Bad Kreuznach

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

Researchers are studying metastatic colorectal carcinoma (mCRC) patients whose tumors have a BRAFV600E mutation, which is known to have a poorer outlook compared to non-mutated cases. Standard treatments after the first therapy have shown limited success, with low response rates and short survival times. This study aims to understand how the combination of encorafenib and cetuximab works in real-world settings, focusing on effectiveness, quality of life, safety, and tolerability in German, Austrian, and Swiss patients who have already received prior therapies. Participants will receive encorafenib combined with cetuximab, treatments that target specific cancer mutations. This study is observational and non-interventional, meaning it records how patients respond to these drugs in routine care without altering their treatment. The study allows initial retrospective data collection and will follow patients longitudinally to gather comprehensive information about their experiences with the therapy. During the study, patients will be monitored for overall survival twelve months after starting treatment. Researchers will assess how well the treatment controls the cancer, side effects experienced, and patients' quality of life. Data will be collected from medical records and patient reports in regular clinical care, providing insights into the real-life use and impact of encorafenib and cetuximab for this patient group.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

Employees working in hospitals often face various stressors that can lead to psychological stress. To address this, programs aimed at building resilience are increasingly offered, but most focus on individual resilience. This study evaluates the Tea(m)Time intervention, which emphasizes strengthening resilience at the team level. The research aims to learn what helps or hinders the implementation of Tea(m)Time and to understand how it supports team resilience in hospital staff. The Tea(m)Time intervention is delivered in two phases. First, team leaders receive training on topics such as healthy leadership, resilience, occupational health and safety, posture, psychological empowerment, agile management, and coaching techniques. After this, teams participate in sessions where each hour begins with self-reflection, followed by assessing and prioritizing stress factors. Teams then collaboratively work on identified problems to find solutions. Participants in both the intervention and control groups complete the FITOR questionnaire, which measures individual, team, and organizational resilience, at three points: before the intervention, at 6 months, and at 12 months. The study involves hospital staff from selected clinics who meet the eligibility criteria. Researchers monitor changes in resilience over time to understand the impact of the Tea(m)Time program.

Researchers are evaluating a new surgical approach for treating insufficiency fractures of the pelvis, which often result in limited mobility. This study focuses on using a titanium fusion implant called iFuse-3D, combined with transiliac-transsacral screws, to stabilize fractures and reduce motion in the sacroiliac joint. This method aims to improve clinical outcomes by preventing micromotion in the fracture area, which could help patients regain their mobility after a pelvic fracture. The treatment involves placing three implants, including the iFuse-3D device, which is made of titanium with a special porous coating designed to prevent joint rotation or displacement. The placement instrument uses guide pins for precise positioning. The study examines patients aged 60 and older who have acute or subacute posterior pelvic girdle pain due to low-energy trauma or spontaneous occurrence. The goal is to assess how many patients regain their pre-fracture mobility by hospital discharge. Participants will be monitored until hospital discharge, which typically occurs about 8 days after surgery. Researchers will measure mobility recovery using the Functional Mobility Score to compare patients' status before their fracture and at discharge. Safety, effectiveness, and clinical outcomes related to the implant and screw placement will be evaluated during this time.