Sentences with phrase «primary outcomes of both trials»

The primary outcomes of both trials are safety (adverse events) tolerability, and a wide array of pharmacokinetic outcomes (which are curiously designated as safety issues).

Not exact matches

Because the trial found no differences in the effect of type of care on any primary clinical outcome, the economic analysis compares only the costs of care rather than their cost - effectiveness.

We searched PubMed, Embase, and Cochrane databases for randomised controlled trials of maintenance tocolysis therapy with nifedipine in preterm labour.We selected trials including pregnant women between 24 and 36 (6/7) weeks of gestation (gestational age, GA) with imminent preterm labour who had not delivered after 48hours of initial tocolysis, and compared maintenance nifedipine tocolysis with placebo / no treatment.The primary outcome was perinatal mortality.

The protective effects of breast feeding have been shown to be dose responsive16 17 18 and minimal breast feeding may not be protective.17 Researchers in lactation have advocated that research on promotion of breast feeding must target exclusive breast feeding, 19 and ours is one of the larger randomised controlled trials with this primary outcome.

No statement of the original prespecified primary and secondary outcomes for the trial.

The primary outcome with the largest difference in this sensitivity analysis was preterm birth, where an analysis restricted to trials with lower risk of bias suggested a larger treatment effect: RR 0.64, (95 % CI 0.51 to 0.81) compared with RR 0.77, (95 % CI 0.62 to 0.94) in the overall analysis.

A randomised controlled trial of caseload midwifery for women at low risk of medical complications (COSMOS)- primary and secondary outcomes

A late - breaking clinical trial, known as the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial, to be presented at the American Heart Association (AHA) Scientific Sessions, November 18, 2013, demonstrates that spironolactone did not reduce the primary outcome of cardiovascular death, heart failure hospitalization, nor surviving a cardiac arrest in patients with heart failure and preserved ejection fraction (pump function).

Although POISE - 2 is a large trial by perioperative standards, the lower (0.86) and upper (1.15) boundary of the hazard ratio for the primary outcome identifies that the possibility of appreciable benefit or harm has not been excluded, Devereaux said.

The study is investigator led and has therefore focused on clinical need, targeting patients with progressive multiple sclerosis in whom most disability is incurred... The study also reports a predominant effect on neurodegenerative rather than inflammatory outcomes, suggesting a novel mechanism of action that might be suitable as combination treatment with immunomodulatory treatments... Further phase 3 studies to measure the effect of simvastatin on sustained disability, particularly in patients with non-relapsing secondary progressive and primary progressive multiple sclerosis, are clearly needed, but this trial represents a promising point from which to develop trials of progressive disease.»

However, the authors stress that «further clinical investigations will be essential to establish the optimal dose, duration and safety, and whether vitamin D2 or D3 have different effects on mortality risk, since the available trials are based on elderly populations in general (an age group with high competing risk of death often due to multiple co-existing disease conditions) and they do not typically include cause - specific deaths as the primary outcomes.»

The researchers report long - term outcomes from the Qidong Hepatitis B intervention Study (QHBIS), a randomized controlled trial of neonatal HBV vaccination that was conducted between 1983 and 1990 in Qidong County, a rural area in China with a high incidence of HBV - related primary liver cancer (PLC) and other liver diseases.

We recruited 11 glaucoma patients and of course our primary outcomes through that first trial with safety.

Potential cardioprotection was based on generally supportive data on lipid levels in intermediate outcome clinical trials, trials in nonhuman primates, and a large body of observational studies suggesting a 40 % to 50 % reduction in risk among users of either estrogen alone or, less frequently, combined estrogen and progestin.2 - 5 Hip fracture was designated as a secondary outcome, supported by observational data as well as clinical trials showing benefit for bone mineral density.6, 7 Invasive breast cancer was designated as a primary adverse outcome based on observational data.3, 8 Additional clinical outcomes chosen as secondary outcomes that may plausibly be affected by hormone therapy include other cardiovascular diseases; endometrial, colorectal, and other cancers; and other fractures.3, 6,9

We also performed subgroup meta - analyses by type of prevention (primary v secondary: in this study, trials involving healthy populations or patients with any specific disease except for cardiovascular disease were classified as primary prevention trials, and trials involving patients with cardiovascular disease were classified as secondary prevention trials), type of supplement by quality and dose (each supplement, vitamins only, antioxidants only, or antioxidants excluding vitamins), type of outcome (cardiovascular death, angina, fatal or non-fatal myocardial infarction, stroke, or transient ischaemic attack), type of outcome in each supplement, type of study design (randomised, double blind, placebo controlled trial v open label, randomised controlled trial), methodological quality (high v low), duration of treatment (< 5 years v ≥ 5 years), funding source (pharmaceutical industry v independent organisation), provider of supplements (pharmaceutical industry v not pharmaceutical industry), type of control (placebo v no placebo), number of participants (≥ 10000 v < 10000), and supplements given singly or in combination with other vitamin or antioxidant supplements by quality.

If simply learning that one is biomarker positive causes a person to perform worse on cognitive testing, then primary outcomes data of AD trials may not be valid.

A primary objective of the program is to start at the clinic, analyzing patient samples from clinical trials testing novel cancer immunotherapies and correlating these results with clinical outcomes.

They suggest that age at onset of ambulation could be a primary outcome measure in clinical trials involving treatment in early infancy.

While many trials have reported reliability regarding their methods as part of the study protocol, few investigations have made reliability the primary outcome.

CAD indicates coronary artery disease; CHF, congestive heart failure; CSM, clinically standardized meditation (a mantra meditation program); MA, meta - analysis; PA, primary analysis; PO, number of trials in which this was a primary outcome for the trial; and TM, transcendental meditation (a mantra meditation program).

The other 4 reports of randomized controlled trials of fasting provide information for primary outcomes other than weight.

In a recent randomised controlled trial (RCT), 32 we showed that an intervention in the form of a culturally tailored parenting support programme was effective in reducing children's behaviour problems 2 months after the intervention, which was our primary outcome measure of the study.

From a range of disciplines the review determined that, to be successful, programmes must involve a partnership between the family and nurse, focus on goals that parents prioritise, build competencies, be non-stigmatising and maintain continuity of care.48 The third review went on to investigate specific evidence - based interventions that focused on this trial's primary outcome areas and had the potential to enhance the effectiveness of SNHV programmes.

Given the primary objectives of the trial and measures collected in existing RCTs, 18, 49 we chose to anchor our sample size calculation around detection of a minimum effect size of 0.3 for the responsivity subscale of the Home Observation Measurement of the Environment (HOME) Inventory (see table 2), to allow comparisons with the original MECSH trial and other international SNHV programmes.60 The sample size applies across all of the subscales of the HOME Inventory and other continuous outcomes as based on number of SDs rather than the actual outcome distributions.

Assuming a drop - out rate from the trial of approximately 20 %; this sample size was sufficient to detect a standardised effect size of 0.4 at 85 % power and α of 0.05 in the primary outcome measure if there was no clustering and a standardised effect size of 0.6 allowing for clustering by course with an intraclass correlation coefficient of 0.178 or less; for this sample size calculation, we conservatively imagined clustering within control families as well as intervention families.

Clinical Outcomes in Measurement based Treatment (COMET): a trial of depression monitoring and feedback to primary care physicians

Using a randomized control trial in more than 90 primary schools in Rio de Janeiro, the evaluation objective is to understand the impact of Programa Compasso in terms of improving teacher outcomes, student social - emotional well - being, and student academic performance.

Calculation of sample size — We designed the trial to detect a minimum important difference in effect size of 0.6 SD on the primary outcome measure.

During this seminar, outcome data from this federally - funded trial will be presented, suggesting that CATCH - IT may be efficacious in preventing depressive episodes in primary care for adolescents and parents willing to engage the program at a modest level, and may be particularly beneficial for adolescents with elevated levels of depressive symptoms.

During this seminar, Dr. Gladstone will present outcome data from this federally - funded trial that suggests CATCH - IT may be efficacious in preventing depressive episodes in primary care for adolescents and parents willing to engage the program at a modest level; this intervention may be particularly beneficial for adolescents with elevated levels of depressive symptoms.

The primary outcome for the trial is the Strengths and Difficulties Questionnaire (SDQ) at 2.5 years: a sample size of 462 will have 90 % power to detect an effect size of 0.35, allowing for 25 % loss to follow - up in this intention - to - treat analysis.12

In the present trial, a wide array of both parent and infant development measures are used, hopefully aiding future researchers to identify appropriate primary and secondary outcomes for trials on infants.

The following data describes treatment outcome maintenance results from a randomized clinical trial investigating the impact of a cognitive behavioral intervention Primary and Secondary Control Enhancement Therapy - Physical Illness (PASCET - PI) as compared to treatment as usual (TAU) on youths with inflammatory bowel disease (IBD).