double blind controlled trial

UNLABELLED: BACKGROUND AND OBJECTIVES: BI 1358894, a novel small-molecule inhibitor of transient receptor potential canonical ion channels, is under development for treatment of major depressive disorder. Phase I trials assessing the safety and pharmacokinetics of BI 1358894 in Caucasian male healthy volunteers (HVs) have been performed. This Phase I, double-blind, placebo-controlled, parallel-group trial assessed the safety, tolerability and pharmacokinetics of BI 1358894 in Japanese male HVs...

IMPORTANCE: It is usually assumed that an individual's classification as a patient or a healthy person is determined by the presence or absence of disease, but little is known about whether the mere awareness of being a patient or a healthy control can play an important role for reporting outcomes. OBJECTIVE: To investigate whether assignment to the role of a patient or a healthy control has an effect on patient-reported outcomes. DESIGN, SETTING, AND PARTICIPANTS: This single center, double-blind, 3-group randomized clinical trial included consecutive patients from a tertiary headache clinic based at a single center in Germany who were invited to participate between October 2019 and June 2023...

PURPOSE: Evidence on the potential beneficial effects of anthocyanin-rich foods and supplements on cognitive performance is mainly based on acute or long-term studies in older adults. However, short-term studies focusing on a younger population are lacking. Therefore, short-term effects of Aronia melanocarpa extract (AME) supplementation on cognitive performance were investigated in healthy young adults. Potential underlying mechanisms were also addressed. METHODS: A randomized, double-blind, placebo-controlled cross-over study was performed involving 35 apparently healthy young adults...

BACKGROUND: Opioids form the basis of perioperative pain management but are associated with multiple side effects. In opioid-free anesthesia (OFA), several non-opioid drugs or neuraxial/regional blocks are used as substitutes for opioids. Ketamine, a N-methyl-d-aspartate antagonist, provides intense analgesia. However, there is a shortage of literature on the effects of ketamine-based OFA on hemodynamics (HD) and postoperative analgesia in patients undergoing thoracolumbar spine surgery...

BACKGROUND: Whether nasal administration of esketamine can provide effective analgesia is unclear in patients with acute pain after preoperative CT-guided needle localization. METHODS: In this double-blind, randomized, placebo-controlled trial, patients were assigned to receive either nasal administration of esketamine (0.3 mg/kg or 0.5 mg/kg) or saline (identical in appearance to esketamine) when they had visual analog scale (VAS) pain scores >3/10 during deep breathing after preoperative CT-guided needle localization...

Introduction Magnesium is recognized for its ability to reduce the onset time of rocuronium while simultaneously extending its duration of action. This study aims to assess the efficacy of magnesium pre-treatment in decreasing the onset time with two different doses of rocuronium in patients undergoing rapid sequence intubation. Materials and methods This randomized prospective double-blind clinical study involved 50 patients classified as American Society Of Anesthesiologists (ASA) I/II, with no preoperative indications of difficult intubation, undergoing elective surgery under general anesthesia...

BACKGROUND: Erosive esophagitis (EE) is a gastroesophageal reflux disease characterized by mucosal breaks in the esophagus. Proton pump inhibitors are widely used as maintenance therapy for EE, but many patients still relapse. In this trial, we evaluated the noninferiority of vonoprazan vs. lansoprazole as maintenance therapy in patients with healed EE. METHODS: We performed a double-blind, double-dummy, multicenter, phase 3 clinical trial among non-Japanese Asian adults with endoscopically confirmed healed EE from April 2015 to February 2019...

BACKGROUND: This study sought to examine the impact of magnesium supplementation on clinical outcomes and biochemical factors among hospitalized patients with COVID-19. METHODS: This double-blind, randomized clinical trial was conducted at Razi Hospital, Ahvaz, Iran, between September 2021 and March 2022. Participants aged 18-70 years with moderate disease severity were enrolled. Magnesium supplementation (300 mg daily) was administered to the intervention group, while the control group received a placebo...

INTRODUCTION: There is a sizable niche for a minimally invasive analgesic technique that could facilitate ambulatory video-assisted thoracoscopic surgery (VATS). Our study aimed to determine the analgesic potential of a single-shot erector spinae plane (ESP) block for VATS. The primary objective was the total hydromorphone consumption with patient-controlled analgesia (PCA) 24 h after surgery. METHODS: We conducted a randomized, controlled, double-blind study with patients scheduled for VATS in two major university-affiliated hospital centres...

PURPOSE: Postoperative changes in gut microbiota may occur in patients undergoing Roux-en-Y gastric bypass surgery. In this study, we evaluate the impact of administering probiotic tablets on the gastrointestinal function and metabolic status of these patients. MATERIALS AND METHODS: This double-blinded randomized clinical trial was conducted from 2021 to 2022 on 135 Roux-en-Y surgery candidates. The intervention group underwent the surgical procedure and started receiving probiotic supplements (Familact Co...

BACKGROUND: Despite advancements in total knee arthroplasty (TKA), 10-20% of patients remain dissatisfied after surgery. Improved anteroposterior (AP) stability provided by medial pivot (MP) implants may theoretically lead to higher patient satisfaction. METHODS: AP stability and patient-reported outcome measures (PROMs) at one-year postsurgery were compared between patients who underwent TKA with MP- (n = 121), posterior stabilized (PS; n = 53) and rotating platform (RP; n = 57) implants in a double-blind multicentre randomized controlled trial (Dutch Trial Register: NL6856, 21-02-2018)...

PURPOSE: To date, no adequate treatment for irritable bowel syndrome with predominant constipation complaints (IBS-C) is available. Fibers with prebiotic properties and probiotic compounds have shown promise in relieving IBS-C-related complaints. We aimed to determine the effects of a 4-week intervention with either an Acacia fiber (AF) with prebiotic properties or a probiotic Bifidobacterium Lactis (BLa80) supplement, compared to a control supplement, on stool pattern, IBS symptoms and Quality of Life (QoL), in IBS-C individuals...

INTRODUCTION: Sepsis remains the major cause of death among hospitalised patients in intensive care. While targeting sepsis-causing pathogens with source control or antimicrobials has had a dramatic impact on morbidity and mortality of sepsis patients, this strategy remains insufficient for about one-third of the affected individuals who succumb. Pharmacological targeting of mechanisms that reduce sepsis-defining organ dysfunction may be beneficial. When given at low doses, the anthracycline epirubicin promotes tissue damage control and lessens the severity of sepsis independently of the host-pathogen load by conferring disease tolerance to infection...

INTRODUCTION: Adjunctive cenobamate was effective and safe for the treatment of uncontrolled focal onset seizures in a randomized, double-blind, placebo-controlled, phase 2 study (YKP3089C017; NCT01866111). This post-hoc analysis assessed the efficacy of adjunctive cenobamate in the treatment of patients with different epileptic etiologies during the study. METHODS: Adult patients with uncontrolled focal seizures who previously received 1 to 3 antiseizure medications (ASMs) were randomly assigned in a ratio of 1:1:1:1 to receive placebo or cenobamate 100, 200 or 400 mg/day...

PURPOSE: A double-blind, placebo-controlled, randomized, proof-of-concept trial aimed to evaluate the efficacy and safety of VerbasnolTM [ Rehmannia glutinosa Libosch leaf-based extract (RGLE)] in females, with moderate to severe acne vulgaris. PARTICIPANTS AND METHODS: Twenty-two females aged 18 to 35 years having moderate to severe acne with Global Acne Grading System (GAGS) scores of 19 to 38 were included in the study and were randomized in a 1:1 ratio to receive either one capsule (100 mg/day) of RGLE or placebo orally after breakfast for 56 days...

BACKGROUND: Guidelines for switching to triple combination therapy directly after monotherapy failure are limited. This study investigated the efficacy, long-term sustainability, and safety of either mono or dual add-on therapy using alogliptin and pioglitazone for patients with type 2 diabetes mellitus (T2DM) who did not achieve their target glycemic range with metformin monotherapy. METHODS: The Practical Evidence of Antidiabetic Combination Therapy in Korea (PEAK) was a multicenter, placebo-controlled, double-blind, randomized trial...

BACKGROUND: Recent developments suggest that neurosteroids may achieve rapid antidepressant effects. As such, neurosteroidogenesis mediated by the translocator protein 18 kDa (TSPO) might constitute a promising option for the treatment of depression. Therefore, the current clinical trial aims to get the first evidence of whether TPSO ligands promote rapid antidepressant effects. Furthermore, we study which mechanisms of action, e.g., modulation of distinct neuronal networks, neurosteroidogenesis, endocrinological mechanisms, TSPO expression or microbiome composition, contribute to their putative antidepressant effects...

BACKGROUND: Parkinson's disease (PD) is a progressive, neurodegenerative illness marked by the loss of dopaminergic neurons, causing motor symptoms. Oral levodopa replacement therapy remains the gold standard in the treatment of PD. It is, nevertheless, a symptomatic treatment. There is currently no effective treatment for PD. Therefore, new therapies for PD are highly desirable. Low-intensity pulsed ultrasound (LIPUS) has been shown to improve behavioral functions in PD animal models...

DESIGN: This study is a randomised, placebo-controlled, triple-arm, phase IIA clinical trial with double masking which investigates the effectiveness and safety of Cannabidiol (CBD) as an analgesic for acute dental pain. The intervention drug, Epidiolex is an FDA-approved CBD oral solution (100 mg/ml) derived from the cannabis plant. The psychoactive ingredient tetrahydrocannabinol (THC) is not included. The maximum recommended daily dose of Epidiolex is 20 mg/kg. 64 patients with moderate-severe odontogenic pain participated in the study and REDCap software was utilised to randomly assign participants into groups: CBD10 (10 mg/kg), CBD20 (20 mg/kg) and placebo...

INTRODUCTION: Ocrelizumab is an approved intravenously administered anti-CD20 antibody for multiple sclerosis (MS). The safety profile and patient preference for conventional versus shorter ocrelizumab infusions were investigated in the ENSEMBLE PLUS study. METHODS: ENSEMBLE PLUS was a randomized, double-blind substudy to the single-arm ENSEMBLE study (NCT03085810), comparing outcomes in patients with early-stage relapsing-remitting MS receiving ocrelizumab 600 mg over the approved 3...