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https://www.readbyqxmd.com/read/28092469/investigational-drugs-in-recent-clinical-trials-for-treatment-resistant-depression
#1
Ricardo P Garay, Carlos A Zarate, Thomas Charpeaud, Leslie Citrome, Christoph U Correll, Ahcène Hameg, Pierre-Michel Llorca
The authors describe the medications for treatment-resistant depression (TRD) in phase II/III of clinical development in the EU and US and provide an opinion on how current treatment can be improved in the near future. Areas covered: Sixty-two trials were identified in US and EU clinical trial registries that included six investigational compounds in recent phase III development and 12 others in recent phase II clinical trials. Glutamatergic agents have been the focus of many studies. A single intravenous dose of the glutamatergic modulator ketamine produces a robust and rapid antidepressant effect in persons with TRD; this effect continues to remain significant for 1 week...
January 16, 2017: Expert Review of Neurotherapeutics
https://www.readbyqxmd.com/read/28092428/reproducibility-of-clinical-events-adjudications-in-a-trial-of-venous-thromboembolism-prevention
#2
P Girard, A Penaloza, F Parent, B Gable, O Sanchez, P Durieux, P Hausfater, S Dambrine, G Meyer, P-M Roy
BACKGROUND: When clinical trials use clinical endpoints, establishing independent Clinical Events Committees (CEC) is recommended to homogenize the interpretation of investigators data. However, the reproducibility of CEC adjudications is almost unexplored. OBJECTIVES: To assess the reproducibility of CEC adjudications in a trial of venous thromboembolism (VTE) prevention. METHODS: The PREVENU study, a multicenter trial of VTE prevention, included 15,351 hospitalized medical patients...
January 16, 2017: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/28092306/tripeptide-k-d-pt-is-well-tolerated-in-mild-to-moderate-ulcerative-colitis-results-from-a-randomized-multicenter-study
#3
Torsten Kucharzik, Gunter Lemmnitz, Christoph Abels, Christian Maaser
BACKGROUND: K(D)PT showed marked anti-inflammatory properties in preclinical studies and exhibited very low toxicity in phase I and preclinical trials. In this study, efficacy and safety of oral K(D)PT were evaluated in patients with mild-to-moderate active ulcerative colitis. METHODS: A multicenter, randomized, double-blind, phase IIa trial was performed comparing add-on oral K(D)PT twice a day (20, 50, or 100 mg) with placebo in patients with mild-to-moderate active ulcerative colitis on baseline medication...
January 12, 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28092280/challenges-and-opportunities-to-enhance-global-drug-development-in-neonates
#4
Alexandra M Smith, Jonathan M Davis
PURPOSE OF REVIEW: This study reviews the history of neonatal drug development, recent legislative efforts designed to facilitate the study of therapeutic agents in neonates, and future steps necessary to advance drug development. RECENT FINDINGS: Although many federal regulations have been introduced over the past 15 years to encourage pediatric and neonatal drug development, the majority of medications that are used in the Neonatal Intensive Care Unit are not approved by the Food and Drug Administration (FDA) for use in neonates...
January 13, 2017: Current Opinion in Pediatrics
https://www.readbyqxmd.com/read/28092106/a-randomised-controlled-trial-examining-the-effect-of-acupuncture-at-the-ex-hn3-yintang-point-on-pre-operative-anxiety-levels-in-neurosurgical-patients
#5
M D Wiles, J Mamdani, M Pullman, J C Andrzejowski
Pre-operative anxiety is an unpleasant state of psychological distress that occurs in up to 87% of patients awaiting neurosurgical procedures. Sedative medication is undesirable in this population due to the need for early postoperative neurological assessment. Acupuncture has previously been shown to reduce pre-operative anxiety, but studies involving neurosurgical patients are lacking. This single-centre, prospective, randomised controlled trial was designed to determine the effect of acupuncture at the EX-HN3 (Yintang point) on pre-operative anxiety levels in neurosurgical patients...
January 16, 2017: Anaesthesia
https://www.readbyqxmd.com/read/28092012/results-of-a-randomized-controlled-trial-analyzing-telemedically-supported-case-management-in-the-first-year-after-living-donor-kidney-transplantation-a-budget-impact-analysis-from-the-healthcare-perspective
#6
Klaus Kaier, Silvia Hils, Stefan Fetzer, Philip Hehn, Anja Schmid, Dieter Hauschke, Lioudmila Bogatyreva, Bernd Jänigen, Przemyslaw Pisarski
: ᅟ: We analyze one-year costs and savings of a telemedically supported case management program after kidney transplantation from the perspective of the German Healthcare System. Recipients of living donor kidney transplantation (N = 46) were randomly allocated to either (1) standard aftercare or (2) standard aftercare plus additional telemedically supported case management. A range of cost figures of each patient's medical service utilization were calculated at month 3, 6 and 12 and analyzed using two-part regression models...
December 2017: Health Economics Review
https://www.readbyqxmd.com/read/28091825/preoperative-sport-improves-the-outcome-of-lumbar-disc-surgery-a-prospective-monocentric-cohort-study
#7
Anja Tschugg, Sara Lener, Sebastian Hartmann, Matthias Wildauer, Wolfgang N Löscher, Sabrina Neururer, Claudius Thomé
A lumbar disc herniation resulting in surgery may be an incisive event in a patient's everyday life. The patient's recovery after sequestrectomy may be influenced by several factors. There is evidence that regular physical activity can lower pain perception and improve the outcome after surgery. For this purpose, we hypothesized that patients performing regular sports prior to lumbar disc surgery might have less pain perception and disability thereafter. Fifty-two participants with a single lumbar disc herniation confirmed on MRI treated by a lumbar sequestrectomy were included in the trial...
January 13, 2017: Neurosurgical Review
https://www.readbyqxmd.com/read/28091532/development-of-the-neuroimmune-modulator-ibudilast-for-the-treatment-of-alcoholism-a-randomized-placebo-controlled-human-laboratory-trial
#8
Lara A Ray, Spencer Bujarski, Steve Shoptaw, Daniel Jo Roche, Keith Heinzerling, Karen Miotto
Current directions in medication development for alcohol use disorder (AUD) emphasize the need to identify novel molecular targets and efficiently screen new compounds aimed at those targets. Ibudilast (IBUD) is a neuroimmune modulator that inhibits phosphodiesterases -4 and -10 and macrophage migration inhibitory factor and was recently found to reduce alcohol intake in rats by approximately 50%. To advance medications development for AUD, the present study consists of a randomized, crossover, double-blind, placebo-controlled laboratory study of IBUD in non-treatment seeking individuals with current (ie, past month) mild-to-severe AUD...
January 16, 2017: Neuropsychopharmacology: Official Publication of the American College of Neuropsychopharmacology
https://www.readbyqxmd.com/read/28090731/addition-of-ezetimibe-to-statins-for-patients-at-high-cardiovascular-risk-systematic-review-of-patient-important-outcomes
#9
REVIEW
Yutong Fei, Gordon Henry Guyatt, Paul Elias Alexander, Regina El Dib, Reed A C Siemieniuk, Per Olav Vandvik, Mark E Nunnally, Huda Gomaa, Rebecca L Morgan, Arnav Agarwal, Ying Zhang, Neera Bhatnagar, Frederick A Spencer
Ezetimibe is widely used in combination with statins to reduce low-density lipoprotein. We sought to examine the impact of ezetimibe when added to statins on patient-important outcomes. Medline, EMBASE, CINAHL, and CENTRAL were searched through July, 2016. Randomized controlled trials (RCTs) of ezetimibe combined with statins versus statins alone that followed patients for at least 6 months and reported on at least one of all-cause mortality, cardiovascular deaths, non-fatal myocardial infarctions (MI), and non-fatal strokes were included...
January 16, 2017: Journal of Evaluation in Clinical Practice
https://www.readbyqxmd.com/read/28090652/a-systematic-review-of-the-analgesic-efficacy-of-cannabinoid-medications-in-the-management-of-acute-pain
#10
REVIEW
A J Stevens, M D Higgins
BACKGROUND: Cannabinergic medications have been postulated to demonstrate efficacy in the management of pain. The aim of this systematic review was to assess the analgesic efficacy and adverse effects of cannabinoids when used for the management of acute pain. METHODS: A systematic review was performed by searching the MEDLINE, EMBASE and CENTRAL databases, and the World Health Organization International Clinical Trials Registry Platform for human randomized controlled trials that assessed the analgesic efficacy of cannabinoids compared to placebo or active comparators...
January 16, 2017: Acta Anaesthesiologica Scandinavica
https://www.readbyqxmd.com/read/28090299/tadalafil-therapy-for-sarcoidosis-associated-pulmonary-hypertension
#11
H J Ford, R P Baughman, R Aris, P Engel, J F Donohue
Sarcoidosis-associated pulmonary hypertension (SAPH) is estimated to occur in at least 5% or more of sarcoidosis patients, and it contributes to significant morbidity and mortality. Optimal therapy for SAPH is not well established. We performed a 24-week open-label trial of tadalafil for SAPH at 2 academic medical centers. Subjects were required to have confirmed sarcoidosis plus a right heart catheterization within 12 months of enrollment showing a mean pulmonary artery pressure ≥ 25 mmHg, a pulmonary artery wedge pressure ≤ 15 mmHg, and a calculated pulmonary vascular resistance ≥ 3 Wood units...
December 2016: Pulmonary Circulation
https://www.readbyqxmd.com/read/28090294/the-effects-of-pulmonary-vasodilating-agents-on-right-ventricular-parameters-in-severe-group-3-pulmonary-hypertension-a-pilot-study
#12
Takahiro Sato, Ichizo Tsujino, Ayako Sugimoto, Toshitaka Nakaya, Taku Watanabe, Hiroshi Ohira, Masaru Suzuki, Satoshi Konno, Noriko Oyama-Manabe, Masaharu Nishimura
Pulmonary arterial hypertension (PAH)-approved vasodilators improve right ventricular (RV) function in patients with PAH. However, whether PAH-approved drugs ameliorate RV morphology and function in lung disease-associated pulmonary hypertension (lung-PH) remains unclear. We aimed to prospectively evaluate the changes in RV volume and ejection fraction (RVEF) in 14 consecutive severe lung-PH patients treated with PAH-approved vasodilators. Severe lung-PH was defined as a mean pulmonary arterial pressure (MPAP) of ≥35 mmHg or an MPAP of ≥25 mmHg with a cardiac index (L/min/m(2)) of <2...
December 2016: Pulmonary Circulation
https://www.readbyqxmd.com/read/28090010/long-term-outcomes-after-percutaneous-lower-extremity-arterial-interventions-with-atherectomy-vs-balloon-angioplasty%C3%A3-propensity-score-matched-registry
#13
Adam Janas, Piotr P Buszman, Krzysztof P Milewski, Szymon Wiernek, Ksenia Janas, Maciej Pruski, Wojciech Wojakowski, Aleksandra Błachut, Wojciech Picheta, Pawel Buszman, Stefan Kiesz
BACKGROUND: The impact of endovascular revascularization of the lower extremity arteries with atherectomy (AT) compared with percutaneous transluminal angioplasty (PTA) is still unclear. Therefore, the aim of the study was to compare long-term outcomes after percutaneous PTA and AT in patients requiring endovascular revascularization.Methods and Results:This was a single-center, retrospective registry of obstructive and symptomatic PAD patients who underwent endovascular revascularization...
January 14, 2017: Circulation Journal: Official Journal of the Japanese Circulation Society
https://www.readbyqxmd.com/read/28089984/achieving-consensus-on-total-joint-replacement-trial-outcome-reporting-using-the-omeract-filter-endorsement-of-the-final-core-domain-set-for-total-hip-and-total-knee-replacement-trials-for-endstage-arthritis
#14
Jasvinder A Singh, Michelle M Dowsey, Michael Dohm, Susan M Goodman, Amye L Leong, Marieke M J H Scholte Voshaar, Peter F Choong
OBJECTIVE: Discussion and endorsement of the OMERACT total joint replacement (TJR) core domain set for total hip replacement (THR) and total knee replacement (TKR) for endstage arthritis; and next steps for selection of instruments. METHODS: The OMERACT TJR working group met at the 2016 meeting at Whistler, British Columbia, Canada. We summarized the previous systematic reviews, the preliminary OMERACT TJR core domain set and results from previous surveys. We discussed preliminary core domains for TJR clinical trials, made modifications, and identified challenges with domain measurement...
January 15, 2017: Journal of Rheumatology
https://www.readbyqxmd.com/read/28089709/objective-assessment-of-dietary-patterns-by-use-of-metabolic-phenotyping-a-randomised-controlled-crossover-trial
#15
Isabel Garcia-Perez, Joram M Posma, Rachel Gibson, Edward S Chambers, Tue H Hansen, Henrik Vestergaard, Torben Hansen, Manfred Beckmann, Oluf Pedersen, Paul Elliott, Jeremiah Stamler, Jeremy K Nicholson, John Draper, John C Mathers, Elaine Holmes, Gary Frost
BACKGROUND: Accurate monitoring of changes in dietary patterns in response to food policy implementation is challenging. Metabolic profiling allows simultaneous measurement of hundreds of metabolites in urine, the concentrations of which can be affected by food intake. We hypothesised that metabolic profiles of urine samples developed under controlled feeding conditions reflect dietary intake and can be used to model and classify dietary patterns of free-living populations. METHODS: In this randomised, controlled, crossover trial, we recruited healthy volunteers (aged 21-65 years, BMI 20-35 kg/m(2)) from a database of a clinical research unit in the UK...
January 12, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28089562/sequential-multiple-assignment-randomized-trials-an-opportunity-for-improved-design-of-stroke-reperfusion-trials
#16
William J Meurer, Nicholas J Seewald, Kelley Kidwell
BACKGROUND: Modern clinical trials in stroke reperfusion fall into 2 categories: alternative systemic pharmacological regimens to alteplase and "rescue" endovascular approaches using targeted thrombectomy devices and/or medications delivered directly for persistently occluded vessels. Clinical trials in stroke have not evaluated how initial pharmacological thrombolytic management might influence subsequent rescue strategy. A sequential multiple assignment randomized trial (SMART) is a novel trial design that can test these dynamic treatment regimens and lead to treatment guidelines that more closely mimic practice...
January 12, 2017: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
https://www.readbyqxmd.com/read/28089473/box-or-virtual-reality-trainer-which-tool-results-in-better-transfer-of-laparoscopic-basic-skills-a-prospective-randomized-trial
#17
Christian Brinkmann, Mathias Fritz, Ulrich Pankratius, Ralf Bahde, Philipp Neumann, Steffen Schlueter, Norbert Senninger, Emile Rijcken
OBJECTIVE: Simulation training improves laparoscopic performance. Laparoscopic basic skills can be learned in simulators as box- or virtual-reality (VR) trainers. However, there is no clear recommendation for either box or VR trainers as the most appropriate tool for the transfer of acquired laparoscopic basic skills into a surgical procedure. DESIGN: Both training tools were compared, using validated and well-established curricula in the acquirement of basic skills, in a prospective randomized trial in a 5-day structured laparoscopic training course...
January 12, 2017: Journal of Surgical Education
https://www.readbyqxmd.com/read/28089286/historical-perspective-on-the-medical-use-of-cannabis-for-epilepsy-ancient-times-to-the-1980s
#18
REVIEW
Daniel Friedman, Joseph I Sirven
There has been a dramatic surge in the interest of utilizing cannabis for epilepsy treatment in the US. Yet, access to cannabis for research and therapy is mired in conflicting regulatory policies and shifting public opinion. Understanding the current state of affairs in the medical cannabis debate requires an examination of the history of medical cannabis use. From ancient Chinese pharmacopeias to the current Phase III trials of pharmaceutical grade cannabidiol, this review covers the time span of cannabis use for epilepsy therapy so as to better assess the issues surrounding the modern medical opinion of cannabis use...
January 11, 2017: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/28089247/-mid-gut-neuroendocrine-tumors-news-on-medical-treatment
#19
Marie Dior, Johann Dreanic, Caroline Prieux-Klotz, Bertrand Brieau, Catherine Brezault, Romain Coriat
CONTEXT: Mid gut neuroendocrine tumors (NET) are rare tumors whose incidence is increasing. Curative surgery remains the gold standard for the treatment of NETs of the small intestine. Surgery should be considered as soon as possible even if a metastatic stage is diagnosed. The management of unresectable well-differentiated metastatic NETs of the small intestine recently changed with the publication of trials demonstrating the benefit of targeted therapies and metabolic radiotherapy, leading to a change of practices and update of French and international recommendations...
January 11, 2017: La Presse Médicale
https://www.readbyqxmd.com/read/28089200/limitations-of-the-current-standards-of-care-for-treating-gout-and-crystal-deposition-in-the-primary-care-setting-a-review
#20
Robert T Keenan
PURPOSE: This article outlines several important issues regarding the management of patients with gout. The topics discussed include best practices for gout based on the most current guidelines, opportunities for improving gout management, and current and emerging therapies for gout. METHODS: [PubMed and Google Scholar databases] were search for all articles and trials published before 2016, using the key terms [hyperuricemia, gout, tophi, joint erosion, joint damage, treatment guidelines, American College of Rheumatology (ACR), European League Against Rheumatism (EULAR), flare, comorbidity, epidemiology, adherence, serum uric acid (sUA), monosodium urate (MSU), <6 mg/dL, MSU crystal formation, as well as individual drug names and classes of treatments of interest (allopurinol, febuxostat, colchicine, non-steroidal anti-inflammatories (NSAIDs)]...
January 11, 2017: Clinical Therapeutics
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