Aarau

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

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.

This research aims to compare two surgical approaches for patients experiencing increased intracranial pressure caused by malignant stroke. It investigates whether using a single surgery with an individually molded space-expanding shield can be a viable alternative to the standard decompressive hemicraniectomy followed by a second surgery called cranioplasty. The study is planned as a randomized, controlled, multicenter trial to evaluate these methods in stroke patients aged 18 to under 70. Participants will be randomly assigned to one of two groups. The experimental group will receive decompressive hemicraniectomy with implantation of a space-expanding shield that allows brain swelling while providing protection in a single surgery. The control group will undergo the standard decompressive hemicraniectomy without the shield and later undergo cranioplasty about 90 days after the initial surgery. Follow-up examinations are scheduled at 1 to 7 days, 6 weeks, 3 months, and 6 months after surgery. During the study, participants will undergo evaluations including neurological assessments and imaging to monitor recovery and complications. Researchers will measure outcomes such as the modified Rankin Scale score at 6 months, number of additional surgeries for intracranial pressure control, infections, wound healing, syndrome of the trephined, survival, cosmetic satisfaction, and quality of life. The total duration of participation for each patient is 6 months, with safety and recovery closely monitored throughout.

Researchers are comparing two treatment combinations for adults with advanced nonsquamous non-small cell lung cancer NSCLC that have a specific KRAS p.G12C mutation and are negative for PD-L1 expression. The study aims to evaluate progression-free survival and overall survival between participants receiving sotorasib with platinum doublet chemotherapy and those receiving pembrolizumab with platinum doublet chemotherapy. This phase 3, randomized, open-label trial is led by Amgen and includes participants with stage IV or advanced stage IIIBC NSCLC. Participants will be randomly assigned to receive either sotorasib orally combined with carboplatin and pemetrexed, or pembrolizumab intravenously combined with the same chemotherapy drugs. These treatments are given as front-line therapy. The study includes a treatment period with these drug combinations and monitoring for outcomes such as response rates and quality of life over several years. During the study, participants will be regularly assessed through various measures including survival status, tumor response, and quality-of-life questionnaires focusing on lung cancer symptoms. Researchers will monitor safety by tracking adverse events, vital signs, and laboratory tests. Treatment concentrations of sotorasib will also be measured up to 64 days after starting. The total study duration includes follow-up for up to approximately 5.5 years to fully evaluate treatment effects and outcomes.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

This research is focused on adults aged 40 and older who have idiopathic pulmonary fibrosis IPF, a lung condition characterized by scarring and reduced lung function. The study aims to evaluate whether the medicine BI 765423 can improve lung capacity compared to a placebo. Participants must have certain lung function levels and evidence of lung fibrosis confirmed by imaging to join the study. Participants are randomly assigned to one of two groups one receives BI 765423 through an intravenous infusion every four weeks, and the other receives a placebo that looks the same but contains no active medicine. The study lasts up to 11 months, during which participants may continue their standard IPF treatments. The main treatment period focuses on observing changes in lung function over 3 to 6 months. During the trial, participants visit the study site several times for screening, treatment, and follow-up assessments. Doctors measure lung function with tests like forced vital capacity FVC and collect blood samples to monitor markers of lung health. The study compares results between the groups to assess the effects of BI 765423, while also monitoring participants overall health and any side effects.

Researchers are evaluating the highest dose of BI 764532 that adults with a brain tumour positive for the tumour marker delta-like 3 DLL3 can tolerate. This study focuses on people with advanced glioma who have not responded to previous treatments. BI 764532 is an antibody-like molecule designed to connect cancer cells and immune system T-cells, potentially helping the immune system fight the tumour. Participants receive BI 764532 through intravenous infusions starting at treatment. If they benefit and tolerate the drug, the treatment continues with regular visits to the study site. The number of visits varies depending on individual response and tolerance. Early visits include monitoring participants safety closely. Throughout the study, doctors monitor general health and record any side effects. Safety assessments are performed regularly. The primary outcome is the occurrence of dose-limiting toxicity during the first up to 4 weeks of dosing. Secondary outcomes include safety over the entire treatment period of up to 26 months. Total participation time depends on treatment response and tolerance.

This research aims to evaluate how the medicine nerandomilast affects lung fibrosis in adults with systemic autoimmune rheumatic diseases who have lung fibrosis. The study includes adults 18 years and older who have not shown improvement in lung function after standard immunosuppressant treatment. Participants have interstitial lung disease related to rheumatic diseases such as rheumatoid arthritis, systemic sclerosis, idiopathic inflammatory myopathy, Sjgrens disease, or mixed connective tissue disease. Participants are randomly divided into two groups one group receives nerandomilast tablets and the other receives placebo tablets that look identical but contain no medicine. Tablets are taken twice daily for at least 26 weeks and up to 1 year. Participants continue their usual immunosuppressant treatments during the study. Participants stay in the study for about 7.5 to 13 months and visit the study site 9 to 10 times. During visits, lung function tests and chest imaging are performed, and participants complete questionnaires about symptoms and quality of life. Researchers compare results between the groups to assess the effects of nerandomilast while monitoring health and any side effects throughout the study.

Glucocorticoids are hormones that help control inflammation and regulate the immune system. In children with blood cancers like acute lymphoblastic leukemia ALL and lymphoblastic lymphoma LBL, these hormones are given as medications to quickly reduce cancer cells. However, this treatment can suppress the bodys natural glucocorticoid production, leading to a deficiency that increases infection risks and is hard to detect due to overlapping chemotherapy side effects. This study aims to understand how often and for how long this deficiency occurs in children with these cancers and to identify those at higher risk. The study observes children diagnosed with ALL or LBL who are treated with glucocorticoids for at least 21 consecutive days. Regular low-dose ACTH tests will be performed during and after treatment to assess the bodys natural glucocorticoid production. These tests are done only when children already have venous access and are hospitalized for treatment, minimizing extra burden. The study follows participants from enrollment until three months after their last glucocorticoid dose. Participants will be monitored through these ACTH tests to detect adrenal insufficiency and its duration. The main outcome measured is the occurrence of adrenal insufficiency, with a secondary focus on how long it lasts. The study involves children up to 18 years old and takes place at two childrens hospitals. The goal is to improve understanding and management of glucocorticoid deficiency during and after cancer treatment, with careful attention to the safety and comfort of the children involved.

Researchers are evaluating whether antibiotic treatment is necessary for children with community-acquired pneumonia caused by the bacterium Mycoplasma pneumoniae. This trial compares the effects of a commonly used antibiotic, azithromycin, with a placebo in children aged 3 to 17 years. The study addresses concerns about increasing antibiotic resistance and aims to improve treatment decisions for this common cause of pneumonia in children. Participants are randomly assigned to receive either azithromycin or a placebo for five days. The azithromycin group takes a daily dose of 10mgkg on the first day followed by 5mgkg on days 2 through 5. This randomized, double-blind, placebo-controlled trial takes place across multiple pediatric centers and includes both ambulatory and hospitalized children. The study involves initial screening to confirm Mycoplasma pneumoniae infection using a specific antibody test before starting the assigned treatment. During the study, researchers will monitor symptom duration, vital signs, and changes in patient care status for up to 28 days. They will also assess overall clinical outcomes, symptom resolution, quality of life impacts on the family, time to return to normal daily activities, and the development of any complications related to the infection. Follow-up includes clinical examinations and parent reports to track progress and safety throughout the study period.