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.
Acute pancreatitis represents an acute inflammatory process of the pancreas, which undergoes local and systemic complications, associated with non-negligible morbidity and mortality, and significant economic and quality of life impact. Even after the recovery phase, the development and persistence of sequelae from the inflammatory/necrotic process, including exocrine and endocrine pancreatic insufficiencies, are frequent. Although well documented as consequence of other pancreatic conditions, exocrine pancreatic insufficiency (EPI) after acute pancreatitis is poorly studied and probably underdiagnosed. The prevalence, diagnosis, independent risk factors and therapeutic approaches for EPI after acute pancreatitis need further investigation. Recent evidence suggests the involvement of the pancreas-intestinal axis and immunological dysfunction in several pancreatic pathologies, although their role in the development of EPI after acute pancreatitis is still scarce. Pancreatic enzyme replacement therapy (PERT) is the only treatment currently available in EPI, but the timing for start and duration of this therapy in acute pancreatitis remain to be established. This study have the following objectives: to determine the prevalence, clinical, analytical and nutritional biomarkers and duration of EPI after acute pancreatitis, as well as changes in gut microbiota and immunologic response, and quality of life in EPI and response to PERT after acute pancreatitis; and to determine the prevalence and biomarkers associated with endocrine pancreatic insufficiency following acute pancreatitis and the presence of gut dysbiosis and immunologic changes in acute pancreatitis according to its severity.
A prospective, single arm, non-randomized pivotal study to evaluate the safety and performance of the Xeltis hemodialysis access graft in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation.
Surgical resection is the only curative treatment in patients diagnosed with lung cancer, the most mortal type of malignancy globally. However, following lung cancer resection, patients experience a substantial deterioration in health-related quality of life and have an increased risk of developing pulmonary complications. Although current clinical guidelines strongly recommend preoperative exercise training to improve clinical outcomes after lung cancer surgery, inaccessibility to facility-based exercise programs is a major barrier to routine participation, with patients indicating a strong preference to exercise in a home-based environment. The primary purpose of the present study was to evaluate the feasibility of a home-based exercise program (HBEP) in lung cancer patients awaiting surgical treatment. The secondary purposes were to evaluate the safety of the HBEP and to explore exercise effects on patients' HRQOL and physical performance, either pre-and post-surgery.
Studies have demonstrated that the reduction in mortality and morbidity due to vaccination extends beyond the targeted infections. This seems to result from the non specific effects of vaccines. BCG, a live attenuated vaccine against TB disease, administered to new borns, is one of the vaccines known to have non specific effects. In Portugal, between 1965 and June 2016, BCG was administered to all new borns. In July 2016, a clinical guideline established that only children under 6 years of age from high-risk groups should be vaccinated. In 2021, the first cohort of children not vaccinated for BCG reached 5 years of age and evidence is needed on the impact of this strategy. Aim: to investigate the incidence of specific and non-specific effects of BCG by comparing the incidence of TB disease and infection, mild and severe morbidity, and mortality in the first 5 years of life of children born between 2010 and 2021 according to their BCG status. Methods: historical birth cohort study of children born between 1st July 2010 and 30th June 2021. The investigators will create a single database that links data from the birth registry, the vaccination registry, the information systems of death certificates, epidemiological surveillance and TB surveillance, Diagnosis Related Groups and of primary health care of children born in the study period to reconstruct chronological sequences of morbidity and mortality events from birth until completion of 5 years of life or 30th June 2021. Only children born in Portugal, live-births and births coded as normal new-born will be included. New borns with low-birth weight (<2kg), premature (<37 weeks) and known or suspected HIV infections will not be included in the study. The follow-up period will be until completion of 5 years of age or 30th June 2022. Data will be analysed to compare the incidence of all-cause mortality (including TB), TB disease and severe and mild morbidity among BCG vaccinated and non-vaccinated children born during the reference period in a total of 11 birth cohorts and will comprise computation of person-time incidence rates for primary outcomes and the probability of surviving (Kaplan Meier method) first and fifth year of life or of not having a hospitalization, emergency department visit or a mild morbidity episode during the follow-up period according to exposure. To explore the effects of several variables on the survival outcomes we will use proportional hazards regression analysis.
Lung cancer accounts for over 11% of global cancer incidence and is the leading cause of cancer death, with numbers in 2020 reaching 1.8 million deaths worldwide. For early-stage lung cancer patients, surgical resection is the recommended treatment and the intervention associated with a better prognosis. However, in consequence of surgery there is a substantial deterioration in health-related quality of life across most dimensions, especially in the first month, with 100% of lung cancer patients concerned about the limitations in their physical function and 96% about the levels of fatigue and pain after lobectomy. Additionally, some patients developed postoperative pulmonary complications, which are associated with increased length of hospital stay and higher risk of mortality. In this context, and considering that the number of lung cancer cases with an indication for surgery will increase by 60% from 2018 to 2040, to find feasible and effective interventions that could optimize postoperative recovery is of major clinical relevance. The primary purpose of this study will be to evaluate the efficacy of home-based preoperative exercise training to improve health-related quality of life after lung cancer surgery. The secondary purpose of this study will be to evaluate the efficacy of the home-based exercise program to improve physical performance and to reduce postoperative complications /length of hospital stay. Participants will be randomly allocated to a preoperative exercise intervention, that will consist of combined aerobic and resistance exercise, or to a control group that will receive usual care (i.e., no exercise training). Based on the strong evidence indicating a therapeutic effect of exercise training on fatigue and physical function, domains of HRQOL especially affected after lung cancer surgery, the investigators hypothesized that the home-based exercise program will be effective to improve these domains before surgery and attenuate its deterioration after surgery, optimizing the recovery in postoperative HRQOL.
The surgical ostomy process happens when it is necessary to open an organ (such as the intestine) in order to maintain a communication channel with the external environment. The need for ostomy surgery can happen as a result of illness, genetic factors, or trauma. Despite the extensive improvements in colorectal surgery, in case there is a need for total or partial extraction and exteriorization of the large intestine (colostomy), it is often necessary to perform a stoma that connects the end of the preserved intestine to the skin, in which cases it is necessary to place a a colostomy bag for stool collection. Thus, there is a substantial number of patients who need to live with a permanent abdominal stoma that significantly affects their quality of life, implying significant changes, both physical and social. It will then be necessary for patients to adjust their daily routines in order to deal with stoma care. The primary objective of this study is to evaluate the Hydrustoma C3 medical devices (plate C3, capsule C3, night bag C3) in terms of its efficacy and safety as colostomy devices. It is also a primary objective of this study to compare the health-related quality of life in patients with colostomy when using a control and Hydrustoma C3 devices.
Heart failure (HF) is a global, public health issue that affects more than 63 million people worldwide; this burden is expected to increase substantially as the population ages. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality; there is also an immense impact on patients' health-related quality of life (HRQoL). On May 5, 2020, the US Food and Drug Administration (FDA) announced the approval of dapagliflozin for heart failure with reduced ejection fraction (HFrEF), regardless of whether the patient has diabetes. Subsequently, there have been additional approvals for this indication by regulatory authorities across the globe." Real-world observational data are necessary to describe dapagliflozin use in real-world settings with detailed clinical data on heart failure symptoms, outcomes, and HRQoL.
The WP3 hospitalized cohort in EuCARE is an observational multicentre study including collection of retrospective (historical) and prospective data from hospitalized COVID-19 patients followed at 12 clinics from 11 countries from 4 continents. In a subset of patients, peripheral blood, viral isolates and/or viral sequences are collected for analysis in WP2 with regards to neutralising antibodies, cellular immunity and SARS-CoV-2 diagnostics. Data and results from analysis of biological material will be analysed by biostatistical methods and with artificial intelligence in WP5. This analysis will focus on the impact on clinical outcome of viral variants / viral sequences as well as the vaccines used and the vaccination schedules.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of RO7303509 treatment in participants with systemic sclerosis (SSc) during a multiple-ascending-dose (MAD) portion of the trial. In the MAD phase, increasing doses of study drug will be tested sequentially. For each dose tested, the MAD stage will consist of a treatment period of 12 weeks followed by either a safety follow-up period of 13 weeks or continued treatment in an optional open-label safety extension (OSE) stage of 52 weeks to assess the long-term safety. All patients in the OSE stage will receive RO7303509 and no patient will receive placebo.
Guillain-Barré syndrome (GBS) is a neurological disease characterized by an inflammation of peripheral nerves, which might be responsible for long-term disability. Respiratory muscle weakness is a complication of GBS and might be responsible for respiratory symptoms, inadequate secretion clearance or hypoventilation, with negative impact on daily life. Inspiratory muscle training has been applied in respiratory and neurological diseases and benefits have been observed in symptoms (e.g., dyspnoea), pulmonary function, exercise capacity and quality of life. Nevertheless, results of this intervention in people with GBS are yet unknown. Moreover, rehabilitation is a key player in the recovery of these highly complex patients, however, the interpretation of the magnitude of its effects has been limited by the absence of minimal clinically important differences for most outcome measures. To overcome these drawbacks, methodologically robust trials are needed to build evidence-based rehabilitation to improve clinical care on GBS. The primary aim of this project (RehabGBs) is to develop an inspiratory muscle training protocol - InspireGBs and assess its effects on respiratory muscle strength, peak cough flow, pulmonary function, dyspnoea, fatigue, functional status and quality of life in people with GBS, through a randomised controlled trial. Secondary aims are to: i) establish minimal clinically important differences of Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Medical Research Council - Manual Muscle Testing, Vital capacity, Maximal Inspiratory Pressure, Peak Cough Flow, Functional Independence Measure and Quality of Life for inpatient rehabilitation programmes of people with GBS ii) Evaluate the prevalence of nocturnal hypoventilation in GBS.