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NCT ID: NCT05866120 Active, not recruiting - Parkinson Disease Clinical Trials

Effects of Land and Water Physiotherapy on Motor Function in Parkinson's Disease

Start date: April 12, 2023
Phase: N/A
Study type: Interventional

Parkinson's disease patients have characteristic postural changes in upper limbs, lower limbs and trunk. The presence of kyphosis is observed as the most common postural deformity. The aim of this study is to verify the effect of dry soil therapy and shallow water therapy on muscle function in individuals with Parkinson's disease? Regarding the benefits, is there a difference between the therapies?

NCT ID: NCT05845528 Active, not recruiting - Fibromyalgia Clinical Trials

Impact of Susceptibility to Placebo on the Effect of Transcranial Direct Current Stimulation (tDCS) in Fibromyalgia

FIBROTEC
Start date: September 16, 2021
Phase: N/A
Study type: Interventional

Fibromyalgia (FM) is a syndrome characterized by generalized musculoskeletal pain, fatigue, non-restorative sleep, cognitive changes, depressive and neurovegetative symptoms. It is known that conventional pharmacological therapies produce responses with little clinical impact in more than 50% of patients. Functional alterations of the motor cortex and its connections with subcortical structures have also been demonstrated in FM. Based on the above, the objective of this research is to identify subgroups of patients with greater potential for responsiveness to treatment with a view to advancing diagnosis and treatment. In this study, the therapeutic target will be transcranial direct current stimulation (tDCS) according to the potential of responsiveness to the placebo effect, with the precise location of the stimulation area by a neuronavigation system, with the objective of counter-regulating the dysfunctional processes responsible for triggering and maintaining FM symptoms. Therefore, this clinical trial aims to compare the efficacy of anodal tDCS applied to the left dorsolateral prefrontal cortex (DLPFC) compared to simulated tDCS in FM, according to susceptibility to placebo effect and serum endorphin levels.

NCT ID: NCT05843682 Active, not recruiting - Clinical trials for Essential Hypertension

Technological Innovation in the Virtual Assistance of Patients With Uncontrolled Arterial Hypertension - Hyper 2

Hyper2
Start date: October 7, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of the use of artificial intelligence in home monitoring in patients with uncontrolled arterial hypertension.

NCT ID: NCT05812586 Active, not recruiting - COVID-19 Clinical Trials

Assessment of Immunogenicity, Safety and Reactogenicity of a Booster Dose of Various COVID-19 Vaccine Platforms in Individuals Primed With Several Regimes.

Start date: March 14, 2023
Phase: Phase 3
Study type: Interventional

SARS-CoV-2 is a highly transmissible and pathogenic coronavirus that emerged in late 2019 and has caused a pandemic of acute respiratory disease, collectively known as COVID-19. Given the relatively short duration of protection after vaccination or SARS-CoV-2 infection and the evolution of immune-evading strains, it is likely that the population will have to be repeatedly boosted until a "universal" Pan-Sarbecovirus vaccine is available. SARS-CoV-2 protein subunit vaccine candidates have shown that, despite adjuvantation, their safety/reactogenicity profile seems to be preferable over mRNA or vectored vaccines, whilst inducing non-inferior immune responses (1,2). In this regard, serious adverse events of special interest from mRNA vaccines seem to be have been substantially underestimated/underreported. In a preliminary analysis by an International consortium, the true incidence seems to be 1,250/million excess risk in vaccinees instead of the 1-2/million reported by the Department of Health and Human Services (3,4). Additionally, in a recent study, the Clover SCB-2019 protein subunit vaccine candidate has shown higher neutralizing antibodies titers against the omicron variant, when compared to an inactivated vaccine (data not published yet). Although Brazil has various vaccine platforms authorized for emergency use or licensed, such as mRNA vaccines, vector-based vaccines, inactivated vaccines, so far Brazil has no access to adjuvanted or non-adjuvanted protein-based vaccines. This study will involve two vaccines registered in Brazil and a protein-based adjuvanted vaccine candidate, SCB-2019/Clover. Protein-based adjuvanted vaccines have the advantage of being from a known and licensed technology that can produce high quantities of vaccine at reasonable Costs of Goods. Protein-based adjuvanted vaccines have also been shown to be highly immunogenic, both in the context of COVID-19 (2,5) and other licensed vaccines (6), with long persistence of immunity and protection. Over 80% of the Brazilian population above the age of 18 years have received a full primary vaccination and another 7% at least one dose of vaccine. The overall booster coverage is about 48% (64% of the adults) (7). Anvisa has authorized 1st and 2nd booster doses of various vaccines in line with the MoH policy which was last updated in March 2022. It can be speculated that, like in other geographies, a third booster will be recommended soon, especially to at risk populations and in the scenario of high circulation of the Omicron BA.5 strain. This study will explore the immunogenicity, safety and reactogenicity of a booster dose of various platforms in fully primed individuals regardless of the number of booster doses they have received prior to the enrollment in the study. This mimics the "real world scenario" at vaccination centers where individuals with different background vaccination schemes show up for "a booster". It would facilitate logistics of immunization substantially if vaccines for boosting, independent of the immunization status, could be interchangeable with respect to safety/reactogenicity and immunogenicity. This study will enroll fully-primed individuals (2 doses of either Pfizer mRNA or Oxford/AZ/Fiocruz or Sinovac/Butantan or 1 dose of Janssen vaccine) who have received their last vaccine dose at least 4 months prior to study entry and who have received either no booster, or 1 or 2 boosters. Individuals will be stratified in cohorts by number of boosters and then randomized to receive one of 3 booster vaccines (AstraZeneca/Fiocruz, Pfizer/Wyeth, SCB-2019/Clover).

NCT ID: NCT05812443 Active, not recruiting - Quality of Life Clinical Trials

Assessment of Sleep Quality and Mental Health After Using Meditation

Start date: April 10, 2023
Phase: N/A
Study type: Interventional

This is a randomized controlled trial that intends to verify the effectiveness of the daily practice of meditation before going to sleep for the improvement of sleep, stress, mental health and quality of life of people with sleep problems.

NCT ID: NCT05809934 Active, not recruiting - Clinical trials for Nonalcoholic Steatohepatitis

A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis

FORTUNA
Start date: March 15, 2023
Phase: Phase 2
Study type: Interventional

A Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis and who are carriers of the PNPLA3 148M Risk Allele

NCT ID: NCT05809531 Active, not recruiting - C3 Glomerulopathy Clinical Trials

An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

VALE
Start date: May 29, 2023
Phase: Phase 3
Study type: Interventional

This study is designed as a long-term extension to Study APL2-C3G-310, and is being conducted to establish the long-term safety and efficacy of pegcetacoplan in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN).

NCT ID: NCT05796661 Active, not recruiting - Acute Kidney Injury Clinical Trials

Patients Undergoing Continuous Venovenous Hemodiafiltration: Effects of Increased Blood Flow

Start date: January 9, 2023
Phase: N/A
Study type: Interventional

Acute Kidney Injure (AKI) is a syndrome with high incidence and prevalence in Intensive Care Units (ICU). It is estimated that 50% of the in the sector present AKI at some point and 10 to 15% require renal replacement therapy (RRT). Although studies do not show the superiority of continuous methods, the most severely ill patients are directed to this type of RRT. A disadvantage of continuous therapies is the need for anticoagulation. Critically ill patients have a pro-clotting state (inflammation) and several risk factors for bleeding (coagulopathies, postoperative, large vessel puncture). On the one hand, ineffective anticoagulation compromises the efficiency of the procedure, shortens the life of the extracorporeal system, consumes resources and increases blood loss due to unexpected and early filter clotting. There is no consensus on what would be the optimal blood flow (Qb) in continuous dialysis, especially when regional citrate anticoagulation (RCA) is used. Theoretically, a higher flow rate would prevent stasis in the system and decrease the risk of filter clotting. Studies show conflicting results. Increasing Qb from 150 to 250 mL/min showed that circuit life and the chance of coagulation were similar. On the other hand, blood flow is important for maintaining the filtration fraction (FF), the ratio of ultrafiltrate flow to plasma flow. Ideally, the FF should be kept below 25% to avoid hemoconcentration and coagulation of the filter. Therefore, the higher the convection rate, the higher the blood flow should be to keep the FF in the optimal range. Since the anticoagulation capacity of citrate is dependent on its concentration, around 4 mmol/L of blood, by increasing the blood flow, the citrate infusion is proportionally increased. Theoretically, the higher citrate load offered should be metabolized and, in theory, could cause its overload with the occurrence of metabolic alkalosis and hypernatremia. This situation occurs when its maximum metabolizing capacity is not reached and there is an excess of citrate infusion relative to the buffering requirement. Thus, we intend to evaluate filter useful life, metabolic control, electrolyte profile and acid-base balance in ICU patients undergoing continuous venovenous hemodiafiltration (CVVHDF), regional citrate anticoagulation during blood flow augmentation.

NCT ID: NCT05796024 Active, not recruiting - Clinical trials for Postoperative Complications

Derivation and Validation of the Extended Care (Ex-Care) Model II

Ex-CareII
Start date: January 2, 2019
Phase:
Study type: Observational

The goal of this study is to develop a novel surgical risk stratification tool designed to adults operated in Brazil. The main question it aims to answer is: •Is the Extended Care (Ex-Care) II model a good tool to assess the risk of death among patients operated in Brazilian hospitals within 30 days after surgery? Information of patients undergoing surgery in the participating hospitals over a period of 24 months will be analyzed to evaluate the relationship of some patients characteristics (called predictors) with the study outcome (probability of death). The sample will be divided in two groups. The first, called derivation sample, will be used for the development of the Ex-Care II model. The second, called validation sample, will evaluate the performance of this new model.

NCT ID: NCT05768854 Active, not recruiting - Clinical trials for Osteogenesis Imperfecta

Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta

Cosmic
Start date: June 14, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the effect of setrusumab vs intravenous bisphosphonates (IV-BP) on reduction in fracture rate, including morphometric vertebral fractures in pediatric participants.