Goppingen

Researchers are monitoring the long-term safety of efgartigimod, a biological treatment, in patients with generalized myasthenia gravis (gMG). This study is a non-interventional, prospective, post-authorization safety study designed to observe patients who are either starting or already receiving efgartigimod, as well as those with gMG who have not been treated with it. The study aims to compare the occurrence of serious infections and other safety outcomes over a period of up to 10 years. Patients with gMG who are expected to begin efgartigimod treatment at enrollment or who are currently in their first treatment cycle will be included in the efgartigimod group. Those with gMG who are not starting efgartigimod and have never received it will be enrolled in a non-efgartigimod group. There are no assigned treatments or interventions from the researchers; the study simply observes patients as they receive routine care. Participants will be followed for up to 10 years to track safety outcomes, including serious infections. Data collection will involve routine clinical assessments and monitoring as per standard medical practice. The study observes the real-world use of efgartigimod and its safety profile in managing gMG, providing valuable long-term information without altering patients' treatment plans.

This research aims to evaluate the effectiveness of trastuzumab deruxtecan (T-DXd) in adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have previously been treated with a trastuzumab-based regimen. The study also collects patient demographic and clinical information, treatment patterns, and safety data including serious adverse events and drug reactions. It includes a disease registry for patients receiving conventional therapies in a real-world European setting. The study is non-interventional, meaning no investigational drugs are administered beyond standard care. Patients receiving T-DXd will be treated according to the Summary of Product Characteristics (SmPC), and data on conventional therapies such as platinum-fluoropyrimidine chemotherapy, nivolumab, ramucirumab-paclitaxel, taxane, irinotecan, and pembrolizumab will also be gathered. Treatment choices and administration follow the physician's decision and routine clinical practice. Participants will be monitored from baseline to about two years to assess the time to next treatment. Researchers will collect clinical data, treatment details, tolerability, and patient surveys to understand outcomes and safety. The study involves regular follow-up and data collection to track treatment effectiveness and patient experience in real-world settings.

Researchers are evaluating the combination of BMS-986504, pembrolizumab, and chemotherapy compared to placebo plus pembrolizumab and chemotherapy in people with first-line metastatic non-small cell lung cancer who have a homozygous MTAP deletion. The study is a randomized phase 2/3 trial focused on assessing clinical benefits in this specific patient group. Participants will receive either BMS-986504 with pembrolizumab and chemotherapy or placebo with pembrolizumab and chemotherapy. The chemotherapy may include drugs such as cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel, given at specified doses on specified days. This treatment is administered as part of the first-line therapy for metastatic disease. During the study, researchers will monitor progression-free survival up to 2 and 5 years using RECIST v1.1 criteria and overall survival up to 5 years. Participants will be assessed regularly for disease progression and survival outcomes. The study includes detailed monitoring to evaluate the effects and safety of the treatment combination over time.

Researchers are evaluating the safety and effectiveness of IPN10200, a medication designed to prevent episodic and chronic migraines in adults aged 18 to 80. Migraines cause severe throbbing pain often accompanied by nausea and sensitivity to light and sound, caused by brain activation releasing pain-related chemicals. IPN10200 works by stopping the release of these chemical messengers, and this phase II study aims to find the right dose that balances safety and efficacy. The study has three periods: first, a screening to check eligibility; second, Step 1 where two different doses of IPN10200 are tested sequentially in two groups, with injections given into muscles of the head, face, and neck and safety monitored over 36 weeks; third, Step 2 where new participants with episodic or chronic migraine are randomly assigned to receive one of two doses or a placebo, also via injections in the same areas, with monitoring continuing until Week 36. Participants will complete a daily electronic migraine diary and questionnaires throughout the study lasting up to 44 weeks. Researchers will monitor safety by tracking adverse events, laboratory changes, vital signs, facial exams, ECG readings, and antibody development. They will also measure changes in monthly migraine days to evaluate treatment effectiveness while ensuring participant safety throughout the study.

Researchers are collecting data on patients diagnosed with BCR-ABL 1-negative myeloid neoplasms, a type of blood cancer classified by the WHO in 2008 and 2016. The study aims to register many patients at participating centers to better understand the disease by analyzing biological features and clinical outcomes, including quality of life. The research also focuses on identifying prognostic and predictive markers by correlating disease characteristics with patient results. Participants will be part of a registry study where samples such as bone marrow aspirates, blood, plasma, buccal swabs, and occasionally skin biopsies are collected and stored. Morphologic and genetic analyses will be performed on these samples. There is no intervention treatment; instead, the study gathers extensive clinical and biological data over time to support research. During the study, patients' clinical characteristics, quality of life, and outcome data will be assessed using specific questionnaires and defined clinical variables. Researchers will monitor treatment decisions, response to therapy, survival rates, and progression-free survival for up to 25 years. This long-term follow-up allows comprehensive tracking of the disease course and patient well-being.

Immune thrombocytopenia (ITP) is a rare blood disorder where the immune system causes a shortage of platelets, leading to increased bleeding risk. New treatment options have emerged recently, but clinical studies often focus on specific patient groups. This research collects real-world data from a broad range of ITP patients to better understand the diagnosis, treatment, and outcomes in everyday care. The study also aims to improve personalized therapy and patient results by gathering detailed clinical and biospecimen information. The study involves creating a national registry where clinical data and biospecimens are collected from patients diagnosed with primary or secondary ITP. Data are gathered prospectively at defined points during the disease course, and patients can also be included retrospectively within 12 months of diagnosis if ongoing documentation is available. This includes information about disease factors, treatment types, complications, quality of life, fatigue, and survival over 5 years. Participants will provide written consent and undergo clinical assessments at enrollment and follow-up visits. Researchers will collect epidemiological data such as disease incidence, age and sex distribution, causes, treatment types, and remission status over 5 years. The registry also includes biospecimen collection to support high-quality, standardized research. This ongoing monitoring will help improve knowledge of ITP and support better patient care.

Researchers are evaluating the rate of leakage in ileo-colic anastomoses constructed with MonoPlus® suture material following right hemicolectomy in patients with right colon cancer. The study aims to determine if this leakage rate within 30 days after surgery is not worse than rates reported in the literature for fully handsewn or stapled-handsewn anastomoses. Leakage after right hemicolectomy is a serious complication affecting patient recovery and varies between 1-10% depending on patient groups and anastomosis type. Patients undergoing elective open or laparoscopic right hemicolectomy or extended right hemicolectomy for cancer will have their ileo-colic anastomosis constructed using MonoPlus® suture material. The surgery may involve either completely hand-sewn or partially sutured anastomoses, and the anastomosis can be created inside or outside the body. Both open and laparoscopic procedures, including conversions between these methods, are included. Participants will be monitored for 30 days postoperatively to assess the rate of anastomosis leakage. The study includes patients aged 18 years or older without peritoneal carcinomatosis or infiltration of vessels, nerves, or bone. Researchers will collect data on surgical outcomes and complications, ensuring informed consent and adherence to data protection. The total participation duration covers the immediate postoperative period critical for detecting leakage.

Researchers are evaluating the effectiveness of maintenance electroconvulsive therapy (mECT) combined with clozapine treatment in patients with treatment-resistant schizophrenia who have responded to an initial course of ECT. Schizophrenia is a serious mental disorder, and about 15-30% of patients do not respond to standard antipsychotic treatments, including clozapine. This trial aims to determine if mECT can delay relapse and increase the number of relapse-free patients compared to clozapine treatment alone, potentially influencing future treatment guidelines. The study involves two phases: first, an acute ECT series to achieve significant clinical improvement, followed by a randomized, blinded phase where responders receive either clozapine alone or clozapine plus maintenance ECT. The trial plans to enroll 84 patients aged 18 to 75 years who have treatment-resistant schizophrenia. Treatment as usual is compared to the addition of mECT, which is delivered as a device-based therapy. Participants will be monitored over 28 weeks in phase II to measure time to relapse as the primary outcome. Secondary assessments include functioning, quality of life, depression, schizophrenia symptoms, catatonia, stress, self-stigmatization, and cognitive performance. The study includes follow-up visits and data analysis over several years, with the last patient completing a 12-month follow-up phase four years after study start.

Researchers are studying severe asthma through the German Asthma Net e.V., which focuses on improving medical care and understanding of this condition. Since there is limited reliable data on how often severe asthma occurs, its characteristics, and treatment patterns, this clinical registry collects detailed information from patients across Germany. The aim is to better characterize severe asthma by gathering data from multiple clinics and practices, helping to optimize diagnosis and treatment over time. Participants in this registry have their sociodemographic details and medical information recorded, including diagnosis, therapy, lung function, laboratory values like IgE and eosinophil granulocytes, asthma symptoms, medication use, smoking status, and additional treatments. This data is collected at a baseline visit and then annually for up to 15 years. Each participant receives a unique study ID to protect privacy, with personal and health data stored securely on separate servers. During the study, patients will be regularly monitored for asthma symptom control, with assessments at baseline, four months, and yearly thereafter for up to 15 years. Researchers will track symptoms, medication use, exacerbations, lung function, and laboratory markers to better understand severe asthma's course and treatment outcomes. This long-term follow-up aims to improve care by providing robust data on severe asthma patients.

This research focuses on adult patients with newly diagnosed or relapsed/refractory acute myeloid leukemia (AML) and related myeloid neoplasms. It aims to register all patients treated at approximately 80-90 sites in Germany and Austria, capturing comprehensive data on patient characteristics, family history, biological disease features, and clinical outcomes. The study also seeks to analyze genetic markers related to the disease and evaluate treatment responses and survival outcomes over an extended period. Patients enrolled in the study will have their disease-related genetic markers analyzed rapidly to inform treatment recommendations. Biosamples such as bone marrow, blood, plasma, skin biopsy, fingernails, hair, sputum, or urine will be collected and stored for further analysis. The study intends to assess measurable residual disease using various methods and correlate biological markers with clinical outcomes. Participants will be observed for up to 10 years, during which researchers will monitor event-free survival, relapse-free survival, cumulative incidence of relapse and death, overall survival, and quality of life. Treatment decisions, response to therapy, and geographical representation will also be recorded. Data collection includes clinical assessments and storage of biosamples, with ongoing evaluation of disease progression and patient outcomes throughout the study period.