six hundred randomly selected pregnant women in third trimester of pregnancy (28-40 weeks of gestation) attending routine antenatal clinic were assessed for physical abuse using Abuse Assessment Screen (AAS) developed by McFarlane. MAIN OUTCOME MEASURES: Abuse status, gestational age at first antenatal visit and lifetime risk factors. ANALYSIS: Descriptive, Univariate and MLR. RESULTS: Of the 600 pregnant women interviewed, 152 (25.33%) women reported abuse during non pregnant state, 132 (22%) women reported physical abuse during index pregnancy and 10 (8.33%) women reported increase in abuse during pregnancy. In majority the abuse site was head and neck and 20% reported being hit in the abdomen. Abuse was recurrent in 92% of women. Six (4.54%) women were hospitalized, 5 (3.78%) needed medical assistance and 19.7% women were afraid of partner (husband). Abused women were twice as likely to begin antenatal care after 32 weeks of gestation as compared to non abused women (OR = 2.5; 95% CI 1.1-5.6, p = 0.02). Abused women were more likely to be Buddhist (p = 0.005), of greater parity with unwanted pregnancy, dwelling in slums (p = 0.005), from extended family (p = 0.005), with low level of education to husband (p = 0.009) and with stress to husband (p = 0.03). CONCLUSIONS: There is significant physical abuse during pregnancy in central India. Routine screen by AAS and a cohort study looking at adverse outcome of pregnancy is recommended.

Adolescent↗