Funchal

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 evaluating the efficacy, safety, and pharmacokinetics of intravenous prasinezumab compared with placebo in people with early-stage Parkinson's disease. Participants must be on stable symptomatic monotherapy with levodopa and meet specific criteria including body weight and disease stage. This Phase III study aims to understand how prasinezumab affects motor progression in Parkinson's disease. Participants will receive either prasinezumab or a placebo through intravenous infusion following a schedule outlined in the study protocol. The study compares these two groups to assess the impact of prasinezumab on disease progression. The treatments are administered regularly over the course of the trial. During the study, participants will be monitored for motor progression using the Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III score, with assessments continuing up to at least week 104. Researchers will also evaluate safety and pharmacokinetics throughout the trial. Participants are required to adhere to contraception requirements and attend scheduled visits for evaluations and infusions.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

Cesarean section is one of the most common surgeries worldwide, making effective control of pain after the procedure very important for mothers. Researchers are studying how to best manage pain after cesarean delivery to help mothers recover quickly, care for their newborns, and safely manage medications while breastfeeding. This randomized clinical trial in Phase 4 aims to compare two ways of giving morphine to control pain after cesarean section: intrathecal morphine and epidural morphine, since current evidence is unclear about which method works better. Participants in this study will be pregnant women scheduled for elective cesarean section at Hospital Central do Funchal. They will be randomly assigned to receive either a single dose of 80 mcg intrathecal morphine or epidural morphine given as a 2.5 mg bolus at the end of surgery and an additional 2.5 mg bolus 24 hours later. These treatments are given as part of their postoperative pain management. During the first 24 hours after surgery, researchers will evaluate the participants' pain levels to measure how well the treatments control pain. Additional assessments will continue for 48 hours to observe pain, sedation, nausea, vomiting, itching, and how pain affects movement and activities. Maternal satisfaction with pain control will also be recorded. Participants will be closely monitored throughout the study to ensure safety and collect these outcomes.

This research aims to understand how the Medtronic Evolut2 FX+ transcatheter aortic valve implantation (TAVI) System works in adults with severe, symptomatic aortic stenosis who need their aortic valve replaced. It focuses on whether using a standardized implantation procedure can improve safety and efficiency for patients. The study also looks at short-term outcomes within 30 days and long-term outcomes at 1 year, including the need for a pacemaker, possible complications, and how well the valve functions over time. Participants will receive the Medtronic Evolut2 FX+ TAVI System as part of their usual medical care. The procedure follows a standardized approach designed to optimize results. The study does not mention additional comparison groups or alternative treatments. All participants will undergo this valve replacement during their hospital stay. During the study, participants will be monitored while in the hospital, and then followed up at 30 days and again at 1 year. Researchers will check heart health, valve function, recovery progress, and any complications that arise. The main outcome measured immediately after the procedure is the technical success of the valve implantation based on VARC-3 criteria. A total of 500 patients will take part across 12 hospitals in Portugal.

Researchers are evaluating the use of sacituzumab tirumotecan combined with pembrolizumab compared to pembrolizumab alone in treating adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death ligand 1 (PD-L1) expression of 50% or higher. This phase 3 study aims to determine if the combination therapy can improve overall survival. Participants must have confirmed NSCLC without certain gene mutations and meet other health criteria, including good performance status. Participants are randomly assigned to receive either sacituzumab tirumotecan plus pembrolizumab or pembrolizumab alone, both given by intravenous infusion. Supportive care measures, such as anti-nausea or blood growth factor treatments, may be provided as needed. Those who complete the first course of pembrolizumab may be eligible for up to nine additional cycles of pembrolizumab if disease progression is confirmed by central review. During the study, participants will be monitored for overall survival up to about 49 months. Researchers will assess responses to treatment using standard criteria and monitor side effects and safety. Various evaluations, including tumor tissue analysis and health status assessments, will be conducted to understand the impact of the treatments. The study also tracks supportive care use and any adverse events throughout participation.

Researchers are investigating whether the drug fazirsiran can reduce liver scarring (fibrosis) in people with liver disease caused by an abnormal alpha-1 antitrypsin protein, specifically those with METAVIR stage F2 to F4 fibrosis. The study also aims to see if fazirsiran slows liver disease progression, assess its effects on liver inflammation and abnormal protein levels, understand how the body processes the drug, and compare liver function and safety outcomes against a placebo. Participants will receive either fazirsiran or a placebo through injections under the skin on Day 1, Week 4, and every 12 weeks thereafter up to Week 196. Liver biopsies will be performed twice to collect tissue samples for evaluation. The study is randomized, double-blind, and placebo-controlled, focusing on long-term treatment and monitoring. Throughout the study, participants will undergo assessments including liver biopsies, imaging, blood tests to measure liver biomarkers, and safety monitoring for side effects. The main outcome is the reduction of liver fibrosis stage by at least one level at Week 106 compared to baseline. The study includes adults aged 18 to 75 years with specific genetic and liver fibrosis criteria and involves monitoring liver health and overall safety for nearly four years.

Researchers are conducting a randomized, multicenter, multinational, double-blind Phase 3 study to compare the pharmacokinetics, efficacy, safety, and immune response of MB11, a proposed nivolumab biosimilar, versus EU- and US-sourced Opdivo® in adults with previously untreated advanced melanoma that cannot be removed by surgery or has spread to other parts of the body. The study aims to show that MB11 is equivalent to Opdivo® in how it is processed by the body and in its effectiveness as a first-line treatment for this serious cancer. Participants will receive either MB11 or EU-/US-Opdivo® through intravenous infusions. For the first 12 treatment cycles, the dose is 3 mg/kg given over 30 minutes every two weeks. Starting from cycle 13, dosing continues every two weeks with either 3 mg/kg or a flat dose of 240 mg given intravenously over 30 minutes. The study is designed to maintain blinding and compare these treatments directly over a period of 24 weeks. During the study, participants will be monitored from week 1 through week 24 for how their bodies absorb and respond to the treatments. Researchers will assess treatment effectiveness, safety, and immune reactions. Participants will undergo various scans, tissue testing, and laboratory evaluations to measure tumor response and organ function. Safety follow-up and adherence to treatment protocols will be part of the overall 24-week observation period.

Researchers are evaluating the safety and effects of a medicine called fazirsiran in people who have alpha-1 antitrypsin deficiency-related liver disease with mild liver scarring (fibrosis). This condition involves the liver producing an abnormal protein called Z-AAT, which builds up and causes liver damage over time. Participants in this Phase 3 study have mild liver scarring and are monitored to see if fazirsiran can reduce the buildup of this abnormal protein and affect liver scarring. Participants will receive either fazirsiran or a placebo injected under the skin for about two years. The study is randomized and double-blind, meaning neither the participants nor the researchers know who receives the medication or placebo. Liver biopsies will be performed twice during the study to assess liver tissue changes, and other assessments will measure lung function and vital signs. During the study, participants will be closely monitored through various tests including lung function tests, CT lung scans, ECGs, laboratory tests, and liver biopsies. Researchers will track any adverse events, changes in vital signs, and clinical laboratory parameters from the start of treatment through the end of the study, which lasts up to 124 weeks. Participants must be able to follow the study procedures and attend scheduled visits over the study period.

Researchers are studying the junctional zone (JZ), an inner layer of the uterus involved in placentation, to understand its role in major pregnancy complications like pre-eclampsia, pre-term labor, and fetal growth restriction. These complications may originate from early pregnancy events linked to defective deep placentation, where the remodeling of blood vessels in the JZ is incomplete. This study focuses on women undergoing assisted reproductive technology (ART) treatments such as in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), and frozen embryo transfer (FET). Participants will have a 3D ultrasound of the uterus performed either on the day of the final oocyte maturation trigger in IVF/ICSI cycles or the day before progesterone administration in FET cycles. The ultrasound will assess the visibility, thickness, and structure of the JZ, which will be classified as regular, irregular, or interrupted. The volume of the JZ will be calculated by subtracting the endometrial volume from the combined volume of the JZ and endometrium. These ultrasound findings will be related to the occurrence of adverse obstetrical outcomes and first trimester screening risk for pre-eclampsia. During the study, all ultrasounds will be performed by the same operator using a standardized technique with a transvaginal probe. The study will exclude participants with uterine abnormalities like myomas, adenomyosis, or endometriosis. Researchers will monitor for pre-eclampsia, pre-term labor before 37 weeks, and fetal growth restriction up to 40 weeks. The goal is to identify uterine characteristics that may predict pregnancy complications in women undergoing ART, helping to improve risk assessment before conception.