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NCT ID: NCT06215027 Not yet recruiting - Breast Cancer Clinical Trials

The Effects of Dance for Breast Cancer Patients Undergoing Surgical Treatment

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

The goal of this non randomized clinical trial, with pre- and post-intervention evaluation, longitudinal, with prospective data collection is to evaluate the effects of dance as a therapeutic intervention in breast cancer patients undergoing surgical treatment.

NCT ID: NCT06214637 Recruiting - Children Clinical Trials

Effectiveness of Melissa Officinalis for the Treatment of Probable Sleep Bruxism in Children and Adolescents

Start date: August 1, 2023
Phase: Phase 1
Study type: Interventional

Objective: To investigate, through a controlled and randomized clinical trial, the effectiveness of using Melissa officinalis in different concentrations in the treatment of children and adolescents with probable sleep bruxism. Methodology: This is a randomized, triple-blind, crossover, and placebo-controlled clinical trial. The research participants will be children aged 5 to 10 years old and adolescents aged 11 to 16 years old who attend dental treatment at the FO/UFRJ Pediatric Dentistry Clinics. After approval by the Human Research Ethics Committee, children and adolescents will undergo homeopathic treatment with Melissa officinalis in different concentrations for possible sleep bruxism. In addition, research participants will undergo an assessment of TMJ, sleep, circadian cycle, quality of life, and quality of life related to oral health. The data will be tabulated and analyzed according to sex, age group, presence of possible sleep bruxism, presence or absence of TMD, circadian characteristics, presence or absence of sleep disorders, daytime and nighttime behavioral characteristics. The data will be tabulated and evaluated using SPSS 21.0. Absolute and relative frequency, odds ratio, correlation analysis and other relevant analyzes and statistical tests (p<0.05) will be carried out in accordance with the objectives proposed by the study

NCT ID: NCT06214442 Recruiting - Menstrual Cycle Clinical Trials

Effects of the Menstrual Cycle on Triceps Surae Properties in Women

Start date: November 10, 2023
Phase:
Study type: Observational

The menstrual cycle is an important biological rhythm, whereby large cyclic fluctuations in endogenous sex hormones, such as estrogen and progesterone, are observed, which can affect performance. Evidence shows that endogenous and exogenous changes in hormone concentrations during the menstrual cycle exert many effects on the nervous and endocrine systems, in addition to the connective tissue, with consequences for the movement system. Pre-clinical studies (i.e., in animal models) show an estrogen association with the structural and mechanical properties of tendons and ligaments. Several elegant studies performed with female participants have tried to establish the mechanism underlying the effect of estrogen on collagen synthesis and its effects on exercise and functionality. Their findings suggest that the tendon properties may be affected when exposed to varying concentrations of estrogen. The largest tendon in humans, the Achilles tendon, has a direct role in functional capacity, activities of daily living, and locomotion. Studies show that the triceps surae's structural and mechanical properties may change throughout the menstrual cycle, and that these changes are related to endogenous and exogenous fluctuations in estrogen and progesterone. Musculotendinous stiffness, which is dependent on the collagen content, has been seen to vary considerably over the course of the menstrual cycle. In addition, it has been reported that females who have been taking the contraceptive pill for at least a year demonstrate lower levels of tendon strain compared to non-pill taking females, indicating a possible influence of hormonal state on tendon mechanical properties. However, the different experimental designs, the varied approaches to the evaluations and the lack of studies with high methodological quality limit our understanding of the effects of the different phases of the menstrual cycle on the triceps surae's neuromechanical properties. The aim of this observational study will be to investigate whether the morphological, mechanical (active and passive), material, and functional properties of the plantar flexor muscles and of the Achilles tendon, as well as functional parameters, change during voluntary contractions throughout the phases of the menstrual cycle in eumenorrheic women and in users of hormonal contraception. Understanding the acute effects of these properties in eumenorrheic women and users of hormonal contraception is essential so that we can adequately plan interventions and prescriptions of physical exercise and rehabilitation aimed for women.

NCT ID: NCT06214429 Recruiting - Clinical trials for Carotid Atherosclerosis

Shear Wave Elastography for Carotid Atherosclerotic Plaques

Start date: March 1, 2023
Phase:
Study type: Observational

The goal of this prospective diagnostic accuracy cohort study is to compare the accuracy of carotid atherosclerotic plaques stiffness assessed by shear wave elastography (SWE) with greyscale median values (GSM), magnetic resonance imaging (MRI) and histopathological findings in patients with carotid atherosclerotic plaques causing stenosis above 50%, symptomatic or not. The main question it aims to answer is: is the plaque stiffness correlatable with GSM values, MRI findings or histopathological findings? Participants will be subjected to a vascular ultrasound study in which the SWE and GSM will be assessed. The second imaging modality for stenosis confirmation will be MRI and patients with confirmed symptomatic stenosis above 50% or assymptomatic stenosis above 70% will be considered for surgery intervention (endarterectomy or angioplasty). Patients that undergo endarterectomy will have the carotid plaques subjected to a histopathological study. The study will not arbitrate about the treatment decision.

NCT ID: NCT06213649 Not yet recruiting - Clinical trials for Acanthamoeba Keratitis

Parasitic Ulcer Treatment Trial

PUTT
Start date: April 2024
Phase: Phase 3
Study type: Interventional

The Parasitic Ulcer Treatment Trial (PUTT) is a multi-center, parallel-group, randomized clinical trial. The purpose of this study is to determine whether including topical corticosteroids in a regimen for acanthamoeba keratitis (AK) will improve vision. Patients presenting to all enrollment centers with evidence of acanthamoeba keratitis will be eligible for the trial if there is evidence of ocular inflammation after 4 weeks of anti-amoebic therapy. Those who agree to participate will be randomized to one of two treatment groups: - Group 1: Topical corticosteroid - Group 2: Topical placebo

NCT ID: NCT06212947 Recruiting - Hypochondroplasia Clinical Trials

A Multicenter Multinational Observational Study of Children With Hypochondroplasia

Start date: November 27, 2023
Phase:
Study type: Observational

This study will assess growth over time and the clinical course of HCH in children by collecting growth measurements and other variables of interest.

NCT ID: NCT06211764 Recruiting - Clinical trials for Non-Muscle Invasive Bladder Neoplasms

A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)

SunRISe-5
Start date: April 9, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of single agent intravesical chemotherapy.

NCT ID: NCT06208150 Recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide

MonumenTAL-6
Start date: January 22, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).

NCT ID: NCT06204627 Recruiting - Chronic Pain Clinical Trials

TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain

TDCS
Start date: September 30, 2023
Phase: N/A
Study type: Interventional

Chronic neck pain leads to decreased quality of life and absenteeism at work, generating great personal and socio-economic impact. It has been shown that patients with chronic pain have late recognition of the laterality of the hand, which is related to the duration of symptoms and pain evoked by the execution of the movement. These findings suggest that chronic pain and the consequent disuse of certain motor functions may involve a reorganization of the cortical representation of the body scheme or motor planning. Non-invasive neuromodulation, such as transcranial direct current stimulation (TDCS), allows modulating cortical excitability and promoting pain relief. This study intends to verify the effects of the association of noninvasive brain stimulation with TDCS with an intervention with visual and motor stimuli related to laterality in patients with neck pain.

NCT ID: NCT06203925 Not yet recruiting - Hepatitis C Clinical Trials

Hepatitis C Virus Self-testing (HCVST) in Sexual and Gender Minorities in Rio de Janeiro

Start date: January 8, 2024
Phase:
Study type: Observational

Sexual and gender minorities (SGM), such as gay, bisexual and other men who have sex with men (MSM) and transgender women (TGW), are at high risk of HCV infection. A recently released guideline by the WHO recommended HCVST to scale-up HCV screening. However, data on delivery-services of HCVST kits and uptake of HCV testing using HCVST remain scarce in Latin American countries. Additionally, data on the usability of HCVST in MSM/TGW, especially blood-based tests, still lacking in Brazil. To evaluate the uptake of HCV testing by the strategy of using HCVST ordered by the internet and delivery by the post in key populations (SGM) living in the metropolitan region of Rio de Janeiro (Brazil). Additionally, an Ancillary study will assess the usability of different kits of HCVST in MSM/TGW using PrEP. Study Design and Population: This protocol will be composed of two studies that will be conducted in parallel. The primary study will be a cohort study in which SGM ≥ 18 years old living in the metropolitan area of Rio de Janeiro who request HCVST will be included. The Ancillary study will be a cross-sectional study where adult MSM or TGW attending a presential visit for PrEP (initiation or follow-up) at INI/FIOCRUZ will be eligible for this study. The investigators estimate that 3,000 persons will request home-delivery of HCVST (Primary study) and 250 participants will be included in the Ancillary study.Study Design and Population: This protocol will be composed of two studies that will be conducted in parallel. The primary study will be a cohort study in which SGM ≥ 18 years old living in the metropolitan area of Rio de Janeiro who request HCVST will be included. The Ancillary study will be a cross-sectional study where adult MSM or TGW attending a presential visit for PrEP (initiation or follow-up) at INI/FIOCRUZ will be eligible for this study. The investigators estimate that 3,000 persons will request home-delivery of HCVST (Primary study) and 250 participants will be included in the Ancillary study. Methods: For the Primary Study, a web-based platform will be built for this project and an educational campaign will be developed in dating apps to encourage HCV testing. The web platform will contain modules with information on HCV infection and a log-in to request HCV self-tests that can be delivered by the post or collected in the centralized pharmacy for HCV testing. People will be encouraged to report their HCVST results in the online platform. People with positive HCV antibody will be linked-to-care for HCV infection confirmation and treatment initiation. For the Ancillary Study, MSM/TGW attending presential visits for PrEP at INI/FIOCRUZ will be invited to perform HCVST (blood-based and oral fluid tests) under supervision of a trained healthcare worker. Participants will read written instructions and watch a video explaining the procedures step-by-step for HCVST. A second HCV test using the same kit will be performed by the healthcare worker for concordance analysis. People with positive HCV antibodies will be linked to HCV infection confirmation and treatment initiation. Data analysis: Descriptive statistical analysis will be used to evaluate the characteristics of people seeking HCVST, participant's preferences, uptake of HCV testing using self-test kits and internet technologies, as well as acceptability, usability and result interpretation of HCVST in a sub-sample of participants. Ethical considerations: Locally, ethics approval will be obtained from the INI/FIOCRUZ. International ethics clearance will be obtained from the World Health Organization Ethics Review Committee (WHO ERC). All participants will be informed of risks and benefits of the procedures and that their participation is voluntary. All participants will be required to sign the informed consent (an online agreement for Primary Study) as required by Brazilian regulations to participate in research studies. All data collected will respect The Brazilian General Data Protection Law (Law nº 13.709/2018).