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Canna Ghia, Shashank Akerkar, Shailaja Sabnis, Urk Rao, Gautam Rambhad
BACKGROUND / OBJECTIVES: Biologic anti-TNFs in India have improved the patient management. Significant proportions of patients lose response over time or do not respond. Possible explanations are suboptimal trough anti-TNFa concentrations or antibodies to anti-TNFs. The aim of this project was to set up and standardize an independent laboratory to test immunogenicity of anti-TNF biologics (infliximab and etanercept). METHODS: Three rheumatologists piloted this project approved by independent ethics committee and carried out in compliance with ICH/GCP guidelines...
September 2016: Journal of the Association of Physicians of India
Krishnananda Samanta, Poulami Jana, Sandra Bäcker, Shirley Knauer, Carsten Schmuck
A novel hybrid compound 1 efficiently shuttles genetic material into HeLa cells at concentrations as low as 0.6 μM, whereas the parent compound PAMAM-G2 is ineffective even at 200 μM. The high efficiency of 1 stems from its capabiliy to form highly condensed ligand-DNA polyplexes. Its binding affinity is actually lower than for the parent dendrimer. Compound 1 is even 200 times more effective and less cytotoxic than PEI, the current gold standard in gene transfection with cationic polymers.
October 13, 2016: Chemical Communications: Chem Comm
Celso Roberto Passeri, Jacira Alves Caracik de Camargo Andrade, Karla Thaíza Tomal, Eduardo Marcucci Pracucho, Livia Paschoalino de Campos, Silvia Helena de Carvalho Sales-Peres
Background: Obesity and metabolic syndrome can be labeled as worldwide outbreak; thus, both have led to serious public health problem. Oral health can be worsened by both, obesity and metabolic syndrome. Tooth loss harms masticatory function, essential status to whom will be submitted to bariatric surgery. Aim: Assess masticatory function of obese candidates to bariatric surgery, who belong to distinct socioeconomic class range, in order to recognize hazard factors and the bias of socioeconomic factor in this context...
2016: Arquivos Brasileiros de Cirurgia Digestiva: ABCD, Brazilian Archives of Digestive Surgery
Dongzhi Wang, Renan Chang, Gang Wang, Baoying Hu, Yong Qiang, Zhong Chen
BACKGROUND: Recent investigations have implicated that Chitosan-nucleotide nanoparticles might be useful non-viral carriers in gene therapy. Polo-like kinase 1 (PLK1) has been reported to be an important oncogene that exerted considerable therapeutic value in hepatocellular carcinoma (HCC). OBJECTIVE: We explored whether Galactosylated chitosan-graft-poly(ethylene glycol) (GCP) nanoparticle-mediated delivery of PLK1 siRNA nucleotides could serve as an effective anti-cancer agent for HCC therapy...
September 26, 2016: Anti-cancer Agents in Medicinal Chemistry
Richard N Jones, Edward R Marcantonio, Jane S Saczynski, Douglas Tommet, Alden L Gross, Thomas G Travison, David C Alsop, Eva M Schmitt, Tamara G Fong, Sevdenur Cizginer, Mouhsin M Shafi, Alvaro Pascual-Leone, Sharon K Inouye
BACKGROUND: Cognitive impairment is a well-recognized risk factor for delirium. Our goal was to determine whether the level of cognitive performance across the nondemented cognitive ability spectrum is correlated with delirium risk and to gauge the importance of cognition relative to other known risk factors for delirium. METHODS: The Successful Aging after Elective Surgery study enrolled 566 adults aged ≥70 years scheduled for major surgery. Patients were assessed preoperatively and daily during hospitalization for the occurrence of delirium using the Confusion Assessment Method...
September 19, 2016: Journal of Geriatric Psychiatry and Neurology
Caroline Hurley, Frances Shiely, Jessica Power, Mike Clarke, Joseph A Eustace, Evelyn Flanagan, Patricia M Kearney
INTRODUCTION: In November 2016, the Integrated Addendum to ICH-GCP E6 (R2) will advise trial sponsors to develop a risk-based approach to clinical trial monitoring. This new process is commonly known as risk based monitoring (RBM). To date, a variety of tools have been developed to guide RBM. However, a gold standard approach does not exist. This review aims to identify and examine RBM tools. METHODS: Review of published and grey literature using a detailed search-strategy and cross-checking of reference lists...
September 15, 2016: Contemporary Clinical Trials
Vittoradolfo Tambone, Dario Sacchini, Antonio G Spagnolo, Rosa Menga, Giovanna Ricci, Roberto Valenti, Massimiliano Andrea Vitali, Massimo Ciccozzi
OBJECTIVE: The study proposes a possible roadmap for the ethical assessment of sham surgery clinical trials (CTs), focusing on methodological aspects, as a result of the lack of this type of practical tool in the literature/practice. BACKGROUND: Surgical procedures are frequently conducted without closely controlled studies. For this reason, these procedures are less rigorous than those for drug/device clinical trials. The aim of a sham (placebo) surgery CT is to carry out a surgical CT with a legitimate control group...
September 14, 2016: Annals of Surgery
Omer Cakmak, Zekeriya Tasdemir, Cuneyt Asim Aral, Serkan Dundar, Halit Bugra Koca
AIM: This cross-sectional study aims to analyse cortisol and dehydroepiandrosterone (DHEA) levels in gingival crevicular fluid (GCF) and saliva in generalized aggressive periodontitis (GAP) and generalized chronic periodontitis (GCP) patients, as well as in periodontally healthy individuals (C). MATERIAL AND METHODS: A total of 92 patients (31 C, 34 GCP and 27 GAP) were included in the study. Clinical parameters including plaque index, gingival index, bleeding on probing, probing depth and clinical attachment level; psychosocial measurements including Beck depression inventory and state-trait anxiety inventory; and hormone levels in GCF and saliva including cortisol and DHEA were evaluated...
August 11, 2016: Journal of Clinical Periodontology
Yodi Mahendradhata, Jamila Nabieva, Riris Andono Ahmad, Patricia Henley, Pascal Launois, Corinne Merle, Christine Maure, Olaf Horstick, Varalakshmi Elango
BACKGROUND: Good clinical practice (GCP) guidelines have been the source of improvement in the quality of clinical trials; however, there are limitations to the application of GCP in the conduct of health research beyond industry-sponsored clinical trials. The UNICEF/UNDP/World Bank/WHO Special Program for Research and Training in Tropical Disease is promoting good practice in all health research involving human through the Good Health Research Practice (GHRP) training program initiative...
2016: Global Health Action
Satish Chandrasekhar Nair, Halah Ibrahim, Omar Sherif Askar
BACKGROUND: Expansion of clinical trials activity into emerging regions has raised concerns regarding participant rights and research ethics. Increasing numbers of observational studies are now conducted in developing economies, including the United Arab Emirates. MATERIALS AND METHODS: This study compares the content of information provided, Good Clinical Practice (GCP) guideline compliance, and readability of informed consent forms (ICFs) for observational compared to interventional studies...
July 2016: Perspectives in Clinical Research
Abdel Naser Zaid, Naim Kittana, Ayman Mousa, Nadia Ghazal, Rana Bustami
BACKGROUND: Treatment of neuropathic pain has always been challenging, not only from the pharmaco-therapeutic/toxicological point of view, but also due to the unpredictable pharmacokinetic (PK) variations among different generic formulations of the same drug, which require further dose optimization. OBJECTIVES: This progressive work aims to evaluate the bioequivalence (BE) of a generic product of 150 mg pregabalin capsule (antineuropathic drug) vs. the reference brand drug Lyrica<sup>®</sup>...
September 2016: International Journal of Clinical Pharmacology and Therapeutics
Juan Pablo Zanin, Elizabeth Abercrombie, Wilma J Friedman
Cerebellar granule cell progenitors (GCP) proliferate extensively in the external granule layer (EGL) of the developing cerebellum prior to differentiating and migrating. Mechanisms that regulate the appropriate timing of cell cycle withdrawal of these neuronal progenitors during brain development are not well defined. The p75 neurotrophin receptor (p75(NTR)) is highly expressed in the proliferating GCPs, but is downregulated once the cells leave the cell cycle. This receptor has primarily been characterized as a death receptor for its ability to induce neuronal apoptosis following injury...
2016: ELife
Tammy T Hshieh, Weiying Dai, Michele Cavallari, Charles Rg Guttmann, Dominik S Meier, Eva M Schmitt, Bradford C Dickerson, Daniel Z Press, Edward R Marcantonio, Richard N Jones, Yun Ray Gou, Thomas G Travison, Tamara G Fong, Long Ngo, Sharon K Inouye, David C Alsop
Three-dimensional Arterial Spin Labeling (ASL) MRI was performed before surgery in a cohort of 146 prospectively enrolled subjects ≥ 70 years old scheduled to undergo elective surgery. We investigated the prospective association between ASL-derived measures of cerebral blood flow (CBF) before surgery with postoperative delirium incidence and severity using whole-brain and globally normalized voxel-wise analysis. We also investigated the cross-sectional association of CBF with patients' baseline performance on specific neuropsychological tests, and with a composite general cognitive performance measure (GCP)...
July 11, 2016: Journal of Cerebral Blood Flow and Metabolism
Nicholas Moore, Yves Juillet, Pierre-Henri Bertoye
The integrity of the data from clinical trials and of its use is an essential element of the scientific method, and of the trust one can have in this method. There are many examples of fraud, and they recur regularly. The objective of this round table was to work on the definition of fraud, on its recognition and prevention especially in the institutional system. Fraud involves an active decision to cheat, and ranges from trying to hide incompetence to wholesale invention of data, patients or studies. Its frequency is difficult to evaluate but might be as high as 1% of all studies or publications...
May 2007: Thérapie
Jaime Arango, Tina Chuck, Susan S Ellenberg, Bridget Foltz, Colleen Gorman, Heidi Hinrichs, Susan McHale, Kunal Merchant, Jonathan Seltzer, Stephanie Shapley, Gretchen Wild
Good Clinical Practice (GCP) is an international standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. The goal of GCP is to ensure the protection of the rights, integrity, and confidentiality of clinical trial participants and to ensure the credibility and accuracy of data and reported results. In the United States, trial sponsors generally require investigators to complete GCP training prior to participating in each clinical trial to foster GCP and as a method to meet regulatory expectations (ie, sponsor's responsibility to select qualified investigators per 21 CFR 312...
July 2016: Therapeutic Innovation & Regulatory Science
Shaolin Gong, Zhihan Wu, Shunliang Xu, Jingfeng Zhang
OBJECTIVE: The purpose of this study is to describe a small case series of primary gastritis cystica polyposa (GCP) and explore its imaging features, endoscopic findings, and pathological manifestations. METHODS: In this institutional review board-approved, HIPAA-compliant, retrospective study, an electronic pathology database in our hospital was searched for all cases of GCP from July 2008 to December 2015, yielding five cases with both radiological and endoscopic examination...
July 5, 2016: Abdominal Radiology
Shin Ebara, Yasuyuki Kobayashi, Katsumi Sasaki, Motoo Araki, Morito Sugimoto, Koichiro Wada, Kei Fujio, Atsushi Takamoto, Toyohiko Watanabe, Hiroyuki Yanai, Yasutomo Nasu
The present case report describes a case of recurrent and advanced urachal carcinoma including neuroendocrine features with iliac bone metastasis after partial cystectomy and adjuvant chemotherapy consisting of irinotecan and cisplatin in a 32-year-old man. He received gemcitabine/cisplatin/ paclitaxel (GCP) combination chemotherapy, consisting of gemcitabin (1,000mg/m2) on day 1, 8, cisplatin (70mg/m2) on day 1, and paclitaxel (80mg/m2) on day 1 and 8. After three cycles of chemotherapy, PET-CT showed complete regression of the disease...
June 2016: Acta Medica Okayama
Hamdi Akan
The History of Clinical Drug Trials in Turkey The history of clinical trials in Turkey dates back to the beginning of the 20th century, but many years had passed with studies done with no compliance to the Good Clinical Practice (GCP) guidelines. This was not due to the lack of legal documents. On the contrary, the first mention of clinical trials in a legal document occurred in 1926; "The Code of Pharmaceutical Products and Preparations No. 1262" law carried the statement: "Experimental drugs can be used in a patient only by his/her permission...
March 5, 2007: Turkish Journal of Haematology: Official Journal of Turkish Society of Haematology
N Vischer, C Pfeiffer, A Joller, I Klingmann, A Ka, Sk Kpormegbe, C Burri
OBJECTIVES: To explore the advantages and challenges of working with the Good Clinical Practice (GCP) ICH E6 guideline and its interpretation from the perspective of clinical trial teams based in sub-Saharan Africa. METHODS: We conducted 60 key informant interviews with clinical trial staff at different levels in clinical research centres in Kenya, Ghana, Burkina Faso and Senegal, and thematically analysed the responses. RESULTS: Clinical trial teams perceived working with ICH-GCP as highly advantageous and regarded ICH-GCP as applicable to their setting and efficiently applied...
June 4, 2016: Tropical Medicine & International Health: TM & IH
Xiaonan Hu, Wei Zhang, Sanguo Zhang, Shuangge Ma, Qizhai Li
MOTIVATION: In large-scale genetic association studies with tens of hundreds of single nucleotide polymorphisms (SNPs) genotyped, the traditional statistical framework of logistic regression using maximum likelihood estimator (MLE) to infer the odds ratios of SNPs may not work appropriately. This is because a large number of odds ratios need to be estimated, and the MLEs may be not stable when some of the SNPs are in high linkage disequilibrium. Under this situation, the P-value combination procedures seem to provide good alternatives as they are constructed on the basis of single-marker analysis...
September 15, 2016: Bioinformatics
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