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.
Neurofibromatosis type 1 (NF1) is a rare, autosomal dominant genetic disorder that is caused by germline mutations in the NF1 tumour suppressor gene, which encodes the tumour suppressor protein neurofibromin 1. Plexiform neurofibromas (PN) are histologically benign nerve sheath tumours, which typically grow along large nerves and plexi. On 5 March 2020, a centralised Marketing Authorisation Application was submitted to the European Medicines Agency (EMA), Marketing Authorisation in EU was granted on 17 Jun 2021. As part of the approval process, a Risk Management Plan (RMP) was developed and submitted to the EMA to summarise the safety concerns emerging from the clinical development program. The RMP included additional pharmacovigilance plans for a noninterventional Post-authorisation Safety Study (PASS) to further characterise the safety of selumetinib in paediatric patients with NF1-related PN in routine clinical practice. The planned non-interventional PASS will address gaps in knowledge identified by the RMP, including the important identified risk and some of the potential risks and missing information on long-term developmental toxicity in children, by characterising the safety profile associated with selumetinib use among paediatric patients (age d 8 to < 18 years old) with a diagnosis of NF1 with symptomatic, inoperable PN. This study is a specific obligation in the context of a conditional marketing authorisation for selumetinib (ie, Category 2 PASS). Study results will contribute to updating the safety profile of selumetinib in a relatively large population of patients with different personal characteristics across multiple health care systems and patterns of real-world clinical practice in European countries and Israel. The study will enrol 2 cohorts: 1. The Base Cohort includes all enrolled patients aged 3 to < 18 years. 2. The Nested Prospective Cohort will include the subset of Base Cohort patients aged 8 to < 18 years who have not reached Tanner Stage V on the index date.
The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. Study details include: Study duration: Participants will be followed until the last on-study participant reaches his/her 60-month post-randomization visit, a decision to end the study has been triggered, or until premature discontinuation from study, whichever occurs first. Treatment duration: 18 weeks, consisting of six 3-week cycles. Health measurement/observation: Improved Disease-Free Survival. Visit frequency: Weekly visit during combination therapy period, once every 3 weeks during monotherapy period, and every 3, 4, or 6 months during the Disease-Free Survival Follow-up period in Year 1, 2 and 3, or 4 and 5 (with telephone contact in between), respectively, and every 3 months (telephone visits allowed) during the Overall Survival Follow-up period.
The present study aims to quantify the impact of a multidomain approach to prevent cognitive decline in individuals from the general population at-high risk of dementia. It will be based on five distinct components: 1) cognitive training; 2) physical exercise; 3) nutrition education; 4) capacitation to deal with cognitive decline; 5) assessment and correction of hearing loss.
The aim of this study is to compare Onivyde manufactured at two different production sites in adult participants with advanced cancer in the pancreas. Adult participants with metastatic pancreatic adenocarcinoma will receive Test Product (TP) and Reference Product (RP) Onivyde in line with its approved indication. The order in which they receive them depends on the group to which they are randomly assigned, this will be referred to as the crossover phase. The average study duration for each participant until end of crossover phase is estimated to be approximately 3 months. After completion of the crossover phase, participants who in the opinion of the investigator will benefit from the treatment will be offered to enter the extension phase where they will receive the commercial Onivyde (RP) until disease progression, withdrawal, unacceptable toxicity or death. Metastatic pancreatic adenocarcinoma is a cancer that has spread (metastasized) beyond the area of the pancreas to other organs of the body. Onivyde is approved for the treatment of metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy, in combination with 5-fluorouracil (5-FU) and leucovorin (LV).
Greater muscular strength and power are relevant qualities for athletic success and decreased injury rate. It is known that dehydration impairs muscular strength and power, although the explanation for this association is not entirely clear. Besides morphological factors, strength production also depends on neural factors which in turn can be affected by dehydration. Some studies tested the effects of dehydration on neuromuscular function using electromyography (EMG) analysis. However, there is no consensus among those studies. Additionally, exercise may disturb water balance. This can further lead to dehydration if the athlete does not properly rehydrate. In this sense, the scientific evidence has identified people who are considered low drinkers that may be more susceptible to cellular shrinkage, potentially impairing health and performance. Thus, it would be expected that athletes regularly exposed to lower amounts of water intake would have beneficial effects in both performance and health if higher water ingestion was promoted, namely an improved neuromuscular function via enhanced cellular hydration. However, any potential benefit of increasing water intake on neuromuscular function is still to be determined using well-designed experimental studies and state-of-the-art methods. Lastly, there is no consensus regarding the diagnosis of dehydration in athletes. The identification of simple indices to measure dehydration in athletes is crucial as many may be inaccurately diagnosed.
This multicentre study will be conduct in several Portuguese institutions, which provide care and supporting services for older adults, with aim to assess the impact of COVID-19 pandemic on the cognitive, emotional and social status of their beneficiaries. Initially, data on global cognitive function, executive function, mood, anxiety, loneliness, and quality of life will be collected. Secondly, a semi-structured interview will be carried out to realize and understand what were the major difficulties experienced by the older adult during the pandemic period.
The purpose of this study is to characterize the distribution of lipoprotein(a) (Lp(a)) levels among participants with a history of ASCVD as defined by their medical history and is 2-fold: - Evaluate the distribution of Lp(a) value in the overall participants with documented history of ASCVD - Evaluate the distribution of Lp(a) value in participants with documented history of ASCVD by demographics and regions
The purpose of this multi-national disease registry is to collect prospectively (with longitudinal follow-up) high-quality, standardized, and contemporaneous data to capture changes in the non-small cell lung cancer (NSCLC) treatment landscape and outcomes over time. The registry will capture data on participants; demographic, clinical characteristics (including biomarker data), treatment patterns, and effectiveness and safety outcomes for advanced NSCLC with mesenchymal-epithelial transition exon 14 (METex14) participants treated with systemic therapy.
Functional constipation (FC) is a common condition associated with aging, lower socioeconomic status, low physical activity and also with reduced fibre, water and magnesium intakes. Different studies have reported a positive association between the intake of hyper-mineral water containing a high content of bicarbonate, calcium, or magnesium, and the improve of the gastrointestinal transit. There is evidence that magnesium and sulphate, both individually, have a laxative action. However, the impact of other minerals is scarce. It has been described different mechanisms explaining how gut microbiota influence the gastrointestinal transit. Specifically, in FC patients, it is important to understand the particularities of their gut microbiota and understand whether the intake of hyper-mineral water, a natural source of minerals, can modify positively the gut microbiota. The aim of the present randomized placebo-controlled pilot trial is to evaluate, for the first time, the effect of the carbonated mineral water consumption in the gastrointestinal transit and in the gut microbiota of subjects with FC.
Comparison on radiotherapy skin set-up markings with lancets versus Comfort Marker 2.0®