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NCT ID: NCT05403307 Completed - COVID-19 Clinical Trials

A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine Among Children in Brazil

Start date: June 8, 2022
Phase:
Study type: Observational

The present test-negative design study aims to estimate the real-world effectiveness of Pfizer-BioNTech BNT162b2 mRNA vaccine on symptomatic SARS-CoV-2 infection and its consequences among children aged 5 to 11 years in the city of Toledo in Southern Brazil. Individuals aged 5 to 11 years who seek the public healthcare system with symptoms suggestive COVID-19 will be enrolled. Participants with a positive reverse transcriptase polymerase chain reaction (RT-PCR) test for SARS-CoV-2 will be classified as cases, and those with negative RT-PCR test for SARS-CoV-2 will be classified as controls. Cases will be followed-up for a period of 3 months by means of structured telephone interviews.

NCT ID: NCT05402007 Completed - COVID-19 Clinical Trials

Effects of Cardiopulmonary Rehabilitation in Participants With Post-COVID 19 Syndrome.

Start date: June 30, 2022
Phase: N/A
Study type: Interventional

COVID-19 is an emerging pandemic disease caused by severe acute respiratory syndrome (SARS-CoV-2). Although the majority of patients infected with SARS-CoV-2 are asymptomatic or have mild symptoms, some patients develop severe symptoms that can protractedly impair their quality of life and functional capacity. SARS-CoV-2 is closely related to severe acute respiratory syndrome (SARS) with direct and indirect effects on several systems, especially the musculoskeletal system, in addition to the respiratory system. Some of these symptoms persist for a long period, called Post-Covid-19 Syndrome, directly interfering with the functional capacity and quality of life of these participants. Cardiopulmonary Rehabilitation exercises are focused on restoring functional capacity in patients affected by cardiopulmonary diseases. The primary objective of this study is to evaluate the clinical and functional effects of a quarterly Cardiopulmonary Rehabilitation exercise program for participants with post-COVID-19 syndrome. The secondary objectives will be: To compare the effects of a supervised program of 12 weeks of supervised exercises and a program of self-performed home exercises, guided by an exercise booklet, of the same duration on muscle strength and peripheral resistance; Compare the effects of a 12-week supervised exercise program and a self-performed home exercise program, guided by an exercise booklet, of the same duration on levels of fatigue and dyspnea in patients with post-COVID-19 syndrome; Compare the effects of a 12-week supervised exercise program and a self-performed home exercise program, guided by an exercise booklet, of the same duration on health-related quality of life and post-COVID-19 functional status.

NCT ID: NCT05401513 Not yet recruiting - Low Back Pain Clinical Trials

Pilates Method in Helicopter Pilots With Low Back Pain

Start date: June 20, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to analyze the effects of an exercise program, based on the Pilates method, on the low back pain and muscle fatigue of Brazilian Air Force helicopter pilots.

NCT ID: NCT05401448 Recruiting - COVID-19 Clinical Trials

Non-specific Effects of FLU-MMR Vaccines in Adults

FLUMMR-BRA
Start date: May 1, 2021
Phase: Early Phase 1
Study type: Interventional

Various observational studies have reported an association between influenza vaccination and lower rates of infection with SARS-Cov-2 and less COVID-19 disease severity have been reported in large epidemiological studies in US, Brazil and Italy. Observational studies from the Netherlands showed also strongly reduced COVID-19 infection rates among influenza-vaccinated healthcare workers, with ORs of 0.61 and 0.49 for the first and second wave of COVID-19, respectively. In addition, in-vitro immunological analyses showed that the quadrivalent inactivated influenza vaccine can induce a trained immunity program against SARS-CoV-2 (2). In-vivo vaccination against influenza was also shown to induce improved interferon responses against SARS-CoV-2, with modulation of hyperinflammatory responses. Trained immunity could be the underlying mechanism for the potential protective effect of influenza vaccine, a mechanism that has also been proven for BCG vaccination, and epidemiological evidence suggests similar non-specific effects of MMR and OPV vaccination. Currently, various clinical trials are being conducted to study the impact of BCG, MMR and OPV vaccination on COVID-19, but prospective clinical data on influenza vaccination are lacking. Although specific COVID-19 vaccines have been developed and are proven effective, there are important reasons for assessing in a controlled randomized trial the effect of influenza and MMR vaccine on COVID19: - Specific COVID-19 vaccines are still not yet available for all segments of the population, and especially not for the majority of the population in developing countries. - The emergence of new SARS-CoV-2 variants, especially the P1 variant from Brazil, may very well be associated with reduced response to vaccines. An immunomodulatory protective vaccine that protects in an antigen-independent manner would be of great importance. - It would also be conceptually important to know whether influenza and the MMR vaccine can induce heterologous protection against another viral infection, in the context of future pandemics.

NCT ID: NCT05401214 Approved for marketing - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Pre-approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this pre-approval access is to provide Niraparib plus Abiraterone Acetate (Nira/AA combination) in the treatment of (a) participant(s) with first line metastatic castration-resistant prostate cancer with specific Homologous Recombination Repair (HRR) gene alterations.

NCT ID: NCT05400486 Recruiting - Chronic Pain Clinical Trials

Comparison of the Additional Effects of Using TENS and Interferential Currents for the Treatment of Individuals With Chronic Nonspecific Neck Pain.

Start date: July 30, 2022
Phase: N/A
Study type: Interventional

In the current clinical and scientific reality, conservative treatment is the most coherent clinical management with a view to the proper rehabilitation of patients with chronic neck pain, with a trend towards the use of therapeutic exercise. However, some uncertainty about the effectiveness of therapeutic exercises still remains, requiring further studies with high methodological rigor, especially with regard to multimodal treatment, such as the combination of therapeutic exercises with photobiomodulation. Thus, the objective of this project is to evaluate the effects of adding photobiomodulation to a program of specific therapeutic exercises for the treatment of individuals with chronic non-specific neck pain. To this end, 60 participants will be randomized into three groups: therapeutic exercise group + photobiomodulation (n = 20), and therapeutic exercise group. There will be 8 treatment sessions and participants will be evaluated before, after the 8 sessions, and 4 weeks after the end of treatment using the Numerical Pain Scale, Neck Disability Index, Catastrophic Thoughts about Pain Scale, and Tampa Kinesiophobia Scale. In the statistical analysis, a linear mixed model will be applied, considering the interaction between the time and group factors. Finally, the addition of photobiomodulation to a therapeutic exercise program is expected to generate clinical improvements for patients with chronic neck pain.

NCT ID: NCT05400473 Recruiting - Chronic Pain Clinical Trials

Effects of Adding Photobiomodulation to a Specific Therapeutic Exercise Program for the Treatment of Individuals With Chronic Nonspecific Neck Pain.

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

In the current clinical and scientific reality, conservative treatment is the most coherent clinical management with a view to the proper rehabilitation of patients with chronic neck pain, with a trend towards the use of therapeutic exercise. However, some uncertainty about the effectiveness of therapeutic exercises still remains, requiring further studies with high methodological rigor, especially with regard to multimodal treatment, such as the combination of therapeutic exercises with photobiomodulation. Thus, the objective of this project is to evaluate the effects of adding photobiomodulation to a program of specific therapeutic exercises for the treatment of individuals with chronic non-specific neck pain. For this, 60 participants will be randomized into two groups: therapeutic exercise group + photobiomodulation (n = 30), and therapeutic exercise group (n = 30). There will be 10 treatment sessions and participants will be evaluated before, after the 10 sessions, and 4 weeks after the end of treatment using the Numerical Pain Scale, Neck Disability Index, Catastrophic Thoughts about Pain Scale, and Tampa Kinesiophobia Scale. In the statistical analysis, a linear mixed model will be applied, considering the interaction between the time and group factors. Finally, the addition of photobiomodulation to a therapeutic exercise program is expected to generate clinical improvements for patients with chronic neck pain.

NCT ID: NCT05399667 Active, not recruiting - Preterm Birth Clinical Trials

Assessment of Body Composition in Premature Children Submitted to an Early Stimulation Program

Start date: January 31, 2020
Phase:
Study type: Observational

This is a cross-sectional study of a randomized clinical trial to investigate nutritional aspects of pre-scholar aged children born preterm submitted to an early stimulation program versus conventional care program. The preterm-born children participated in the project entitle "Early Intervention Program for Preterm Infants and Their Parents: establishing the impact at 18 Months Corrected Age" (NCT02835612), which performed a continuous early stimulation in very and extremely preterm infant's families in their first 12 to 18 months. In the present study, preterm born children currently with 3 to 6 years old and their mothers (or legal guardian) are once more invited to a one-day visit for a nutritional and clinical evaluation at the Clinical Research Center of Hospital de Clínicas de Porto Alegre/Brazil. In the consultation, preterm born children and theirs mothers are submitted to the following exams: body composition by electrical bioimpedance, clinical and physical evaluation, anthropometric measurements, and children's eating habits, eating behavior and parental educational style in food through specific questionnaires. Moreover, this study will also investigate a group of pre-scholar health children born at term to obtain reference values for variables analysed. The goal with these findings is to determine if an early stimulation program could present a positive impact in anthropometric outcomes and nutritional aspects in this more vulnerable preterm born population.

NCT ID: NCT05398497 Not yet recruiting - Breast Cancer Clinical Trials

FreezIng bReaST Cancer in Brazil: a Before-after Study

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

Image-guided tumor ablation is a non-surgical, minimally invasive therapy available for local therapy of some carcinomas as an alternative to surgical treatment. This study assesses whether cryoablation can be used as an alternative to surgery in cases of early invasive breast carcinoma.

NCT ID: NCT05398445 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)

ROCKET-Ignite
Start date: May 31, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.