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Randomized double blinded controlled studies

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https://www.readbyqxmd.com/read/28634219/early-use-of-n-acetylcysteine-nac-with-nitrate-therapy-in-patients-undergoing-primary-percutaneous-coronary-intervention-for-st-segment-elevation-myocardial-infarction-reduces-myocardial-infarct-size-the-naciam-trial
#1
Sivabaskari Pasupathy, Rosanna Tavella, Suchi Grover, Betty Raman, Nathan E K Procter, Yang T Du, Gnanadevan Mahadavan, Irene Stafford, Tamila Heresztyn, Andrew Holmes, Christopher Zeitz, Margaret Arstall, Joseph B Selvanayagam, John D Horowitz, John F Beltrame
Background -Contemporary ST-elevation myocardial infarction (STEMI) management involves primary percutaneous coronary intervention (PCI) with on-going studies focusing on infarct size reduction utilizing ancillary therapies. N-acetylcysteine (NAC) is an antioxidant with reactive oxygen species scavenging properties that also potentiates the effects of nitroglycerin (NTG) and thus represents a potentially beneficial ancillary therapy in primary PCI. The NACIAM (NACIn Acute Myocardial infarction) trial examined the effects of NAC on infarct size in STEMI patients undergoing PCI...
June 20, 2017: Circulation
https://www.readbyqxmd.com/read/28634000/dose-dependent-effects-of-abobotulinumtoxina-dysport%C3%A2-on-spasticity-and-active-movements-in-adults-with-upper-limb-spasticity-secondary-analysis-of-a-phase-3-study
#2
Michael W O'Dell, Allison Brashear, Robert Jech, Thierry Lejeune, Philippe Marque, Djamel Bensmail, Ziyad Ayyoub, David M Simpson, Magali Volteau, Claire Vilain, Philippe Picaut, Jean Michel Gracies
BACKGROUND: AbobotulinumtoxinA has beneficial effects on spasticity and active movements in hemiparetic adults with upper limb spasticity (ULS). However, evidence-based information on optimal dosing for clinical use is limited. OBJECTIVE: To describe joint-specific dose effects of abobotulinumtoxinA in adults with ULS. DESIGN: Secondary analysis of a phase 3 study (NCT01313299). SETTING: Multi-center, international, double-blind, placebo-controlled clinical trial...
June 17, 2017: PM & R: the Journal of Injury, Function, and Rehabilitation
https://www.readbyqxmd.com/read/28633147/tranexamic-acid-safely-reduced-blood-loss-in-hemi-and-total-hip-arthroplasty-for-acute-femoral-neck-fracture-a-randomized-clinical-trial
#3
Chad D Watts, Matthew T Houdek, S Andrew Sems, William W Cross, Mark W Pagnano
OBJECTIVES: We aimed to determine whether (1) tranexamic acid (TXA) reduces the incidence of transfusion (2) TXA reduces the calculated blood loss, and (3) there are any observable differences in 30- and 90-day complications with TXA administration during arthroplasty for femoral neck fracture (FNF). DESIGN: Prospective, double-blinded, randomized controlled trial. SETTING: Level 1 Academic Trauma Center. PATIENTS/PARTICIPANTS: One hundred thirty-eight patients who presented with a low-energy, isolated, FNF (AO 31B) treated with either hemi- or total hip arthroplasty within 72 hours of injury were randomized to either the TXA group (69 patients) or placebo group (69 patients)...
July 2017: Journal of Orthopaedic Trauma
https://www.readbyqxmd.com/read/28632557/vertebral-end-plate-perforation-for-intervertebral-disc-height-preservation-after-single-level-lumbar-discectomy-a-randomized-controlled-trial
#4
Miha Vodičar, Robert Košak, Matevž Gorenšek, Robert Korez, Tomaž Vrtovec, Jadran Koder, Vane Antolič, Rok Vengust
STUDY DESIGN: Pilot single-centre, stratified, prospective, randomized, double-blinded, parallel-group, controlled study. OBJECTIVE: To determine whether vertebral end-plate perforation after lumbar discectomy causes annulus reparation and intervertebral disc volume restoration. To determine that after 6 months there would be no clinical differences between the control and study group. SUMMARY OF BACKGROUND DATA: Low back pain is the most common long-term complication after lumbar discectomy...
July 2017: Clinical Spine Surgery
https://www.readbyqxmd.com/read/28632527/assessment-of-postoperative-analgesic-drug-efficacy-method-of-data-analysis-is-critical
#5
Lars Peter Kloster Andersen, Ismail Gögenur, Henrik Torup, Jacob Rosenberg, Mads Utke Werner
BACKGROUND: Pain intensity ratings and opioid consumption (OC) are ubiquitous indicators of pain in postoperative trials of the efficacy of interventional procedures. Unfortunately, consensus on the appropriate statistical handling of these outcomes has not been reached. The aim of this article was, therefore, to reexamine original data obtained from a postoperative analgesic drug trial, applying a collection of standard statistical methods in analgesic outcome assessments. Furthermore, a modified integrated assessment method of these outcomes was evaluated...
June 19, 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28631250/lactobacillus-salivarius-nk02-a-potent-probiotic-for-clinical-application-in-mouthwash
#6
Neda Sajedinejad, Mojgan Paknejad, Behzad Houshmand, Hakimeh Sharafi, Reza Jelodar, Hossein Shahbani Zahiri, Kambiz Akbari Noghabi
A specific strain of naturally occurring oral lactobacilli was isolated and identified based on morphological, biochemical, and 16S rRNA gene sequencing. The phylogenetic affiliation of the isolate confirmed that the NK02 strain had close association with the Lactobacillus salivarius. An effective mouthwash was developed for treatment of periodontitis and suppression of the indicator bacterium Aggregatibacter actinomycetemcomitans which is an obvious pathogen of periodontal disease. The mouthwash containing L...
June 19, 2017: Probiotics and Antimicrobial Proteins
https://www.readbyqxmd.com/read/28630573/effects-of-suspended-moxibustion-on-delayed-onset-muscle-soreness-a-randomized-controlled-double-blind-pilot-study
#7
Ding Meng, Dong Xiaosheng, Wang Xuhui, Wang Xu, Zhang Xijin
The objective of this study was to investigate the effects of suspended moxibustion upon tender point on delayed onset muscle soreness. The study was a randomized double-blind controlled trial with 50 subjects in each group. Subjects in moxibustion group received suspended moxibustion upon tender point (by palpation) twice. The controls received no treatment. Each subject received treatments twice, 24 hr and 48 hr after the delayed onset muscle soreness induction. The measurements of Pain Visual Analog Scale, maximum isometric muscle strength and circumference were made immediately after delayed onset muscle soreness induction, before and after every treatment session and 72 hr after delayed onset muscle soreness induction...
June 2017: Journal of Sports Science & Medicine
https://www.readbyqxmd.com/read/28629665/efficacy-and-safety-of-tofacitinib-monotherapy-tofacitinib-with-methotrexate-and-adalimumab-with-methotrexate-in-patients-with-rheumatoid-arthritis-oral-strategy-a-phase-3b-4-double-blind-head-to-head-randomised-controlled-trial
#8
Roy Fleischmann, Eduardo Mysler, Stephen Hall, Alan J Kivitz, Robert J Moots, Zhen Luo, Ryan DeMasi, Koshika Soma, Richard Zhang, Liza Takiya, Svitlana Tatulych, Christopher Mojcik, Sriram Krishnaswami, Sujatha Menon, Josef S Smolen
BACKGROUND: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. The Oral Rheumatoid Arthritis triaL (ORAL) Strategy aimed to assess the comparative efficacy of tofacitinib monotherapy, tofacitinib plus methotrexate, and adalimumab plus methotrexate for the treatment of rheumatoid arthritis in patients with a previous inadequate response to methotrexate. METHODS: ORAL Strategy was a 1 year, double-blind, phase 3b/4, head-to-head, non-inferiority, randomised controlled trial in patients aged 18 years or older with active rheumatoid arthritis despite methotrexate therapy...
June 15, 2017: Lancet
https://www.readbyqxmd.com/read/28629540/kinetics-and-dose-dependency-of-intranasal-oxytocin-effects-on-amygdala-reactivity
#9
Franny B Spengler, Johannes Schultz, Dirk Scheele, Maximiliane Essel, Wolfgang Maier, Markus Heinrichs, René Hurlemann
BACKGROUND: Current neuroimaging perspectives on a variety of mental disorders emphasize dysfunction of the amygdala. The neuropeptide oxytocin (OXT), a key mediator in the regulation of social cognition and behavior, accumulates in cerebrospinal fluid after intranasal administration in macaques and humans and modulates amygdala reactivity in both species. However, the translation of neuromodulatory OXT effects to novel treatment approaches is hampered by the absence of studies defining the most effective dose and dose-response latency for targeting the amygdala...
May 10, 2017: Biological Psychiatry
https://www.readbyqxmd.com/read/28628970/a-randomized-double-blind-clinical-study-on-blood-pressure-reduction-and-blood-lipid-profile-amelioration-on-treatment-with-ankascin-568
#10
Chien-Li Chen, Jen-Ho Tseng, Tzu-Ming Pan, Sheng-Huang Hsiao
Hypertension and cardiovascular complications are the leading causes of death worldwide. Antihypertensive drugs often cause various side effects, and improper use of antihypertensive medications can result in irreparable damage. Edible fungi of the Monascus species have been used as traditional Chinese medicines in Southeast Asia for several centuries. The fermented products of Monascus purpureus NTU 568 (ANKASCIN 568) possess a number of functional secondary metabolites including the anti-inflammatory pigments monascin and ankaflavin...
June 30, 2017: Chinese Journal of Physiology
https://www.readbyqxmd.com/read/28628810/gh-administration-decreases-subcutaneous-abdominal-adipocyte-size-in-men-with-abdominal-obesity
#11
Miriam A Bredella, Kalypso Karastergiou, Stijn A Bos, Anu V Gerweck, Martin Torriani, Susan K Fried, Karen K Miller
OBJECTIVE: To investigate the effects of short-term GH administration on abdominal subcutaneous adipocyte size and CT attenuation in men with abdominal obesity. DESIGN: 6-week, randomized, double-blind, placebo-controlled study of GH (starting dose 2μg/kg/d) vs placebo of 15 abdominally obese men (mean age: 34±6years; mean BMI: 37.7±6.1kg/m(2), mean IGF-1 SDS: -1.9±0.5) who underwent abdominal subcutaneous adipose tissue (SAT) aspirations to determine adipocyte size, CTs for body composition and measures of glucose tolerance at baseline and 6weeks...
June 12, 2017: Growth Hormone & IGF Research
https://www.readbyqxmd.com/read/28628374/effects-of-a-multispecies-probiotic-supplement-on-bone-health-in-osteopenic-postmenopausal-women-a-randomized-double-blind-controlled-trial
#12
Sadegh Jafarnejad, Kurosh Djafarian, Mohammad Reza Fazeli, Mir Saeed Yekaninejad, Abdolrahman Rostamian, Seyed Ali Keshavarz
OBJECTIVE: The development of alternative approaches to prevent and/or treat osteoporosis, as a chronic progressive bone disease, is being considered currently. Among dietary supplements, probiotics may have favorable effects on bone metabolism. Therefore, the aim of this study was to evaluate the effects of a multispecies probiotic supplementation on bone biomarkers and bone density in osteopenic postmenopausal women. METHODS: This randomized double-blind placebo-controlled clinical trial was performed on 50 patients with osteopenia aged 50-72 years...
June 19, 2017: Journal of the American College of Nutrition
https://www.readbyqxmd.com/read/28627732/the-acute-effect-of-loperamide-on-ileostomy-output-a-randomized-double-blinded-placebo-controlled-cross-over-study
#13
Katrine Kristensen, Niels Qvist
High stoma output is a common problem in patients with ileostomy and can lead to dehydration and electrolyte disturbances. The first drug of choice to reduce stoma output is often loperamide. The aim was to assess the acute effect of loperamide on (a) ileostomy output in g/day, (b) gastrointestinal transit time and (c) patient-reported effects. A total of 12 patients completed this double-blinded, randomized, placebo-controlled, cross-over study, consisting of a 3-day treatment period with loperamide 12 mg/day or placebo followed by the reverse after a washout period of 5-7 days...
June 19, 2017: Basic & Clinical Pharmacology & Toxicology
https://www.readbyqxmd.com/read/28627217/using-plantar-electrical-stimulation-to-improve-postural-balance-and-plantar-sensation-among-patients-with-diabetic-peripheral-neuropathy
#14
Bijan Najafi, Talal K Talal, Gurtej Singh Grewal, Robert Menzies, David G Armstrong, Lawrence A Lavery
OBJECTIVE: People with diabetic peripheral neuropathy (DPN) often exhibit deteriorations in motor-performance mainly due to lack of plantar-sensation. The study explored effectiveness of plantar electrical-stimulation therapy to enhance motor-performance among people with DPN. DESIGN AND METHODS: Using a double-blinded model, 28 volunteers with DPN (age: 57.8 ± 10.2 years) were recruited and randomized to either intervention (IG: n = 17) or control (CG: n = 11) group...
February 1, 2017: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/28627029/treatment-by-a-moisturizer-of-xerosis-and-cracks-of-the-feet-in-men-and-women-with-diabetes-a-randomized-double-blind-placebo-controlled-study
#15
H Gin, M Rorive, S Gautier, M Condomines, M Saint Aroman, E Garrigue
AIM: To evaluate a moisturizer containing urea, glycerine and petrolatum for healing deep open fissures on the feet of people with diabetes. If left untreated, open fissures, an entry point for bacteria, can lead to infection, ulceration and further complications. METHODS: This randomized, double-blind, multicentre study at 19 hospitals, general practices and diabetologists in France and Belgium included participants with diabetes and a deep open target fissure on their heel...
June 19, 2017: Diabetic Medicine: a Journal of the British Diabetic Association
https://www.readbyqxmd.com/read/28626868/intrathecal-dexamethasone-vs-meperidine-for-prevention-of-shivering-during-transurethral-prostatectomy-a-randomized-controlled-trial
#16
S M Moeen, A M Moeen
BACKGROUND: Shivering is a common complication after spinal anesthesia. Also, during transurethral prostatectomy a large amount of irrigating fluids is used which may cause hypothermia and shivering. We hypothesized that intrathecal dexamethasone could effectively attenuate post-spinal shivering following transurethral prostatectomy as intrathecal meperidine. METHODS: Ninety male patients, ASA II-III, 50-75 years old were included in this prospective and randomized double-blind study...
June 18, 2017: Acta Anaesthesiologica Scandinavica
https://www.readbyqxmd.com/read/28626468/efficacy-and-safety-of-mlc601-in-the-treatment-of-mild-cognitive-impairment-a-pilot-randomized-double-blind-placebo-controlled-study
#17
Hossein Pakdaman, Ali Amini Harandi, Mehdi Abbasi, Hosein Delavar Kasmaei, Farzad Ashrafi, Koroush Gharagozli, Farhad Assarzadegan, Behdad Behnam, Mehran Arabahmadi
BACKGROUND AND AIM: Mild cognitive impairment (MCI) is characterized by declined cognitive function greater than that expected for a person's age. The clinical significance of this condition is its possible progression to dementia. MLC601 is a natural neuroprotective medication that has shown promising effects in Alzheimer disease. Accordingly, we conducted this randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of MLC601 in MCI patients. METHODS: Seventy-two patients with a diagnosis of MCI were recruited...
January 2017: Dementia and Geriatric Cognitive Disorders Extra
https://www.readbyqxmd.com/read/28625806/a-randomized-placebo-controlled-double-blinded-crossover-trial-of-pioglitazone-for-severe-asthma
#18
Maryann Kaler, Amisha V Barochia, Nargues A Weir, Rosemarie A Cuento, Mario Stylianou, Mark J Roth, Armando C Filie, Ellen C Vaughey, Steven D Nathan, Stewart J Levine
The PPAR-γ agonist, pioglitazone, was associated with significant side effects and did not improve the primary outcome measure of the Juniper Asthma Quality of Life Questionnaire (AQLQ) score in severe asthmatics. We conclude that no further studies should be performed with pioglitazone for severe asthma.
June 15, 2017: Journal of Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/28625615/efficacy-and-safety-of-abobotulinumtoxina-dysport%C3%A2-for-the-treatment-of-hemiparesis-in-adults-with-upper-limb-spasticity-previously-treated-with-botulinum-toxin-sub-analysis-from-a-phase-3-randomized-controlled-trial
#19
Christina Marciniak, Peter McAllister, Heather Walker, Allison Brashear, Steven Edgley, Thierry Deltombe, Svetlana Khatkova, Marta Banach, Fatma Gul, Claire Vilain, Philippe Picaut, Anne-Sophie Grandoulier, Jean-Michel Gracies
OBJECTIVE: To assess the efficacy and safety of abobotulinumtoxinA in adults with upper limb spasticity previously treated with botulinum toxin A (BoNT-A). DESIGN: A post-hoc analysis from a Phase 3, prospective, double-blind, randomized, placebo-controlled study SETTING: 34 neurology or rehabilitation clinics in nine countries. PARTICIPANTS: Adults aged 18-80 years with hemiparesis, ≥6 months after stroke or traumatic brain injury. This analysis focused on a subgroup of subjects with previous onabotulinumtoxinA or incobotulinumtoxinA treatment (n=105 of 243 in the total trial population) in the affected limb...
June 15, 2017: PM & R: the Journal of Injury, Function, and Rehabilitation
https://www.readbyqxmd.com/read/28625456/the-effect-of-ondansetron-on-analgesic-efficacy-of-acetaminophen-after-hysterectomy-a-randomized-double-blinded-placebo-controlled-trial
#20
Onur Koyuncu, Steve Leung, Jing You, Menekse Oksar, Selim Turhanoglu, Cagla Akkurt, Kenan Dolapcioglu, Hanifi Sahin, Daniel I Sessler, Alparslan Turan
OBJECTIVES: To determine that perioperative ondansetron reduces the analgesic efficacy of acetaminophen. DESIGN: Randomized, double-blinded study. PATIENTS: 120 patients ASA I-II who underwent abdominal hysterectomy. INTERVENTIONS: All the patients were given 1g acetaminophen at skin closure. Patients were divided into two groups; ondansetron HCl (8mg, 2ml IV) (Group I, N=60) and saline (2ml IV) (Group II, N=60) at the skin closure...
August 2017: Journal of Clinical Anesthesia
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