Search results for "Randomized controlled"
showing 10 items of 2220 documents
Avelumab versus standard second line treatment chemotherapy in metastatic colorectal cancer patients with microsatellite instability: The SAMCO-PRODI…
2021
Abstract Immune checkpoint inhibitors have failed in treating metastatic colorectal cancer (mCRC) patients except those with dMMR/MSI tumors. However, until very recently we had only non-comparative promising data in this population with anti-programmed cell death 1/ programmed cell death ligand 1 (PD1/PD-L1) antibodies alone or combined with anti- cytotoxic T-lymphocyte-associated protein 4 (CTLA4) antibodies. This comparative phase II trial (NCT 03186326), conducted in more than 100 centers in France, will include dMMR/MSI mCRC patients with progression after a first-line treatment with chemotherapy ± targeted therapies, to evaluate efficacy and safety of the anti-PDL1 Avelumab versus a s…
Chemotherapy-induced neutropenia and treatment efficacy in advanced non-small-cell lung cancer: a pooled analysis of three randomised trials
2005
Summary Background Chemotherapy is the standard treatment for advanced non-small-cell lung cancer, and myelosuppression is a common side-effect. We aimed to assess whether haematological toxic effects could be a biological measure of drug activity and a marker of efficacy. Methods We analysed data for 1265 patients who received chemotherapy (vinorelbine, gemcitabine, gemcitabine and vinorelbine, cisplatin and vinorelbine, or cisplatin and gemcitabine) within three randomised trials. Primary landmark analyses were restricted to 436 patients who received all six planned chemotherapy cycles and who were alive 180 days after randomisation. Neutropenia was categorised on the basis of worst WHO g…
Validity of a questionnaire developed to measure the impact of a high‐fidelity simulation intervention: A feasibility study
2019
To evaluate the validity and responsiveness of a questionnaire developed to measure the impact of a high-fidelity simulation intervention.A pre- and postintervention design.In August 2017, 107 participants completed a questionnaire measuring knowledge and perceived self-confidence pre- and postintervention. Validity of the questionnaire was determined by expert reviews, individual interviews and estimates of the changes in knowledge and perceived self-confidence. The changes were estimated by the differences between paired proportions of participants. The responsiveness of the ordered categorical item scores on self-confidence was evaluated by the measure of systematic group change and indi…
PCA3 as a second-line biomarker in a prospective controlled randomized opportunistic prostate cancer screening programme
2017
Objectives: PCA3 performance as a single second line biomarker is compared to the European Randomised Study of Screening for Prostate Cancer risk calculator model 3 (ERSPC RC-3) in an opportunistic screening in prostate cancer (PCa). Material and methods: 5,199 men, aged 40-75y, underwent prostate-specific antigen (PSA) screening and digital rectal examination (DRE). Men with a normal DRE and PSA >= 3 ng/ml had a PCA3 test done. All men with PCA3 >= 35 underwent an initial biopsy (IBx) 12 cores. Men with PCA3 = 3 ng/ml and DRE is normal, IBx could be avoided in 12.5% less than if ERSPC RC-3 is used and would reduce the false negative cases by 36.2%. At a FU of 21.7 months, this dual protoco…
How much Is needed? Comparison of the effectiveness of different pain education dosages in patients with fibromyalgia
2019
AbstractObjectiveTo assess the effect of different dosages of pain neuroscience education (PNE) programs on central nociceptive processing in patients with fibromyalgia. Second, to compare the effects of different dosages of PNE programs on numerical pain rating scale (NPRS), disability, and psychological variables.DesignSingle-blind randomized controlled trial.SettingThree fibromyalgia centers in Spain (Valencia, Alcorcón, Alcalá de Henares).SubjectsSeventy-seven patients with fibromyalgia.MethodsParticipants were randomized to four groups of PNE: 1) high-dose PNE (N = 20), 2) low–concentrated dose PNE (N = 20), 3) diluted low-dose PNE (N = 20), and (4) control treatment (N = 17), conducte…
Efficacy of a proprioceptive exercise program in patients with nonspecific neck pain: a randomized controlled trial.
2020
BACKGROUND Nonspecific neck pain is associated with chronic pain, disability, reduced cervical mobility, postural control disorders and impaired proprioceptive control. AIM The aim of this study was to compare the effectiveness of two therapeutic exercise programs (i.e. cervical proprioception and cervical mobility) in reducing pain and disability in individuals with nonspecific neck pain. We further aimed to compare the effectiveness of the two treatments in improving pressure pain threshold, cervical range of motion and head repositioning accuracy. DESIGN This study was designed as a randomized controlled trial. SETTING This study took place in a private rehabilitation clinic. POPULATION …
Enteral versus parenteral early nutrition in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group study (N…
2017
International audience; BackgroundWhether the route of early feeding affects outcomes of patients with severe critical illnesses is controversial. We hypothesised that outcomes were better with early first-line enteral nutrition than with early first-line parenteral nutrition.MethodsIn this randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2 trial) done at 44 French intensive-care units (ICUs), adults (18 years or older) receiving invasive mechanical ventilation and vasopressor support for shock were randomly assigned (1:1) to either parenteral nutrition or enteral nutrition, both targeting normocaloric goals (20–25 kcal/kg per day), within 24 h after intubatio…
Improvement in quality of life with omalizumab in patients with severe allergic asthma.
2006
Patients with severe persistent asthma experience daily symptoms and frequent serious exacerbations that contribute to a significant impairment of health-related quality of life (QoL).A pooled analysis was completed of six controlled clinical trials that evaluated the effect of add-on omalizumab on asthma-related QoL in patients with severe persistent allergic (IgE-mediated) asthma. Asthma-related QoL was assessed at baseline and treatment endpoint using the well-validated Juniper Asthma Quality of Life Questionnaire (AQLQ). Change from baseline in AQLQ total score was compared between treatments using analysis of covariance methods. The percentage of patients who achieved a clinically mean…
Sequential treatment of ADHD in mother and child (AIMAC study): importance of the treatment phases for intervention success in a randomized trial
2018
Abstract Background The efficacy of parent-child training (PCT) regarding child symptoms may be reduced if the mother has attention-deficit/hyperactivity disorder (ADHD). The AIMAC study (ADHD in Mothers and Children) aimed to compensate for the deteriorating effect of parental psychopathology by treating the mother (Step 1) before the beginning of PCT (Step 2). This secondary analysis was particularly concerned with the additional effect of the Step 2 PCT on child symptoms after the Step 1 treatment. Methods The analysis included 143 mothers and children (aged 6–12 years) both diagnosed with ADHD. The study design was a two-stage, two-arm parallel group trial (Step 1 treatment group [TG]: …
Risk factors for high myopia: a 22‐year follow‐up study from childhood to adulthood
2018
PURPOSE To determine the effect of the definition of high myopia on its prevalence and risk factors for high myopia. METHODS A total of 240 myopic schoolchildren (119 boys and 121 girls) at the mean age of 10.9 years (range 8.8-12.8 years) were recruited to a randomized clinical trial of myopia treatment among children from 3rd- and 5th grades of school referred for an eye examination due to poor distant vision and having no previous spectacles. Clinical follow-ups, including refraction with cycloplegia, were conducted annually at 3 years [third follow-up here = clinical follow-up 1, (n = 237)], and thereafter twice at approximately 10-year intervals [clinical follow-ups 2 (n = 179) and 3, …