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NCT ID: NCT05117593 Completed - Clinical trials for Rheumatoid Arthritis

Investigate the Safety, Tolerability and Pharmacokinetics of FBL-MTX

FolSmart
Start date: June 28, 2021
Phase: Phase 1
Study type: Interventional

This is a prospective, single-center, randomized, double-blind, placebo-controlled, single-ascending dose (SAD) phase 1 study to evaluate the safety, tolerability and pharmacokinetics of FBL-MTX in healthy male and female subjects.

NCT ID: NCT05114395 Completed - Covid19 Clinical Trials

Comparison Between a Telerehabilitation Program for Urinary Incontinence Versus a Conventional Face-to-face Program

Start date: March 8, 2021
Phase: N/A
Study type: Interventional

Urinary incontinence (UI) is defined as any involuntary loss of urine. It affects a significant percentage of the population, mainly female, with a prevalence of 21.4% in Portuguese women, having a negative impact on quality of life and sexual function. About half presents with stress UI (SUI), followed by mixed UI (MUI), with isolated urgency UI being less common. Pelvic floor rehabilitiation is a first line treatment for SUI and MUI, however, it is not yet defined which is the best treatment program or the ideal strategies to improve adherence to it. Telerehabilitation assumed a leading role in the covid pandemic phase, although there are few studies on pelvic floor rehabilitation for UI, none in Portugal to date. The authors aim to evaluate the effectiveness of a hybrid program of pelvic floor rehabilitation in female patients with SUI and MUI with a predominance of SUI, including consultation and face-to-face sessions complemented with telerehabilitation.

NCT ID: NCT05111795 Completed - Clinical trials for Hepatocellular Carcinoma

Holmium-166 Retrospective Collection of Real-World Data

RECORD
Start date: January 17, 2022
Phase:
Study type: Observational

The primary objective of the study is to further describe the general safety and clinical performance of QuiremSpheresTM Holmium-166 Microspheres and QuiremScoutTM Holmium-166 Microspheres in a real-world post-market setting, with specific attention to outcomes per tumor origin.

NCT ID: NCT05107323 Completed - Teachers Clinical Trials

Feasibility and Effectiveness Study of a Compassionate Mind Training Program for Teachers

COMP-S
Start date: April 1, 2018
Phase: N/A
Study type: Interventional

Given the growing research on the multidimensional benefits of compassion cultivation, the current study sought to explore the feasibility and effectiveness of a Compassionate Mind Training intervention for Teachers (CMT-T) on teachers' psychological distress, wellbeing and compassion to self and others using a randomised controlled and stepped wedge design. The CMT-T specifically aimed at promoting positive affect and satisfaction with professional life and reducing symptoms of depression, anxiety, stress, and burnout, by increasing the flows of compassion (for self, for others and from others), self-compassion and compassion to others motivations and actions, and by diminishing fears of compassion (for self, for others and from others) and self-criticism. Furthermore, the present study aimed to explore the impact of the CMT-T on heart rate variability (HRV), an indicator of vagal regulatory activity and a physiological marker of a person's ability to flexibly respond to environmental challenges and regulate emotional responses. In light of previous research pointing to the role of individual differences in self-criticism on how individuals respond to compassion-based interventions, this study aimed to examine how self-criticism would influence the effects of the CMT-T intervention. Baseline self-criticism was hypothesized to impact the CMT-T effects on the primary and secondary outcome variables. In addition, the current study aimed to examine whether the effects of attending the CMT-T were sustained at 3-month post-intervention. Given that the inter-relationship between the three flows of compassion (i.e., compassion for others, being open to compassion from others, and self-compassion) is a key aspect of the CMT approach, the study sought to explore whether the associations between the flows of compassion would change from before to after the CMT-T, particularly whether these were strengthened after training. Finally, this study aimed to examine the mechanisms of change for the primary outcome variables at post-intervention. It is hypothesized that the changes occurred after the CMT-T intervention were mediated by changes in competencies for compassion for self, for others and from others, decreased levels fears of compassion for self, from others and from others, enhanced affect regulation, diminished self-criticism.

NCT ID: NCT05100849 Completed - Clinical trials for Psychiatric Disorder

Kinect-based Versus Tablet-based Cognitive Training: a Pilot Study With Psychiatric Patients

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

This study aims to analyze which cognitive training experimental condition - Tablet versus Kinect - results in greater cognitive, mood, quality of life, and functional gains in a sample of chronic psychiatric patients.

NCT ID: NCT05099640 Completed - Phenylketonuria Clinical Trials

A Study of PTC923 in Participants With Phenylketonuria

Start date: September 30, 2021
Phase: Phase 3
Study type: Interventional

The main purpose of this trial is to evaluate the efficacy of PTC923 in reducing blood phenylalanine (Phe) levels in participants with phenylketonuria as measured by mean change in blood Phe levels from baseline to Weeks 5 and 6 (that is, the average of each respective treatment dose 2-week period of double-blind treatment).

NCT ID: NCT05099159 Completed - Hot Flashes Clinical Trials

A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2)

Start date: October 29, 2021
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat women who have hot flashes after women have been through the menopause. Hot flashes are caused by the hormonal changes that happen when a woman's body has been through the menopause. Menopause is when women stop having a menstrual cycle, also called a period. During the menopause, the ovaries increasingly produce less sex hormones as a result of the natural ageing process and related hormonal adjustments. The decline in hormone production can lead to various symptoms which, in some cases, can have a very adverse effect on a menopausal woman's quality of life. The study treatment, elinzanetant, was developed to treat symptoms caused by hormonal changes. It works by blocking a protein called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. There are treatments for hot flashes in women who have been through the menopause, but may cause medical problems for some people. In this study, the researchers will learn how well elinzanetant works compared to a placebo in women who have been through the menopause and have hot flashes. A placebo looks like a treatment but does not have any medicine in it. To compare these study treatments, the doctors will ask the participants to record information about the participants' hot flashes in an electronic diary. The researchers will study the number of hot flashes the participants have and how severe the hot flashes are. The researchers will look at the results from before treatment, after 4 weeks, and after 12 weeks of treatment. The participants in this study will take two capsules of either elinzanetant or the placebo once a day. The participants who take elinzanetant will take it for 26 weeks. The participants who take the placebo will take it for 12 weeks and then take elinzanetant for the next 14 weeks. During the study, the participants will visit the site approximately 9 times and perform 1 visit by phone. Each participant will be in the study for approximately 36 weeks. The treatment duration will be 26 weeks. During the study, the participants will: - record information about the participants' hot flashes in an electronic diary - answer questions about the participants' symptoms The doctors will: - check the participants' health - take blood samples - ask the participants questions about what medicines the participants are taking and if the participants are having adverse events An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if doctors do not think the adverse events might be related to the study treatments.

NCT ID: NCT05094505 Completed - Clinical trials for Diabetes Mellitus, Type 2

Isolated and Combined Effect of a Low Carbohydrate Diet and Exercise in Hypoxia in Patients With Type 2 Diabetes

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effects of isolated chronic exercise in hypoxia and combined exercise in hypoxia with a low carbohydrate diet on hypoxia-induced transcription factor (HIF1-α); glycaemic control and cardiovascular risk factors in patients with type 2 diabetes.

NCT ID: NCT05090501 Completed - Indoor Exercise Clinical Trials

The Effects of High Intensity Circuit Training in Nature Vs. Indoor on Exercise Performance, and Wellbeing

Start date: October 15, 2022
Phase: N/A
Study type: Interventional

Exercising in a nature setting has been credited with benefits for health and well-being, more so than exercising indoors. Additionally, motoric performance in the same exercise (e.g., running speed, more strenuous physical activity) has been reported in some studies to be greater if practiced outdoors, in a nature setting. The explanation may be in the inherent variability of natural landscapes, the textures, elevations, obstacles and objects which are not found in standard built and indoor settings. Indoor settings are characterized by safe, organized, patterned textures and objects created for specific ends, which inhibit variability in physical and physiological behavior. Variability in the environment turns into variability in body systems, which benefits health, well-being, and skill acquisition. Variability in behavior depends also on the task. Running or walking is essentially a journey throughout the environment in which interaction with obstacles, puddles, and other runners is part of the variability of the activity. On the other hand, physical activity such as HICT is done in a small area, and is a scripted, prescribed activity (e.g., push-ups, sit-ups), which lowers the amount of variability in behavior. The aim of this trial is to test if a low variability activity shows differences in performance, wellbeing, and behavior measures according to the amount of variability in the environment. In this trial the participants will engage in two high intensity circuit training (HICT) interventions - one in an indoor setting, and another in a nature setting. The HICT intervention includes 12 calisthenic exercises, and will be performed at a self-selected intensity by the participants. Each exercise will be performed during one minute, followed by 30 seconds of rest where the participants will be instructed what the next exercise will be. Before exercising, the participants put a heart rate monitor and two inertial measurement units (IMUs) on the right arm and leg, according to the correct usage guidelines, and rate their positive affect, arousal, and perceived exertion. Immediately after exercising, they rate the same measures again. Research Hypotheses: Greater movement variability, heart rate variability, performance, wellbeing, and arousal during HICT in nature setting than indoor setting.

NCT ID: NCT05090072 Completed - End-of-life Clinical Trials

Advanced Directives in Palliative Care (DAVPAL)

DAVPAL
Start date: September 10, 2018
Phase: N/A
Study type: Interventional

A prospective, single-blinded, controlled, and randomized trial to find if physician's use of the Portuguese Advance Directives, in palliative care, as a communication tool between patients and caregivers, improves the agreement and reliability between patients and their health surrogates, in their decisions about end-of-life care.