There are about 3194 clinical studies being (or have been) conducted in Portugal. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The purpose of this randomized, open-label, 2-arm, phase 3 study is to assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic SCLC with high levels of DLL3, who have first disease progression during or following front-line platinum-based chemotherapy.
The aim of this study is to assess prospectively the critical period prior to the development of Acute-on-Chronic Liver Failure (ACLF) (1), to uncover mechanistic and pathophysiological processes associated with the development and clinical course of ACLF (2) and to identify the precipitating events of ACLF (3).
The purpose of this study is to investigate the long-term safety and efficacy of risankizumab in the treatment of moderate to severe chronic plaque psoriasis.
The study was designed to test patient acceptance and system usability and to assess clinical outcomes of a home-based rehabilitation program using a novel kinematic biofeedback system in the rehabilitation after total knee replacement versus conventional rehabilitation, This system allows the patients to perform independent rehabilitation sessions at home, under remote monitoring from the clinical team. The investigators hypothesize that the system will be well received by patients and that the clinical outcomes will be at least similar those of conventional rehabilitation. This is a quasi-randomized controlled trial with active comparator. Patients will be enrolled pre-operatively and divided into 2 groups: experimental group and conventional rehabilitation group according to geographical criteria. Both groups will perform 8 weeks of rehabilitation starting between day 7 and 10 after surgery. The experimental group will perform daily rehabilitation sessions at home using the system, under remote monitoring from a physical therapist. The conventional rehabilitation group will perform 1h rehabilitation sessions 3 times a week, at home, given by a physical therapist. The following feasibility outcomes will be registered: enrollment rate, retention rate (drop-outs), compliance to the program, independence of use, need for therapist contact and patient satisfaction. Clinical outcomes will be measured at weeks 4 and 8 and then at 3 and 6 months. The primary outcome will be measured in terms of patient performance in the Timed-up-and-Go (TUG) test in comparison with the pre-operative score. Secondary outcomes will be measured in terms of: b) Knee Osteoarthritis Outcome Score); c) range of motion of the knee joint.
The study was designed to compare the clinical outcomes of a home-based rehabilitation program using a novel digital biofeedback system against conventional home-based rehabilitation after total hip replacement This system allows the patients to perform independent rehabilitation sessions at home, under remote monitoring from the clinical team. The investigators hypothesise that the clinical outcomes of a home-based rehabilitation program will be at least similar to the outcomes of a traditional home-based rehabilitation with face-to-face sessions. This is a single-center, prospective, parallel-group pilot study with active comparator. Patients will be enrolled pre-operatively and then divided into 2 groups: experimental group and conventional rehabilitation group. Both groups will perform an 8-week rehabilitation program starting between day 7 and 10 after surgery. The experimental group will perform daily exercise sessions at home using the system, under remote monitoring from a physical therapist. The conventional rehabilitation group will perform 3 home-based rehabilitation sessions per week, each with 1h duration, given by a physical therapist. Outcomes will be measured at weeks 4 and 8 and then at 3 and 6 months. The primary outcome is the change in patient performance measured by the Timed-up-and-Go (TUG) test between in comparison with the pre-operative score. Secondary outcomes will be measured in terms of: a) Hip Osteoarthritis Outcome Score (HOOS); b) range of motion of the hip joint (lying flexion/abduction; standing flexion/adbuction/hyperextension)
The purpose of this study is to determine whether intravenous iron supplementation using ferric carboxymaltosis (FCM) reduces hospitalisation and mortality in patients with iron deficiency and heart failure.
The study was designed to evaluate the impact of a novel kinematic biofeedback system - SWORD - in the motor performance of patients after stroke. The SWORD system combines inertial motion trackers and a mobile app, allowing digitization of patient motion and providing real-time audiovisual biofeedback. The investigators hypothesize that the biofeedback feedback provided by the SWORD system improves patient performance, defined as an increase in the number of correct movements. The design of the study is a cross-over randomized clinical trial. Patients will be randomized into two groups. Both will perform two separate sessions consisting of one exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in both experimental settings: with and without biofeedback. Group 1 will perform the exercise with biofeedback first and without biofeedback after, with an interval >24h. Group 2 will perform the exercise in the opposite order. The SWORD system will be used to record movement data in both sessions, but the feedback was only active in one of them.
Phase 1: The European ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation in non-heart failure conditions. The purpose is to examine the effects of ASV on quality of life, daytime symptoms and sleep, to describe usage patterns of ASV with regards to patient characteristics and to document adverse events related to therapy for a therapy safety analysis. A pilot phase will enrol at least 200 patients to test the feasibility of the registry. After the pilot phase will be completed and an intermediate data analysis had been performed, the registry will be expanded over several countries across Europe with the goal of enrolling up to 800 patients over a period of 5 years. Phase 2: The READ-ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation in non-heart failure conditions. The purpose is to examine the effects of ASV on quality of life, daytime symptoms and sleep, to describe usage patterns of ASV with regards to patient characteristics and to document adverse events related to therapy for a therapy safety analysis.
Following the licencing of a new drug, Defitelio®, indicated for the treatment of severe Veno-Occlusive Disease of the liver (sVOD), a rare but serious complication of haematopoietic stem cell transplantation (HSCT), as a specific obligation (SOB), the manufacture and marketing Authorisation Holder (MHA) (Gentium, a Jazz Pharmaceuticals Company) was required by PRAC (Pharmacovigilance Risk Assessment Committee) to set up a disease registry to collect safety and outcome data, and to assess patterns of utilization of Defitelio® in the post-approval setting. This registry is a Post Authorization Safety Study (PASS), is being coordinated in collaboration with the European Society for Blood and Marrow Transplantation (EBMT). For this study, anonymised clinical data are being collected from patients who develop VOD and and treated with and patients who have been treated with Defitelio® for conditions other than sVOD. The study DOES NOT involve decisions about treatment, which are clinical decisions, but merely collection of data for patients who develop this complication, whether or not they receive treatment and for patients who are treated with Defitelio® for any other reasons.The study DOES NOT involve decisions about treatment, which are clinical decisions, but merely collection of data for patients who develop this complication, whether or not they receive treatment and for patients who are treated with Defitelio® for any other reasons.
Given the lack of support for lifestyle management in post-career and considering the high rates of physical inactivity and overweight in former elite athletes, the aim of this research project is to analyze the efficacy and effectiveness of a lifestyle intervention in former athletes.