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Randomized double blinded controlled studies

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https://www.readbyqxmd.com/read/28731266/a-randomized-double-blind-placebo-controlled-crossover-study-of-the-effects-of-levetiracetam-on-cognition-mood-and-balance-in-healthy-older-adults
#1
Mike R Schoenberg, Ruba S Rum, Katie E Osborn, Mary Ann Werz
OBJECTIVE: The cognitive and mood effects of levetiracetam (LEV) in older adults are not known. This study compared the cognitive and mood effects of LEV to placebo in healthy older adults. METHODS: Cognitive, mood, and balance variables were compared between LEV and placebo using a randomized, double-blind, placebo-controlled crossover study with two 5-week treatment periods. Healthy volunteers (n = 20) aged 65-80 (mean age 72.4) received either LEV or placebo in which the LEV target dose was 1,000 mg/day...
July 21, 2017: Epilepsia
https://www.readbyqxmd.com/read/28730743/inulin-type-fructans-and-whey-protein-both-modulate-appetite-but-only-fructans-alter-gut-microbiota-in-adults-with-overweight-obesity-a-randomized-controlled-trial
#2
Raylene A Reimer, Holly J Willis, Jasmine M Tunnicliffe, Heekuk Park, Karen L Madsen, Adriana Soto-Vaca
SCOPE: Independently, prebiotics and dietary protein have been shown to improve weight loss and/or alter appetite. Our objective was to determine the effect of combined prebiotic and whey protein on appetite, body composition and gut microbiota in adults with overweight/obesity. METHODS AND RESULTS: In a 12 week, placebo-controlled, double-blind study, 125 adults with overweight/obesity were randomly assigned to receive isocaloric snack bars of: 1) Control; 2) Inulin-type fructans (ITF); 3) Whey protein; 4) ITF + Whey protein...
July 21, 2017: Molecular Nutrition & Food Research
https://www.readbyqxmd.com/read/28729879/safety-and-immunogenicity-of-the-quadrivalent-human-papillomavirus-qhpv-vaccine-in-hiv-positive-spanish-men-who-have-sex-with-men-msm
#3
Carmen Hidalgo-Tenorio, Jessica Ramírez-Taboada, Concepción Gil-Anguita, Javier Esquivias, Mohamed Omar-Mohamed-Balgahata, Antonio SamPedro, Miguel Lopez-Ruz, Juan Pasquau
BACKGROUND: Safety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccine were evaluated in HIV-positive Spanish MSM. The prevalence of High Squamous Intraepithelial Lesions (HSIL) and genotypes of high-risk human papillomavirus (HR-HPV) were also determined, as well as risk factors associated with the presence of HR-HPV in anal mucosa. METHODS: This is a randomised, double blind, placebo-controlled trial of the quadrivalent HPV (qHPV) vaccine...
2017: AIDS Research and Therapy
https://www.readbyqxmd.com/read/28729154/tremelimumab-as-second-line-or-third-line-treatment-in-relapsed-malignant-mesothelioma-determine-a-multicentre-international-randomised-double-blind-placebo-controlled-phase-2b-trial
#4
Michele Maio, Arnaud Scherpereel, Luana Calabrò, Joachim Aerts, Susana Cedres Perez, Alessandra Bearz, Kristiaan Nackaerts, Dean A Fennell, Dariusz Kowalski, Anne S Tsao, Paul Taylor, Federica Grosso, Scott J Antonia, Anna K Nowak, Maria Taboada, Martina Puglisi, Paul K Stockman, Hedy L Kindler
BACKGROUND: New therapeutic strategies for malignant mesothelioma are urgently needed. In the DETERMINE study, we investigated the effects of the cytotoxic-T-lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibody tremelimumab in patients with previously treated advanced malignant mesothelioma. METHODS: DETERMINE was a double-blind, placebo-controlled, phase 2b trial done at 105 study centres across 19 countries in patients with unresectable pleural or peritoneal malignant mesothelioma who had progressed after one or two previous systemic treatments for advanced disease...
July 17, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28728956/ataluren-in-patients-with-nonsense-mutation-duchenne-muscular-dystrophy-act-dmd-a-multicentre-randomised-double-blind-placebo-controlled-phase-3-trial
#5
Craig M McDonald, Craig Campbell, Ricardo Erazo Torricelli, Richard S Finkel, Kevin M Flanigan, Nathalie Goemans, Peter Heydemann, Anna Kaminska, Janbernd Kirschner, Francesco Muntoni, Andrés Nascimento Osorio, Ulrike Schara, Thomas Sejersen, Perry B Shieh, H Lee Sweeney, Haluk Topaloglu, Már Tulinius, Juan J Vilchez, Thomas Voit, Brenda Wong, Gary Elfring, Hans Kroger, Xiaohui Luo, Joseph McIntosh, Tuyen Ong, Peter Riebling, Marcio Souza, Robert J Spiegel, Stuart W Peltz, Eugenio Mercuri
BACKGROUND: Duchenne muscular dystrophy (DMD) is a severe, progressive, and rare neuromuscular, X-linked recessive disease. Dystrophin deficiency is the underlying cause of disease; therefore, mutation-specific therapies aimed at restoring dystrophin protein production are being explored. We aimed to assess the efficacy and safety of ataluren in ambulatory boys with nonsense mutation DMD. METHODS: We did this multicentre, randomised, double-blind, placebo-controlled, phase 3 trial at 54 sites in 18 countries located in North America, Europe, the Asia-Pacific region, and Latin America...
July 17, 2017: Lancet
https://www.readbyqxmd.com/read/28728599/a-phase-iii-randomized-two-armed-double-blind-parallel-active-controlled-and-non-inferiority-clinical-trial-to-compare-efficacy-and-safety-of-biosimilar-adalimumab-cinnora%C3%A2-to-the-reference-product-humira%C3%A2-in-patients-with-active-rheumatoid-arthritis
#6
Ahmadreza Jamshidi, Farhad Gharibdoost, Mahdi Vojdanian, Soosan G Soroosh, Mohsen Soroush, Arman Ahmadzadeh, Mohammad Ali Nazarinia, Mohammad Mousavi, Hadi Karimzadeh, Mohammad Reza Shakibi, Zahra Rezaieyazdi, Maryam Sahebari, Asghar Hajiabbasi, Ali Asghar Ebrahimi, Najmeh Mahjourian, Amin Mohammadinejad Rashti
BACKGROUND: This study aimed to compare efficacy and safety of test-adalimumab (CinnoRA®, CinnaGen, Iran) to the innovator product (Humira®, AbbVie, USA) in adult patients with active rheumatoid arthritis (RA). METHODS: In this randomized, double-blind, active-controlled, non-inferiority trial, a total of 136 patients with active RA were randomized to receive 40 mg subcutaneous injections of either CinnoRA® or Humira® every other week, while receiving methotrexate (15 mg/week), folic acid (1 mg/day), and prednisolone (7...
July 20, 2017: Arthritis Research & Therapy
https://www.readbyqxmd.com/read/28728559/effect-of-insulin-therapy-and-dietary-adjustments-on-safety-and-performance-during-simulated-soccer-tests-in-people-with-type-1-diabetes-study-protocol-for-a-randomized-controlled-trial
#7
Javier Calvo-Marín, Gabriel Torrealba-Acosta, Matthew Campbell, Jesse Gaboury, Ajmol Ali, Chih Hao Chen-Ku
BACKGROUND: Despite the reduction in glycemic derangement in patients with type 1 diabetes mellitus (T1D) through dietary and therapeutic adjustments implemented before, during and after continuous exercise, evidence for its effectiveness with intermittent forms of exercise, such as soccer, is still lacking. METHODS/DESIGN: We designed a study protocol for a randomized, crossover, double-blinded, controlled trial, for the evaluation of the effect that a strategy of dietary and therapeutic modifications may have on safety and performance of persons with T1D in soccer training sessions and cognitive testing...
July 20, 2017: Trials
https://www.readbyqxmd.com/read/28728437/does-continuous-diffusion-of-oxygen-improve-diabetic-foot-ulcer-healing
#8
Lawrence A Lavery, Easton C Ryan
The objective of this article is to evaluate the study design, rational and results of Continuous Diffusion of Oxygen Therapy (CDOT) to heal diabetic foot ulcers (DFUs). The study was a double-blinded placebo controlled randomized clinical study to evaluate DFUs over a 12-week period. The primary outcome was the proportion of ulcers that healed and the secondary outcome that was reported was the time to ulcer healing. In the per protocol analysis and in the intent to treat analysis, a higher proportion of DFUs healed in the CDOT group (per protocol 46% vs 22%, P = ...
July 1, 2017: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/28727704/evaluating-the-adjuvant-effect-of-dexamethasone-to-ropivacaine-in-transversus-abdominis-plane-block-for-inguinal-hernia-repair-and-spermatocelectomy-a-randomized-controlled-trial
#9
Robert Wegner, Duane Akwar, Sarah Guzman-Reyes, Greesha Pednekar, Rabail Chaudhry, Navneet Grewal, Naveen Kukreja, Omar L Mancillas, George W Williams, Omonele Nwokolo
BACKGROUND: The transversus abdominis plane (TAP) block is a relatively straightforward regional technique used for postoperative analgesia in patients undergoing abdominal surgeries. Various adjuvants have been used in past to prolong the duration of action of analgesia in peripheral nerve blocks. Several studies investigating the analgesic efficacy of dexamethasone added to local anesthetic agents, such as bupivacaine, have shown promising results. However, there are few studies comparing the efficacy of dexamethasone with ropivacaine...
July 2017: Pain Physician
https://www.readbyqxmd.com/read/28727654/growth-and-nutritional-biomarkers-of-preterm-infants-fed-a-new-powdered-human-milk-fortifier-a-randomized-trial
#10
Jacques Rigo, Jean-Michel Hascoët, Claude Billeaud, Jean-Charles Picaud, Fabio Mosca, Amandine Rubio, Elie Saliba, Michaël Radkë, Umberto Simeoni, Bernard Guillois, Virginie de Halleux, Jonathan Jaeger, Laurent Ameye, Nicholas P Hays, Johannes Spalinger
OBJECTIVES: Assess growth and nutritional biomarkers of preterm infants fed human milk (HM) supplemented with a new powdered HM fortifier (nHMF) or a control HM fortifier (cHMF). The nHMF provides similar energy content, 16% more protein (partially hydrolyzed whey), and higher micronutrient levels than the cHMF, along with medium-chain triglycerides and docosahexaenoic acid. METHODS: In this controlled, multicenter, double-blind study, a sample of preterm infants ≤32 weeks or ≤1500 g were randomized to receive nHMF (n = 77) or cHMF (n = 76) for a minimum of 21 days...
July 19, 2017: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/28727160/the-long-term-effect-of-a-zinc-acetate-and-chlorhexidine-diacetate-containing-mouth-rinse-on-intra-oral-halitosis-a-randomized-clinical-trial
#11
Seida Erovic Ademovski, Carina Mårtensson, G Rutger Persson, Stefan Renvert
AIM: To evaluate the long-term effects of a zinc acetate and chlorhexidine diacetate mouth rinse (Zn/CHX) on intra-oral halitosis. MATERIALS AND METHODS: Forty-six adults with intra-oral halitosis were randomized into a 6-month, double-blind, placebo-controlled clinical study. The presence of intra-oral halitosis was evaluated at baseline, 3, and 6 months after treatment by assessment of organoleptic score (OLS) and by total volatile sulphur compounds (T-VSC), hydrogen sulphide (H2 S) and methyl mercaptan (MM) concentrations in exhaled air...
July 20, 2017: Journal of Clinical Periodontology
https://www.readbyqxmd.com/read/28726273/epigallocatechin-gallate-enhances-treatment-efficacy-of-oral-nifedipine-against-pregnancy-induced-severe-pre-eclampsia-a-double-blind-randomized-and-placebo-controlled-clinical-study
#12
D-D Shi, J-J Guo, L Zhou, N Wang
WHAT IS KNOWN AND OBJECTIVE: Oral nifedipine is commonly used to treat pre-eclampsia, one of the most severe complications during pregnancy, but its clinical efficacy is less than ideal. Epigallocatechin gallate (EGCG), a natural compound from green tea, could benefit cardiovascular health especially hypertension. We investigated the clinical efficacy of EGCG, when complemented with oral nifedipine, in treating pre-eclampsia. METHODS: A total of 350 pregnant women with severe pre-eclampsia were recruited and randomized to receive oral nifedipine, together with placebo (NIF+placebo) or EGCG (NIF+EGCG)...
July 20, 2017: Journal of Clinical Pharmacy and Therapeutics
https://www.readbyqxmd.com/read/28726270/equimolar-mixture-of-nitroux-oxyde-and-oxygen-during-post-operative-physiotherapy-in-patients-with-cerebral-palsy-a-randomized-double-blind-placebo-controlled-study
#13
A Delafontaine, A Presedo, D Mohamed, D Lopes, C Wood, C Alberti
BACKGROUND: The administration of an equimolar mixture of nitrous oxide and oxygen (N2O) is recommended during painful procedures. However, the evaluation of its use during physiotherapy after surgery has not been reported, although pain may hamper physiotherapy efficiency. This study investigated whether the use of N2O improves the efficacy of post-operative physiotherapy after multilevel surgery in patients with cerebral palsy. METHOD: It was a randomized 1:1, double-blind, placebo-controlled study...
July 20, 2017: European Journal of Pain: EJP
https://www.readbyqxmd.com/read/28725629/evaluation-the-effect-of-50-and-100%C3%A2-mg-doses-of-cuminum-cyminum-essential-oil-on-glycemic-indices-insulin-resistance-and-serum-inflammatory-factors-on-patients-with-diabetes-type-ii-a-double-blind-randomized-placebo-controlled-clinical-trial
#14
Sahar Jafari, Roghieh Sattari, Sa'id Ghavamzadeh
AIM: The purpose of this study was to evaluate the effect of 50 and 100 mg doses of green cumin essential oil on glycemic and inflammatory indices in patients with diabetes type II. METHOD: In this randomized double-blind placebo-controlled clinical trial, subjects were divided into three groups after selecting them randomly according to the inclusion criteria: 1 - Cuminum cyminum capsule (100 mg/day,n = 33), 2 - C. cyminum capsule (50 mg/day, n = 33), and 3 - placebo (n = 33)...
July 2017: Journal of Traditional and Complementary Medicine
https://www.readbyqxmd.com/read/28724883/calcium-prepartions-do-not-inhibit-allergic-reactions-a-randomized-controlled-trial
#15
Klaudia Matysiak, Michał Matuszewski, Wojciech Feleszko
INTRODUCTION    Massive consumption of dietary supplements, including vitamins and minerals, has recently became a serious public issue in Europe. When ingested, they may negatively affect pharmacological activity of various medications, including anti-allergic drugs. Calcium preparations are well-known and commonly used in some European countries as a popular remedy for allergy-related skin reactions, such as itching, erythema and wheals, as well as insect bites. However, their action has not been reliably proven yet...
June 27, 2017: Polish Archives of Internal Medicine
https://www.readbyqxmd.com/read/28724799/galantamine-alleviates-inflammation-and-insulin-resistance-in-patients-with-metabolic-syndrome-in-a-randomized-trial
#16
Fernanda M Consolim-Colombo, Carine T Sangaleti, Fernando O Costa, Tercio L Morais, Heno F Lopes, Josiane M Motta, Maria C Irigoyen, Luiz A Bortoloto, Carlos Eduardo Rochitte, Yael Tobi Harris, Sanjaya K Satapathy, Peder S Olofsson, Meredith Akerman, Sangeeta S Chavan, Meggan MacKay, Douglas P Barnaby, Martin L Lesser, Jesse Roth, Kevin J Tracey, Valentin A Pavlov
BACKGROUND: Metabolic syndrome (MetS) is an obesity-driven condition of pandemic proportions that increases the risk of type 2 diabetes and cardiovascular disease. Pathophysiological mechanisms are poorly understood, though inflammation has been implicated in MetS pathogenesis. The aim of this study was to assess the effects of galantamine, a centrally acting acetylcholinesterase inhibitor with antiinflammatory properties, on markers of inflammation implicated in insulin resistance and cardiovascular risk, and other metabolic and cardiovascular indices in subjects with MetS...
July 20, 2017: JCI Insight
https://www.readbyqxmd.com/read/28724365/leflunomide-is-equally-efficacious-and-safe-compared-to-low-dose-rituximab-in-refractory-rheumatoid-arthritis-given-in-combination-with-methotrexate-results-from-a-randomized-double-blind-controlled-clinical-trial
#17
Harindu Wijesinghe, Priyadharshini Galappatthy, Rajiva de Silva, Suranjith L Seneviratne, Ushagowry Saravanamuttu, Preethi Udagama, Melanie Hart, Peter Kelleher, Upul Senerath, Rohini Fernandopulle, Lilani P Weerasekera, Lalith S Wijayaratne
BACKGROUND: The standard dose of rituximab used in rheumatoid arthritis (RA) is 1000 mg but recent studies have shown that low dose (500 mg) is also effective. Efficacy of low dose rituximab in rheumatoid arthritis (RA) refractory to first-line non-biologic Disease Modifying Anti Rheumatic Drugs (DMARDs), compared to leflunomide is unknown. In a tertiary care referral setting, we conducted a randomized, double blind controlled clinical trial comparing the efficacy and safety of low-dose rituximab-methotrexate combination with leflunomide-methotrexate combination...
July 19, 2017: BMC Musculoskeletal Disorders
https://www.readbyqxmd.com/read/28724186/inositol-hexaphosphate-insp6-as-an-effective-topical-treatment-for-patients-receiving-adjuvant-chemotherapy-after-breast-surgery
#18
S Proietti, V Pasta, A Cucina, C Aragona, E Palombi, I Vucenik, M Bizzarri
OBJECTIVE: Oral treatment with inositol hexaphosphate (InsP6) has shown to be efficient in decreasing adverse effects in patients with breast cancer under chemotherapy. This study was aimed at evaluating and comparing the efficacy of topical InsP6 in improving quality of life in women treated with anticancer drugs. PATIENTS AND METHODS: The study was a double-blind, randomized controlled trial (RCT) with allocation concealment of 20 patients in two groups, one (experimental) applied 4% topical formulation of InsP6 once a day, whereas the second one (control) a gel containing hyaluronic acid...
June 2017: European Review for Medical and Pharmacological Sciences
https://www.readbyqxmd.com/read/28723227/extended-release-guanfacine-does-not-show-a-large-effect-on-tic-severity-in-children-with-chronic-tic-disorders
#19
Tanya K Murphy, Thomas V Fernandez, Barbara J Coffey, Omar Rahman, Allison Gavaletz, Camille E Hanks, Caitlin S Tillberg, Laura Ibanez Gomez, Denis G Sukhodolsky, Lily Katsovich, Lawrence Scahill
OBJECTIVE: To evaluate the tolerability, safety, and preliminary efficacy of extended-release guanfacine in children with chronic tic disorders, including Tourette's disorder (collectively referred to as CTD). METHODS: This was a multisite, 8-week, randomized, double-blind, placebo-controlled trial. The primary outcome measure was the Yale Global Tic Severity Scale (YGTSS) total score. Key secondary outcomes included the Improvement item of Clinical Global Impressions-Improvement (CGI-I) scale and the Tic Symptom Self-report (TSSR)...
July 19, 2017: Journal of Child and Adolescent Psychopharmacology
https://www.readbyqxmd.com/read/28722815/influence-of-morphine-and-naloxone-on-pain-modulation-in-rheumatoid-arthritis-chronic-fatigue-syndrome-fibromyalgia-and-controls-a-double-blind-randomized-placebo-controlled-cross-over-study
#20
Linda Hermans, Jo Nijs, Patrick Calders, Luc De Clerck, Greta Moorkens, Guy Hans, Sofie Grosemans, Tine Roman De Mettelinge, Joanna Tuynman, Mira Meeus
BACKGROUND: Impaired pain inhibitory and enhanced pain facilitatory mechanisms are repeatedly reported in patients with central sensitization pain. However, the exact effects of frequently prescribed opioids on central pain modulation are still unknown. METHODS: A randomized, double-blind, placebo-controlled cross-over trial was carried out. Ten CFS/FM patients, 11 RA patients and 20 controls were randomly allocated to the experimental (10 mg morphine or 0.2 mg/ml Naloxone) and placebo (2 ml Aqua) group...
July 19, 2017: Pain Practice: the Official Journal of World Institute of Pain
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