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Bystander Effect clinical trials

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NCT ID: NCT06178016 Not yet recruiting - Clinical trials for Intimate Partner Violence

Efficacy of Bystander Intervention Program in Nursing Students

Start date: September 19, 2024
Phase: N/A
Study type: Interventional

The research will be conducted in a randomized control group experimental research design. The study aims to evaluate the effectiveness of the bystander intervention program developed for dating violence in nursing students. The Bystander Intervention Program will be developed after a literature review on the subject and taking into account previous evidence-based research. The population of the study will consist of Istanbul University-Cerrahpaşa Florence Nightingale Faculty of Nursing, Department of Nursing, Turkish Program 1st year students (N=130). In the sample size calculation, the data reported in similar studies in the literature were used (Rothman et al. 2018). The representativeness of the study was calculated as β=80%, α=0.05 (effect size: 0.6), and a total of 80 samples were calculated as a result of power analysis, 40 intervention, and 40 control groups. Participants will be assigned to the experimental or control group by computer-based simple randomization method. Data will be collected between September, 19 2024, and December 19, 2024. Data will be collected face-to-face using the Individual Information Form, Bystander Efficacy Scale, Intention to Help Scale-Short Version, Bystander Behavior Scale (For Friends), and Program Evaluation Form. The data obtained from the research will be evaluated with the SPSS package program.

NCT ID: NCT04168320 Terminated - Clinical trials for Unresectable Malignant Solid Neoplasm

SBRT-based PArtial Tumor Irradiation of HYpoxic Segment

SBRT-PATHY
Start date: October 30, 2018
Phase: Phase 1
Study type: Interventional

This study uses an unconventional radiotherapy schedule developed at our institute, consisting of a short course high-dose partial irradiation targeting exclusively the hypoxic segment of a bulky tumors, which in our preliminary study has shown to be capable of inducing abscopal and bystander effects. This approach is delivered by using a stereotactic radiotherapy technique so as to spare nearby organs at risk including the peritumoral immune microenvironment from irradiation as much as possible. Our approach consists of a single or up to 3 radiotherapy doses of at least 10 Gy per fraction prescribed to the 70% isodose line encompassing the hypoxic target volume. Radiotherapy will be administered at the precise timing determined specifically for each patient based on the serially mapped homeostatic immune fluctuations by monitoring the blood levels of the cytokines and inflammatory markers over the 2 weeks prior to irradiation. This is done in order to synchronize the radiation treatment with the favorable, most active anti-tumor immune system phase, so as to stimulate and increase anti-tumor immune system activity. This is a monocentric, prospective, two-arm, phase I proof of principle study in which the investigator will enroll subjects with oligometastatic and/or locally advanced (N+) cancers with at least one "bulky" lesion (maximum diameter of at least 6 cm or greater). Patients with life expectancy of at least 3 months, who are ineligible for systemic therapy or experience disease progression with systemic therapies will be included. Radiotherapy will be administered to arm 1 at an estimated "less favorable time-position in immune cycle", while the second arm will have it administered at the estimated "most favorable time-position in immune cycle". The primary endpoint will be the response rate of the non-targeted effects both bystander (local, at the level of the partially treated bulky tumor) and abscopal (distant, at the non-treated metastatic sites), defined as a tumor regression of at least 30%. Secondary endpoints will be safety, survival and analysis of the best timing for the administration of radiotherapy.