Funchal

Researchers are evaluating the use of elafibranor in adults with Primary Biliary Cholangitis PBC who also have cirrhosis, a serious liver condition involving scarring. PBC is a slowly progressing disease that damages bile ducts, causing bile acids to build up and harm the liver further. This study aims to see if elafibranor can better prevent worsening of the disease, including the need for liver transplant or death, compared to a placebo. The safety of long-term use and effects on symptoms like itching and tiredness will also be assessed. Participants will be randomly assigned to take either one 80 mg tablet of elafibranor or a matching placebo tablet once daily, taken orally with or without food, at about the same time each morning. The treatment period can last up to 3.5 years in a double-blind setting, meaning neither participants nor researchers know who receives the drug or placebo. This design allows a direct comparison of elafibranors impact on disease progression and safety over a long term. Throughout the study, participants will undergo regular assessments including blood tests, physical exams, vital signs, ECGs, and liver imaging to monitor liver function and stiffness. Researchers will track a range of outcomes such as survival without clinical events, changes in liver and blood markers, symptom severity, and quality of life measures. Safety monitoring will continue until 4 weeks after the last dose. Each participant may be involved for up to 3.5 years from baseline to final evaluation.

Researchers are evaluating the efficacy, safety, and how the body processes pharmacokinetics prasinezumab compared with a placebo in people with early-stage Parkinsons disease who are already on stable levodopa treatment. This phase III study aims to better understand how prasinezumab affects the progression of motor symptoms in this population. Participants will be randomly assigned to receive either prasinezumab or placebo through intravenous IV infusions during a double-blind treatment period. After completing this phase, eligible participants can join an Open Label Extension OLE phase where they will receive prasinezumab. The treatments are given as scheduled IV infusions. During the study, participants will undergo regular assessments including evaluations of motor function using the Movement Disorder Society Unified Parkinsons Disease Rating Scale MDS-UPDRS Part III. Blood samples will be taken to measure drug levels and immune responses. Safety will be closely monitored, including tracking adverse events and infusion reactions. The primary outcome is the time until confirmed motor progression, with follow-up lasting up to at least 104 weeks.

Researchers are evaluating the effects of the medicine BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. This study includes people with or without type 2 diabetes and those who may or may not be taking certain blood pressure medicines such as ACE inhibitors or ARBs. The goal is to understand if adding BI 690517 to empagliflozin helps reduce the risk of kidney failure, heart disease, or hospitalization due to heart failure. The study has two parts. In the first part, all participants receive empagliflozin or a placebo similar to BI 690517 for at least six weeks while continuing any indicated ACEi or ARB treatments. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the remainder of the study. The study lasts about three to four years until enough events related to kidney or heart health occur. During the study, participants visit the study site about four times in the first six months and then every six months afterward. At these visits, doctors check health status, collect blood and urine samples, measure blood pressure and weight, assess kidney function, and monitor any side effects. Researchers track the time until worsening kidney disease, heart failure hospitalizations, or cardiovascular death to compare outcomes between treatment groups.

Cesarean section is a common surgical procedure worldwide, and managing acute postoperative pain effectively is crucial in obstetric anesthesiology. Researchers are evaluating whether intrathecal morphine provides better pain relief after elective cesarean delivery compared to the standard epidural morphine. This randomized clinical trial aims to clarify the optimal opioid administration route to support faster maternal recovery, newborn care, and safe breastfeeding. Pregnant women undergoing elective cesarean section will be randomly assigned to receive either intrathecal morphine at a dose of 80 mcg or epidural morphine given as a 2.5 mg bolus at the end of surgery, followed by another 2.5 mg bolus 24 hours later. The study focuses on comparing the effectiveness of these two analgesia methods during the first 24 hours after surgery. Participants will be monitored for pain levels during the first 24 and 48 hours after surgery, need for additional pain medication, sedation levels, nausea, vomiting, itching, impact of pain on movement and activities, and overall satisfaction with pain management. All evaluations will assess safety and comfort during recovery, with the primary outcome being pain control at 24 hours post-cesarean. The trial is conducted at Hospital Central do Funchal and lasts through the initial postoperative period.

This research aims to understand how the Medtronic Evolut FX transcatheter aortic valve implantation TAVI System performs in adults with severe, symptomatic aortic stenosis who require valve replacement. The study focuses on whether using a standardized procedure for implanting this valve system can improve safety and efficiency. It also looks at patient outcomes both shortly after the procedure 30 days and in the longer term 1 year, including the need for pacemakers, complications, and valve function. Participants will receive the Medtronic Evolut FX TAVI System as part of their regular medical care for severe aortic stenosis. This is an observational registry capturing routine practice data, with no experimental treatments assigned. The study will follow patients from their hospital stay through 30 days and up to 1 year after the procedure to monitor health and recovery. During the study, participants will be closely observed through hospital records and follow-up visits to assess heart health, valve function, and recovery progress. Researchers will measure technical success immediately after the procedure, as well as monitor events like pacemaker implantation, hospital stay length, mortality, stroke, bleeding, kidney injury, vascular complications, valve issues requiring further treatment, rehospitalizations, and prosthetic valve function over 30 days and 1 year. A total of 500 participants across 12 hospitals will take part in this registry lasting until April 2028.

Researchers are evaluating the combination of sacituzumab tirumotecan and pembrolizumab compared to pembrolizumab alone in adults with metastatic non-small cell lung cancer NSCLC whose tumors have high PD-L1 expression 50 or greater. The study aims to determine if adding sacituzumab tirumotecan improves overall survival compared to pembrolizumab by itself. This is a phase 3, randomized, open-label trial sponsored by Merck Sharp Dohme LLC. Participants in the experimental group receive sacituzumab tirumotecan through intravenous infusion on Days 1, 15, and 29 of each 6-week cycle, along with pembrolizumab 400 mg IV every 6 weeks for up to 18 cycles. Pre-medications such as diphenhydramine, an H2 antagonist, acetaminophen, and dexamethasone are given before the first 4 sacituzumab tirumotecan infusions. The control group receives pembrolizumab 400 mg IV every 6 weeks for up to 18 cycles. Supportive care measures are allowed as needed. Throughout the study, participants undergo regular assessments including tumor evaluations using RECIST 1.1 criteria, quality of life questionnaires, and monitoring for adverse events. The primary outcome is overall survival measured for up to approximately 49 months. Secondary outcomes include progression-free survival, response rates, symptom changes, and treatment tolerability over up to 77 months. Participants may continue pembrolizumab monotherapy for up to 9 additional cycles if disease progression is confirmed after initial treatment.

Researchers are evaluating fazirsiran, an investigational drug, to see if it can reduce liver scarring fibrosis and slow disease progression in people with liver disease caused by an abnormal alpha-1 antitrypsin protein. The study compares fazirsiran to a placebo and aims to understand how the drug affects the body, including its impact on liver inflammation and abnormal protein levels. Liver biopsies will be taken twice to assess changes in liver scarring. Participants will receive either fazirsiran or a placebo through subcutaneous injections. The dosing schedule includes an injection on Day 1, at Week 4, and then every 12 weeks up to Week 196. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the drug or placebo during the treatment period. During the study, participants will undergo liver biopsies and various assessments including imaging techniques and blood tests to monitor liver function, protein levels, liver stiffness, and inflammation. Researchers will also track side effects, lung function, vital signs, and laboratory results from the start of treatment through up to Week 230. The main focus is on measuring changes in liver fibrosis after 106 weeks, with ongoing safety and efficacy evaluations throughout the study.

Researchers are evaluating MB11, a proposed biosimilar to nivolumab, compared to EU- and US-sourced Opdivo in adults with untreated advanced unresectable or metastatic melanoma. This phase 3 randomized, double-blind, multinational study aims to compare the pharmacokinetics, efficacy, safety, and immune response of these treatments in this patient population. The trial is sponsored by mAbxience Research S.L. Participants will receive either MB11 or one of two versions of Opdivo through intravenous infusions at a dose of 3 mgkg over 30 minutes every two weeks for the first 12 cycles. From cycle 13 onwards, dosing continues every two weeks with either the same weight-based dose or a flat dose of 240 mg. The study includes multiple treatment groups to assess the biosimilar against the reference products under similar conditions. Throughout the study, participants will undergo regular monitoring, including assessments of drug levels in the blood, tumor response by imaging, safety checks, and immune system evaluations. The primary outcomes focus on pharmacokinetic equivalence and treatment efficacy by week 24, with extended follow-up through week 52 to compare other efficacy and safety measures. The total duration and detailed schedules will be managed to support thorough evaluation of these treatments in advanced melanoma.

This research aims to evaluate the safety and effects of fazirsiran in people with alpha-1 antitrypsin deficiency-associated liver disease who have mild liver scarring fibrosis. This condition involves the liver producing an abnormal protein called Z-AAT that can build up and damage liver cells, potentially leading to serious liver problems. The study focuses on adults aged 18 to 75 who already have mild liver fibrosis and seeks to understand how well participants tolerate the treatment and its long-term safety. Participants will be randomly assigned to receive either fazirsiran or a placebo. Fazirsiran is given as a subcutaneous injection of 200 mg on Day 1, Week 4, and then every 12 weeks up to Week 100. The placebo group receives matching injections on the same schedule. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo during the study period. During the study, participants will have liver biopsies twice to collect tissue samples and undergo various tests including lung function checks, vital sign monitoring, ECGs, and blood tests to track changes in liver scarring and protein levels. Researchers will closely observe any adverse events and changes in clinical laboratory results from the start of treatment through Week 124. The study will also assess changes in liver inflammation, fibrosis scores, and markers of liver injury to understand the treatments impact over about two years of participation.

This research investigates the uterine junctional zone JZ, an internal layer of the uterus involved in placentation, and its connection to major obstetrical complications like pre-eclampsia, pre-term labor, and fetal growth restriction in women undergoing assisted reproductive technology ART such as IVF, ICSI, or frozen embryo transfer. The study aims to understand how structural and functional changes in the JZ before conception may relate to these pregnancy complications. The study uses three-dimensional 3D ultrasound to evaluate the JZ on the day of final oocyte maturation trigger or before starting luteal phase support for frozen embryo transfer. Measurements include the quality of JZ visualization, its thickness described as regular, irregular, or interrupted, and JZ volume calculated by subtracting endometrial volume. Ultrasound exams are standardized and performed transvaginally by the same operator. Participants will undergo a 3D ultrasound at a specific time during their ART cycle. Researchers will monitor for adverse obstetrical outcomes including pre-eclampsia, pre-term labor, and fetal growth restriction up to 40 weeks of pregnancy, as well as assess high-risk first trimester screening for pre-eclampsia at 12 weeks. The study will help relate JZ characteristics to pregnancy outcomes, with all ultrasound data collected and analyzed prospectively.