Stralsund

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

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 evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the efficacy and safety of inavolisib combined with Phesgo compared to placebo with Phesgo as maintenance therapy in participants who have previously untreated HER2-positive advanced breast cancer with PIK3CA mutations. This Phase III, multicenter, randomized, double-blind, placebo-controlled study focuses on participants with locally advanced or metastatic breast cancer, aiming to understand the treatment impact after initial induction therapy. Participants will receive inavolisib orally once daily on Days 1 to 21 of each 21-day cycle, starting on Day 1 of Cycle 1 during maintenance treatment. Phesgo will be administered subcutaneously every three weeks on Day 1 of each cycle. The study includes an induction therapy phase where taxane-based chemotherapy is given after Phesgo. Optional endocrine therapy such as tamoxifen, aromatase inhibitors, or fulvestrant may be used based on the investigator's choice, with luteinizing hormone-releasing hormone agonists administered according to local guidelines. During the study, participants will be monitored for progression-free survival for up to approximately 40 months. Assessments include evaluation of heart function, organ function, and overall health status. Researchers will track the safety and effectiveness of the treatment combination through regular clinical evaluations and laboratory tests. The total duration includes maintenance treatment cycles and follow-up to measure outcomes and monitor safety.

Researchers are evaluating bronchoscopic lung volume reduction using thermoablation as a treatment for patients with severe emphysema. This prospective, randomized, open-label clinical trial compares this interventional procedure to the usual conservative standard therapy guided by GOLD guidelines. The study aims to provide evidence supporting this procedure as an effective and safe treatment option to improve care for emphysema patients based on current medical knowledge. The treatment involves using the InterVapor® System, which applies heated water vapor to ablate targeted lung regions. This process triggers lung remodeling through inflammation and healing, reducing tissue and air volume in diseased lung areas. The resulting lung volume reduction is expected to improve lung function, exercise capacity, and quality of life by decompressing healthier lung segments and enhancing respiratory muscle efficiency. Participants will be monitored for changes in patient-reported disease-specific quality of life over 9 months. The study includes assessments such as pulmonary function tests, high-resolution CT scans, blood gas measurements, dyspnea scoring, and a 6-minute walk test. Researchers will also evaluate safety and treatment effects through follow-up visits, with total participation lasting at least 9 months to track outcomes and any adverse events.

Researchers are evaluating the safety, effectiveness, and quality of life for combining Abemaciclib with either an Aromatase Inhibitor or Fulvestrant in women with hormone receptor positive, HER2 negative metastatic breast cancer. This includes both premenopausal and postmenopausal patients receiving first-line treatment. The trial also explores biomarker research to understand responses and resistance to this combined endocrine therapy. Participants receive Abemaciclib 150 mg orally every 12 hours along with either an Aromatase Inhibitor (Anastrozole, Letrozole, or Exemestane) taken once daily in 28-day cycles, or Fulvestrant given by injection on days 1 and 15 of the first cycle, then on day 1 of subsequent 28-day cycles. Side effects and patient-reported outcomes are monitored using the CANKADO digital health app, allowing daily tracking alongside standard clinical documentation. During the study, patients regularly report symptoms and side effects through the app, and undergo laboratory tests, imaging, and clinical assessments to monitor disease progression and treatment safety. The main outcome measured is progression-free survival over up to 48 months. Safety and quality of life are also closely observed throughout the trial period.

Researchers are evaluating the effectiveness and safety of combining carboplatin, paclitaxel, bevacizumab, and niraparib compared to carboplatin and paclitaxel followed by niraparib alone in women newly diagnosed with advanced ovarian, peritoneal, or fallopian tube cancer. This Phase III international, multicenter, randomized open trial focuses on patients with specific advanced stages of these cancers who have undergone or plan to undergo surgery and chemotherapy. The study aims to see if adding bevacizumab to the treatment improves progression free survival. All participants first receive one cycle of chemotherapy with carboplatin and paclitaxel. Based on tumor BRCA testing, patients are then randomly assigned to one of two groups: one group receives five more cycles of carboplatin and paclitaxel followed by daily niraparib for up to three years; the other group receives the same chemotherapy combined with bevacizumab, continuing bevacizumab for up to one year and niraparib daily for up to three years. Treatment schedules follow a three-week cycle. Participants will be closely monitored throughout the trial with frequent assessments to track progression free survival until either 586 events occur or three years after the last patient joins, whichever happens first. The study includes detailed safety evaluations, laboratory tests, and patient questionnaires. To participate, women must meet specific health criteria, including performance status and organ function, and agree to follow study procedures for up to three years of treatment and observation.

Researchers are collecting new real-world data on first-line treatment for women newly diagnosed with advanced high-grade epithelial ovarian cancer in Germany. This study aims to understand how maintenance treatment with Poly ADP ribose polymerase inhibitors (PARPi) affects routine medical care, patient outcomes, and treatment sequences, especially in those undergoing surgery and chemotherapy. It also explores patient-reported experiences, physician insights, genetic testing practices, and drug safety in this setting. The study observes patients receiving first-line platinum-based chemotherapy, including those who have completed primary debulking surgery. It includes patients who have started or are planning to start chemotherapy, with the total number of chemotherapy cycles tailored by the treating physician. Women of childbearing potential must use reliable contraception during the study. The study does not involve any experimental interventions but monitors treatments as they occur in regular clinical practice. Participants will be followed to evaluate progression-free survival and other outcomes up to 84 months from the start of chemotherapy. Patient-reported outcomes will be collected electronically to capture experiences and needs during and after maintenance therapy. The study also tracks the use of BRCA/HRD testing, treatment safety, and physician experiences to better understand care patterns and long-term results in routine clinical settings.

Researchers are studying both early and advanced/metastatic breast cancer to improve therapy decisions and healthcare quality. Metastatic breast cancer patients often have the poorest prognosis, and there is a need to better understand tumor characteristics to guide targeted therapies. This study aims to establish methods for analyzing molecular features of tumors and metastases using blood samples, as tumor biopsies can be invasive and are not routinely performed despite recommendations. Participants will have blood samples taken during routine blood draws to analyze tumor expression, mutations, gene copy number changes, and other molecular markers. The study focuses on creating a comprehensive infrastructure for molecular assessment in breast cancer patients at different stages. The research also explores healthcare outcomes and economics to enhance patient integration and awareness. Participants will be monitored to discover biomarkers that predict progression-free survival in metastatic breast cancer and assess disease-free survival in early breast cancer over up to 60 months. The study involves routine clinical assessments and blood collections, with data collected on tumor characteristics and patient health outcomes. Overall participation spans long-term follow-up to evaluate progression and survival measures.

Researchers are evaluating two medications, prednisolone and colchicine, for treating acute gout attacks, a common rheumatic disease where urate crystals cause severe joint pain. This study focuses on patients treated in general practice, including those with common health conditions often excluded in past research. The goal is to determine if prednisolone is comparable or only slightly less effective than colchicine in reducing pain during gout attacks. This phase 4 trial is conducted as a double-blind, randomized, controlled study across multiple university sites in Germany. Participants will be randomly assigned to receive either prednisolone or colchicine tablets for five days, with both groups also receiving placebo tablets to maintain blinding. The study uses the double-dummy method to ensure neither patients nor doctors know which treatment is given. Additionally, participants have the option to undergo a dual-energy CT scan of their feet to detect urate crystal deposits, which may provide insights into disease burden. During the study, patients will visit their general practitioner twice: once at the start and again after about one week. They will complete daily diaries tracking pain, joint swelling, tenderness, and any additional pain medication use for six days. Blood tests will check uric acid levels, inflammation, and kidney function. After four weeks, participants will be contacted by phone to assess recovery, recurrence, treatment, work incapacity, and side effects. The main measurement is the highest pain level reported on day 3 after starting treatment.