Ostrava Mesto

Researchers are studying the long-term safety and tolerability of home-based peroneal electrical transcutaneous neuromodulation (peroneal eTNM4) using the URIS I2 device in people with Parkinson's disease (PD) or Essential Tremor (ET). A previous 6-week pilot study with 24 participants showed that this treatment was safe, well tolerated, and had high adherence with no treatment-related adverse events. Although not designed to prove effectiveness, initial results suggested improvements in tremor that lasted for weeks after treatment ended. This extension study aims to further assess the safety, tolerability, and effectiveness of this treatment over a longer period. The study uses the URIS I2 neurostimulator to deliver non-invasive electrical stimulation directly to the peroneal nerve at home. Participants will continue treatment over a 24-month period as outlined in the study protocol. This device has been previously assessed for conformity and is used without any changes in its application procedure. The trial is open-label and will be conducted at a single site. During the study, participants will be monitored regularly to assess safety and tolerability by recording any treatment-emergent adverse events from the start of treatment until the end of the 24 months. The study will also evaluate the effects on symptoms related to movement disorders. Participants must comply with study requirements, including stable medication doses and avoiding other study participation during this trial. The total involvement duration spans the entire 24-month treatment period with ongoing assessments throughout.

Researchers are studying advanced renal cell carcinoma (RCC) that has returned after prior adjuvant therapy. The trial aims to find out if treatment with belzutifan and zanzalintinib helps patients live longer and delays disease progression compared to treatment with cabozantinib. This is a Phase 3 randomized study focusing on participants with recurrent advanced RCC who have previously received anti-PD-1/L1 therapy. Participants are randomly assigned to receive one of two oral drug regimens: either belzutifan combined with zanzalintinib, both taken once daily, or cabozantinib alone, also taken once daily. The study compares these treatments to assess their effects on disease control and overall survival. During the study, participants will be monitored for progression-free survival and overall survival for up to approximately 73 months. Researchers will evaluate how well the cancer responds to treatment and track any changes in health status over time. Safety and effectiveness of the treatments will be closely followed throughout the study period.

Researchers are investigating new treatments for metastatic cervical cancer, which is cancer that has spread from the cervix to other parts of the body. This Phase 3 study aims to evaluate the safety and effectiveness of combining sacituzumab tirumotecan (sac-TMT), an antibody drug that targets cancer cells, with pembrolizumab and bevacizumab. The study seeks to find out if this combination can help people live longer or keep their cancer from worsening compared to standard treatments. The study has two parts. In Part 1, participants receive sac-TMT together with pembrolizumab and bevacizumab to assess safety. In Part 2, after standard initial treatment, those whose cancer does not progress will be randomly assigned to maintenance treatment with either pembrolizumab alone or sac-TMT plus pembrolizumab. Bevacizumab may be added during maintenance treatment based on the doctor's decision. All treatments are given through intravenous infusions, and participants may receive rescue medications to manage side effects before sac-TMT infusion. Participants will be monitored for adverse events and treatment tolerability over several months. The study measures include progression-free survival and overall survival, assessed by independent review. Safety and treatment continuation rates are tracked during Part 1 for up to approximately 66-69 months, while Part 2 outcome measures extend up to 48-60 months. Various assessments, including laboratory tests and evaluations of cancer status, will be performed throughout the study to understand treatment effects and participant well-being.

Researchers are studying adults with confirmed Primary Biliary Cholangitis (PBC) and cirrhosis, a scarring of the liver caused by damage to bile ducts. PBC is a slowly progressing disease that causes bile acid buildup and further liver damage, which can lead to cirrhosis. This study aims to evaluate if elafibranor, a daily medication, can prevent worsening clinical outcomes such as the need for liver transplant or death, compared to a placebo. It also looks at the safety of long-term elafibranor use and its effect on symptoms like itching and tiredness. Participants will take either an 80 mg tablet of elafibranor or a matching placebo once daily for up to 3.5 years in a double-blind setup, meaning neither the participants nor researchers know who receives which treatment. This long-term treatment period is designed to monitor the drug's impact over time. The study includes two groups: one receiving elafibranor and the other receiving placebo, with treatment lasting up to approximately 42 months. During the study, participants will be regularly assessed from the start until 4 weeks after treatment ends, with a maximum involvement of 3.5 years. Researchers will measure event-free survival, tracking if participants avoid clinical events indicating disease worsening. Safety monitoring will include tracking side effects and overall health, while symptom impact will be evaluated. Participants will provide informed consent and follow the study protocol throughout this extended observation period.

Researchers are conducting a phase 3 study to evaluate the safety and effectiveness of orforglipron for treating hypertension in adults who are overweight or have obesity. The study framework supports two independent trials and aims to better understand how orforglipron works in this specific population with high blood pressure and excess weight. Participants receive orforglipron or a placebo orally once daily. The study includes screening and baseline visits to confirm eligibility based on blood pressure and body mass index. Treatment is randomized and double-blind, meaning neither participants nor researchers know who receives the active medication or placebo during the trial. Throughout the study, researchers monitor blood pressure and other health factors to assess the number of participants assigned to each treatment group. Safety and efficacy are evaluated regularly, with ongoing observation of participants’ response to the medication and any potential side effects.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are evaluating the safety and effectiveness of orforglipron for treating people who have both hypertension and are either overweight or obese. This study is part of a larger master protocol called GZPL and focuses specifically on these health conditions. The trial is designed as a Phase 3 study to provide important information about this potential treatment. Participants will receive either orforglipron or a placebo, both given orally once daily. The study compares these two groups to understand the impacts of orforglipron on blood pressure and weight-related health issues. The treatment period lasts up to 36 weeks, during which participants are monitored closely. During the study, participants will have their office systolic blood pressure measured to track changes from the start of the trial to week 36. Researchers will also monitor safety and other health measures throughout the trial. The study involves regular visits and assessments to ensure participant well-being and to gather thorough data on the treatment's effects.

This research aims to assess the effectiveness and safety of orforglipron for treating hypertension in adults with obesity or overweight. It is conducted as part of the GZPL master protocol and focuses on participants who have both high blood pressure and elevated body weight. The study is designed as a Phase 3 clinical trial to provide detailed evaluation of this new treatment approach. Participants will receive either orforglipron or a placebo, both given orally once daily. The study compares these two groups to understand the benefits and any side effects of orforglipron when used for managing hypertension in this specific population. The treatment period and detailed dosing schedule are based on the master protocol, which guides participant management and study procedures. During the study, participants will have their systolic blood pressure measured regularly to track changes from the start through week 36. Researchers will monitor safety and treatment effects closely, following all procedures outlined in the master protocol. The overall duration of participant involvement and additional assessments are determined by the master protocol guidelines for this comprehensive evaluation.

Researchers are evaluating ASTX030, a combination of azacitidine and cedazuridine, as a treatment for myeloid neoplasms including myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML). This multi-phase study includes Phase 1 through Phase 3 monotherapy arms and Phase 1 and Phase 2 combination therapy arms with venetoclax. The study aims to assess pharmacokinetics, safety, efficacy, and drug interactions over an approximate duration of 8 years. The study treatments involve oral administration of ASTX030 and azacitidine, with some arms including subcutaneous azacitidine for comparison. Phase 1 monotherapy includes dose escalation and expansion stages, while Phase 2 and Phase 3 monotherapy arms are randomized crossover studies comparing oral ASTX030 to subcutaneous azacitidine. The combination therapy arms explore ASTX030 combined with venetoclax in participants with treatment-nafve AML, either in an open-label randomized exploratory setting or a single-arm study. Participants undergo evaluations including pharmacokinetic measurements such as total cycle area under the curve (AUC) for drug exposure, assessment of treatment-emergent adverse events, and investigator-assessed complete response rates. Monitoring occurs at multiple timepoints up to 36 months in some study arms. Safety, efficacy, and drug interaction assessments are integral throughout the study, with follow-up periods extending up to 8 years.

Researchers are evaluating the recurrence-free survival of women with advanced HRD-positive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and clear cell carcinoma of the ovary after complete tumor removal. This phase II, randomized, open-label study compares two treatment strategies involving chemotherapy and maintenance therapy with niraparib. The study focuses on patients with no residual tumor mass following primary tumor debulking and aims to determine if fewer cycles of chemotherapy followed by niraparib maintenance are as effective as the standard number of chemotherapy cycles plus niraparib. Participants are randomly assigned to one of two groups: one receiving 3 cycles of carboplatin plus paclitaxel chemotherapy followed by niraparib maintenance, and the other receiving 6 cycles of carboplatin plus paclitaxel followed by niraparib maintenance. Randomization is based on genetic analysis and disease stage. Tumor assessments using CT or MRI scans will be done at defined intervals after treatment starts and during maintenance. Blood markers and safety monitoring will be conducted regularly throughout the treatment period. During the study, patients will have clinical visits every 3 weeks during chemotherapy and monthly during the first 11 months of maintenance, then quarterly thereafter. Safety is monitored continuously through adverse event reporting. The study plans to enroll 640 patients across about 60 sites in six European countries over 36 months. The primary outcome measured is recurrence-free survival over 8 years.