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A Double-blind, Escalating Dose, Randomized, Placebo-controlled Study Assessing PK, Safety, Tolearbility In Non-ambulant DMD Subjects PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest A Double-blind, Escalating Dose, Randomized, Placebo-controlled Study Assessing PK, Safety, Tolearbility In Non-ambulant DMD Subjects articles that have been published worldwide.
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The purpose of this randomized, placebo-controlled, double-blind study was to investigate the preventive effect of topical administration of atorvastatin (ATV) on the acute radiation-induced skin toxicity in patients with breast cancer.
The role of "Integrated Pulmonary Index" monitoring during morphine-based intravenous patient-controlled analgesia administration following supratentorial craniotomies: a prospective, randomized, double-blind controlled study.
Morphine is commonly used in postoperative analgesia, but opioid related respiratory depression causes a general reluctance for its use. The "Integrated Pulmonary Index" is a tool calculated from noninvasively obtained respiratory and hemodynamic parameters. The aim of this prospective, randomized, double blind and placebo-controlled study is to determine more safe and effective dose for morphine in patient-controlled analgesia following supratentorial craniotomy using "Integrated Pulmonary Index". Clinical...
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.
Crossover double blind, randomized placebo-controlled trial.
Omalizumab, a humanized recombinant monoclonal anti-IgE antibody proved to be effective in patients with chronic spontaneous urticaria (CSU), including severe and treatment-refractory CSU. Here we report omalizumab's effect on gene expression in skin biopsies from CSU patients enrolled in a double-blind, placebo-controlled study.
This 2-part study evaluated the QT/QTc prolongation potential and safety and pharmacokinetics of the antiemetic rolapitant, a neurokinin-1 receptor antagonist. Part 1 was a randomized, placebo-controlled single-dose-escalation study assessing the safety of a single high dose of rolapitant. Part 2 was a randomized, placebo- and positive-controlled, double-blind parallel-group study including 4 treatment arms: rolapitant at the highest safe dose established in part 1, placebo, moxifloxacin 400 mg (positive co...
To evaluate the efficacy and safety of anakinra in treating acute gout flares in a randomized, double-blind, placebo-controlled, active comparator, non-inferiority (NI) trial.
Oxidative stress plays a pivotal role in the pathogenesis of type 2 diabetes (T2D). In vitro and animal studies have shown that resveratrol exerts an antioxidant effect, but clinical trials addressing this effect in patients with T2D are limited. The aim of this study was to determine whether resveratrol supplementation affects oxidative stress markers in a randomized, placebo-controlled, double-blind clinical trial.
αβ integrin is a validated target in inflammatory bowel disease. This randomized, phase 2b, placebo-controlled, double-blind study evaluated the efficacy and safety of the anti-αβ antibody abrilumab in patients with moderate-to-severe ulcerative colitis (UC) despite treatment with conventional therapies.
A randomized, double-blinded, crossover, placebo controlled trial was conducted to evaluate the efficacy and safety of 0.075% capsaicin lotion for treating painful diabetic neuropathy (PDN).
IBS is associated with an intestinal dysbiosis and faecal microbiota transplantation (FMT) has been hypothesised to have a positive effect in patients with IBS. We performed a randomised, double-blind placebo-controlled trial to investigate if FMT resulted in an altered gut microbiota and improvement in clinical outcome in patients with IBS.
Elevated levels of blood lipids are well-documented risk factors for cardiovascular disease. For cardiovascular risk reduction, preventive strategies to lower blood cholesterol levels are essential, and these strategies include lifestyle modification and cholesterol-lowering agents. We aim to investigate the cholesterol-lowering effects and safety of yellow yeast rice in a randomized, controlled, double-blind, and parallel group study.
Phase 2b study of evocalcet (KHK7580), a novel calcimimetic, in Japanese patients with secondary hyperparathyroidism undergoing hemodialysis: A randomized, double-blind, placebo-controlled, dose-finding study.
Evocalcet has been developed as a new calcimimetic agent for hemodialysis (HD) patients with secondary hyperparathyroidism (HDSHPT), eliciting fewer gastrointestinal symptoms and drug interactions. We evaluated the efficacy, safety, and optimal starting dose of evocalcet in HDSHPT.
Efficacy and safety of omalizumab (Xolair®) for cholinergic urticaria in patients unresponsive to a double dose of antihistamines: a randomized mixed double-blind and open-label placebo-controlled clinical trial.
Cholinergic urticaria (UCOL) is a highly disabling inducible urticaria triggered by an increase in core body temperature.
Efficacy and safety of a triple active sore throat lozenge in the treatment of patients with acute pharyngitis: Results of a multi-centre, randomised, placebo-controlled, double-blind, parallel-group trial (DoriPha).
The aim of this multi-centre, randomised, double-blind, placebo-controlled trial was to compare the efficacy and safety of the fixed combination of 0.5 mg tyrothricin, 1.0 mg benzalkonium chloride, and 1.5 mg benzocaine (study drug marketed as Dorithricin ) in repeat dosing for 3 days to match placebo lozenges in the treatment of acute pharyngitis in adults.
In the search for additional pharmacologic treatments of patients with obsessive-compulsive disorders (OCD), the glutamatergic system is attracting growing interest. While adjuvant memantine to a standard medication with a selective serotonin-reuptake inhibitor (SSRI) appears to reduce OCD symptoms, the adjuvant effect of gabapentin is less certain. The aim of the present randomized, double-blind and three-arm clinical trial was therefore to assess whether, compared to placebo, gabapentin (GAB) or memantine...
The posterior cingulate cortex (PCC) is involved in food craving in obese food addicted individuals. This randomised, double-blind, placebo-controlled parallel study explored the potential therapeutic effects of infraslow neurofeedback (ISF-NF) on food craving targeting the PCC in obese women with symptoms of food addiction. Participants received six sessions of either ISF-NF (n = 11) or placebo (n = 10) over a three-week period. There were no reported adverse effects. Electrophysiologically, there ...
Standard therapeutic approaches to reduce social anxiety in autistic adults have limited effectiveness. Since 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy shows promise as a treatment for other anxiety disorders, a blinded, placebo-controlled pilot study was conducted.
Regorafenib, a multikinase inhibitor that inhibits angiogenesis, growth, and proliferation, prolongs survival as monotherapy in patients with refractory colorectal cancer. This international, double-blind, placebo-controlled, multicenter trial assessed the efficacy of regorafenib with folinic acid, fluorouracil, and irinotecan (FOLFIRI) as a second-line treatment for metastatic colorectal cancer.
The aim of this study was to investigate the role of Lactobacillus (L.) reuteri DSM 17983 in the treatment of functional constipation in children. The trial was a single-center randomized, double-blind, placebo-controlled study. Patients were allocated into the two groups; intervention group which received L. reuteri DSM 17983 and lactulose and placebo group which received placebo and lactulose.Due to small recruitment rate study was terminated prematurely, therefore only 33 children (12 girls, median age 4...
To evaluate the effect of a single preoperative dose of 125 mg methylprednisolone (MP) on glycemic homeostasis early after fast-track total hip and knee arthroplasty.
This 19-week, double-blind, placebo-controlled, randomized phase 2 study evaluated the efficacy, safety, and tolerability of adjunctive cariprazine (0.1-0.3 and 1.0-2.0 mg/day) as an antidepressant treatment for adults with treatment-resistant major depressive disorder (MDD) (NCT00854100). The primary endpoint was change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score and the secondary was change in the Clinical Global Impression-Intensity score. Additional efficacy parameters were a...