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Filter by:This phase II trial tests whether 177-Lutetium-PSMA given before stereotactic body radiotherapy (SBRT) works to improve cancer control rate in patients with 1-5 prostate cancer tumors that have come back after prior treatment (oligorecurrent). Radioactive drugs, such as 177-Lutetium-PSMA, may carry radiation directly to tumor cells and not harm normal cells. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving 177-Lutetium-PSMA before SBRT may make the SBRT more effective.
No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemotherapy plus surgery and incidental pathologic lymph node metastasis following initial surgery for esophageal squamous cell carcinoma (ESCC).Controversy still exists regarding the role of adjuvant immunotherapy for ESCC patients who do not achieve pCR after neoadjuvant chemotherapy plus surgery and clinical T1-2 N0 patients with incidental pathologic lymph node metastasis following initial surgery. To investigate the outcomes of adjuvant Sintilimab in patients with locally advanced ESCC, we initiated this randomized controlled trial (RCT).
This phase II MATCH treatment trial identifies the effects of copanlisib hydrochloride (copanlisib) in patients whose cancer has a genetic change called PIK3CA mutation. Copanlisib may stop the growth of cancer cells by blocking PIK3, a protein needed for cell growth. Researchers hope to learn if copanlisib will shrink this type of cancer or stop its growth.
Rationale: Diagnostic medical imaging is essential in health care and guides patient management decisions. Rapid advances in imaging technology have enabled diagnosis at an early disease stage. Nevertheless, striving for early diagnosis leads to substantial overuse of diagnostic tests (too many tests are performed) and overdiagnosis (diagnosed abnormalities that are unlikely to affect a patient's health or well-being), with dire consequences to patient outcomes and health care costs. Computerized decision support systems (CDSS), such as the European Society of Radiology (ESR) iGuide, have been developed to guide referring physicians at the point of care. Objective: The overall objective of this project is to promote the appropriate, meaningful, value-based and personalized use of medical imaging. The specific objectives of this study are to evaluate the trends over time with implementation of a CDSS to guide imaging referrals (ESR iGuide) in key outcomes related to the appropriate use of diagnostic imaging tests, and to compare these trends between departments randomized between implementation of the active intervention (with decision support) and the control condition (no decision support). Study design: The study will be performed as a multi-center cluster randomized trial with departments acting as clusters combined with a before-after-revert design. Four hospitals with each 8 participating departments for a total of 32 clusters will be included in the study. All departments will start with the control condition. Subsequently, stratified per specialty (surgical vs non-surgical), half of the departments - chosen at random - will switch to the active intervention while the other half in the control condition. Study population: The study population consists of patients of eligible participating departments for whom a diagnostic imaging procedure is considered, and for whom a diagnostic imaging request is entered in a computerized order entry in such a form that it is registered by the CDSS. Intervention: The control condition will consist of computerized order entry with structured data entry of the clinical indication and tracking of the imaging exams requested. The CDSS is implemented but without decision support and physicians are blinded to these referral guidelines. Without their knowledge their imaging requests are categorized as appropriate, under certain conditions appropriate, or inappropriate. They receive no feedback to their requests. In the active intervention the CDSS is implemented with decision support. Physicians are made aware of the referral guidelines and appropriate exams are suggested. Their imaging requests are categorized as appropriate, under certain conditions appropriate, or inappropriate and feedback is provided. Physicians are able to change their request in response to the feedback. In the revert condition decision support is removed to study the sustainable educational effect of temporary use of the system. Main study parameters/endpoints: The primary outcome is the proportion of inappropriate diagnostic imaging exams requested per cluster (department). Inappropriateness is determined by the decision support system and is based on the ESR imaging referral guidelines. Secondary outcomes are the overall absolute number of imaging exams ordered (total and by exam type), estimated medical radiation from diagnostic imaging in investigated groups, and estimated medical costs for diagnostic imaging from the healthcare system perspective in investigated groups. Amendment November 2023: At Johannes Gutenberg University Mainz, the CDSS could not be integrated into the hospital's internal computerized order entry system as required for the study. Therefore, departments from this hospital were not eligible for inclusion. Therefore, and 24 instead of 32 departments were from three locations (Augsburg, Kiel, Lübeck) were randomized accordingly. In a qualitative description of the process of integrating the CDSS in the local hospitals, Mainz will still be included.
This is a prospective multi-center randomized clinical trial designed to demonstrate that daily online adaptive radiotherapy with concomitant chemotherapy for stage III non-small cell lung cancer (NSCLC) will result in decreased acute respiratory and esophageal toxicity compared with non-adaptive radiotherapy with concomitant chemotherapy. The timepoint for this assessment will be 1 month following the end of radiotherapy and will use the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
The aim of this study is to explore the diagnostic efficacy of oral glucose tolerance test in early pregnancy and establish the prediction model for gestational diabetes mellitus, so as to provide the optimal screening of gestational diabetes mellitus in the first trimester. The treatment started when the pregnancy was confirmed by transvaginal ultrasound (around 6 weeks of gestation) and continued until 42 days postpartum. The study is a single center, prospective cohort study. A total of 781 participants within 14 weeks of gestation were recruited.
This project aims to understand the local feasibility and acceptability of MamaMeals (a home-delivered nutritious, postpartum meal delivery program) and MamaMatters (a moderated social media-based peer support group) among peripartum women who are eligible for federal supplemental nutrition assistance programs such as The Special Supplemental Nutrition Program for Women, Infants and Children (WIC) or Supplemental Nutrition Assistance Program (SNAP). The investigators will conduct a prospective randomized controlled trial (RCT) of these two interventions among postpartum individuals. Analyses will be performed to determine the relative risk of postpartum depressive or anxiety symptoms (primary outcome) and overall well-being and maternal/infant health (secondary/exploratory outcomes) between groups. Findings from this pilot intervention study will inform a future, large RCT exploring the effectiveness of MamaMeals and/or MamaMatters on reducing postpartum mental health symptoms and cardiovascular morbidity among individuals with food insecurity during and after pregnancy.
SL03-OHD-105 is an open-label, multicenter, phase 1b trial designed to evaluate SL-172154 administered in combination with pegylated liposomal doxorubicin (PLD) or mirvetuximab soravtansine (MIRV) in patients with platinum resistant ovarian cancer. Approximately 102 patients will be enrolled in this study in two phases: dose escalation and dose expansion.
The purpose of the study is to evaluate the safety and tolerability of HLX60 combined with HLX10 in order to determine the maximum tolerated dose (MTD) and Recommended Phase 2 dose (RP2D) and to evaluate the preliminary efficacy for each combination regimen.
This multi-center retrospective study collected clinical, laboratory, and CT pulmonary angiography parameters with acute pulmonary embolism patients from admission to predict adverse outcomes within 30 days after admission into hospital.