scholarly journals Non-invasive cardiac assessment in high risk patients (The GROUND study): rationale, objectives and design of a multi-center randomized controlled clinical trial

Trials ◽  
2008 ◽  
Vol 9 (1) ◽  
Author(s):  
Alexander M de Vos ◽  
Annemarieke Rutten ◽  
Hester J van de Zaag-Loonen ◽  
Michiel L Bots ◽  
Riksta Dikkers ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
High Risk Patients ◽  
Non Invasive ◽  
Randomized Controlled ◽  
Cardiac Assessment ◽  
Risk Patients

scholarly journals Radiotherapy versus radiotherapy combined with temozolomide in high-risk low-grade gliomas after surgery: study protocol for a randomized controlled clinical trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Jingjing Wang ◽  
Ying Wang ◽  
Yan He ◽  
Hui Guan ◽  
Ling He ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
World Health ◽  
Controlled Clinical Trial ◽  
Low Grade ◽  
Who Grade ◽  
Low Grade Gliomas ◽  
High Risk Patients ◽  
Randomized Controlled ◽  
Risk Patients

Abstract Background It has been reported that radiation therapy (RT) followed by procarbazine, lomustine, and vincristine (PCV) chemotherapy could improve progression-free survival (PFS) and overall survival (OS) in patients with high-risk World Health Organization (WHO) grade 2 gliomas after surgery. However, procarbazine is not available in China. In clinical practice, Chinese doctors often use radiotherapy combined with temozolomide (TMZ) to treat these patients, although large-scale prospective studies are lacking. This trial aims to confirm whether RT combined with temozolomide can improve PFS and OS in high-risk patients with low-grade gliomas (LGGs). Methods/design This is a two-group, randomized controlled trial (RCT) enrolling patients who have LGGs (WHO grade 2) and are aged 40 years or older without regard to the extent of resection or are aged younger than 40 years old with subtotal resection or biopsy. An estimated 250 patients will be enrolled. Eligible participants will be randomly assigned to receive RT alone or RT plus TMZ chemotherapy in a 1:1 ratio. The same RT will be given to all eligible participants regardless of whether they are randomly assigned to the RT group or the chemoradiotherapy (CRT) group. While in the CRT group, patients will receive adjuvant TMZ with or without concurrent radiochemotherapy. The primary outcome of this trial is PFS, and it will be analyzed by the intention-to-treat approach. Secondary outcomes include OS, adverse events, and cognitive function. Discussion The objective of our research is to assess the effect of radiotherapy coupled with TMZ in high-risk patients with LGGs after surgery, compared with RT alone. Different histological types and molecular subtypes will be examined, and a corresponding subgroup analysis will be conducted. Our data can provide evidence for postoperative adjuvant therapy in patients with high-risk LGGs in China. Trial registration Chinese Clinical Trial Registry, ChiCTR1800015199. Registered on 13 March 2018.

scholarly journals Impact of Life Skills Training on Adolescents’ Inclination to Risky Behaviors: A Randomized Controlled Clinical Trial

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Elham Fallah ◽  
Mehdi Birjandi ◽  
Kobra Rashidi ◽  
Mohammad Almasian
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Risk Behaviors ◽  
Life Skills ◽  
Skills Training ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Life Skills Training ◽  
High Risk Behaviors ◽  
Randomized Controlled

Background: High-risk behaviors of adolescents and failure to correct their insights and attitudes can have many negative consequences. Objectives: The purpose of this study was to determine the effect of life skills training on adolescents’ tendency to engage in high-risk behaviors. Methods: The present study was a randomized controlled clinical trial, in which 100 high school students from both sexes were selected via the multistage cluster random sampling method and divided into the intervention (n = 50) and control (n = 50) groups using the block randomization method with a block size of 4. Eight life skills training group discussion sessions of 45 minutes weekly were held for the intervention groups for two months, and a one-hour follow-up session was held 20 days after the end of the eight sessions. The study instruments included a demographic questionnaire and the Iranian adolescents’ risk-taking scale. After confirming the validity and reliability of the instruments and obtaining written informed consent of the participants, they were asked to fill out the questionnaires. Using SPSS 18, the data were analyzed by standard deviations for quantitative variables and percentages for qualitative data, as well as chi-squared test, the independent t-test, and repeated-measures analysis of variance, the results being reported at a significance level of 0.05. Results: The results showed that life skills training led to significant decreases in the mean scores of high-risk behaviors, including drug abuse, alcohol consumption, smoking, and violence, at different times in the intervention group in both sexes (P < 0.05), while no significant changes were observed in the control group. Conclusions: The results showed that life skills training can reduce adolescents’ tendency to engage in high-risk behaviors.

Early Treatment of Prethreshold Retinopathy of Prematurity

2020 ◽  
pp. 157-162
Author(s):  
Alan D. Penman ◽  
Kimberly W. Crowder ◽  
William M. Watkins
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Retinopathy Of Prematurity ◽  
Early Treatment ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Conventional Management ◽  
Randomized Controlled ◽  
Structural Measures

The Early Treatment for Retinopathy of Prematurity (ETROP) study, a randomized, controlled clinical trial, compared peripheral retinal ablation with conventional management (observation and treatment if the eye developed threshold retinopathy of prematurity [ROP]) in infants with unilateral or bilateral high-risk ROP. Early treatment of high-risk prethreshold ROP significantly reduced unfavorable outcomes in both primary and secondary (structural) measures. The results of this study showed that it is possible to identify characteristics of ROP that predict which eyes are most likely to benefit from early peripheral retinal ablation.

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