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Randomized double blinded controlled studies

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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
#1
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/28101779/randomized-controlled-trial-of-topical-emla-and-vapocoolant-spray-for-reducing-pain-during-wdpt-vaccination
#2
Navratan Kumar Gupta, Amit Upadhyay, Ajeet Kumar Dwivedi, Astha Agarwal, Vijay Jaiswal, Abhishek Singh
BACKGROUND: Intramuscular vaccination is among the most common source of iatrogenic pain in infants. Vapocoolant sprays are rapid-acting alternative to topical anesthetics. They provide transient anesthesia via evaporation induced skin cooling, and reduce pain due to vaccine injection in children and adults. The objective was to compare the synergistic analgesic effect of eutectic mixture of local anesthetics (EMLA) with breastfeeding (EB group) and vapocoolant spay with breastfeeding (VB group) to that of only breastfeeding (BO group) during whole cell diptheria, pertussis and tetanus (wDPT) vaccination...
January 19, 2017: World Journal of Pediatrics: WJP
https://www.readbyqxmd.com/read/28101565/use-of-neuromuscular-electrical-stimulation-to-preserve-the-thickness-of-abdominal-and-chest-muscles-of-critically-ill-patients-a-randomized-clinical-trial
#3
Ana M Dall' Acqua, Amanda Sachetti, Laura J Santos, Fernando A Lemos, Tanara Bianchi, Wagner S Naue, Alexandre S Dias, Graciele Sbruzzi, Silvia R R Vieira
OBJECTIVE: To evaluate and compare the effects of neuromuscular electrical stimulation combined with conventional physical therapy on muscle thickness in critically ill patients. DESIGN: Double-blind, randomized controlled trial. PATIENTS: Twenty-five patients participated in the study. METHODS: Patients on mechanical ventilation for 24-48 h were randomized to an intervention group (neuromuscular electrical stimulation + conventional physical therapy) or a conventional group (sham neuromuscular electrical stimulation + conventional physical therapy)...
January 19, 2017: Journal of Rehabilitation Medicine
https://www.readbyqxmd.com/read/28100922/the-effects-of-missed-doses-of-amlodipine-and-losartan-on-blood-pressure-in-older-hypertensive-patients
#4
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
#5
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/28100402/the-randomized-controlled-trial-of-late-surfactant-effects-on-respiratory-outcomes-at-1-year-corrected-age
#6
Roberta L Keller, Eric C Eichenwald, Anna Maria Hibbs, Elizabeth E Rogers, Katherine C Wai, Dennis M Black, Philip L Ballard, Jeanette M Asselin, William E Truog, Jeffrey D Merrill, Mark C Mammel, Robin H Steinhorn, Rita M Ryan, David J Durand, Catherine M Bendel, Ellen M Bendel-Stenzel, Sherry E Courtney, Ramasubbareddy Dhanireddy, Mark L Hudak, Frances R Koch, Dennis E Mayock, Victor J McKay, Jennifer Helderman, Nicolas F Porta, Rajan Wadhawan, Lisa Palermo, Roberta A Ballard
OBJECTIVE: To determine the effects of late surfactant on respiratory outcomes determined at 1-year corrected age in the Trial of Late Surfactant (TOLSURF), which randomized newborns of extremely low gestational age (≤28 weeks' gestational age) ventilated at 7-14 days to late surfactant and inhaled nitric oxide vs inhaled nitric oxide-alone (control). STUDY DESIGN: Caregivers were surveyed in a double-blinded manner at 3, 6, 9, and 12 months' corrected age to collect information on respiratory resource use (infant medication use, home support, and hospitalization)...
January 16, 2017: Journal of Pediatrics
https://www.readbyqxmd.com/read/28099499/oral-microbiota-in-infants-fed-a-formula-supplemented-with-bovine-milk-fat-globule-membranes-a-randomized-controlled-trial
#7
Niklas Timby, Magnus Domellöf, Pernilla Lif Holgerson, Christina E West, Bo Lönnerdal, Olle Hernell, Ingegerd Johansson
BACKGROUND: In a recent study, supplementation of infant formula with milk fat globule membranes (MFGM) decreased the incidence of otitis media in infants <6 months of age. OBJECTIVES: The aim of the present study was to characterize the oral microbiota in infants fed MFGM-supplemented formula and compare it to that of infants fed standard formula or breast milk. METHODS: In a prospective double-blinded randomized controlled trial, exclusively formula-fed infants <2 months of age were randomized to be fed experimental formula (EF, n = 80) with reduced energy and protein and supplemented with a bovine MFGM concentrate, or standard formula (SF, n = 80) until 6 months of age...
2017: PloS One
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
#8
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/28097356/effect-of-etelcalcetide-vs-cinacalcet-on-serum-parathyroid-hormone-in-patients-receiving-hemodialysis-with-secondary-hyperparathyroidism-a-randomized-clinical-trial
#9
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
#10
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
#11
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/28096005/effect-of-recorded-male-lullaby-on-physiologic-response-of-neonates-in-nicu
#12
Leila Taheri, Marzieh Kargar Jahromi, Mohammad Abbasi, Mohsen Hojat
PURPOSE: Most infants in the NICU are exposed to sensory overloads and deprivations as part of their care. This study conducted to assess the effect of lullaby on physiologic response of neonates admitted to NICU. METHOD: This is a randomized double-blind intervention trial which was performed on 52 neonates in Jahrom (Iran) 2013-2014. The samples were randomly assigned into lullaby group and a control group (sampling was sequential and randomization was by lottery)...
February 2017: Applied Nursing Research: ANR
https://www.readbyqxmd.com/read/28095924/sonolysis-in-prevention-of-brain-infarctions-during-internal-carotid-endarterectomy-sonobirdie-trial-study-protocol-for-a-randomized-controlled-trial
#13
Tomáš Hrbáč, David Netuka, Vladimír Beneš, Vladimír Nosáľ, Petra Kešnerová, Aleš Tomek, Táňa Fadrná, Vladimír Beneš, Jiří Fiedler, Vladimír Přibáň, Miroslav Brozman, Kateřina Langová, Roman Herzig, David Školoudík
BACKGROUND: Carotid endarterectomy (CEA) is a beneficial procedure for selected patients with an internal carotid artery (ICA) stenosis. Surgical risk of CEA varies from between 2 and 15%. The aim of the study is to demonstrate the safety and effectiveness of sonolysis (continual transcranial Doppler monitoring, TCD) using a 2-MHz diagnostic probe with maximal diagnostic energy on the reduction of the incidence of stroke, transient ischemic attack (TIA) and brain infarction detected using magnetic resonance imaging (MRI) by the activation of the endogenous fibrinolytic system during CEA...
January 17, 2017: Trials
https://www.readbyqxmd.com/read/28095795/intrathecal-magnesium-sulfate-does-not-reduce-the-ed50-of-intrathecal-hyperbaric-bupivacaine-for-cesarean-delivery-in-healthy-parturients-a-prospective-double-blinded-randomized-dose-response-trial-using-the-sequential-allocation-method
#14
Fei Xiao, Wenping Xu, Ying Feng, Feng Fu, Xiaomin Zhang, Yinfa Zhang, Lizhong Wang, Xinzhong Chen
BACKGROUND: Addition of intrathecal magnesium sulfate to local anesthetics has been reported to potentiate spinal anesthesia and prolong analgesia in parturients. The current study was to determine whether intrathecal magnesium sulfate would reduce the dose of hyperbaric bupivacaine in spinal anesthesia with bupivacaine and sufentanil for cesarean delivery. METHODS: Sixty healthy parturients undergoing scheduled cesarean delivery were randomly assigned to receive spinal anesthesia with 0...
January 17, 2017: BMC Anesthesiology
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
#15
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
#16
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
#17
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/28094033/vancomycin-added-to-the-wash-solution-of-the-cell-saver-effect-on-bacterial-contamination
#18
A Perez-Ferrer, E Gredilla-Díaz, J de Vicente-Sánchez, R Navarro-Suay, F Gilsanz-Rodríguez
OBJECTIVES: The aim of this study is to test whether the addition of a low-dose of antibiotic (vancomycin) to the wash solution (saline) of the cell-saver reduces the incidence of bacterial contamination of the autologous red blood cell (RBCs) concentrate recovered. MATERIAL AND METHOD: Experimental, randomized, double-blind, parallel group study performed on 20 consecutive patients scheduled for posterior spinal fusion surgery. Intraoperative bleeding was processed through a cell-saver: HaemoLite(®) 2+, in which the RBCs were washed according to randomization group, with saline (control group) or saline+10μg/ml(-1) vancomycin (vanco group)...
January 13, 2017: Revista Española de Anestesiología y Reanimación
https://www.readbyqxmd.com/read/28093815/nigella-sativa-supplementation-improves-asthma-control-and-biomarkers-a-randomized-double-blind-placebo-controlled-trial
#19
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/28093466/effects-of-sacubitril-valsartan-versus-olmesartan-on-central-hemodynamics-in-the-elderly-with-systolic-hypertension-the-parameter-study
#20
Bryan Williams, John R Cockcroft, Kazuomi Kario, Dion H Zappe, Patrick C Brunel, Qian Wang, Weinong Guo
Effective treatment of systolic hypertension in elderly patients remains a major therapeutic challenge. A multicenter, double-blind, randomized controlled trial with sacubitril/valsartan (LCZ696), a first-in-class angiotensin receptor neprilysin inhibitor, was conducted to determine its effects versus olmesartan (angiotensin receptor blocker) on central aortic pressures, in elderly patients (aged ≥60 years) with systolic hypertension and pulse pressure >60 mm Hg, indicative of arterial stiffness. Patients (n=454; mean age, 67...
January 16, 2017: Hypertension
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