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Impactful clinical trials

L Jonker, F Memon
Since recent research indicates that other modalities are at a minimum non-inferior to the NICE-recommended hormonal agent prostaglandin E2 (PGE2 ), a retrospective cohort study was conducted on 1971 consecutively induced singleton pregnancies. Multinominal regression analysis showed that the odds ratio (OR) for vaginal delivery with balloon-mediated labour induction (84% vaginal deliveries; OR 1.6; 95% CI 0.7-3.5) is similar to the PGE2 agents propess (81%; OR 1.2; 95% CI 0.68-1.98) and prostin (79%; OR 0...
March 22, 2018: Journal of Obstetrics and Gynaecology: the Journal of the Institute of Obstetrics and Gynaecology
(no author information available yet)
In the context of the White Book of Physical and Rehabilitation Medicine (PRM), this paper deals with Research, the future of PRM. PRM students and specialists are mainly involved in biomedical research, investigating the biological processes, the causes of diseases, their medical diagnosis, the evaluation of their consequences on functioning, disability and health and the effects of health interventions at an individual and a societal level. Most of the current PRM research, often interdisciplinary, originates from applied research which, using existing knowledge, is directed towards specific goals...
April 2018: European Journal of Physical and Rehabilitation Medicine
Rashmi Goyat, Pragya Rai, Jongwha Chang, Charles D Ponte, Xi Tan
BACKGROUND: Both diabetes and antidiabetic drugs (ADDs) increase the risk for cardiovascular (CV) diseases. Due to the increasing concern about CV safety associated with ADDs, the US FDA revised regulatory guidelines in 2008 to include CV safety as an endpoint. OBJECTIVE: The objective of the current study was to conduct a systematic review with meta-analysis to compare CV mortality of oral ADDs approved before and after the FDA's 2008 guidance. METHODS: Three electronic databases (PubMed, Scopus, and the Clinical Trial Registry) were searched to retrieve studies published up to 24 February 2017...
March 21, 2018: Clinical Drug Investigation
Akira Endo, Atsushi Shiraishi, Kiyohide Fushimi, Kiyoshi Murata, Yasuhiro Otomo
BACKGROUND: Although continuous regional arterial infusion (CRAI) of protease inhibitors and broad antibiotics has been suggested as one of the therapeutic option for patients with acute necrotic pancreatitis (ANP), the effectiveness has not been well-corroborated in clinical studies. METHODS: We conducted a retrospective cohort study using a Japanese national administrative database. Severe acute pancreatitis patients with a poorly enhanced pancreas region (i.e...
March 21, 2018: Journal of Gastroenterology
M Heinemann, S G Welker, F G Holz, R P Finger
BACKGROUND AND OBJECTIVES: Physical activity (PA) impacts age-related diseases but its measurement is difficult. The acceptance of wrist-worn accelerometers (ACC) in older patients with eye diseases was evaluated and the results were compared with a validated activity questionnaire. MATERIALS AND METHODS: In this study 50 patients underwent a clinical examination and were interviewed with the International Physical Activity Questionnaire (IPAQ). They then wore an ACC for 7 days and then for 30 days...
March 21, 2018: Der Ophthalmologe: Zeitschrift der Deutschen Ophthalmologischen Gesellschaft
Andrea Schlegel, Xavier Muller, Philipp Dutkowski
Purpose of Review: In this review, we highlight which livers may benefit from additional treatment before implantation and describe the concept of hypothermic machine liver perfusion. Furthermore, we explain why cold oxygenated perfusion concepts could potentially lead to a breakthrough in this challenging field of transplantation. Accordingly, we summarize recent clinical applications of different hypothermic perfusion approaches. Recent Findings: The impact of end-ischemic, hypothermic liver perfusion in liver transplantation is currently assessed by two multicenter, randomized controlled trials...
2018: Current Transplantation Reports
Lucie D Cluver, Franziska Meinck, Janina I Steinert, Yulia Shenderovich, Jenny Doubt, Rocio Herrero Romero, Carl J Lombard, Alice Redfern, Catherine L Ward, Sibongile Tsoanyane, Divane Nzima, Nkosiyapha Sibanda, Camille Wittesaele, Sachin De Stone, Mark E Boyes, Ricardo Catanho, Jamie McLaren Lachman, Nasteha Salah, Mzuvukile Nocuza, Frances Gardner
Objective: To assess the impact of 'Parenting for Lifelong Health: Sinovuyo Teen', a parenting programme for adolescents in low-income and middle-income countries, on abuse and parenting practices. Design: Pragmatic cluster randomised controlled trial. Setting: 40 villages/urban sites (clusters) in the Eastern Cape province, South Africa. Participants: 552 families reporting conflict with their adolescents (aged 10-18)...
2018: BMJ Global Health
Ensaf M Al-Hujaily, Tanvir Khatlani, Zeyad Alehaideb, Rizwan Ali, Bader Almuzaini, Bahauddeen M Alrfaei, Jahangir Iqbal, Imadul Islam, Shuja Malik, Bader A Marwani, Salam Massadeh, Atef Nehdi, Barrak Alsomaie, Bader Debasi, Ibraheem Bushnak, Saeed Noibi, Syed Hussain, Wahid Abdul Wajid, Jean-Pierre Armand, Sheraz Gul, Julen Oyarzabal, Rana Rais, Chas Bountra, Ahmed Alaskar, Bander Al Knawy, Mohamed Boudjelal
The 'Therapeutics discovery: From bench to first in-human trials' conference, held at the King Abdullah International Medical Research Center (KAIMRC), Ministry of National Guard Health Affairs (MNGHA), Kingdom of Saudi Arabia (KSA) from October 10-12, 2017, provided a unique opportunity for experts worldwide to discuss advances in drug discovery and development, focusing on phase I clinical trials. It was the first event of its kind to be hosted at the new research center, which was constructed to boost drug discovery and development in the KSA in collaboration with institutions, such as the Academic Drug Discovery Consortium in the United States of America (USA), Structural Genomics Consortium of the University of Oxford in the United Kingdom (UK), and Institute of Materia Medica of the Chinese Academy of Medical Sciences in China...
March 2018: Biomedical Reports
E J Gibson, N Begum, I Koblbauer, G Dranitsaris, D Liew, P McEwan, A A Tahami Monfared, Y Yuan, A Juarez-Garcia, D Tyas, M Lees
Background: Economic models in oncology are commonly based on the three-state partitioned survival model (PSM) distinguishing between progression-free and progressive states. However, the heterogeneity of responses observed in immuno-oncology (I-O) suggests that new approaches may be appropriate to reflect disease dynamics meaningfully. Materials and methods: This study explored the impact of incorporating immune-specific health states into economic models of I-O therapy...
2018: ClinicoEconomics and Outcomes Research: CEOR
Adrian Egli, Jyotshna Mandal, Desiree M Schumann, Michael Roth, Brad Thomas, D Lorne Tyrrell, Francesco Blasi, Kostantinos Kostikas, Wim Boersma, Branislava Milenkovic, Alicia Lacoma, Katharina Rentsch, Gernot G U Rohde, Renaud Louis, Joachim G Aerts, Tobias Welte, Antoni Torres, Michael Tamm, Daiana Stolz
BACKGROUND: Interferon lambdas (IFNLs) have important anti-viral/bacterial and immunomodulatory functions in the respiratory tract. How do IFNLs impact COPD and its exacerbations? METHODS: Five hundred twenty eight patients were recruited in a prospective observational multicentre cohort (PROMISE) study. The genetic polymorphisms (rs8099917 and rs12979860) within the IFNL3/4 gene region and circulating levels of IFNL3 in COPD patients were determined and associated with disease activity and outcome during a median follow-up of 24 months...
March 21, 2018: BMC Pulmonary Medicine
Stewart A Vella, Christian Swann, Marijka Batterham, Katherine M Boydell, Simon Eckermann, Andrea Fogarty, Diarmuid Hurley, Sarah K Liddle, Chris Lonsdale, Andrew Miller, Michael Noetel, Anthony D Okely, Taren Sanders, Joanne Telenta, Frank P Deane
BACKGROUND: There is a recognised need for targeted community-wide mental health strategies and interventions aimed specifically at prevention and early intervention in promoting mental health. Young males are a high need group who hold particularly negative attitudes towards mental health services, and these views are detrimental for early intervention and help-seeking. Organised sports provide a promising context to deliver community-wide mental health strategies and interventions to adolescent males...
March 21, 2018: BMC Public Health
Giovanni Ciccarelli, Saverio D'Elia, Michele De Paulis, Paolo Golino, Giovanni Cimmino
The role of low-density lipoproteins (LDLs) as a major risk factor for cardiovascular disease has been demonstrated by several epidemiological studies. The molecular basis for LDLs in atherosclerotic plaque formation and progression is not completely unraveled yet. Pharmacological modulation of plasma LDL-C concentrations and randomized clinical trials addressing the impact of lipid-lowering interventions on cardiovascular outcome have clearly shown that reducing plasma LDL-C concentrations results in a significant decrease in major cardiovascular events...
March 17, 2018: Diseases (Basel)
Javad Heshmati, Mahdi Sepidarkish, Nazli Namazi, Fatemeh Shokri, Mahsa Yavari, Siavash Fazelian, Masoud Khorshidi, Farzad Shidfar
Dyslipidemia is the main risk factor for developing cardiovascular disease. There are discrepancies in the effects of calcium supplementation on modulation of lipid status. Therefore, we aimed to summarize the effects of dietary calcium supplement on circulating lipoprotein concentrations and atherogenic indices in overweight and obese individuals. We conducted a systematic literature search from 2000 until July 2016. PubMed, Scopus, Cochran Library, and ISI Web of Science databases were searched for clinical trials written in English...
March 21, 2018: Journal of Dietary Supplements
Muhammad R Afzal, Omar Kahaly, Raul Weiss, Mahmoud Houmsse, Emile G Daoud, John D Hummel
BACKGROUND: Successful pulmonary vein isolation (PVI) is the most reliable predictor of success after ablation in patients with atrial fibrillation (AF). Adenosine triphosphate (ATP) unmasks the dormant conduction and can be used to improve the effectiveness of PVI. The impact of ATP guided PVI on clinical outcomes is discordant in various randomized controlled trials (RCTs). OBJECTIVES: To delineate the incremental benefit of ATP during PVI in patients with AF through a meta-analysis...
March 21, 2018: Expert Review of Cardiovascular Therapy
Raquel González, Clara Pons-Duran, Mireia Piqueras, John J Aponte, Feiko O Ter Kuile, Clara Menéndez
BACKGROUND: The World Health Organization recommends intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine for malaria for all women who live in moderate to high malaria transmission areas in Africa. However, parasite resistance to sulfadoxine-pyrimethamine has been increasing steadily in some areas of the region. Moreover, HIV-infected women on cotrimoxazole prophylaxis cannot receive sulfadoxine-pyrimethamine because of potential drug interactions. Thus, there is an urgent need to identify alternative drugs for prevention of malaria in pregnancy...
March 21, 2018: Cochrane Database of Systematic Reviews
Francesco Sparano, Michele Cavo, Pasquale Niscola, Tommaso Caravita, Fabio Efficace
PURPOSE: We performed a systematic review to quantify the amount of evidence-based data available on patient-reported outcomes (PRO) in Relapsed/Refractory Multiple Myeloma (RRMM) patients and to examine the added value of such studies in supporting clinical decision-making. METHODS: We conducted a search in PubMed/Medline and the Cochrane Library to identify studies published between January 1990 and May 2017. All studies, regardless of the design, including patients with RRMM and also evaluating PRO were considered...
March 20, 2018: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
Zhichao Wu, Felipe A Medeiros
Visual field testing is an important endpoint in glaucoma clinical trials, and the testing paradigm used can have a significant impact on the sample size requirements. To investigate this, this study included 353 eyes of 247 glaucoma patients seen over a 3-year period to extract real-world visual field rates of change and variability estimates to provide sample size estimates from computer simulations. The clinical trial scenario assumed that a new treatment was added to one of two groups that were both under routine clinical care, with various treatment effects examined...
March 20, 2018: Scientific Reports
Teppei Okamoto, Shingo Hatakeyama, Hirotake Kodama, Hirotaka Horiguchi, Yuka Kubota, Koichi Kido, Masaki Momota, Shogo Hosogoe, Yoshimi Tanaka, Tooru Takashima, Fumitada Saitoh, Tadashi Suzuki, Chikara Ohyama
BACKGROUND: Although aortic calcification has a significant negative impact on prognosis in patients on hemodialysis (HD), risk factors for aortic calcification progression remain unclear. The aim of this study was to investigate the relationship between malnutrition and aortic calcification progression in patients on HD. METHODS: Between April 2015 and October 2016, we treated 232 patients on HD. Of those, we retrospectively evaluated data from 184 patients who had had regular blood tests and computed tomography (CT) scans...
March 20, 2018: BMC Nephrology
Peter J Carr, Niall S Higgins, Marie L Cooke, Gabor Mihala, Claire M Rickard
BACKGROUND: Most people admitted to hospitals worldwide require a vascular access device (VAD). Hundreds of millions of VADs are inserted annually in the USA with reports of over a billion peripheral intravenous catheters used annually worldwide. Numerous reports suggest that a team approach for the assessment, insertion, and maintenance of VADs improves clinical outcomes, the patient experience, and healthcare processes. OBJECTIVES: To compare the use of the vascular access specialist team (VAST) for VAD insertion and care to a generalist model approach for hospital or community participants requiring a VAD in terms of insertion success, device failure, and cost-effectiveness...
March 20, 2018: Cochrane Database of Systematic Reviews
Zbyszko Chowaniec, Anna Skoczyńska
Cardiovascular diseases are still the main cause of death in Poland and throughout the world. Independent risk factors of cardiovascular disease, in addition to elevated LDL cholesterol, are both low HDL levels and high levels of non-HDL cholesterol. Plasma phospholipid-transfer protein (PLTP) and cholesteryl ester transfer protein (CETP) both play a major role in the metabolism of those lipoproteins. A lack of these proteins increases HDL and lowers LDL levels. In the light of current knowledge, it seems reasonable to search for compounds that may decrease the activity of CETP, and thus reduce the incidence of cardiovascular disease...
March 16, 2018: Advances in Clinical and Experimental Medicine: Official Organ Wroclaw Medical University
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