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Randomized double blinded controlled studies

Korgün Ökmen, Burcu Metin Ökmen, Serra Topal
STUDY OBJECTIVE: Laparoscopic techniques are commonly used in surgical operations of the gallbladder. There are very few regional anesthesia methods used to achieve this goal. We aimed to investigate the effect of ultrasound-guided posterior quadratus lumborum block (QLB), administered bilaterally on pain scores after laparoscopic cholecystectomy operations. DESIGN: Prospective, double blind, randomized controlled clinical trial. SETTING: Single-institution, tertiary hospital...
June 18, 2018: Journal of Clinical Anesthesia
Robert Ross MacLean, Andrew J Waters, Emily Brede, Mehmet Sofuoglu
OBJECTIVE: Drugs that enhance cholinergic transmission have demonstrated promise treating addictive disorders. Galantamine, an acetylcholinesterase inhibitor, may reduce cigarette smoking in otherwise healthy treatment-seeking smokers. METHODS: The current study is a double-blind, placebo-controlled, study that randomized daily smokers (n = 60) to receive one of two doses of galantamine extended release (8 or 16 mg/day), or a placebo treatment. Participants completed a smoking choice task as well as study measures and cognitive tasks in the laboratory and daily life using ecological momentary assessment...
June 21, 2018: Human Psychopharmacology
Anna G Nilsson, Daniel Sundh, Fredrik Bäckhed, Mattias Lorentzon
The importance of the gut microbiome for bone metabolism in mice has recently been demonstrated, but no studies are available in humans. Lactobacillus reuteri ATCCPTA 6475 (L. reuteri 6475) has been reported to increase bone mineral density (BMD) in mice but its effect on the human skeleton is unknown. The objective of this trial was to investigate if L. reuteri 6475 affects bone loss in older women with low BMD. In this double-blind, placebo-controlled study, women from the population who were 75 to 80 years old and had low BMD were randomized to orally receive 1010 colony-forming units of L...
June 21, 2018: Journal of Internal Medicine
Jean-Michel Molina, Douglas Ward, Indira Brar, Anthony Mills, Hans-Jürgen Stellbrink, Luis López-Cortés, Peter Ruane, Daniel Podzamczer, Cynthia Brinson, Joseph Custodio, Hui Liu, Kristen Andreatta, Hal Martin, Andrew Cheng, Erin Quirk
BACKGROUND: Bictegravir, co-formulated with emtricitabine and tenofovir alafenamide, has shown good efficacy and tolerability, and similar bone, renal, and lipid profiles to dolutegravir, abacavir, and lamivudine, in treatment-naive adults with HIV-1 infection, without development of treatment-emergent resistance. Here, we report 48-week results of a phase 3 study investigating switching to bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir, abacavir, and lamivudine in virologically suppressed adults with HIV-1 infection...
June 15, 2018: Lancet HIV
Sang-Ho Jo, Sung-Ji Park, Eung Ju Kim, Soo-Joong Kim, Hyun-Jae Cho, Jong-Min Song, Jinho Shin, Jin Joo Park, Joon-Han Shin, Kyoo-Rok Han, Dong-Ju Choi
BACKGROUND: The efficacy of a combination of a calcium channel blocker (CCB) plus chlorthalidone (diuretic) versus a CCB plus an angiotensin receptor blocker (ARB) in patients not responding to CCB monotherapy has not been evaluated previously. We plan to compare the efficacy and safety of S-amlodipine (CCB) plus chlorthalidone versus S-amlodipine plus telmisartan (ARB) combinations among hypertension patients unresponsive to amlodipine monotherapy. METHODS/DESIGN: This study is a prospective, randomized, double-blind, multicenter, parallel, non-inferiority phase 4 study...
June 20, 2018: Trials
Ahmed A Badawy, Samaa A Kasem, Doaa Rashwan, Tarek Al Menesy, Ghada Adel, Ali M Mokhtar, Yasmin A Badawy
BACKGROUND: Short acting inhalational anesthetic (Desflurane) produces emergence agitation (EA) in pediatrics with an incidence up to 80%. The aim of the present study was to examine the role of Gabapentin oral solution in attenuating desflurane associated EA in children after strabismus surgery under general anesthesia. METHODS: Seventy patients, 2-6 years old, scheduled for strabismus surgery were randomly allocated into two groups (35 each); Control group (c): received 5 ml of oral strawberry juice (placebo) and Gabapentin group (G) received 5 mg/Kg gabapentin oral solution in 5 ml strawberry juice, 1 h before anesthesia...
June 20, 2018: BMC Anesthesiology
R Lopez-Martos, L-M Gonzalez-Perez, P Ruiz-Canela-Mendez, F-J Urresti-Lopez, J-L Gutierrez-Perez, P Infante-Cossio
BACKGROUND: To assess whether the techniques of percutaneous needle electrolysis (PNE) and deep dry needling (DDN) used on trigger points (TrP) of lateral pterygoid muscle (LPM) can significantly reduce pain and improve function in patients with myofascial pain syndrome (MPS) compared to a control group treated with a sham needling procedure (SNP). MATERIAL AND METHODS: Sixty patients diagnosed with MPS in the LPM were selected and randomly assigned to one of three groups...
June 20, 2018: Medicina Oral, Patología Oral y Cirugía Bucal
Peel Jung, Su B Park, Hyung W Kim, Dae H Kang, Cheol W Choi, Su J Kim, Hyeong S Nam, Dae G Ryu, Joung B Hong, Dong J Kim
BACKGROUND: Endoscopic inspection of colonic mucosa is disturbed by colonic folds and peristalsis, which may result in missed polyps. Cimetropium bromide, an antispasmodic agent, inhibits peristalsis and colonic spasms, which may improve polyp detection. The purpose of this randomized, double-blind, placebo-controlled study was to investigate whether cimetropium bromide could improve polyp and adenoma detection in the colorectum and right colon. METHODS: Patients undergoing screening or diagnostic colonoscopy were randomized to receive intravenous cimetropium bromide (5 mg) or placebo after cecal intubation...
June 2018: Medicine (Baltimore)
Mi Ju Son, Ojin Kwon, Sungha Kim, Young-Eun Kim, So Young Jung, Bo-Young Kim, Jeong In Kang, Jun-Hwan Lee, Dong-Hyo Lee
INTRODUCTION: A herbal formula, Galgeun-tang-ga-cheongung-sinyi (GGTCS), is traditionally used for the treatment of rhinosinusitis in East Asian countries. However, there is a dearth of clinical evidence supporting the effects of this medication. Here, we describe the protocol for a randomized controlled study designed to investigate the efficacy and safety of GGTCS for the treatment of chronic rhinosinusitis (CRS). METHODS AND ANALYSIS: To investigate the clinical efficacy and safety of GGTCS for the treatment of CRS, a randomized, double-blind, placebo-controlled, parallel group, clinical trial has been designed...
June 2018: Medicine (Baltimore)
Won-Seok Kim, Sungmin Cho, Seo Hyun Park, Ji-Young Lee, SuYeon Kwon, Nam-Jong Paik
BACKGROUND: We designed this study to prove the efficacy of the low-cost Kinect-based virtual rehabilitation (VR) system for upper limb recovery among patients with subacute stroke. METHODS: A double-blind, randomized, sham-controlled trial was performed. A total of 23 subjects with subacute stroke (<3 months) were allocated to sham (n = 11) and real VR group (n = 12). Both groups participated in a daily 30-minute occupational therapy for upper limb recovery for 10 consecutive weekdays...
June 2018: Medicine (Baltimore)
Kashinath Dixit, Dinesh Venkata Kamath, Krishnaraju Venkata Alluri, Barbara A Davis
AIMS: LI85008F is a novel, proprietary herbal blend containing extracts of Moringa oleifera and Murraya koeingii leaves plus extract of Curcuma longa root. Weight loss efficacy of LI85008F was first demonstrated in obese adults and has now been re-evaluated in healthy overweight adults via a 16-week randomized, double-blind, placebo-controlled clinical study. MATERIAL & METHODS: One hundred and forty overweight participants (Body mass index 27 to 29.9 kg/m2 , 29...
June 19, 2018: Diabetes, Obesity & Metabolism
A Melmer, P Kempf, L Lunger, T R Pieber, J K Mader, C Stettler, H Tilg, C F Ebenbichler, M Laimer
We investigated short-term effects of dapagliflozin as adjunct to insulin on insulin sensitivity, postprandial glucose excursions, and ketone body production in T1DM. Seven male patients completed the randomized, double-blind, placebo controlled cross-over trial and received 10mg of dapagliflozin daily for 3 days followed by placebo, or reverse. At day 3, hyperinsulinemic, euglycemic clamps and oral glucose tolerance test clamps with repeated blood sampling were performed. Required glucose infusion and blood glucose excursions did not differ significantly between dapagliflozin and placebo (p=0...
June 19, 2018: Diabetes, Obesity & Metabolism
Grit Andersen, Grégory Meiffren, Daniela Lamers, J Hans DeVries, Aymeric Ranson, Cyril Seroussi, Bertrand Alluis, Martin Gaudier, Olivier Soula, Tim Heise
AIMS: To investigate safety and efficacy of BioChaperone insulin lispro (BCLIS), an ultra-rapid formulation of insulin lispro (LIS) in patients with type 1 diabetes. MATERIALS AND METHODS: In this randomized, double-blind study, patients self-administered individualized bolus doses of BCLIS or LIS during two 14-day periods in a crossover fashion. Postprandial blood glucose (PPG) was assessed following individualized solid mixed meal tests (MMT) (50% carbs, 29% fat, 21% proteins) with additional randomization for the sequence of timing of insulin administration, immediately (t0), 15 minutes before (t-15) and 15 minutes after (t+15) meal start on days 1, 2 and 3 and with t0 administration on day 14...
June 19, 2018: Diabetes, Obesity & Metabolism
David J Kazierad, Kristin Chidsey, Veena R Somayaji, Arthur J Bergman, Roberto A Calle
AIMS: To conduct a dose-response assessment of the efficacy and safety of the glucagon receptor antagonist PF-06291874 in adults with type 2 diabetes (T2DM) receiving stable doses of metformin. MATERIALS AND METHODS: This randomized, double-blind, statin-stratified, placebo-controlled, 4-arm, parallel-group study was conducted in patients with T2DM receiving background metformin. After an 8-week, non-metformin oral antidiabetic agent washout period, 206 patients were randomized to placebo or PF-06291874 (30, 60, or 100 mg once daily) for 12 weeks...
June 19, 2018: Diabetes, Obesity & Metabolism
Erika F Augustine, Christopher A Beck, Heather R Adams, Sara Defendorf, Amy Vierhile, Derek Timm, Jill M Weimer, Jonathan W Mink, Frederick J Marshall
Mycophenolate, an immunosuppressant, is commonly used off-label for autoimmune neurological conditions. In CLN3 disease, a neurodegenerative disorder of childhood, preclinical and clinical data suggest secondary autoimmunity and inflammation throughout the central nervous system are key components of pathogenesis. We tested the short-term tolerability of mycophenolate in individuals with CLN3 disease, in preparation for possible long-term efficacy trials of this drug. We conducted a randomized, double-blind, placebo-controlled, crossover study of mycophenolate in 19 ambulatory individuals with CLN3 disease to determine the safety and tolerability of short-term administration (NCT01399047)...
June 20, 2018: JIMD Reports
Patricia A Walicke, Franz Hefti, Roxanne Bales, Shiao-Ping Lu, Jon L Ruckle, Mark T Brown, Christine R West, David L Shelton
Introduction: The neurotrophin nerve growth factor has a demonstrated role in pain transduction and pathophysiology. Objectives: Two randomized, double-blind, placebo-controlled, phase 1 studies were conducted to evaluate safety, tolerability, and analgesic efficacy of single doses of tanezumab, a humanized anti-nerve growth factor monoclonal antibody, in chronic or acute pain. Methods: In the first study (CL001), patients with moderate to severe pain from osteoarthritis (OA) of the knee received a single intravenous infusion of tanezumab (3-1000 μg/kg) or placebo in a dose-escalation (part 1; N = 42) or parallel-arm (part 2; N = 79) study design...
May 2018: Pain Reports (Baltimore, Md.)
Héctor César Durán-Vega, Arturo Ramírez-Montañana, Octavio Gonzalez Galindo, Andrés Medina Gutierrez, Adriana Zapata González, Evangelina Gonzalez Galindo, Iván Arturo Arellano Silva
Background: Breast augmentation surgery is still 1 of the most popular procedures in plastic surgery. Like other surgical procedures, it has been traditionally handled with nonsteroidal anti-inflammatory drugs and narcotics, which had many adverse effects; therefore, alternatives with the same effectiveness are being researched. The aim of this study was to investigate the efficacy of ropivacaine breast pocket irrigation during primary breast augmentation surgery to control pain during the first postoperative hours...
May 2018: Plastic and Reconstructive Surgery. Global Open
Francisco Fernández-Avilés, Ricardo Sanz-Ruiz, Jan Bogaert, Ana Casado Plasencia, Inmaculada Gilaberte, Ann Belmans, María Eugenia Fernández-Santos, Dominique Charron, Miguel Mulet, Raquel Yotti, Itziar Palacios, Manuel Luque, Rafael Sádaba, J A San Roman, Mariano Larman, Pedro L Sánchez, Juan Sanchis, Manuel F Jimenez-Navarro, Piet Claus, Reem Al-Daccak, Eleuterio Lombardo, José Luis Abad, Olga Delarosa, Lucia Corcostegui, Javier Bermejo, Stefan Janssens
<u>Rationale:</u> Allogeneic cardiac stem cells (AlloCSC-01) have shown protective, immunoregulatory and regenerative properties with a robust safety profile in large animal models of heart disease. <u>Objective:</u> To investigate the safety and feasibility of early administration of AlloCSC-01 in patients with ST-segment elevation myocardial infarction (STEMI). <u>Methods and Results:</u> CAREMI was a phase I/II multicenter, randomized, double-blind, placebo-controlled trial in patients with STEMI, LVEF ≤ 45% and infarct size ≥ 25% of left ventricular (LV) mass by cardiac magnetic resonance (MR), who were randomized (2:1) to receive AlloCSC-01 or placebo through the intracoronary route at day 5-7...
June 19, 2018: Circulation Research
Yen-Ting Cho, Wen-Yen Hsu, Li-Fong Lin, Yen-Nung Lin
BACKGROUND: Lateral epicondylitis is frequently seen in racquet sport players and the treatments are usually symptomatic rather than curative. Taping therapy is cheap and easy to apply in the sport field. In this study we valued the effectiveness of Kinesio taping (KT) on immediate pain control for patients with chronic lateral epicondylitis. METHODS: We conducted a randomized, double-blinded, cross-over study with 15 patients with chronic lateral epicondylitis...
June 19, 2018: BMC Musculoskeletal Disorders
Soo-Kyung Kang, Yeon-Hee Lee, Hyeji Park, Jin Y Ro, Q-Schick Auh
OBJECTIVES: This placebo-controlled randomized double-blinded clinical study assessed the analgesic efficacy of intramuscular morphine in TMD patients with myofascial pain and sex dependent responses of the morphine treatment. SUBJECTS AND METHODS: Men and women with TMD were treated with morphine (1.5 or 5 mg), lidocaine or saline in the masseter muscle. VAS of pain intensity, PPT and PPtol were compared between treatment groups and gender. An additional group was treated with morphine in the trapezius muscle to evaluate the systemic effect of morphine that may reduce pain in the masseter muscle...
June 19, 2018: Oral Diseases
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