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.
Severe Acute Respiratory Syndrome (SARS) Coronavirus (CoV) 2 infection and the associated coronavirus disease 2019 (COVID-19) are the most recent international health threat challenging our ability to protect populations, to avoid severe outcomes and to understand both the population dynamics of this new condition and the breath of individual responses. Gathering information on the clinical course of the disease and the risk of transmission is essential to design effective therapeutic solutions and preventive measures. The aim of the study proposed, to be carried out at University Hospital Center of "São João" (CHUSJ), is to recruit and follow-up a cohort of patients diagnosed with SARS-CoV-2 infection, to evaluate the clinical course of SARS-CoV-2 infection and COVID-19 cases, to identify prognostic factors and to measure the risk of reinfection. Additionally, researchers intend to characterize the patients and household contacts to describe the dynamics of infection, to calculate household infection attack rate, and to perform the genetic sequencing of SARS-CoV-2 to understand determinants of disease course (namely long-term effects) and risk of household transmission. A sample of participants, identified during the process of evaluation of symptomatic individuals, at the same institution, and negative for SARS-CoV-2 will be selected as negative controls. Participants will be consecutively recruited and the study is expected to enroll patients as long as the pandemic remains. Information will be gathered based on clinical individual charts, hospital data-bases (example: for administrative data) and individual computer assisted interviews to be performed at pre-defined intervals (3, 12 and 24 months) or according to clinical needs. The project was approved by the local Ethical Committee and the Data Protection relevant authorities.
The lack of ADAMTS13 is the only biological marker that is specific for aTTP diagnosis8 and the assessment of ADAMTS13 is of clinical importance because it is essential for the rapid differential diagnosis between aTTP and other TMA. Furthermore, monitoring of ADAMTS13 activity is useful to ensure biological remission (ADAMTS13 levels > 10%) as well as predicting relapses. Due to the high mortality rate of aTTP, treatment should be started as soon as the disease is suspected, sometimes even before confirmation with the ADAMTS13 test results. This situation may lead to misdiagnose some patients and leave them without the appropriate treatment. In conclusion, ADAMTS13 activity assay is crucial for an early diagnosis and optimal management of acute aTTP and any delay in ADAMTS13 results will have a negative impact on the diagnosis, treatment and prognosis of the patient. There are currently 2 techniques available for the ADAMTS13 activity determination, the fluorescence resonance energy transfer (FRET) and the Technozym chromogenic enzyme-linked immunosorbent assay (ELISA). Both are considered reference methods but they require considerable skill because they are highly manual and this increases the risk of error. Furthermore, these methods are time-consuming, not widely available and, in case of the ELISA method, it requires a new calibration at each run. The inter-laboratory variability is also a challenge and therefore a validation and/or interpretation method could be needed. Recently, a new and first fully automated HemosIL AcuStar ADAMTS13 Activity assay (Instrumentation Laboratory, Bedford, Massachusetts, United States) has been developed. HemosIL AcuStar ADAMTS13 Activity assay is a two steps chemiluminescent immunoassay (CLIA) with an analytical time of 33 minutes for the quantitative measurement of ADAMTS13 activity in human-citrated plasma on the ACL AcuStar analyser. The immunoassay uses the GST-VWF73 substrate in combination with magnetic particles for rapid separation and chemiluminescence technology detection. The ADAMTS13 present in the plasma sample cleavages the GST-VWF73 substrate and the detection of the generated fragments is based upon an isoluminol-labelled monoclonal antibody that specifically reacts with the cleaved peptide. The emitted light is proportional to the ADAMTS13 activity in the sample. This new ADAMTS13 assay method has been compared with the other two available techniques in two different studies. First, Favresse et al. published the results of the comparison between Technozym activity ELISA assay and the new HemosIL AcuStar chemiluminescent assay. On the other hand, Valsecchi et al. have recently published the results of validation of this new technique in comparison with ELISA and FRETS in 176 samples. Both studies conclude that the new chemiluminescent ADAMTS13 activity assay showed a good correlation and excellent clinical performance for the diagnosis of severe ADAMTS13 deficiency with the FRETS-VWF73 assay and a commercial ELISA when considering only ADAMTS13 activity values below 10% (the internationally accepted cut-off for a diagnosis of severe ADAMTS13 deficiency typical of aTTP). Finally, Stratmann et al. have just published another study comparing the HemosIL AcuStar chemiluminescent assay with two commercially available ADAMTS13 assay kits using 24 paired test samples derived from 10 consecutively recruited patients13 and their results corroborate the previously published data suggesting that the AcuStar assay could be a valuable and accurate tool for ADAMTS13 activity testing and aTTP diagnostic. In this context, a unique opportunity to validate this new technique is generated, both retrospectively with our already available data from frozen samples and also in the context of a large prospective study. This will be the first study worldwide testing HemosIL AcuStar method in real clinical practice aTTP population (Spanish and Portuguese aTTP populations) with the aim to standardize the diagnosis and follow-up methodology for the disease.
As the investigators have shown before, there was a tendency for a reduction of anxiety levels on university students after 30 minutes, with auriculotherapy treatment before examinations have started. However, the effect was effective and clinically significant after 48 hours comparing auriculotherapy with placebo and no treatment. In this sense, the investigators intend to perform a new study with a large sample and introduce a new hypothesis. So, this study aims to detect the clinical effect of two auriculotherapy techniques on the anxiety levels of university students.
The investigators propose an observational study including patients with inflammatory bowel disease under biological therapy with anti-TNF, anti-integrin α₄β₇ or anti-interleukin 12-23 (Ustekinumab), followed by an external Gastroenterology consultation at Centro Hospitalar Tondela-Viseu.
The purpose of this study is to collect and evaluate pregnancy outcomes, pregnancy complications, and fetal/neonatal/infant outcomes in women exposed to patisiran-LNP.
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by the presence of bone in soft tissue where bone normally does not exist, known as Heterotopic Ossification (HO). It is often associated with painful, recurrent episodes of soft tissue swelling (flare-ups) that lead to abnormal stiffening and immobility (ankyloses) of major joints with cumulative and irreversible loss of movement and disability. This study will evaluate the efficacy of 2 dosing regimens of IPN60130 in inhibiting new HO volume compared with placebo (a dummy treatment) in adult and paediatric participants with FOP. It will be assessed by a scan (provides internal images of the body) called low dose Whole Body Computed Tomography (WBCT), excluding head. Adults and participants 5 years of age or older are also eligible for a sub study to evaluate HO lesions assessed by another type of scan, Fluorine-18-labelled natrium fluoride Positron Emission Tomography-Computed Tomography ([18F]NaF PET-CT ).
The purpose of this study is to complement Study CBYL719C2301 (SOLAR-1) and obtain more comprehensive data on the efficacy and safety of alpelisib (BYL719) in combination with fulvestrant compared with placebo plus fulvestrant in men or postmenopausal women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation who progressed or relapsed on or after treatment with an AI plus a CDK4/6 inhibitor.
Dementia is a neurodegenerative syndrome that leads to cognitive deficits and, consequently, affects functionality and quality of life. This study will explore the clinical impact of a customized cognitive stimulation program, using Musiquence.
IMPAHCT: Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial is a Phase 2b/Phase 3 study to evaluate the safety and efficacy of AV-101 (dry powder inhaled imatinib) in patients with Pulmonary Arterial Hypertension (PAH). The Phase 2b part of the study will assess three doses to establish an optimal dose for the Phase 3 part of the study. The Phase 2b primary endpoint will be the placebo corrected change in pulmonary vascular resistance (PVR). The Phase 3 primary endpoint will be the placebo corrected change in 6-minute walk distance (6MWD) after 24 weeks of treatment.
The purpose of this study evaluates the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who were heterozygous for F508del and a minimal function mutation (F/MF participants).