Ahaus

This trial studies adults aged 50 to under 80 with mild or moderate calcific aortic valve stenosis and elevated lipoproteina levels. Researchers are assessing the safety, tolerability, and ability of pelacarsen TQJ230 given once monthly by injection to slow the progression of this heart valve condition. The study compares pelacarsen to a placebo in a randomized, double-blind design. Participants receive either pelacarsen 80 mg or a matching placebo as a subcutaneous injection monthly. They continue treatment and monitoring for up to 36 months to observe changes in heart valve narrowing and calcium buildup. The study also tracks lipoproteina levels and clinical heart-related events during this period. Throughout the study, participants will have regular assessments including imaging to measure aortic valve function and calcium score, blood tests for lipoproteina, and monitoring for safety. The main outcomes analyzed after 36 months include changes in valve jet velocity and calcium score, alongside clinical events. Participants remain under medical care while being observed for any effects of the study drug or placebo.

Researchers are studying the impact and burden of three skin conditions moderate or severe alopecia areata, non-segmental vitiligo, and moderate to severe hidradenitis suppurativa. The study includes adolescents and adults and aims to understand how these conditions affect quality of life and daily functioning in a large global population. This is an observational study where participants with each condition will have a single visit for data collection following routine clinical practice. No experimental treatments are given instead, the study gathers information during this one visit to assess disease characteristics and impact. During the visit, participants will complete questionnaires and clinical assessments specific to their condition. These include tools measuring symptom impact, hair loss severity, skin depigmentation, and quality of life related to each disease. This helps researchers better understand the real-world burden of these conditions. Participation involves only this one visit, with no long-term follow-up or additional procedures.

Researchers are studying the use of bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin, known as triple therapy, in adults with primary hypercholesterolemia or mixed dyslipidemia. The study aims to evaluate the effectiveness and safety of this combination in real-world clinical practice, focusing on lowering LDL cholesterol LDL-C levels. This is an observational study, meaning no drugs are administered by the study team instead, existing treatments are monitored. Participants are adults who have started triple therapy within the past four weeks and are followed for up to one year. The study looks at LDL-C changes after 8 weeks and 1 year of treatment, adherence to the therapy, side effects, and cardiovascular events such as heart attacks and strokes. No new treatments are given instead, researchers collect information on the participants ongoing treatments involving bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. During the study, participants LDL-C levels, laboratory values, and treatment adherence are regularly reviewed. Researchers will also record any adverse events and track major cardiovascular events over the year. The primary measurement is the change in LDL-C from before treatment to 8 weeks after starting triple therapy. Participants health is followed through routine clinical assessments, and the study lasts for up to one year after beginning triple therapy.

This clinical trial investigates the efficacy and safety of bimekizumab compared with placebo in adults with palmoplantar pustulosis PPP, a skin condition causing pustules on the palms and soles. The study is a Phase 3, randomized, double-blind, placebo-controlled trial with an open-label extension, aiming to evaluate treatment responses and safety outcomes in participants diagnosed with PPP for at least 24 weeks and who are candidates for systemic therapy or phototherapy. Participants are randomly assigned to one of two groups one group receives bimekizumab for the entire study duration, while the other receives placebo initially before switching to bimekizumab in the maintenance phase. Treatments are given at specified time points throughout the study, which includes an initial treatment period followed by a maintenance period under open-label conditions. During the study, participants undergo assessments including the Palmoplantar pustulosis-Investigator Global Assessment PPP-IGA response at Week 16, Palmoplantar Pustulosis Area Severity Index PPPASI responses at Weeks 8 and 16, and quality of life evaluations via the Dermatology Life Quality Index DLQI. Researchers monitor pain scores, adverse events, and serious side effects from baseline through safety follow-up up to Week 117. Participants will be closely observed through regular visits and evaluations during these periods.

Researchers are studying the management of moderate to severe dry eye disease by comparing two types of eye drops Artelac Complete MDO and VISMED MULTI. The study aims to evaluate the performance and safety of these treatments. It is a double-masked, randomized, parallel group, non-inferiority study sponsored by Dr. Gerhard Mann chem.-pharm. Fabrik GmbH. Participants will self-administer either Artelac Complete MDO eye drops or VISMED MULTI eye drops. The study involves a treatment period leading to a key assessment at Day 90 Visit 3. Before randomization, participants will use a preservative-free tear substitute at least three times daily for around 10 days. The study compares the two treatments by measuring eye health and dry eye symptoms over time. During the study, participants will have their dry eye symptoms evaluated using the Ocular Surface Disease Index OSDI score at baseline and Day 90. Other assessments include tear film break-up time and ocular surface staining at screening and randomization visits. The primary outcome is the change in total OSDI score after 90 days. Participants must comply with treatment and follow-up visits, which will monitor safety and treatment effects throughout the study duration.

Researchers are investigating the real-world use of encorafenib plus binimetinib for patients with unresectable advanced or metastatic melanoma that has a BRAF V600 mutation. This observational study focuses on documenting treatment effects, quality of life, safety, and tolerability after these drugs became commercially available in Germany, Austria, and Switzerland. The study specifically looks at patients treated in the first and second line settings after prior checkpoint inhibitor therapy. The study observes patients who are treated with encorafenib plus binimetinib according to the approved product guidelines. Participants may have started this treatment up to six months before joining the study or may begin treatment soon after enrollment. The study tracks treatment details, effectiveness, side effects, and patient-reported outcomes over a median treatment duration of about 12 months, with a total observation period of up to 90 months. Participants will be followed through regular documentation of their disease and treatment progress, including patient and disease profiles, treatment sequences, adverse events, and quality of life assessments using questionnaires. The main outcome measured is progression-free survival at 12 months after treatment start. Researchers will also evaluate treatment duration, interruptions, dose intensity, and physician satisfaction. Long-term safety and prognostic factors will be monitored throughout the observation period until study completion in September 2027.

This research aims to compare the vision outcomes and patient satisfaction of six different types of artificial lenses intraocular lenses or IOLs implanted during cataract surgery. It focuses on how well these lenses help people see at far, middle, and near distances, how satisfied patients are with their vision after surgery, and how often glasses are still needed. The study addresses an important need for better intermediate vision following cataract surgery by evaluating modern extended depth-of-focus lenses against a standard monofocal lens. Participants will have cataract surgery in both eyes, 1 to 2 weeks apart, receiving one of six lens types TECNIS Eyhance, AcrySof IQ Vivity, LuxSmart, Rayner EMV, Eyecryl SERT, or the standard monofocal CT ASPHINA 409M lens. The procedure is standardized with a single experienced surgeon performing all implantations. Each lens uses a different optical design to potentially improve vision at various distances, especially intermediate vision important for daily tasks. During the study, participants undergo vision tests at multiple distances, contrast sensitivity tests under different lighting conditions, and fill out questionnaires about their vision quality and daily activities. Follow-up visits occur at 1 day, 1 week, 1 month, and 3 months after surgery to monitor visual performance, patient satisfaction, lens stability, and any complications. Researchers measure outcomes such as distance-corrected intermediate visual acuity, binocular defocus curve, contrast sensitivity, and vision-related quality of life to help guide lens selection for future patients.

Researchers are investigating the best timing for radiotherapy in women with high-risk breast cancer who have received neoadjuvant chemotherapy. The study compares preoperative radiotherapy to the standard postoperative radiotherapy to see if it improves disease-free survival and reduces radiation-related late side effects. This is a randomized phase III trial conducted internationally to address an important gap in breast cancer treatment. Participants are randomly assigned to receive either radiotherapy before surgery or the usual radiotherapy after surgery. Both treatments include radiation to the whole breast or chest wall, with additional boosts to the tumor bed when breast-conserving surgery is performed. If lymph nodes are involved, radiation to regional lymph nodes is also given. Treatments follow national and international guidelines and are carefully monitored. Throughout the study, participants will be followed for 6 to 10 years to assess disease-free survival as the main outcome. Researchers will also track local and regional recurrences, metastasis-free survival, overall and disease-specific survival, cosmetic results, quality of life, arm lymphedema, brachial plexus toxicity, and other treatment-related side effects. Regular evaluations by physicians and patient questionnaires will help monitor safety and effectiveness over the long term.

This research aims to evaluate the long-term outcomes, performance, and ongoing safety of the BIOMONITOR III and its possible successors in everyday clinical use. It focuses on patients with conditions such as tachycardia, atrial fibrillation, syncope, bradycardia, or cryptogenic stroke. The study is designed as an observational registry, allowing additional scientific investigations with minimal extra effort for participants and study sites. Participants will receive a BIOTRONIK Implantable Cardiac Monitor ICM and will use the CardioMessenger device to support the BIOTRONIK Home Monitoring system. The registry monitors patients under routine clinical care without introducing experimental treatments or interventions. Data collection includes the insertion procedure and success rate of the device, as well as the time taken to reach a relevant diagnosis starting from device implantation. Throughout the study, participants will be observed during their regular clinical care visits. Researchers will collect information on device performance, safety, and diagnostic timelines. The study will continue until August 30, 2027, tracking patient outcomes over this extended period. Participation involves consenting to the use of home monitoring technology and agreeing to data collection related to the implanted device and clinical events.

Researchers are evaluating the impact of implantable cardioverter-defibrillators ICDs on patients who have survived a myocardial infarction heart attack and have a severely reduced left ventricular ejection fraction LVEF of 35% or less. This group is at increased risk of sudden cardiac death caused by dangerous heart rhythms. Past landmark trials showed ICDs improved survival, but advances in medical therapy have changed patient outcomes, prompting the need to reassess the benefits and risks of ICDs alongside current optimal treatments. In this randomized trial, participants receive optimal medical therapy OMT based on European Society of Cardiology guidelines for managing heart failure and chronic coronary syndromes. One group will also receive an ICD device, while the other group will not. The study compares outcomes between these two groups to determine if OMT without ICD is not worse than OMT with ICD in preventing death. The trial includes patients with symptomatic heart failure and reduced LVEF after a myocardial infarction. Participants will be followed over time with regular evaluations to monitor health and outcomes. Researchers will measure the time from randomization to death from any cause as the primary outcome, with additional assessments including cardiovascular death, sudden cardiac death, hospital readmissions, length of hospital stays, and quality of life over a year. The study is event-driven and expects to observe outcomes about 15 months after the last participant is enrolled. Safety and effectiveness of treatments will be carefully monitored throughout.