Introduction to Randomized Placebo Controlled

The first stage; a double-blind randomized placebo-controlled study will focus on identifying the optimal dose to achieve meaningful change in GSH and Glu during short-term (4 weeks) NAC treatment in 36 women aged 16–24 years with NSSI.

Randomized placebo-controlled trials of nsH1RAs reporting cough endpoints in adolescents or adults with chronic cough or cough-associated allergic respiratory conditions (allergic rhinitis, allergic asthma, or atopic cough) were included.

The CATCH study is a phase IIB double-blind randomized placebo-controlled trial.

The aim of this analysis was to assess the efficacy and safety of the various medications available for severe and non-severe COVID-19 patients based on randomized placebo-controlled trials (RPCTs).

Methods : A single-center randomized placebo-controlled clinical trial involving outpatients with early and mild SARS-CoV-2 infection was conducted.

A pharmaceutical-grade formulation of purified CBD derived from Cannabis sativa has been evaluated in several randomized placebo-controlled adjunctive-therapy trials, which resulted in its regulatory approval for the treatment of seizures associated with Dravet syndrome, Lennox-Gastaut syndrome and tuberous sclerosis complex.

Forty-nine patients were evaluated from three cenobamate regulatory trials: two open-label extensions of randomized placebo-controlled studies and one open-label safety study at the Johns Hopkins Hospital (JHU).

Five randomized placebo-controlled trials with 11 arms were included in the quantitative analysis.

Results The 5HT1F receptor agonist lasmiditan, following two positive randomized placebo-controlled trials, was FDA-approved for the acute treatment of migraine.

MATERIALS AND METHODS ERECT (NCT00737893) is a phase 2, double-blinded, randomized placebo-controlled trial (July 2017-December 2019) evaluating the impact of perioperative erythropoietin on recovery of erectile function and other patient-reported, health-related quality of life outcomes after bilateral nerve-sparing RP (3, 6, 9, and 12-months).

OBJECTIVE The aim of the present randomized placebo-controlled single-center study was to assess the efficacy and safety of a new vaginal gel (Meclon Idra - Alfasigma) in the treatment of vulvovaginal atrophy (VVA).

BackgroundThe Placebo Group Simulation Approach (PGSA) aims at partially replacing Randomized Placebo-Controlled Trials (RPCTs) using data from historical control groups in order to decrease the needed number of study participants exposed to lengthy placebo treatment.

Confirmation of efficacy and safety requires randomized placebo-controlled trials.

Methods: In a randomized placebo-controlled trial, 74 patients with COPD with stable conditions were followed for two months after a random assignment to the placebo and montelukast (10 mg/d) groups.

We searched PubMed, Embase, Cochrane Library, Scopus, and PsycINFO, and the references of the identified articles for randomized and non-randomized placebo-controlled trials.

METHODS We conducted a systematic review and frequentist network meta-analysis, searching five electronic databases for randomized placebo-controlled trials of individuals diagnosed with CUD receiving pharmacotherapy with or without concomitant psychotherapy.

Methods In a male-only parallel randomized placebo-controlled double-blind trial, we investigated the effects of IN-OXT (24 IU) on visual fixation on pictures of faces and emotion recognition in an interactive ball-tossing game that probed processing of social and nonsocial stimuli.

A randomized placebo-controlled study was conducted to assess the effects of combination therapy of milled brown flaxseed and hesperidin during lifestyle intervention on controlling cardiovascular risk in prediabetes.

Recently, however, three relatively small randomized placebo-controlled trials did not find these agents to be superior to placebo.

Randomized placebo-controlled trials demonstrated the efficacy of antifibrotic treatment in non-IPF progressive fibrosing ILD (fILD).

METHODS The Starting Testosterone and Exercise after Hip Injury (STEP-HI) Study is a 6-month Phase 3 multicenter randomized placebo-controlled trial designed to compare supervised exercise (EX) plus 1% testosterone topical gel, with EX plus placebo gel, and with enhanced usual care (EUC).

A randomized placebo-controlled trial was conducted (IRCT20111219008458N2).

We followed single centered, cross-sectional, cohort study with subsequent randomized placebo-controlled design for supplementation and follow up.

DesignWe designed a perspective, randomized placebo-controlled double-blind trial.

A randomized placebo-controlled trial is warranted.

The impact of erdostein on the rate and duration of COPD exacerbations has been proved in randomized placebo-controlled trial RESTORE.

Findings from the randomized placebo-controlled phase III NEURO-TTR study showed treatment benefit of inotersen, an antisense oligonucleotide, for preserving or improving HRQOL after 65 weeks of treatment.

This approval was preceded by an open-label study and three randomized placebo-controlled trials, each assessing the safety, tolerability, and efficacy of brexanolone, using mean Hamilton Rating Scale for Depression (HAM-D) score reduction as the primary outcome.

STUDY SELECTION Randomized placebo-controlled CVOTs of SGLT2is and GLP-1RAs that reported HRs (95% CIs) for 1) major adverse cardiovascular event (MACE) in patients with diabetes and 2) cardiovascular (CV) death/hospitalization for heart failure (HHF) in patients with HF and reduced ejection fraction (HFrEF).

In this randomized placebo-controlled trial, we assessed functional brain activation during learning and memory retrieval in healthy volunteers performing associative learning tasks aiming to translate facilitated relearning by SSRIs.

gov identifier: NCT03680274), a randomized placebo-controlled trial of high-dose intravenous vitamin C.

DESIGN We conducted a systematic review (PubMed, PsycInfo, Cochrane databases, up to August 2020) and a random-effect meta-analysis of double-blind, randomized placebo-controlled trials (RCTs) involving melatonin and melatonin-agonists in the treatment of antipsychotic-induced metabolic changes.

This study plans to enroll 1224 patients from 34 VA Medical Centers into a 12- week prospective, randomized placebo-controlled clinical trial comparing trazodone, eszopiclone, and gabapentin.

Additional large-scale randomized placebo-controlled studies on the role of vitamin D in COVID-19 pathogenesis are needed.

Further investigations in larger cohorts and randomized placebo-controlled trials should be performed to confirm these findings as well as to improve delivery strategies to the brain, through the inherent barriers and ultimately to the malignant cells.

In this double-blind randomized placebo-controlled counterbalanced human laboratory experiment, we examined the effects of three different dose ratios of CBD: THC (1:1, 2:1 and 3:1) on neural noise, an electrophysiological biomarker of psychosis known to be sensitive to cannabinoids as well as subjective and psychotomimetic effects.

METHODS As part of a monocentric randomized placebo-controlled double-blind study (registered at www.

Efficacy and safety of canakinumab in Schnitzler syndrome: a multicenter randomized placebo-controlled study.

Summarizing five randomized placebo-controlled trials, the authors concluded that “collagen is effective in improving OA symptoms by the decrease of both WOMAC [Western Ontario and McMaster Universities Osteoarthritis] index and VAS [Visual Analog Scale pain] score.

To evaluate the efficiency of allogeneic MSCs for the treatment of critical lower limb ischemia (randomized placebo-controlled study).

MATERIALS AND METHODS A 26-week randomized placebo-controlled study investigated the efficacy and safety of liraglutide 1.

Based on data that angiogenesis plays a role in urothelial carcinoma growth and progression, a randomized placebo-controlled trial was performed with the primary objective of testing whether patients treated with GC and bevacizumab (GCB) have superior overall survival (OS) than patients treated with GC and placebo (GCP).

In an investigator-initiated double-blind randomized placebo-controlled trial the effect of 18 weeks of treatment with liraglutide on diastolic function was assessed in type 2 diabetes patients and echocardiographic signs of diastolic dysfunction (echo-Doppler determined E/e'≥9 or/and lateral e'≤10 cm/sec).

Additionally, the effects of administering a single ascending dose of PF-06835919 on fructose metabolism markers in healthy human study participants were assessed in a randomized placebo-controlled phase 1 study.

Materials and Methods: This double-blind randomized placebo-controlled trial in four month was conducted on 120 angiography candidates in Valiasr hospital, Birjand, Iran.

Remdesivir has demonstrated clinical benefits in randomized placebo-controlled trials (RCTs) in patients with coronavirus disease 2019 (COVID-19)1-4 and was first approved for COVID-19 patients.

Methods The present article summarizes the evidence gathered with this new migraine preventive drug class from randomized placebo-controlled clinical trials.

CONCLUSIONS Randomized placebo-controlled trials of ketorolac use in this population are lacking; however, most published reports noted efficacy and safety with ketorolac in properly selected infants.

We investigated the genetic (AKT1 rs1130233) and epigenetic modulation of brain function during fear processing in a 2-session, double-blind, cross-over, randomized placebo-controlled THC administration, in 36 healthy males.

Erectile Dysfunction A Prospective Randomized Placebo-Controlled Study Evaluating the Effect of Low-Intensity Extracorporeal Shockwave Therapy (LI-ESWT) in Men With Erectile Dysfunction Following Radical Prostatectomy.

Objective We aimed to conduct a double-blind, parallel-arm, single-cohort, remote, randomized placebo-controlled trial for a self-administered behavioral skills-based VR program in community-based individuals with self-reported chronic low back pain during the COVID-19 pandemic.

Noteworthy, the available data is mostly found in patents and supplier brochures, and not in randomized placebo-controlled studies.

Experimental Design: In a double-blind randomized placebo-controlled trial performed in the Amsterdam University Medical Center, we assigned 24 cachectic patients with metastatic HER2-negative gastroesophageal cancer to either allogenic FMT (healthy obese donor) or autologous FMT, prior to palliative chemotherapy (capecitabine and oxaliplatin).

STUDY DESIGN Randomized placebo-controlled cross-over study.

Further large-scale, randomized placebo-controlled clinical trials are, however, awaited to validate these findings.

Methods A prospective randomized placebo-controlled study was conducted with blinded to patients.

RESULTS Our review of 7 recently published randomized placebo-controlled trials with 2348 subjects receiving SLIT, reported increased efficacy, safety, supportive immunological parameters (IgE and IgG4 levels pre- and post-treatment levels) and improved quality of life.

Meta-analyses of randomized placebo-controlled ω-3 PUFAs intervention-trials suggest that primarily eicosapentaenoic acid (EPA), but not docosahexaenoic acid (DHA), is responsible for the proposed antidepressant effect.

Conclusions and relevance The present study is the first randomized placebo-controlled trial of smoked cannabis for PTSD.

Methods: This is a two-arm, parallel-group, prospective randomized placebo-controlled clinical trial.

CONCLUSION This study suggests that dupilumab may be an effective treatment for patients with CPUO and supports the design of future randomized placebo-controlled trials to prove its efficacy.

OBJECTIVE To provide a systematic review and meta-analysis of randomized placebo-controlled trials for common therapy classes for AR to assess standardized treatment effect on validated patient-reported outcomes and physiologic measures of airflow.

A randomized placebo-controlled trial of the BNT162b2 vaccine has demonstrated a 95% efficacy in preventing COVID-19 disease.

The aim of this randomized placebo-controlled crossover study was to compare the acute effect on young athletes of a single session of roller massager (RM) with that obtained from passive static stretching (PSS) and a placebo intervention (PL) on hamstring flexibility and on strength.

MATERIAL AND METHODS This randomized placebo-controlled trial assigned 150 patients undergoing unilateral primary total hip arthroplasty who underwent direct anterior approach surgery to 3 groups: group A received TXA plus topical CSS; group B received TXA only; and group C received placebo.

CONCLUSIONS The totality of blinded, randomized placebo-controlled data shows that renal denervation is safe and provides genuine reduction in blood pressure for at least 6 months post-procedure.

The authors conducted the first randomized placebo-controlled trial testing the effect of the KCNQ2/3 positive modulator ezogabine on reward circuit activity and clinical outcomes in patients with depression.

Phase I–II clinical trials of the vaccine have started that consist of two stages: Stage 1 is an open study of the safety, reactogenicity, and immunological activity of the vaccine with the involvement of 14 volunteers aged 18–30 years; Stage 2 is a single blind, comparative, randomized placebo-controlled study with the involvement of 86 volunteers.

6vz_jLtTkCJ6tzGx5HdiGv Video abstract: Effect of Dupilumab on Laboratory Parameters in Adolescents with Atopic Dermatitis: Results from a Randomized Placebo-Controlled Phase 3 Clinical Trial (MP4 175137 KB) Video abstract: Effect of Dupilumab on Laboratory Parameters in Adolescents with Atopic Dermatitis: Results from a Randomized Placebo-Controlled Phase 3 Clinical Trial (MP4 175137 KB).

DESIGN Systematic review and random effects meta-analysis of blinded randomized placebo-controlled trials reporting the effect extended-release naltrexone on alcohol consumption SETTING: Outpatient clinics PARTICIPANTS: 7 trials evaluating a total of 1500 adults with AUD receiving monthly injections of either placebo or extended-release naltrexone at doses of 150-400mg for 2-6 months and some form of behavioral therapy.

The recent double-blind randomized placebo-controlled trial (DBRPCT) reported that adjunctive melatonin administration was not superior to placebo in improving the mania scale scores of patients who received mood stabilizers or antipsychotics.

This randomized placebo-controlled trial (NCT01896895; EudraCT number 2012-004821-26) assessed the efficacy, safety, and treatment effect duration of incobotulinumtoxinA (Xeomin, Merz Pharmaceuticals GmbH), a BoNT-A formulation without complexing proteins, in BoNT-A-naïve adults with blepharospasm.

AIM This randomized placebo-controlled trial assesses the effect of a 26-week intervention composed of either 2.

Methods: This study was a single-blind randomized placebo-controlled trial.

Messenger RNA (mRNA) BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) COVID-19 vaccines have been shown to be effective in preventing symptomatic COVID-19 in randomized placebo-controlled Phase III trials (1,2); however, the benefits of these vaccines for preventing asymptomatic and symptomatic SARS-CoV-2 (the virus that causes COVID-19) infection, particularly when administered in real-world conditions, is less well understood.

Methods: This was a randomized placebo-controlled, double-masked study.

Objective To assess the effectiveness of PBM to mitigate clinical signs of PD in a prospective proof-of-concept study, using a combination of transcranial and remote treatment, in order to inform on best practice for a larger randomized placebo-controlled trial (RCT).

0–30 kg/m2) adults between 18–45 y old were recruited to this single-blinded randomized placebo-controlled study.

More recently, inhaled treprostinil showed positive effects on the primary endpoint (six-min walk-distance) in the largest prospective randomized placebo-controlled trial to date in this patient population.

BACKGROUND We have reported earlier in a randomized placebo-controlled trial that WRSS1, a live oral Shigella sonnei vaccine candidate is safe in Bangladeshi adults and children, and elicits antigen-specific antibody responses.

This was a randomized placebo-controlled triple-blind clinical trial.

Through a double-blind randomized placebo-controlled phase 2 trial, we will determine whether microbiota restoration using fecal microbiota transplantation (FMT) prevents infections in AML patients.

Key Points Question What is the safety, tolerability, pharmacodynamic, and pharmacokinetic profile of the histone deacetylase inhibitor FRM-0334 in participants with progranulin gene (GRN) haploinsufficiency? Findings In this randomized placebo-controlled clinical trial including 27 participants with GRN haploinsufficiency, FRM-0334 was safe and well tolerated; however, it failed to increase plasma progranulin and cerebrospinal fluid progranulin and failed to demonstrate dose-dependent oral bioavailability.

Empirical AF in intensive care unit (ICU) is current practice, although a recent randomized placebo-controlled trial did not demonstrate any survival benefit [2].

Methods This double-blind randomized placebo-controlled study will investigate the efficacy of probiotics to prevent radiation-induced enteropathy in patients with gynecologic or urologic cancer who received pelvic radiotherapy.

The present research tests the efficacy an empathic-supervision exercise with PPOs to mitigate recidivism in a longitudinal, randomized placebo-controlled field experiment with 216 officers who supervise ∼20,478 APPs.

Serum CFP-10 peptide signal was blinded evaluated in cryopreserved sera of 519 BCG-immunized, HIV-exposed infants (284 HIV-infected, 235 HIV-uninfected) from a multi-center randomized placebo-controlled isoniazid prophylaxis trial conducted in southern Africa between 2004 and 2008, who were followed up to 192 weeks for Mtb infection and TB.

This was a randomized placebo-controlled trial.

We describe the design of a 26-wk randomized placebo-controlled trial with multiple-micronutrient–fortified biscuits (MMBs) among adolescent girls in northeastern Ghana.

AIM To evaluate whether sildenafil use is associated with increased risk of BCR in patients receiving prostate RT, we performed a secondary analysis of a randomized placebo-controlled trial (RPCT) that compared sildenafil citrate to placebo during and after prostate RT.