Introduction to Trials Evaluating

METHODS: Data from 4 12-week, randomized, placebo-controlled trials evaluating tegaserod 6 mg b.

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 repeated failures of large-scale clinical trials evaluating the efficacy of well-established cardioprotective therapies in HFpEF highlight the need for a paradigm shift in our approach to its treatment.

We make the case for a robust early and small-scale clinical evaluation stage, between the in silico algorithm development/ validation (covered by the upcoming TRIPOD-AI statement2 and STARD-AI statement3) and large-scale clinical trials evaluating AI interventions (covered by the CONSORT-AI statement4).

A PubMed search was conducted to identify randomized controlled trials evaluating the use of conventional systemic NSAIDs as pain management for children in the perioperative or emergency department (traumatic injury) setting.

We systematically searched MEDLINE, Embase, and the Cochrane Library from inception to January 2021 via Ovid to identify randomized controlled trials evaluating the efficacy of glucocorticoids in the treatment of patients with ARDS.

The PubMed, Embase, and Cochrane Library databases were searched until April 21, 2021, for randomized or quasi-randomized controlled trials evaluating the effect of arm slings on gait or balance in patients with poststroke hemiplegia.

Randomized or quasi-randomized controlled trials evaluating the effects of perioperative exercise training versus control in patients with GI cancer were eligible.

MOTIVATE (NCT03105128) and ADVANCE (NCT03104413) were two double-blind, randomised, placebo (PBO)-controlled phase 3 trials evaluating the efficacy and safety of RZB as induction therapy for CD after inadequate response or intolerance to biologic treatment, or conventional or biologic treatment.

Methods Patient data (n = 127) from two multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trials evaluating the safety and efficacy of brexanolone injection in adults with PPD were employed for these posthoc analyses.

Here, we report exploratory analyses of the associations of tumor mutational burden (TMB), a 4-gene inflammatory gene expression signature, and BRAF mutation status with tumor response, progression-free survival, and overall survival in patients with advanced melanoma treated as part of the CheckMate 066 and 067 phase III clinical trials evaluating immuno-oncology therapies.

The study aim was to evaluate the impact of obesity on overall survival (OS), progression free survival (PFS), and occurrence of serious adverse events (SAE) in clinical trials evaluating bevacizumab for advanced non-small cell lung cancer (NSCLC).

As in most previous randomized controlled trials evaluating psychological interventions delivered directly to people living with dementia, the involvement of a family carer (termed a supporter in this study) is a prerequisite of participation.

The results of previous randomized controlled trials evaluating the efficacy of p-RF administered to the suprascapular nerve were mixed, and there is a lack of published studies on PNS effects.

The ITIP project was conducted at Kamuzu Central Hospital and Bwaila District Hospital in Lilongwe, Malawi between June 2016 and April 2019 and included two prospective, double-blind, randomized controlled clinical trials evaluating the duration of amoxicillin dispersible tablet (DT) treatment for non-severe community-acquired pneumonia among children 2–59 months of age.

Further prospective randomized controlled clinical trials evaluating the specific effect of the various used materials are needed.

This review will focus on key aspects of completed trials evaluating adjuvant therapy in resectable pancreatic cancer and will provide an overview of emerging evidence supporting the use of neoadjuvant treatment strategies for both resectable and borderline resectable pancreatic cancer.

Recently, key trials evaluating neoadjuvant chemotherapy for resectable pancreatic cancer have reported results.

Results As of 21 July 2021, we identified 47 trials evaluating convalescent plasma (21 trials), intravenous immunoglobulin (IVIg) (5 trials), umbilical cord mesenchymal stem cells (5 trials), bamlanivimab (4 trials), casirivimab-imdevimab (4 trials), bamlanivimab-etesevimab (2 trials), control plasma (2 trials), peripheral blood non-haematopoietic enriched stem cells (2 trials), sotrovimab (1 trial), anti-SARS-CoV-2 IVIg (1 trial), therapeutic plasma exchange (1 trial), XAV-19 polyclonal antibody (1 trial), CT-P59 monoclonal antibody (1 trial) and INM005 polyclonal antibody (1 trial) for the treatment of covid-19.

Multiple clinical trials evaluating immunotherapies for the treatment of ACC have been conducted, and many more are ongoing or planned.

In this review, we discuss results from clinical trials evaluating the efficacy and safety of acalabrutinib in patients with CLL, MCL, and Waldenstrom’s macroglobulinemia.

Randomised controlled trials evaluating the incidence and intensity of postendodontic pain and flareup published in English from 1 January 2000 to 15 April 2020 were searched.

DATA SOURCES: Systematic reviews and meta-analyses of randomized controlled trials evaluating a therapeutic intervention on mortality in critical care, published between January 2009 and March 2019 in high impact factor general medical or critical care journals and by Cochrane.

Methods This study was a systematic review and meta-analysis of randomized trials evaluating the effect of dual trigger versus hCG trigger for follicular maturation on pregnancy outcomes in women undergoing in vitro fertilization (IVF).

STUDY SELECTION: Randomized trials evaluating the pudendal nerve block effect in patients undergoing hemorrhoidectomy were selected.

The evidence supports the use of these novel assays to help identify SOT recipients at increased risk and highlights the need for larger prospective trials evaluating these modalities in this high-risk population.

Prospective trials evaluating the protective effect of BCG vaccination are ongoing and will add further insight into the effect of BCG on COVID-19 illness.

Results of ongoing trials evaluating either pembrolizumab alone or in combination with other antineoplastic regimens are expected to confirm its efficacy in this setting of patients.

The World Health Organization (WHO) living guideline on drugs to prevent COVID-19 has recently advised that ongoing trials evaluating hydroxychloroquine in chemoprophylaxis should stop.

To overcome the issue of limited power, an individual participant data meta-analysis of randomised trials evaluating forms of trauma-focused cognitive behavioural therapy in children and adolescents aged 6–18 years will be conducted.

There are currently ongoing randomised trials evaluating risk-adapted surgical and minimally invasive approaches to the management of good prognosis disease.

METHODS A systematic review and meta-analysis utilizing the MEDLINE, Cochrane, and Scopus database was performed to identify randomized and non-randomized control trials evaluating baseline characteristics and hospitalizations.

This review observed that there are no randomised control trials evaluating dual-surgeon versus single-surgeon operating for scoliosis.

Methods We analyzed ORR alone or in combination with DOR (RMTR) in available phase I, II, and III trials evaluating nivolumab monotherapy or in combination with ipilimumab across solid tumor types.

Main inclusion criteria: prospective, phase II/III trials evaluating EGFR-tyrosine kinase inhibitors, ≥10 EGFR+ patients included, data on bone metastases and/or bone-related outcomes available.

Most respondents felt there was equipoise surrounding future trials evaluating nerve blocks/catheters, but less so for surgical catheters.

Future trials evaluating the addition of avelumab to standard treatment in MSS mCRC are warranted especially in this patient subpopulation.

Six trials evaluating cemiplimab (n = 3) and pembrolizumab (n = 3) were eligible for inclusion.

Six trials evaluating empagliflozin, canagliflozin, dapagliflozin and ertugliflozin met the inclusion/exclusion criteria, which comprised 46,969 patients, mostly with established CVD.

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.

Risk of bias was high in 5/7 trials evaluating our primary outcome.

This comprehensive analysis will present the problem of overtreatment in early-stage breast cancer, review evidence supporting the use of anthracyclines in the pre-taxane era, analyze comparative trials evaluating taxanes with or without anthracyclines in biologically unselected and selected patient populations, and explore published work aimed at defining anthracycline-sensitive tumor types.

The purpose of this study was to determine the utility of applying a fragility analysis to comparative trials evaluating Achilles tendon injuries.

PURPOSE: Results from adjuvant trials evaluating 6 cycles of epirubicin-based chemotherapy regimens suggested these programs may be more effective than 4 cycles of doxorubicin-based chemotherapy.

ConclusionsIrrespective of their HER2 status, the prognosis for MA tumours remains poor and adjuvant trials evaluating anti-androgens should be considered.

Four trials evaluating 1052 patients were included.

Similarly, visual acuity measured for longer periods in four trials evaluating different interventions was also not statistically significant (RRs ranged from 0.

High-quality trials evaluating this intervention are needed to provide further certainty regarding the rates of adverse events.

High-quality trials evaluating this intervention are needed to provide further certainty regarding the rates of adverse effects and postoperative pain of using devices compared to standard approaches.

Because interest and the popularity of ashwagandha has increased in several Western countries, there are an increasing number of human trials evaluating its efficacy across a range of conditions.

However, results from human trials evaluating exercise and bone adaptation with NSAID consumption have been less conclusive.

Fifty-one of 189 evaluable patients from three prospective phase-II trials evaluating a sequential targeted treatment (clinicaltrials.

CONCLUSIONS The landscape of phase II trials evaluating PD-1/PD-L1 inhibitors with other anticancer therapies is heterogeneous.

Results: Among 15 trials evaluating 14 treatments, nivolumab achieved the best overall survival (OS) benefit; zalutumumab and buparlisib + paclitaxel provided the best progression-free survival benefit and objective response rate.

Most of the ongoing studies are a combination of these interests, with 15 trials evaluating the concurrent RT+IO with IO consolidation strategy.

A major question that remains unanswered, in the light of what are now several negative trials evaluating the benefit of intrapartum ultrasound for this purpose, is whether it may only be useful in cases where there is uncertainty in clinical findings.

By the letter, therefore, we now have two negative trials evaluating singletest ruleout strategies, but for different reasons.

This knowledge is crucial to help identify the more promising molecules for COVID-19 and help design trials evaluating these molecules.

Methods This narrative review examined recent examples of Zelen design trials evaluating clinical and public health interventions.

There are several trials evaluating the clinical effects of a variety of commercially available and self-made devices.

Several trials evaluating nivolumab-containing treatments are ongoing in patients with not only advanced EC, but also locally advanced EC, and these investigational treatments might improve the clinical outcomes of EC patients.

CONCLUSIONS Published trials evaluating the effect of non-implanted electrical stimulation on post-stroke incontinence are few and heterogenous.

Background In 2014, a systematic review found large gaps in the quality of reporting of measures used in 86 published trials evaluating the effectiveness of patient decision aids (PtDAs).

METHOD Bibliographic databases MEDLINE, Embase, APA PsycInfo, and CINAHL were searched from inception to February 2020 for randomized controlled trials evaluating treatments for adolescent depression.

Randomised controlled trials evaluating treatments for venous leg ulcers provide important evidence to inform clinical decision-making.

Utilizing this information, treatment of newly diagnosed and relapsed HL has become a rapidly evolving field with multiple clinical trials evaluating novel treatment approaches incorporating targeted immunotherapy.

The high reliability of principal component-based epigenetic clocks will make them particularly useful for applications in personalized medicine and clinical trials evaluating novel aging interventions.

METHODS Electronic databases were searched for randomized clinical trials evaluating interventions in patients with symptomatic oral lichen planus.

Novel study designs may be necessary to address placebo response in future clinical trials evaluating interventions for fatigue in MS.

Further trials evaluating anti-CTLA-4 agents should be carefully studied in biomarker-selected patients.

Currently, the only monoclonal antibody (mAb) approved for AD treatment is dupilumab, an antagonist of the IL-4 receptor alpha (IL-4Rα) subunit common to IL-4 and IL-13 receptors, but clinical trials evaluating anti-IL-13 mAbs are providing promising results.

Simple Summary Considering the high incidence and mortality of breast cancer, a lot of trials evaluating new drugs for the treatment of this disease are currently ongoing.

These consortia are similar to large randomized clinical trials evaluating new drugs and have multiple centres that recruit hundreds of patients in more than 20 countries.

5 These reports led to the rapid publication of expert guidance statements that advocated consideration of escalated thromboprophylaxis doses in critically ill patients with COVID-19,6,7 pending the results of randomized clinical trials evaluating different doses.

Randomized clinical trials evaluating different treatment strategies of pathological scars, including triamcinolone acetonide (TAC), verapamil (VER), 5-fluorouracil (5-FU), botulinum toxin A (BTA), bleomycin (BLM), and silicone gels were included in the study.

Multiple clinical trials evaluating immunotherapies for the treatment of ACC have been conducted, and many more are ongoing or planned.

In addition to previous data from this trial regarding the predictive value of high plasma TMB (≥9 mut/Mb), this data further supports that there may be independent subgroups of PDAC, beyond MSI-H, that may benefit from immunotherapy, and trials evaluating immunotherapy in subgroups of PDAC with these profiles are warranted.

Clinical trials evaluating immune checkpoint inhibitors (ICIs) in UM have demonstrated response rates lower than those seen in cutaneous melanoma.

Herein, we conducted an up-to-date and comprehensive meta-analysis including recently published data of phase III clinical trials evaluating immune-based combinations in mRCC.

Methods Randomized clinical trials evaluating systemic agents in first and second line settings in aHCC from inception to April 2020 were identified by searching PubMed, EMBASE, and Cochrane Databases and the annual ASCO and ESMO conferences from 2017 to 2020.

All completed Phase III randomised controlled trials evaluating systemic anti-cancer therapies in metastatic gastroesophageal malignancies for the period 01.

BACKGROUND AND AIM Prospective trials evaluating efficacy of specific diet restriction in functional dyspepsia (FD) are scarce.

Additional prospective trials evaluating efficacy and safety are warranted.

However, long-term trials evaluating clinical outcomes with transdermal and other alternate HT regimens are limited.

Although there are promising results regarding their prognostic role, large randomized trials evaluating clinical outcomes are lacking.

Results In April 2020, a total of 580 trials evaluating COVID-19 treatment were registered.

Currently, there is limited but very increasing reassuring information concerning vaccines to prevent SARS-CoV-2 during pregnancy, and in this review, we also emphasize the results (mostly positive) provided by the few small trials evaluating COVID-19 vaccines in pregnant patients.

90-day hospitalization could be used as an early endpoint in trials evaluating liver SBRT.

An individual patient-data meta-analysis of randomized trials evaluating liver pedicle clamping is urgently needed.

It is recommended that randomized trials evaluating drug safety objectively measure and report ototoxic hearing loss as an adverse event.

Further translation research in the mechanism of ARDS and continuing with clinical trials evaluating drug efficacy for ARDS in COVID-19 is needed.

As more and more drugs with translational potential are identified, the number of clinical trials evaluating combinations has increased considerably and the demand to prioritize combinations having potential for success over the ones that are unlikely to be successful is rising.

First results from clinical trials evaluating combinations of these therapies are encouraging with response rates never observed before in patients with HCC.

Two randomised, controlled clinical trials evaluating oral antibiotics in patients with CLBP indicate that for certain subsets of patients, the reduction in pain and disability achieved with antibiotic therapy may be significant.

A systematic review of 44 randomized, placebo-controlled trials evaluating oral phlebotonics suggested efficacy for some signs such as edema, although the global evidence for their efficacy was insufficient to recommend routine use.

Randomized trials evaluating long-term benefits of IVUS in STEMI are needed.

Prior to 2008, there was a paucity of randomized controlled trials evaluating long-term cardiovascular outcomes with glucose-lowering therapies.

Four trials showed intervention benefits for systolic and diastolic BP with confidence intervals excluding no effect, and among these were all three of the trials evaluating self-monitoring of blood pressure with mobile phone-based telemedicine.

Method A systematic review of randomized controlled trials evaluating self-management support interventions was conducted following the Cochrane handbook & PRISMA guidelines.