Straubing

Researchers are evaluating the effectiveness of a commercial toothpaste containing a novel compound aimed at supporting a healthy oral microbiome in people with periodontitis. This multi-center controlled clinical study focuses on volunteers who receive professional tooth cleaning every 3 to 6 months during a non-treatment period between supportive periodontitis therapy sessions. The study aims to determine how well this toothpaste works when used at home. Participants will brush their teeth twice daily with the allocated toothpaste for three months. The toothpaste includes common ingredients like sodium fluoride and cleaning agents, plus a new compound designed to benefit the oral microbiome. The study involves monitoring the participants during this 3-month period while they maintain their usual professional tooth cleaning routine. During the study, participants will be assessed before and after the 3 months of toothpaste use to evaluate its efficacy. Researchers will collect data on oral health, including the presence of specific bacteria and plaque control. Participants will be monitored for safety and adherence, and the main outcome is the toothpastes effect on the oral microbiome after 12 weeks of use.

Researchers are evaluating Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma HNSCC. This phase 3 trial aims to assess the safety and effectiveness of Dostarlimab as a sequential therapy following chemoradiation treatment in participants with this type of cancer. Participants are randomly assigned to receive either Dostarlimab or a placebo, both given as intravenous infusions. The study is double-blind, meaning neither the participants nor the researchers know which treatment is being given. The treatments follow completion of chemoradiation with cisplatin and radiotherapy intended to cure the cancer. During the study, participants will be monitored for up to approximately 5 years. Researchers will evaluate event-free survival and overall survival, with safety assessments including treatment-emergent adverse events and laboratory tests. Blood samples will be taken to measure drug levels and immune responses. This long-term follow-up will help understand the effects and safety of Dostarlimab after chemoradiation therapy.

Researchers are evaluating the effectiveness of TAR-210 compared to investigators choice of intravesical chemotherapy in people with intermediate-risk non-muscle invasive bladder cancer IR-NMIBC who have specific FGFR mutations or fusions. This Phase 3 randomized study aims to compare disease-free survival between these treatment options, with the goal of understanding which may better prevent recurrence or progression of the cancer. Participants are randomly assigned to one of two groups. Group A receives TAR-210, which is inserted into the bladder on Day 1 and removed after 12 weeks, with one insertion every 12 weeks over about one year. Group B receives intravesical chemotherapy using mitomycin C or gemcitabine, chosen by the investigator, given once weekly for 4 to 6 doses followed by maintenance treatment for at least six months up to one year. The study includes a substudy with similar treatment groups. During the trial, participants will undergo multiple cystoscopies and urinary tumor resections as needed to monitor for disease recurrence or progression. Researchers will measure disease-free survival from the time of randomization until recurrence, progression, or death over approximately four years. Additional assessments include quality of life questionnaires, adverse events monitoring, and survival outcomes. Participants are followed closely with various evaluations throughout the study duration.

Researchers are evaluating the effectiveness and safety of two fixed-duration treatment combinations for adults with previously untreated chronic lymphocytic leukemia CLL. The study compares sonrotoclax plus zanubrutinib with venetoclax plus acalabrutinib to determine which regimen may better manage this condition. This Phase 3 trial aims to provide insights into these oral therapies for CLL patients needing initial treatment. Participants will be randomly assigned to receive either sonrotoclax and zanubrutinib or venetoclax and acalabrutinib. Both treatment groups will follow a fixed duration of therapy, after which participants will be observed without active treatment. The study drugs are taken orally, and the treatment period is followed by a monitoring phase to evaluate ongoing health. During the study, participants will undergo evaluations including imaging tests to measure disease status and assessments of bone marrow and organ function. Researchers will track progression-free survival and minimal residual disease levels up to about 70 months. Other outcomes such as overall survival, response rates, adverse events, and quality of life will also be monitored. The total study duration extends until November 2031, offering long-term follow-up for participants.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are evaluating whether systematic pelvic and para-aortic lymphadenectomy LNE improves overall survival in patients with stage I or II endometrial cancer who have a high risk of recurrence. The trial also looks at how LNE affects disease-free survival, quality of life, complications, side effects, and the number of lymph nodes removed. A total of 640 patients with specific histological types and stages of endometrial cancer will take part in this study. Participants will be randomly assigned to one of two groups. In Arm A, patients will undergo the standard surgical procedure including total hysterectomy and bilateral salpingo-oophorectomy, with an omentectomy added for certain cancer types. In Arm B, patients will receive the same standard surgery plus systematic pelvic and para-aortic lymphadenectomy reaching up to the left renal vein. The study compares these two surgical approaches. Throughout the study, participants will be monitored for overall survival over 60 months. Researchers will also assess disease-free and disease-specific survival at multiple time points up to five years. Serious complications will be recorded during surgery and follow-up visits. Quality of life will be evaluated regularly using standardized questionnaires. The number of lymph nodes removed will be documented during surgery to support the evaluation of treatment impact and safety.

Researchers are evaluating whether a preference-oriented quality of life QoL monitoring system with specific diagnostic and therapeutic options can improve the well-being of patients with lung cancer during routine follow-up care. This study builds on successful QoL interventions for breast and colorectal cancer and aims to adapt the system for lung cancer patients in multiple centers. The study uses electronic QoL questionnaires and links patient data with a cancer registry to support analysis. Participants are randomly assigned to one of two groups. The intervention group receives real-time results from an electronic QoL monitoring system based on the EORTC QLQ-C30 and QLQ-LC29 questionnaires, along with access to a multiprofessional network of therapists such as pain therapy, psychotherapy, social support, nutrition counseling, physiotherapy, fitness, respiratory therapy, and palliative care. The control group also completes QoL assessments but neither patients nor their physicians receive the results however, the therapist network is available for both groups. QoL is assessed at study entry and monthly for six months. Throughout the six-month follow-up, participants complete QoL questionnaires at baseline and monthly intervals. Researchers monitor the proportion of patients needing QoL therapy based on a profile with eight dimensions, with a focus on whether the intervention reduces this need after six months. Data collection includes linking clinical information from a cancer registry. The study involves multiple assessments, therapeutic referrals, and ongoing monitoring to evaluate quality of life improvements in lung cancer patients.

Researchers are evaluating treatment options for patients with locoregionally recurrent PD-L1 positive head and neck squamous cell carcinoma HNSCC to see if combining re-radiochemotherapy Re-RCT with pembrolizumab immunotherapy improves overall survival compared to pembrolizumab alone, with or without chemotherapy. This phase III, randomized, open-label trial focuses on patients whose tumors express PD-L1 with a combined positive score of 1 or higher and who have previously received radiation or chemoradiation at least six months prior. Participants are assigned to one of two groups. One group receives re-radiochemotherapy, including radiotherapy doses of 55.8Gy to 63.0Gy and weekly cisplatin or carboplatin if needed, followed by pembrolizumab infusions every three weeks for up to two years. The other group receives pembrolizumab monotherapy for up to two years, with the option of additional chemotherapy cycles involving cisplatin or carboplatin combined with 5-fluorouracil based on physician choice. The study compares these two treatment approaches to assess their impact on survival. During the study, participants undergo regular assessments including treatment visits, laboratory tests to monitor organ and marrow function, and pregnancy testing for females of childbearing potential. Researchers will measure overall survival at two years as the primary outcome. The trial requires participants to commit to treatment and scheduled visits throughout the study period, with ongoing monitoring to evaluate health status, treatment adherence, and safety.