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NCT ID: NCT05689632 Recruiting - Obesity Clinical Trials

Vitamins D and K Effects on Vascular Function in Obese Adults.

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

A prospective, randomized, placebo-controlled, double-blind study that aims to evaluate the effects of combined vitamin D3 and K2-MK7 supplementation on vascular function, sympathetic tone, metabolic biomarkers and inflammatory factors in a population of overweight or obese adults and deficient or insufficient serum levels of vitamin D.

NCT ID: NCT05687773 Recruiting - Parkinson Disease Clinical Trials

The Effect of Immersion in Virtual Reality on Upper Limb Functionality in Subjects With Parkinson's Disease: Randomized Clinical Trial

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

Introduction: Parkinson's Disease (PD) is characterized as a neurodegenerative disorder associated with the progressive loss of dopamine in the basal ganglia region, resulting in classic motor symptoms such as bradykinesia, rigidity, postural instability and tremor. Such symptoms end up affecting the functionality of the upper limbs (ULM) in this population. In recent years, therapy based on Virtual Reality (VR) has been gaining popularity, but studies in the area are still lacking. Objective: To verify the benefits of immersive and non-immersive virtual reality in the functionality of the upper limbs in individuals with PD, and to identify possible differences between them. Methodology: This is a randomized clinical trial, in which the evaluators will be separate from the experimental groups (single-blind). Subjects with PD will be randomized into two groups: Immersive group (IVR), which will receive treatment with virtual reality games in an immersive environment through Leap Motion Controller (LMC) devices together with image projection on a Head-mounted -display (Oculus Quest) and the non-immersive group (RVnI) in which they will receive treatment with the CML on a flat screen. Both treatments will focus on broad and fine upper limb tasks, in a protocol with 4 activities and duration of 27 minutes, twice a week, for eight weeks. The two groups will be evaluated in three moments: before the intervention, immediately after 8 weeks and 60 days after the end of the interventions. They will be analyzed in terms of ADLs, through the TEMPA test and part II of the unified assessment of PD (MDS-UPDRS II); motor assessment (part III) of the MDS-UPDRS and motor staging of PD (Hoehn & Yahr); manual dexterity through the Box and Block test and through the Nine Hole Peg Test; cognition by Montreal Cognitive Assessment (MoCA); quality of life through the PD questionnaire (PDQ-39); the usability of the system (SUS); and possible side effects (Simulator Sickness Questionnaire). This study is expected to show that treatment with immersive VR has greater positive effects than non-immersive VR on the functionality of the upper limbs of individuals with PD.

NCT ID: NCT05687266 Recruiting - NSCLC Clinical Trials

Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin for First-Line Treatment of Patients With Advanced NSCLC Without Actionable Genomic Alterations

AVANZAR
Start date: December 29, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, open-label, multicenter, global study to compare the efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).

NCT ID: NCT05686070 Not yet recruiting - Clinical trials for Acute Non-cardioembolic Ischemic Stroke

A Study to Learn More About Asundexian (Also Called BAY2433334) for Prevention of Ischemic Stroke in Male and Female Participants Aged 18 Years and Older Who Already Had Such a Stroke Due to a Blood Clot That Formed Outside the Heart and Travelled to the Brain, or Temporary Stroke-like Symptoms

OCEANIC-STROKE
Start date: February 16, 2023
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to prevent an ischemic stroke which occurs when a blood clot travelled to the brain in people who within the last 72 hours had: - a stroke due to a blood clot that formed outside the heart (acute non-cardioembolic ischemic stroke), or - temporary stroke-like symptoms with a high risk of turning into a stroke (high-risk transient ischemic attack), and who are planned to receive standard of care therapy. Ischemic strokes or transient ischemic attacks result from a blocked or reduced blood flow to a part of the brain. They are caused by blood clots that travel to the brain and block the vessels that supply it. If these blood clots form elsewhere than in the heart, the stroke is called non-cardioembolic. People who already had a non-cardioembolic stroke are more likely to have another stroke. This is why they are treated preventively with an antiplatelet therapy, the current standard of care. Antiplatelet medicines prevent platelets, components of blood clotting, from clumping together. Anticoagulants are another type of medicine that prevents blood clots from forming by interfering with a process known as coagulation (or blood clotting). The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. The way it works, it aims to further improve the standard of care with regard to the risk of bleeding. The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who recently had a non-cardioembolic ischemic stroke or temporary stroke-like symptoms when given in addition to standard antiplatelet therapy. A placebo is a treatment that looks like a medicine but does not have any medicine in it. Another aim is to compare the occurrence of major bleeding events during the study between the asundexian and the placebo group. Major bleedings have a serious or even life-threatening impact on a person's health. Dependent on the treatment group, the participants will either take asundexian or placebo as tablets once a day for at least 3 months up to 31 months. Approximately every 3 months during the treatment period, either a phone call or a visit to the study site is scheduled on an alternating basis. In addition, one visit before and up to two visits after the treatment period are planned. During the study, the study team will: - Check vital signs such as blood pressure and heart rate - Examine the participants' heart health using an electrocardiogram (ECG) - Take blood samples - Ask the participants questions about how they are feeling and what adverse events they are having. 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 they do not think the adverse events might be related to the study treatments. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study.

NCT ID: NCT05685134 Recruiting - Brugada Syndrome Clinical Trials

Invasive and Clinical Features in Patients With Brugada Syndrome Undergoing Catheter Ablation

Start date: November 3, 2020
Phase: N/A
Study type: Interventional

This clinical trial aims to learn about the electrophysiological and clinical effects of radiofrequency catheter ablation in patients with Brugada syndrome. The main questions it seeks to answer are: - What are the immediate effects of catheter radiofrequency ablation in cardiac electrophysiology? - What is the relation between invasive and clinical features in patients with Brugada syndrome undergoing ablation? Researchers will compare ablation and control groups to see if there is a difference in clinical and invasive markers of the disease in one year of follow-up.

NCT ID: NCT05685030 Recruiting - Colic Clinical Trials

Probiotics Strains for Infant Colic

Start date: January 5, 2023
Phase: Phase 2
Study type: Interventional

Interest in the use of probiotics as a potential treatment to reduce crying in babies with colic has increased lately. Recent studies have reported that the gut microbiota in infants with colic is characterized by lower proportions of Lactobacilli and Bifidobacteria and higher proportions of opportunistic proteobacteria (such as Escherichia coli, Enterobacter aerogenes and Klebsiella spp.) in comparison with the control babies. Therefore, based on data in the literature, it is understood that there is evidence of the effectiveness of using probiotics, either alone or in the form of a blend, to alleviate the symptoms of infantile colic.

NCT ID: NCT05683639 Recruiting - Infertility, Female Clinical Trials

Heated and Non Heated Ovarian Aspiration Needle Protocol

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

The success of IVF is influenced by factors as cause of infertility and age. Furthermore, there is a large influence of external factors, from the laboratory environment, handling and cultivation of gametes and embryos. The existence of factors capable of affecting the success of the treatment lead to the need of a quality control to attenuate the unfavorable effects. After ovarian stimulation, follicular aspiration is performed. At this moment, factors such as aspiration technique, needle type and temperature are the main variables to be controlled. It is known that oocytes are the more sensitive cells to temperature fluctuations. Currently, the standard protocol for follicular aspiration does not include the warming of the aspiration needle. However, due to the existing evidence in the literature, that the follicular fluid temperature drops during the aspiration procedure, this work aims to evaluate the influence of a pre warming of the aspiration needle as a new protocol.

NCT ID: NCT05683574 Not yet recruiting - Clinical trials for Third Molar Extraction

Fixed-dose Combination of Etoricoxib + Cyclobenzaprine for Pain Relief After Third Molar Extraction in Brazil

BENCOX
Start date: June 30, 2024
Phase: Phase 3
Study type: Interventional

Etoricoxib and cyclobenzaprine hydrochloride are active pharmaceutical ingredients (APIs) already registered in the country as mono-drugs. These products are widely used for the proposed indications, and their safety and efficacy profiles are known in daily clinical practice. Once the absence of a pharmacokinetic interaction between etoricoxib and cyclobenzaprine hydrochloride has been confirmed in relative bioavailability studies, this phase 3 study will be conducted for demonstrating the superiority of the new FDC over etoricoxib 90 mg (Arcoxia®) and cyclobenzaprine hydrochloride 15 mg (XL - Mitrul®) in the treatment of moderate to serious pain associated with muscle spasm. The purpose is to provide a new, effective, and safe therapeutic option to address these cases. Etoricoxib and cyclobenzaprine hydrochloride are active pharmaceutical ingredients (APIs) already registered in the country as mono-drugs. These products are widely used for the proposed indications, and their safety and efficacy profiles are known in daily clinical practice. Once the absence of a pharmacokinetic interaction between etoricoxib and cyclobenzaprine hydrochloride has been confirmed in relative bioavailability studies, this phase 3 study will be conducted for demonstrating the superiority of the new FDC over etoricoxib 90 mg (Arcoxia®) and cyclobenzaprine hydrochloride 15 mg (XL - Mitrul®) in the treatment of moderate to serious pain associated with muscle spasm. The purpose is to provide a new, effective, and safe therapeutic option to address these cases.

NCT ID: NCT05683106 Not yet recruiting - Clinical trials for Diabetic Neuropathies

Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy

Start date: March 6, 2023
Phase: N/A
Study type: Interventional

The present study aims to evaluate the efficacy and safety of the use of customized silicone digital orthoses for six months in the distribution of plantar pressure, in the reduction of pre-ulcerative lesions and plantar ulcers in the forefoot, foot deformities, quality of life and foot health and functionality in people with diabetes and neuropathy with risk category 2 and 3 for ulcers, according to the International Working Group on Diabetic Foot.

NCT ID: NCT05677529 Recruiting - Parkinson Disease Clinical Trials

Prodromal and Overt Parkinson's Disease Epidemiological Study in Brazil

PROBE-PD
Start date: April 30, 2021
Phase:
Study type: Observational

Parkinson's Disease (PD) affects people universally, including all ethnic and socioeconomic groups, as a highly prevalent neurodegenerative disorder. However, there are several additional challenges for people living with PD in developing countries, especially those with low socioeconomic status. There is limited access to neurological care in Brazil due to an uneven distribution of neurologists and neurological facilities, which is more critical in the poorest regions. In addition, people in these vulnerable communities are more exposed to environmental pollution, including pesticides and metals used in agriculture and mining, respectively. Therefore, reliable data on the prevalence and incidence of PD in Brazil are essential to understand the proportion of this limited access to care for patients with PD, its burden in the region, and the potential role of environmental and lifestyle risk factors in PD. Unfortunately, the literature describes few epidemiological data on PD in Latin America, including Brazil, with an evident need for more information in their regions remarkably different. The investigators will carry out a population-based study in four municipalities in Brazil (Veranópolis-RS, Belém-PA, Jacobina-BA and Candangolândia-DF), comprising distinct communities in terms of ethnic groups, education levels, and environmental and lifestyle exposures, to portray the differences in Brazilian society. The present study will screen all people living in these regions aged 60 and over for parkinsonian symptoms and REM sleep behavior disorder (RBD). At least one neurologist will examine those selected to determine the diagnosis of PD or related disorders. The study also will evaluate a random sample of those individuals with a negative screen. Each participant selected after the screening will undergo clinical assessments and interview with the addition of a comprehensive questionnaire on clinical and sociodemographic data, prodromal symptoms, as well as lifestyle and environmental exposures, including occupational use and non-occupational use of pesticides and metals. An equal sample of blood and hair will be collected from individuals with PD and controls. The study will determine the prevalence of PD and related disorders in these distinct communities. An exploratory analysis also will be performed to determine the association between PD and each variable investigated.