The importance of Good Clinical Practice guidelines and its role in clinical trials

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects. It is very important to understand the background of the formation of the ICH-GCP guidelines as this, in itself, explains the reasons and the need for doing so. In this paper, we address the historical background and the events that led up to the formation of these guidelines. Today, the ICH-GCP guidelines are used in clinical trials throughout the globe with the main aim of protecting and preserving human rights

Phytobezoar: an unusual cause of intestinal obstruction

Small bowel phytobezoars are rare and almost always obstructive. There have been previously reported cases of phytobezoars in the literature, however there are few reports on radiological findings for small bowel bezoars. Barium studies characteristically show an intraluminal filling defect of variable size that is not fixed to the bowel wall with barium filling the interstices giving a mottled appearance. On CT scan, the presence of a round or ovoid intraluminal mass with a ‘mottled gas’ pattern is believed to be pathognomonic. Since features on CT scans are characteristics and physical findings are of little assistance in the diagnosis of bezoar, the diagnostic value of CT needs to be emphasised

Effects of adiponectin on markers of endothelial activation and markers of inflammation in human coronary artery endothelial cells

This study investigates the effect of adiponectin on endothelial activation and inflammatory marker secretion by human coronary artery endothelial cells (HCEAC) in vitro.Methodology: HCAEC at the seventh passage were divided into two groups and incubated or 24 hours at 37° C and 5% CO2 as follows: Control, and adiponectin-treated (30 μg/ml adiponectin) groups. Supernatants were analysed for ICAM-1, E-selectin, PAI-1 and IL-6 and COX-2 using ELISA. RT-PCR was used to analyse gene expression of ICAM-1, E-selectin, PAI-, IL-6, COX-2, NFkBp50 and NFkBp65. Data were analysed using independent t-test. Results: ICAM-1 and E-selectin level was significantly higher in leptin-adiponectin-treated groups (P<0.01). Endothelial activation marker protein level have no significant difference in adiponectin group when compared to control group.  mRNA expression showed significant increase in adiponectin group as compared to control. PAI-1 and COX-2 showed no significant increase in the level of protein in adiponectin group but IL-6 showed significant increased in the protein level (P<0.001) while mRNA expression of PAI-1 (P<0.05), COX-2 (P<0.01) and IL-6 (P<0.001) showed significant increase in treated group as compared to control. mRNA expression also showed significant increase in both the NFkBp50 and NFkBp65 signalling pathway.Conclusion: Adiponectin increases the secretion of IL-6 from HCEAC. This adipokinesmight have a significant role in the inflammatory and pro-atherogenic state of obesity.Keywords: HCAEC, Adiponectin, ICAM-1, E-selectin, IL-6, PAI-1, COX-2, NFkB

Pengaruh Pemberian Kasein Hidrolisat Terhadap Pertumbuhan Dan Hasil Tanaman Stroberi Varietas Lokal Berastagi (Fragaria X Ananassa Duchesne) Hasil Kultur Meristem

Pemberian kasein hidrolisat mampu meningkatkan pertumbuhan dan hasil tanaman stroberi. Peningkatan dosis kasein hidrolisat akan meningkatkan asam amino, jumlah klorofil dan aktivitas fotosintesis pada tanaman. Tujuan penelitian adalah mendapatkan dosis dan waktu pemberian kasein hidrolisat yang tepat terhadap pertumbuhan dan hasil tanaman stroberi. Bahan-bahan yang digunakan pada penelitian ini adalah bibit stroberi varietas Berastagi hasil kultur meristem, pupuk kandang, pupuk NPK 16:16:16, arang sekam, tanah, polibag, insektisida Prefonofos 500 g/L, fungisida Propineb 70% dan Tebuconazole 25%. Rancangan yang digunakan adalah acak kelompok dengan 9 perlakuan dan 3 ulangan. Perlakuan terdiri dari tanpa pemberian kasein hidrolisat (D0), dosis 5,81 mg/100/ml diberikan setiap 1 minggu (D1), dosis 11,62 mg/100/ml diberikan setiap 1 minggu (D2), dosis 23,31 mg/100/ml diberikan setiap 1 minggu (D3), dosis 46,62 mg/100/ml diberikan setiap 1 minggu (D4), dosis 11,62 mg/100/ml diberikan setiap 2 minggu (D5), dosis 23,24 mg/100/ml diberikan setiap 2 minggu (D6), dosis 46,62 mg/100/ml diberikan setiap 2 minggu (D7) dan dosis 93,24 mg/100/ml diberikan setiap 2 minggu (D8). Penelitian dilaksanakan di Screen house Balitjestro, Kota Batu, mulai bulan Desember sampai April 2014. Hasil penelitian ini menunjukkan pemberian dosis 11,62 mg/100/ml per rumpun (D5) lebih efektif dibandingkan dosis lainnya karena dapat menekan biaya produksi tanaman stroberi

Sarcopenia predicts reduced liver growth and reduced resectability in patients undergoing portal vein embolization before liver resection - A DRAGON collaborative analysis of 306 patients

Background: After portal vein embolization (PVE) 30% fail to achieve liver resection. Malnutrition is a modifiable risk factor and can be assessed by radiological indices. This study investigates, if sarcopenia affects resectability and kinetic growth rate (KGR) after PVE. Methods: A retrospective study was performed of the outcome of PVE at 8 centres of the DRAGON collaborative from 2010 to 2019. All malignant tumour types were included. Sarcopenia was defined using gender, body mass and skeletal muscle index. First imaging after PVE was used for liver volumetry. Primary and secondary endpoints were resectability and KGR. Risk factors impacting liver growth were assessed in a multivariable analysis. Results: Eight centres identified 368 patients undergoing PVE. 62 patients (17%) had to be excluded due to unavailability of data. Among the 306 included patients, 112 (37%) were non-sarcopenic and 194 (63%) were sarcopenic. Sarcopenic patients had a 21% lower resectability rate (87% vs. 66%, p &lt; 0.001) and a 23% reduced KGR (p = 0.02) after PVE. In a multivariable model dichotomized for KGR ≥2.3% standardized FLR (sFLR)/week, only sarcopenia and sFLR before embolization correlated with KGR. Conclusion: In this largest study of risk factors, sarcopenia was associated with reduced resectability and KGR in patients undergoing PVE.</p

Antimicrobial resistance among migrants in Europe: a systematic review and meta-analysis

BACKGROUND: Rates of antimicrobial resistance (AMR) are rising globally and there is concern that increased migration is contributing to the burden of antibiotic resistance in Europe. However, the effect of migration on the burden of AMR in Europe has not yet been comprehensively examined. Therefore, we did a systematic review and meta-analysis to identify and synthesise data for AMR carriage or infection in migrants to Europe to examine differences in patterns of AMR across migrant groups and in different settings. METHODS: For this systematic review and meta-analysis, we searched MEDLINE, Embase, PubMed, and Scopus with no language restrictions from Jan 1, 2000, to Jan 18, 2017, for primary data from observational studies reporting antibacterial resistance in common bacterial pathogens among migrants to 21 European Union-15 and European Economic Area countries. To be eligible for inclusion, studies had to report data on carriage or infection with laboratory-confirmed antibiotic-resistant organisms in migrant populations. We extracted data from eligible studies and assessed quality using piloted, standardised forms. We did not examine drug resistance in tuberculosis and excluded articles solely reporting on this parameter. We also excluded articles in which migrant status was determined by ethnicity, country of birth of participants' parents, or was not defined, and articles in which data were not disaggregated by migrant status. Outcomes were carriage of or infection with antibiotic-resistant organisms. We used random-effects models to calculate the pooled prevalence of each outcome. The study protocol is registered with PROSPERO, number CRD42016043681. FINDINGS: We identified 2274 articles, of which 23 observational studies reporting on antibiotic resistance in 2319 migrants were included. The pooled prevalence of any AMR carriage or AMR infection in migrants was 25·4% (95% CI 19·1-31·8; I2 =98%), including meticillin-resistant Staphylococcus aureus (7·8%, 4·8-10·7; I2 =92%) and antibiotic-resistant Gram-negative bacteria (27·2%, 17·6-36·8; I2 =94%). The pooled prevalence of any AMR carriage or infection was higher in refugees and asylum seekers (33·0%, 18·3-47·6; I2 =98%) than in other migrant groups (6·6%, 1·8-11·3; I2 =92%). The pooled prevalence of antibiotic-resistant organisms was slightly higher in high-migrant community settings (33·1%, 11·1-55·1; I2 =96%) than in migrants in hospitals (24·3%, 16·1-32·6; I2 =98%). We did not find evidence of high rates of transmission of AMR from migrant to host populations. INTERPRETATION: Migrants are exposed to conditions favouring the emergence of drug resistance during transit and in host countries in Europe. Increased antibiotic resistance among refugees and asylum seekers and in high-migrant community settings (such as refugee camps and detention facilities) highlights the need for improved living conditions, access to health care, and initiatives to facilitate detection of and appropriate high-quality treatment for antibiotic-resistant infections during transit and in host countries. Protocols for the prevention and control of infection and for antibiotic surveillance need to be integrated in all aspects of health care, which should be accessible for all migrant groups, and should target determinants of AMR before, during, and after migration. FUNDING: UK National Institute for Health Research Imperial Biomedical Research Centre, Imperial College Healthcare Charity, the Wellcome Trust, and UK National Institute for Health Research Health Protection Research Unit in Healthcare-associated Infections and Antimictobial Resistance at Imperial College London