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https://www.readbyqxmd.com/read/28820746/no-effects-of-d-cycloserine-enhancement-in-exposure-with-response-prevention-therapy-in-panic-disorder-with-agoraphobia-a-double-blind-randomized-controlled-trial
#1
Mieke Klein Hofmeijer-Sevink, Puck Duits, Marleen M Rijkeboer, Adriaan W Hoogendoorn, Harold J van Megen, Nienke C Vulink, Damiaan A Denys, Marcel A van den Hout, Anton J van Balkom, Danielle C Cath
PURPOSE/BACKGROUND: D-cycloserine (DCS) is a partial N-methyl-D-aspartate receptor agonist that potentially augments response to exposure therapy in anxiety disorders by enhancing extinction learning. This randomized, double-blinded, placebo-controlled augmentation trial examined (1) the effectiveness of adding 125 mg of DCS to exposure therapy (before or directly after the first 6 treatment sessions) in patients with panic disorder with agoraphobia and (2) the effectiveness of DCS augmentation preceding exposure relative to DCS augmentation directly postexposure...
August 18, 2017: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28819003/skeletal-muscle-signaling-metabolism-and-performance-during-sprint-exercise-in-severe-acute-hypoxia-after-the-ingestion-of-antioxidants
#2
David Morales-Alamo, Borja Guerra, Jesus Gustavo Ponce-Gonzalez, Amelia Guadalupe-Grau, Alfredo Santana, Marcos Martin-Rincon, Miriam Gelabert-Rebato, Joan Aureli Cadefau, Roser Cussó, Cecilia Dorado, Jose A L Calbet
The aim of this study was to determine reactive oxygen species (ROS) could play a role in blunting Thr(172)-AMPKα phosphorylation in human skeletal muscle after sprint exercise in hypoxia and to elucidate the potential signaling mechanisms responsible for this response. Nine volunteers performed a single 30s sprint (Wingate test) in two occasions while breathing hypoxic gas (PIO2=75 mmHg): one after the ingestion of placebo (P) and another following the intake of antioxidants (A) (α-lipoic acid, vitamin C, and vitamin E), with a randomized double-blind design...
August 17, 2017: Journal of Applied Physiology
https://www.readbyqxmd.com/read/28818518/seladelpar-mbx-8025-a-selective-ppar-%C3%AE-agonist-in-patients-with-primary-biliary-cholangitis-with-an-inadequate-response-to-ursodeoxycholic-acid-a-double-blind-randomised-placebo-controlled-phase-2-proof-of-concept-study
#3
David Jones, Pol F Boudes, Mark G Swain, Christopher L Bowlus, Michael R Galambos, Bruce R Bacon, Yvonne Doerffel, Norman Gitlin, Stuart C Gordon, Joseph A Odin, David Sheridan, Markus-Alexander Wörns, Virginia Clark, Linsey Corless, Heinz Hartmann, Mark E Jonas, Andreas E Kremer, George F Mells, Peter Buggisch, Bradley L Freilich, Cynthia Levy, John M Vierling, David E Bernstein, Marek Hartleb, Ewa Janczewska, Fedja Rochling, Hemant Shah, Mitchell L Shiffman, John H Smith, Yun-Jung Choi, Alexandra Steinberg, Monika Varga, Harinder Chera, Robert Martin, Charles A McWherter, Gideon M Hirschfield
BACKGROUND: Many patients with primary biliary cholangitis have an inadequate response to first-line therapy with ursodeoxycholic acid. Seladelpar is a potent, selective agonist for the peroxisome proliferator-activated receptor-delta (PPAR-δ), which is implicated in bile acid homoeostasis. This first-in-class study evaluated the anti-cholestatic effects and safety of seladelpar in patients with an inadequate response to ursodeoxycholic acid. METHODS: The study was a 12-week, double-blind, placebo-controlled, phase 2 trial of patients with alkaline phosphatase of at least 1·67 times the upper limit of normal (ULN) despite treatment with ursodeoxycholic acid...
August 14, 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28818433/dose-ranging-design-and-analysis-methods-to-identify-the-minimum-effective-dose-med
#4
Yijie Zhou, Su Chen, Danielle Sullivan, Yihan Li, Ying Zhang, Wangang Xie, Hongtao Zhang, Yuanyuan Tang, Li Wang, Alan Hartford, Bo Yang
In dose ranging clinical trials, it is critical to investigate the dose-response profile and to identify a minimum effective dose (MED) to guide the dose selection for phase 3 confirmatory trials. Traditional dose ranging trials focus on pairwise comparisons between placebo and each investigational dose, while in recent years MCP-Mod (Multiple Comparison Procedures & Modeling) arose and gained popularity in the design and analysis of dose ranging trials. Comprehensive comparison between MCP-Mod and other methods have been made on continuous variables assuming a normal distribution...
August 14, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28818050/administration-of-two-probiotic-strains-during-early-childhood-does-not-affect-the-endogenous-gut-microbiota-composition-despite-probiotic-proliferation
#5
Martin Frederik Laursen, Rikke Pilmann Laursen, Anni Larnkjær, Kim F Michaelsen, Martin Iain Bahl, Tine Rask Licht
BACKGROUND: Probiotics are increasingly applied to prevent and treat a range of infectious, immune related and gastrointestinal diseases. Despite this, the mechanisms behind the putative effects of probiotics are poorly understood. One of the suggested modes of probiotic action is modulation of the endogenous gut microbiota, however probiotic intervention studies in adults have failed to show significant effects on gut microbiota composition. The gut microbiota of young children is known to be unstable and more responsive to external factors than that of adults...
August 17, 2017: BMC Microbiology
https://www.readbyqxmd.com/read/28817997/positive-impact-of-cladribine-on-quality-of-life-in-people-with-relapsing-multiple-sclerosis
#6
Dayo Afolabi, Christo Albor, Lukasz Zalewski, Dan R Altmann, David Baker, Klaus Schmierer
BACKGROUND: A number of elements of the pivotal 'cladribine tablets treating multiple sclerosis orally' (CLARITY) trial have remained unpublished. OBJECTIVE: To report the impact of cladribine on health-related quality of life (QoL) in people with relapsing multiple sclerosis (pwRMS). METHODS: QoL data from the phase III trial of two different doses (3.5 and 5.15 mg/kg) of oral cladribine in pwRMS were acquired from the European Medicines Agency through Freedom of Information...
August 1, 2017: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/28817201/exposure-response-modeling-and-power-analysis-of-components-of-acr-response-criteria-in-rheumatoid-arthritis-part-2-continuous-model
#7
Liang Li, Yi Zhang, Lian Ma, Ping Ji, Sarah Yim, Badrul A Chowdhury, Suresh Doddapaneni, Jiang Liu, Yaning Wang, Chandrahas Sahajwalla
Population pharmacokinetic/pharmacodynamic (PK/PD) models were developed to quantitate the exposure-response relationships using continuous longitudinal data on American College of Rheumatology (ACR) subcomponents, that is, tender-joint count (TJC), swollen-joint count (SJC), C-reactive protein, patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, and patient's assessment of physical function for 5 biologics approved for use in rheumatoid arthritis...
September 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28817199/exposure-response-modeling-and-power-analysis-of-components-of-acr-response-criteria-in-rheumatoid-arthritis-part-1-binary-model
#8
Liang Li, Yi Zhang, Lian Ma, Ping Ji, Sarah Yim, Badrul Chowdhury, Suresh Doddapaneni, Jiang Liu, Yaning Wang, Chandrahas Sahajwalla
American College of Rheumatology (ACR) response criteria is used to assess improvement in tender and swollen joint counts and in 3 of the 5 core measures (acute-phase reactant, physician global assessment, patient global assessment, pain, and physical function). From the clinical trial data on 5 approved biological products for the treatment of rheumatoid arthritis, population pharmacokinetic/pharmacodynamic models were developed to quantitatively describe the relationship between exposure and response rates of 3 individual components of ACR response criteria...
September 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28815614/resveratrol-for-alzheimer-s-disease
#9
REVIEW
Christine Sawda, Charbel Moussa, R Scott Turner
The amyloid hypothesis suggests that the progressive accumulation and deposition of central nervous system (CNS) amyloid with aging is the proximate cause of Alzheimer's disease (AD). Thus, targeting molecular mechanisms of aging may be a viable treatment approach. Caloric restriction prevents diseases of aging, including AD, in animal models, perhaps by activation of sirtuins. The sirtuins (e.g., mammalian SIRT1) are deacetylases that link energy balance (NAD(+) /NADH) to regulation of gene transcription. Resveratrol is a potent activator of SIRT1, and thus may mimic caloric restriction to prevent diseases of aging...
August 16, 2017: Annals of the New York Academy of Sciences
https://www.readbyqxmd.com/read/28814530/a-high-fat-diet-decreases-bone-mass-in-growing-mice-with-systemic-chronic-inflammation-induced-by-low-dose-slow-release-lipopolysaccharide-pellets
#10
Jay J Cao, Brian R Gregoire, Chwan-Li Shen
Background: Chronic inflammation is associated with increased bone resorption and is linked to osteopenia, or low bone mass. Obesity is also associated with low-grade chronic upregulation of inflammatory cytokines.Objective: This study investigated the effect of high-fat (HF) diet-induced obesity on bone structure changes in growing mice with existing systemic chronic inflammation induced by low-dose, slow-release lipopolysaccharide (LPS).Methods: Forty-eight 6-wk-old female C57BL/6 mice were randomly assigned to 4 treatment groups (n = 12/group) in a 2 × 2 factorial design-control (placebo) or LPS treatment (1...
August 16, 2017: Journal of Nutrition
https://www.readbyqxmd.com/read/28812044/monte-carlo-simulations-of-randomized-clinical-trials-in-epilepsy
#11
Daniel M Goldenholz, Joseph Tharayil, Robert Moss, Evan Myers, William H Theodore
BACKGROUND: The placebo response in epilepsy randomized clinical trials (RCTs) has recently been shown to largely reflect underlying natural variability in seizure frequency. Based on this observation, we sought to explore the parameter space of RCT design to optimize trial efficiency and cost. METHODS: We used one of the world's largest patient reported seizure diary databases, SeizureTracker.com to derive virtual patients for simulated RCTs. We ran 1000 randomly generated simulated trials using bootstrapping (sampling with replacement) for each unique combination of trial parameters, sweeping a large set of parameters in durations of the baseline and test periods, number of patients, eligibility criteria, drug effect size, and patient dropout...
August 2017: Annals of Clinical and Translational Neurology
https://www.readbyqxmd.com/read/28811898/lentinula-edodes-mycelia-extract-plus-adjuvant-chemotherapy-for-breast-cancer-patients-results-of-a-randomized-study-on-host-quality-of-life-and-immune-function-improvement
#12
Yukiko Nagashima, Shigehumi Yoshino, Shigeru Yamamoto, Noriko Maeda, Tatsuya Azumi, Yoshifumi Komoike, Kiyotaka Okuno, Tsutomu Iwasa, Junji Tsurutani, Kazuhiko Nakagawa, Oka Masaaki, Nagano Hiroaki
Anthracycline-based chemotherapies for breast cancer are known to adversely affect patients' quality of life (QOL) and immune function. For that reason, adjuvants that improve those impairments are required. A randomized double-blind study was conducted to evaluate the effectiveness of Lentinula edodes mycelia extract (LEM), which is an oral biological response modifier (BRM) medicine for cancer patients as such an adjuvant. A total of 47 breast cancer patients who were scheduled to receive postoperative adjuvant anthracycline-based chemotherapy, i...
September 2017: Molecular and Clinical Oncology
https://www.readbyqxmd.com/read/28811096/topical-anaesthetic-use-prior-to-rigid-gas-permeable-contact-lens-fitting
#13
Felicity R Gill, Paul J Murphy, Christine Purslow
PURPOSE: To investigate effect of topical anaesthetic (TA) during gas permeable (GP) contact lens (CL) fitting on subjective and objective measures of patient anxiety. METHODS: 47 subjects (mean±sd age=26.9±4.9years; soft CL wearers, 18, neophytes, 29). Each subject randomly assigned to Group A or B, and attended on two occasions, one week apart. First visit: subject received bilaterally either a single drop of TA (0.5% proxymetacaine) (Group A) or placebo (0...
August 12, 2017: Contact Lens & Anterior Eye: the Journal of the British Contact Lens Association
https://www.readbyqxmd.com/read/28810625/inhaled-corticosteroids-improve-lung-function-airway-hyper-responsiveness-and-airway-inflammation-but-not-symptom-control-in-patients-with-mild-intermittent-asthma-a-meta-analysis
#14
Wei Du, Ling Zhou, Yingmeng Ni, Yuanyuan Yu, Fang Wu, Guochao Shi
It remains controversial whether inhaled corticosteroid (ICS) should be used in patients with intermittent asthma. The present study aimed to assess the effect of ICS compared with placebo or other therapies in patients with intermittent asthma. Medline, Embase and CNKI databases were searched up to June 2016 and a meta-analysis was conducted. The findings demonstrated that in adult patients, when compared with placebo, ICS increased forced expiratory volume in 1 sec FEV1 [standardized mean difference (SMD), 0...
August 2017: Experimental and Therapeutic Medicine
https://www.readbyqxmd.com/read/28808948/tiotropium-bromide-in-children-and-adolescents-with-asthma
#15
Hengameh H Raissy, H William Kelly
Evidence is emerging on the use of long-acting muscarinic antagonists (LAMAs) in the management of asthma. Tiotropium bromide (Spiriva(®) Respimat(®)) is the only LAMA approved in children and adolescents. As the use of tiotropium becomes more common in clinical practice, it is necessary to review the existing data to identify patients who may benefit from the addition of this medication to their daily asthma regimen. This review discusses recent evidence on the safety and efficacy of tiotropium bromide in the management of asthma in children and adolescents...
August 14, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28807795/d-cycloserine-facilitates-extinction-learning-and-enhances-extinction-related-brain-activation
#16
Anne Klass, Benjamin Glaubitz, Martin Tegenthoff, Silke Lissek
Extinction learning is modulated by N-methyl D-aspartate receptors (NMDAR) particularly in prefrontal and hippocampal brain regions. The use of of NMDA agonists in exposure therapy of anxiety disorders has been investigated in various patient groups. Behavioral results showed beneficial effects of pre-learning administration of the partial NMDAR agonist D-Cycloserine (DCS) on therapy success. However, the impact of DCS upon non-fear-related contextual extinction, and associated recruitment of extinction-relevant brain regions is as yet unknown...
August 11, 2017: Neurobiology of Learning and Memory
https://www.readbyqxmd.com/read/28807667/inhibition-of-beta-catenin-signaling-in-the-skin-rescues-cutaneous-adipogenesis-in-systemic-sclerosis-a-randomized-double-blind-placebo-controlled-trial-of-c-82
#17
Robert Lafyatis, Julio C Mantero, Jessica Gordon, Nina Kishore, Mary Carns, Howard Dittrich, Robert Spiera, Robert W Simms, John Varga
Several studies have suggested that Wnts might contribute to skin fibrosis in systemic sclerosis (SSc) by affecting the differentiation of pluripotent dermal cells. We tested C-82, a therapeutic that inhibits canonical Wnt signaling by blocking the interaction of cAMP Response Element-Binding Protein with β-Catenin and inhibiting Wnt-activated genes. We utilized previously unreported trial design, formulating C-82 for topical application and conducting a placebo controlled, double-blinded clinical trial in which patients with diffuse cutaneous SSc were treated with C-82 or placebo on opposite forearms...
August 11, 2017: Journal of Investigative Dermatology
https://www.readbyqxmd.com/read/28805670/appetite-and-gut-hormones-response-to-a-putative-%C3%AE-glucosidase-inhibitor-salacia-chinensis-in-overweight-obese-adults-a-double-blind-randomized-controlled-trial
#18
Lihong Hao, Yvette Schlussel, Krista Fieselmann, Stephen H Schneider, Sue A Shapses
Animal studies indicate Salacia reduces body weight, possibly due to its α-glucosidase inhibitor (α-GI) properties, but this has not been examined previously. In this study, a randomized, placebo-controlled, three-way cross-over design was used to evaluate whether Salacia Chinensis (SC) reduces appetite in healthy overweight/obese individuals (body mass index 28.8 ±3.6 kg/m²; 32 ± 12 years). Forty-eight participants were fasted overnight and consumed a dose of SC (300 or 500 mg) or placebo with a fixed breakfast meal at each visit...
August 12, 2017: Nutrients
https://www.readbyqxmd.com/read/28804807/plasma-cortisol-response-cannot-be-classically-conditioned-in-a-taste-endocrine-paradigm-in-humans
#19
Liubov Petrakova, Karoline Boy, Marisa Kügler, Sven Benson, Harald Engler, Lars Möller, Manfred Schedlowski
RATIONALE: Peripheral immune responses can be modified by associative learning procedures. Less is known, however, whether and to what extent neuroendocrine parameters can be classically conditioned. OBJECTIVES: In this randomized double-blind study, we modified an established paradigm to behaviorally condition endocrine responses in humans. METHODS: Thirty-one healthy male participants received a distinctively flavored green drink as the conditioned stimulus (CS) and intravenous injections of corticotropin-releasing hormone (CRH) (CRH group, N = 17) or NaCl (placebo group, N = 14) as the unconditioned stimulus (US) during two subsequent acquisition trials...
August 13, 2017: Psychopharmacology
https://www.readbyqxmd.com/read/28804455/comparison-of-the-long-term-effect-of-positioning-the-cathode-in-tdcs-in-tinnitus-patients
#20
Sarah Rabau, Giriraj S Shekhawat, Mohamed Aboseria, Daniel Griepp, Vincent Van Rompaey, Marom Bikson, Paul Van de Heyning
Objective: Transcranial direct current stimulation (tDCS) is one of the methods described in the literature to decrease the perceived loudness and distress caused by tinnitus. However, the main effect is not clear and the number of responders to the treatment is variable. The objective of the present study was to investigate the effect of the placement of the cathode on the outcome measurements. Methods: Patients considered for the trial were chronic non-pulsatile tinnitus patients with complaints for more than 3 months and a Tinnitus Functional Index (TFI) score that exceeded 25...
2017: Frontiers in Aging Neuroscience
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