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.
Helicobacter pylori (Hp) is a gram-negative bacterium that colonizes human gastric mucosa and is associated with chronic gastritis that can progress to severe complications such as peptic ulcer disease, gastric adenocarcinoma and gastric mucosa-associated lymphoid tissue lymphoma. More than half of the world's population is infected with H. pylori and Portugal is one of the countries with the highest Hp burden. All of infected patients should be treated, however, H. pylori treatment is challenged by the continuously rising antibiotic resistance which has reached alarming levels worldwide. For this reason, it is now well accepted that tailoring treatment of H. pylori infection based on systematic antimicrobial susceptibility testing is useful to avoid the increase of antibiotic resistance. Our aims are to determine prospectively the efficacy and safety of first-line H. pylori eradication treatment based on resistance profile (determined by molecular methods) vs. empirical bismuth quadruple therapy, to evaluate the accuracy of H. pylori detection by polymerase chain reaction (PCR) (vs. histopathological examination) and to estimate the prevalence of H. pylori infection and H. pylori resistance to clarithromycin and levofloxacin in Portugal. This prospective study will be the first national study to investigate the benefits of tailored H. pylori eradication treatment. The investigators expect that this project will be able to demonstrate the non-inferiority of susceptibility-guided treatment comparing with empirical therapy, and our results may change H. pylori treatment recommendations by systematically applying antibiotic susceptibility testing before prescribing eradication therapy.
The study is being done to see if ziltivekimab can be used to treat participants living with heart failure and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (inactive substance that looks like the study medicine but does not contain any medicine). The treatment participants get is decided by chance. Participant's chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study is expected to last for up to 1 year and 4 months.
The work carried out in Youth Detention Centers (YDC) represents a set of challenges for caregivers, who are in the frontline of juvenile delinquency. These professionals have daily to cope daily with work and relational challenges, while experiencing high levels of stress and physical and emotional fatigue. As such, taking care of the well-being of these professionals is of paramount importance, moreso as they are fundamental in the rehabilitation of young offenders. Still, the usual training/interventions offered to these professionals does not consider/fit to their psychological, emotional, or psychical difficulties. Recent studies have explored the impact of contextual cognitive-behavioral interventions with caregivers (e.g., parents of individuals with developmental disabilities, nurses, healthcare providers), namely those based on Mindfulness and Self-Compassion. The Mindfulness Self-Compassion Program (MSC) has been found to be effective in reducing caregivers' overwhelmed feelings about their own suffering and/or the suffering of others. This clinical trial intends to explore the adequacy of the adapted form of MSC (12 group sessions) to caregivers working in YDC, and to establish its effectiveness. Two main studies will be carried out: 1) a parallel non-randomized clinical trial, in which the effectiveness of the program will be explored, as well as the mechanisms of change of the participants' responsiveness to the intervention; and 2) individual interviews to assess qualitatively the participants' perception about the usefulness and impact of the intervention (concerning their relationship with youth and with work colleagues, their relationship with themselves and the general climate of the YDC). A sample of youth placed in each selected YDC will be recruited and will be assessed through self-report questionnaires at the same moments as caregivers samples. It is hypothesized that the adapted form of MSC will produce significant improvements in outcome measures when comparing caregivers who receive the intervention program with those in the control group. Specifically, it is expected an improvement in caregivers' positive feelings and well-being, in their sensitivity and compassion towards others' suffering, as well as a decrease on some indicators of stress and suffering. Consequently, it is also expected that youth in YDC perceive more warmth and safeness experiences with caregivers and report increases in their interpersonal functioning.
Retrospective evaluation of the value of additive therapeutic plasma exchange (PEX) compared to standard medical therapy (SMT) in Amanita toxin-associated acute liver failure in children and adolescents within the last 10 years at a international group of liver transplant centers.
Percutaneous pulmonary valve revalvulation (PPVR) has emerged as an alternative to surgery for the treatment of congenital heart disease with right ejection pathway dysfunction. The Melody valve (Medtronic Inc., Minneapolis, Minnesota) was the first to be used, validated in 2006 by the European Commission and in 2010 by the Food and Drug Administration (FDA). Subsequently, the Sapien valve (Edwards SAPIEN pulmonic transcatheter heart valve, Edwards Lifesciences, Irvine, California) was subsequently approved for PPVR (Europe, 2010; FDA 2016). Infective endocarditis (IE) after PPVR is currently a major concern with an incidence after Melody PPVR estimated at 3%, much higher than the rate of prosthetic left-heart IE. The Sapien valve has been introduced more recently and some cases of IE have been published. Despite the attention this issue is receiving, there are few studies of sufficient size or statistical power to elucidate the risk factors for developing an IE after PPVR according to the type of valve implanted. Recently, a multicenter study was published by the American team of McElhinney et al (J Am Coll Cardiol 2021 ; 78 :575-589). Although it was a sizeable cohort (2476 patients), there was a large disparity in the ratio of patients who underwent revalvulation with either the Melody or Sapien valve, in favor of Melody patients (2038 Melody patients vs. 438 Sapien patients). In this study, the estimated risk of IE was higher for patients who received a Melody valve, according to univariable analysis but not anymore after multivariate analysis. To further answer this question, we develop an international retrospective multicenter registry whose main objective will be to characterize the incidence rate of infective endocarditis after percutaneous pulmonary revalvulation according to the type of valve implanted (Melody vs. Sapien) using a large population of patients with comparable characteristics (match-population).
This research project aims to analyze the effects of different resistance training volumes on cognitive function, oxidative stress, immunological response, lipid profile, glycemic status, liver function, muscle function, hemodynamic response, and physical performance in individuals with mild cognitive impairment. First the investigators will analyze the effects of a single resistance training session (acute effects) with one and three sets on hemodynamic and physical performance in individuals with mild cognitive impairment. After, the investigators will analyze the effects of an 8-week resistance training program with one or three sets on cognitive function, oxidative stress, immunological response, lipid profile, glycemic status, liver function, muscle function, hemodynamic response, and physical performance in individuals with mild cognitive impairment. The investigators hypothesize that a single resistance training session of one or three sets will increase the acute hemodynamic and physical performance stress in individuals with mild cognitive impairment, although with a higher magnitude in the session with three sets. Furthermore, we hypothesize that eight weeks of resistance training with one or three sets will induce similar improvements in cognitive function, oxidative stress, immunological response, lipid profile, glycemic status, liver function, muscle function, hemodynamic response, and physical performance in individuals with mild cognitive impairment.
The goal of this observational study is to understand if there is a correlation between the evolution of MELD-Na and symptomatic burden of patients with advanced chronic liver disease. All patients with chronic liver disease will be invited to participate in the study. Patients will be followed prospectively with assessment of their MELD-Na score and symptom burden, according to the Edmonton Symptom Assessment System scale.
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 12 years and older. Study details include: At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY). For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period. The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600 (ESTUARY).
Physical inactivity and a sedentary lifestyle are prevalent in the population with intellectual and developmental disabilities, and they do not comply with the World Health Organisation's physical activity guidelines. Due to physical inactivity and a sedentary lifestyle, these individuals have low levels of physical fitness (decreasing functional capacity and success in carrying out activities of daily living), with an increased risk of acquiring other comorbidities such as type II diabetes, hypertension, cholesterol and metabolic syndrome, affecting their quality of life. One of the reasons found in the literature for physical inactivity and sedentary lifestyles in individuals with intellectual and developmental disabilities is the existence of barriers that prevent/difficulty their practice, namely the lack of adapted physical exercise programmes, limited financial resources and lack of venues for their practice. Consequently, there is a dearth of research, including little clarity on the intervention protocols used and a variety of methodologies that address the applicability of non-pharmacological, psychological and psychosocial interventions, such as physical exercise programmes, for the promotion of various variables. One of the most studied relationships is between exercise and the promotion of physical fitness, confirming its direct impact on functional capacity. Bearing in mind that studies on cognitive decline only assess some variables that may be associated but do not represent it on their own, such as attention, memory and language fluency. With regard to quality of life, an 8-week multidisciplinary exercise intervention programme aimed to improve quality of life, professional and peer support for activity, abdominal strength and metabolic equivalent gait of the tasks, however, the physical exercise programme is unclear and multimodal. On the other hand, a previous systematic review associated the effects of physical exercise with variables related to quality of life, namely pain, general health and anxiety. In studies focusing on physical activity, these variables have been shown to be predictors of quality of life, however, studies with physical exercise programmes are still cautious or unclear. Thus, alternative and innovative solutions to promote/maintain physical function, reduce the risk of onset of cognitive decline in early life and promote/maintain the quality of life of individuals with Intellectual and Developmental Difficulty should include physical exercise. Taking this introductory approach into account, this non-randomised experimental study aimed to analyse the effects of two 24-week physical exercise programmes (indoor and outdoor) on functional capacity, cognitive decline and quality of life in institutionalised individuals with intellectual and developmental disabilities.
This project will study the effect of a respiratory training program on woodwind and brass players, using an inspiratory muscle training equipment. The goal is to understand whether it is possible to develop the inspiratory muscles of wind players through regular and planned training. Fourteen young wind players will be selected, in which 7 will be male and 7 will be female, playing different instruments. Inspiratory muscle training will be performed with the POWERBreath Plus Medium Resistance, and will consist of 30 maximal inspirations, twice a day, for 5 weeks.