Introduction to 3 Randomized

What is/are 3 Randomized?

3 Randomized - Seven clinical trials – 3 randomized controlled trials, 1 unrandomized clinical trial and 3 uncontrolled clinical trials were identified. ^[1] A total of 23 randomized controlled trials were included in this network meta-analysis. ^[2] RESULTS Of 343 randomized patients (LEV 177; TPM 166), 211 (61. ^[3] EVIDENCE SYNTHESIS We identified 9 studies to be included in the qualitative synthesis and 3 randomized controlled trials (RCTs) to be included in the quantitative synthesis and the meta-analysis. ^[4] Methods: Analyses were carried out to assess the association between clinical characteristics and margin involvement as well as the effects of individual margin involvement on site of recurrence and overall and recurrence-free survival using individual patient data from the European Study Group for Pancreatic Cancer (ESPAC)-3 randomized controlled trial. ^[5] We identified 18 studies on PTSD including 13 randomized controlled trials (RCTs; 654 participants) and 5 single-group trials (60 participants). ^[6] Methods: A secondary analysis from 3 randomized clinical trials involving ED patients with acute chest pain was performed to determine whether a care pathway, ACES (Accelerated Chest pain Evaluation with Stress imaging), reduces the racial disparity in index visit cardiac testing between African American (AA) and White patients. ^[7] Results: A total of 1,885 cases were included in 13 randomized controlled studies. ^[8] RESULTS There were 13 randomized controlled-trial studies published from 1998 to 2017. ^[9] Seven articles, including 3 randomized controlled trials and 4 case series, were included in our analysis. ^[10] 3400 articles were retrieved, and abstracts were further screened using the inclusion criteria to obtain a final set of 83 randomized controlled trials and retrospective/prospective studies. ^[11] The efficacy and safety of mechanical hemodynamic support in patients undergoing high-risk percutaneous coronary intervention with or without cardiogenic shock: Bayesian approach network meta-analysis of 13 randomized controlled trials. ^[12] METHODS: Crossover evaluation with 3 randomized-order, 10-min conditions: at rest and with and without a gas mask using 2 different filtered cartridges, each with a distinct inspiratory resistance (cartridge A = 3. ^[13] Results: A total of 7 studies were included to perform a meta-analysis, 3 randomized trials and 4 observational studies with 2211 patients, 1281 treated with Crush and 930 with Culotte. ^[14] Of the 370 enrolled, 40 had T-NHL: 12 were not randomized due to ineligibility (n = 1), choice (n = 2), or progression (n = 9), leaving 13 randomized to control and 15 to autologous stem cell transplantation (ASCT). ^[15] Therefore, it included 63 randomized trials looking at the effectiveness and cost-effectiveness of exercise-based cardiac rehabilitation in patients with coronary heart disease. ^[16] Results We enrolled 16 studies (1,863 participants) including 3 randomized controlled trials (RCTs) and 13 observational studies. ^[17] METHODS A subset of patients (n=116) enrolled in three Phase-3 randomized clinical trials (AMAGINE-1,2,3) participated in a mechanistic sub-study where punch biopsies were collected (lesional and non-lesional skin) between baseline and 12-weeks. ^[18] Seventeen healthy subjects (23 ± 2 years) performed with the 10-repetition maximum load on the leg press (211 ± 45 kg) a total of 40 repetitions with 720 seconds of rest in 3 randomized experimental sessions with the same work-to-rest ratio. ^[19] After data extraction and quality evaluation, 13 randomized controlled trials, including 1559 patients, were assessed in this analysis. ^[20] The meta‐analyses of 13 randomized controlled trials and 22 uncontrolled before‐and‐after studies (1420 participants) revealed significant reductions on AHI (d = −0. ^[21] We report results from 30 of 33 randomized with analyzable food photos. ^[22] Results: In total, 13 randomized controlled trials involving 1190 patients were included. ^[23] We provided one-time cash transfers of about USD 1000 to over 10,500 poor households across 653 randomized villages in rural Kenya. ^[24] Results: A total of 3,584 cycles were identified from 13 randomized controlled trials. ^[25] ) with poorly controlled persistent asthma that participated as control subjects in 1 of 3 randomized trials of urban school-based asthma care (study duration: 7-10 months). ^[26] Results Data were extracted from 28 studies, including 4 controlled studies (3 randomized). ^[27] The analysis was based on primary data from 3 randomized controlled trials (COU-AA-302, IMPACT, and PREVAIL). ^[28] Methods: A systematic search of Medline, Embase, CINAHL, SPORTDiscus, and Springer identified 13 randomized control trials utilizing an exercise intervention combined with blood flow restriction, while measuring at least one objective measure of physical function. ^[29] A total of 1,756 patients (853 randomized to placebo and 903 to MRA) ≥75 years of age, along with 4,411 patients (2,242 randomized to placebo and 2,169 to MRA) <75 years of age were included. ^[30] 47 patients met inclusion criteria, 23 randomized to the experimental group and 24 to the control group. ^[31] We reviewed the results of 3 randomized controlled trials and their subgroup analyses and open-label extensions. ^[32] Proportional Effect of Aspirin on CVD and Bleeding Risk The proportional (relative) effect of aspirin on CVD and bleeding risk was obtained from an updated systematic review and meta-analysis of 13 randomized controlled trials that included 164225 participants and compared aspirin (daily dose, 50 to 500 mg) with an inactive control among adults without established CVD (7). ^[33] The research was carried out in factorial 2×3 Randomized Complete Block Design which consist of mulch and unmulched condition as 1 st factor and three different planting depth of (10cm, 15cm and 20cm) as 2 nd factor. ^[34] Results Nineteen studies with a total of 15,320 participants, including 13 randomized controlled trials (RCTs), were included. ^[35] The testing protocol consisted of 3 randomized trials of treadmill walking for 5 minutes in each of three conditions: unloaded, single-strap bag and double-strap bag. ^[36] Results— Fifty-one studies (3 randomized controlled trials, 13 prepost intervention studies, and 35 observational studies) with in total 8467 patients were included. ^[37] After irrelevant articles were discarded, 5 articles (3 randomized controlled trials and 2 retrospective chart reviews) including 636 subjects were analyzed. ^[38] BACKGROUND Preoperative long-course chemoradiotherapy (CRT) and short-course radiotherapy (SCR) for locally advanced rectal cancer (LARC) were found to have equivalent outcomes in 3 randomized trials. ^[39] Results: A total of 614 participants were included in 13 randomized controlled studies. ^[40] METHODS Based on a literature search from 1 January 1946 to 11 April 2018, we identified 133 randomized controlled trials allocating healthy or hypertensive individuals to SR or usual sodium intake. ^[41] New since the 2013 guideline are 3 randomized controlled trials (RCTs) that support the use of nonstatin lipid-modifying medications to reduce ASCVD events in patients at highest risk. ^[42] Results A total of 1645 subjects in 13 randomized controlled trials (RCTs) were enrolled, including 768 cases in the trial group and 877 cases in the control group. ^[43] Results Of 733 randomized pts (niraparib, 487; PBO, 246), 373 (51%) were HRDpos (niraparib, 247; PBO, 126). ^[44] We searched PubMed from inception until October 3, 2018, for phase 2 and 3 randomized controlled trials (RCTs) evaluating the effects of 2. ^[45] None of the 3 randomized controlled trials (RCTs) in patients who had failed PDE5i monotherapy found a superior effect on IIEF scores from the combination of androgen plus PDE5i compared with PDE5i monotherapy. ^[46] RESULTS 3 randomized controlled trials (RCTs, n=421) and 5 observational studies (n=6683) were included in this updated meta-analysis. ^[47] Results: Forty-eight out of 503 randomized patients (9. ^[48] Outcomes were measured in 3 randomized conditions (no brace, forearm band, or elbow sleeve). ^[49] 4% female) were enrolled in a 2 × 3 randomized-controlled trial (RCT) that compared an intervention and wait-list control group. ^[50]

double blind placebo

BackgroundIn a phase 3 randomized, double-blind, placebo-controlled trial, treatment with idelalisib, a phosphoinositol-3 kinase δ inhibitor, + bendamustine/rituximab improved progression-free survival (PFS) and overall survival (OS) in adult patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL). ^[1] METHOD Four ongoing Phase 3 randomized, double-blind, placebo-controlled, outpatient, US studies are investigating the efficacy and safety of once-daily SPN-812 for ADHD in children (ages 6-11; 100-400mg) and adolescents (ages 12-17; 200-600mg). ^[2] Methods: This phase 3 randomized, double-blind, placebo-controlled withdrawal trial in 26 adults with LEMS compared efficacy of amifampridine phosphate versus placebo over a 4-day period. ^[3] Patients from 3 randomized, double-blind, placebo-controlled studies who met DSM-IV-TR or DSM-5 criteria for bipolar I disorder with a current major depressive episode were identified to have concurrent manic symptoms by baseline Young Mania Rating Scale total score ≥4. ^[4] Methods Patients rolled over into this 52-week study (amended to 26 weeks) from 3 randomized, double-blind, placebo-controlled studies. ^[5]

non randomized controlled

This systematic review and meta-analysis of 23 randomized and non randomized controlled trials in 3389 children, of which more than 90% of the studies (21 among the 23 studies) concerned pediatric cardiac surgical patients, revealed that trials where GDFHT aiming to determine the impact on postoperative outcome in children were not developed compared to what has been realized in adults. ^[1] RESULTS In total, 16 studies with 4457 patients, including 3 randomized controlled trials (RCTs) and 13 non-randomized controlled trials (nRCTs), were analyzed. ^[2] The included studies consist of 8 uncontrolled trial, 7 case reports, 3 randomized controlled trials and 1 non-randomized controlled trials. ^[3] EVIDENCE SYNTHESIS A total of 27 studies were included, namely 3 randomized and 24 non-randomized controlled studies, resulting in 4712 patients, 2690 (57%) participants to some ERAS protocol and 2022 (43%) controls receiving standard of care. ^[4] Principal findingsThirty-eight studies that provided level II or level III evidence were included (33 randomized-controlled trials and five non-randomized-controlled studies). ^[5]

placebo controlled trial

In recent phase 2 and phase 3 randomized placebo-controlled trials, teprotumumab rapidly achieved improvement in clinical endpoints defining TED, including improved proptosis and diplopia. ^[1] CONCLUSIONS In this phase 3 randomized, placebo-controlled trial involving participants with sickle cell disease, voxelotor significantly increased hemoglobin levels and reduced markers of hemolysis. ^[2] We aimed at estimating the placebo rates of remission, response, and mucosal healing (MH) in phase 2 and 3 randomized placebo-controlled trials of biologics and small molecule drugs that used homogeneous criteria for the assessment of outcomes. ^[3] Methods: Data came from the phase 3 randomized placebo-controlled trial MEASURE 1 (NCT01358175)1 in which patients were treated with secukinumab (intravenous loading of 10 mg/kg at weeks 0, 2, and 4, followed by secukinumab subcutaneously at a dose of either 75 mg or 150 mg every 4 weeks) over 208 weeks. ^[4] Results A total of 13 randomized placebo-controlled trials for a total 1142 cases were identified involving pimavanserin (n=4), clozapine (n=2), olanzapine (n=3), and quetiapine (n=4). ^[5]

double blind trial

METHODS In this phase 3 randomized, double-blind trial, we randomly assigned patients with hyperphosphatemia receiving maintenance hemodialysis to receive twice-daily oral tenapanor (3, 10, or 30 mg [the latter down-titrated, if needed]) for 8 weeks. ^[1] SOLAR-1, a Phase 3 randomized, double-blind trial (NCT02437318), investigated efficacy and safety of ALP (α-specific PI3K inhibitor) + FUL in pts with HR+, HER2— ABC. ^[2] In this phase 3 randomized, controlled, double-blind trial of treatment-naïve patients with EGFR mutant NSCLC, osimertinib was compared to standard-of-care EGFR TKIs (i. ^[3]

mg every 4

Methods: Osteoarthritic patients (aged ≥18 years) from four phase 3 randomized, double-blind (DB), placebo-controlled studies were randomized to receive placebo, fulranumab 1 mg every 4 weeks (Q4wk), or 3 mg Q4wk in 16-week DB phase, followed by a 52-week post-treatment follow-up phase. ^[1] Methods: Osteoarthritic patients (aged ≥18 years) from 4 phase 3 randomized, double-blind (DB), placebo-controlled studies were randomized to receive placebo, fulranumab 1 mg every 4 weeks (Q4wk), or 3 mg Q4wk in 16-week DB phase, followed by a 52-week post-treatment follow-up phase. ^[2]

% time spent

METHODS Older adults (N = 9) completed four 3-hour treatment conditions consisting of a seated control and 3 randomized conditions: (1) 20% time spent in continuous LPA, 80% seated; (2) 40% time spent in continuous LPA, 60% seated; and (3) 60% time spent in continuous LPA, 40% seated. ^[1]

Phase 3 Randomized

BackgroundIn a phase 3 randomized, double-blind, placebo-controlled trial, treatment with idelalisib, a phosphoinositol-3 kinase δ inhibitor, + bendamustine/rituximab improved progression-free survival (PFS) and overall survival (OS) in adult patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL). ^[1] Recently, the Fondazione Italiana Linfomi ran a phase 3 randomized trial that included MRD-based decision-making, with the objective of comparing standard maintenance with a tailored maintenance/consolidation programme based on MRD and FDGPET in advanced stage FL. ^[2] Methods Baseline blood cultures were taken from adult patients enrolled in Phase 3 randomized, double-blind clinical studies of OMC. ^[3] Design, Setting, and Participants An open-label, multicenter, phase 3 randomized clinical trial of 1313 Asian patients with stage III colon cancer was conducted investigating the noninferiority of 3 vs 6 months of adjuvant oxaliplatin-based chemotherapy. ^[4] OBJECTIVES To evaluate the performance of PSOW with regorafenib effectiveness data from previously treated patients with metastatic colorectal cancer based on the Czech national registry data (regorafenib) and a global phase 3 randomized clinical trial (RCT) (placebo). ^[5] Combinations of conventional androgen deprivation therapy (ADT) with docetaxel or abiraterone have shown encouraging results in several phase 3 randomized trials and were consequently implemented in current clinical guidelines. ^[6] We collected germline whole genome sequencing data from IMvigor211, a recent phase 3 randomized controlled trial comparing atezolizumab (anti-PD-L1) monotherapy to chemotherapy in bladder cancer. ^[7] However, there has been no phase 3 randomized controlled trials to prove FFX is superior to GN in APC. ^[8] These results will need to be validated in the ongoing Phase 3 randomized, double-blind, global trials comparing RDZ to VAN for the treatment of CDI. ^[9] Key Points Question Do the abstracts of oncology randomized clinical trials with results of marginal statistical significance express uncertainty, and what characteristics are associated with uncertainty expression? Findings This systematic review and meta-analysis of 556 phase 3 randomized clinical trials found that most of the abstracts do not fully express uncertainty, and that uncertainty expression decreases when the P value surrounding a result is below its prespecified α level. ^[10] This approval was based on the findings of three phase 3 randomized clinical trials (RCTs): CALGB 100104 [2], IFM 2005-02 [3] and RV-MM-PI-209 [4], which were designed with time to progression (TTP)/progression free survival (PFS) as the primary endpoint. ^[11] Incidence of interstitial lung disease in patients with HER2-positive advanced breast cancer treated with everolimus and trastuzumab: A combined analysis of two phase 3 randomized controlled trials [abstract]. ^[12] In the 2 phase 3 randomized controlled trials and their extensions (5), a single dose of canakinumab during an acute attack provided rapid pain relief and prolonged prophylaxis and reduced the risk for a new attack by 62% versus triamcinolone acetate (P 0. ^[13] Design, Setting, and Participants This multiple-cohort study included updated individual patient-level data of men with clinical T1-4N0-1M0 prostate cancer from the following 3 cohorts: Surveillance, Epidemiology, and End Results (SEER [n = 296 273]); 5 equal-access regional medical centers within the Veterans Affairs health system (VA [n = 3972]); and 4 pooled National Cancer Institute-sponsored Radiation Therapy Oncology Group phase 3 randomized clinical trials (RCTs [n = 5854]). ^[14] Efficacy and safety of eflapegrastim confirmed in reducing severe neutropenia in breast cancer patients treated with myelosuppressive chemotherapy in the second Phase 3 randomized controlled multinational trial compared to pegfilgrastim (RECOVER trial) [abstract]. ^[15] We performed a comprehensive search of phase 3 randomized clinical trials published in the literature through September 2018. ^[16] CONCLUSION In 3 phase 3 randomized clinical trials, benralizumab provided notable improvement in morning PEF 2 days after initiation and clinically meaningful improvements within 3 weeks for patients with severe, uncontrolled eosinophilic asthma. ^[17] The Evaluation of Liraglutide in Pediatrics with Diabetes (Ellipse) phase 3 randomized control trial was conducted at 84 sites in 25 countries from 2012 to 2018. ^[18] Methods: The study was an open label, single centre, parallel, phase 3 randomized study with 1:1 randomization between maintenance pemetrexed arm and erlotinib arm. ^[19] These findings will be tested in a phase 3 randomized clinical trial. ^[20] Objectives: To assess the effects of belimumab on disease activity across multiple organ domains in Japanese patients from the Phase 3 randomized, double-blind, North-East Asia study, BEL113750 (NCT01345253). ^[21] The research, from the large phase 3 randomized trial STIC CTC, was presented at the 2018 San Antonio Breast Cancer Symposium, which was held December 4 – 8, 2018. ^[22] Methods: Osteoarthritic patients (aged ≥18 years) from four phase 3 randomized, double-blind (DB), placebo-controlled studies were randomized to receive placebo, fulranumab 1 mg every 4 weeks (Q4wk), or 3 mg Q4wk in 16-week DB phase, followed by a 52-week post-treatment follow-up phase. ^[23] However, there are no phase 3 randomized data to inform on its combination with trastuzumab for patients with human epidermal growth factor receptor 2 (HER2)–positive disease. ^[24] Hence, we conducted a phase 3 randomized non-inferiority study with the primary objective of comparing the overall survival (OS) between PLDG and standard dose of gemcitabine with platinum. ^[25] Background: This post hoc analysis of a Japanese phase 3 randomized study (ClinicalTrials. ^[26] Phase 3 randomized clinical trials (RCTs) have shown significant improvements in fatigue for sarilumab, based on the 13-item Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue measure. ^[27] Methods: Patients were treated in a phase 3 randomized trial comparing whole breast irradiation (50 Gy in 25 fractions to the whole breast, plus 10 Gy in 5 fractions to the tumor bed) to APBI (30 Gy in 5 nonconsecutive fractions) using the intensity-modulated radiotherapy technique. ^[28] Patient and methods: Documentation on common symptomatic adverse events for the three drugs was collected from five different sources: 1) FDA product summary information; 2) EMA product summary information; 3) phase 3 Randomized Controlled Trials (RCT) leading to drug approval; 4) audit of the electronic patient files focusing on the oncologist’s documentation of adverse events and 5) individual patient interview (n = 16) focusing on adverse events. ^[29] In recent phase 2 and phase 3 randomized placebo-controlled trials, teprotumumab rapidly achieved improvement in clinical endpoints defining TED, including improved proptosis and diplopia. ^[30] In a phase 3 randomized controlled trial, ART-123 failed to show any differences in 28-day mortality compared to placebo [3]. ^[31] Pivotal phase 3 randomized controlled trials (RCTs) were considered. ^[32] Methods Radiographic progression was assessed in 2 phase 3 randomized controlled trials (RCTs), as previously described2,3. ^[33] The combination of venetoclax and obinutuzumab (treatment-naïve, only in United States) or rituximab (relapsed/refractory) has granted approval from the regulatory authorities in United States and Europe, based on phase 3 randomized studies. ^[34] MethodsSubjects completing the final visit in the parent phase 3 randomized, double-blind, controlled equivalence study comparing the efficacy and safety of the biosimilar ABP 501 with adalimumab reference product (RP) were enrolled in this open-label extension (OLE) study. ^[35] METHOD Four ongoing Phase 3 randomized, double-blind, placebo-controlled, outpatient, US studies are investigating the efficacy and safety of once-daily SPN-812 for ADHD in children (ages 6-11; 100-400mg) and adolescents (ages 12-17; 200-600mg). ^[36] Methods A Very Early Rehabilitation Trial (AVERT) was an international, multicenter (56 sites), phase 3 randomized controlled trial, spanning 2006–2015. ^[37] Key Points Question Does an association exist between the sponsorship and conduct of phase 3 randomized clinical trials for cancer drugs despite negative or absent phase 2 trials for the drug, and does an association exist for overall patient survival and such phase 3 trials? Findings This analysis of 67 studies found that both industry and academia conducted negative phase 3 trials of cancer drugs. ^[38] CONCLUSIONS In this phase 3 randomized, placebo-controlled trial involving participants with sickle cell disease, voxelotor significantly increased hemoglobin levels and reduced markers of hemolysis. ^[39] In this issue of European Urology, Kelly and colleagues [1] present the results of BOXIT, a phase 3 randomized controlled trial in which they compared daily preventive celecoxib for secondary chemoprevention with placebo among patients with initial or recurrent intermediateor high-risk NMIBC. ^[40] Data reviewed here include: preliminary results from CLL12, long-term results of CLL8 and MD Anderson Cancer Center (MDACC) data with FCR, 7-year follow-up of PCYC-1102/1103 (phase 2 data) with ibrutinib, results of two-phase 3 randomized trials comparing CIT to ibrutinib, E1912 and A041202, and results of HELIOS and other phase 2 trials evaluating CIT combined with ibrutinib. ^[41] Design, Setting, and Participants In this multicenter, open-label, phase 3 randomized clinical trial, patients with endometrial cancer at high-risk stage I or II or stage III or IV that did not extend beyond the abdominal cavity and had 2 cm or greater residual tumor were included from 118 institutions in Japan from November 24, 2006, to January 7, 2011. ^[42] Methods: This phase 3 randomized, double-blind, placebo-controlled withdrawal trial in 26 adults with LEMS compared efficacy of amifampridine phosphate versus placebo over a 4-day period. ^[43] Post hoc analyses of two phase 3 randomized, vehicle‐controlled, 4‐week trials (ATMOS‐1 [NCT02530281] and ATMOS‐2 [NCT02530294]) were performed to assess efficacy and safety of topical anticholinergic glycopyrronium tosylate (GT) in pediatric patients. ^[44] Our objective was to assess the implementation of ePRO measures of Duration and Severity of MJS, Severity of Worst Tiredness, and Severity of Worst Joint Pain in baricitinib RA-BEAM and RA-BUILD phase 3 randomized clinical trials (RCTs). ^[45] A pooled analysis of 11 phase 3 randomized, controlled clinical trials was performed. ^[46] METHODS We present primary efficacy data from part 1 of an ongoing phase 3 randomized trial of a tetravalent dengue vaccine candidate (TAK-003) in regions of Asia and Latin America in which the disease is endemic. ^[47] This article reviews fostmatinib's mechanism of action and its clinical safety and efficacy in 2 industry-sponsored multicenter phase 3 randomized controlled trials in North America, Australia, and Europe (FIT1 and FIT2). ^[48] METHODS In this phase 3 randomized, double-blind trial, we randomly assigned patients with hyperphosphatemia receiving maintenance hemodialysis to receive twice-daily oral tenapanor (3, 10, or 30 mg [the latter down-titrated, if needed]) for 8 weeks. ^[49] Since most phase 3 randomized clinical trials have shown non-inferiority in efficacy across different agents, considerations regarding their different safety profiles inevitably play a crucial role in the everyday choice about which of them should be employed for the treatment of ABSSSI. ^[50]

Included 3 Randomized

RESULTS Fourteen studies met the inclusion criteria, which included 3 randomized controlled trials with their companion economic evaluations, 4 model-based, 2 cohort, 1 pre and post, and 1 prospective controlled trial. ^[1] Guideline development methods An international expert panel developed recommendations based on a systematic review {with searches done to July 2018}* that included 3 randomized controlled trials (RCTs) (n =10447, mean age 62 to 68 y, 53% to 66% men, {follow-up 90 d}*). ^[2]

Defuse 3 Randomized

Importance The DEFUSE 3 randomized clinical trial previously demonstrated benefit of endovascular thrombectomy for acute ischemic stroke in the 6- to 16-hour time window. ^[1] Methods— DEFUSE 3 randomized patients to thrombectomy or medical management who presented 6 to 16 hours from last known well with proximal middle cerebral artery or internal carotid artery occlusion and had target core and perfusion mismatch volumes on computed tomography or magnetic resonance imaging. ^[2]

X 3 Randomized

The experimental design was a 4 x 3 randomized block design, with four traffic situations (tractor traffic, tractor and harvester traffic, tractor and harvester traffic and sprayer and random traffic) and three furrow configurations (double disk in all rows, double disk in the lines without traffic and stem in those that receive the traffic and double disc in the lines without contact of tire with absence of furrowers in the traffic lines). ^[1] The experimental layout composed a 5 x 3 x 3 Randomized Complete Block Design arrangement, with treatment levels: 1 MGY, 2 MGY, 4 MGY, and 6 MGY, selectively allotted to the different accession based on a preliminary dosimetry test. ^[2]

3 randomized controlled

Seven clinical trials – 3 randomized controlled trials, 1 unrandomized clinical trial and 3 uncontrolled clinical trials were identified. ^[1] A total of 23 randomized controlled trials were included in this network meta-analysis. ^[2] EVIDENCE SYNTHESIS We identified 9 studies to be included in the qualitative synthesis and 3 randomized controlled trials (RCTs) to be included in the quantitative synthesis and the meta-analysis. ^[3] Methods: Analyses were carried out to assess the association between clinical characteristics and margin involvement as well as the effects of individual margin involvement on site of recurrence and overall and recurrence-free survival using individual patient data from the European Study Group for Pancreatic Cancer (ESPAC)-3 randomized controlled trial. ^[4] We identified 18 studies on PTSD including 13 randomized controlled trials (RCTs; 654 participants) and 5 single-group trials (60 participants). ^[5] Results: A total of 1,885 cases were included in 13 randomized controlled studies. ^[6] RESULTS There were 13 randomized controlled-trial studies published from 1998 to 2017. ^[7] Seven articles, including 3 randomized controlled trials and 4 case series, were included in our analysis. ^[8] 3400 articles were retrieved, and abstracts were further screened using the inclusion criteria to obtain a final set of 83 randomized controlled trials and retrospective/prospective studies. ^[9] The efficacy and safety of mechanical hemodynamic support in patients undergoing high-risk percutaneous coronary intervention with or without cardiogenic shock: Bayesian approach network meta-analysis of 13 randomized controlled trials. ^[10] Results We enrolled 16 studies (1,863 participants) including 3 randomized controlled trials (RCTs) and 13 observational studies. ^[11] After data extraction and quality evaluation, 13 randomized controlled trials, including 1559 patients, were assessed in this analysis. ^[12] The meta‐analyses of 13 randomized controlled trials and 22 uncontrolled before‐and‐after studies (1420 participants) revealed significant reductions on AHI (d = −0. ^[13] Results: In total, 13 randomized controlled trials involving 1190 patients were included. ^[14] RESULTS Fourteen studies met the inclusion criteria, which included 3 randomized controlled trials with their companion economic evaluations, 4 model-based, 2 cohort, 1 pre and post, and 1 prospective controlled trial. ^[15] Results: A total of 3,584 cycles were identified from 13 randomized controlled trials. ^[16] We collected germline whole genome sequencing data from IMvigor211, a recent phase 3 randomized controlled trial comparing atezolizumab (anti-PD-L1) monotherapy to chemotherapy in bladder cancer. ^[17] However, there has been no phase 3 randomized controlled trials to prove FFX is superior to GN in APC. ^[18] The analysis was based on primary data from 3 randomized controlled trials (COU-AA-302, IMPACT, and PREVAIL). ^[19] We reviewed the results of 3 randomized controlled trials and their subgroup analyses and open-label extensions. ^[20] Proportional Effect of Aspirin on CVD and Bleeding Risk The proportional (relative) effect of aspirin on CVD and bleeding risk was obtained from an updated systematic review and meta-analysis of 13 randomized controlled trials that included 164225 participants and compared aspirin (daily dose, 50 to 500 mg) with an inactive control among adults without established CVD (7). ^[21] Incidence of interstitial lung disease in patients with HER2-positive advanced breast cancer treated with everolimus and trastuzumab: A combined analysis of two phase 3 randomized controlled trials [abstract]. ^[22] In the 2 phase 3 randomized controlled trials and their extensions (5), a single dose of canakinumab during an acute attack provided rapid pain relief and prolonged prophylaxis and reduced the risk for a new attack by 62% versus triamcinolone acetate (P 0. ^[23] Results Nineteen studies with a total of 15,320 participants, including 13 randomized controlled trials (RCTs), were included. ^[24] Efficacy and safety of eflapegrastim confirmed in reducing severe neutropenia in breast cancer patients treated with myelosuppressive chemotherapy in the second Phase 3 randomized controlled multinational trial compared to pegfilgrastim (RECOVER trial) [abstract]. ^[25] Results— Fifty-one studies (3 randomized controlled trials, 13 prepost intervention studies, and 35 observational studies) with in total 8467 patients were included. ^[26] After irrelevant articles were discarded, 5 articles (3 randomized controlled trials and 2 retrospective chart reviews) including 636 subjects were analyzed. ^[27] Results: A total of 614 participants were included in 13 randomized controlled studies. ^[28] METHODS Based on a literature search from 1 January 1946 to 11 April 2018, we identified 133 randomized controlled trials allocating healthy or hypertensive individuals to SR or usual sodium intake. ^[29] New since the 2013 guideline are 3 randomized controlled trials (RCTs) that support the use of nonstatin lipid-modifying medications to reduce ASCVD events in patients at highest risk. ^[30] Results A total of 1645 subjects in 13 randomized controlled trials (RCTs) were enrolled, including 768 cases in the trial group and 877 cases in the control group. ^[31] We searched PubMed from inception until October 3, 2018, for phase 2 and 3 randomized controlled trials (RCTs) evaluating the effects of 2. ^[32] None of the 3 randomized controlled trials (RCTs) in patients who had failed PDE5i monotherapy found a superior effect on IIEF scores from the combination of androgen plus PDE5i compared with PDE5i monotherapy. ^[33] RESULTS 3 randomized controlled trials (RCTs, n=421) and 5 observational studies (n=6683) were included in this updated meta-analysis. ^[34] RESULTS: 13 randomized controlled trials met the inclusion criteria. ^[35] RESULTS A total of 13 randomized controlled trials met inclusion criteria and were included in the final analysis. ^[36] RESULTS We identified 3 randomized controlled trials, at low risk of bias, that enrolled 1739 patients with cancer-associated VTE. ^[37] Results A total of 13 randomized controlled trials containing 851 patients was included. ^[38] A systematic literature review identified 13 randomized controlled trials of antipsychotics in adolescents with schizophrenia-spectrum disorders. ^[39] In an analysis of 93 randomized controlled trials (RCTs), in 32 of those trials (404 patients with HTN), both ET and medications, together, effectively lowered BP compared to controlled conditions. ^[40] RESULTS We identified 4 eligible studies for the meta-analysis, including 3 randomized controlled trials. ^[41] RESULTS A total of 13 randomized controlled trials in the meta-analysis included 548 patients in the RIPC cohort and 549 controls. ^[42] Background To determine the efficacy of a new typhoid conjugate vaccine in an endemic setting in sub-Saharan Africa, the Typhoid Vaccine Acceleration Consortium is conducting a phase-3 randomized controlled trial in Blantyre, Malawi. ^[43] Patient and methods: Documentation on common symptomatic adverse events for the three drugs was collected from five different sources: 1) FDA product summary information; 2) EMA product summary information; 3) phase 3 Randomized Controlled Trials (RCT) leading to drug approval; 4) audit of the electronic patient files focusing on the oncologist’s documentation of adverse events and 5) individual patient interview (n = 16) focusing on adverse events. ^[44] RBI, RRI, NNT, NNH, and CI calculated from placebo event rates and odds ratios, adjusted for age and National Institutes of Health Stroke Scale score, in article based on individual patient data analysis of 3 randomized controlled trials (n =414). ^[45] In a phase 3 randomized controlled trial, ART-123 failed to show any differences in 28-day mortality compared to placebo [3]. ^[46] Prospective evidence from phase-3 randomized controlled trials on the safety and efficacy of CTRT in breast cancer is required before its routine use can be recommended. ^[47] Four papers were withheld, including two phase-3 randomized controlled trials, one phase-2 open-label clinical trial and one phase-1 open-label clinical trial. ^[48] Pivotal phase 3 randomized controlled trials (RCTs) were considered. ^[49] In total, 23 randomized controlled trials and one nonrandomized controlled study consisting of 45 treatment arms with 14 different active substances were included in the qualitative synthesis. ^[50]

3 randomized clinical

Methods: A secondary analysis from 3 randomized clinical trials involving ED patients with acute chest pain was performed to determine whether a care pathway, ACES (Accelerated Chest pain Evaluation with Stress imaging), reduces the racial disparity in index visit cardiac testing between African American (AA) and White patients. ^[1] METHODS A subset of patients (n=116) enrolled in three Phase-3 randomized clinical trials (AMAGINE-1,2,3) participated in a mechanistic sub-study where punch biopsies were collected (lesional and non-lesional skin) between baseline and 12-weeks. ^[2] Design, Setting, and Participants An open-label, multicenter, phase 3 randomized clinical trial of 1313 Asian patients with stage III colon cancer was conducted investigating the noninferiority of 3 vs 6 months of adjuvant oxaliplatin-based chemotherapy. ^[3] OBJECTIVES To evaluate the performance of PSOW with regorafenib effectiveness data from previously treated patients with metastatic colorectal cancer based on the Czech national registry data (regorafenib) and a global phase 3 randomized clinical trial (RCT) (placebo). ^[4] Key Points Question Do the abstracts of oncology randomized clinical trials with results of marginal statistical significance express uncertainty, and what characteristics are associated with uncertainty expression? Findings This systematic review and meta-analysis of 556 phase 3 randomized clinical trials found that most of the abstracts do not fully express uncertainty, and that uncertainty expression decreases when the P value surrounding a result is below its prespecified α level. ^[5] This approval was based on the findings of three phase 3 randomized clinical trials (RCTs): CALGB 100104 [2], IFM 2005-02 [3] and RV-MM-PI-209 [4], which were designed with time to progression (TTP)/progression free survival (PFS) as the primary endpoint. ^[6] Design, Setting, and Participants This multiple-cohort study included updated individual patient-level data of men with clinical T1-4N0-1M0 prostate cancer from the following 3 cohorts: Surveillance, Epidemiology, and End Results (SEER [n = 296 273]); 5 equal-access regional medical centers within the Veterans Affairs health system (VA [n = 3972]); and 4 pooled National Cancer Institute-sponsored Radiation Therapy Oncology Group phase 3 randomized clinical trials (RCTs [n = 5854]). ^[7] We performed a comprehensive search of phase 3 randomized clinical trials published in the literature through September 2018. ^[8] CONCLUSION In 3 phase 3 randomized clinical trials, benralizumab provided notable improvement in morning PEF 2 days after initiation and clinically meaningful improvements within 3 weeks for patients with severe, uncontrolled eosinophilic asthma. ^[9] Importance The DEFUSE 3 randomized clinical trial previously demonstrated benefit of endovascular thrombectomy for acute ischemic stroke in the 6- to 16-hour time window. ^[10] These findings will be tested in a phase 3 randomized clinical trial. ^[11] Results This review included 13 randomized clinical studies of 1272 patients. ^[12] Results: Among 3,436 studies, 23 randomized clinical trials (RCTs) met our selection criteria which included data from 12,876 patients. ^[13] Key Points Question Do null results on cognitive function in cardiovascular trials exclude worthwhile benefit? Findings In this secondary analysis of 3 randomized clinical trials including 45 029 participants undergoing cognitive assessment, the prevention of nonfatal cardiovascular events in 4. ^[14] Phase 3 randomized clinical trials (RCTs) have shown significant improvements in fatigue for sarilumab, based on the 13-item Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue measure. ^[15] We found 1241 records in our initial search, of which 13 randomized clinical trials (RCTs) with 15 treatment arms were included. ^[16] Findings From 17 607 literature citations associated with the 17 PICO questions, 145 studies, including 63 randomized clinical trials with 23 143 patients and 82 observational studies with more than 4 million patients, were analyzed. ^[17] Key Points Question Does an association exist between the sponsorship and conduct of phase 3 randomized clinical trials for cancer drugs despite negative or absent phase 2 trials for the drug, and does an association exist for overall patient survival and such phase 3 trials? Findings This analysis of 67 studies found that both industry and academia conducted negative phase 3 trials of cancer drugs. ^[18] Design, Setting, and Participants In this multicenter, open-label, phase 3 randomized clinical trial, patients with endometrial cancer at high-risk stage I or II or stage III or IV that did not extend beyond the abdominal cavity and had 2 cm or greater residual tumor were included from 118 institutions in Japan from November 24, 2006, to January 7, 2011. ^[19] 1 The pivotal 3 randomized clinical trials of the CHAMPION trial program (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition)2–4 were pooled in an analysis showing that cangrelor treatment in comparison with clopidogrel reduced periprocedural ischemic complications but increased the risk of mild bleeding. ^[20] Our objective was to assess the implementation of ePRO measures of Duration and Severity of MJS, Severity of Worst Tiredness, and Severity of Worst Joint Pain in baricitinib RA-BEAM and RA-BUILD phase 3 randomized clinical trials (RCTs). ^[21] Results: In total 23 randomized clinical trials comprising 11,687 patients were included in this meta-analysis. ^[22] Results A total of 13 randomized clinical trials were included in the Mate analysis, including 1 450 subjects, 721 in the intervention group and 729 in the control group. ^[23] Since most phase 3 randomized clinical trials have shown non-inferiority in efficacy across different agents, considerations regarding their different safety profiles inevitably play a crucial role in the everyday choice about which of them should be employed for the treatment of ABSSSI. ^[24] To better assess the incidence of exclusion criteria based on HIV status, we analyzed oncologic phase 3 randomized clinical trials (RCTs) and their eligibility requirements, with the goal of determining factors associated with HIV exclusion criteria (HEC) and analyzing HEC trends over time. ^[25] Design, Setting, and Participants In this phase 3 randomized clinical trial, men with low-risk prostate cancer were enrolled from sites within the National Cancer Institute’s National Clinical Trials Network in the United States, Canada, and Switzerland. ^[26] We illustrate the performance of our method using simulations based on resampling data from a completed, phase 3 randomized clinical trial of a new surgical treatment for stroke; the proposed estimator achieves a 12% gain in relative efficiency compared to the Kaplan–Meier estimator. ^[27] RESULTS A total of 11 prospective studies (3 randomized clinical trials and 8 cohort studies) including 575601 participants were identified to be eligible for our present meta-analysis. ^[28] In April 2019, two major Phase 3 randomized clinical trials were published that assessed primary renal outcomes in diabetic kidney disease (DKD) in type 2 diabetes mellitus (T2DM). ^[29] Only 1 phase 3 randomized clinical trial has demonstrated an overall survival (OS) benefit from an α-emitting RI, radium 223 (223Ra), vs standard of care. ^[30] This pooled analysis of data from phase 3 randomized clinical trials assesses the association of sex with toxic effects, treatment adherence, surgical procedures, and long-term outcomes after standard multimodal treatment in patients with rectal cancer. ^[31] METHODS Data are issued from an international phase 3 randomized clinical trial comparing the efficacy of perindopril/indapamide/amlodipine vs. ^[32] With this background, in part 2 (the companion to this article), the observational literature is briefly summarized, largely to identify its weaknesses, but also to develop hypotheses derived from it that have been recently tested in 3 randomized clinical trials of sedation versus general anesthesia for endovascular thrombectomy. ^[33] Key Points Question Are intensive care unit-based interventions aimed at surrogate decision-makers associated with differences in patient-centered outcomes and improved surrogate decision-maker–centered outcomes? Findings In this systematic review and meta-analysis of 13 randomized clinical trials including 10 453 patients, diverse interventions were associated with a 2-day reduction in intensive care unit length of stay only among patients who died, without an association with overall mortality. ^[34] Overall, 13 randomized clinical trials (RCTs) involving 840 subjects with T2DM were included in the meta-analysis. ^[35] Design, Setting, and Participants An adaptive phase 2b/3 randomized clinical trial comprising 2 parts that included adult patients (n = 868) with septic shock requiring more than 5 μg/min of norepinephrine. ^[36] The current study uses data from 3 randomized clinical trials to examine the effect of various intervention approaches on alcohol-induced blackouts. ^[37] Results This meta-analysis included 23 randomized clinical trials that reported on 9322 men (67. ^[38] RESULTS Of 770 potentially relevant articles, the authors included 13 randomized clinical trials in which researchers studied the efficacy of chlorhexidine, essential oils, cetylpyridinium chloride, and herbal products. ^[39] Results A total of 9 studies which met the eligibility criteria—3 randomized clinical trials and 6 nonrandomized studies published in English from 2010 to 2018—were considered for this systematic review; 396 patients with breast cancer, as well as 40 experts in the medical and nursing fields, and 3 software engineers were included. ^[40] Results The search identified 13 randomized clinical trials of low-dose aspirin use for primary prevention, enrolling 134 446 patients. ^[41] The training, validation, and testing of FCNN were based on ~1000 magnetic resonance imaging (MRI) datasets acquired on relapsing–remitting MS patients, as a part of a phase 3 randomized clinical trial. ^[42] Design, Setting, and Participants A Markov model was developed to compare the lifetime cost and effectiveness of nivolumab plus ipilimumab vs sunitinib in the first-line treatment of mRCC using outcomes data from the CheckMate 214 phase 3 randomized clinical trial, which included 1096 patients with mRCC (median age, 62 years) and compared nivolumab plus ipilimumab vs sunitinib as first-line treatment of mRCC. ^[43] Design, Setting, and Participants A phase 3 randomized clinical trial was conducted from December 15, 2015, to December 12, 2017. ^[44] Results: We found 3 randomized clinical trials (2 published and 1 ongoing) comprising 66 children. ^[45] Design, Setting, and Participants International phase 3 randomized clinical trials with patients with metastatic prostate cancer and initiation from January 1, 2008, or later were identified through internal databases of the US Food and Drug Administration. ^[46]

3 randomized trial

Results: A total of 7 studies were included to perform a meta-analysis, 3 randomized trials and 4 observational studies with 2211 patients, 1281 treated with Crush and 930 with Culotte. ^[1] Therefore, it included 63 randomized trials looking at the effectiveness and cost-effectiveness of exercise-based cardiac rehabilitation in patients with coronary heart disease. ^[2] Recently, the Fondazione Italiana Linfomi ran a phase 3 randomized trial that included MRD-based decision-making, with the objective of comparing standard maintenance with a tailored maintenance/consolidation programme based on MRD and FDGPET in advanced stage FL. ^[3] Combinations of conventional androgen deprivation therapy (ADT) with docetaxel or abiraterone have shown encouraging results in several phase 3 randomized trials and were consequently implemented in current clinical guidelines. ^[4] ) with poorly controlled persistent asthma that participated as control subjects in 1 of 3 randomized trials of urban school-based asthma care (study duration: 7-10 months). ^[5] The testing protocol consisted of 3 randomized trials of treadmill walking for 5 minutes in each of three conditions: unloaded, single-strap bag and double-strap bag. ^[6] BACKGROUND Preoperative long-course chemoradiotherapy (CRT) and short-course radiotherapy (SCR) for locally advanced rectal cancer (LARC) were found to have equivalent outcomes in 3 randomized trials. ^[7] The research, from the large phase 3 randomized trial STIC CTC, was presented at the 2018 San Antonio Breast Cancer Symposium, which was held December 4 – 8, 2018. ^[8] Methods: Patients were treated in a phase 3 randomized trial comparing whole breast irradiation (50 Gy in 25 fractions to the whole breast, plus 10 Gy in 5 fractions to the tumor bed) to APBI (30 Gy in 5 nonconsecutive fractions) using the intensity-modulated radiotherapy technique. ^[9] Data reviewed here include: preliminary results from CLL12, long-term results of CLL8 and MD Anderson Cancer Center (MDACC) data with FCR, 7-year follow-up of PCYC-1102/1103 (phase 2 data) with ibrutinib, results of two-phase 3 randomized trials comparing CIT to ibrutinib, E1912 and A041202, and results of HELIOS and other phase 2 trials evaluating CIT combined with ibrutinib. ^[10] In a systemic review, 145 studies (63 randomized trials and 82 observational studies) encompassing 23,143 adult patients were identified for analysis. ^[11] METHODS We present primary efficacy data from part 1 of an ongoing phase 3 randomized trial of a tetravalent d