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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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SER120 is the first FDA-approved pharmacotherapy for nocturia. SER120 efficacy/safety was evaluated in 2 randomized, double-blind, placebo-controlled studies (DB3 and DB4).
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.
Safety, tolerability and immunogenicity of the ExPEC4V (JNJ-63871860) vaccine for prevention of invasive Extraintestinal pathogenic Escherichia coli disease: a phase 1, randomized, double-blind, placebo-controlled study in healthy Japanese participants.
This Phase 1, randomized, double-blind, placebo-controlled study was conducted to evaluate the safety, tolerability and immunogenicity of different doses of ExPEC4V conjugate vaccine (4-16µg Polysaccharide [PS]/serotype) in healthy Japanese participants, stratified into younger (≥20 to
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...
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.
Effect of high-dose ginsenoside complex (UG0712) supplementation on physical performance of healthy adults during a 12-week supervised exercise program: A randomized placebo-controlled clinical trial.
Ginseng has been used as an ergogenic agent, although evidence for its effectiveness is weak. A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the effect of a ginsenoside complex (UG0712) on changes in exercise performance.
The objective of this study was to evaluate the electrocardiographic effects of hawthorn in healthy adult volunteers. It was double-blind cross-over trial randomized 20 healthy adult volunteers to receive either a single oral 160-mg dose of hawthorn or matching placebo. Triplicate 12-lead electrocardiograms were taken before treatment and at 1-, 2-, 4-, and 6-hr post-dose. Following at least a 7-day washout period, participants were crossed over to the opposing treatment arm and had the measurements repeate...
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.
Increased excitability of motor neurons in patients with amyotrophic lateral sclerosis may be a relevant factor leading to motor neuron damage. This randomized, double-blind, 3-way cross-over, placebo-controlled study evaluated peripheral motor nerve excitability-testing as biomarker of hyperexcitability and assessed effects of riluzole and retigabine in 18 patients with amyotrophic lateral sclerosis. We performed excitability-testing at baseline, and twice after participants had received a single dose of e...
Although evidence suggests that dopaminergic systems are involved in pain processing, the effects of dopaminergic interventions on pain remains questionable. This randomized, double blinded, placebo-controlled, cross-over study was aimed at exploring the effect of the dopamine agonist apomorphine on experimental pain evoked by cold stimulation and on spontaneous pain in patients with lumbar radicular (neuropathic) pain.
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.
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.
We evaluated the effects of therapeutic and supratherapeutic doses of tramadol hydrochloride on the corrected QT (QTc) interval in healthy adults (aged 18-55 years) in a randomized, phase I, double-blind, placebo- and positive-controlled, multiple-dose, 4-way crossover study. Participants were randomized to receive 1 of 4 treatments (A-D), 1 each in 4 treatment periods (1-4), separated by a washout period (7-15 days). Treatment A comprised tramadol 400 mg (therapeutic dose) on days 1 through 3, tramadol ...
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.
Nemolizumab, an anti-interleukin-31 receptor A monoclonal antibody, improved pruritus, dermatitis, and sleep in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments in a phase II, 12-week, randomized, double-blind, placebo-controlled study (Part A) (NCT01986933).
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.