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Biomedical subjects

S Garg

Publications and source records attributed to S Garg.

At least 19 recordsLinked to original sources

Efficacy and safety of preprandial human insulin inhalation powder versus injectable insulin in patients with type 1 diabetes.

AIMS/HYPOTHESIS: The efficacy and safety of human insulin inhalation powder (HIIP) plus insulin glargine were compared to subcutaneously injected insulin (SC insulin) plus insulin glargine in patients with type 1 diabetes. METHODS: This was a randomised, open-label crossover study in which one group of patients received preprandial HIIP plus insulin glargine for 12 weeks, followed by the same duration with preprandial SC insulin (lispro or regular) plus insulin glargine. Another group of patients received the reverse treatment sequence. The trial was designed as a non-inferiority comparison of the two treatments for effect on HbA(1c); blood glucose levels were also monitored. Safety assessments included adverse event reporting and hypoglycaemic events. RESULTS: HbA(1c) at endpoint was 7.95+/-0.12% for the HIIP treatment and 8.06+/-0.12% for the SC insulin treatment; mean changes from baseline to endpoint were -0.08 and 0.00%, respectively, (p=NS). The upper limit of the 95% CI of mean difference in HbA(1c) between the two treatments was 0.02%, indicating that HIIP was not inferior relative to SC insulin, as measured against the pre-defined margin of 0.3%. Fasting blood glucose was significantly lower for HIIP treatment (8.09+/-0.33 mmol/l; n=117) than for SC insulin treatment (9.05+/-0.33 mmol/l; n=111) (p=0.01). Safety profiles were comparable between the two treatments. The rate of any hypoglycaemia (least-squares mean adjusted for 30 days+/-SE) was 8.9+/-0.7 and 8.2+/-0.8 for HIIP and SC insulin treatments, respectively, (p=0.29). The rate of nocturnal hypoglycaemia was greater for HIIP (4.2+/-0.4) than for SC insulin (2.7+/-0.4; p<0.001). CONCLUSIONS/INTERPRETATION: HIIP was similar in efficacy to SC insulin for glycaemic control in type 1 diabetes mellitus. The two treatments had comparable safety profiles.

Administration, Inhalation↗

Endoscopic management of liver abscesses and cysts that communicate with intrahepatic bile ducts.

BACKGROUND AND STUDY AIMS: The formation of a communication between liver abscesses or cysts and intrahepatic bile ducts is an uncommon cause of significant bile leak. Surgical management of biliary fistulas is associated with high morbidity and mortality. We performed a prospective study of endoscopic management of this type of biliary fistula. PATIENTS AND METHODS: We studied 26 patients who had either liver abscesses or hepatic cysts that had ruptured into the intrahepatic bile ducts. The presence of a biliary fistula was suspected by jaundice and/or by the appearance of bile in percutaneous drainage effluent from a liver abscess and was confirmed by endoscopic retrograde cholangiopancreatography. Once the route of the fistula between the liver abscess or cyst and the intrahepatic bile duct had been defined by cholangiography, patients underwent treatment by sphincterotomy, and either biliary stenting or nasobiliary drainage. Nasobiliary drains or biliary stents (both 7 Fr) were placed according to standard techniques. Nasobiliary drains were removed when bile leakage stopped and closure of the fistula was confirmed by cholangiography; stents were removed after an interval of 4-6 weeks. RESULTS: Of a total of 525 patients with hepatic abscesses or cysts who were seen over a 5-year period, there were 26 patients who developed a demonstrable communication between liver abscesses (n = 20; 16 amebic, four pyogenic) or hydatid cysts (n = 6) and intrahepatic bile ducts (right intrahepatic bile ducts in 22 patients, left intrahepatic bile ducts in four patients). We performed either sphincterotomy with insertion of a nasobiliary drain (n = 20) or sphincterotomy with biliary stenting (n = 6). The fistulas healed in all patients after a mean time of 4 days (range 2-20 days) after endoscopic treatment. We were able to remove the nasobiliary drainage catheters and stents 6-34 days after their placement. CONCLUSIONS: In this case series, endoscopic therapy appears to be an effective mode of treatment for biliary fistulas complicating liver abscesses and cysts.

Adult↗

Profile of chronic hepatitis B virus in children in India: experience with 116 children.

BACKGROUND: Hepatitis B virus (HBV) infection in children is mostly asymptomatic and therefore the disease burden is likely to be under appreciated. There is limited information on the profile of chronic HBV infection in children from the Indian subcontinent. METHOD: In 116 (male:female 89:27) children, aged <15 years, with persistent HBsAg positivity for more than 6 months, a clinical, biochemical, virological and histological assessment was carried out. RESULTS: At presentation, 21.6% of children were symptomatic, with icterus in 12%. Features of decompensation such as ascites (7%) and gastrointestinal (GI) bleed (5%) were noted uncommonly. Five (4.3%) children had hepatocellular carcinoma (HCC) at presentation. Elevated alanine aminotransferase (ALT) was observed in 76% of subjects (median 61; range 14-815). A significantly higher proportion of children with hepatitis B early antigen (HbeAg) positive status had higher histological activity index (HAI) (84% vs 16%, P < 0.001) and fibrosis score (80% vs 20%, P = 0.007). A strong positive correlation was noted between aspartate aminotransferase (AST), ALT, HBV-DNA and histological severity of the disease (HAI > or =4, fibrosis > or =2). Median HBV-DNA levels were significantly higher in the HBeAg positive compared to the HBeAg negative group (25.6 vs 0.7 pg/mL, P = 0.004). Seventy-four percent of the mothers had evidence of past or present HBV infection. CONCLUSIONS: Majority of the children with chronic HBV infection are asymptomatic at presentation. HBeAg positive status reflects histologically more severe disease, and a higher level of HBV-DNA. Almost two-thirds of the children may have acquired their HBV infection perinataly.

Adolescent↗

Multiple cranial nerve palsies associated with type 2 diabetes mellitus.

Although isolated cranial nerve palsies are common in patients with diabetes mellitus, multiple simultaneous cranial neuropathies are rare. We report a 48-year-old man, a known case of diabetes mellitus, who presented with facial palsy, foot drop and painful ophthalmoplegia of the left eye. The initial differential diagnosis included diabetic polyneuropathy, septic cavernous sinus thrombosis, mucormycosis and the Tolosa Hunt syndrome. Magnetic resonance (MR) imaging findings were consistent with those of the Tolosa Hunt syndrome. The patient had a remarkable complete resolution of his ophthalmoplegia after four weeks of steroid treatment, with repeat MR imaging showing resolution of the initial changes.

Comorbidity↗

Congenital anomaly rate in offspring of mothers with diabetes treated with insulin lispro during pregnancy.

AIM: To determine the rate of major congenital anomalies in offspring of a large group of women with diabetes mellitus treated with insulin lispro (Humalog). METHODS: This multinational, multicentre, retrospective study included mothers with diabetes mellitus (diagnosed prior to conception) who were treated with insulin lispro for at least 1 month before conception and during at least the first trimester of pregnancy. Anomalies were assessed by two independent dysmorphologists not affiliated with the sponsor. RESULTS: The charts of 496 women were reviewed for 533 pregnancies resulting in 542 offspring (500 live births, 31 spontaneous and seven elective abortions, and four stillbirths). Mothers' characteristics: mean (+/- SD) age was 29.9 (+/- 5.2) years, 85.6% were Caucasian and 97.2% had Type 1 diabetes mellitus. Insulin lispro continued to be the main mealtime insulin for more than 96% of the women during the second and third trimester. The dysmorphologists determined that 27 (5.4%) offspring had major congenital anomalies and 2 (0.4%) offspring had minor congenital anomalies. CONCLUSIONS: The rate of major congenital anomalies was 5.4% [95% CI (3.45%, 7.44%)] for offspring of mothers with diabetes mellitus treated with insulin lispro before and during pregnancy. The current published rates of major anomalies in infants born to mothers with diabetes treated with insulin are between 2.1 and 10.9%. This suggests that the anomaly rate with insulin lispro treatment does not differ from the published major congenital anomaly rates for other insulin treatments.

Abnormalities, Drug-Induced↗

Threshold Amsler grid as a screening tool for asymptomatic patients on hydroxychloroquine therapy.

BACKGROUND/AIMS: Patients taking hydroxychloroquine (HCQ) are at risk of developing classic bull's eye maculopathy. Currently, the standard Amsler grid (AG) is one of the most useful methods to identify such lesions. However, AG is a suprathreshold target and may not detect relative central scotomas. The aim of this study was to determine if the threshold Amsler grid (TAG) test, which varies light transmission through two cross polarising filters, allows increased detection of scotomas caused by HCQ toxicity. METHODS: 56 rheumatological patients taking HCQ and 12 similar patients not taking HCQ were tested by AG, red Amsler grid (RAG), and TAG. RESULTS: No scotomas were observed in patients never treated with HCQ. Among patients who had been treated with HCQ, AG revealed scotomas in two of 56 (3.64%) patients; in contrast, six (10.7%) and 37 (66.1%) scotomas were identified by RAG and TAG testing respectively. Additionally, the average area of each scotoma detected by all three methods expanded from 34.5 square degrees of central field loss on AG testing to 71 square degrees on RAG and 117 on TAG. CONCLUSION: By decreasing the perceived luminance of the suprathreshold AG, TAG testing provides a novel alternative to detect shallow scotomas and areas of depressed retinal activity secondary to HCQ toxicity.

Adult↗

Adrenomyeloneuropathy.

Adrenomyeloneuropathy is a rare X-linked inherited disorder of peroxisomes characterized by the accumulation of very long chain fatty acids (VLCFA) in the central and peripheral nervous system, adrenal glands and testis leading to the dysfunction of these organs and systems. The phenotypic expression is highly variable, childhood cerebral adrenoleukodystrophy and adrenomyeloneuropathy being the main variants. Here we report a case of adrenomyeloneuropathy presenting initially as Addison's disease, which remained undiagnosed for many years with many rare features. We could not locate any other publication on this subject in the indexed journals of literature published from India.

Adolescent↗

Community based study on sero-prevalence of syphilis in New Delhi (India).

Syphilis continues to be a major health problem in India. Data regarding sero-prevalence of syphilis is largely hospital based. Majority of community based studies have been conducted on select groups. Therefore, these studies do not reflect the true prevalence of syphilis in general population. The objective of the study was to determine the sero-prevalence of syphilis in the urban and rural communities of New Delhi, using both VDRL and TPHA for screening and FTA-ABS for confirmation and discrepant analysis. Serum specimens from 178 males and 227 females aged between 15-49 years were tested. VDRL test was put up using VDRL antigen from serologist, Kolkata. TPHA and FTA-ABS were performed using commercially available kits. 6.91% (28/405) subjects were found to be seropositive for syphilis (males 10.11%, females 4.40%). Syphilis seropositivity was found to be significantly associated with low income (p=0.02) and presence of symptoms suggestive of STIs (p=0.00) among males. Positive syphilis serology was significantly associated with trichomoniasis in females (p=0.00). Community based studies utilizing one non-treponemal test plus one treponemal test for screening purpose and an additional specific test for confirmation should be used for designing a control programme.

Adolescent↗

Ion-exchange resins: carrying drug delivery forward.

Ion-exchange resins (IER), or ionic polymer networks, have received considerable attention from pharmaceutical scientists because of their versatile properties as drug-delivery vehicles. In the past few years, IER have been extensively studied in the development of novel drug-delivery systems (DDSs) and other biomedical applications. Some of the DDSs containing IER have been introduced into the market. In this review, the applications of IER in drug delivery research are discussed.

Journal Article↗

Chemistry and pharmacology of the Citrus bioflavonoid hesperidin.

Hesperidin, a bioflavonoid, is an abundant and inexpensive by-product of Citrus cultivation. A deficiency of this substance in the diet has been linked with abnormal capillary leakiness as well as pain in the extremities causing aches, weakness and night leg cramps. No signs of toxicity have been observed with the normal intake of hesperidin or related compounds. Both hesperidin and its aglycone hesperetin have been reported to possess a wide range of pharmacological properties. This paper reviews various aspects of hesperidin and its related compounds, including their occurrence, physical and chemical properties, analysis, pharmacokinetics, safety and toxicity and the marketed products available. A special emphasis has been laid on the pharmacological properties and medicinal uses of these compounds.

Citrus↗

Properties of a new acid-buffering bioadhesive vaginal formulation (ACIDFORM).

Vaginal prophylactic methodology may prevent heterosexual transmission of the HIV and other sexually transmitted disease-causing organisms as well as unplanned pregnancies. A new delivery system (ACIDFORM) was designed with acid-buffering, bioadhesive, and viscosity-retaining properties to (1) maintain the acidic vaginal milieu (the low pH inactivates many pathogens and spermatozoa), (2) form a protective layer over the vaginal/cervical epithelium (minimizing contact with pathogenic organisms), and (3) provide long-term vaginal retention. A Phase I clinical study with ACIDFORM provided initial information about its safety and showed the formation of a layer over the vaginal/cervical epithelium [1; Amaral et al., Contraception 1999;60:361-6]. To study the properties of the gel (without active ingredient) in more detail, ACIDFORM's acid-buffering, bioadhesive, viscosity-retaining, and spermicidal properties were compared in vitro to marketed formulations, and its long-term stability was assessed. ACIDFORM, either when titrated with NaOH or when mixed directly with semen, is highly acid buffering and much more effective than Aci-Jel, a commercial acid-buffering vaginal product. ACIDFORM adheres well to two model membranes (excised sheep vagina and cellophane) and is more bioadhesive than Conceptrol, Advantage S, Replens, Aci-Jel, and K-Y jelly. On dilution, ACIDFORM also retains its viscosity better than these marketed products. ACIDFORM is spermicidal and is stable for at least 2 years. These results suggest that ACIDFORM has advantages over presently marketed vaginal delivery systems. The gel may either be useful by itself as an antimicrobial contraceptive product or as a formulation vehicle for an active ingredient with antimicrobial and/or contraceptive properties.

Acrylic Resins↗

Caveolin-1 expression is associated with high-grade bladder cancer.

OBJECTIVES: To assess the levels of caveolin-1 in a series of bladder tumor specimens of varying stage and grade and to identify possible links between caveolin-1 status and clinical behavior. Caveolae have emerged as sites of important regulatory events at the cell membrane in many different cell types. Caveolins are the main structural components of caveolae and belong to a family of highly conserved integral membrane proteins. The function of caveolin-1 appears to be intrinsically linked to cell signaling modulation by multiple pathways. Modification of CAV-1 gene expression appears to be a common feature of the oncogenically transformed phenotype. METHODS: Using a rabbit polyclonal antibody against caveolin-1 and immunohistochemistry, we assessed caveolin-1 protein expression in 89 formalin-fixed, paraffin-embedded bladder tumor sections. The patient group studied included 71 men and 18 women (mean age +/- SD 69.7 +/- 10.9 years). The stage was Ta-T1 in 68 and T2-T4 in 21 tumors in this series. The clinical follow-up was 1 to 38 months (mean 21.2 +/- 9.9). RESULTS: A statistically significant association was observed between caveolin-1 immunoreactivity and tumor grade (P = 0.0118, chi-square test), with 8 (21%) of 38 G3, 1 (3%) of 30 G2, and 0 of 21 G1 tumors positive for caveolin-1. When the clinical data were examined in conjunction with caveolin-1 status, no statistically significant relationship was seen between caveolin-1 expression and tumor multiplicity, tumor recurrence, tumor progression, or patient survival. CONCLUSIONS: The results of our study demonstrate that altered expression of caveolin-1 protein is a component of tumor dedifferentiation in a subset of high-grade bladder cancers. This pilot study provides a basis for further investigation of the role of caveolin-1 and the function of caveolae in the most aggressive forms of this tumor.

Aged↗

Clinical evaluation of the GlucoWatch biographer: a continual, non-invasive glucose monitor for patients with diabetes.

A device providing frequent, automatic, and non-invasive glucose measurements for persons with diabetes has been developed: the GlucoWatch biographer. This device extracts glucose through intact skin via reverse iontophoresis where it is detected by an amperometric biosensor. The biographer can provide glucose readings every 20 min for 12 h. The performance of this device was evaluated in two large clinical studies in a controlled clinical environment (n=231), and the home environment (n=124). Accuracy of the biographer was evaluated by comparing the automatic biographer readings to serial finger-stick blood glucose (BG) measurements. Biographer performance was comparable in both environments. Mean difference between biographer and finger-stick measurements was -0.01 and 0.26 mmol l(-1) for the clinical and home environments, respectively. The mean absolute value of the relative difference was 1.06 and 1.18 mmol l(-1) for the same studies. Correlation coefficient (r) between biographer and finger-stick measurements was 0.85 and 0.80 for the two studies. In both studies, over 94% of the biographer readings were in the clinically acceptable A+B region of the Clarke Error Grid. A slight positive bias is observed for the biographer readings at low BG levels. Biographer accuracy is relatively constant over all rates of BG changes, except when BG decreases more than 10 mmol l(-1) h(-1), which occurred for only 0.2% of points in the home environment study. Biographer precision, as measured by CV%, is approx. 10%. Skin irritation, characterized by erythema and edema, was either non-existent or mild in >90% of subjects and resolved in virtually all subjects without treatment in several days.

Blood Glucose Self-Monitoring↗

Socio-cultural aspects of menstruation in an urban slum in Delhi, India.

This paper attempts to understand the experience of menstruation in the socio-cultural context of an urban Indian slum. Observations were gathered as part of a larger study of reproductive tract infections in women in Delhi, using both qualitative and quantitative methods. The qualitative phase consisted of 52 in-depth interviews, three focus groups discussions and five key informant interviews. In the quantitative phase inferences were drawn from 380 respondents. Mean age at menarche was 13.5. Onset of menarche is associated with physical maturity and the ability to marry and reproduce. However, a culture of silence surrounds menarche, an event which took the women interviewed almost by surprise. Most were previously unaware that it would happen and the information they were given was sparse. Menstruation is associated with taboos and restrictions on work, sex, food and bathing, but the taboos observed by most of the women were avoidance of sex and not participating in religious practices; the taboo on not going into the kitchen, which had been observed in rural joint households, was not being observed after migration from rural areas due to lack of social support mechanisms. There is a clear need to provide information to young women on these subjects in ways that are acceptable to their parents, schools and the larger community, and that allow them to raise their own concerns. Education on these subjects should be envisaged as a long-term, continuous process, beginning well before menarche and continuing long after it.

Adolescent↗

Effectiveness of syndromic approach in management of reproductive tract infections in women.

Syndromic approach was used to identify reproductive tract infections (RTI) by a trained public health nurse among 130 ever-married women aged 15-45 years selected by a systematic random sampling method in a resettlement colony, Chandigarh. A lady medical officer in the dispensary examined and treated 48 (37%) referred symptomatic women as per syndromic approach guidelines. They were suffering from vaginitis (52.1%), cervicitis (20.8%), pelvic inflammatory disease (PID) (14.6%), urinary tract infections and PID (4.2%) and 4 did not have any clinical abnormality. Poor menstrual hygiene was observed among 72.7% women with RTI. Follow-up done after one month showed effectiveness in terms of symptomatic relied in 72.7% while 9.1% discontinued treatment and 4.5% did not comply with the medications. Training of nurses, health workers, dais, anganwadi workers regarding RTI identification and referral using syndromic approach and promotion of menstrual hygiene, genital hygiene and health care seeking behaviour would help in reducing the burden of RTI in the community.

Adolescent↗