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https://www.readbyqxmd.com/read/27911471/the-effects-of-coenzyme-q10-supplementation-on-glucose-metabolism-and-lipid-profiles-in-women-with-polycystic-ovary-syndrome-a-randomized-double-blind-placebo-controlled-trial
#1
Mansooreh Samimi, Maryam Zarezade Mehrizi, Fatemeh Foroozanfard, Hossein Akbari, Mehri Jamilian, Shahnaz Ahmadi, Zatollah Asemi
BACKGROUND: Data on the effects of coenzyme Q10 (CoQ10) supplementation on metabolic profiles among subjects with polycystic ovary syndrome (PCOS) are scarce. OBJECTIVE: This study was done to evaluate the effects of CoQ10 supplementation on glucose metabolism and lipid profiles in subjects with PCOS. DESIGN, PATIENTS AND MEASUREMENTS: This randomized double-blind, placebo-controlled trial was conducted on 60 women diagnosed with PCOS. Subjects were randomly assigned into two groups to intake either 100 mg CoQ10 supplements (N=30) or placebo (N=30) per day for 12 weeks...
December 2, 2016: Clinical Endocrinology
https://www.readbyqxmd.com/read/27911344/patient-perspectives-on-deep-brain-stimulation-clinical-research-in-early-stage-parkinson-s-disease
#2
Lauren Heusinkveld, Mallory Hacker, Maxim Turchan, Madelyn Bollig, Christina Tamargo, William Fisher, Lauren McLaughlin, Adria Martig, David Charles
The FDA approved a multicenter, double-blind, Phase III, pivotal trial testing deep brain stimulation in 280 people with very early stage Parkinson's disease (PD; IDE#G050016). In partnership with The Michael J. Fox Foundation for Parkinson's Research, we conducted a survey to investigate motivating factors, barriers, and gender differences for participation in a trial testing DBS in early PD. The majority of survey respondents (72%) indicated they would consider learning more about participating. Men and women with early PD are likely to consider enrolling in trials of invasive therapies that may slow symptom progression and help future patients...
November 30, 2016: Journal of Parkinson's Disease
https://www.readbyqxmd.com/read/27910156/ixekizumab-treatment-improves-fingernail-psoriasis-in-patients-with-moderate-to-severe-psoriasis-results-from-the-randomized-controlled-and-open-label-phases-of-uncover-3
#3
P van de Kerkhof, L Guenther, A B Gottlieb, M Sebastian, J J Wu, P Foley, A Morita, O Goldblum, L Zhang, J Erickson, S Ball, P Rich
BACKGROUND: Fingernail psoriasis is difficult to treat. OBJECTIVE: The objective was to evaluate the effect of ixekizumab, a monoclonal antibody selectively targeting IL-17A, on fingernail psoriasis. METHODS: This Phase 3, double-blind trial (UNCOVER-3) randomized patients to placebo, etanercept (50-mg twice weekly), or 80 mg ixekizumab as one injection every 4 (IXE Q4W) or 2 weeks (IXE Q2W) after a 160-mg starting dose. At Week 12, ixekizumab patients received open-label IXE Q4W through Week 60; placebo patients received a 160-mg starting ixekizumab dose and etanercept patients a 4-week placebo washout before starting IXE Q4W...
November 5, 2016: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/27910150/randomised-clinical-trial-exploratory-phase-2-study-of-ono-2952-in-diarrhoea-predominant-irritable-bowel-syndrome
#4
W E Whitehead, K Duffy, J Sharpe, T Nabata, M Bruce
BACKGROUND: ONO-2952 is a novel and selective inhibitor of translocator protein 18 kDa that reduces stress-induced defecation and visceral hyperalgesia in rat models. AIM: To evaluate the efficacy and safety of ONO-2952 in females with irritable bowel syndrome with diarrhoea in an exploratory proof-of-concept study. METHODS: A randomised, double-blind, placebo-controlled study was conducted at 49 US centres. Two hundred subjects with irritable bowel syndrome with diarrhoea (Rome III criteria) were randomised to ONO-2952 20 mg, or 60 mg, or placebo...
January 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/27909781/the-ability-of-low-magnitude-mechanical-signals-to-normalize-bone-turnover-in-adolescents-hospitalized-for-anorexia-nervosa
#5
A D DiVasta, H A Feldman, C T Rubin, J S Gallagher, N Stokes, D P Kiel, B D Snyder, C M Gordon
: We sought to determine whether low-magnitude mechanical stimulation (LMMS) normalizes bone turnover among adolescents hospitalized for anorexia nervosa (AN). Brief, daily LMMS prevents the decline in bone turnover typically seen during bed rest in AN. LMMS may have application for patients with AN in the inpatient setting to protect bone health. INTRODUCTION: Malnourished adolescents with AN requiring medical hospitalization are at high risk for rapid reduction in skeletal quality...
December 1, 2016: Osteoporosis International
https://www.readbyqxmd.com/read/27909175/psilocybin-promising-results-in-double-blind-trials-require-confirmation-by-real-world-evidence
#6
Alasdair Breckenridge, Diederick E Grobbee
No abstract text is available yet for this article.
December 2016: Journal of Psychopharmacology
https://www.readbyqxmd.com/read/27909165/psilocybin-produces-substantial-and-sustained-decreases-in-depression-and-anxiety-in-patients-with-life-threatening-cancer-a-randomized-double-blind-trial
#7
Roland R Griffiths, Matthew W Johnson, Michael A Carducci, Annie Umbricht, William A Richards, Brian D Richards, Mary P Cosimano, Margaret A Klinedinst
: Cancer patients often develop chronic, clinically significant symptoms of depression and anxiety. Previous studies suggest that psilocybin may decrease depression and anxiety in cancer patients. The effects of psilocybin were studied in 51 cancer patients with life-threatening diagnoses and symptoms of depression and/or anxiety. This randomized, double-blind, cross-over trial investigated the effects of a very low (placebo-like) dose (1 or 3 mg/70 kg) vs. a high dose (22 or 30 mg/70 kg) of psilocybin administered in counterbalanced sequence with 5 weeks between sessions and a 6-month follow-up...
December 2016: Journal of Psychopharmacology
https://www.readbyqxmd.com/read/27909164/rapid-and-sustained-symptom-reduction-following-psilocybin-treatment-for-anxiety-and-depression-in-patients-with-life-threatening-cancer-a-randomized-controlled-trial
#8
Stephen Ross, Anthony Bossis, Jeffrey Guss, Gabrielle Agin-Liebes, Tara Malone, Barry Cohen, Sarah E Mennenga, Alexander Belser, Krystallia Kalliontzi, James Babb, Zhe Su, Patricia Corby, Brian L Schmidt
BACKGROUND: Clinically significant anxiety and depression are common in patients with cancer, and are associated with poor psychiatric and medical outcomes. Historical and recent research suggests a role for psilocybin to treat cancer-related anxiety and depression. METHODS: In this double-blind, placebo-controlled, crossover trial, 29 patients with cancer-related anxiety and depression were randomly assigned and received treatment with single-dose psilocybin (0...
December 2016: Journal of Psychopharmacology
https://www.readbyqxmd.com/read/27909139/safety-and-efficacy-of-sbi-087-a-subcutaneous-agent-for-b-cell-depletion-in-patients-with-active-rheumatoid-arthritis-results-from-a-phase-ii-randomized-double-blind-placebo-controlled-study
#9
Nemanja Damjanov, Malgorzata Tlustochowicz, Jacob Aelion, Maria Greenwald, Annette Diehl, Indranil Bhattacharya, Elena Peeva, Sandeep Menon, Ian Gourley
OBJECTIVE: To evaluate subcutaneous SBI-087 to treat rheumatoid arthritis (RA). METHODS: A total of 210 adult patients with active RA were randomized to receive either 200 mg SBI-087 or placebo (Pbo), according to one of these patterns: SBI/Pbo/Pbo (SBI on Day 1), SBI/SBI/Pbo (SBI days 1 and 15), SBI/Pbo/SBI (SBI days 1 and 84), SBI/SBI/SBI (SBI days 1, 15, and 84), or Pbo/Pbo/Pbo (Pbo all 3 days). All patients were seropositive and taking background methotrexate...
December 2016: Journal of Rheumatology
https://www.readbyqxmd.com/read/27909081/five-year-efficacy-and-safety-of-tocilizumab-monotherapy-in-patients-with-rheumatoid-arthritis-who-were-methotrexate-and-biologic-naive-or-free-of-methotrexate-for-6-months-the-ambition-study
#10
Graeme Jones, Thomas Wallace, Matthew J McIntosh, Laura Brockwell, Juan J Gómez-Reino, Anthony Sebba
OBJECTIVE: To report on the 5-year efficacy and safety results of the AMBITION (Actemra versus Methotrexate double-Blind Investigative Trial In mONotherapy) monotherapy study (ClinicalTrials.gov: NCT00109408, NCT00720798). METHODS: Patients with rheumatoid arthritis for whom biologics had not failed or who did not discontinue methotrexate because of lack of efficacy or tolerability were followed up for 5 years to assess the efficacy and serious adverse events (SAE) of tocilizumab (TCZ) monotherapy...
December 1, 2016: Journal of Rheumatology
https://www.readbyqxmd.com/read/27908567/the-effect-of-topical-5-flurouracil-application-post-endoscopic-inferior-turbinoplasty
#11
Amjad F Nuseir, Mohammad Alsalem, Mouhamad Alzahr, Muthanna Ababneh, Ahmad I Alomari, Firas Alzoubi
RATIONALE AND OBJECTIVES: Adhesions are the most common complication after nasal surgery and revision. 5-Fluorouracil (5-FU) reduces various adhesions and epithelial growth related complications. The aim of this study was to evaluate the effects of 5-flurouracil application in the nasal cavity after a multi-procedure nasal surgery in term of complications frequency. MATERIALS AND METHODOLOGY: Institutional ethical approval was granted and a double-blinded prospective clinical trial was conducted to study the effect of 5-fu on post-operative complications...
November 23, 2016: American Journal of Otolaryngology
https://www.readbyqxmd.com/read/27908454/fulvestrant-500-mg-versus-anastrozole-1-mg-for-hormone-receptor-positive-advanced-breast-cancer-falcon-an-international-randomised-double-blind-phase-3-trial
#12
John F R Robertson, Igor M Bondarenko, Ekaterina Trishkina, Mikhail Dvorkin, Lawrence Panasci, Alexey Manikhas, Yaroslav Shparyk, Servando Cardona-Huerta, Kwok-Leung Cheung, Manuel Jesus Philco-Salas, Manuel Ruiz-Borrego, Zhimin Shao, Shinzaburo Noguchi, Jacqui Rowbottom, Mary Stuart, Lynda M Grinsted, Mehdi Fazal, Matthew J Ellis
BACKGROUND: Aromatase inhibitors are a standard of care for hormone receptor-positive locally advanced or metastatic breast cancer. We investigated whether the selective oestrogen receptor degrader fulvestrant could improve progression-free survival compared with anastrozole in postmenopausal patients who had not received previous endocrine therapy. METHODS: In this phase 3, randomised, double-blind trial, we recruited eligible patients with histologically confirmed oestrogen receptor-positive or progesterone receptor-positive, or both, locally advanced or metastatic breast cancer from 113 academic hospitals and community centres in 20 countries...
November 28, 2016: Lancet
https://www.readbyqxmd.com/read/27908281/health-technology-assessment-of-drugs-for-rare-diseases-insights-trends-and-reasons-for-negative-recommendations-from-the-cadth-common-drug-review
#13
REVIEW
Ghayath Janoudi, William Amegatse, Brendan McIntosh, Chander Sehgal, Trevor Richter
BACKGROUND: A shift in biochemical research towards drugs for rare diseases has created new challenges for the pharmaceutical industry, government regulators, health technology assessment agencies, and public and private payers. In this article, we aim to comprehensively review, characterize, identify possible trends, and explore reasons for negative reimbursement recommendations in submissions made to the Common Drug Review (CDR) for drugs for rare diseases (DRD) at the Canadian Agency for Drugs and Technologies in Health (CADTH), a publicly funded pan-Canadian health technology assessment agency...
December 1, 2016: Orphanet Journal of Rare Diseases
https://www.readbyqxmd.com/read/27907978/comparison-of-the-single-dose-pharmacokinetics-pharmacodynamics-and-safety-of-two-novel-oral-formulations-of-dimethandrolone-undecanoate-dmau-a-potential-oral-male-contraceptive
#14
R Ayoub, S T Page, R S Swerdloff, P Y Liu, J K Amory, A Leung, L Hull, D Blithe, A Christy, J H Chao, W J Bremner, C Wang
Dimethandrolone (DMA, 7α,11β-dimethyl-19-nortestosterone) has both androgenic and progestational activities, ideal properties for a male hormonal contraceptive. In vivo, dimethandrolone undecanoate (DMAU) is hydrolyzed to DMA. We showed previously that single oral doses of DMAU powder in capsule taken with food are well tolerated and effective at suppressing both LH and testosterone (T), but absorption was low. We compared the pharmacokinetics and pharmacodynamics of two new formulations of DMAU, in castor oil and in self-emulsifying drug delivery systems (SEDDS), with the previously tested powder formulation...
December 1, 2016: Andrology
https://www.readbyqxmd.com/read/27906937/transversus-abdominis-plane-block-in-the-management-of-acute-postoperative-pain-syndrome-after-caesarean-section-a-randomized-controlled-clinical-trial
#15
Pierfrancesco Fusco, Vincenza Cofini, Emiliano Petrucci, Paolo Scimia, Tullio Pozone, Giuseppe Paladini, Gaspare Carta, Stefano Necozione, Battista Borghi, Franco Marinangeli
BACKGROUND: The international literature is unclear regarding the analgesic efficacy of the transversus abdominis plane block (TAPB) after a Caesarean section (CS). OBJECTIVES: The aim of this study was to determine whether a correctly performed ultrasound-guided TAPB (USG-TAPB) could provide better control of acute postoperative pain during the first 72 hours after CS and if it could provide a faster postoperative recovery. STUDY DESIGN: A double-blind, randomized, controlled clinical trial on pregnant women who underwent CS...
November 2016: Pain Physician
https://www.readbyqxmd.com/read/27906936/analgesic-effect-of-nalbuphine-when-added-to-intravenous-regional-anesthesia-a-randomized-control-trial
#16
Mohamed Hassan Bakri, Eman Ahmed Ismail, Sayed Kaoud Abd-Elshafy
BACKGROUND: Different adjuvant drugs are currently added to lidocaine for intravenous regional anesthesia (IVRA) to decrease tourniquet and postoperative pain. OBJECTIVE: The aim of the study was to examine the effect of nalbuphine when added toIVRA. STUDY DESIGN: Prospective, randomized, double-blind, controlled clinical trial. SETTING: Assiut University Hospitals. METHODS: One hundred-six adult patients scheduled for unilateral hand surgery under IVRA were randomized into 2 equal groups...
November 2016: Pain Physician
https://www.readbyqxmd.com/read/27906935/long-term-prednisolone-in-post-stroke-complex-regional-pain-syndrome
#17
Jayantee Kalita, Usha Misra, Ajit Kumar, Sanjeev K Bhoi
BACKGROUND: There is no study on the long-term use of prednisolone in post-stroke complex regional pain syndrome-1 (CRPS1). OBJECTIVE: To evaluate the efficacy and safety of long-term low dose prednisolone in post-stroke CRPS-I. STUDY DESIGN: Open-labeled randomized controlled trial. SETTING: Tertiary care teaching institute. METHODS: Seventy-seven out of 396 (19.4%) patients with stroke had CRPS-1 and 58 met the inclusion criteria...
November 2016: Pain Physician
https://www.readbyqxmd.com/read/27906839/endothelin-contributes-to-the-blood-pressure-rise-triggered-by-hypoxia-in-severe-obstructive-sleep-apnea
#18
Christophe Janssen, Atul Pathak, Guido Grassi, Philippe van de Borne
BACKGROUND: Obstructive sleep apnea (OSA) is strongly correlated with an increased risk of systemic hypertension. However, the link between systemic hypertension and nocturnal apneas remains incompletely understood. Animal studies suggest an implication of the endothelin system. The aim of the present study is to determine if endogenous endothelin plays a role in the increase in blood pressure observed during hypoxic episodes in OSA patients, in addition to peripheral chemoreflex and neural sympathetic activation...
January 2017: Journal of Hypertension
https://www.readbyqxmd.com/read/27906800/lactobacillus-reuteri-dsm-17938-in-the-treatment-of-functional-abdominal-pain-in-children-rct-study
#19
Oleg Jadrešin, Iva Hojsak, Zrinjka Mišak, Alemka Jaklin Kekez, Tena Trbojević, Lana Ivković, Sanja Kolaček
OBJECTIVES: Beneficial therapeutic effect of probiotics has been reported in children with the irritable bowel syndrome (IBS) but not consistently in other functional abdominal pain-related disorders. The aim of this study was to investigate the effect of Lactobacillus (L.) reuteri DSM 17938 in the treatment of functional abdominal pain (FAP) and IBS in children. METHODS: Children (age 4-18 years) referred to pediatric gastroenterologist at Children's Hospital Zagreb from May 2012 to December 2014, diagnosed as FAP or IBS, were randomized to receive L...
November 30, 2016: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/27905884/the-efficacy-of-pivmecillinam-3%C3%A2-days-or-5%C3%A2-days%C3%A2-t-i-d-against-community-acquired-uncomplicated-lower-urinary-tract-infections-a-randomized-double-blinded-placebo-controlled-clinical-trial-study-protocol
#20
Filip Jansåker, Niels Frimodt-Møller, Lars Bjerrum, Jenny Dahl Knudsen
BACKGROUND: Uncomplicated lower urinary tract infections (LUTI) are very common, and presumably around 200,000 female patients are treated for this annually in Denmark. The current Danish national clinical practice guidelines recommend pivmecillinam as a first-line drug (i.e., 400 mg t.i.d. for 3 days). Pivmecillinam is also one of the first-line drugs recommended in the international guidelines for LUTIs (i.e., 400 mg b.i.d. for 5 days). The international recommended duration is based on evidence saying that a 7-day regimen is better than a 3-day regimen...
December 1, 2016: BMC Infectious Diseases
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