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Curcumin has been shown to reduce exercise-induced oxidative stress (OS) and inflammation. The purpose of this investigation was to examine the effects of curcumin supplementation on OS, inflammation, muscle damage, and muscle soreness. Nineteen males participated in a randomized, double-blinded, placebo-controlled trial to examine the effects of curcumin supplementation (1.5 g/day) compared to a placebo (PLA) following a muscle-damaging protocol (MDP) on OS, inflammation, muscle damage, and soreness. Par...
N-Acetylcysteine for Pediatric Obsessive-Compulsive Disorder: A Small Pilot Study.
Many children and adults with Obsessive-Compulsive Disorder (OCD) fail to respond to first-line pharmacological and behavioral treatments. Glutamate dysfunction may contribute to the development of OCD. N-acetylcysteine (NAC), a glutamate modulating drug, has shown to be a promising agent in adults with OCD. We conducted a double-blind, placebo-controlled clinical trial from July 2012 to January 2017. Children ages 8 to 17 years with OCD were assigned to receive NAC (up to 2700 mg/day) or the matching pl...
Immune Thrombocytopenia-A Disease or a Group of Disorders? Where Do We Stand in 2019?
63-Year-Old Woman With Abdominal Pain and Thrombocytopenia.
Estimation of treatment allocation in a randomised, double-blinded, placebo-controlled trial.
AIM OF THE STUDY: The internal validity of double blinding in randomised placebo-controlled trials (RCTs) has become a target of criticism. The goal of this study was to investigate (a) how accurately the patients and their treating physicians were able to guess their assigned treatment, and (b) predictors for an accurate guess.
The guide recommends SSRI and SNRI drugs as first-line treatments for generalized anxiety disorder (GAD). Therefore, we aimed to update the evidence using network meta-analysis by comparing the efficacy and acceptability of first-line drugs. The relevant electronic databases were searched for placebo-controlled and head-to-head trials of 11 drugs used for the acute treatment of adults with GAD from 1980 up to January 1, 2019. Data on demographics, clinical, and treatment information were extracted from each...
There have been a number of angiogenic gene therapy trials, yielding mixed results as to efficacy, but demonstrating uniform short-term treatment safety. Data regarding long-term safety of angiogenic gene therapy are limited. Double-blind VIF-CAD trial (NCT00620217) assessed myocardial perfusion and clinical data in 52 refractory coronary artery disease (CAD) patients randomized into treatment (VIF; n = 33) and Placebo (n = 19) arms. VIF group received electromechanical system NOGA-guided intramyoca...
This pooled analysis assessed the efficacy of ertugliflozin versus placebo as monotherapy or with other antihyperglycaemic agents across patient subgroups defined by demographic and disease characteristics.
The objective of this study was to evaluate the efficacy, tolerability, and safety of 120 mg DFN-15 vs placebo for the acute treatment of migraine.
Heparin-induced thrombocytopenia (HIT) is caused by platelet-activating antibodies that recognize platelet factor 4/heparin (PF4/hep)-complexes. The in vitro demonstration of PF4/hep antibodies using functional assays is essential for an optimal management of patients suspected to have HIT. However, conventional functional assays are technically challenging and limited to specialized laboratories. In contrast, flow cytometers are commonly used in routine laboratories. The aim of this study is to investigate...
Oxidative stress is part of the entire pathological process that underlies the development of Alzheimer's disease (AD), including the mild cognitive impairment (MCI) stage. Twendee X (TwX) is a supplement containing a strong antioxidative mix of eight antioxidants, which has been shown to have a clinical and therapeutic benefit in AD model mice. Here, we conducted a multicenter, randomized, double-blind, and placebo-controlled prospective interventional study to evaluate the efficacy of TwX in mitigating MC...
Treatment of Combined Autoimmune Neutropenia and Immune Thrombocytopenia with Methotrexate.
Severe thrombocytopenia during Natalizumab therapy: A case report.
This 24-week double-blind placebo-controlled multicenter randomized phase 2 trial evaluated efficacy and safety of onabotulinumtoxinA (onabotA; BOTOX) vs. placebo for major depressive disorder (MDD) [NCT02116361]. Primary endpoint was the change in Montgomery-Åsberg Depression Rating Scale (MADRS); secondary endpoints were Clinical Global Impressions-Severity and 17-item Hamilton Depression Rating Scale at week 6. A total of 255 adult females were treated. OnabotA 30 U approached significance compared to p...
In the phase II, randomized, double-blind, placebo-controlled Supplementation of Vigantol Oil versus Placebo Add-on in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) Receiving Rebif Treatment (SOLAR) study (NCT01285401), we assessed the efficacy and safety of add-on vitamin D in patients with RRMS.
In some clinical studies men and women have been found to differ in their ability to quit smoking, perhaps as a result of progesterone. The primary aim of this study was to provide a preliminary test of whether progesterone (PRO), as compared with placebo (PBO), was more effective for smoking cessation in men and women.
This is a double-blind, placebo-controlled, parallel-grouped clinical trial, which was designed to investigate the potential effects of melatonin add-on treatment with lithium and risperidone on acute manic episodes in patients with bipolar disorder (BD). A total of 54 patients were included and randomly assigned into two groups of melatonin and placebo. The trial group received 3 mg/day risperidone, 900 mg/day lithium, and 6 mg/day melatonin. The placebo group received the same dose of risperidone and lith...
Few studies have investigated the prophylactic efficacy of dexmedetomidine (DEX) in postpartum depressive symptoms (PDS). A randomized, double-blind, placebo-controlled trial was conducted to investigate whether the administration of DEX, immediately after delivery and for patient controlled intravenous analgesia (PCIA), can attenuate PDS.
Influence of methazolamide on the human control of breathing: A comparison to acetazolamide.
Acetazolamide is used to prevent/treat acute mountain sickness and both central and obstructive sleep apnoea. Methazolamide, like acetazolamide reduces hypoxic pulmonary vasoconstriction, but has fewer side effects including less skeletal muscle function impairment. Since methazolamide's effects on respiratory control in humans are unknown, we (1) compared the effects of oral methazolamide and acetazolamide on ventilatory control, and (2) determined the ventilation-log PO relationship in humans. In a double...
Immune Thrombocytopenia-A Neglected Adverse Event of PD-1 and PD-L1 Inhibitors in Clinical Trials.
Previous studies have found that patients with Immune thrombocytopenia (ITP) have an increased risk of arterial thrombosis (AT) and venous thromboembolism (VTE). However, risk factors for thrombosis in adults with primary ITP remain unassessed in large cohorts. Aim To assess the occurrence and impact of risk factors for AT and VTE in patients with primary ITP in France and Sweden.
This report describes novel clinical data assessing pharmacodynamics of insulin glargine/lixisenatide (iGlarLixi) compared with placebo and insulin glargine alone, to determine pharmacokinetics of lixisenatide, and to assess safety of iGlarLixi in Japanese patients with type 2 diabetes mellitus (T2DM). In a single-center, open-label, randomized, placebo-controlled crossover study, patients received subcutaneous iGlarLixi 5U/5μg and 10U/10μg, placebo, and 5U insulin glargine. The primary endpoint was area ...
Clinical Bioequivalence of Wixela Inhub and Advair Diskus in Adults With Asthma.
Wixela Inhub is a dry powder inhaler approved as a generic equivalent to Advair Diskus (fluticasone propionate [FP]/salmeterol fixed-dose combination) for patients with asthma or chronic obstructive pulmonary disease (COPD). This study aimed at confirming the local (lung) therapeutic equivalence of both the FP and salmeterol components of Wixela Inhub (test [T]) to Advair Diskus (reference [R]) after inhalation. This randomized, double-blind, double-dummy, placebo-controlled, parallel-group study in patien...
Patients with chronic inflammatory autoimmune diseases benefit from a broad spectrum of immunosuppressive and anti-proliferative medication available today. However, nearly all of these therapeutic compounds have unwanted toxic side effects. Recent knowledge about the neurobiology of placebo responses document that associative learning procedures can be utilized for dose reduction in immunopharmacotherapy while simultaneously maintaining treatment efficacy.
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