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 safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10.
This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy/performance and safety of NBTXR3/RT±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with LA-HNSCC.
Mindful Moment (a web-based mindful and compassionate parenting training) is a self-guided program for postpartum mothers, based on the Mindful Parenting Training developed by Bögels and Restifo (2014) and the Mindful with Your Baby Training (Potharst et al., 2017, 2019). The main goal of this research is to assess the feasibility (e.g., user's adherence, dropout) and acceptability of Mindful Moment and to gather preliminary evidence of its efficacy. This pilot RCT (Randomized Controlled Trial) will be a two-arm trial. Mothers with a child aged up to 18 months old will be enrolled in the study. A minimum number of 60 mothers will be enrolled in the study. After agreeing to participate in the study, the mothers will be screened for the presence of parenting stress (PSS [Parenting Stress Scale] ≥ 41, Mixão et al., 2007). In case of 41 points score or more, mothers will be asked to complete baseline assessment. Then, mothers who completed baseline assessment will be randomly assigned to one of two conditions: the intervention (Mindful Moment program) or the control condition (Waiting-List control [WLC]). The sample will be recruited online. The feasibility of Mindful Moment will be evaluated in terms of user's adherence and dropout. Participation in this study will last 16 weeks. The Mindful Moment program will last 8 weeks. Participants in both conditions will be invited via email to complete baseline, post-intervention, and follow-up assessment (8-weeks after post-intervention). Assessments will include self-report questionnaires to assess user's acceptability and satisfaction, several indicators (e.g., parenting stress, depressive and anxiety symptoms, infant's temperament), and mechanisms that may be involved in the treatment response (e.g., mindful parenting, self-compassion).
EU SolidAct is a randomized, multifactorial, adaptive platform trial for COVID-19 and emerging infectious diseases and pandemics. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to hospital with COVID-19. The platform is designed for running phase 2 and phase 3 trials, and with modular data capture (end point/safety data, biobanking, add-on studies) depending on the capacity of participating sites. The study consists of two parts with different primary end points depending on disease stage: EU SolidAct part A includes hospitalized patients with moderate disease, whereas EU SolidAct part B includes hospitalized patients with severe and critical disease.
This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent participants with mild to moderate coronavirus disease 2019 (COVID-19) in the outpatient setting.
The excessive accumulation of fluid between the membranes surrounding the lung, a clinical condition commonly referred to as "pleural effusion", is caused by one of three factors: increased production of pleural fluid, decreased ability to reabsorb pleural fluid or a mixture both. The basis of pleural effusion accumulation may originate from multiple pathologies: from benign and extrapulmonary conditions to intrinsic pleural pathology (inflammatory or neoplastic primary or metastatic) in which the accumulation of fluid in the pleural space is mainly due to changes in the structure of the pleural membrane (loss of integrity and / or infiltration by neoplastic cells). An example of extrapulmonary conditions is the pleural effusion observed in patients with congestive heart failure in which there is increase in hydrostatic capillary pressure, due to failure of the cardio circulatory pump. The distinction between benign and malignant causes is currently a diagnostic challenge that usually requires the collection of material (cells immersed in the pleural fluid or even a histological sample). The first step of this investigation is currently the cytological evaluation of the pleural fluid, that is, the observation of cells, of an initial sample of the pleural fluid. This procedure is associated with an average sensitivity of 62% while a second sample through thoracentesis improves the sensitivity of the diagnosis by 10%. In certain cases, however, it is not possible to diagnose by analyzing the pleural fluid and, as a rule, a more invasive diagnostic method is recommended, such as pleural biopsy (collected by puncture with a "blind" needle, echo guided or computed tomography guided or obtained by means of direct visualization of the pleural cavity through pleuroscopy). The diagnostic yield of this approach can reach up to 97% (in the case of pleural biopsy obtained by medical thoracoscopy). However, it implies greater morbidity and greater consumption of resources (material and human). The development of a more sensitive and specific and at the same time less invasive diagnostic method for pleural fluid may contribute to a more effective screening of patients, limiting the use of more invasive methods to only patients with a higher risk of malignant pathology.
The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene. The purpose of the first study part is to find the highest dose of a medicine called zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink. In this study, zongertinib is given to people for the first time. Participants take zongertinib as tablets once a day or twice a day. The participants are in the study for as long as they benefit from and can tolerate treatment. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by zongertinib.
The primary objectives of this study are to evaluate the safety of single IV doses of UX701 in patients with Wilson disease, to select the UX701 dose with the best benefit/risk profile based on the totality of safety and efficacy data and to evaluate the effect of UX701 on copper regulation.
This study aims to characterize pain sensitivity and psychological profile of CLBP patients in comparison with pain free adults, and explore their predictive role on hypnosis outcomes, an effective intervention for pain control.
The junctional zone (JZ) is an internal layer of the myometrium, with unique characteristics that allow its visualization as a hypoechogenic structure in three-dimensional (3D) ultrasound. Although traditionally evaluated by magnetic resonance imaging, 3D reconstruction offers an opportunity for reliable and easily accessible assessment. The only study that evaluated the thickness of the JZ in 3D ultrasound in the context of assisted reproductive technology (ART) found that the smaller the thickness of the JZ, the greater the rate of embryonic implantation. This project aims to evaluate the relationship between the characteristics of the ZJ in 3D ultrasound, and the clinical outcomes of ART treatments, namely in vitro fertilization cycles, intracytoplasmic sperm injection and frozen embryo transfer (FET). Additionally, the intra and inter-observer variability of the characteristics of the JZ will be determined. In a prospective and observational study with the inclusion of 200 cases, a 3D ultrasound will be performed on the day on which the final oocyte maturation is triggered or, on FET, on the day prior to the administration of progesterone. The images will be evaluated independently by two observers. The principal investigator will evaluate the images in two stages. After the quality of visualization of the JZ is classified, its thickness will be measured and described as regular, irregular or interrupted. The volume of the ZJ will be obtained by subtracting the endometrial volume from the volume of the junctional zone and the endometrium. These characteristics will be related to the clinical outcomes of each cycle: clinical pregnancy rate and abortion rate.