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NCT ID: NCT05099640 Completed - Phenylketonuria Clinical Trials

A Study of PTC923 in Participants With Phenylketonuria

Start date: September 30, 2021
Phase: Phase 3
Study type: Interventional

The main purpose of this trial is to evaluate the efficacy of PTC923 in reducing blood phenylalanine (Phe) levels in participants with phenylketonuria as measured by mean change in blood Phe levels from baseline to Weeks 5 and 6 (that is, the average of each respective treatment dose 2-week period of double-blind treatment).

NCT ID: NCT05096936 Completed - Clinical trials for Urinary Incontinence,Stress

Pilates Method and/or Photobiomodulation in Women With Stress Urinary Incontinence

PBMT-IUE
Start date: October 14, 2021
Phase: N/A
Study type: Interventional

The present study is a clinical intervention applied to patients with urinary incontinence, with the intention of verifying the effects of the Pilates method associated or not with photobiomodulation with static magnetic field. The sample will consist of women with stress urinary incontinence from Bento Gonçalves attended at the school clinic of Faculdade Cenecista de Bento Gonçalves.

NCT ID: NCT05085847 Completed - Stress Clinical Trials

Effects of Mindfulness-based Intervention on Epigenetic Mechanisms, Cognition Function, Stress Response, and Well-being

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effect of a mindfulness-based intervention on DNAmethylation, cognitive functions, stress response, and well-being in healthy female adults.

NCT ID: NCT05083949 Completed - Healthy Clinical Trials

A Study in Healthy Humans to Assess the Relative Bioavailability of One Fixed-dose Combination Tablet Empagliflozin/Metformin Versus Jardiance® Tablet and Glifage® Tablet Administered Together

InPedILD®
Start date: July 23, 2021
Phase: Phase 1
Study type: Interventional

This trial is to establish bioequivalence of the fixed dose combination (FDC) tablets (containing 12.5 mg empagliflozin/850 mg metformin) (Test, T) compared with the single tablets (10 mg empagliflozin and Glifage® 850 mg tablets) (Reference, R).

NCT ID: NCT05083052 Completed - Dentin Sensitivity Clinical Trials

Propolis in Reducing Dentin Hypersensitivity

Start date: November 5, 2020
Phase: N/A
Study type: Interventional

Objective: This randomized, double-blind, parallel, placebo-controlled clinical trial aims to evaluate the effect of propolis with two distinct concentrations (10% and 15%), and the impact on volunteers' quality of life. Materials and methods: Volunteers meeting the inclusion and exclusion criteria will be randomized and allocated into three groups: Group 1- placebo - toothpaste without active ingredient, Group 2- toothpaste with 10% propolis and Group 3. - toothpaste with 15% propolis. Number of teeth will be used as sample unit, totaling 22 teeth per group. Volunteers will receive oral hygiene instruction with guidance to brush their teeth three times a day with toothpaste corresponding to the groups in which they will be allocated for 30 days. The evaluation of dentin hypersensitivity will be performed with three (3) evaluation times: baseline (immediately before the beginning of treatment), 15 and 30 days, through tactile and evaporative stimuli, using the visual analog scale (VAS). The self-reported evaluation of the volunteers will be done through a questionnaire before the beginning and after one month with the completion of the research to determine the impact of treatment on their quality of life. The data regarding HD in VAS, if present normal distribution, will be used Two-way analysis of variance (ANOVA) with Tukey's post hoc for comparison between treatments. However, if the data show anormal distribution, Friedman to compare the different times in the same group (intra group), and Kruskal Wallis to make the comparison between groups (inter group). To evaluate the QEHD ordinal data, Wilcoxon and Mann-Whitney tests will be used. Bioestat 5.3 (Belém, Pará, Brazil) will be used, considering an alpha level of 5%.

NCT ID: NCT05081674 Completed - Lung Neoplasm Clinical Trials

Brazilian Lung Immunotherapy Study

BLISS
Start date: January 1, 2020
Phase: Phase 2
Study type: Interventional

Immunotherapy with anti-PD-1/PD-L1 agents either as single agents or combined with chemotherapy is now considered the standard of care for patients with non-small-cell lung cancer. However, it has not been incorporated in the Brazilian Public Health System because of concerns about patient eligibility, safety and costs. It is known that simple biomarkers can be used to select patients for immunotherapy, such as EGRF, ALK and PD-L1 status in the tumors. We created a treatment protocol based on these 3 markers and treated 154 patients with non-small-cell-lung cancer in a Public Hospital in Brazil. The goal of this project is to identify the prevalence of these markers in the Brazilian population (to estimate patient eligibility), outcomes and costs of therapy.

NCT ID: NCT05081414 Completed - Heart Failure Clinical Trials

Efficacy of the PEAC-IC: a Randomized Controlled Clinical Trial

PEAC-IC
Start date: October 26, 2021
Phase: N/A
Study type: Interventional

A randomized parallel single-center clinical trial, blinded for the evaluation of the outcomes and statistical analysis. The current hypothesis is that PEAC-IC will improve self-care behavior, knowledge about heart failure, health-related quality of life, and the number of hospitalizations and searches for emergency services in the participants with heart failure.

NCT ID: NCT05081076 Completed - Peri-Implantitis Clinical Trials

Health of Peri-implant Tissues Adjacent to Zirconia

Start date: August 15, 2021
Phase: N/A
Study type: Interventional

Background: The control and maintenance of implants, bone tissue and soft tissue are fundamental for the clinical success of implant prostheses (PSIs). The type of ceramic surface finish can modify the biological response of peri-implant tissues adjacent to PSIs over time. Objective: To prospectively assess whether the peri-implant health of soft and hard tissues adjacent to monolithic zirconia PSIs varies with the type of surface finish (glazed or polished). It will also be evaluated if the patient perceives any clinical, comfort or satisfaction difference. Methodology: The study design is a randomized, prospective, paired clinical trial, with intra-subject comparison. The sample will consist of consecutive patients in need and indication for treatment with monolithic zirconia PSIs, attended at the Military Policlinic of Porto Alegre and in a private practice by a single specialist researcher. For each PSI, the allocation of a glazed or polished surface in contact with the soft gingival tissue will be randomized on the mesial and distal sides of the crown. Data will be collected by routine clinical and radiographic examination with a focus on peri-implant health (hygiene index, gingival bleeding index, crestal bone level), satisfaction questionnaire and intraoral images (thermography and photographs), after one week of installation of the PSI and in six months, one year and two years. The data will be analyzed by descriptive and inferential statistics, at the significance level of 0.05.

NCT ID: NCT05081050 Completed - Quality of Life Clinical Trials

Short Implants Supporting Single Crowns in the Posterior Region

Start date: September 20, 2021
Phase:
Study type: Observational

The aim of the present project is to evaluate functional, biological and technical variables, as well as quality of life and satisfaction as indicators of long-term clinical performance of single prostheses on short implants in the posterior region with a 10-year prospective follow-up. This proposal refers to a clinical research project with a 10-year follow-up of single crowns on short implants (6 mm) in the posterior region of the maxilla and mandible. The cohort has started in 2010 through a project funded by the International Team for Implantology. The main clinical results with a 4-year follow-up showed the influence of biomechanical factors (implant/crown ratio) on short-term treatment success and increased risk over time. The sample will consist of participants from the cohort of the research project established in 2010, who received a single crown on a short implant (6-mm Standard Plus Wide Neck SLA) in the posterior region of the maxilla or mandible according to eligibility criteria and standardized clinical procedures. Data will be collected by clinical and image exams, questionnaires (for sleep bruxism, satisfaction and quality of life), recording of maximum occlusal force, measurement of perimplant bone changes, and calculation of the clinical crown-implant ratio. Data will be analyzed by descriptive and inferential statistics with survival analysis and multivariable models, if assumptions are met, at the significance level of 0.05.

NCT ID: NCT05077930 Completed - COVID-19 Clinical Trials

Convalescent Plasma Therapy for Hospitalized Patients With COVID-19

Start date: January 6, 2022
Phase: Phase 2
Study type: Interventional

Plasma from donors who have recovered from coronavirus disease 2019 (COVID-19) contain antibodies to SARS-CoV-2 and may be a potential therapy for hospitalized patients with COVID-19. The efficacy of high-titer convalescent plasma for COVID-19, however, still unclear. The present study aims to evaluate the efficacy and safety of using convalescent plasma for treating hospitalized patients with COVID-19.