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NCT ID: NCT05317117 Recruiting - Malaria Clinical Trials

Evaluating the Clinical Performance and Usability of Novel Malaria RDTs in Brazil

Start date: July 4, 2022
Phase: N/A
Study type: Interventional

Prospective cross-sectional diagnostic accuracy study with 1,000 patient participants and 30 lay provider/health care worker participants. The patient participant population will be recruited at clinics. At the point of care, study staff will collect capillary blood samples and conduct malaria microscopy (both the standard of care and study specific research-grade microscopy) and two index tests: the NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and the NxTek™ Malaria P.f/P.v RDT. Venous blood will be collected and transferred to the laboratory where the reference PCR assay and three comparator RDTs will be run. The index RDTs will also be repeated in the laboratory. All clinical management of study participants will follow the standard of care for malaria diagnosis in Brazil and will be based on the standard microscopy result. Confirmatory testing may also be conducted, such as typing and sequencing of Plasmodium genes and antigens of interest, including but not limited to HRP2, HRP3, and pLDH as well as the human inflammatory response marker CRP. The lay provider/health worker participants will include intended users of the index tests. They will be surveyed to assess index test usability through a questionnaire to assess label and packaging comprehension as well as results interpretation.

NCT ID: NCT05315154 Recruiting - Breast Cancer Clinical Trials

Sentinel Lymph Node Biopsy Versus no Axillary Surgery in Early Breast Cancer

VENUS
Start date: October 2, 2019
Phase: N/A
Study type: Interventional

The VENUS trial is a prospective, multicenter, noninferiority, randomized, controlled clinical trial that compares sentinel lymph node biopsy versus no axillary surgery in women with early breast cancer (tumor <5cm) and node-negative after clinical palpation and axillary ultrasound.

NCT ID: NCT05312879 Recruiting - Clinical trials for Proteinuric Kidney Disease

Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Proteinuric Kidney Disease

AMPLITUDE
Start date: March 30, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease.

NCT ID: NCT05312736 Recruiting - Gyrate Atrophy Clinical Trials

Gyrate Atrophy Ocular and Systemic Study

GYROS
Start date: November 21, 2023
Phase:
Study type: Observational

The Gyrate Atrophy Ocular and Systemic Study characterizes the natural history of ornithine levels and retinal degeneration (RD) associated with disease-causing OAT variants in the presence of standard care dietary treatment regimens over 4 years. The research goal is to understand the impact of OAT mutations on plasma ornithine levels and retinal degeneration.

NCT ID: NCT05311410 Recruiting - SARS-CoV2 Infection Clinical Trials

Viral Kinetics of SARS-CoV-2 in Patients With COVID-19 in the Intensive Care Unit Undergoing Dental Procedures

VKSPCICUDP
Start date: September 20, 2021
Phase: N/A
Study type: Interventional

The prevalence and clinical relevance of viremia in patients with COVID-19 have not been well investigated. Seeking to understand the need for dentistry to perform bloody procedures in critically ill patients with COVID-19 admitted to the ICU, the quantification of the magnitude of viral replication may play a fundamental role in this scenario. For this, it is necessary to study the viremia kinetics of SARS-CoV-2, seeking to assess whether there is any characteristic pattern that may be associated with a worse clinical outcome of the patient with COVID-19 after undergoing bloody dental procedures, therefore, the objective of this research will be to investigate the occurrence of viral kinetics produced by dental procedures in patients with SARS-CoV-2 in Intensive Care Units, where, in addition to analyzing the oral health condition, the viral kinetics of SARS-CoV-2 will also be investigated by means of reverse transcription polymerase chain reaction (RT-PCR) examination of blood samples from patients with COVID-19 undergoing bloody dental treatment. This research is expected to identify risks and consequences regarding the possibility of performing bloody dental treatment in patients with COVID-19 in serious condition, in addition to verifying the association of the impact of oral infection foci on this profile of patients.

NCT ID: NCT05310019 Recruiting - Edema Clinical Trials

Effect of Electroacupuncture in Patients Submitted Orthognathic Surgery and Mentoplasty

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

Goals. To evaluate the effect of electroacupuncture on paresthesia and myofunctional changes in patients undergoing bimaxillary orthognathic surgery and mentoplasty. Methodology: this is a controlled, randomized, blinded clinical trial. The sample will consist of 62 individuals in each group (general sample = 124 participants). Therefore, 124 young adults, aged between 18 and 50 years, both sexes, with at least 24 teeth, with Class II or III skeletal malocclusion, diagnosed by cephalometric radiographs, who underwent orthognathic surgery in the period from 1 to 30 days before the start of physical therapy, be available to perform the proposed postoperative treatment for six weeks. Participants will be equally and randomly distributed into two experimental groups: GF (Physiotherapy Group), GFE (Physiotherapy plus Electroacupuncture Group). The variables to be studied will be: socioepidemiological data; sensitivity assessment by the Semmes-Weinstein monofilament test; Edema assessment by the MD Anderson Cancer Center Head and Neck Lymphedema protocol, validated in Portuguese; assessment of mandibular movements using a Western-DC digital caliper; Assessment of masticatory function using the Chewing Quality Assessment Questionnaire. Data will be analyzed descriptively and organized into tables. Subsequently, the normality of continuous variables will be tested by the Kolmogorov-Smirnov test. As the variables are normally distributed, we will use parametric tests such as the paired t test, independent t test, ANOVA and Pearson's correlation. Nonparametric tests such as Wilcoxon paired signed rank test, Mann-Whitney U test, Kruskal Wallis test, Spearman correlation test will be used in case of non-normality of continuous variables. The significance level will be adjusted to 5% in all analyses.

NCT ID: NCT05309278 Recruiting - Aging Clinical Trials

Remote Physical and Cognitive Training Effects in Older Adults at Increased Risk of Clinical-functional Vulnerability

Start date: July 26, 2022
Phase: N/A
Study type: Interventional

This study is a randomized, single-blind, parallel, controlled, superiority trial. The main objective is to verify the chronic effects of a remote 12-week low-intensity physical training program alone or in combination with cognitive training on functional, cognitive, and occupational capacity, as well as on the self-reported quality of life.

NCT ID: NCT05308732 Recruiting - Clinical trials for Head and Neck Neoplasms

Safety and Tolerability of the Use of Copaiba in Patients With Oral Cancer Submitted to Radiotherapy

Start date: May 11, 2021
Phase: Phase 1
Study type: Interventional

This study aims to propose an alternative and auxiliary methodology for the prevention and treatment of Oral Mucositis (OM) in patients undergoing radiotherapy or radio and chemotherapy for head and neck neoplasms through the use of copaiba-based mouthwash, since the treatment that currently has proven efficacy for the prevention of OM(Low Power Laser Therapy) cannot be applied in tumor regions due to the risk of stimulating the tissue proliferation of malignant cells.

NCT ID: NCT05306600 Recruiting - Breast Cancer Clinical Trials

Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System

Start date: November 9, 2022
Phase:
Study type: Observational

This project aims to perform complete sequencing of the somatic (tumor) and germline exomes during clinical investigation of cancer patients treated through the Brazilian Unified Health System to generate genomic and phenotypic data for the Brazilian Ministry of Health's National Precision Genomics and Health Program, called Genomas Brasil, as well as to collect data on the population's ancestry.

NCT ID: NCT05306171 Recruiting - Burnout Clinical Trials

Online Training for Healthcare Professionals: a Possible Strategy for Prevention of Burnout

Start date: March 10, 2022
Phase: N/A
Study type: Interventional

This study aims to evaluate the effects of online training on self-esteem and occupational stress of healthcare professionals, in order to evaluate the potential of this intervention as a preventive measure to Burnout syndrome. The study will be developed in three phases,the first being the period of one week before the intervention(t0), when instruments will be first applied.The second phase corresponds to intervention period, when the instruments will be reapplied after the second (t1), third (t2) and fourth (t3) training intervention. The third phase corresponds to the follow up (t4-t8), when all instruments used in the second phase will be reapplied in 2 months (t4), 4 months (t5), 6 months (t6), 8 months (t7) and 12 months (t8) after the end of the intervention. The sample will consist of 100 health professionals randomized into two groups (50 in each group): intervention group (I), formed by those who will participate in the online training and control group (C), formed by those who will receive the intervention after research is finished. The hypotheses are: the online training will have greater effect on the increase of self-esteem, and will be identified in health professionals: low levels of global self-esteem, high levels of occupational stress and average levels of burnout.