Indications and Fetal Outcomes of Caesarean Section in Sindhu Sadabahar Hospital, Sindhupalchok.

Background There has been a sustained increase in the rate of caesarean section in the last few years around the world. Caesarean section (CS) Audit which plays an important role in the analysis of rate, indications and outcomes of caesarean section, helps to modify the trend of caesarean delivery. Objective This study was done to know the indications and outcomes of caesarean section in Sindhu Sadabahar Hospital, Khadichaur, Sindhupalchok. Method A hospital based descriptive study was conducted in gynaecological department of Sindhu Sadabahar hospital, Sindhupalchok over 14 months period from 1st Baisakh 2070 to 30thAshad 2071 (14th April 2013 to 14th July 2014) among 218 women who underwent caesarean section. Result The foetal distress was the leading indication of caesarean section (34%, n=74). Non-progress of labour and prolonged second stage of labour were seen in 15.6% (n=34) women respectively. There was 3.2% (n=7) fresh still birth and 1.8% (n=4) early neonatal death. Total perinatal death was 5% (n=11). There were 12.1% (n=27) low birth weight baby and 9.9% (n=22) macrosomic baby. ≤ 5/10 Appearance, Pulse, Grimace, Activity and Respiration (APGAR) score at five minutes was seen in 35.5% (n=79) neonates. Conclusion This study showed that majority of patients had an emergency cesarean section for foetal distress, nonprogress of labour and prolonged second stage of labour. Prevalence of caesarean section was higher than the caesarean rate (15%) recommended by World Health Organization (WHO). Cesarean sections performed for appropriate medical or obstetric indications are life saving for both the mother as well as the new born.

Randomised clinical trial: a phase 1, dose-ranging study of the anti-matrix metalloproteinase-9 monoclonal antibody GS-5745 versus placebo for ulcerative colitis.

BACKGROUND: Matrix metalloproteinase-9 is a proteolytic enzyme whose expression is increased in ulcerative colitis. AIM: To evaluate the safety and efficacy of GS-5745, a fully humanised anti-matrix metalloproteinase-9 monoclonal antibody, in moderately-to-severely active ulcerative colitis. METHODS: We randomised 74 patients with ulcerative colitis to treatment with single or multiple ascending intravenous or subcutaneous doses of GS-5745 or placebo. Multiple-dose cohorts received either IV infusions (0.3, 1.0, 2.5 or 5.0 mg/kg GS-5745 or placebo) every 2 weeks (three total IV infusions) or five weekly SC injections (150 mg GS-5745 or placebo). The primary outcomes were the safety, tolerability and pharmacokinetics of escalating single and multiple doses of GS-5745. Exploratory analyses in the multiple-dose cohorts included clinical response (≥3 points or 30% decrease from baseline in Mayo Clinic score and ≥1 point decrease in the rectal bleeding subscore or a rectal bleeding subscore ≤1) and clinical remission (a complete Mayo Clinic score ≤2 with no subscore >1) at Day 36. Biological effects associated with a clinical response to GS-5745 were explored using histological and molecular approaches. RESULTS: Twenty-three of the 42 patients (55%) receiving multiple doses of GS-5745 had adverse events, compared with 5/8 patients (63%) receiving placebo. GS-5745 showed target-mediated drug disposition, approximately dose-proportional increases in maximum plasma concentration and more than dose-proportional increases in the area under the plasma drug concentration-time curve. Clinical response occurred in 18/42 patients (43%) receiving GS-5745 compared with 1/8 patients (13%) receiving placebo. Clinical remission occurred in 6/42 patients (14%) receiving GS-5745 and 0/8 (0%) receiving placebo. Patients with a clinical response to GS-5745 had reductions in matrix metalloproteinase-9 tissue levels (mean 48.9% decrease from baseline compared with a mean 18.5% increase in nonresponders, P = 0.008) significant improvements in histopathology scores (confirmed with three separate histological disease activity indices), as well as changes in colonic gene expression that were consistent with reduced inflammation. CONCLUSION: This phase 1 trial provides preliminary evidence for the safety and therapeutic potential of GS-5745 in the treatment of ulcerative colitis.

Phase 2b, randomized, double-blind 12-week studies of TZP-102, a ghrelin receptor agonist for diabetic gastroparesis.

BACKGROUND: TZP-102, a potent, oral, ghrelin receptor agonist, improved diabetic gastroparesis symptoms in Phase 2a. METHODS: Patients with type 1 or 2 diabetes, delayed gastric half-emptying (T(1/2)), and ≥3 months gastroparesis symptoms randomized 1 : 1 : 1 to double-blind placebo, 10-mg, or 20-mg TZP-102 once daily for 12 weeks (Study TZP-102-CL-G003). Study TZP-102-CL-G004 patients randomized 1 : 1 to 10-mg TZP-102:placebo three-times-daily. Primary endpoint was change-from-baseline through Weeks 11-12 in Daily Diary of Gastroparesis Symptoms Questionnaire (GSDD) via electronic Patient Recorded Outcome device: worst severity of nausea, early satiety, bloating, and upper abdominal pain in 24 h (0 = none-to-5 = very severe). GSDD Composite Score for eligibility was ≥2.5 (Day-14-to-baseline). Patient Overall Treatment Evaluation (OTE) provided an anchor-based minimal clinically important difference (MCID) for GSDD Composite Score. KEY RESULTS: Study TZP-102-CL-G003 enrolled 201 outpatients: females 72%; Caucasians 87%; type 2 diabetes 61%; insulin-dependent 65%; age mean ± SD 53 ± 11.3 years; HbA1c 7.8 ± 1.5%; GCSI 3.4 ± 0.7; GSDD Composite 3.6 ± 0.6; gastric T1/2 131 ± 32 min; n = 69 (10-mg), n = 66 (20-mg), n = 66 (placebo). Primary endpoint (GSDD): significant improvement in all arms, although not for TZP-102 vs placebo: mean change-from-baseline -1.7, -1.4, -1.5 (10-mg, 20-mg, placebo); Gastroparesis Cardinal Symptom Index -1.8, -1.6, -1.5, respectively. The OTE (all patients) at Week-12 was: Patient 3.7 ± 3.2 and Physician 3.6 ± 3.0 with median score for both of 5.0 = important on scale of improvement; individual MCID was 1.61 and 0.94 for group analyses, greater than expected. Study TZP-102-CL-G004 with similar demographic/disease characteristics was prematurely terminated for efficacy futility (n = 64 with Week-4 assessments). CONCLUSIONS & INFERENCES: Efficacy of TZP-102 was not demonstrated compared with placebo in diabetic gastroparesis; however, there was substantial symptom improvement in all arms (ClinicalTrials.gov NCT01452815/NCT01664637).

Investigation of the microstructure of milk protein concentrate powders during rehydration: alterations during storage.

The aim of this work was to use scanning electron microscopy to investigate the microstructure of rehydrated milk protein concentrate powder (MPC) particles. A sample preparation method for scanning electron microscopy analysis of rehydrated MPC particles is described and used to characterize the time course of dissolution and the effects of prior storage on the dissolution process. The results show that a combination of different types of interactions (e.g., bridges, direct contact) between casein micelles results in a porous, gel-like structure that restrains the dispersion of individual micelles into the surrounding liquid phase without preventing water penetration and solubilization of nonmicellar components. During storage of the powder, increased interactions occur between and within micelles, leading to compaction of micelles and the formation of a monolayer skin of casein micelles packed close together, the combination of which are proposed to be responsible for the slow dissolution of stored MPC powders.

Hydrocolloid gel particles: formation, characterization, and application.

Hydrocolloid gel particles of micron and sub-micron size are particularly attractive for use in many applications in the food, agricultural, pharmaceutical, and chemical industries, due to their biocompatibility, perception as "natural" materials, and soft-solid texture. Industrial applications for such particles include uses as texturizers in confectionery and cosmetic products, slow-release encapsulation agents for flavors, nutrients, and pharmaceutical products, and thickeners in soups and sauces. Properties such as particle size, hardness, shape, texture, and molecular release rates can be important for individual applications. In addition, product formats will determine specific needs for physical form (e.g. dry or wet) and compatibility with other components. The diverse range of potential applications for hydrocolloid gel particles provide a driver for understanding-led tailoring of raw material and process conditions. This review introduces some of the materials that are used to form hydrocolloid gel particles and the corresponding gel formation mechanisms. One issue of importance in the production of hydrocolloid gel particles is the control of particle properties, such as release profiles, strength, and detectability within products. An alternative technique to traditional methods of hydrocolloid gel particle production is evaluated and a model for control of particle size, and subsequently other particle properties, is proposed. Key properties of hydrocolloid gel particles are identified and characterization methods for evaluating these properties are described.

Effect of high power ultrasound and ageing on the physical properties of bovine Semitendinosus and Longissimus muscles.

Tenderness is an important meat quality parameters and the use of high power ultrasound to disrupt muscle structure may prove effective for reducing both myofibrillar and collagenous toughness. The experiment was carried out with Longissimus lumborum et thoracis and Semitendinosus muscles from 3 to 4 year old steers. Uncooked beef samples (60×40×20mm) were treated with high power ultrasound (24kHz, 12W/cm(2)) for up to 240s, and aged for up to 8.5 days before evaluation of pH, drip loss, cook losses Warner-Bratzler shear (WBS), compression hardness, and colour. Ultrasound treatment significantly reduced WBS force and hardness, but significantly increased pH. Ageing significantly reduced hardness and WBS force, but there was no significant interaction between ultrasound treatment and ageing time. Ultrasound treatment did not affect any of the colour parameters (L(∗)a(∗)b(∗), chroma and hue) but the ageing time significantly increased the lightness, chroma and hue. There was no significant effect of ultrasound treatment on drip loss, but it did significantly reduce the cook and total loss. During ageing, cook loss and total losses significantly increased. The results suggest that high power ultrasound is capable of reducing objective texture measurements of beef without compromising the other quality parameters investigated.

Encapsulation of lemon oil by paste method using beta-cyclodextrin: encapsulation efficiency and profile of oil volatiles.

Microencapsulation of lemon oil was undertaken by kneading with beta-cyclodextrin, at a beta-cyclodextrin to lemon oil ratio of 88:12 (w/w). The resulting paste samples of the complex were vacuum- or spray-dried. Ten selected lemon oil flavor volatiles (alpha-pinene, sabinene, beta-pinene, beta-myrcene, limonene, gamma-terpinene, terpinolene, linalool, neral, and geranial) in the complex were analyzed periodically after 1, 2, 5, 10, 15, 20, and 30 min of kneading time. The results indicated that the levels of these volatiles were not significantly different (P > 0.05) irrespective of mixing time or type of the drying (vacuum- or spray-drying) used. An optimum mixing time was found to be 15 min, at which time the maximum encapsulation of lemon oil (97.7 mg/g of beta-cyclodextrin) was obtained in the complex powder.