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https://www.readbyqxmd.com/read/29351138/the-effect-of-melatonin-upon-postacute-withdrawal-among-males-in-a-residential-treatment-program-m-paws-a-randomized-double-blind-placebo-controlled-trial
#1
Corry D Bondi, Khalid M Kamal, David A Johnson, Paula A Witt-Enderby, Vincent J Giannetti
OBJECTIVE: Assess the effect of melatonin (5 mg) compared with placebo as an adjuvant treatment along with current behavioral and pharmacotherapy for 28 days on weekly self-reported severity of anxiety, depression, stress, and sleep complaints, and also how sleep is affecting daily life in males 18 years of age and older in recovery from substance use at a residential program in south-western Pennsylvania. BACKGROUND: Individuals in recovery experience a variety of symptoms including, but are not limited to, anxiety, depression, sleep difficulties, and stress...
January 18, 2018: Journal of Addiction Medicine
https://www.readbyqxmd.com/read/29348926/a-double-blind-placebo-controlled-single-ascending-dose-study-of-remyelinating-antibody-rhigm22-in-people-with-multiple-sclerosis
#2
Andrew Eisen, Benjamin M Greenberg, James D Bowen, Douglas L Arnold, Anthony O Caggiano
Objective: The objective of this paper is to assess, in individuals with clinically stable multiple sclerosis (MS), the safety, tolerability, pharmacokinetics (PK) and exploratory pharmacodynamics of the monoclonal recombinant human antibody IgM22 (rHIgM22). Methods: Seventy-two adults with stable MS were enrolled in a double-blind, randomized, placebo-controlled, single ascending-dose, Phase 1 trial examining rHIgM22 from 0.025 to 2.0 mg/kg. Assessments included MRI, MR spectroscopy, plasma PK, and changes in clinical status, laboratory values and adverse events for three months...
October 2017: Multiple Sclerosis Journal—Experimental, Translational and Clinical
https://www.readbyqxmd.com/read/29348727/efficacy-and-safety-of-panax-ginseng-berry-extract-on-glycemic-control-a-12-wk-randomized-double-blind-and-placebo-controlled-clinical-trial
#3
Han Seok Choi, Sunmi Kim, Min Jung Kim, Myung-Sunny Kim, Juewon Kim, Chan-Woong Park, Daebang Seo, Song Seok Shin, Sang Woo Oh
Background: Antihyperglycemic effects of Panax ginseng berry have never been explored in humans. The aims of this study were to assess the efficacy and safety of a 12-wk treatment with ginseng berry extract in participants with a fasting glucose level between 100 mg/dL and 140 mg/dL. Methods: This study was a 12-wk, randomized, double-blind, placebo-controlled clinical trial. A total of 72 participants were randomly allocated to two groups of either ginseng berry extract or placebo, and 63 participants completed the study...
January 2018: Journal of Ginseng Research
https://www.readbyqxmd.com/read/29348651/depressive-mood-ratings-are-reduced-by-mdma-in-female-polydrug-ecstasy-users-homozygous-for-the-l-allele-of-the-serotonin-transporter
#4
K P C Kuypers, R de la Torre, M Farre, L Xicota, E B de Sousa Fernandes Perna, E L Theunissen, J G Ramaekers
MDMA exerts its main effects via the serotonergic system and the serotonin transporter. The gene coding for this transporter determines the expression rate of the transporter. Previously it was shown that healthy individuals with the short allelic variant ('s-group') of the 5-HTTLPR-polymorphism displayed more anxiety and negative mood, and had a lower transcriptional efficiency compared to individuals who are homozygous for the l-allele ('l-group'). The present study aimed to investigate the role of the 5-HTTLPR polymorphism in MDMA-induced mood effects...
January 18, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29347996/the-apathy-in-dementia-methylphenidate-trial-2-admet-2-study-protocol-for-a-randomized-controlled-trial
#5
Roberta W Scherer, Lea Drye, Jacobo Mintzer, Krista Lanctôt, Paul Rosenberg, Nathan Herrmann, Prasad Padala, Olga Brawman-Mintzer, William Burke, Suzanne Craft, Alan J Lerner, Allan Levey, Anton Porsteinsson, Christopher H van Dyck
BACKGROUND: Alzheimer's disease (AD) is characterized not only by cognitive and functional decline, but also often by the presence of neuropsychiatric symptoms. Apathy, which can be defined as a lack of motivation, is one of the most prevalent neuropsychiatric symptoms in AD and typically leads to a worse quality of life and greater burden for caregivers. Treatment options for apathy in AD are limited, but studies have examined the use of the amphetamine, methylphenidate. The Apathy in Dementia Methylphenidate Trial (ADMET) found that treatment of apathy in AD with methylphenidate was associated with significant improvement in apathy in two of three outcome measures, some evidence of improvement in global cognition, and minimal adverse events...
January 18, 2018: Trials
https://www.readbyqxmd.com/read/29347988/efficacy-of-melatonin-for-sleep-disturbance-following-traumatic-brain-injury-a-randomised-controlled-trial
#6
Natalie A Grima, Shantha M W Rajaratnam, Darren Mansfield, Tracey L Sletten, Gershon Spitz, Jennie L Ponsford
BACKGROUND: The study aimed to determine the efficacy of melatonin supplementation for sleep disturbances in patients with traumatic brain injury (TBI). METHODS: This is a randomised double-blind placebo-controlled two-period two-treatment (melatonin and placebo) crossover study. Outpatients were recruited from Epworth and Austin Hospitals Melbourne, Australia. They had mild to severe TBI (n = 33) reporting sleep disturbances post-injury (mean age 37 years, standard deviation 11 years; 67% men)...
January 19, 2018: BMC Medicine
https://www.readbyqxmd.com/read/29347975/single-low-dose-primaquine-for-blocking-transmission-of-plasmodium-falciparum-malaria-a-proposed-model-derived-age-based-regimen-for-sub-saharan-africa
#7
W Robert Taylor, Htee Khu Naw, Kathryn Maitland, Thomas N Williams, Melissa Kapulu, Umberto D'Alessandro, James A Berkley, Philip Bejon, Joseph Okebe, Jane Achan, Alfred Ngwa Amambua, Muna Affara, Davis Nwakanma, Jean-Pierre van Geertruyden, Muhindo Mavoko, Pascal Lutumba, Junior Matangila, Philipe Brasseur, Patrice Piola, Rindra Randremanana, Estrella Lasry, Caterina Fanello, Marie Onyamboko, Birgit Schramm, Zolia Yah, Joel Jones, Rick M Fairhurst, Mahamadou Diakite, Grace Malenga, Malcolm Molyneux, Claude Rwagacondo, Charles Obonyo, Endalamaw Gadisa, Abraham Aseffa, Mores Loolpapit, Marie-Claire Henry, Grant Dorsey, Chandy John, Sodiomon B Sirima, Karen I Barnes, Peter Kremsner, Nicholas P Day, Nicholas J White, Mavuto Mukaka
BACKGROUND: In 2012, the World Health Organization recommended blocking the transmission of Plasmodium falciparum with single low-dose primaquine (SLDPQ, target dose 0.25 mg base/kg body weight), without testing for glucose-6-phosphate dehydrogenase deficiency (G6PDd), when treating patients with uncomplicated falciparum malaria. We sought to develop an age-based SLDPQ regimen that would be suitable for sub-Saharan Africa. METHODS: Using data on the anti-infectivity efficacy and tolerability of primaquine (PQ), the epidemiology of anaemia, and the risks of PQ-induced acute haemolytic anaemia (AHA) and clinically significant anaemia (CSA), we prospectively defined therapeutic-dose ranges of 0...
January 18, 2018: BMC Medicine
https://www.readbyqxmd.com/read/29347917/does-different-information-disclosure-on-placebo-control-affect-blinding-and-trial-outcomes-a-case-study-of-participant-information-leaflets-of-randomized-placebo-controlled-trials-of-acupuncture
#8
Soyeon Cheon, Hi-Joon Park, Younbyoung Chae, Hyangsook Lee
BACKGROUND: While full disclosure of information on placebo control in participant information leaflets (PILs) in a clinical trial is ethically required during informed consent, there have been concerning voices such complete disclosures may increase unnecessary nocebo responses, breach double-blind designs, and/or affect direction of trial outcomes. Taking an example of acupuncture studies, we aimed to examine what participants are told about placebo controls in randomized, placebo-controlled trials, and how it may affect blinding and trial outcomes...
January 18, 2018: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/29346838/first-in-human-study-to-assess-safety-pharmacokinetics-and-pharmacodynamics-of-bms-962212-a-direct-reversible-small-molecule-factor-xia-inhibitor-in-non-japanese-and-japanese-healthy-subjects
#9
Vidya Perera, Joseph M Luettgen, Zhaoqing Wang, Charles E Frost, Cynthia Yones, Cesare Russo, John Lee, Yue Zhao, Frank P LaCreta, Xuewen Ma, Robert M Knabb, Dietmar Seiffert, Mary DeSouza, Pierre Mugnier, Brenda Cirincione, Takayo Ueno, Robert J A Frost
AIMS: To assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of BMS-962212, a first-in-class Factor XIa inhibitor, in Japanese and non-Japanese healthy subjects. METHODS: This was a randomized, placebo-controlled, double-blind, sequential, ascending dose study of 2 hour (Part A) and 5 day (Part B) intravenous (IV) infusions of BMS-962212. Part A used 4 doses (1.5, 4, 10, and 25 mg h-1 ) assigned to BMS-962212 or placebo in a 3:1 ratio per dose. Part B used 4 doses (1, 3, 9, and 20 mg h-1 ) enrolling Japanese (n = 4 active, n = 1 placebo) and non-Japanese subjects (n = 4 active, n = 1 placebo) per dose...
January 18, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29345593/antithrombotic-therapy-after-tavr
#10
Tobias Geisler, Michal Droppa, Karin Mueller, Oliver Borst
Transvascular aortic valve replacement (TAVR) has emerged as a treatment option in patients with severe aortic stenosis who are inoperable and has recently been evaluated in patients with intermediate surgical risk. The number of procedures is increasing worldwide in parallel with the demographic changes in industrial countries. The risk for cerebral embolism is of main concern and represents a major determinant for prognosis and quality of live after TAVR. The empiric antithrombotic therapy consists of dual antiplatelet therapy (DAPT); however the risk-benefit of this approach is lacking evidence from randomized, placebo-controlled trials regarding choice and duration of antithrombotic treatment...
January 17, 2018: Current Vascular Pharmacology
https://www.readbyqxmd.com/read/29345426/single-dose-intravenous-iron-in-southeast-asian-heart-failure-patients-a-pilot-randomized-placebo-controlled-study-practice-asia-hf
#11
Tee Joo Yeo, Poh Shuan Daniel Yeo, Farid Abdul Hadi, Timothy Cushway, Kim Yee Lee, Fang Fang Yin, Anne Ching, Ruili Li, Seet Yoong Loh, Shir Lynn Lim, Raymond Ching-Chiew Wong, Bee Choo Tai, Arthur Mark Richards, Carolyn S P Lam
AIMS: Iron deficiency is highly prevalent in Southeast Asians with heart failure (HF) and associated with worse outcomes. This trial aimed to assess the effect of intravenous iron in Southeast Asians hospitalized with decompensated HF. METHODS AND RESULTS: Fifty patients hospitalized for acute decompensated HF, regardless of ejection fraction, with iron deficiency (defined as serum ferritin <300 ng/mL if transferrin saturation is <20%) were randomized to receive either one dose of intravenous ferric carboxymaltose (FCM) 1000 mg or placebo (0...
January 18, 2018: ESC Heart Failure
https://www.readbyqxmd.com/read/29345158/the-impact-of-probiotics-and-n-3-long-chain-polyunsaturated-fatty-acids-on-intestinal-permeability-in-pregnancy-a-randomised-clinical-trial
#12
K Mokkala, P Pussinen, N Houttu, E Koivuniemi, T Vahlberg, K Laitinen
A disruption in intestinal barrier integrity may predispose individuals to metabolic aberrations, particularly during the vulnerable period of pregnancy. We investigated whether intestinal permeability, as measured by serum zonulin concentration, changes over the duration of pregnancy and whether this change is reflected in lipopolysaccharide (LPS) activity. Second, we tested in a randomised double-blind placebo controlled clinical trial the impact of consuming dietary probiotics and/or long chain polyunsaturated fatty acid (LC-PUFA) supplements in lowering serum zonulin concentration and LPS activity...
January 18, 2018: Beneficial Microbes
https://www.readbyqxmd.com/read/29344879/antiplatelet-aspirin-therapy-as-a-new-option-in-the-treatment-of-vasculogenic-erectile-dysfunction-a-prospective-randomized-double-blind-placebo-controlled-study
#13
Zeki Bayraktar, Selami Albayrak
PURPOSE: To investigate the efficiency of antiplatelet (aspirin) therapy in vasculogenic erectile dysfunction (VED) patients with a high mean platelet volume. METHODS: A total of 184 patients diagnosed with VED between the ages of 18 and 76 were randomly divided into two groups and treated for 6 weeks [group 1: 120 patients (mean age 48.3), aspirin 100 mg/day; group 2: 64 patients (mean age 47.7), placebo 100 mg/day]. The changes from baseline to end point in erectile function scores on the International Index of Erectile Function (IIEF-EF) and the number of patients who answered "yes" to questions 2 and 3 of the sexual encounter profile (SEP) were compared statistically...
January 17, 2018: International Urology and Nephrology
https://www.readbyqxmd.com/read/29344464/cannabinoids-in-the-treatment-of-epilepsy-hard-evidence-at-last
#14
REVIEW
Emilio Perucca
The interest in cannabis-based products for the treatment of refractory epilepsy has skyrocketed in recent years. Marijuana and other cannabis products with high content in Δ(9) - tetrahydrocannabinol (THC), utilized primarily for recreational purposes, are generally unsuitable for this indication, primarily because THC is associated with many undesired effects. Compared with THC, cannabidiol (CBD) shows a better defined anticonvulsant profile in animal models and is largely devoid of adverse psychoactive effects and abuse liability...
December 2017: Journal of Epilepsy Research
https://www.readbyqxmd.com/read/29344037/the-effects-of-ginger-on-fasting-blood-sugar-hemoglobin-a1c-and-lipid-profiles-in-patients-with-type-2-diabetes
#15
Motahareh Makhdoomi Arzati, Niyaz Mohammadzadeh Honarvar, Ahmad Saedisomeolia, Siyamand Anvari, Mohammad Effatpanah, Raoofe Makhdoomi Arzati, Mir Saeed Yekaninejad, Rezvan Hashemi, Mahmoud Djalali
Background: Lipid and glycemic abnormalities are prevalent in diabetes leading to long term complications. Use of safe and natural foods instead of medications is now considered by many scientists. Objectives: This study aimed at determining the effect of ginger on lipid and glucose levels of patients with type 2 diabetes mellitus. Methods: In a double-blind placebo-controlled trial, 50 patients with type 2 diabetes were randomly allocated to 2 groups of intervention (n = 25) and placebo (n = 25)...
October 2017: International Journal of Endocrinology and Metabolism
https://www.readbyqxmd.com/read/29343962/functioning-outcomes-with-adjunctive-treatments-for-major-depressive-disorder-a-systematic-review-of-randomized-placebo-controlled-studies
#16
REVIEW
Emmanuelle Weiller, Catherine Weiss, Christopher P Watling, Christopher Edge, Mary Hobart, Hans Eriksson, Maurizio Fava
Objective: Patients with major depressive disorder (MDD) with inadequate response to antidepressant treatment (ADT) may suffer a prolonged loss of functioning. This review aimed to determine if self-rated functional measures are informative in randomized placebo-controlled studies of adjunctive therapy in patients with MDD and inadequate response to ADT. Methods: This was a systematic literature review of articles in any language from the MEDLINE database published between January 1990 and March 2017...
2018: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/29343944/quantitative-assessment-of-the-effects-of-chitosan-intervention-on-blood-pressure-control
#17
Haohai Huang, Ying Zou, Honggang Chi
Background: Chitosan is a popular dietary fiber often used to reduce dietary fat absorption to control weight and blood lipids. However, its effects on blood pressure (BP) have not been fully elucidated. We evaluated the effects of chitosan administration on systolic blood pressure (SBP) and diastolic blood pressure (DBP) through a pooled analysis of available randomized controlled trials (RCTs). Materials and methods: Electronic searches were conducted in Medline, Cochrane Library, Scopus, and EMBASE to identify relevant human placebo-control RCTs...
2018: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29343510/limited-radiographic-progression-and-sustained-reductions-in-mri-inflammation-in-patients-with-axial-spondyloarthritis-4-year-imaging-outcomes-from-the-rapid-axspa-phase-iii-randomised-trial
#18
Désirée van der Heijde, Xenofon Baraliakos, Kay-Geert A Hermann, Robert B M Landewé, Pedro M Machado, Walter P Maksymowych, Owen R Davies, Natasha de Peyrecave, Bengt Hoepken, Lars Bauer, Tommi Nurminen, Juergen Braun
OBJECTIVES: To report 4-year imaging outcomes in the RAPID-axSpA (NCT01087762) study of patients with ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA), treated with certolizumab pegol (CZP). METHODS: This phase III, randomised trial was placebo-controlled and double-blind to week 24, dose-blind to week 48 and open-label to week 204. Patients fulfilling the Assessment of Spondyloarthritis International Society (ASAS) axSpA criteria with active disease were stratified (AS/nr-axSpA) according to the modified New York (mNY) criteria at randomisation...
January 17, 2018: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/29343509/efficacy-and-safety-of-tregalizumab-in-patients-with-rheumatoid-arthritis-and-an-inadequate-response-to-methotrexate-results-of-a-phase-iib-randomised-placebo-controlled-trial
#19
Ronald F van Vollenhoven, Edward Clark Keystone, Vibeke Strand, Cesar Pacheco-Tena, Jiří Vencovský, Frank Behrens, Arthur Racewicz, Daniela Zipp, Faiza Rharbaoui, Ralf Wolter, Luise Knierim, Rainer Schmeidl, Xuefei Zhou, Silke Aigner, Benjamin Dälken, Andrea Wartenberg-Demand
OBJECTIVE: To evaluate the efficacy, biological activity and safety of tregalizumab in patients with active rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX). METHODS: 321 patients were randomised (1:1:1:1) to placebo or tregalizumab 25, 100 or 200 mg once-weekly subcutaneously in addition to MTX treatment. Responders at week 12 continued the same treatment, and non-responders at week 12 were escalated to the next higher tregalizumab dose level or re-randomised from placebo to active treatment...
January 17, 2018: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/29343468/onabotulinum-toxin-a-injections-for-sleep-bruxism-a-double-blind-placebo-controlled-study
#20
William G Ondo, Jerald H Simmons, Muhammad H Shahid, Vera Hashem, Christine Hunter, Joseph Jankovic
OBJECTIVES: To test the safety and efficacy of onabotulinum toxin-A (BoNT-A) injections into the masseter and temporalis muscles in patients with symptomatic sleep bruxism. METHODS: Participants 18 to 85 years old with clinically diagnosed sleep bruxism confirmed by polysomnography were enrolled in this randomized, placebo-controlled, 1:1, parallel-design trial with open-label extension. Participants were injected with BoNT-A 200 units (60 into each masseter and 40 into each temporalis) or placebo and were evaluated at 4 to 8 weeks after the initial treatment visit...
January 17, 2018: Neurology
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