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Randomized controlled clinical trial

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https://www.readbyqxmd.com/read/29656373/evaluation-of-disease-activity-in-patients-with-rheumatoid-arthritis-treated-with-tofacitinib-by-rapid3-post-hoc-analyses-from-two-phase-3-trials
#1
Vibeke Strand, Eun Bong Lee, Yusuf Yazici, Ara Dikranian, Bethanie Wilkinson, Liza Takiya, Chuanbo Zang, Eustratios Bananis, Martin J Bergman
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. We evaluated the relationship between disease activity, according to Routine Assessment of Patient Index Data 3 (RAPID3) after 6-month treatment with tofacitinib, and long-term outcomes at 24 months. This was a post hoc analysis of two 24-month, phase 3, randomized controlled trials in methotrexate (MTX)-naïve (ORAL Start [NCT01039688]) or MTX-inadequate responder patients (ORAL Scan [NCT00847613]) receiving tofacitinib 5 or 10 mg twice daily (BID) as monotherapy or with background MTX...
April 14, 2018: Clinical Rheumatology
https://www.readbyqxmd.com/read/29656279/drug-eluting-resorbable-magnesium-scaffold-implantation-in-st-segment-elevation-myocardial-infarction-a-pilot-study
#2
Quentin de Hemptinne, Fabien Picard, Rachid Briki, Ahmad Awada, Paul-Gaël Silance, Dariouch Dolatabadi, Nadia Debbas, Philippe Unger
OBJECTIVES: To assess feasibility and short-term clinical outcomes associated with resorbable magnesium scaffold (RMS) implantation in the setting of primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI). BACKGROUND: RMS implantation has demonstrated favorable clinical outcomes in stable coronary artery disease patients. However, to date, data are lacking in the setting of STEMI. METHODS: This is a single-center prospective non-randomized pilot study...
April 15, 2018: Journal of Invasive Cardiology
https://www.readbyqxmd.com/read/29655852/aidi-injection-plus-platinum-based-chemotherapy-for-stage-iiib-iv-non-small-cell-lung-cancer-a-meta-analysis-of-42-rcts-following-the-prisma-guidelines
#3
Jue Wang, Guochun Li, Lili Yu, Tingting Mo, Qibiao Wu, Zhou Zhou
ETHNOPHARMACOLOGICAL RELEVANCE: Aidi injection is one of the most commonly used Chinese patent medicines for advanced non-small cell lung cancer (NSCLC). It is made from an extraction of Mylabris Phalerata, Radix Astragalus, Radix Ginseng, and Acanthopanax Senticosus. AIM OF THE STUDY: The objective of this study is to evaluate the efficacy and safety of Aidi injection in combination with platinum-based chemotherapy for stage IIIB/IV NSCLC. MATERIALS AND METHODS: A systematic review and meta-analysis were performed following the PRISMA (the Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines...
April 12, 2018: Journal of Ethnopharmacology
https://www.readbyqxmd.com/read/29655779/postprandial-glucose-and-insulin-response-to-a-high-fiber-muffin-top-containing-resistant-starch-type-4-in-healthy-adults-a-double-blind-randomized-controlled-trial
#4
Maria L Stewart, J Paul Zimmer
OBJECTIVES: VERSAFIBE™ 2470 resistant starch (RS) is an RS type 4 that is derived from high-amylose maize starch,70% total dietary fiber (TDF; AOAC method 2009.01). This was a randomized, double-blind, crossover study to evaluate the postprandial blood glucose and insulin responses of healthy adults (n = 28) after the consumption of a muffin top made with VERSAFIBE™ 2470 RS (11.6 g TDF fiber muffin top) or a control muffin top (0.9 g TDF). METHODS: The muffin tops were matched for weight, total carbohydrate, sugars, protein, and fat...
February 13, 2018: Nutrition
https://www.readbyqxmd.com/read/29655772/predicting-chronic-spontaneous-urticaria-symptom-return-after-omalizumab-treatment-discontinuation-exploratory-analysis
#5
Marta Ferrer, Ana Giménez-Arnau, Diego Saldana, Nico Janssens, Maria-Magdalena Balp, Sam Khalil, Valéry Risson
BACKGROUND: Omalizumab is highly effective in controlling chronic spontaneous urticaria (CSU) symptoms; however, patients can experience symptom return upon treatment discontinuation. Pivotal clinical trials have identified two categories of patients who experience symptom return: rapid and slow. OBJECTIVE: To identify potential predictors of the speed of symptom return after stopping omalizumab treatment. METHODS: Phase III randomized controlled trial (RCT) data from ASTERIA I (n=319; 6x4-weekly injections of omalizumab 75, 150, 300 mg or placebo; NCT01287117) and ASTERIA II (n=323; 3x4-weekly injections of omalizumab 75, 150, 300 mg or placebo; NCT01292473) were pooled to identify predictors of symptom return after stopping omalizumab treatment (16-week follow-up)...
April 12, 2018: Journal of Allergy and Clinical Immunology in Practice
https://www.readbyqxmd.com/read/29655505/midterm-outcome-of-transcatheter-versus-surgical-aortic-valve-replacement-in-low-to-intermediate-risk-patients-a-meta-analysis-of-randomized-controlled-trials
#6
Yanwei Wang, Yijiang Zhou, Li Zhang, Jianhua Zhu
BACKGROUND: Current guidelines recommend transcatheter aortic valve replacement (TAVR) in patients with severe symptomatic aortic stenosis (AS) who are not suitable for conventional surgical aortic valve replacement (SAVR). In light of the recent trend in performing TAVR in patients with lower risk profile, we assessed the midterm outcome comparing TAVR and SAVR for the treatment of patients with severe AS at low to intermediate risk. METHODS: PubMed, EBSCO, and Cochrane CENTRAL were systematically searched for randomized controlled trials that reported the clinical outcomes of TAVR versus SAVR in patients at low to intermediate surgical risk with at least 2 years of follow-up...
June 2018: Journal of Cardiology
https://www.readbyqxmd.com/read/29655489/the-cochleural-alternating-acoustic-beam-therapy-caabt-a-pre-clinical-trial
#7
Chunli Liu, Han Lv, Tao Jiang, Jing Xie, Lu He, Guopeng Wang, Jiao Liu, Zhenchang Wang, Shusheng Gong
PURPOSE: We intend to assess the effectiveness of a novel tinnitus treatment therapy, the Cochleural Alternating Acoustic Beam Therapy (CAABT) using the psychoacoustic measures, the questionnaires and rs-fMRI. MATERIALS AND METHODS: In this study, we enrolled 11 older than 18 years old Chinese patients with normal hearing who had unilateral, chronic (longer than 6 months), sensorineural tinnitus, of frequencies between 125-8000 Hz, and an average loudness of 31 dB...
April 3, 2018: American Journal of Otolaryngology
https://www.readbyqxmd.com/read/29653344/a-randomized-controlled-trial-of-comprehensive-early-intervention-care-in-patients-with-first-episode-psychosis-in-japan-1-5-year-outcomes-from-the-j-cap-study
#8
Atsushi Nishida, Shuntaro Ando, Syudo Yamasaki, Shinsuke Koike, Kayo Ichihashi, Yuji Miyakoshi, Sanae Maekawa, Tomohisa Nakamura, Tatsunobu Natsubori, Eriko Ichikawa, Hiroki Ishigami, Kojiro Sato, Asami Matsunaga, Jo Smith, Paul French, Hirohiko Harima, Yoshiki Kishi, Izumi Fujita, Kiyoto Kasai, Yuji Okazaki
The first episode of psychosis represents a critical period wherein comprehensive early intervention in psychosis (EIP) may alter the course of illness. However, evidence from randomized controlled trials that have examined the impact of comprehensive EIP care on clinical and functional recovery assessed by independent blinded raters is limited. The objective of this study was to conduct a single-blinded multicenter trial comparing comprehensive EIP care and standard care in young patients with first-episode psychosis (FEP) in Japan (J-CAP Study)...
April 8, 2018: Journal of Psychiatric Research
https://www.readbyqxmd.com/read/29652929/immunogenicity-and-safety-of-three-consecutive-production-lots-of-the-non-replicating-smallpox-vaccine-mva-a-randomised-double-blind-placebo-controlled-phase-iii-trial
#9
Edgar Turner Overton, Steven J Lawrence, Eva Wagner, Katrin Nopora, Siegfried Rösch, Philip Young, Darja Schmidt, Christian Kreusel, Sonja De Carli, Thomas P Meyer, Heinz Weidenthaler, Nathaly Samy, Paul Chaplin
BACKGROUND: Modified Vaccinia Ankara (MVA) is a live, viral vaccine under advanced development as a non-replicating smallpox vaccine. A randomised, double-blind, placebo-controlled phase III clinical trial was conducted to demonstrate the humoral immunogenic equivalence of three consecutively manufactured MVA production lots, and to confirm the safety and tolerability of MVA focusing on cardiac readouts. METHODS: The trial was conducted at 34 sites in the US. Vaccinia-naïve adults aged 18-40 years were randomly allocated to one of four groups using a 1:1:1:1 randomization scheme...
2018: PloS One
https://www.readbyqxmd.com/read/29652784/a-prospective-randomized-multicenter-study-comparing-silicated-calcium-phosphate-versus-bmp-2-synthetic-bone-graft-in-posterolateral-instrumented-lumbar-fusion-for-degenerative-spinal-disorders
#10
Marc Coughlan, Mark Davies, Adriaan K Mostert, Dharmin Nanda, Paul C Willems, Geoffrey Rosenberg, Richard Ferch
STUDY DESIGN: A prospective, Phase IV, multicenter, randomized study. OBJECTIVE: To compare vertebral fusion success rates following posterolateral fusion ((PLF)/posterolateral intertransverse fusion (PITF)) surgery. The surgical procedure combined posterior lumbar interbody fusion (PLIF) and PLF with internal fixation over one or two levels using silicated calcium phosphate (SiCaP) or bone morphogenetic protein (BMP)-2 as graft material in patients with a degenerative disorder of the lumbar spine...
April 12, 2018: Spine
https://www.readbyqxmd.com/read/29652768/effect-of-one-stage-versus-two-stage-palatoplasty-on-hypernasality-and-fistula-formation-in-children-with-complete-unilateral-cleft-lip-and-palate-a-randomized-controlled-trial
#11
Rajgopal R Reddy, Srinivas Gosla Reddy, Anusha Chilakalapudi, Swapnika Kokali, Ewald M Bronkhorst, Ann W Kummer, Stefaan J Bergé, Anne Marie Kuijpers-Jagtman
BACKGROUND: Is one or two-stage palatoplasty more effective preventing fistula formation and hypernasality in patients with complete unilateral cleft lip and palate? METHODS: This parallel blocked randomized controlled trial included 100 patients with non-syndromic complete unilateral cleft lip and palate with a repaired cleft lip, divided into 2 groups of 50 each. Group A had one-stage palatoplasty at age 12-13 months while group B had two-stage palatoplasty with soft palatoplasty at age 12-13 months and hard palatoplasty at age 24-25 months...
March 28, 2018: Plastic and Reconstructive Surgery
https://www.readbyqxmd.com/read/29652755/comprehensive-treatment-and-rehabilitation-of-patients-with-osteosarcoma-of-the-mandible
#12
Anatolij Sergeevich Utyuzh, Alexei Valerievich Yumashev, Hans Walter Lang, Angelina Olegovna Zekiy, Richard Michailovich Lushkov
OBJECTIVE: The article studies state-of-the art physical therapeutic techniques as a high degree of relevance to minimize invalidation and improve quality of life for patients with dental osteosarcoma. MATERIALS AND METHODS: A randomized controlled clinical trial was conducted in 21 patients with osteogenic sarcoma of mandible (C41.1). There were 10 patients in the experimental group and 11 patients in the control group. RESULTS: A comprehensive treatment and rehabilitation program for patients with osteosarcoma of mandible was developed...
April 12, 2018: Implant Dentistry
https://www.readbyqxmd.com/read/29652567/a-khorasan-wheat-based-replacement-diet-improves-risk-profile-of-patients-with-nonalcoholic-fatty-liver-disease-nafld-a-randomized-clinical-trial
#13
Monica Dinu, Anne Whittaker, Giuditta Pagliai, Ilaria Giangrandi, Barbara Colombini, Anna Maria Gori, Claudia Fiorillo, Matteo Becatti, Alessandro Casini, Stefano Benedettelli, Francesco Sofi
OBJECTIVE: KAMUT khorasan is an ancient grain with widely acclaimed health benefits. The aim of this study was to investigate the effects of a replacement diet with ancient khorasan wheat products in patients with NAFLD, in comparison to a similar replacement diet with control products made from organic semi-whole-grain modern wheat. METHODS: Forty NAFLD patients (12 M/28 F; age 55.2 ± 10.4 years) with mild to moderate liver steatosis were included. The experimental design was a randomized, double-blind, parallel-arm study with 20 participants assigned to consume either KAMUT khorasan or control wheat products (pasta, bread, crackers, biscuits) over a 3-month period...
April 13, 2018: Journal of the American College of Nutrition
https://www.readbyqxmd.com/read/29652088/non-invasive-brain-stimulation-techniques-for-chronic-pain
#14
REVIEW
Neil E O'Connell, Louise Marston, Sally Spencer, Lorraine H DeSouza, Benedict M Wand
BACKGROUND: This is an updated version of the original Cochrane Review published in 2010, Issue 9, and last updated in 2014, Issue 4. Non-invasive brain stimulation techniques aim to induce an electrical stimulation of the brain in an attempt to reduce chronic pain by directly altering brain activity. They include repetitive transcranial magnetic stimulation (rTMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), transcranial random noise stimulation (tRNS) and reduced impedance non-invasive cortical electrostimulation (RINCE)...
April 13, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29652078/total-cardiovascular-events-analysis-of-the-examine-trial-in-patients-with-type-2-diabetes-and-recent-acute-coronary-syndrome
#15
Matthew A Cavender, William B White, Yuyin Liu, Joseph M Massaro, Richard M Bergenstal, Cyrus R Mehta, Faiez Zannad, Simon Heller, William C Cushman, Christopher P Cannon
BACKGROUND: Alogliptin, a dipeptidyl-peptidase 4 inhibitor, is approved for the treatment of patients with type 2 diabetes. EXAMINE was a randomized-controlled clinical trial designed to demonstrate the cardiovascular safety of alogliptin. In the trial, 5380 patients with established T2DM who had a recent ACS event (between 15-90 days) were randomized to treatment with either alogliptin or placebo. HYPOTHESIS: To better understand and describe the cardiovascular (CV) safety of alogliptin, we analyzed data from the EXAMINE randomized clinical trial to determine whether treatment with alogliptin affected recurrent and total CV events...
April 13, 2018: Clinical Cardiology
https://www.readbyqxmd.com/read/29651953/comparison-between-supervised-and-partly-supervised-cardiac-rehabilitation-protocols-in-hypertensive-patients-a-randomized-controlled-trial
#16
Larissa Barreto Parreira, Priscila Valverde de Oliveira Vitorino, Paulo Cesar Brandao Veiga Jardim, Ana Luiza Lima Sousa, Thiago Veiga Jardim, Watila de Moura Sousa, Alberto Fenrando Oliveira Justo, Weimar Kunz Sebba Barroso
BACKGROUND: Hypertension (HTN) is the main cause of cardiovascular diseases accounting for one third of global mortality. Physical exercise reduces the incidence and prevalence of HTN and cardiovascular morbidity and mortality. Exercises recommended for hypertensive patients include supervised cardiac rehabilitation, which occurs in rehabilitation centers, and partly supervised rehabilitation, with individual prescription of exercises conducted at patients' residences. OBJECTIVE: Compare clinical and functional parameters of hypertensive patients subjected to two cardiac rehabilitation protocols: supervised and partly supervised...
April 13, 2018: Current Hypertension Reviews
https://www.readbyqxmd.com/read/29651873/effectiveness-of-virtual-reality-training-for-balance-and-gait-rehabilitation-in-people-with-multiple-sclerosis-a-systematic-review-and-meta-analysis
#17
María Jesús Casuso-Holgado, Rocío Martín-Valero, Ana F Carazo, Esther M Medrano-Sánchez, M Dolores Cortés-Vega, Francisco José Montero-Bancalero
OBJECTIVE: To evaluate the evidence for the use of virtual reality to treat balance and gait impairments in multiple sclerosis rehabilitation. DESIGN: Systematic review and meta-analysis of randomized controlled trials and quasi-randomized clinical trials. METHODS: An electronic search was conducted using the following databases: MEDLINE (PubMed), Physiotherapy Evidence Database (PEDro), Cochrane Database of Systematic Reviews (CDSR) and (CINHAL)...
April 1, 2018: Clinical Rehabilitation
https://www.readbyqxmd.com/read/29651853/oleogel-s10-to-accelerate-healing-of-donor-sites-monocentric-results-of-phase-iii-clinical-trial
#18
B Lipový, M Fiamoli, R Mager, Z Jelínková, J Jarkovský, Z Chaloupková, J Holoubek, I Suchánek, P Brychta
MATERIAL AND METHODS: Oleogel-S10, an ointment containing betulin-rich triterpene dry extract from birch bark was tested in an open, blindly evaluated, prospective, controlled, randomized multicentre study to improve wound healing in donor sites. The primary endpoint was time to wound closure, and secondary endpoints were scar related measurements at the time of wound closure, and 3 and 12 months after wound closure (POSAS, laser speckle contrast analysis, viscoelastic analysis). RESULTS: We report the results from a single centre (Department of Burns and Reconstructive Surgery, University Hospital Brno) of this phase III clinical trial...
2018: Acta Chirurgiae Plasticae
https://www.readbyqxmd.com/read/29651816/theoretical-and-hands-on-guidance-from-dental-hygienists-promotes-good-oral-health-in-elderly-people-living-in-nursing-homes-a-pilot-study
#19
B Seleskog, L Lindqvist, I Wårdh, A Engström, I von Bültzingslöwen
OBJECTIVES: Oral health in nursing homes for elderly is often unsatisfactory, and oral health education to nursing staff has not shown sufficient results why there is need for novel approaches. The aim of the study was to trial a new oral healthcare educational programme and to evaluate the effects on residents' oral health. In addition, attitudes among the nursing staff in the intervention nursing home were explored. METHODS: In a controlled clinical trial, two comparable nursing homes were randomly assigned for intervention or control...
April 12, 2018: International Journal of Dental Hygiene
https://www.readbyqxmd.com/read/29651786/the-why-when-and-how-to-test-for-obstructive-sleep-apnea-in-patients-with-atrial-fibrillation
#20
REVIEW
Lien Desteghe, Jeroen M L Hendriks, R Doug McEvoy, Ching Li Chai-Coetzer, Paul Dendale, Prashanthan Sanders, Hein Heidbuchel, Dominik Linz
Sleep apnea is associated with increased cardiovascular risk and may be important in atrial fibrillation (AF) management. It is present in up to 62% of the AF population and is highly under-recognized and underdiagnosed. Obstructive sleep apnea (OSA) is strongly associated with AF and non-randomized trials have shown that its treatment can help to reduce AF recurrences and maintain sinus rhythm. The 2016 European Society of Cardiology guidelines for the management of AF recommend that AF patients should be questioned regarding the symptoms of OSA and that OSA-treatment should be optimized to improve AF treatment results...
April 12, 2018: Clinical Research in Cardiology: Official Journal of the German Cardiac Society
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