Ludwigsburg

Researchers are evaluating how well once-weekly insulin icodec maintains blood sugar levels compared to daily basal insulin injections in adults with type 2 diabetes. The study focuses on people who need to start basal insulin treatment after using other glucose-lowering medications. This phase 4 trial aims to assess insulin icodecs effectiveness in real-world clinical practice over about 13 months. Participants will be randomly assigned to receive either weekly subcutaneous injections of insulin icodec or daily subcutaneous injections of basal insulin analogues such as insulin glargine, detemir, or degludec. The study compares these two insulin regimens as part of standard type 2 diabetes care. Treatment continues during the 52-week period to monitor blood sugar control and treatment satisfaction. Throughout the study, participants will undergo assessments including measuring changes in glycated hemoglobin HbA1c from baseline to week 52. They will also complete questionnaires on treatment adherence, satisfaction, and burden, and researchers will track severe hypoglycemia episodes and insulin doses. The trial spans about 13 months, providing thorough monitoring of treatment impact and safety in daily clinical use.

Researchers are studying the use of bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin, known as triple therapy, in adults with primary hypercholesterolemia or mixed dyslipidemia. The study aims to evaluate the effectiveness and safety of this combination in real-world clinical practice, focusing on lowering LDL cholesterol LDL-C levels. This is an observational study, meaning no drugs are administered by the study team instead, existing treatments are monitored. Participants are adults who have started triple therapy within the past four weeks and are followed for up to one year. The study looks at LDL-C changes after 8 weeks and 1 year of treatment, adherence to the therapy, side effects, and cardiovascular events such as heart attacks and strokes. No new treatments are given instead, researchers collect information on the participants ongoing treatments involving bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. During the study, participants LDL-C levels, laboratory values, and treatment adherence are regularly reviewed. Researchers will also record any adverse events and track major cardiovascular events over the year. The primary measurement is the change in LDL-C from before treatment to 8 weeks after starting triple therapy. Participants health is followed through routine clinical assessments, and the study lasts for up to one year after beginning triple therapy.

Researchers are evaluating the addition of Tersolisib LY4064809STX-478 to other anti-cancer drugs as a first treatment for adults with advanced hormone receptor-positive HRhuman epidermal growth factor receptor 2-negative HER2- breast cancer that has a PIK3CA mutation. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand the efficacy and safety of this combination compared to placebo, focusing on improving outcomes for patients with this specific genetic change. Participants receive LY4064809 orally in one of two doses combined with a CDK46 inhibitor such as Ribociclib, Palbociclib, or Abemaciclib and endocrine therapy ET administered orally or via intramuscular injection. The comparison group receives a placebo combined with the same CDK46 inhibitor and ET. The study includes two parts Part 1 explores dose optimization, and Part 2 evaluates the treatment combinations effectiveness and safety as a first-line therapy. During the study, participants will have regular assessments to monitor cancer response, progression, and safety over an estimated period of up to 5 years or more. Researchers will measure outcomes such as overall response rate, progression-free survival, duration of response, overall survival, and quality of life. Treatment continues as long as the cancer benefits without intolerable side effects. Safety monitoring, laboratory tests, and quality of life questionnaires are part of the participant involvement throughout the trial.

Researchers are evaluating the use of the EndoTEM system during endoscopic removal of polyps in the distal colon, specifically adenomas or early carcinomas larger than 2 cm in the rectum or distal sigmoid colon. The study aims to determine if this new device enables complete polyp resection and is safe to use. The trial is conducted by Robert Bosch Gesellschaft fcr Medizinische Forschung mbH RBMF and focuses on feasibility and safety outcomes. Participants will undergo polyp removal using the EndoTEM system, a flexible port that allows insertion of a second instrument alongside the endoscope. This device includes a curved rigid grasping instrument with a rotatable and angled 2 cm tip. The procedure involves endoscopic submucosal dissection performed routinely with this system. There are no additional comparison groups or placebo treatments. Throughout the study, participants will complete questionnaires about fecal continence and quality of life before and after the procedure. Researchers will monitor technical success from the initial resection to a follow-up endoscopy after six months. They will also assess resection rates, procedure duration, complications, need for surgery, and recurrence during follow-ups up to six months. Standard clinical care is maintained before, during, and after the intervention, with total participation lasting at least six months.

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 the non-inferiority of minimally invasive radical hysterectomy compared to abdominal radical hysterectomy in patients with early-stage cervical cancer. This prospective, randomized, multicenter trial includes patients with specific cervical cancer types and stages, aiming to compare disease-free survival as the primary outcome. Secondary outcomes include overall survival, disease recurrence, quality of life, complications, and serious adverse events. Participants are randomly assigned to one of two groups the experimental arm receives laparoscopic or robot-assisted radical or simple hysterectomy, while the control arm undergoes abdominal radical or simple hysterectomy. Both arms follow guidelines for lymph node dissection or sentinel lymph node biopsy, with specific protective measures for the minimally invasive approach. Surgery type may vary depending on tumor risk according to SHAPE criteria. During the study, patients will be followed for at least five years after surgery. Assessments include survival outcomes, disease recurrence starting six months post-surgery, quality of life questionnaires, lymphatic side effects, complications, adverse events, and health care cost analysis. Monitoring will continue up to one year for complications and serious adverse events, ensuring comprehensive evaluation of treatment effects and safety over time.

Researchers are evaluating the effectiveness and safety of combining perioperative FLOT chemotherapy with an intraoperative Hyperthermic IntraPEritoneal Chemoperfusion HIPEC procedure compared to FLOT chemotherapy alone in patients with resectable localized and locally advanced diffuse or mixed type adenocarcinoma of the stomach and Type IIIII gastroesophageal junction GEJ. This phase III, multicenter, randomized, open-label study focuses on patients who have received neoadjuvant FLOT therapy and do not have distant metastases, aiming to assess progression- and disease-free survival among other outcomes. Participants receive 3 to 6 cycles of biweekly neoadjuvant FLOT chemotherapy before surgery. After tumor assessment, patients without disease progression are randomized to one of two groups Arm A continues with surgery followed by four cycles of postoperative FLOT chemotherapy, while Arm B undergoes surgery combined with intraoperative HIPEC using cisplatin at 426C for 90 minutes, followed by the same postoperative FLOT cycles. Surgery typically occurs 4 to 6 weeks after the last FLOT dose, and postoperative treatment begins within 6 to 12 weeks after surgery. Throughout the study, tumor assessments using CT or MRI are performed before surgery and every three months afterward until progression, relapse, death, or study end. Clinical visits assess blood counts and toxicity before each treatment cycle. Safety monitoring includes tracking adverse and serious adverse events. Patient-reported quality of life and pain are measured regularly. The total follow-up extends up to five years to evaluate survival outcomes and relapse rates, with an initial safety phase after the first 20 patients receiving HIPEC.

This research aims to compare the effectiveness and safety of a procedure called TIPS transjugular intrahepatic portosystemic shunt versus standard drug therapy in patients with cirrhosis who develop hepatorenal syndrome-acute kidney injury HRS-AKI at various stages. Cirrhosis can lead to serious complications including kidney injury, and while current treatments improve kidney function, risks remain high. The study evaluates whether reducing pressure in the portal vein through TIPS placement can improve outcomes compared to standard care with drugs like terlipressin and albumin. Participants will be randomly assigned to receive either TIPS implantation plus standard care or standard medication therapy alone, which mainly involves terlipressin and albumin noradrenaline may be used if terlipressin is not tolerated. The TIPS procedure creates a pathway to reduce portal vein pressure, potentially improving kidney function. The study is multicenter and will follow patients for at least 12 months to compare survival without liver transplant and other health outcomes. Throughout the study, participants will be monitored with regular assessments including survival rates up to 12 months, kidney function improvement, need for additional treatments, hospital stays, and quality of life measures. Safety and complications will also be tracked. The study aims to provide detailed information on how TIPS compares to standard drug therapy over time in patients with cirrhosis and HRS-AKI, with a focus on transplant-free survival and kidney health.

Researchers are evaluating the effectiveness and safety of two treatment strategies for patients newly diagnosed with advanced ovarian, peritoneal, or fallopian tube cancer. This international, multicenter, randomized, open Phase III trial compares carboplatinpaclitaxel chemotherapy followed by niraparib alone versus carboplatinpaclitaxel combined with bevacizumab followed by both bevacizumab and niraparib. The study includes patients with high-grade, non-mucinous, non-clear cell epithelial tumors at specific advanced stages who have had surgery or plan chemotherapy with interval debulking surgery. All patients receive an initial cycle of carboplatin and paclitaxel before randomization. After central testing of tumor BRCA status, participants are randomly assigned to one of two arms Arm 1 continues with five more cycles of carboplatin and paclitaxel followed by daily niraparib for up to three years Arm 2 receives five cycles of carboplatin and paclitaxel plus bevacizumab, then maintenance bevacizumab for up to one year alongside daily niraparib for up to three years. This design aims to determine if adding bevacizumab improves outcomes over the standard treatment. Participants undergo frequent assessments including scans and laboratory tests to monitor progression-free survival and other health outcomes. Researchers also evaluate overall survival, time to additional therapies, treatment-related side effects, and quality of life up to several years after enrollment. Patients attend regular visits for treatment, monitoring, and completion of questionnaires, with safety follow-up 30 days after the last dose. The entire observation period can last up to 66 months after the last patient joins the trial.

This research investigates GLSI-100 immunotherapy in people with HER2neu positive breast cancer who are at high risk for their cancer returning. It focuses on participants who have completed both neoadjuvant and postoperative adjuvant standard treatments. The study is Phase 3, randomized, double-blinded, and placebo-controlled, involving subjects who are HLA-A*02 positive as well as an open-label group of non-HLA-A*02 positive subjects. The goal is to evaluate the treatments impact on invasive breast cancer-free survival over a median follow-up of 4 years. Participants receive 6 primary immunization injections of GLSI-100 or placebo intradermally once a month for the first 6 months, followed by 5 booster injections spaced 6 months apart, totaling 11 injections over 3 years. There are three groups one receiving placebo 0.9% normal saline, one receiving GLSI-100 immunotherapy in HLA-A*02 positive subjects, and an open-label arm for non-HLA-A*02 positive subjects receiving GLSI-100 under the same schedule. During the study, participants undergo regular monitoring and assessments including invasive disease-free survival, distant disease-free survival, overall survival, and quality of life questionnaires at baseline and up to 36 months. Researchers track safety and treatment effects over a median 4-year follow-up. The study continues until December 2031, aiming to provide comprehensive data on long-term outcomes and quality of life for participants receiving these treatments.