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Randomized placebo controlled double blind

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https://www.readbyqxmd.com/read/29228369/nicotine-gum-as-a-therapeutic-approach-for-low-blood-pressure-in-parkinson-s-disease-a-randomized-pilot-study
#1
Joanne DiFrancisco-Donoghue, Min-Kyung Jung, Adena Leder
Introduction: One cause for low blood pressure (BP) in Parkinson's disease (PD) is denervation of the sympathetic nervous system and reduced levels of norepinephrine. Nicotine increases heart rate and BP acutely by causing sympathetic stimulation. The absorption rate of nicotine gum is relatively quick and is absorbed at a constant rate. Our objective was to evaluate how nicotine gum affects acute low BP in PD. Methods: Ten subjects (age 69.3±8.8) completed this double blind, placebo controlled, cross-over design trial using nicotine gum (4 mg) and placebo gum on two separate days...
December 1, 2017: Nicotine & Tobacco Research: Official Journal of the Society for Research on Nicotine and Tobacco
https://www.readbyqxmd.com/read/29228247/a-randomized-double-blind-placebo-and-active-comparator-controlled-phase-i-study-of-analgesic-antihyperalgesic-properties-of-asp8477-a-fatty-acid-amide-hydrolase-inhibitor-in-healthy-female-subjects
#2
Klaus Schaffler, Ashraf Yassen, Peter Reeh, Paul Passier
Objectives: To evaluate the analgesic/antihyperalgesic effect of ASP8477. Design: Randomized, double-blind, double-dummy, cross-over, placebo- and active comparator-controlled study. Setting: HPR Dr. Schaffler GmbH, Munich, Germany. Subjects: Healthy female subjects aged 18-65 years. Methods: Eligible subjects were randomly assigned to one of six treatment sequences and received multiple ascending doses of ASP8477, duloxetine, and placebo over three treatment periods (each consisting of 21-day dosing separated by 14-day washout periods)...
December 8, 2017: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/29227377/effectiveness-of-low-dose-diuretics-for-blood-pressure-reduction-to-optimal-values-in-prehypertension-a-randomized-clinical-trial
#3
Flávio D Fuchs, Sandra C Fuchs, Carlos E Poli-de-Figueiredo, José A Figueiredo Neto, Luiz César N Scala, José F Vilela-Martin, Leila B Moreira, Hilton Chaves, Marco Mota Gomes, Marcos R de Sousa, Ricardo Pereira E Silva, Iran Castro, Evandro José Cesarino, Ana Luiza Lima Sousa, João Guilherme Alves, André Avelino Steffens, Andréa Araujo Brandão, Luiz Aparecido Bortolotto, Abrahão Afiune Neto, Antônio C Nóbrega, Roberto Silva Franco, Dario C Sobral Filho, Fernando Nobre, Rosane Schlatter, Miguel Gus, Caroline Nespolo De David, Leticia Rafaelli, Guilhermo Prates Sesin, Otávio Berwanger, Paul K Whelton
BACKGROUND: To determine the effectiveness of low-dose diuretic therapy to achieve an optimal level of blood pressure (BP) in adults with prehypertension. METHODS: The PREVER-prevention trial was a randomized, parallel, double-blinded, placebo-controlled trial, with 18 months of follow-up, conducted at 21 academic medical centers in Brazil. Of 1772 individuals evaluated for eligibility, 730 volunteers with prehypertension who were aged 30-70 years, and who did not reach optimal blood pressure after 3 months of lifestyle intervention, were randomized to a fixed association of chlorthalidone 12...
December 7, 2017: Journal of Hypertension
https://www.readbyqxmd.com/read/29227175/effects-of-28-day-bifidobacterium-animalis-subsp-lactis-hn019-supplementation-on-colonic-transit-time-and-gastrointestinal-symptoms-in-adults-with-functional-constipation-a-double-blind-randomized-placebo-controlled-and-dose-ranging-trial
#4
Alvin Ibarra, Mathilde Latreille-Barbier, Yves Donazzolo, Xavier Pelletier, Arthur C Ouwehand
Bifidobacterium animalis subsp. lactis HN019 (HN019) ameliorates chronic idiopathic constipation. Our aim was to determine the efficacy and safety of 28-day supplementation with 1 × 109 or 1 × 1010 CFU of HN019/day for constipation. A total of 228 adults who were diagnosed with functional constipation according to the Rome III criteria were randomized in a double-blind and placebo-controlled trial. Colonic transit time (CTT), the primary outcome, and secondary outcomes that were measured using inventories-patient assessment of constipation symptoms (PAC-SYM) and quality of life (PAC-QoL), bowel function index (BFI), bowel movement frequency (BMF), stool consistency, degree of straining, bowel emptying, bloating, and pain severity-were assessed...
December 11, 2017: Gut Microbes
https://www.readbyqxmd.com/read/29226862/the-rationale-and-design-of-the-reducing-pathology-in-alzheimer-s-disease-through-angiotensin-targeting-radar-trial
#5
Patrick G Kehoe, Peter S Blair, Beth Howden, David L Thomas, Ian B Malone, Jeremy Horwood, Clare Clement, Lucy Selman, Hannah Baber, Athene Lane, Elizabeth Coulthard, Anthony Peter Passmore, Nick C Fox, Ian B Wilkinson, Yoav Ben-Shlomo
BACKGROUND: Anti-hypertensives that modify the renin angiotensin system may reduce Alzheimer's disease (AD) pathology and reduce the rate of disease progression. OBJECTIVE: To conduct a phase II, two arm, double-blind, placebo-controlled, randomized trial (ISRCTN: 93682878; EudraCT: 2012-003641-15) of losartan to test the efficacy of Reducing pathology in Alzheimer's Disease through Angiotensin TaRgeting (RADAR). METHODS: Men and women aged at least 55 years with mild-to-moderate AD will be randomly allocated 100 mg encapsulated generic losartan or placebo once daily for 12 months after successful completion of a 2-week open-label phase and 2-week placebo washout to establish drug tolerability...
December 6, 2017: Journal of Alzheimer's Disease: JAD
https://www.readbyqxmd.com/read/29226809/vitamin-d-supplementation-in-chronic-schizophrenia-patients-treated-with-clozapine-a-randomized-double-blind-placebo-controlled-clinical-trial
#6
Amir Krivoy, Roy Onn, Yael Vilner, Eldar Hochman, Shira Weizman, Amir Paz, Shmuel Hess, Roi Sagy, Shiri Kimhi-Nesher, Ehud Kalter, Tal Friedman, Zvi Friedman, Gil Bormant, Sharon Trommer, Avi Valevski, Abraham Weizman
BACKGROUND: While accumulating evidence suggests that vitamin D deficiency may be involved in the risk to develop schizophrenia and its outcome, there are no studies on vitamin D supplementation in this context. We sought to assess the effect of vitamin D supplementation on psychiatric, cognitive and metabolic parameters in chronic clozapine-treated schizophrenia patients. METHODS: This eight-week, randomized, double-blind, placebo-controlled clinical trial, recruited schizophrenia patients who had been maintained on clozapine treatment for at least 18weeks and had low levels of vitamin D (<75nmol/l) and total PANSS scores >70 (to ascertain the presence of residual symptoms)...
December 2, 2017: EBioMedicine
https://www.readbyqxmd.com/read/29226626/randomized-clinical-study-of-safety-pharmacokinetics-and-pharmacodynamics-of-ripk1-inhibitor-gsk2982772-in-healthy-volunteers
#7
Kathleen Weisel, Nicola E Scott, Debra J Tompson, Bartholomew J Votta, Sujith Madhavan, Kat Povey, Allen Wolstenholme, Monica Simeoni, Todd Rudo, Lauren Richards-Peterson, Tarjinder Sahota, J Gene Wang, John Lich, Joshua Finger, Adeline Verticelli, Michael Reilly, Peter J Gough, Philip A Harris, John Bertin, Mei-Lun Wang
GSK2982772 is a highly selective inhibitor of receptor-interacting protein kinase 1 (RIPK1) being developed to treat chronic inflammatory diseases. This first-in-human study evaluated safety, tolerability, pharmacokinetics (PK), and exploratory pharmacodynamics (PD) of GSK2982772 administered orally to healthy male volunteers. This was a Phase I, randomized, placebo-controlled, double-blind study. In Part A, subjects received single ascending doses of GSK2982772 (0.1-120 mg) or placebo in a crossover design during each of 4 treatment periods...
December 2017: Pharmacology Research & Perspectives
https://www.readbyqxmd.com/read/29226545/nitrous-oxide-oxygen-mixture-for-analgesia-in-adult-cancer-patients-with-breakthrough-pain-a-randomized-double-blind-controlled-trial
#8
Q Liu, L-L Gao, Y-L Dai, Y-X Li, Y Wang, C-F Bai, G-X Mu, X-M Chai, W-J Han, L-J Zhou, Y-J Zhang, L Tang, J Liu, J-Q Yu
BACKGROUND: The aim of this study was to assess the efficacy of a fixed nitrous oxide/oxygen mixture for the management of breakthrough cancer pain. METHODS/DESIGN: A double-blind, placebo-controlled, randomized clinical trial was undertaken in the Medical ward of Tumor Hospital of General Hospital of Ningxia Medical University. 240 cancer patients with breakthrough pain were recruited and randomly received a standard pain treatment (morphine sulphate immediate release) plus a pre-prepared nitrous oxide/oxygen mixture, or the standard pain treatment plus oxygen...
December 11, 2017: European Journal of Pain: EJP
https://www.readbyqxmd.com/read/29225576/vitamin-d-enhances-efficacy-of-oral-nifedipine-in-treating-preeclampsia-with-severe-features-a-double-blinded-placebo-controlled-and-randomized-clinical-trial
#9
Dan-Dan Shi, Yong Wang, Jun-Jun Guo, Ling Zhou, Na Wang
Vitamin D (VD) has exhibited immunomodulatory role in the pathogenesis of preeclampsia. We hypothesize VD potentiate nifedipine treatment for preeclampsia by shortened the time to control blood pressure and prolong time before subsequent hypertensive crisis. We conduct a randomized trial of 683 primigravid women with preeclampsia, who were assigned to different treatment groups, either nifedipine+placebo or nifedipine+VD orally, by random after screening. Primary endpoints include time to control hypertension and time before another hypertensive crisis...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/29225313/ingestion-of-coffee-polyphenols-improves-a-scaly-skin-surface-and-the-recovery-rate-of-skin-temperature-after-cold-stress-a-randomized-controlled-trial
#10
Sachie Ueda, Masanori Tanahashi, Yuko Higaki, Kayoko Iwata, Yoshinori Sugiyama
Coffee polyphenols (CPPs) derived from coffee beans have beneficial effects on blood pressure and vascular endothelial function. In addition, CPPs suppress ultraviolet light induced erythema. However, the effects of CPPs on dry skin and cutaneous vascular function have not been clarified. We investigated the effects of CPPs on dry skin and the recovery rate (RR) of skin temperature after a cold-stress test as a measure of vascular function in subjects with visible scaliness in a double-blind, placebo-controlled, randomized study...
2017: Journal of Nutritional Science and Vitaminology
https://www.readbyqxmd.com/read/29224638/predictors-of-perioperative-major-bleeding-in-patients-who-interrupt-warfarin-for-an-elective-surgery-or-procedure-analysis-of-the-bridge-trial
#11
Nathan P Clark, James D Douketis, Vic Hasselblad, Sam Schulman, Andrei L Kindzelski, Thomas L Ortel
BACKGROUND: The use of low-molecular weight heparin bridge therapy during warfarin interruption for elective surgery/procedures increases bleeding. Other predictors of bleeding in this setting are not well described. METHODS: BRIDGE was a randomized, double-blind, placebo-controlled trial of bridge therapy with dalteparin 100 IU/kg twice daily in patients with atrial fibrillation requiring warfarin interruption. Bleeding outcomes were documented from the time of warfarin interruption until up to 37 days postprocedure...
January 2018: American Heart Journal
https://www.readbyqxmd.com/read/29224040/treatment-of-auditory-hallucinations-with-bilateral-theta-burst-stimulation-ctbs-protocol-of-a-randomized-double-blind-placebo-controlled-multicenter-trial
#12
Christian Plewnia, Bettina Brendel, Tobias Schwippel, Peter Martus, Joachim Cordes, Alkomiet Hasan, Andreas J Fallgatter
Auditory verbal hallucinations (AH) are core symptoms of schizophrenia. They are often severely distressing and refractory to therapy. Their perception is associated with increased activity in temporoparietal areas of the brain. Repetitive transcranial magnetic stimulation (rTMS) can reduce focal brain hyperactivity and has been shown to ameliorate AH. However, controlled multicenter clinical trials are still missing, effect sizes are moderate, and the treatment with rTMS is time consuming. Continuous theta burst stimulation (cTBS) is a quicker and potentially more effective technique to reduce cortical hyperactivity...
December 9, 2017: European Archives of Psychiatry and Clinical Neuroscience
https://www.readbyqxmd.com/read/29223745/buparlisib-plus-fulvestrant-in-postmenopausal-women-with-hormone-receptor-positive-her2-negative-advanced-breast-cancer-progressing-on-or-after-mtor-inhibition-belle-3-a-randomised-double-blind-placebo-controlled-phase-3-trial
#13
Angelo Di Leo, Stephen Johnston, Keun Seok Lee, Eva Ciruelos, Per E Lønning, Wolfgang Janni, Ruth O'Regan, Marie-Ange Mouret-Reynier, Dimitar Kalev, Daniel Egle, Tibor Csőszi, Roberto Bordonaro, Thomas Decker, Vivianne C G Tjan-Heijnen, Sibel Blau, Alessio Schirone, Denis Weber, Mona El-Hashimy, Bharani Dharan, Dalila Sellami, Thomas Bachelot
BACKGROUND: Activation of the PI3K/AKT/mTOR pathway occurs frequently in breast cancer that is resistant to endocrine therapy. Approved mTOR inhibitors effectively inhibit cell growth and proliferation but elicit AKT phosphorylation via a feedback activation pathway, potentially leading to resistance to mTOR inhibitors. We evaluated the efficacy and safety of buparlisib plus fulvestrant in patients with advanced breast cancer who were pretreated with endocrine therapy and mTOR inhibitors...
December 6, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29223722/the-effectiveness-of-intravenous-parecoxib-on-the-incidence-of-ipsilateral-shoulder-pain-after-thoracotomy-a-randomized-double-blind-placebo-controlled-trial
#14
Tanyong Pipanmekaporn, Yodying Punjasawadwong, Somrat Charuluxananan, Worawut Lapisatepun, Pavena Bunburaphong, Settapong Boonsri, Apichat Tantraworasin, Nutchanart Bunchungmongkol
OBJECTIVES: To determine the incidence of ipsilateral shoulder pain (ISP) with the therapeutic use of parecoxib compared with a placebo after thoracotomy. DESIGN: A prospective, randomized, double-blind, placebo-controlled trial. SETTING: A tertiary-care university hospital. PARTICIPANTS: Adult patients undergoing an elective thoracotomy between June 2011 and February 2015. INTERVENTIONS: Patients were allocated randomly into the parecoxib group (n = 80) and the control group (n = 80)...
June 1, 2017: Journal of Cardiothoracic and Vascular Anesthesia
https://www.readbyqxmd.com/read/29223708/comparison-of-neuroplastic-responses-to-cathodal-transcranial-direct-current-stimulation-and-continuous-theta-burst-stimulation-in-subacute-stroke
#15
Pierre Nicolo, Cécile Magnin, Elena Pedrazzini, Gijs Plomp, Anaïs Mottaz, Armin Schnider, Adrian G Guggisberg
OBJECTIVE: To investigate the effects of cathodal transcranial direct current stimulation (tDCS) and continuous theta burst stimulation (cTBS) on neural network connectivity and motor recovery in individuals with subacute stroke. DESIGN: Double-blinded, randomized, placebo-controlled study. SETTING: Stroke subjects recruited through a university hospital rehabilitation program. PARTICIPANTS: Stroke inpatients (N=41; mean age 65y, range 28-85; mean weeks poststroke 5, range 2-10) with resultant paresis in the upper extremity (mean Fugl-Meyer score 14, range 3-48)...
December 6, 2017: Archives of Physical Medicine and Rehabilitation
https://www.readbyqxmd.com/read/29223706/cross-over-clinical-trial-for-evaluating-the-safety-of-camel-s-milk-intake-in-patients-who-are-allergic-to-cow-s-milk-protein
#16
E M Navarrete-Rodríguez, L A Ríos-Villalobos, C R Alcocer-Arreguín, B E Del-Rio-Navarro, J M Del Rio-Chivardi, O J Saucedo-Ramírez, J J L Sienra-Monge, R V Frias
BACKGROUND: Cow's milk protein allergy (CMPA) affects between 0.6 and 0.9% of the general population, and its treatment implies the total elimination of the intake of this protein. Camel's milk has been suggested as an alternative for patients over one year of age who suffer from CMPA due to the difference in the amino acid sequence from that of cow's milk. The objective of this study was to evaluate the safety and tolerability of camel's milk in children with CMPA. METHODS: Crossed clinical trial for the use of camel's milk vs...
December 6, 2017: Allergologia et Immunopathologia
https://www.readbyqxmd.com/read/29223557/efficacy-and-safety-of-adding-omega-3-fatty-acids-in-statin-treated-patients-with-residual-hypertriglyceridemia-romantic-rosuvastatin-omacor-in-residual-hypertriglyceridemia-a-randomized-double-blind-and-placebo-controlled-trial
#17
Chee Hae Kim, Kyung Ah Han, Jaemyung Yu, Sang Hak Lee, Hui Kyung Jeon, Sang Hyun Kim, Seok Yeon Kim, Ki Hoon Han, Kyungheon Won, Dong-Bin Kim, Kwang-Jae Lee, Kyungwan Min, Dong Won Byun, Sang-Wook Lim, Chul Woo Ahn, SeongHwan Kim, Young Joon Hong, Jidong Sung, Seung-Ho Hur, Soon Jun Hong, Hong-Seok Lim, Ie Byung Park, In Joo Kim, Hyoungwoo Lee, Hyo-Soo Kim
PURPOSE: The purpose of this study was to examine the efficacy and safety of adding ω-3 fatty acids to rosuvastatin in patients with residual hypertriglyceridemia despite statin treatment. METHODS: This study was a multicenter, randomized, double-blind, placebo-controlled study. After a 4-week run-in period of rosuvastatin treatment, the patients who had residual hypertriglyceridemia were randomized to receive rosuvastatin 20 mg/d plus ω-3 fatty acids 4 g/d (ROSUMEGA group) or rosuvastatin 20 mg/d (rosuvastatin group) with a 1:1 ratio and were prescribed each medication for 8 weeks...
December 6, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29223441/edoxaban-for-the-management-of-elderly-japanese-patients-with-atrial-fibrillation-ineligible-for-standard-oral-anticoagulant-therapies-rationale-and-design-of-the-eldercare-af-study
#18
Ken Okumura, Gregory Y H Lip, Masaharu Akao, Kimihiko Tanizawa, Masayuki Fukuzawa, Kenji Abe, Masahiro Akishita, Takeshi Yamashita
Edoxaban-a non-vitamin K antagonist oral anticoagulant (NOAC)- 60-mg and 30-mg once-daily dose regimens are noninferior versus well-managed warfarin for the prevention of stroke or systemic embolic events (SEE) with less major bleeding in patients with nonvalvular atrial fibrillation (NVAF). There are no published data from phase 3 clinical trials specifically evaluating the use of NOACs in elderly NVAF patients, especially those considered ineligible for available oral anticoagulants. The Edoxaban Low-Dose for EldeR CARE AF patients (ELDERCARE-AF) study is a phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study that will compare the safety and efficacy of once-daily edoxaban 15 mg versus placebo in Japanese patients with NVAF ≥80 years of age who are considered ineligible for standard oral anticoagulant therapy...
December 2017: American Heart Journal
https://www.readbyqxmd.com/read/29222993/supplementation-of-gamma-aminobutyric-acid-gaba-affects-temporal-but-not-spatial-visual-attention
#19
Anna Leonte, Lorenza S Colzato, Laura Steenbergen, Bernhard Hommel, Elkan G Akyürek
In a randomized, double-blind, and placebo-controlled experiment, the acute effects of gamma-aminobutyric acid (GABA) supplementation on temporal and spatial attention in young healthy adults were investigated. A hybrid two-target rapid serial visual presentation task was used to measure temporal attention and integration. Additionally, a visual search task was used to measure the speed and accuracy of spatial attention. While temporal attention depends primarily on the distribution of limited attentional resources across time, spatial attention represents the engagement and disengagement by relevant and irrelevant stimuli across the visual field...
December 6, 2017: Brain and Cognition
https://www.readbyqxmd.com/read/29222139/effect-of-losartan-on-rv-dysfunction-results-from-the-double-blind-randomized-redefine-trial-in-adults-with-repaired-tetralogy-of-fallot
#20
Jouke P Bokma, Michiel M Winter, Arie P van Dijk, Hubert W Vliegen, Joost P van Melle, Folkert Meijboom, Martijn C Post, Jacqueline K Berbee, S Matthijs Boekholdt, Maarten Groenink, Aeilko H Zwinderman, Barbara J M Mulder, Berto J Bouma
Background -The effect of angiotensin II receptor blockers (ARBs) on right ventricular (RV) function is still unknown. ARBs are beneficial in patients with acquired left ventricular (LV) dysfunction and recent findings suggested a favorable effect in symptomatic patients with systemic RV dysfunction. The current study aimed to determine the effect of losartan, an ARB, on subpulmonary RV dysfunction in adults after repair of tetralogy of Fallot (rTOF). Methods -REDEFINE is an investigator-initiated, multicenter, prospective, 1:1 randomized, double-blind, placebo-controlled study...
December 8, 2017: Circulation
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