Straubing

Researchers are evaluating the effectiveness of a new commercial toothpaste that contains a novel compound aimed at supporting a healthy oral microbiome in people with periodontitis. This study is conducted at multiple centers and involves volunteers who regularly receive professional tooth cleaning every 3 to 6 months as part of their supportive periodontitis therapy. The study aims to compare the dental hygiene maintained by using this new toothpaste versus regular cleaning methods during a 3-month period. During the study, participants will brush their teeth twice daily using the assigned toothpaste and will be asked not to rinse their mouth after spitting out the toothpaste. The study product includes standard ingredients like sodium fluoride and cleaning agents along with the new microbiome-modulating compound. Participants will continue their regular professional tooth cleaning schedule between 2 recall visits, and the treatment effect will be observed over a 12-week period. Participants will be assessed at the start and end of the 3 months for the toothpaste's efficacy, focusing on changes in oral health and microbiome balance. The study monitors safety and effectiveness through clinical evaluations, including microbiological analysis of biofilm and oral health status. The total participation time covers the 12 weeks of treatment and observation.

Researchers are evaluating the safety and effectiveness of Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma (HNSCC). This phase 3 randomized, double-blind, placebo-controlled study focuses on patients who have completed chemoradiation therapy with cisplatin and radiation and have no distant metastatic disease. The study requires confirmation of PD-L1 positive tumor status and specific testing for oropharyngeal carcinoma cases. Participants will receive either Dostarlimab or a placebo as an intravenous infusion following their chemoradiation treatment. The study monitors these treatments as sequential therapy to assess their impact on disease progression. Treatments are administered in a controlled, blinded manner to compare outcomes between the two groups effectively. During the study, participants will be followed for up to approximately five years to measure event-free survival, with evaluations conducted by blinded independent central review. Assessments will include monitoring for safety, disease status, and any adverse events throughout the study period. This long-term follow-up aims to provide comprehensive data on the effectiveness and safety of Dostarlimab as post-chemoradiation therapy in this patient population.

Axial spondyloarthritis (axSpA) is an immune-related inflammatory disease mainly affecting the spine, causing chronic back pain and significantly impacting quality of life with symptoms like sleep problems, social isolation, and emotional distress. This research is evaluating the real-world effectiveness of the drug upadacitinib in controlling disease activity and managing pain in adults with active axSpA in Germany. Participants will receive oral upadacitinib tablets as prescribed by their doctors before joining the study, following local guidelines on dosage and treatment. The study will last about 52 weeks, during which participants will continue their prescribed treatment and attend regular medical visits as part of routine care. Throughout the study, researchers will monitor disease activity and treatment effects using medical assessments, side effect checks, and questionnaires. The main focus is on how many participants achieve and maintain low disease activity scores over 24 and 52 weeks, assessing both clinical and patient-reported outcomes related to pain and disease burden.

Researchers are evaluating the effectiveness of TAR-210 compared to a single-agent intravesical chemotherapy in adults with intermediate-risk non-muscle invasive bladder cancer (NMIBC) who have specific fibroblast growth factor receptor (FGFR) mutations or fusions. This phase 3 randomized study aims to compare disease-free survival between these treatments. Eligible participants must have a confirmed diagnosis of intermediate-risk NMIBC with certain risk factors and be willing to undergo multiple cystoscopies and assessments throughout the study. Participants will receive either TAR-210, which is delivered directly into the bladder, or one of the investigator-chosen intravesical chemotherapy drugs, including Gemcitabine or MMC, also administered into the bladder. Prior to randomization, visible tumors must be fully removed, and the absence of disease confirmed. The study includes a main study group and a substudy group with slightly different eligibility criteria based on tumor grade and risk factors. During the study, participants will be closely monitored through cystoscopies and surgical assessments (TURBT) to evaluate cancer recurrence or progression. The primary outcome measure is disease-free survival, tracked from randomization until the first documented cancer recurrence, progression, or death, over approximately four years and two months. Safety and treatment adherence will also be assessed throughout the study period.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are evaluating whether systematic pelvic and para-aortic lymphadenectomy (LNE) improves overall survival in women with stage I or II endometrial cancer who have a high risk of recurrence. The study also aims to assess the impact of LNE on disease-free survival, quality of life, complications, side effects, and the number of lymph nodes removed. A total of 640 patients with confirmed high-risk endometrial cancer will be included in the trial. Participants will be randomly assigned to one of two groups. In the first group, patients will undergo a total hysterectomy and bilateral salpingo-oophorectomy, with an additional omentectomy if they have serous or clear cell cancer types. The second group will receive the same procedures plus systematic pelvic and para-aortic lymphadenectomy up to the level of the left renal vein. This approach allows comparison between standard surgery and surgery with lymphadenectomy. During the study, patients will be monitored for overall survival over 60 months. Researchers will also evaluate disease-free survival and quality of life, while tracking complications and side effects of the treatments. Informed consent will be obtained, and patients’ compliance and health status will be regularly assessed. The trial includes close follow-up to observe long-term effects and outcomes of the surgical procedures.

Researchers are evaluating whether a preference-oriented quality of life (QoL) monitoring system with specific diagnostic and therapeutic options can improve the quality of life in patients with lung cancer during their routine follow-up care. This approach builds on previous successful studies in breast and colorectal cancer patients that showed benefits from identifying and treating QoL deficits. The study uses an electronic system tailored to lung cancer patients' and physicians' preferences to assess QoL across multiple dimensions. The study is a two-arm randomized controlled trial involving primary lung cancer patients treated at six hospitals. Participants are assigned to either an intervention group, which receives electronic QoL monitoring with real-time access to results and a multi-professional network of healthcare providers for therapy (including pain therapy, psychotherapy, social support, nutrition counseling, physiotherapy, fitness, respiratory therapy, and palliative care), or a control group, which also undergoes QoL monitoring but neither patients nor physicians see the results. Both groups have access to the therapist network. Participants complete QoL questionnaires at study entry and monthly for six months. Researchers link QoL data with clinical information from the Bavarian Cancer Registry. The main outcome is the proportion of patients needing QoL therapy in at least one area six months after starting the study. Throughout the study, patients and physicians are supported with tailored interventions, and the study monitors changes in QoL deficits to assess the effectiveness of the preference-oriented monitoring approach.

Researchers are conducting a Phase III randomized controlled trial to assess whether combining re-radiochemotherapy (Re-RCT) with sequential immunotherapy using pembrolizumab improves overall survival compared to treatment with pembrolizumab alone, with or without chemotherapy, in patients with locoregionally recurrent PD-L1 positive head and neck squamous cell carcinoma (HNSCC). Participants must have a PD-L1 combined positive score of 1 or higher and have previously undergone radiochemotherapy to the neck at least six months prior. In the experimental group, patients receive re-irradiation with single doses of 1.8 Gy totaling between 55.8 Gy and 63.0 Gy, alongside weekly cisplatin at 40 mg/m² body surface area. This is followed by intravenous pembrolizumab (200 mg) every three weeks starting 8 to 14 days after completing re-radiochemotherapy. The comparator group receives pembrolizumab alone, either with cisplatin and 5-fluorouracil (5-FU) or alternative chemotherapy regimens such as carboplatin plus 5-FU or carboplatin alone, administered at specified doses and intervals. Participants will undergo scheduled visits and examinations throughout the trial, with assessments including survival monitoring over two years. Eligibility requires adequate organ function and performance status, with safety monitored closely. The study aims to measure overall survival as the primary outcome, evaluating the potential benefit of adding re-radiochemotherapy to pembrolizumab-based treatment in this patient population.