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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
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
https://www.readbyqxmd.com/read/29221945/the-relationship-of-physical-performance-and-osteoporosis-prevention-with-vitamin-d-in-older-african-americans-poda
#10
Ruban Dhaliwal, Mageda Mikhail, Gianina Usera, Alexandra Stolberg, Shahidul Islam, Louis Ragolia, John F Aloia
RATIONALE: Vitamin D deficiency is associated with bone loss, poor muscle strength, falls and fracture. This information in older African Americans (AAs) is sparse. OBJECTIVE: The study of the relationship of Physical performance, Osteoporosis prevention with vitamin D in older African Americans (PODA) is a randomized, double-blind, placebo-controlled 3-year trial examining the effect of vitamin D on bone loss and physical performance in older AA women. METHODS: 260 healthy AA women aged >60years were assigned to receive placebo or vitamin D3...
December 5, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29221844/gabapentin-as-an-adjuvant-therapy-for-prevention-of-acute-phantom-limb-pain-in-pediatric-patients-undergoing-amputation-for-malignant-bone-tumors-a-prospective-double-blind-randomized-controlled-trial
#11
Xiandi Wang, Ying Yi, Dingbo Tang, Yi Chen, Yanhua Jiang, Jun Peng, Jiwei Xiao
CONTEXT: Gabapentin is reported to have an analgesic effect of reducing phantom-limb pain(PLP) in adult patients. There's no study on preoperative use of gabapentin in pediatric population in term of PLP prevention. OBJECTIVE: To determine whether gabapentin could be used as an adjuvant agent of opioid-based pain control to lower the rate of phantom-limb pain in pediatric patients undergoing amputation for malignant bone tumors in observation period of 60 days post-operatively...
December 5, 2017: Journal of Pain and Symptom Management
https://www.readbyqxmd.com/read/29221604/effect-of-evolocumab-on-lipoprotein-particles
#12
Peter P Toth, Naveed Sattar, Dirk J Blom, Seth S Martin, Steven R Jones, Maria Laura Monsalvo, Mary Elliott, Mike Davis, Ransi Somaratne, David Preiss
The level of low-density lipoprotein cholesterol (LDL-C) reflects the cholesterol carried mainly by low-density lipoprotein particles (LDL-P). LDL-C, however, does not always correlate with LDL-P because of the variable amounts of cholesterol per particle. Consideration of LDL-P concentrations in addition to LDL-C may help guide therapeutic decisions in a select number of patients. Evolocumab is a fully human monoclonal antibody directed against proprotein convertase subtilisin-kexin type 9 that lowers both LDL-C and cardiovascular events...
November 8, 2017: American Journal of Cardiology
https://www.readbyqxmd.com/read/29221491/a-phase-iii-randomized-trial-of-gantenerumab-in-prodromal-alzheimer-s-disease
#13
Susanne Ostrowitzki, Robert A Lasser, Ernest Dorflinger, Philip Scheltens, Frederik Barkhof, Tania Nikolcheva, Elizabeth Ashford, Sylvie Retout, Carsten Hofmann, Paul Delmar, Gregory Klein, Mirjana Andjelkovic, Bruno Dubois, Mercè Boada, Kaj Blennow, Luca Santarelli, Paulo Fontoura
BACKGROUND: Gantenerumab is a fully human monoclonal antibody that binds aggregated amyloid-β (Aβ) and removes Aβ plaques by Fc receptor-mediated phagocytosis. In the SCarlet RoAD trial, we assessed the efficacy and safety of gantenerumab in prodromal Alzheimer's disease (AD). METHODS: In this randomized, double-blind, placebo-controlled phase III study, we investigated gantenerumab over 2 years. Patients were randomized to gantenerumab 105 mg or 225 mg or placebo every 4 weeks by subcutaneous injection...
December 8, 2017: Alzheimer's Research & Therapy
https://www.readbyqxmd.com/read/29220121/effects-of-rate-on-analgesia-in-kilohertz-frequency-spinal-cord-stimulation-results-of-the-proco-randomized-controlled-trial
#14
Simon J Thomson, Moein Tavakkolizadeh, Sarah Love-Jones, Nikunj K Patel, Jianwen Wendy Gu, Amarpreet Bains, Que Doan, Michael Moffitt
OBJECTIVE: The PROCO RCT is a multicenter, double-blind, crossover, randomized controlled trial (RCT) that investigated the effects of rate on analgesia in kilohertz frequency (1-10 kHz) spinal cord stimulation (SCS). MATERIALS AND METHODS: Patients were implanted with SCS systems and underwent an eight-week search to identify the best location ("sweet spot") of stimulation at 10 kHz within the searched region (T8-T11). An electronic diary (e-diary) prompted patients for pain scores three times per day...
December 8, 2017: Neuromodulation: Journal of the International Neuromodulation Society
https://www.readbyqxmd.com/read/29219935/intrathecal-morphine-for-laparoscopic-segmental-colonic-resection-as-part-of-an-enhanced-recovery-protocol-a-randomized-controlled-trial
#15
Mark V Koning, Aart Jan W Teunissen, Erwin van der Harst, Elisabeth J Ruijgrok, Robert Jan Stolker
BACKGROUND AND OBJECTIVES: Management of postoperative pain after laparoscopic segmental colonic resections remains controversial. We compared 2 methods of analgesia within an Enhanced Recovery After Surgery (ERAS) program. The goal of the study was to investigate whether administration of intrathecal bupivacaine/morphine would lead to an enhanced recovery. METHODS: A single-center, randomized, double-blind controlled trial was performed (NL43488.101.13). Patients scheduled for laparoscopic segmental intestinal resections were considered...
December 6, 2017: Regional Anesthesia and Pain Medicine
https://www.readbyqxmd.com/read/29219213/effect-of-a-pheromone-on-stress-associated-reactivation-of-feline-herpesvirus-1-in-experimentally-inoculated-kittens
#16
Elena T Contreras, E Hodgkins, V Tynes, A Beck, F Olea-Popelka, M R Lappin
BACKGROUND: Stress contributes to reactivation of feline herpesvirus-1 (FHV-1). The usage of pheromones to decrease stress in FHV-1 experimentally inoculated kittens has not previously been investigated. HYPOTHESIS/OBJECTIVES: To determine whether a feline pheromone would lessen stress, resulting in decreased recurrence of FHV-1-associated illness in kittens. ANIMALS: Twelve 5-month-old, purpose-bred kittens. METHODS: Randomized, double-blind, placebo-controlled clinical trial...
December 8, 2017: Journal of Veterinary Internal Medicine
https://www.readbyqxmd.com/read/29218680/cardiovascular-profile-of-valbenazine-analysis-of-pooled-data-from-three-randomized-double-blind-placebo-controlled-trials
#17
Dao Thai-Cuarto, Christopher F O'Brien, Roland Jimenez, Grace S Liang, Joshua Burke
INTRODUCTION: Valbenazine is a novel vesicular monoamine transporter 2 inhibitor approved for the treatment of tardive dyskinesia in adults. OBJECTIVE: Using data from double-blind, placebo-controlled trials, analyses were conducted to evaluate the cardiovascular effects of once-daily valbenazine in patients with a psychiatric disorder who developed tardive dyskinesia after exposure to a dopamine-blocking medication. METHODS: Data were pooled from three 6-week, double-blind, placebo-controlled trials: KINECT (NCT01688037), KINECT 2 (NCT01733121), and KINECT 3 (NCT02274558)...
December 7, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29217859/efficacy-of-transdermal-buprenorphine-patch-on-post-operative-pain-relief-after-elective-spinal-instrumentation-surgery
#18
Saikat Niyogi, Pratibha Bhunia, Jisnu Nayak, Sankari Santra, Amita Acharjee, Indrani Chakraborty
Background and Aims: Transdermal buprenorphine patch (TDB) is increasingly used for chronic pain management because of non-invasive dosing, longer duration of action and minimal side effects. However its role in acute post-operative pain management for spinal instrumentation surgery is not well established. The aim of this study was to evaluate the analgesic efficacy of buprenorphine patch for postoperative pain relief in patients undergoing spinal instrumentation surgery. Methods: In this randomised, placebo-controlled, double-blinded, prospective study, 70 adult patients undergoing elective spinal instrumentation surgery were randomly allocated into two groups-TDB Group (buprenorphinepatch) and TDP Group (placebo patch)...
November 2017: Indian Journal of Anaesthesia
https://www.readbyqxmd.com/read/29217757/novel-mitochondria-targeting-peptide-in-heart-failure-treatment-a-randomized-placebo-controlled-trial-of-elamipretide
#19
Melissa A Daubert, Eric Yow, Gary Dunn, Sotir Marchev, Huiman Barnhart, Pamela S Douglas, Christopher O'Connor, Sidney Goldstein, James E Udelson, Hani N Sabbah
BACKGROUND: Mitochondrial dysfunction and energy depletion in the failing heart are innovative therapeutic targets in heart failure management. Elamipretide is a novel tetrapeptide that increases mitochondrial energy; however, its safety, tolerability, and therapeutic effect on cardiac structure and function have not been studied in heart failure with reduced ejection fraction. METHODS AND RESULTS: In this double-blind, placebo-controlled, ascending-dose trial, patients with heart failure with reduced ejection fraction (ejection fraction, ≤35%) were randomized to either a single 4-hour infusion of elamipretide (cohort 1 [n=8], 0...
December 2017: Circulation. Heart Failure
https://www.readbyqxmd.com/read/29217669/maternal-choline-supplementation-during-the-third-trimester-of-pregnancy-improves-infant-information-processing-speed-a-randomized-double-blind-controlled-feeding-study
#20
Marie A Caudill, Barbara J Strupp, Laura Muscalu, Julie E H Nevins, Richard L Canfield
Rodent studies demonstrate that supplementing the maternal diet with choline during pregnancy produces life-long cognitive benefits for the offspring. In contrast, the two experimental studies examining cognitive effects of maternal choline supplementation in humans produced inconsistent results, perhaps because of poor participant adherence and/or uncontrolled variation in intake of choline or other nutrients. We examined the effects of maternal choline supplementation during pregnancy on infant cognition, with intake of choline and other nutrients tightly controlled...
December 7, 2017: FASEB Journal: Official Publication of the Federation of American Societies for Experimental Biology
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