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Randomized placebo controlled double blind

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https://www.readbyqxmd.com/read/28103433/baseline-extent-of-damage-predicts-spinal-radiographic-progression-in-korean-patients-with-ankylosing-spondylitis-treated-with-golimumab
#1
Jeong Seok Lee, Yeong Wook Song, Tae Hwan Kim, Won Tae Jung, Seung Geun Lee, Sung Hwan Park, Gwan Gyu Song, Dae Young Yu, Stephen Xu, Eun Young Lee
Background/Aims: For patients with ankylosing spondylitis (AS), golimumab has consistent efficacy in controlling disease activity over 5 years but its benefit in preventing radiographic progression was less clear at 4 years. To predict radiographic progression, we analyzed the baseline characteristics of AS patients in a Korean population. Methods: Sixty-eight Korean patients with AS participated in the phase 3, multicenter, randomized, placebo-controlled, double-blind trial (GO-RAISE) which has previously been described...
January 20, 2017: Korean Journal of Internal Medicine
https://www.readbyqxmd.com/read/28102098/a-randomized-double-blind-placebo-controlled-trial-of-fruit-and-vegetable-concentrates-on-intermediate-biomarkers-in-head-and-neck-cancer
#2
Mridul Datta, Edward G Shaw, Glenn J Lesser, L Douglas Case, Mara Z Vitolins, Charles Schneider, Bart Frizzell, Christopher Sullivan, Mark Lively, Elizabeth Franzmann, Jennifer J Hu
BACKGROUND: Head and neck cancer (HNC) patients are at an increased risk for developing second primary tumors (SPTs). Diets rich in fruits and vegetables (FVs) may lower HNC risk. FV concentrates may offer a potential alternative to increasing FV intake. METHODS: We conducted a randomized, double-blind, placebo-controlled trial to evaluate whether Juice PLUS+ (JP; a commercial product with multiple FV concentrates) has an effect on p27 and Ki-67, biomarkers associated with the risk of SPTs...
January 1, 2017: Integrative Cancer Therapies
https://www.readbyqxmd.com/read/28100922/the-effects-of-missed-doses-of-amlodipine-and-losartan-on-blood-pressure-in-older-hypertensive-patients
#3
Peter W de Leeuw, Robert Fagard, Abraham A Kroon
This randomized, double-blind, parallel-group, multicenter study compared the efficacy of amlodipine and losartan in an older hypertensive population, focusing on therapeutic coverage in the case of missed doses. Following a 4-week, single-blind, placebo washout period, 211 patients were randomly assigned to receive either 5 mg of amlodipine once daily or 50 mg of losartan once daily. Doses were doubled after 6 weeks of treatment if the diastolic blood pressure exceeded 90 mm Hg. After the 12-week treatment period, patients received the placebo for 2 days (drug holiday) to simulate two missed doses of antihypertensive medication...
January 19, 2017: Hypertension Research: Official Journal of the Japanese Society of Hypertension
https://www.readbyqxmd.com/read/28100425/safety-and-efficacy-of-adjunctive-second-generation-antidepressant-therapy-with-a-mood-stabiliser-or-an-atypical-antipsychotic-in-acute-bipolar-depression-a-systematic-review-and-meta-analysis-of-randomised-placebo-controlled-trials
#4
Alexander McGirr, Paul A Vöhringer, S Nassir Ghaemi, Raymond W Lam, Lakshmi N Yatham
BACKGROUND: Although mania and hypomania define bipolar disorder, depressive episodes are more common and impairing, with few proven treatments. Adjunctive therapy with second-generation antidepressants is widely used to treat acute bipolar depression, but their efficacy and safety remain controversial. METHODS: In this systematic review and meta-analysis, we searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov from inception to Jan 31, 2016, for randomised, double-blind, placebo-controlled trials of second-generation antidepressants adjunctive to a mood stabiliser or an antipsychotic in patients with acute bipolar depression...
December 2016: Lancet Psychiatry
https://www.readbyqxmd.com/read/28099183/memantine-as-an-adjuvant-treatment-for-obsessive-compulsive-symptoms-in-manic-phase-of-bipolar-disorder-a-randomized-double-blind-placebo-controlled-clinical-trial
#5
Ali Sahraian, Leila Razeghian Jahromi, Ahmad Ghanizadeh, Arash Mowla
PURPOSE/BACKGROUND: The aim of this study is to examine the effects of memantine as an adjuvant treatment for obsessive compulsive (OC) symptoms in patients with bipolar disorder (BD) type I, manic phase. METHODS/PROCEDURES: In this 16-week double-blind placebo-controlled randomized clinical trial, 58 patients in the manic phase of BD who had OC symptoms were randomly allocated to receive memantine or placebo plus their routine medications (lithium + olanzapine + clonazepam)...
January 18, 2017: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28098165/combination-of-mometasone-furoate-and-oxymetazoline-for-the-treatment-of-adenoid-hypertrophy-concomitant-with-allergic-rhinitis-a-randomized-controlled-trial
#6
Wenlong Liu, Lifeng Zhou, Qingxiang Zeng, Renzhong Luo
In the clinic, approximately 30% of children with adenoid hypertrophy (AH) concomitant with allergic rhinitis (AR) report poor responses to intranasal steroids. To determine whether the combination of mometasone furoate (MF) and oxymetazoline (OXY) is more effective than either agent alone, we performed a two-stage, parallel, randomized, double-blind, double-dummy, clinical trial with 240 AH children with concomitant perennial AR. During the first stage, all children were randomly assigned to the MF or control group for six weeks of treatment...
January 18, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28097356/effect-of-etelcalcetide-vs-cinacalcet-on-serum-parathyroid-hormone-in-patients-receiving-hemodialysis-with-secondary-hyperparathyroidism-a-randomized-clinical-trial
#7
Geoffrey A Block, David A Bushinsky, Sunfa Cheng, John Cunningham, Bastian Dehmel, Tilman B Drueke, Markus Ketteler, Reshma Kewalramani, Kevin J Martin, Sharon M Moe, Uptal D Patel, Justin Silver, Yan Sun, Hao Wang, Glenn M Chertow
Importance: Secondary hyperparathyroidism contributes to extraskeletal calcification and is associated with all-cause and cardiovascular mortality. Control is suboptimal in the majority of patients receiving hemodialysis. An intravenously (IV) administered calcimimetic could improve adherence and reduce adverse gastrointestinal effects. Objective: To evaluate the relative efficacy and safety of the IV calcimimetic etelcalcetide and the oral calcimimetic cinacalcet...
January 10, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28096877/efficacy-and-safety-of-bitopertin-in-patients-with-schizophrenia-and-predominant-negative-symptoms-subgroup-analysis-of-japanese-patients-from-the-global-randomized-phase-2-trial
#8
Yoshio Hirayasu, Shin-Ichi Sato, Norifumi Shuto, Miwa Nakano, Teruhiko Higuchi
OBJECTIVE: The aim of the present study was to perform a subgroup analysis of data from a phase II global, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of bitopertin, a glycine reuptake inhibitor that activates N-methyl-D-aspartate receptors by increasing the concentration of glycine in the synaptic cleft, in Japanese and non-Japanese patients with schizophrenia and predominant negative symptoms. METHODS: Patients with schizophrenia and predominant negative symptoms on one or two antipsychotic drugs, including atypical antipsychotic drugs (olanzapine, risperidone, quetiapine, aripiprazole, and paliperidone) as the primary treatment, received bitopertin (10, 30, or 60 mg/day) or placebo once daily for 8 weeks as an add-on treatment...
January 2017: Psychiatry Investigation
https://www.readbyqxmd.com/read/28096578/the-effect-of-pregabalin-and-s-ketamine-in-total-knee-arthroplasty-patients-a-randomized-trial
#9
Lajla Kadic, Frank G van Haren, Oliver Wilder-Smith, Jorgen Bruhn, Jacques J Driessen, Maarten C de Waal Malefijt
BACKGROUND AND AIMS: Pain reduction is important for rehabilitation after total knee arthroplasty. Intra- and peri-articular infiltration with local anesthetics may be an alternative to commonly used locoregional techniques. Adding pregabalin orally and s-ketamine intravenously may further reduce postoperative pain. MATERIAL AND METHODS: This prospective, randomized, double-blind, placebo-controlled study compared two methods of perioperative analgesia. Control patients received a standardized multimodal postoperative analgesic regime of paracetamol, diclofenac, and piritramide-patient-controlled analgesia, including ropivacaine knee infiltration during surgery...
October 2016: Journal of Anaesthesiology, Clinical Pharmacology
https://www.readbyqxmd.com/read/28095573/results-of-a-phase-2-randomized-vehicle-controlled-study-evaluating-the-efficacy-tolerability-and-safety-of-daily-or-twice-daily-sb204-for-the-treatment-of-acne-vulgaris
#10
Lawrence F Eichenfield, Linda Stein Gold, Walter K Nahm, Fran E Cook-Bolden, David M Pariser
OBJECTIVE: This randomized, double-blind, placebo-controlled, Phase 2 study compared efficacy, tolerability, and safety of SB204 once or twice daily to vehicle in the treatment of acne vulgaris. METHODS: Eligible subjects were to be between 12 and 40 years old, have facial acne vulgaris with 25 to 70 non-inflammatory lesions, 20 to 40 inflammatory lesions, no more than 2 nodules, and a baseline Investigator's Global Assessment (IGA) score of moderate or severe. The co-primary efficacy endpoints were the absolute change in inflammatory and non-inflammatory lesion counts and IGA success rate (baseline to week 12)...
December 1, 2016: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/28094841/phase-2-randomized-double-blind-study-of-pracinostat-in-combination-with-azacitidine-in-patients-with-untreated-higher-risk-myelodysplastic-syndromes
#11
Guillermo Garcia-Manero, Guillermo Montalban-Bravo, Jesus G Berdeja, Yasmin Abaza, Elias Jabbour, James Essell, Roger M Lyons, Farhad Ravandi, Michael Maris, Brian Heller, Amy E DeZern, Sunil Babu, David Wright, Bertrand Anz, Ralph Boccia, Rami S Komrokji, Philip Kuriakose, James Reeves, Mikkael A Sekeres, Hagop M Kantarjian, Richard Ghalie, Gail J Roboz
BACKGROUND: The prognosis of patients with higher risk myelodysplastic syndromes (MDS) remains poor despite available therapies. Histone deacetylase inhibitors have demonstrated activity in patients with MDS and in vitro synergy with azacitidine. METHODS: A phase 2 randomized, placebo-controlled clinical trial of azacitidine and pracinostat was conducted in patients who had International Prognostic Scoring System intermediate-2-risk or high-risk MDS. The primary endpoint was the complete response (CR) rate by cycle 6 of therapy...
January 17, 2017: Cancer
https://www.readbyqxmd.com/read/28094194/mabp1-as-a-novel-antibody-treatment-for-advanced-colorectal-cancer-a-randomised-double-blind-placebo-controlled-phase-3-study
#12
Tamas Hickish, Thierry Andre, Lucjan Wyrwicz, Mark Saunders, Tomasz Sarosiek, Judit Kocsis, Radim Nemecek, Wojciech Rogowski, Krzysztof Lesniewski-Kmak, Lubos Petruzelka, Ron N Apte, Prasant Mohanty, Michael Stecher, John Simard, Aimery de Gramont
BACKGROUND: MABp1, an antibody that targets interleukin 1α, has been associated with antitumour activity and relief of debilitating symptoms in patients with advanced colorectal cancer. We sought to establish the effect of MABp1 with a new primary endpoint in patients with advanced colorectal cancer. METHODS: Eligible patients for the double-blind phase of this ongoing, placebo-controlled, randomised, phase 3 trial, had metastatic or unresectable disease, Eastern Cooperative Oncology Group performance status score 1 or 2, systemic inflammation, weight loss, and other disease-related morbidities associated with poor prognosis, and were refractory to oxaliplatin and irinotecan...
January 13, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28093815/nigella-sativa-supplementation-improves-asthma-control-and-biomarkers-a-randomized-double-blind-placebo-controlled-trial
#13
Abdulrahman Koshak, Li Wei, Emad Koshak, Siraj Wali, Omer Alamoudi, Abdulrahman Demerdash, Majdy Qutub, Peter Natesan Pushparaj, Michael Heinrich
Poor compliance with conventional asthma medications remains a major problem in achieving asthma control. Nigella sativa oil (NSO) is used traditionally for many inflammatory conditions such as asthma. We aimed to investigate the benefits of NSO supplementation on clinical and inflammatory parameters of asthma. NSO capsules 500 mg twice daily for 4 weeks were used as a supplementary treatment in a randomized, double-blind, placebo-controlled trial in asthmatics (clinicaltrials.gov: NCT02407262). The primary outcome was Asthma Control Test score...
January 17, 2017: Phytotherapy Research: PTR
https://www.readbyqxmd.com/read/28091647/phytosterol-nutritional-supplement-improves-pregnancy-and-neonatal-complications-of-gestational-diabetes-mellitus-in-a-double-blind-and-placebo-controlled-clinical-study
#14
Fang Gao, Guangya Wang, Linxia Wang, Ningning Guo
Gestational diabetes mellitus (GDM) is an increasingly serious health problem among pregnant women. Phytosterol-enriched spreads are known to reduce total cholesterol (TC) and low-density lipoprotein (LDL), but little is known about their effects on GDM. We aimed to examine the effect of the daily consumption of phytosterol-enriched spreads on both the maternal and neonatal outcomes of GDM patients. GDM patients during the third trimester of pregnancy were enrolled and assigned randomly to consume a regular spread or phytosterol-enriched spread daily until the end of their pregnancy...
January 16, 2017: Food & Function
https://www.readbyqxmd.com/read/28091641/effects-of-pomegranate-extract-in-supplementing-gonadotropin-releasing-hormone-therapy-on-idiopathic-central-precocious-puberty-in-chinese-girls-a-randomized-placebo-controlled-double-blind-clinical-trial
#15
Jinsheng Liu, Jiulai Tang
Central precocious puberty (CPP) without organic abnormality is called idiopathic CPP (ICPP). The objective of this trial was to evaluate the effects of pomegranate extract in supplementing gonadotropin-releasing hormone (GnRH) analog therapy on ICPP-affected girls in the Chinese population. 286 girls, diagnosed with ICPP were initially enrolled into this trial, and among them 225 eligible patients were randomized to receive a combinational GnRH analog treatment supplemented with either a placebo or pomegranate extract on a daily basis for a period of 3 months...
January 16, 2017: Food & Function
https://www.readbyqxmd.com/read/28091532/development-of-the-neuroimmune-modulator-ibudilast-for-the-treatment-of-alcoholism-a-randomized-placebo-controlled-human-laboratory-trial
#16
Lara A Ray, Spencer Bujarski, Steve Shoptaw, Daniel Jo Roche, Keith Heinzerling, Karen Miotto
Current directions in medication development for alcohol use disorder (AUD) emphasize the need to identify novel molecular targets and efficiently screen new compounds aimed at those targets. Ibudilast (IBUD) is a neuroimmune modulator that inhibits phosphodiesterases -4 and -10 and macrophage migration inhibitory factor and was recently found to reduce alcohol intake in rats by approximately 50%. To advance medications development for AUD, the present study consists of a randomized, crossover, double-blind, placebo-controlled laboratory study of IBUD in non-treatment seeking individuals with current (ie, past month) mild-to-severe AUD...
January 16, 2017: Neuropsychopharmacology: Official Publication of the American College of Neuropsychopharmacology
https://www.readbyqxmd.com/read/28091362/epicutaneous-immunotherapy-for-the-treatment-of-peanut-allergy-in-children-and-young-adults
#17
Stacie M Jones, Scott H Sicherer, A Wesley Burks, Donald Y M Leung, Robert W Lindblad, Peter Dawson, Alice K Henning, M Cecilia Berin, David Chiang, Brian P Vickery, Robbie D Pesek, Christine B Cho, Wendy F Davidson, Marshall Plaut, Hugh A Sampson, Robert A Wood
BACKGROUND: Peanut allergy is common, life-threatening, and without therapeutic options. We evaluated peanut epicutaneous immunotherapy (EPIT) by using Viaskin Peanut for peanut allergy treatment. OBJECTIVE: We sought to evaluate the clinical, safety, and immunologic effects of EPIT for the treatment of peanut allergy. METHODS: In this multicenter, double-blind, randomized, placebo-controlled study, 74 participants with peanut allergy (ages 4-25 years) were treated with placebo (n = 25), Viaskin Peanut 100 μg (VP100; n = 24) or Viaskin Peanut 250 μg (VP250; n = 25; DBV Technologies, Montrouge, France)...
October 20, 2016: Journal of Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/28090524/the-samukeppra-study-in-prehospital-status-epilepticus-lessons-for-future-study
#18
COMMENT
Andrew C Schomer, Jaideep Kapur
In the Lancet Neurology article "Prehospital treatment with levetiracetam plus clonazepam or placebo plus clonazepam in status epilepticus (SAMUKeppra): a randomised, double-blind, phase 3 trial" the authors conducted a prehospital, randomized controlled study to determine which treatment is more effective for status epilepticus (SE): benzodiazepine alone, or in combination with levetiracetam (LEV). Although the study had negative results, several aspects of the trial design likely masked any added effect that LEV may have had in controlling SE, including: higher doses of benzodiazepines, lower thresholds for determining cessation of SE, and a smaller sample size...
December 2016: Annals of Translational Medicine
https://www.readbyqxmd.com/read/28089468/obtain-a-outcome-benefits-of-tranexamic-acid-in-hip-arthroplasty-a%C3%A2-randomized-double-blinded-controlled-trial
#19
Andrew Fraval, Peter Effeney, Lena Fiddelaers, Belinda Smith, Ben Towell, Phong Tran
BACKGROUND: We examined whether the blood conserving effect of tranexamic acid (TXA) in total hip arthroplasty using the direct anterior approach, translates to an effect on functional outcomes in the perioperative period. METHODS: We conducted a single-center, randomized, double-blinded, placebo-controlled trial. One hundred one patients were randomized to receive either TXA or an equivalent volume of normal saline. The primary outcome measure was thigh swelling...
December 8, 2016: Journal of Arthroplasty
https://www.readbyqxmd.com/read/28088806/effects-of-aloe-sterol-supplementation-on-skin-elasticity-hydration-and-collagen-score-a-12-week-double-blind-randomized-controlled-trial
#20
Miyuki Tanaka, Yuki Yamamoto, Eriko Misawa, Kazumi Nabeshima, Marie Saito, Koji Yamauchi, Fumiaki Abe, Fukumi Furukawa
BACKGROUND/AIMS: Our previous study confirmed that Aloe sterol stimulates collagen and hyaluronic acid production in human dermal fibroblasts. This study aims to investigate whether Aloe sterol intake affects skin conditions. METHODS: We performed a 12-week, randomized, double-blind, placebo-controlled study to evaluate the effects of oral Aloe sterol supplementation on skin elasticity, hydration, and the collagen score in 64 healthy women (age range 30-59 years; average 44...
January 14, 2017: Skin Pharmacology and Physiology
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