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Randomized double blinded controlled studies

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https://www.readbyqxmd.com/read/28214095/whether-preventive-low-dose-magnesium-sulphate-infusion-has-an-influence-on-postoperative-pain-perception-and-the-level-of-serum-beta-endorphin-throughout-the-total-abdominal-hysterectomy
#1
K Haryalchi, M Abedinzade, K Khanaki, M M Ghanaie, F M Zadeh
OBJECTIVE: Due to the known role of preventive low dose magnesium sulphate on postoperative pain management, in this randomized, double-blinded, placebo-controlled study, we tried to investigate the possible relationship between low dose intra-operative magnesium sulphate infusion, postoperative analgesia and the level of serum beta-endorphin during total abdominal hysterectomy under general anesthesia. METHODS: Forty women undergoing total abdominal hysterectomy were randomly allocated into 2 groups (20 in each arm)...
February 14, 2017: Revista Española de Anestesiología y Reanimación
https://www.readbyqxmd.com/read/28214091/multidonor-intensive-faecal-microbiota-transplantation-for-active-ulcerative-colitis-a-randomised-placebo-controlled-trial
#2
Sudarshan Paramsothy, Michael A Kamm, Nadeem O Kaakoush, Alissa J Walsh, Johan van den Bogaerde, Douglas Samuel, Rupert W L Leong, Susan Connor, Watson Ng, Ramesh Paramsothy, Wei Xuan, Enmoore Lin, Hazel M Mitchell, Thomas J Borody
BACKGROUND: The intestinal microbiota is implicated in the pathogenesis of ulcerative colitis. Faecal microbiota transplantation is a novel form of therapeutic microbial manipulation, but its efficacy in ulcerative colitis is uncertain. We aimed to establish the efficacy of intensive-dosing, multidonor, faecal microbiota transplantation in active ulcerative colitis. METHODS: We conducted a multicentre, double-blind, randomised, placebo-controlled trial at three hospitals in Australia...
February 14, 2017: Lancet
https://www.readbyqxmd.com/read/28214040/reinforcement-of-intestinal-epithelial-barrier-by-arabinoxylans-in-overweight-and-obese-subjects-a-randomized-controlled-trial-arabinoxylans-in-gut-barrier
#3
Bouke N Salden, Freddy J Troost, Ellen Wilms, Pilar Truchado, Ramiro Vilchez-Vargas, Dietmar H Pieper, Ruy Jáuregui, Massimo Marzorati, Tom van de Wiele, Sam Possemiers, Ad A Masclee
BACKGROUND & AIMS: Obesity and metabolic diseases are associated with alterations in microbial composition and impaired gut barrier. Previous in vitro and animal studies have shown that arabinoxylans (AX) have the potential to modulate gut microbiota and gut barrier and therefore could have a protective role. Primary aim of the study was to investigate the effect of AX on intestinal permeability. Secondary aims included the effect of AX on gene transcription and protein expression of tight junctions (TJ), intestinal microbiota composition and activity, immune response and metabolic markers in overweight and obese individuals...
February 3, 2017: Clinical Nutrition: Official Journal of the European Society of Parenteral and Enteral Nutrition
https://www.readbyqxmd.com/read/28213645/transcranial-direct-current-stimulation-modulates-neuronal-networks-in-attention-deficit-hyperactivity-disorder
#4
Anna Sotnikova, Cornelia Soff, Enzo Tagliazucchi, Katja Becker, Michael Siniatchkin
Anodal transcranial direct current stimulation (tDCS) of the prefrontal cortex has been repeatedly shown to improve working memory (WM). Since patients with attention deficit hyperactivity disorder (ADHD) are characterized by both underactivation of the prefrontal cortex and deficits in WM, the modulation of prefrontal activity with tDCS in ADHD patients may increase their WM performance as well as improve the activation and connectivity of the WM network. In the present study, this hypothesis was tested using a double-blind sham-controlled experimental design...
February 17, 2017: Brain Topography
https://www.readbyqxmd.com/read/28213593/randomised-double-blind-parallel-group-placebo-controlled-study-to-evaluate-the-analgesic-efficacy-and-safety-of-vvz-149-injections-for-postoperative-pain-following-laparoscopic-colorectal-surgery
#5
Srdjan S Nedeljkovic, Darin J Correll, Xiaodong Bao, Natacha Zamor, Jose L Zeballos, Yi Zhang, Mark J Young, Johanna Ledley, Jessica Sorace, Kristen Eng, Carlyle P Hamsher, Rajivan Maniam, Jonathan W Chin, Becky Tsui, Sunyoung Cho, Doo H Lee
INTRODUCTION: In spite of advances in understanding and technology, postoperative pain remains poorly treated for a significant number of patients. In colorectal surgery, the need for developing novel analgesics is especially important. Patients after bowel surgery are assessed for rapid return of bowel function and opioids worsen ileus, nausea and constipation. We describe a prospective, double-blind, parallel group, placebo-controlled randomised controlled trial testing the hypothesis that a novel analgesic drug, VVZ -149, is safe and effective in improving pain compared with providing opioid analgesia alone among adults undergoing laparoscopic colorectal surgery...
February 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28213480/a-common-genetic-variant-risk-score-is-associated-with-drug-induced-qt-prolongation-and-torsade-de-pointes-risk-a-pilot-study
#6
David G Strauss, Jose Vicente, Lars Johannesen, Ksenia Blinova, Jay W Mason, Peter Weeke, Elijah R Behr, Dan M Roden, Raymond Woosley, Gulum Kosova, Michael A Rosenberg, Christopher Newton-Cheh
Background -Drug-induced QT interval prolongation, a risk factor for life-threatening ventricular arrhythmias, is a potential side effect of many marketed and withdrawn medications. The contribution of common genetic variants previously associated with baseline QT interval to drug-induced QT prolongation and arrhythmias is not known. Methods -We tested the hypothesis that a weighted combination of common genetic variants contributing to QT interval at baseline, identified through genome-wide association studies, can predict individual response to multiple QT-prolonging drugs...
February 17, 2017: Circulation
https://www.readbyqxmd.com/read/28211600/feasibility-of-early-physical-therapy-for-dizziness-after-a-sports-related-concussion-a-randomized-clinical-trial
#7
J C Reneker, A Hassen, R S Phillips, M C Moughiman, M Donaldson, J Moughiman
The purpose of this study was to (a) assess the feasibility of recruitment/retention of participants, protocol/resource management, and participant safety, and (b) estimate the size of the effect between the experimental and control groups. This was a feasibility study conducted as a prospective pilot double-blind randomized clinical trial. Subjects aged 10-23 years old with acute concussion and dizziness were enrolled from sports medicine centers. Forty-one participants were randomized into treatment and were seen for physical therapy beginning at 10 days post-concussion...
February 17, 2017: Scandinavian Journal of Medicine & Science in Sports
https://www.readbyqxmd.com/read/28211216/low-dose-eplerenone-treatment-decreases-aortic-stiffness-in-patients-with-resistant-hypertension
#8
Tatjana Kalizki, Bernhard M W Schmidt, Ulrike Raff, Annemarie Reinold, Thomas K Schwarz, Markus P Schneider, Roland E Schmieder, Andreas Schneider
Vascular damage is aggravated in animal models of hypertension with mineralocorticoid (MR) excess and in hypertensive patients with primary hyperaldosteronism. MR antagonism has shown to provide effective blood pressure (BP)-control in patients with treatment resistant hypertension (TRH), but the concurrent effects on the vasculature have not been examined. In a randomized, double-blinded, placebo-controlled parallel-group study, 51 patients with TRH received either eplerenone 50 mg or placebo for 6 months together with additional antihypertensives titrated to achieve a BP target of <140/90 mm Hg...
February 17, 2017: Journal of Clinical Hypertension
https://www.readbyqxmd.com/read/28210662/time-course-of-glatiramer-acetate-efficacy-in-patients-with-rrms-in-the-gala-study
#9
Mat D Davis, Natalia Ashtamker, Joshua R Steinerman, Volker Knappertz
OBJECTIVE: To determine the time to efficacy onset of glatiramer acetate (GA) 40 mg/mL 3-times-weekly formulation (GA40). METHODS: This post hoc analysis of data from the 1-year, double-blind, placebo-controlled phase of the Glatiramer Acetate Low-Frequency Administration study (NCT01067521) of GA40 in patients with relapsing-remitting MS (RRMS) sought to determine the timing of efficacy onset using a novel data-censoring approach. RESULTS: Compared with placebo-treated patients, those receiving GA40 exhibited a >30% reduction in the accumulated annualized relapse rate (ARR) within 2 months of initiating treatment and generally sustained this treatment difference during the 1-year study...
March 2017: Neurology® Neuroimmunology & Neuroinflammation
https://www.readbyqxmd.com/read/28209728/evaluation-of-cell-therapy-on-exercise-performance-and-limb-perfusion-in-peripheral-artery-disease-the-cctrn-patients-with-intermittent-claudication-injected-with-aldh-bright-cells-pace-trial
#10
Emerson C Perin, Michael P Murphy, Keith L March, Roberto Bolli, John Loughran, Phillip C Yang, Nicholas J Leeper, Ronald L Dalman, Jason Q Alexander, Timothy D Henry, Jay H Traverse, Carl J Pepine, R David Anderson, Scott Berceli, James T Willerson, Raja Muthupillai, Amir A Gahremanpour, Ganesh Raveendran, Omaida C Velazquez, Joshua M Hare, Ivonne H Schulman, Vijaykumar S Kasi, William R Hiatt, Bharath Ambale-Venkatesh, João A Lima, Doris A Taylor, Micheline M Resende, Adrian P Gee, April G Durett, Jeannette Bloom, Sara Richman, Patricia G'Sell, Shari Williams, Fouzia Khan, Elsie G Ross, Michelle R Santoso, JoAnne Goldman, Dana Leach, Eileen Handberg, Benjamin Y C Cheong, Nichole A Piece, Darcy DiFede, Barb Bruhn-Ding, Emily Caldwell, Judy Bettencourt, Dejian Lai, Linda B Piller, Lara M Simpson, Michelle Cohen, Shelly L Sayre, Rachel W Vojvodic, Lem Moyé, Ray F Ebert, Robert D Simari, Alan T Hirsch
Background -Atherosclerotic peripheral artery disease (PAD) affects 8-12% of Americans over 65 and is associated with a major decline in functional status, increased myocardial infarction and stroke rates, and increased risk of ischemic amputation. Current treatment strategies for claudication have limitations. PACE is an NHLBI-sponsored, randomized, double-blind, placebo-controlled phase 2, exploratory clinical trial designed to assess safety and efficacy of autologous bone marrow-derived aldehyde dehydrogenase bright (ALDHbr) cells in PAD patients and to explore associated claudication physiologic mechanisms...
February 16, 2017: Circulation
https://www.readbyqxmd.com/read/28209507/ultrasound-guided-pulsed-radiofrequency-stimulation-of-posterior-tibial-nerve-a-potential-novel-intervention-for-recalcitrant-plantar-fasciitis
#11
Yung-Tsan Wu, Chih-Ya Chang, Yu-Ching Chou, Chun-Chang Yeh, Tsung-Ying Li, Heng-Yi Chu, Liang-Cheng Chen
OBJECTIVE: To evaluate the therapeutic benefit of ultrasound-guided pulsed radiofrequency (PRF) stimulation at the posterior tibial nerve (PTN) in patients with recalcitrant plantar fasciitis (PF). DESIGN: A prospective, randomized, double-blinded, placebo-controlled trial (12-week follow-up). SETTING: Outpatient of local medical center settings. PARTICIPANTS: Thirty-six patients with recalcitrant PF were randomized and 36 participants were included in the final data analysis...
February 13, 2017: Archives of Physical Medicine and Rehabilitation
https://www.readbyqxmd.com/read/28209155/intranasal-oxytocin-reduces-provoked-symptoms-in-female-patients-with-posttraumatic-stress-disorder-despite-exerting-sympathomimetic-and-positive-chronotropic-effects-in-a-randomized-controlled-trial
#12
M Sack, D Spieler, L Wizelman, G Epple, J Stich, M Zaba, U Schmidt
BACKGROUND: Posttraumatic stress disorder (PTSD) is a severe psychiatric disease accompanied by neuroendocrine changes such as adrenergic overdrive and hence an elevated cardiovascular morbidity. Current pharmacotherapeutic options for PTSD are less than suboptimal, necessitating the development of PTSD-specific drugs. Although the neuropeptide oxytocin has been repeatedly suggested to be effective in PTSD treatment, there are, to our knowledge, only three studies that have assessed its efficacy on the intensity of PTSD symptoms in PTSD patients - among them one symptom provocation study in male veterans...
February 17, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28208713/effects-of-an-encapsulated-fruit-and-vegetable-juice-concentrate-on-obesity-induced-systemic-inflammation-a-randomised-controlled-trial
#13
Evan J Williams, Katherine J Baines, Bronwyn S Berthon, Lisa G Wood
Phytochemicals from fruit and vegetables reduce systemic inflammation. This study examined the effects of an encapsulated fruit and vegetable (F&V) juice concentrate on systemic inflammation and other risk factors for chronic disease in overweight and obese adults. A double-blinded, parallel, randomized placebo-controlled trial was conducted in 56 adults aged ≥40 years with a body mass index (BMI) ≥28 kg/m². Before and after eight weeks daily treatment with six capsules of F&V juice concentrate or placebo, peripheral blood gene expression (microarray, quantitative polymerase chain reaction (qPCR)), plasma tumour necrosis factor (TNF)α (enzyme-linked immunosorbent assay (ELISA)), body composition (Dual-energy X-ray absorptiometry (DEXA)) and lipid profiles were assessed...
February 8, 2017: Nutrients
https://www.readbyqxmd.com/read/28208535/re-a-double-blind-placebo-controlled-randomized-phase-1-cross-over-study-with-alln-177-an-orally-administered-oxalate-degrading-enzyme
#14
Dean G Assimos
No abstract text is available yet for this article.
March 2017: Journal of Urology
https://www.readbyqxmd.com/read/28207287/thiamine-as-a-renal-protective-agent-in-septic-shock-a-secondary-analysis-of-a-randomized-double-blind-placebo-controlled-trial
#15
Ari Moskowitz, Lars W Andersen, Michael N Cocchi, Mathias Karlsson, Parth V Patel, Michael W Donnino
RATIONALE: Acute kidney injury (AKI) is common in patients with sepsis and has been associated with high mortality rates. The provision of thiamine to septic patients may reduce the incidence and severity of sepsis-related AKI and thereby prevent renal failure requiring renal replacement therapy (RRT). OBJECTIVES: To test the hypothesis that thiamine supplementation mitigates kidney injury in septic shock. METHODS: This was a secondary analysis of a single-center, randomized, double-blind trial comparing thiamine to placebo in patients with septic shock...
February 16, 2017: Annals of the American Thoracic Society
https://www.readbyqxmd.com/read/28207168/design-and-rationale-of-the-ebbinghaus-trial-a-phase-3-double-blind-placebo-controlled-multicenter-study-to-assess-the-effect-of-evolocumab-on-cognitive-function-in-patients-with-clinically-evident-cardiovascular-disease-and-receiving-statin-background-lipid
#16
Robert P Giugliano, Francois Mach, Kenton Zavitz, Christopher Kurtz, Jingjing Schneider, Huei Wang, Anthony Keech, Terje R Pedersen, Marc S Sabatine, Peter S Sever, Narimon Honarpour, Scott M Wasserman, Brian R Ott
Some observational studies raised concern that statins may cause memory impairment, leading to a US Food and Drug Administration warning. Similar questions were raised regarding proprotein convertase subtilisin/kexin-type 9 inhibitors (PCSK9i) and neurocognitive function. No prospectively designed study has evaluated the relationship between long-term PCSK9i use and cognition changes. Patients with prior cardiovascular disease treated with maximally tolerated statin enrolled in FOURIER (the randomized, double-blind, placebo-controlled cardiovascular outcome study of the PCSK9i evolocumab) could participate in this prospective assessment of cognitive function (EBBINGHAUS)...
February 16, 2017: Clinical Cardiology
https://www.readbyqxmd.com/read/28206732/clinical-efficacy-and-safety-of-a-new-once-daily-1000-mg-suspension-versus-twice-daily-500-mg-tablets-of-micronized-purified-flavonoid-fraction-in-patients-with-symptomatic-chronic-venous-disorders-a-randomized-controlled-trial
#17
Patrick Carpentier, Debora Karetova, Harunarashid Hanafiah, Elisabeth Enriquez-Vega, Andrej Dzupina, Miso Sabovic, Lourdes Reina Gutierrez, Somboom Subwongcharoen, Hasan Tüzün, Arnaud Maggioli
BACKGROUND: Chronic venous disorders (CVD) is estimated to affect 30% to 50% of women and 10% to 30% of men. The most widely prescribed treatment for CVD worldwide is micronized purified flavonoid fraction 500 mg (MPFF). The aim of this clinical trial was to develop a new once daily 1000 mg oral suspension of MPFF. METHODS: In an international, randomized, double-blind, parallel-group study, symptomatic individuals classified CEAP C0s to C4s were randomized in either treatment arm and treated for 8 weeks...
February 15, 2017: International Angiology: a Journal of the International Union of Angiology
https://www.readbyqxmd.com/read/28206682/cost-effectiveness-of-groin-hernia-repair-from-a-randomized-clinical-trial-comparing-commercial-versus-low-cost-mesh-in-a-low-income-country
#18
J Löfgren, A Matovu, A Wladis, C Ibingira, P Nordin, E Galiwango, B C Forsberg
BACKGROUND: Over 200 million people worldwide live with groin hernia and 20 million are operated on each year. In resource-scarce settings, the superior surgical technique using a synthetic mesh is not affordable. A low-cost alternative is needed. The objective of this study was to calculate and compare costs and cost-effectiveness of inguinal hernia mesh repair using a low-cost versus a commercial mesh in a rural setting in Uganda. METHODS: This is a cost-effectiveness analysis of a double-blinded RCT comparing outcomes from groin hernia mesh repair using a low-cost mesh and a commercially available mesh...
February 16, 2017: British Journal of Surgery
https://www.readbyqxmd.com/read/28205278/optimal-dose-of-ramosetron-in-female-patients-with-irritable%C3%A2-bowel-syndrome-with-diarrhea-a-randomized-placebo-controlled-phase-ii-study
#19
S Fukudo, K Matsueda, K Haruma, M Ida, H Hayase, H Akiho, Y Nakashima, M Hongo
BACKGROUND: Previous studies showed that 5 μg of ramosetron, a serotonin (5-hydroxytryptamine: 5-HT)-3 receptor antagonist, is only effective in male patients with irritable bowel syndrome (IBS) with diarrhea (IBS-D). We hypothesized that either dose 1.25, 2.5, or 5 μg of ramosetron would be effective in female patients with IBS-D. METHODS: This randomized, double-blind, placebo-controlled, phase II dose-finding exploratory trial included 409 female outpatients with IBS-D treated in Japan...
February 16, 2017: Neurogastroenterology and Motility: the Official Journal of the European Gastrointestinal Motility Society
https://www.readbyqxmd.com/read/28205208/skin-to-skin-care-for-procedural-pain-in-neonates
#20
REVIEW
Celeste Johnston, Marsha Campbell-Yeo, Timothy Disher, Britney Benoit, Ananda Fernandes, David Streiner, Darlene Inglis, Rebekah Zee
BACKGROUND: Skin-to-skin care (SSC), often referred to as 'kangaroo care' (KC) due to its similarity with marsupial behaviour of ventral maternal-infant contact, is one non-pharmacological intervention for pain control in infants. OBJECTIVES: The primary objectives were to determine the effect of SSC alone on pain from medical or nursing procedures in neonates compared to no intervention, sucrose or other analgesics, or additions to simple SSC such as rocking; and to determine the effects of the amount of SSC (duration in minutes), method of administration (e...
February 16, 2017: Cochrane Database of Systematic Reviews
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