Introduction to Versus Placebo
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Versus Placebo sentence examples within randomized controlled trial
To summarize the evidence from systematic reviews (SRs) of randomized controlled trials (RCTs) evaluating the efficacy and safety of sodium‐glucose cotransporter‐2 (SGLT2) inhibitors versus placebo or active comparators for type 2 diabetes mellitus.
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Method: This secondary analysis of a randomized controlled trial of an injection of GC and local anaesthetic (LA) versus placebo included 44 patients with GTPS.
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Versus Placebo sentence examples within randomized double blind
70 individuals were enrolled in a parallel-group, randomized, double-blind, placebo-controlled, forced-titration trial of CBZ (n=35) versus placebo (n=35).
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METHODS
This was a randomized, double-blind, placebo-controlled trial of sucralfate versus placebo conducted between 2017 and 2018 in an urban pediatric emergency department.
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Versus Placebo sentence examples within randomised controlled trial
We tested this hypothesis in a follow-up study of children born to obese mothers who had participated in a randomised controlled trial of metformin versus placebo in pregnancy (EMPOWaR).
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5 In a multicenter exploratory, randomised controlled trial of various pharmacologic agents used for PDA closure versus placebo in 202 very preterm infants (<28 weeks' gestation) of whom 49% were intubated on IMV and 48% required nasal ventilation of CPAP, treated at 6– 14 days after birth, no differences in rates of ligation, the presence of PDA at hospital discharge, nor any differences in NEC, BPD, BPD and/or death, or death were found among those receiving pharmacologic closure versus placebotreated infants, while the rate of lateonset neonatal sepsis was increased among treated infants.
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Versus Placebo sentence examples within least squares mean
In Part B of the 2-part, phase 2 LILAC study (NCT02847598), the primary endpoint was met: BIIB059 significantly reduced CLE activity, as evidenced by a statistically significant dose response and statistically significant differences in least-squares mean percent changes in Cutaneous Lupus Erythematosus Disease Area and Severity Index – Activity (CLASI-A) score1 versus placebo.
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At week 16, hemoglobin had increased significantly with ferric maltol versus placebo (least-squares mean [standard error] difference: 0.
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Versus Placebo sentence examples within double blind randomized
METHODS
92 biomarkers associated with immunity, chemotaxis, and metabolism were measured in plasma samples from 61 PWH with NAFLD who participated in a double-blind, randomized trial of tesamorelin versus placebo for 12 months.
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STUDY DESIGN
A prospective double-blind randomized controlled trial of mupirocin versus placebo in S.
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Versus Placebo sentence examples within randomized clinical trial
Methods
This randomized clinical trial compared HCTZ 50 mg versus placebo for 3 days in patients with ADHF and signs of congestion.
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RESEARCH QUESTION
Does a single high-dose (540,000 IU) enteral treatment of vitamin D3 given shortly after hospital admission in vitamin D deficient, critically-ill patients improve long-term global cognition or executive function?
STUDY DESIGN AND METHODS
This study evaluated long-term cognitive outcomes among patients enrolled in a multicenter, blinded, randomized clinical trial comparing vitamin D3 treatment versus placebo in critically-ill adults with vitamin D deficiency.
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Versus Placebo sentence examples within randomised double blind
Methods We performed a randomised double-blind placebo-controlled single-centre trial of simvastatin at a daily dose of 40 mg versus placebo in patients with Global Initiative for Chronic Obstructive Lung Disease criteria grades 2–4 at a tertiary care pulmonology department in Austria.
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We report results of pooled analyses from 2 randomised, double-blind, placebo-controlled phase 3 studies (SINUS 24 [NCT02912468]; SINUS-52 [NCT02898454]) to evaluate dupilumab effect versus placebo in adults with CRSwNP with/without SCS use and sinonasal surgery.
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Versus Placebo sentence examples within 95 % confidence
Versus Placebo sentence examples within phase 3 trial
In the era of VEGFtargeted therapy, a randomised controlled phase 3 trial of pazopanib versus placebo in treatmentnaive mRCC which allowed crossover into the active treatment arm upon progression demonstrated no statistically significant difference in final overall survival (OS) between pazopanibtreated and placebotreated patients (22.
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The phase 3 trial PALISADE, comparing peanut (Arachis hypogaea) allergen powder-dnfp (PTAH) oral immunotherapy versus placebo in peanut-allergic children, reported that a significantly higher percentage of PTAH-treated participants tolerated higher doses of peanut protein after 1 year of treatment.
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Versus Placebo sentence examples within progression free survival
Background Sunitinib prolonged progression-free survival (PFS) versus placebo in patients with metastatic pancreatic neuroendocrine tumors (panNETs) in a phase III trial.
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BACKGROUND
Olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, has previously been shown to extend progression-free survival versus placebo when given to patients with relapsed high-grade serous or endometrioid ovarian cancer who were platinum sensitive and who had a BRCA1 or BRCA2 (BRCA1/2) mutation, as part of the SOLO2/ENGOT-Ov21 trial.
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Versus Placebo sentence examples within hazard ratio 0
Results: Empagliflozin reduced the combined risk of cardiovascular death, hospitalization for heart failure, or an emergency or urgent heart failure visit requiring intravenous treatment (432 versus 546 patients [empagliflozin versus placebo, respectively]; hazard ratio, 0.
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In adults, month 12 glycemic worsening was less on LIRA+MET versus placebo (hazard ratio 0.
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Versus Placebo sentence examples within double blind randomised
Methods: An 8-week parallel arm, double-blind, randomised, placebo-controlled trial of OROS-methylphenidate versus placebo in 200 male prisoners from two young offender prisons in Southeast England and Scotland.
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SELECTION CRITERIA
We considered double-blind, randomised controlled trials (RCTs) of cilostazol versus placebo, or versus other drugs used to improve claudication distance in patients with stable intermittent claudication.
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Versus Placebo sentence examples within chronic kidney disease
AGREE II, Appraisal of Guidelines for Research and Evaluation II; ALT, alanine aminotransferase; AST, aspartate aminotransferase; AUC, area under the receiver operating characteristic curve; BMI, body mass index; CAP, controlled attenuation parameter; CKD, chronic kidney disease; CT, computed tomography; CVD, cardiovascular disease; ELF, enhanced liver fibrosis; FIB-4, fibrosis-4 index; FLI, fatty liver index; GLP-1, glucagon-like peptide-1; GRADE, Grading of Recommendations, Assessment, Development and Evaluation; GREACE, GREek Atorvastatin and Coronary-heart-disease Evaluation; HCC, hepatocellular carcinoma; HIS, hepatic steatosis index; KASL, the Korean Association for the Study of the Liver; LDL-C, low density lipoprotein cholesterol; LT, liver transplantation; MAFLD, metabolic (dysfunction)-associated fatty liver disease; METs, metabolic equivalents of task; MRE, magnetic resonance elastography; MRI-PDFF, MRI proton density fat fraction; MRI, magnetic resonance imaging; MRS, MR spectroscopy; NAFL, nonalcoholic fatty liver; NAFLD, nonalcoholic fatty liver disease; NAS, NAFLD activity score; NASH, nonalcoholic steatohepatitis; NFS, NAFLD fibrosis score; NLFS, NAFLD liver fat score; PIVENS, Pioglitazone versus Vitamin E versus Placebo for the Treatment of Nondiabetic Patients with Nonalcoholic Steatohepatitis; PNPLA3, the patatin-like phospholipase domain–containing 3; PPAR-γ, peroxisome proliferator activated receptor gamma; SAMM50, sorting and assembly machinery component 50; SWE, shear wave elastography; T2DM, type 2 diabetes mellitus; TM6SF2, transmembrane 6 superfamily, member 2.
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Introduction Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that has demonstrated safety and efficacy versus placebo in phase III trials in patients with anemia of chronic kidney disease (CKD) who were not on dialysis (NDD).
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Versus Placebo sentence examples within statistically significant improvement
Results: Both the q4w and q2w dupilumab + TCS regimens resulted in clinically meaningful and statistically significant improvement in signs, symptoms, and quality of life (QOL) versus placebo + TCS in all prespecified endpoints.
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FINDINGS
For HbA1c and FPG, the results suggested a statistically significant improvement with evogliptin versus placebo (HbA1c, -0.
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Versus Placebo sentence examples within mg twice daily
METHODS
We conducted a randomized control trial of amoxicillin 500 mg twice daily versus placebo for 7 days in women ages 18-45 without vaginitis who screened positive for vaginal colonization with GV by qPCR.
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1,2 In STYLE (NCT03123471), oral apremilast 30 mg twice daily (BID) demonstrated significantly greater improvements in moderate to severe plaque psoriasis of the scalp, scalp itch, whole body itch, and QOL versus placebo3 during the 16-week, placebo-controlled phase; safety and tolerability were consistent with the known safety profile of apremilast.
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Versus Placebo sentence examples within coronary heart disease
SELECTION CRITERIA
Randomised clinical trials assessing the effects of antibiotics versus placebo or no intervention for secondary prevention of coronary heart disease in adult participants (≥18 years).
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We conducted a systematic review and meta-analysis to explore the influence of colchicine administration versus placebo on treatment efficacy for coronary heart disease.
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Versus Placebo sentence examples within improved overall survival
Cabozantinib improved overall survival (OS) and progression-free survival (PFS) versus placebo in patients with previously treated HCC.
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BACKGROUND
In the phase 3 KEYNOTE-189 study (NCT02578680), pembrolizumab plus pemetrexed and platinum-based chemotherapy (pemetrexed-platinum) significantly improved overall survival (OS) and progression-free survival (PFS) in patients with previously untreated metastatic nonsquamous NSCLC versus placebo plus pemetrexed-platinum.
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Versus Placebo sentence examples within attention deficit hyperactivity
Objective: Delayed-release and extended-release methylphenidate (DR/ER-MPH), the first stimulant predicted to be absorbed primarily in the colon, demonstrated significant improvements in attention-deficit/hyperactivity disorder (ADHD) symptoms and functional impairment from awakening until evening versus placebo in clinical trials.
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Objective: To examine the efficacy of lisdexamfetamine (LDX) versus placebo on behavioral attributes of sluggish cognitive tempo (SCT) in adults with attention-deficit/hyperactivity disorder (ADHD) and SCT.
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Versus Placebo sentence examples within plus fulvestrant significantly
PURPOSE
In MONARCH 2, abemaciclib plus fulvestrant significantly prolonged progression-free survival (PFS) and overall survival (OS) versus placebo plus fulvestrant in patients with hormone receptor positive (HR+), HER2- advanced breast cancer.
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Conclusions: The study met its primary endpoint, demonstrating that dalpiciclib plus fulvestrant significantly improved PFS versus placebo plus fulvestrant, with a manageable safety profile.
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Versus Placebo sentence examples within included randomized controlled
We included randomized controlled trials (RCTs) in addition to cohort studies that compared tofacitinib oral treatment versus placebo in patients with active UC, with a moderate to severe degree.
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We included randomized controlled trials comparing the effects of psychotropic drugs versus placebo or versus another drug of the same class, for at least 5 weeks.
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Versus Placebo sentence examples within adjusted mean difference
Pairwise comparisons showed greater mean improvement from baseline in MCCB overall composite T-score at week 12 with BI 425809 10 mg and 25 mg versus placebo (adjusted mean difference 1·98 [95% CI 0·43-3·53] for 10 mg and 1·73 [0·18-3·28] for 25 mg; standardised effect size 0·34 for 10 mg and 0·30 for 25 mg).
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The study met its primary endpoint: the adjusted mean difference in 2-h C-peptide AUC at 12 months for imatinib versus placebo treatment was 0·095 (90% CI -0·003 to 0·191; p=0·048, one-tailed test).
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Versus Placebo sentence examples within nivolumab plus ipilimumab
Versus Placebo sentence examples within non small cell
Patients & methods: PACIFIC was a Phase III study of durvalumab versus placebo after CRT in patients with unresectable, stage III non-small-cell lung cancer.
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Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial.
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Versus Placebo sentence examples within 2 results showed
1 Phase 2 results showed deucravacitinib was efficacious and well tolerated versus placebo in patients with moderate to severe plaque psoriasis or active psoriatic arthritis.
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Phase 2 results showed deucravacitinib was efficacious and well tolerated versus placebo (PBO) in patients with active psoriatic arthritis (PsA).
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Versus Placebo sentence examples within % 95 %
Significant improvements in markers of haemolysis, as assessed by the difference in adjusted mean percentage change from baseline at week 72 versus placebo, were observed in the voxelotor 1500 mg group in indirect bilirubin concentrations (-26·6% [95% CI -40·2 to -12·9]) and percentage of reticulocytes (-18·6% [-33·9 to -3·3]).
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Among patients with chronic pain, moderate certainty evidence found that medical cannabis probably results in a small improvement in sleep quality versus placebo (modeled risk difference [RD] for achieving the minimally important difference [MID], 8% [95% CI, 3 to 12]).
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Versus Placebo sentence examples within low certainty evidence
IR methylphenidate versus placebo We found very low-certainty evidence that, compared with placebo, IR methylphenidate may reduce symptoms of ADHD when measured with investigator-rated scales (MD -20.
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Ketorolac versus placebo Very low-certainty evidence from eight studies (658 participants) suggests that ketorolac results in a large increase in the number of participants achieving at least 50% pain relief over four hours compared to placebo, but the evidence is very uncertain (risk ratio (RR) 2.
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Versus Placebo sentence examples within simvastatin 40 mg
Patients with compensated cirrhosis with clinically significant portal hypertension will be stratified based upon the concomitant use of nonselective beta-blockers and randomized to simvastatin 40 mg/day versus placebo for up to 24 months.
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Patients with compensated cirrhosis with clinically significant portal hypertension will be stratified based upon the concomitant use of nonselective beta-blockers and randomized to simvastatin 40 mg/day versus placebo for up to 24 months.
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Versus Placebo sentence examples within magnetic resonance imaging
METHODS AND RESULTS
We performed a systematic review and meta-analysis of RCTs to compare SGLT2i versus placebo (treatment duration >3 months) on cardiac remodelling parameters as measured by cardiac magnetic resonance imaging (cMRI) in patients with HF and/or diabetes.
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In a phase 2b dose-ranging study of baricitinib in combination with traditional disease-modifying antirheumatic drugs (DMARDs) in RA patients, magnetic resonance imaging showed that baricitinib 2 mg or 4 mg once daily provided dose-dependent suppression of synovitis, osteitis, erosion and cartilage loss at weeks 12 and 24 versus placebo.
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Versus Placebo sentence examples within double blind placebo
This investigator-initiated phase 2, double-blind, placebo-controlled study of SLE that was refractory to conventional treatment randomly assigned 52 patients to belimumab versus placebo 4 to 8 weeks after treatment with rituximab.
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PURPOSE
The double-blind, placebo-controlled, phase III TOURMALINE-MM1 study demonstrated a statistically significant improvement in progression-free survival with ixazomib-lenalidomide-dexamethasone (ixazomib-Rd) versus placebo-Rd in patients with relapsed or refractory multiple myeloma.
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Versus Placebo sentence examples within blinded placebo controlled
The CaCo trial [2], which is an ongoing double-blinded, placebo-controlled, randomized trial comparing the effect of different doses of caffeine versus placebo on bowel recovery after elective colectomy, is also randomizing patients to study groups only after the surgical procedure.
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