Ahaus

Researchers are evaluating the effects of pelacarsen (TQJ230), given as a monthly injection under the skin, in people with mild to moderate calcific aortic valve stenosis. This study aims to see if pelacarsen can safely slow the progression of this heart valve condition compared to a placebo. The trial is a phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers. Participants will receive either pelacarsen 80 mg or a matching placebo once a month. Before starting the treatment, they must have elevated lipoprotein(a) levels and be optimally treated for existing cardiovascular risk factors. The study focuses on those aged 50 to under 80 years with mild or moderate calcific aortic valve stenosis. During the 36 months of participation, researchers will monitor changes in peak aortic jet velocity and aortic valve calcium score to assess disease progression. Safety, tolerability, and the impact of the treatment will be evaluated. Participants will undergo regular assessments, including laboratory tests and clinical evaluations, to track heart valve condition and overall health throughout the study.

Researchers are conducting a global study to understand the impact of moderate to severe alopecia areata (AA), non-segmental vitiligo (NSV), and hidradenitis suppurativa (HS) on adolescents and adults. This study aims to assess the burden these conditions place on patients' quality of life and daily functioning in a large real-world population. The study involves participants diagnosed by a physician with one of the three conditions: AA, NSV, or HS. There are no interventional treatments or medications being tested in this study, as it is observational in nature. Data collection focuses on patient-reported outcomes and measures that evaluate disease severity and its effects. Participants will complete various questionnaires and assessments related to their condition, such as the Alopecia Areata Symptom Impact Scale (AASIS) for AA, the Severity of Alopecia Tool (SALT) for scalp hair loss in AA, the Facial Vitiligo Area Scoring Index (F-VASI) and Vitiligo Quality of Life Score (VitiQoL) for vitiligo, and the Dermatology Life Quality Index (DLQI) and International Hidradenitis Suppurativa Severity Scoring System (IHS4) for HS. These tools help researchers understand how symptoms affect quality of life and disease severity. The study collects information up to the day of the study visit.

Researchers are evaluating the effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.

Researchers are evaluating the safety and effectiveness of bimekizumab compared to a placebo in adults who have palmoplantar pustulosis (PPP), a skin condition affecting the palms and soles. This Phase 3 study aims to better understand how well bimekizumab works in treating PPP and to assess any safety concerns in participants with this condition. Participants will be randomly assigned to receive either bimekizumab or a matching placebo at specific scheduled times. The study includes a double-blind period where neither the participants nor the researchers know which treatment is being given. An open-label extension phase will follow, allowing all participants to receive bimekizumab to further evaluate its effects. During the study, participants will undergo assessments to measure the severity of their PPP, including the Palmoplantar Pustulosis Investigator Global Assessment (PPP-IGA) response at Week 16. Researchers will monitor skin symptoms, treatment safety, and overall health. The study involves regular visits and evaluations to track progress and any side effects over the course of the trial.

Researchers are investigating the real-world use, effectiveness, quality of life impact, safety, and tolerability of the combination of encorafenib and binimetinib in patients with unresectable advanced or metastatic melanoma that has a specific BRAF V600 mutation. This prospective, longitudinal, non-interventional study focuses on patients in Germany, Austria, and Switzerland who receive these drugs after they became commercially available. The study includes patients receiving first or second line treatment, particularly after prior checkpoint inhibitor therapy. The study observes patients treated with encorafenib plus binimetinib according to approved prescribing guidelines (Summary of Product Characteristics). Patients may have started treatment within six months before joining the study or plan to start soon. No experimental interventions are given; instead, the study collects real-life treatment data under routine clinical care in multiple centers across the three countries. Participants will be followed to gather information on progression-free survival at 12 months after starting treatment. Data collected include safety, tolerability, quality of life, and treatment patterns. The study documents patient outcomes and treatment experiences in a naturalistic setting without altering standard care. Participation duration depends on treatment and follow-up schedules determined by routine clinical practice and study timelines.

Researchers are comparing the performance of six different types of intraocular lenses (IOLs) used in cataract surgery to help people see better at various distances, especially intermediate distances like those needed for computer work and daily tasks. This study focuses on adults aged 22 to 85 who need cataract surgery in both eyes and aims to understand which lens offers the best vision quality, patient satisfaction, and reduced dependence on glasses. The trial evaluates five advanced extended depth-of-focus (EDOF) lenses against a standard monofocal lens, addressing the gap in knowledge about real-world vision outcomes with these newer technologies. Participants will undergo cataract surgery on both eyes, receiving one of six lens types: TECNIS Eyhance, AcrySof IQ Vivity, LuxSmart, Rayner EMV, Eyecryl SERT, or the monofocal CT ASPHINA 409M. Each lens uses different optical designs to extend the range of clear vision, particularly for intermediate distances. Surgeries are standardized, and patients select their preferred lens after learning about each option. Follow-up visits occur at 1 day, 1 week, 1 month, and 3 months after surgery to monitor recovery and lens performance. During the study, participants will complete vision tests at multiple distances including 60cm and 80cm, contrast sensitivity tests under different lighting conditions, and questionnaires about their quality of vision and daily activities. Researchers measure visual acuity, depth of focus, contrast sensitivity, and patient-reported outcomes such as visual symptoms and life impact. Safety and lens stability are monitored throughout the 3-month follow-up period to provide comprehensive information for choosing the best IOL option.

Researchers are evaluating the timing of radiotherapy for women with high-risk breast cancer who have already received neoadjuvant chemotherapy (NACT). This phase III international trial compares whether giving radiotherapy before surgery (preoperative) leads to better disease-free survival (DFS) and fewer late radiation side effects compared to the standard approach of radiotherapy after surgery (postoperative). The study aims to find the best timing for radiotherapy to prevent cancer recurrence and improve survival outcomes. Participants will receive either preoperative radiotherapy or postoperative radiotherapy after completing neoadjuvant chemotherapy and surgery. Radiotherapy may target the whole breast or chest wall and, if lymph nodes are involved, the regional lymph nodes as well. The treatment approach follows established guidelines and includes the possibility of an additional radiation boost to the tumor bed in breast-conserving therapy. During the study, participants will be monitored for disease-free survival over 6 to 10 years. Researchers will assess cancer recurrence, survival, and radiation-related late effects. Patients will undergo regular evaluations including clinical assessments and imaging as needed to follow their health status. The trial requires informed consent and includes safety monitoring throughout the long-term follow-up period.

This research aims to assess the long-term outcomes, performance, and safety of the BIOMONITOR III implantable cardiac monitors (ICMs) and their possible successors in real-life clinical settings. The study also serves as a platform for additional scientific and regulatory investigations with minimal extra effort for both clinical sites and patients. It focuses on patients with conditions such as tachycardia, atrial fibrillation, syncope, bradycardia, and cryptogenic stroke. Participants will receive a BIOTRONIK Implantable Cardiac Monitor and use the CardioMessenger device as part of the BIOTRONIK Home Monitoring system. The study observes routine clinical care with these devices and may include submodules for further research. The timeline includes monitoring the time to diagnosis starting from the device insertion. Throughout the study, participants will be regularly monitored using the implanted device and home monitoring technology. Researchers will track outcomes related to device performance, safety, and the time it takes to reach relevant diagnoses. Participants provide informed consent and agree to use the home monitoring system during the study period, contributing to long-term data collection and safety assessment.

Researchers are studying patients who have survived a heart attack (myocardial infarction) and are at higher risk for sudden cardiac death caused by dangerous heart rhythms. This study focuses on patients with a severely reduced heart function measured by left ventricular ejection fraction (LVEF) of 35% or less. Previous landmark trials showed that implantable cardioverter-defibrillators (ICDs) improved survival compared to medical therapy alone, but since then, new medications have decreased sudden death rates and the need for ICD therapy. Because ICDs carry risks and costs, this study aims to compare modern optimal medical therapy (OMT) alone versus OMT with ICD implantation to see if medical therapy without ICD is not worse for patient survival. Participants will be divided into two groups: one receiving OMT only and the other receiving OMT plus an ICD device. The ICD options include transvenous ICDs, subcutaneous defibrillators, or a newer extravascular ICD with substernal lead placement. OMT will follow current European guidelines for managing coronary syndromes and heart failure. The study is designed to assess outcomes over time from the point of randomization. During the study, researchers will track survival by measuring the time until death from any cause, expecting about 15 months of follow-up after the last participant joins. Patients must have a history of heart attack at least three months prior, symptomatic heart failure, and have been on OMT for at least three months before enrollment. Safety and effectiveness of treatments will be monitored closely throughout the study period.

Researchers are conducting a prospective, non-interventional observational study to evaluate the long-term effects of dupilumab treatment in patients aged 6 years and older with atopic dermatitis (AD). The study aims to understand the characteristics of AD patients in Germany who receive dupilumab under everyday conditions, including their medical history, socio-demographic and disease-related features, associated atopic comorbidities and type 2 inflammation diseases, as well as their previous and ongoing AD treatments. The study will also assess therapeutic response rates at Month 6 and long-term efficacy at Months 12 and 24 by measuring disease control with tools such as the Atopic Dermatitis Control Tool (ADCT) and Recap of Atopic Eczema (RECAP). Additionally, the study will observe dosing patterns, reasons for treatment changes, and collect long-term safety data. Participants will receive dupilumab treatment as part of their routine care without any intervention from the study. The observation period for each participant lasts up to 2 years or until dupilumab treatment is discontinued. Visits will be scheduled according to the standard of care, and the study will collect data on variations in dosing regimens, treatment initiation or discontinuation reasons, and concomitant therapies. During the study, participants or their guardians will complete questionnaires to assess signs, symptoms, quality of life, and disease control related to atopic dermatitis. Researchers will monitor outcomes such as the number of patients maintaining controlled disease states between Months 6 and 12, and changes in ADCT and RECAP scores over 52 weeks. Safety data will also be collected throughout the observation period to evaluate the long-term effects of dupilumab in both adult and pediatric patients.