OBJECTIVE In obese women, 1) to assess whether lower gestational weight gain (GWG) during pregnancy in the lifestyle intervention group of a randomized controlled trial (RCT) resulted in differences in offspring anthropometrics and body composition, and 2) to compare offspring outcomes to a reference group of children born to women with a normal Body Mass Index (BMI). RESEARCH DESIGN AND METH...

BACKGROUND Electronic data capture (EDC) systems have been widely used in clinical research, but mobile device-based electronic data capture (mEDC) system has not been well evaluated. OBJECTIVE The aim of our study was to evaluate the feasibility, advantages, and challenges of mEDC in data collection, project management, and telemonitoring in a randomized controlled trial (RCT). METHODS We ...

s this treatment effective? The best study to answer this question is a randomized controlled trial (RCT). Once a RCT is found to answer the therapeutic question of interest the reader must decide whether or not the authors took all of the important steps to minimize bias. The strength of the inference that we can take from the trial is based upon how well the authors have planned, executed and...

objective: glutamate antagonists including anticonvulsant topiramate have been recommended for the pharmacological management of schizophrenia. methods: a randomized, double-blind, placebo controlled clinical trial was performed on 32 patients diagnosed with schizophrenia (18-45 years old). baseline information was gathered on demographic characteristics, vital signs, height, weight, smoking ha...

BACKGROUND Elective single embryo transfer (eSET) in a selected group of patients (i.e. young patients with at least one good quality embryo) reduces the number of multiple pregnancies in an IVF programme. However, the reduced overall multiple pregnancy rate (PR) is still unacceptably high. Therefore, a randomized controlled trial (RCT) was conducted comparing eSET and double embryo transfer (D...

Abstract Introduction Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is the cornerstone of antithrombotic in patients ST-segment elevation myocardial infarction (STEMI). Yet, there uncertainty surrounding optimal timing for initiation inhibitor. This study aims to evaluate effectiveness safety pretreatment by means systematic review meta-analysis studies primary percutaneou...

BACKGROUND Effective interventions for young adults with severe, multiple problems - such as psychosocial and psychiatric problems, delinquency, unemployment and substance use - are scarce but urgently needed in order to support an adequate transition to adulthood. A multimodal day treatment program called "New Opportunities" (in Dutch: "De Nieuwe Kans"; DNK) was specifically developed to targe...

BACKGROUND Randomized Clinical Trial (RCT) designs range from highly selective resulting in lack of external validity to more inclusive, requiring large sample sizes to observe significant results. Few publications, however, have compared excluded to enrolled participants. We aimed to assess our trial's design based on the effectiveness versus efficacy continuum using the Pragmatic-Explanatory ...

Use of historical control data to augment a small internal arm in randomized trial (RCT) can lead significant improvement the efficiency trial. It introduces risk potential bias, since population is often rather different from RCT. Power prior approaches have been introduced discount mitigate impact difference. However, even with Bayesian dynamic borrowing which based on outcome similarity two ...

Abstract The coronavirus disease-2019 (COVID-19) pandemic has led to the irrational use of drugs in absence clinical management guidelines. Access individual participant data (IPD) from trials aids evidence synthesis approaches. We undertook a rapid review infer IPD sharing intentions based on availability statements by principal investigators (PIs) drug and vaccine context COVID-19. Searches w...