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NCT ID: NCT05352815 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec

COMBINE 1
Start date: June 1, 2022
Phase: Phase 3
Study type: Interventional

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin icodec taken once a week in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to insulin icodec. Participants will either get IcoSema or insulin icodec. Which treatment participants get is decided by chance. IcoSema and insulin icodec are both new medicines that doctors cannot prescribe. Participants will get IcoSema or insulin icodec, which participants must inject once a week with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will have 21 clinic visits, 31 phone/video calls with the study doctor, and 4 contacts with the site that can either be clinic visits or phone/video calls At 11 clinic visits participants will have blood samples taken. At 7 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. Not applicable for China: Participants will be asked to wear a sensor that measures their blood sugar level all the time during a 5 week period at the end of the study.

NCT ID: NCT05336513 Completed - Clinical trials for Rheumatoid Arthritis

The Effect of an Anti-inflammatory Diet in Patients With Rheumatoid Arthritis

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

Rheumatoid arthritis (RA) is an autoimmune disease that affects 0.5-1% of the population and in which his remission is not always achieved, affecting physical and mental well-being and quality of life (QL). As a complement to pharmacotherapy, dietary intervention should be evaluated as a treatment option. The main objective of this parallel controlled randomized clinical trial is to check the effect of an anti-inflammatory dietary intervention, compared to a diet based on the principles of the Mediterranean diet (control), on disease activity (AD) and improving QL. Patients will be instructed to follow an anti-inflammatory diet (DAI) or a control diet (DC) for 6 months. The AD and QL will be evaluated at the end of the intervention. As there are no dietary guidelines for RA, this study aims to provide scientific evidence about the impact of diet therapy on reducing AD and improving QL.

NCT ID: NCT05336448 Completed - Critical Illness Clinical Trials

POCUS AI in Critically Ill Patients

PocusAI-Crit
Start date: July 27, 2021
Phase:
Study type: Observational [Patient Registry]

This is a prospective study that aims to assess the differences in point-of-care ultrasound assessment (POCUS) with portable and ultra-portable devices, using conventional vs artificial intelligence (AI) methodologies, performed by experienced vs inexperienced physicians, in critically ill patients.

NCT ID: NCT05335642 Completed - Clinical trials for Abdominal Aortic Aneurysm Without Rupture

Secondary Intervention and Surveillance After EVAR

Start date: June 1, 2021
Phase:
Study type: Observational

This is a retrospective cohort study of consecutive patients submitted to elective EVAR, between February/2009 and May/2019 in a single institution. Symptomatic or ruptured AAA, mycotic aneurysms, isolated iliac aneurysms and complex abdominal aortic repairs were excluded. The primary outcomes were freedom from secondary intervention and compliance with follow-up, defined as surveillance imaging performed within a periodicity no longer than 18 months.

NCT ID: NCT05334082 Completed - Balance Clinical Trials

Effects of the FIFA 11+ on Physical Performance and Injury Prevention in Female Futsal Players

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

The FIFA 11 + is an injury prevention that has shown to improve physical performance and prevent injuries in male futsal players, however, this injury prevention program has not been tested in female futsal players. The investigators aim to test the effects of the FIFA 11 + program on physical performance and injury prevention in female futsal players.

NCT ID: NCT05321680 Completed - Dementia Clinical Trials

Withdrawal of Antidementia Drugs in Advanced Dementia (WADAD)

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

Dementia is a chronic progressive mental disorder that adversely affects higher cortical functions, including cognition and behavior leading up to disability and dependence in daily life activities. It has become a major public health concern because of its increasing prevalence, chronicity, burden for caregivers, and the high personal and financial costs needed for care. Alzheimer disease (AD) is the most prevalent form of dementia, occurring in 5% to 7% of individuals older than 60. In Portugal, Santana et al study estimated that 160 287 people above 60 years had a diagnosis of dementia in 2013 (prevalence of 5,9%).The increasing national and international prevalence of dementia and its associated burden then imparts a high priority on delivering safe and effective treatment options. Currently approved treatments available for the symptomatic management of mild to moderate AD include cholinesterase inhibitors (ChEIs) (donepezil, rivastigmine, and galantamine) and a N-methyl- D-aspartate receptor antagonist (memantine). These drugs are also given off-label for other types of dementia (vascular and mixed dementias), with treatment continuing through advanced disease stages. Given that ChEIs have demonstrated short-term modest stabilization on measures of cognition and global functioning in randomized controlled trials (RCTs), several practice guidelines have proposed ChEIs for the treatment of all stages of AD, with some advocating ChEI discontinuation if tolerability issues arise, or if there is no longer a noticeable clinical benefit. Further studies in this setting are important as patients with severe dementia are more functionally impaired, present with comorbid illnesses, posing a higher risk of polypharmacy. In addition, ChEIs have a potential risk of adverse events including nausea, diarrhea, insomnia, vomiting, muscle cramping, fatigue, and weight loss. Less commonly, ChEI might be associated with rhabdomyolysis, convulsions, falls, syncope, pneumonia and death. Because cognitive and behavioral impairments change during the progressive disease course, the effects of medications may be unpredictable, especially over long durations of treatment. It might be challenging to weigh minimally beneficial effects against predicted harms of continued treatment, considering both patient and caregiver-centered care goals besides less clinically relevant cognitive outcomes. Only a small number of discontinuation RCTs were conducted to date but involved relatively few participants with heterogeneous designs, disease severities and outcomes. As so, clinicians take individualized discontinuation decisions and the only consensual domains are a lack of response and a loss of effectiveness. The present pragmatic clinical trial will compare the efficacy of maintaining pharmacological treatment versus treatment cessation on cognition, behavior, functional disability and quality of life of patients and caregivers, among patients with severe dementia due to AD, with or without small vessel subcortical vascular disease. The investigators will consider other important endpoints besides cognitive functioning including mood, apathy, energy and neuropsychiatric symptoms. Moreover, this trial will try to look for outcomes that engage patients and families in treatment decisions.

NCT ID: NCT05316766 Completed - Stroke Clinical Trials

Multi-user Touch Surfaces for Promoting Social Participation and Self-efficacy in Upper-limb Stroke Rehabilitation

Start date: March 29, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the efficacy of conventional therapy with a framework intervention for upper limb motor rehabilitation based on the promotion of self-efficacy and social participation/interaction through a multi-user touch surface

NCT ID: NCT05313971 Completed - Clinical trials for Stress, Psychological

Impact of Self-awareness in Medical Students

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

Objectives: The goal of this study is to understand whether self-knowledge, using the Enneagram, has a long-term impact as a modifying factor of the quality of life, self-compassion and compassion of medical students. Methods: An initial sample of 48 medical students answered, before, immediately after and 9 months after an intervention, an online questionnaire with 6 scales. The intervention group took a self-knowledge and communication course based on the Enneagram. The control group was recruited by matching the sociodemographic variables with the intervention group. The data obtained was subject to descriptive and inferential statistical analysis and qualitative content analysis.

NCT ID: NCT05295511 Completed - Healthy Aging Clinical Trials

Effects of a Recreational Team Handball-based Programme on Health and Physical Fitness of Middle-aged and Older Men

(H4HM)
Start date: December 1, 2017
Phase: N/A
Study type: Interventional

The present study aims at analyzing the dose-response effects of a recreational team handball-based exercise programme on cardiovascular, metabolic, musculoskeletal and physical fitness markers of inactive middle-aged and older men, without previous experience with the sport. The researchers hypothesized a positive weekly training frequency effect on health and physical fitness outcomes.

NCT ID: NCT05292261 Completed - Menopause Clinical Trials

Effects of a Recreational Team Handball-based Programme on Health and Physical Fitness of Postmenopausal Women

H4HW
Start date: January 2, 2016
Phase: N/A
Study type: Interventional

This study aimed at determining the short- (16 weeks) and long-term (36 weeks) health and physical fitness effects and adherence of recreational team handball training for postmenopausal women without previous experience with the sport. The investigators hypothesized that short-term recreational team handball training would result in positive health and physical fitness adaptations and that the health and physical fitness improvements achieved after the first 16 weeks would be maintained or further improved at the long-term. Moreover, the investigators also hypothesized that the adherence to this exercise mode would be maintained throughout the 36 weeks (long-term) compared to the first 16 weeks (short-term).