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Controlled clinical trial

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https://www.readbyqxmd.com/read/29793053/aggressive-fluid-and-sodium-restriction-in-decompensated-heart-failure-with-preserved-ejection-fraction-results-from-a-randomized-clinical-trial
#1
Karina Sanches Machado d'Almeida, Eneida Rejane Rabelo-Silva, Gabriela Corrêa Souza, Melina Maria Trojahn, Sofia Louise Santin Barilli, Graziella Aliti, Luís Eduardo Rohde, Andreia Biolo, Luís Beck-da-Silva
OBJECTIVES: Sodium and fluid restriction is commonly prescribed for heart failure patients. However, its role in the treatment of heart failure with preserved ejection fraction (HFpEF) remains unclear. The aim of this study was to compare the effect of a diet with sodium and fluid restriction with an unrestricted diet in patients admitted for decompensated HFpEF. METHODS: Patients were randomized to a diet with sodium (0.8 g/d) and fluid (800 mL/d) restriction (intervention group [IG]) or an unrestricted diet (control group [CG]) and followed for 7 d or hospital discharge...
March 21, 2018: Nutrition
https://www.readbyqxmd.com/read/29792940/a-randomized-control-trial-to-determine-the-effectiveness-and-physiological-effects-of-spinal-manipulation-and-spinal-mobilization-compared-to-each-other-and-a-sham-condition-in-patients-with-chronic-low-back-pain-study-protocol-for-the-relief-study
#2
Brian C Clark, David W Russ, Masato Nakazawa, Christopher R France, Stevan Walkowski, Timothy D Law, Megan Applegate, Niladri Mahato, Samuel Lietkam, James Odenthal, Daniel Corcos, Simeon Hain, Betty Sindelar, Robert J Ploutz-Snyder, James S Thomas
BACKGROUND: Low back pain (LBP) is one of the most common reasons for seeking medical care. Manipulative therapies are a common treatment for LBP. Few studies have compared the effectiveness of different types of manipulative therapies. Moreover, the physiologic mechanisms underlying these treatments are not fully understood. Herein, we present the study protocol for The Researching the Effectiveness of Lumbar Interventions for Enhancing Function Study (The RELIEF Study). METHODS AND STUDY DESIGN: The RELIEF Study is a Phase II RCT with a nested mechanistic design...
May 21, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29792929/recent-advances-in-intra-articular-drug-delivery-systems-for-osteoarthritis-therapy
#3
REVIEW
Pierre Maudens, Olivier Jordan, Eric Allémann
Osteoarthritis (OA) is the most common degenerative disease of the joint. Despite many reports and numerous clinical trials, OA is not entirely understood, and there is no effective treatment available for this disease. To satisfy this unmet medical need, drug delivery systems (DDSs) containing disease-modifying OA drugs (DMOADs) for intra-articular (IA) administration are required to improve the health of OA patients. DDSs should provide controlled and/or sustained drug release, enabling long-term treatment with a reduced number of injections...
May 21, 2018: Drug Discovery Today
https://www.readbyqxmd.com/read/29792554/effect-of-acetazolamide-and-methazolamide-on-diaphragm-and-dorsiflexor-fatigue-a-randomized-controlled-trial
#4
Paolo B Dominelli, Chris J McNeil, Tyler Dennis Vermeulen, Troy J R Stuckless, Courtney V Brown, Giulio S Dominelli, Erik Richard Swenson, Lucas J Teppema, Glen Edward Foster
Acetazolamide, a carbonic anhydrase (CA) inhibitor used clinically and to prevent acute mountain sickness, worsens skeletal muscle fatigue in animals and humans. In animals, methazolamide, a methylated analogue of acetazolamide and an equally potent CA inhibitor, reportedly exacerbates fatigue less than acetazolamide. Accordingly, we sought to determine, in humans, if methazolamide would attenuate diaphragm and dorsiflexor fatigue compared to acetazolamide. Healthy men (dorsiflexor: n=12; diaphragm: n=7) performed fatiguing exercise on three occasions, after ingesting acetazolamide (250 mg three times a day) and then in random order, methazolamide (100 mg twice a day) or placebo for 48 h...
May 24, 2018: Journal of Applied Physiology
https://www.readbyqxmd.com/read/29792533/efficacy-of-the-resilience-and-adjustment-intervention-after-traumatic-brain-injury-a-randomized-controlled-trial
#5
Jeffrey S Kreutzer, Jennifer H Marwitz, Adam P Sima, Ana Mills, Nancy H Hsu, Herman R Lukow
OBJECTIVE: Examine a psychoeducational and skill-building intervention's effectiveness for individuals after traumatic brain injury (TBI), using a two-arm, parallel, randomized, controlled trial with wait-listed control. METHODS: The Resilience and Adjustment Intervention (RAI) targets adjustment challenges and emphasizes education, skill-building and psychological support. Overall, 160 outpatients were randomly assigned to a treatment or wait-list control (WLC) group...
May 24, 2018: Brain Injury: [BI]
https://www.readbyqxmd.com/read/29792372/sativex%C3%A2-as-add-on-therapy-vs-further-optimized-first-line-antispastics-savant-in-resistant-multiple-sclerosis-spasticity-a-double-blind-placebo-controlled-randomised-clinical-trial
#6
Jolana Markovà, Ute Essner, Bülent Akmaz, Marcella Marinelli, Christiane Trompke, Arnd Lentschat, Carlos Vila Silván
Purpose/aim: To evaluate the efficacy of tetrahydrocannabinol [THC]:cannabidiol [CBD] oromucosal spray (Sativex®) as add-on therapy to optimized standard antispasticity treatment in patients with moderate to severe multiple sclerosis (MS) spasticity. METHODS: Sativex as Add-on therapy Vs. further optimized first-line ANTispastics (SAVANT) was a two-phase trial. In Phase A, eligible patients received add-on THC:CBD spray for 4 weeks to identify initial responders (≥ 20% improvement from baseline in spasticity 0-10 numerical rating scale [NRS] score)...
May 24, 2018: International Journal of Neuroscience
https://www.readbyqxmd.com/read/29792288/tralokinumab-for-severe-uncontrolled-asthma-stratos-1-and-stratos-2-two-randomised-double-blind-placebo-controlled-phase-3-clinical-trials
#7
Reynold A Panettieri, Ulf Sjöbring, AnnaMaria Péterffy, Peter Wessman, Karin Bowen, Edward Piper, Gene Colice, Christopher E Brightling
BACKGROUND: Tralokinumab is an anti-interleukin-13 human monoclonal antibody developed for the treatment of severe, uncontrolled asthma. These clinical trials aimed to assess the efficacy and safety of tralokinumab in this population. METHODS: STRATOS 1 and STRATOS 2 were randomised, double-blind, parallel-group, placebo-controlled, phase 3 clinical trials that enrolled participants aged 12-75 years with severe asthma that was inadequately controlled despite use of inhaled corticosteroids (≥500 μg per day fluticasone or equivalent) and a long-acting β2 agonist (but not oral corticosteroids)...
May 18, 2018: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/29792241/efficacy-of-digital-cbt-for-insomnia-to-reduce-depression-across-demographic-groups-a-randomized-trial
#8
Philip Cheng, Annemarie I Luik, Cynthia Fellman-Couture, Edward Peterson, Christine L M Joseph, Gabriel Tallent, Kieulinh Michelle Tran, Brian K Ahmedani, Timothy Roehrs, Thomas Roth, Christopher L Drake
BACKGROUND: Insomnia and depression are highly comorbid and mutually exacerbate clinical trajectories and outcomes. Cognitive behavioral therapy for insomnia (CBT-I) effectively reduces both insomnia and depression severity, and can be delivered digitally. This could substantially increase the accessibility to CBT-I, which could reduce the health disparities related to insomnia; however, the efficacy of digital CBT-I (dCBT-I) across a range of demographic groups has not yet been adequately examined...
May 24, 2018: Psychological Medicine
https://www.readbyqxmd.com/read/29792226/treatment-of-depression-and-or-anxiety-outcomes-of-a-randomised-controlled-trial-of-the-tree-theme-method%C3%A2-versus-regular-occupational-therapy
#9
A Birgitta Gunnarsson, Petra Wagman, Katarina Hedin, Carita Håkansson
BACKGROUND: Depression and anxiety disorders are a major concern in western countries, and because these often have a negative affect on everyday life interventions based on activities in everyday life are needed. The Tree Theme Method® (TTM) is a client-centred occupational therapy intervention designed to increase the ability to cope with, and to enhance satisfaction with, everyday life, both at home and at work. The aim of this study was to compare the short term outcomes of the TTM intervention with regular occupational therapy treatment for people with depression and/or anxiety disorders...
May 23, 2018: BMC Psychology
https://www.readbyqxmd.com/read/29792215/adding-left-atrial-appendage-closure-to-open-heart-surgery-provides-protection-from-ischemic-brain-injury-six-years-after-surgery-independently-of-atrial-fibrillation-history-the-laacs-randomized-study
#10
Jesper Park-Hansen, Susanne J V Holme, Akhmadjon Irmukhamedov, Christian L Carranza, Anders M Greve, Gina Al-Farra, Robert G C Riis, Brian Nilsson, Johan S R Clausen, Anne S Nørskov, Christina R Kruuse, Egill Rostrup, Helena Dominguez
BACKGROUND: Open heart surgery is associated with high occurrence of atrial fibrillation (AF), subsequently increasing the risk of post-operative ischemic stroke. Concomitant with open heart surgery, a cardiac ablation procedure is commonly performed in patients with known AF, often followed by left atrial appendage closure with surgery (LAACS). However, the protective effect of LAACS on the risk of cerebral ischemia following cardiac surgery remains controversial. We have studied whether LAACS in addition to open heart surgery protects against post-operative ischemic brain injury regardless of a previous AF diagnosis...
May 23, 2018: Journal of Cardiothoracic Surgery
https://www.readbyqxmd.com/read/29792202/the-effects-of-a-lifestyle-focused-text-messaging-intervention-on-adherence-to-dietary-guideline-recommendations-in-patients-with-coronary-heart-disease-an-analysis-of-the-text-me-study
#11
Karla Santo, Karice Hyun, Laura de Keizer, Aravinda Thiagalingam, Graham S Hillis, John Chalmers, Julie Redfern, Clara K Chow
BACKGROUND: A healthy diet is an important component of secondary prevention of coronary heart disease (CHD). The TEXT ME study was a randomised clinical trial of people with CHD that were randomised into standard care or a text-message programme in addition to standard care. This analysis aimed to: 1) assess the effects of the intervention onadherence to the dietary guideline recommendations; 2) assess the consistency of effect across sub-groups; and 3) assess whether adherence to the dietary guideline recommendations mediated the improvements in objective clinical outcomes...
May 23, 2018: International Journal of Behavioral Nutrition and Physical Activity
https://www.readbyqxmd.com/read/29792152/sorbinil-an-aldolase-reductase-inhibitor-in-fighting-against-diabetic-complications
#12
Qi Huang, Qiong Liu, Dongsheng Ouyang
BACKGROUND: Aldose reductase (AR) is involved in pathogenesis of diabetes, which is one of the major threats to global public health. OBJECTIVE: In this review article, we have discussed the role of sorbinil, an AR inhibitor (ARI), in preventing diabetic complications. RESULTS: AR contributes in diabetes by generating excess intracellular superoxide and other mediators of oxidative stress through polyol pathway. Inhibition of AR activity thus might be potential approach for the management of diabetic complications...
May 23, 2018: Medicinal Chemistry
https://www.readbyqxmd.com/read/29792136/zinc-dependent-histone-deacetylase-inhibitors-in-cancer-therapeutics-recent-update
#13
Panagiotis I Georgianos, Maria Divani, Theodoros Eleftheriadis, Peter R Mertens, Vassilios Liakopoulos
BACKGROUND: Despite optimal management of diabetic kidney disease (DKD) with intensive glycemic control and administration of agents blocking the renin-angiotensin-aldosterone-system, the residual risk for nephropathy progression to end-stage-renal-disease (ESRD) remains high. Sodium-glucose co-transporter type 2 (SGLT-2)-inhibitors represent a newly-introduced anti-diabetic drug class with pleiotropic actions extending above their glucose-lowering efficacy. Herein, we provide an overview of preclinical and clinical-trial evidence supporting a protective effect of SGLT-2 inhibitors on DKD...
May 23, 2018: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/29792085/role-of-selenium-supplementation-in-prevention-of-late-onset-sepsis-among-very-low-birth-weight-neonates-a-systematic-review-of-randomized-controlled-trials
#14
Bhawan Garg, Anju Bansal, Nandkishor Kabra
BACKGROUND: Neonatal sepsis is one of the most common cause of neonatal morbidity and mortality. Selenium has antioxidant and immune-modulating properties. AIM: The aim of this systematic review is to evaluate role of selenium supplementation in the prevention of late onset sepsis (LOS) among very low birth weight (VLBW) neonates. METHODS: We searched literature for this review by searching the Cochrane Central Register of Controlled Trials (CENTRAL) electronic PubMed, Embase and Google Scholar...
May 23, 2018: Journal of Maternal-fetal & Neonatal Medicine
https://www.readbyqxmd.com/read/29792074/lessons-learned-conducting-a-multi-center-trial-with-a-military-population-the-tinnitus-retraining-therapy-trial
#15
Roberta W Scherer, Leonora D Sensinger, Benigno Sierra-Irizarry, Craig Formby
Background The Tinnitus Retraining Therapy Trial (TRTT), a randomized, placebo-controlled, multi-center trial, evaluated the efficacy of tinnitus retraining therapy and its individual components, tinnitus-specific educational counseling and sound therapy versus the standard of care, in military practice to improve study participants' quality of life. The trial was conducted at six US military hospitals to take advantage of the greater prevalence of tinnitus in the military population. Methods During the trial, various challenges arose that were uniquely related to the military setting...
May 1, 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29791926/meniscus-repair-in-children-and-adolescents-a-systematic-review-of-treatment-approaches-meniscal-healing-and-outcomes
#16
Márcio Balbinotti Ferrari, Colin P Murphy, João Luiz Ellera Gomes
Although the consequences of traumatic meniscus tears and the importance of meniscal repair are well-established in adults, the same cannot be said for the young population. Better evidence regarding the outcomes following traumatic meniscal tears in children would improve our understanding of this increasing pathology and help define important factors in deciding the best treatment option. A systematic review was performed according to the Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines using the Cochrane Database of Systematic Review, Cochrane Central Register of Controlled Trials, MEDLINE Ovid, and MEDLINE PubMed databases...
May 23, 2018: Journal of Knee Surgery
https://www.readbyqxmd.com/read/29791910/melatonin-attenuates-histopathological-changes-in-the-hippocampus-of-infantile-rats-with-kaolin-induced-hydrocephalus
#17
Mehmet Turgut, Meral Baka, Yiğit Uyanıkgil
OBJECTIVE/AIM: Hydrocephalus is defined as an incapacitating neurological disorder characterized by ventricular enlargement in children, but the effects of melatonin on this hydrocephalus have not yet been fully elucidated. In the present experiment, we attempted to investigate the effects of exogenous melatonin administration on hydrocephalus-induced hippocampal changes in infantile rats. METHODS: In this study, we randomly divided 45 Swiss albino rats aged 2 weeks into 3 groups: group I, the control group received a sham injection with needle insertion only; groups II and III were given kaolin injections before treatment - group II, the hydrocephalus group, was treated with an isotonic NaCl solution, and group III, the hydrocephalus plus melatonin group, was treated with 0...
May 23, 2018: Pediatric Neurosurgery
https://www.readbyqxmd.com/read/29791895/effect-of-postprandial-administration-of-esomeprazole-on-reflux-symptoms-in-gastroesophageal-reflux-disease-a-randomized-controlled-trial
#18
Doron Boltin, Ibrahim Zvidi, Maria Raskin, Hen Kayless, Hemda Schmilovitz-Weiss, Rachel Gingold-Belfer, Yaron Niv, Ram Dickman
BACKGROUND: Esomeprazole is commonly administered with food; however, clinical data to support this practice are lacking. We aimed to determine the effect of postprandial ingestion of esomeprazole on reflux symptoms among patients with gastroesophageal reflux disease (GERD). METHODS: Consecutive patients with GERD adequately controlled with esomeprazole 40 mg daily, entered a 2-week lead-in period during which esomeprazole was administered 30 min before breakfast...
May 23, 2018: Digestive Diseases
https://www.readbyqxmd.com/read/29791822/extracorporeal-membrane-oxygenation-for-severe-acute-respiratory-distress-syndrome
#19
Alain Combes, David Hajage, Gilles Capellier, Alexandre Demoule, Sylvain Lavoué, Christophe Guervilly, Daniel Da Silva, Lara Zafrani, Patrice Tirot, Benoit Veber, Eric Maury, Bruno Levy, Yves Cohen, Christian Richard, Pierre Kalfon, Lila Bouadma, Hossein Mehdaoui, Gaëtan Beduneau, Guillaume Lebreton, Laurent Brochard, Niall D Ferguson, Eddy Fan, Arthur S Slutsky, Daniel Brodie, Alain Mercat
BACKGROUND: The efficacy of venovenous extracorporeal membrane oxygenation (ECMO) in patients with severe acute respiratory distress syndrome (ARDS) remains controversial. METHODS: In an international clinical trial, we randomly assigned patients with very severe ARDS, as indicated by one of three criteria - a ratio of partial pressure of arterial oxygen (Pao2 ) to the fraction of inspired oxygen (Fio2 ) of less than 50 mm Hg for more than 3 hours; a Pao2 :Fio2 of less than 80 mm Hg for more than 6 hours; or an arterial blood pH of less than 7...
May 24, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29791672/jacobson-and-truax-method-evaluation-of-the-clinical-effectiveness-of-a-home-care-program-after-prostatectomy
#20
Luciana Regina Ferreira Pereira da Mata, Mariana Ferreira Vaz Gontijo Bernardes, Cissa Azevedo, Tânia Couto Machado Chianca, Maria da Graça Pereira, Emilia Campos de Carvalho
OBJECTIVE: to exemplify the applicability of the Jacobson and Truax Method in a nursing intervention study that analyzed the effectiveness of a home care teaching program after radical prostatectomy. METHOD: this is a descriptive study concerning the applicability of the Jacobson and Truax Method in the data analysis of a clinical trial. The intervention consisted of a teaching program for hospital discharge after radical prostatectomy through oral guidance, writing, and telephonic reinforcement...
2018: Revista Latino-americana de Enfermagem
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