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Randomised Control Study

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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
#1
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/29792287/safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-glpg1690-a-novel-autotaxin-inhibitor-to-treat-idiopathic-pulmonary-fibrosis-flora-a-phase-2a-randomised-placebo-controlled-trial
#2
Toby M Maher, Ellen M van der Aar, Olivier Van de Steen, Lisa Allamassey, Julie Desrivot, Sonia Dupont, Liesbeth Fagard, Paul Ford, Ann Fieuw, Wim Wuyts
BACKGROUND: Idiopathic pulmonary fibrosis (IPF) causes irreversible loss of lung function. People with IPF have increased concentrations of autotaxin in lung tissue and lysophosphatidic acid (LPA) in bronchoalveolar lavage fluid and exhaled condensate. GLPG1690 (Galapagos, Mechelen, Belgium) is a novel, potent, selective autotaxin inhibitor with good oral exposure. We explored the effects of GLPG1690 in patients with IPF. METHODS: This was a randomised, double-blind, placebo-controlled phase 2a study done in 17 centres in Italy, Ukraine and the UK...
May 18, 2018: Lancet Respiratory 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
#3
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/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
#4
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/29791009/withdrawn-interventions-for-replacing-missing-teeth-1-versus-2-stage-implant-placement
#5
REVIEW
Marco Esposito, Maria Gabriella Grusovin, Yun Shane Chew, Paul Coulthard, Helen V Worthington
BACKGROUND: Implants may be placed penetrating the oral mucosa (1-stage procedure) or can be completely buried under the oral mucosa (2-stage procedure) during the healing phase of the bone at the implant surface. With a 2-stage procedure the risk of having unwanted loading onto the implants is minimized, but a second minor surgical intervention is needed to connect the healing abutments and more time is needed prior to start the prosthetic phase because of the wound-healing period required in relation to the second surgical intervention...
May 23, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29790635/the-effect-of-12-week-garlic-supplementation-on-symptom-relief-in-overweight-or-obese-women-with-knee-osteoarthritis
#6
Ahmad Salimzadeh, Elham Alipoor, Sahar Dehghani, Mehdi Yaseri, Mostafa Hosseini, Christine Feinle-Bisset, Mohammad Javad Hosseinzadeh-Attar
AIMS: Chronic joint pain and stiffness, and functional disability, are the major debilitating features of osteoarthritis (OA). The aim of this study was to assess the effect of 12-week supplementation with a garlic supplement on knee osteoarthritis outcomes in overweight or obese women. METHODS: Seventy-six postmenopausal overweight or obese women (25≤BMI≤40 kg/m2 ) with medically diagnosed knee OA participated in this randomised double-blind, placebo-controlled, parallel-design trial...
May 23, 2018: International Journal of Clinical Practice
https://www.readbyqxmd.com/read/29790581/the-pharmacokinetics-pharmacodynamics-and-tolerability-of-pur0200-a-novel-tiotropium-formulation-in-chronic-obstructive-pulmonary-disease
#7
Dave Singh, Arjun Ravi, Katie Kane, Tess Schmalbach, David L Hava
AIMS: PUR0200 is a tiotropium bromide formulation engineered with the iSPERSE dry powder delivery technology. PUR0200 is being developed as a bioequivalent alternative to tiotropium bromide delivered using Spiriva® HandiHaler® (HH). We investigated the bronchodilator effects, pharmacokinetics and safety of PUR0200 in COPD patients. METHODS: This was a randomised, placebo-controlled, crossover study with different PUR0200 doses and the comparator tiotropium HH...
May 23, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29790479/long-term-clinical-outcomes-after-bioresorbable-and-permanent-polymer-drug-eluting-stent-implantation-final-five-year-results-of-the-century-ii-randomised-clinical-trial
#8
William Wijns, Mariano Valdes-Chavarri, Gert Richardt, Raul Moreno, Andrés Íñiguez-Romo, Emanuele Barbato, Didier Carrié, Kenji Ando, Béla Merkely, Ran Kornowski, Hélène Eltchaninoff, Sinisa Stojkovic, Shigeru Saito
AIMS: The aim of this study was to establish the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster) by comparison with an everolimus-eluting stent with permanent polymer (PP-EES; XIENCE). METHODS AND RESULTS: CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) is a large-scale, prospective, multicentre, randomised single-blind, controlled, non-inferiority trial conducted at 58 study sites globally, including Europe, Japan and Korea, powered to prove non-inferiority for freedom from target lesion failure (TLF: cardiac death, target vessel-related myocardial infarction [MI] and target lesion revascularisation) at nine months...
May 23, 2018: EuroIntervention
https://www.readbyqxmd.com/read/29790478/validation-of-a-novel-non-hyperaemic-index-of-coronary-artery-stenosis-severity-the-resting-full-cycle-ratio-validate-rfr-study
#9
Johan Svanerud, Jung-Min Ahn, Allen Jeremias, Marcel van 't Veer, Ankita Gore, Akiko Maehara, Aaron Crowley, Nico H J Pijls, Bernard De Bruyne, Nils P Johnson, Barry Hennigan, Stuart Watkins, Colin Berry, Keith G Oldroyd, Seung-Jung Park, Ziad A Ali
AIMS: Randomised controlled trials have reported instantaneous wave-free ratio (iFR) to be non-inferior to fractional flow reserve (FFR) for major adverse cardiovascular events at one year; however, iFR is limited by sensitive landmarking of the pressure waveform, and the assumption that maximal flow and minimal resistance occur during a fixed period of diastole. We sought to validate the resting full-cycle ratio (RFR), a novel non-hyperaemic index of coronary stenosis severity based on unbiased identification of the lowest distal coronary pressure to aortic pressure ratio (Pd/Pa), independent of the ECG, landmark identification, and timing within the cardiac cycle...
May 23, 2018: EuroIntervention
https://www.readbyqxmd.com/read/29790266/clindamycin-to-reduce-preterm-birth-in-a-low-resource-setting-a-randomised-placebo-controlled-clinical-trial
#10
Mrutyunjaya B Bellad, Matthew K Hoffman, Ashalata A Mallapur, Umesh S Charantimath, Geetanjali M Katageri, Ganachari, Avinash Kavi, Umesh Y Ramdurg, Sheshidhar G Bannale, Amit Revankar, Nancy L Sloan, Bhalachandra Kodkany, Shivaprasad S Goudar, Richard J Derman
OBJECTIVE: To determine if oral Clindamycin reduces the risk of preterm birth in women with abnormal vaginal microflora as evidenced by a vaginal pH ≥5·0. DESIGN: Randomised double-blind placebo controlled trial. SETTING: Rural southern India. POPULATION: Pregnant women with a singleton foetus between 13 0/7 weeks and 20 6/7 weeks. METHODS: Pregnant women were recruited during prenatal visits in Karnataka India from October 2013 to July 2015...
May 22, 2018: BJOG: An International Journal of Obstetrics and Gynaecology
https://www.readbyqxmd.com/read/29790196/rituximab-is-ineffective-for-treatment-of-fatigue-in-primary-biliary-cholangitis-a-phase-2-randomised-controlled-trial
#11
Amardeep Khanna, Laura Jopson, Denise Howel, Andrew Bryant, Andrew Blamire, Julia L Newton, David E Jones
Primary Biliary Cholangitis (PBC) is a chronic cholestatic liver disease. Half of patients experience debilitating fatigue which is currently untreatable. Previous studies have shown muscle bioenergetic abnormalities in PBC, including increased muscle acidosis with exercise linked to the anti-mitochondrial antibody (AMA) diagnostic of the disease, and reduced anaerobic threshold. In this study we addressed the hypothesis that fatigue in PBC is driven by muscle bioenergetic abnormality related to AMA, and that AMA reduction with B-cell depletion therapy will improve fatigue...
May 23, 2018: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/29789878/nuts-as-a-replacement-for-carbohydrates-in-the-diabetic-diet-a-reanalysis-of-a-randomised-controlled-trial
#12
David J A Jenkins, Cyril W C Kendall, Benoît Lamarche, Monica S Banach, Korbua Srichaikul, Edward Vidgen, Sandy Mitchell, Tina Parker, Stephanie Nishi, Balachandran Bashyam, Russell J de Souza, Christopher Ireland, Sathish C Pichika, Joseph Beyene, John L Sievenpiper, Robert G Josse
AIMS/HYPOTHESIS: In line with current advice, we assessed the effect of replacing carbohydrate consumption with mixed nut consumption, as a source of unsaturated fat, on cardiovascular risk factors and HbA1c in type 2 diabetes. The data presented here are from a paper that was retracted at the authors' request ( https://doi.org/10.2337/dc16-rt02 ) owing to lack of adjustment for repeated measures in the same individual. Our aim, therefore, was to fix the error and add new complementary data of interest, including information on clotting factors and LDL particle size...
May 23, 2018: Diabetologia
https://www.readbyqxmd.com/read/29789607/point-of-care-microspirometry-to-facilitate-the-copd-diagnostic-process-in-primary-care-a-clustered-randomised-trial
#13
Tjard R Schermer, Maria Vatsolaki, Robbert Behr, Joke Grootens, Riet Cretier, Reinier Akkermans, Joke Denis, Patrick Poels, Lisette van den Bemt
We studied if pre-bronchodilator FEV1 /FEV6 determinations with microspirometers by GPs improve the diagnostic process for COPD in a 6-8 month clustered randomised controlled trial in Dutch general practices ( http://www.trialregister.nl : NTR4041). GPs allocated to microspirometry (MI) used COPD-6® microspirometers in patients ≥50 years old with a smoking history and respiratory complaints that could indicate undiagnosed COPD and ask to refer patients for full spirometry if MI was positive (FEV1 /FEV6 <0...
May 22, 2018: NPJ Primary Care Respiratory Medicine
https://www.readbyqxmd.com/read/29789130/the-effects-of-alcohol-on-plasma-lipid-mediators-of-inflammation-resolution-in-patients-with-type-2-diabetes-mellitus
#14
Anne Barden, Sujata Shinde, Michael Phillips, Lawrence Beilin, Emilie Mas, Jonathan M Hodgson, Ian Puddey, Trevor A Mori
BACKGROUND: Type 2 diabetes mellitus is characterized by peripheral insulin resistance and low-grade systemic inflammation. Inflammation resolution is recognised as an important process driven by specialised pro-resolving mediators of inflammation (SPMs) and has the potential to moderate chronic inflammation. Alcohol has the potential to affect synthesis of SPMs by altering key enzymes involved in SPM synthesis and may influence ongoing inflammation associated with Type 2 diabetes mellitus...
June 2018: Prostaglandins, Leukotrienes, and Essential Fatty Acids
https://www.readbyqxmd.com/read/29789034/pharmacological-properties-of-cannabidiol-in-the-treatment-of-psychiatric-disorders-a-critical-overview
#15
G M Mandolini, M Lazzaretti, A Pigoni, L Oldani, G Delvecchio, P Brambilla
Cannabidiol (CBD) represents a new promising drug due to a wide spectrum of pharmacological actions. In order to relate CBD clinical efficacy to its pharmacological mechanisms of action, we performed a bibliographic search on PUBMED about all clinical studies investigating the use of CBD as a treatment of psychiatric symptoms. Findings to date suggest that (a) CBD may exert antipsychotic effects in schizophrenia mainly through facilitation of endocannabinoid signalling and cannabinoid receptor type 1 antagonism; (b) CBD administration may exhibit acute anxiolytic effects in patients with generalised social anxiety disorder through modification of cerebral blood flow in specific brain sites and serotonin 1A receptor agonism; (c) CBD may reduce withdrawal symptoms and cannabis/tobacco dependence through modulation of endocannabinoid, serotoninergic and glutamatergic systems; (d) the preclinical pro-cognitive effects of CBD still lack significant results in psychiatric disorders...
May 23, 2018: Epidemiology and Psychiatric Sciences
https://www.readbyqxmd.com/read/29788982/tisu-extracorporeal-shockwave-lithotripsy-as-first-treatment-option-compared-with-direct-progression-to-ureteroscopic-treatment-for-ureteric-stones-study-protocol-for-a-randomised-controlled-trial
#16
Samuel McClinton, Sarah Cameron, Kathryn Starr, Ruth Thomas, Graeme MacLennan, Alison McDonald, Thomas Lam, James N'Dow, Mary Kilonzo, Robert Pickard, Ken Anson, Frank Keeley, Neil Burgess, Charles Terry Clark, Sara MacLennan, John Norrie
BACKGROUND: Urinary stone disease is very common with an estimated prevalence among the general population of 2-3%. Ureteric stones are associated with severe pain as they pass through the urinary tract and have significant impact on patients' quality of life due to the detrimental effect on their ability to work and need for hospitalisation. Most ureteric stones can be expected to pass spontaneously with supportive care. However, between one-fifth and one-third of cases require an intervention...
May 22, 2018: Trials
https://www.readbyqxmd.com/read/29788807/evidence-for-telehealth-group-based-treatment-a-systematic-review
#17
Melanie T Gentry, Maria I Lapid, Matthew M Clark, Teresa A Rummans
Background Interest in the use of telehealth interventions to increase access to healthcare services is growing. Group-based interventions have the potential to increase patient access to highly needed services. The aim of this study was to systematically review the available literature on group-based video teleconference services. Methods The English-language literature was searched using Ovid MEDLINE, PubMed, PsycINFO and CINAHL for terms related to telehealth, group therapy and support groups. Abstracts were reviewed for relevance based on inclusion criteria...
January 1, 2018: Journal of Telemedicine and Telecare
https://www.readbyqxmd.com/read/29788248/respiratory-tract-infections-in-patients-with-inflammatory-bowel-disease-safety-analyses-from-vedolizumab-clinical-trials
#18
Brian G Feagan, Fatima Bhayat, Mona Khalid, Aimee Blake, Simon P L Travis
Background and Aims: Vedolizumab, a humanised monoclonal antibody for the treatment of inflammatory bowel disease, selectively blocks gut lymphocyte trafficking. This may reduce the risk of respiratory tract infections [RTIs] compared with systemic immunosuppressive therapies. To assess this possibility, we evaluated the rates of RTIs in clinical trials of vedolizumab. Methods: Patient-level data from Phase 3 randomised controlled trials [RCTs] of vedolizumab in ulcerative colitis [UC; GEMINI 1] and Crohn's disease [CD; GEMINI 2], and a long-term safety study [UC and CD] were pooled...
May 17, 2018: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/29788233/autologous-haematopoietic-stem-cell-transplantation-for-crohn-s-disease-a-retrospective-survey-of-long-term-outcomes-from-the-european-society-for-blood-and-marrow-transplantation
#19
Charlotte K Brierley, Cristina Castilla-Llorente, Myriam Labopin, Manuela Badoglio, Montserrat Rovira, Elena Ricart, Daan Dierickx, Severine Vermeire, Peter Hasselblatt, Juergen Finke, Francesco Onida, Andrea Cassinotti, Jack Satsangi, Majid Kazmi, Antonio López-Sanromán, Carsten Schmidt, Dominique Farge, Simon P L Travis, Chris J Hawkey, John A Snowden
Background/Aims: Autologous haematopoietic stem cell transplantation (AHSCT) is a therapeutic option for patients with severe, treatment-refractory Crohn's disease (CD). The evidence base for AHSCT for CD is limited, with one randomised trial (ASTIC) suggesting benefit. The aim of this study was to evaluate safety and efficacy for patients undergoing AHSCT for CD in Europe outside the ASTIC trial. Methods: We identified 99 patients in the European Society for Blood and Marrow Transplantation (EBMT) registry who were eligible for inclusion...
May 18, 2018: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/29788164/what-is-the-optimal-systemic-treatment-of-men-with-metastatic-hormone-naive-prostate-cancer-a-stopcap-systematic-review-and-network-meta-analysis
#20
C L Vale, D J Fisher, I R White, J R Carpenter, S Burdett, N W Clarke, K Fizazi, G Gravis, N D James, M D Mason, M K B Parmar, L H Rydzewska, C J Sweeney, M R Spears, M R Sydes, J F Tierney
Background: Our prior Systemic Treatment Options for Cancer of the Prostate systematic reviews showed improved survival for men with metastatic hormone-naive prostate cancer when abiraterone acetate plus prednisolone/prednisone (AAP) or docetaxel (Doc), but not zoledronic acid (ZA), were added to androgen-deprivation therapy (ADT). Trial evidence also suggests a benefit of combining celecoxib (Cel) with ZA and ADT. To establish the optimal treatments, a network meta-analysis (NMA) was carried out based on aggregate data (AD) from all available studies...
May 1, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
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