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  • Development and Application of a Musical Game for Motor Rehabilitation

    Phase

    N/A

    Span

    30 weeks

    Sponsor

    Universidade da Madeira

    Funchal

    Recruiting

    Healthy Volunteers

  • Uterine Junctional Zone and Its Relation to Adverse Obstetrical Outcomes in Assisted Reproductive Technology

    During pregnancy, unique vascular changes occur, associated with decidualization of the maternal tissues in response to trophoblast invasion, first in the endometrium and subsequently in the myometrial JZ. The JZ broadly represents the inner third of the myometrium that, together with its overlying endometrium, is involved in placentation. Defective deep placentation, defined by the absent or incomplete remodelling of the JZ segment of the spiral arteries, may be associated with a spectrum of obstetrical complications, ranging from late miscarriage and pre-term labour to fetal growth restriction and pre-eclampsia. Thus, the primary site of vascular pathology in pregnancies lies not in the placenta or decidua but in the JZ. To understand how impaired remodelling of the myometrial JZ prior to conception may predispose to subsequent defective deep placentation, it is important to first describe the structural and functional changes in the JZ at the time of embryo implantation, and subsequently analyse the distinguishing features of defective deep placentation associated with different pregnancy disorders. Thus, non-invasive assessment of the JZ prior to conception may turn out to be useful in identifying those women at risk of major obstetrical complications. This project aims to evaluate the relationship between the characteristics of the ZJ in 3D ultrasound, and major adverse obstetrical outcomes in assisted reproductive technology (ART) treatments, namely in vitro fertilization cycles, intracytoplasmic sperm injection and frozen embryo transfer (FET). 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. 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 major obstetrical adverse outcomes: pre-eclampsia, pre-term labour and fetal growth restriction. The relation with a high-risk first trimester screening for pre-eclampsia will also be accessed. After explaining the study and obtaining written consent, a 3D ultrasound will be performed for uterine evaluation, on the day of the final oocyte maturation trigger in cases of IVF / ICSI. In cases of FET, the ultrasound evaluation will be carried out on the day before the start of the luteal phase support. All ultrasounds will be performed in a standardized manner by the same operator. With an empty bladder, in a lithotomy position, a 2D transvaginal ultrasound will be performed using a GE Voluson 730 Expert® ultrasound, with an endovaginal probe with a 4-8MHz frequency. Identification of endometriosis lesions or acquired uterine abnormalities such as leiomyomas or adenomyosis will be exclusion criteria. After evaluating the number and maximum dimension of the ovarian follicles and the endometrial thickness, the three-dimensional volume box will be placed to encompass the entire uterus in longitudinal section, with minimal inclusion of para-uterine structures. A maximum acquisition angle of 90º and maximum quality will be used. To minimize artifacts, during the acquisition both the probe and the woman must remain immobile, being asked to hold their breath. Then, a three-dimensional volume will be generated by automatic 360º rotation of the transducer. For each case, two volumes will always be obtained.

    Phase

    N/A

    Span

    127 weeks

    Sponsor

    Centro Hospitalar Lisboa Norte

    Funchal, Madeira

    Recruiting

  • Virtual Reality for Coping With Involuntary Early Pregnancy Loss

    Early pregnancy loss occurs in about 20% of all pregnancies and can lead to chronic grief and psychological distress symptomatology. Although the high prevalence, it is still a very undervalued event, and proper follow-up and psychological guidance are often absent. The present research study aims to evaluate the feasibility of a psychological VR-based approach in a controlled pilot study with 20 women who suffered an early gestational loss in the last 6 months. Using the developed prototype, the experimental VR group will have an intervention program lasting four weeks, with 3 weekly sessions of 45-60 minutes. The investigators aimed to verify if the use of the proposed VR paradigm will significantly reduce symptoms of grief, depression, anxiety and post-traumatic stress, and that this reduction will be significantly greater compared to the control group. The study proposed is very innovative in terms of the target population and the use of VR, specifically designed to address gestational loss. In addition, it opens a new avenue of research on a topic that is still silenced and considered taboo in society. Thus, this interdisciplinary research has an expected scientific, technological, and social impact, namely: 1) contributes to a better understanding of the process of psychological recovery after an early gestational loss; 2) contributes to the advancement of technologies aimed at psychological support; 3) has the potential to accelerate the resolution of grief by bringing emotional and psychological support to women who do not have access to other means of support; and 4) contributes to reducing the economic burden on health care by providing tools to improve the well-being of patients.

    Phase

    N/A

    Span

    127 weeks

    Sponsor

    Universidade da Madeira

    Funchal

    Recruiting

    Healthy Volunteers

  • Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and Scarring (Fibrosis) Due to an Abnormal Version of Alpha-1 Antitrypsin Protein

    Phase

    3

    Span

    317 weeks

    Sponsor

    Takeda

    Funchal

    Recruiting

  • Study to Learn About the Safety of Fazirsiran and if it Can Help People With Alpha-1 Antitrypsin Liver Disease With Mild Liver Scarring (Fibrosis)

    Phase

    3

    Span

    235 weeks

    Sponsor

    Takeda

    Funchal

    Recruiting

  • Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

    The I CAN study will enroll approximately 510 eligible participants with IgAN who are high risk of disease progression. Participants will be on stable concomitant IgAN treatment(s) consistent with standard of care for patients with IgAN for at least 3 months prior to Screening. Approximately 450 participants will be randomized in a 1:1 allocation ratio to receive a weight-based IV infusion of either ravulizumab or placebo. An interim analysis may be conducted at Week 34 to evaluate change in proteinuria and the final analysis will be conducted at Week 106 to evaluate eGFR. In addition, approximately 60 participants with eGFR 20-29 mL/min/1.73m2 will be enrolled in an Advanced Kidney Disease (AdKD) Cohort After Week 106, all participants have the option to enter an Open-label Ravulizumab Access Period.

    Phase

    3

    Span

    352 weeks

    Sponsor

    Alexion Pharmaceuticals, Inc.

    Funchal

    Recruiting

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