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NCT ID: NCT05639478 Enrolling by invitation - Clinical trials for Diabetes; Neuropathy, Polyneuropathy (Manifestation)

FOot CAre and Exercises ImplementatioN for People With Diabetes in Primary Care

FOCAIN
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The main objective of this type 2 hybrid implementation effectiveness trial is to implement a contextually appropriate preventive intervention for 12 weeks face to face group foot and ankle exercises for people with diabetic foot in the primary care of the city of Limeira/SP, through the training of Primary Care workers. The study will monitor the implementation itself and the clinical outcomes: clinical and functional status and quality of life.

NCT ID: NCT05611021 Enrolling by invitation - Clinical trials for Cardiovascular Diseases

Acute Responses to Arm-Crank Exercise on Cardiovascular Function of Patients With Peripheral Artery Disease

Start date: June 8, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to analyze acute responses of arm-cranking exercise on cardiovascular function of peripheral arterial disease patients and compare it to the main exercise recommendation, walking exercise.

NCT ID: NCT05515536 Enrolling by invitation - Friedreich Ataxia Clinical Trials

A Study to Assess the Safety and Efficacy of Vatiquinone in Participants With Friedreich Ataxia

Start date: December 8, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the long-term safety of vatiquinone in participants with Friedreich ataxia (FA) previously exposed to vatiquinone.

NCT ID: NCT05352919 Enrolling by invitation - Clinical trials for Systemic Lupus Erythematosus (SLE)

A Study to Evaluate the Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adults With Active Systemic Lupus Erythematosus

EMERALD
Start date: June 10, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of litifilimab in participants with active systemic lupus erythematosus (SLE). The secondary objectives of this study are to evaluate the long-term effect of litifilimab on disease activity in participants with SLE, to evaluate the long-term effect of litifilimab in participants with SLE in maintaining low disease activity, to evaluate the effect of litifilimab in participants with active SLE in preventing irreversible organ damage, to assess long-term use of oral corticosteroid (OCS) with participants receiving litifilimab treatment, to assess the impact of litifilimab on participant-reported Health-Related Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE, to evaluate long-term effect of litifilimab on laboratory parameters, and to evaluate immunogenicity of litifilimab.

NCT ID: NCT05303532 Enrolling by invitation - Cancer Clinical Trials

Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab

ROSY-D
Start date: April 19, 2022
Phase: Phase 3
Study type: Interventional

The rationale of the ROSY-D study is to continue to provide study treatment for patients who have participated in a parent study with Durvalumab and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.

NCT ID: NCT05287139 Enrolling by invitation - Quality of Life Clinical Trials

QOL of Women With HR-Positive Metastatic BC Treated in the First-line Setting: Comparison Between Public and Private Institutions.

BRAVE
Start date: July 14, 2021
Phase:
Study type: Observational

Assess the quality of life in patients with hormone receptor positive, human epidermal growth factor receptor-type 2 negative metastatic breast cancer treated in first line (patients with new metastasis or recurrence during adjuvant endocrine therapy): comparison between public and private institutions. The hypothesis to be evaluated is that patients treated in private institutions have a better quality of life when compared to patients treated in public institutions.

NCT ID: NCT05285046 Enrolling by invitation - Clinical trials for Bacterial Infections

Phenotypic Profile and Molecular Mechanism of Resistance in Carbapenemase-producing Enterobacterales and Pseudomonas Aeruginosa Isolates From Brazilian Hospitals: Implications for the Introduction of IMIPENEM-RELEBACTAM

Start date: April 1, 2022
Phase:
Study type: Observational

The global dissemination of carbapenem-resistant Enterobacteriaceae (CRE) and Pseudomonas aeruginosa (CRPA) are a significant threat to health care, especially for severely ill patients. Antibiotics currently used to treat CRE and CRPA infections are usually toxic and not very effective. Novel treatments include beta-lactamase inhibitors with broad-spectrum activity, among them IMI-REL. IMI-REL is a promising molecule due to the ability of REL to diminish carbapenem MICs to the susceptible range, potentially restoring the activity of this potent drug. However, few studies have systematically examined IMI-REL activity against a diverse clinical collection of CRE and CRPA strains, in particular from a region where the resistance is high, and the main mechanisms are in general unknown (Brazil- Latin America). As the use of molecular diagnostics becomes increasingly available in clinical settings, it is crucial to identify molecular markers predicting antimicrobial efficacy to guide therapeutic decision-making. In the present study, we will acess different species of CRE and CRPA from clinically relevant isolates to determine if the species, clonal lineage, and resistance gene profile, have influence to the response to IMI-REL.

NCT ID: NCT05273424 Enrolling by invitation - Clinical trials for Chronic Kidney Diseases

Clinical Outcomes of Hemodialysis in Brazil (COHEBRA): a Prospective Cohort Study

COHEBRA
Start date: June 1, 2017
Phase:
Study type: Observational

Introduction: Chronic kidney disease (CKD) is characterized by progressive decrease in glomerular filtration rate (GFR), eventually reaching the end-stage renal disease (ESRD) requiring renal replacement therapy (RRT). The decrease in GFR is associated with a linear increase in cardiovascular mortality. Dysfunction of the autonomic nervous system (ANS) has been well documented in patients with CKD, especially in people with ESRD. The renal ischemia causes both the excessive activation of the renin-angiotensin-aldosterone system (RAAS) by increasing renin release, as sympathetic ANS, through the afferent sympathetic nerves. The overactivated RAAS and sympathetic SNA feedback each other, which contributes to cardiovascular disease (CVD) in CKD. Despite the involvement of these systems in the pathogenesis of CVD in CKD, drugs that block the RAAS or sympathetic SNA have shown heterogeneous effects in CVD in this population. A potential explanation is the genetic heterogeneity, such as the polymorphism in the gene for angiotensin converting enzyme (ACE).In addition, the inflammatory process associated with CKD is regarded as central player in the general degenerative changes backing CKD on HD shorter survival, which in many aspects is like accelerated aging. Skeletal muscles are also affected in a pattern like aging sarcopenia, with loss of function and mass. Objectives: to evaluate the impact of ECA gene polymorphism, HRV, body composition, functional capacity, muscle strength, inflammatory factors and other potential predictors on the survival of patients with CKD treated by HD in a single center in southern Brazil. Methodology: Prospective cohort study. The sample will consist of adult patients with CKD on HD longer than 90 days. Sociodemographic and clinical data is collected from clinical records. HRV analysis is performed using a Micromed@ electrocardiogram device® with a recording of the standard deviation of all normal intervals (SDNN), square root of the mean of the squares of the differences between consecutive intervals (RMSSD), low frequency band (LF) and high frequency (HF) after a midweek HD session. The polymorphism of the ECA gene was evaluated by polymerase chain reaction method in peripheral blood DNA sample. Muscle quality and thickness has been obtained by ultrasound. Functional capacity by 6-minute walking test and muscle strength by dynamometer. The data will be analyzed using Stata 15.0 statistical package.

NCT ID: NCT05267483 Enrolling by invitation - Sepsis Clinical Trials

Evaluation of Usage Patterns and Outcomes in Patients Receiving Ceftolozane/Tazobactan (C/T) in Brazilian Hospitals

Start date: April 1, 2022
Phase:
Study type: Observational

Ceftolozane/Tazobactan (C/T) is a recent option to manage multidrug resistant gram-negative infections in hospital patients. Despite several randomized controlled trials describing safety and efficacy of C/T, real world evidence of its use, including indications, length of treatment and outcomes are lacking. Understanding prescribing patterns of a new drug may help identifying possible knowledge gaps to target future randomized controlled trials. Additionally, real world evidence may help identifying practices and outcomes outside a clinical trial context.

NCT ID: NCT05183841 Enrolling by invitation - Clinical trials for Bronchiectasis Adult

Bronchodilators on the Exercise Capacity of Bronchiectasis Patients

Start date: April 14, 2022
Phase: N/A
Study type: Interventional

The bronchodilators (BD) have been widely used in bronchiectasis (BCE) therapeutic and have been shown to be effective in improving exercise capacity in patients with chronic obstructive pulmonary disease and asthma. However the BD effect on the exercise capacity of patients with BCE is poorly known. Besides, the respiratory mechanics pattern of the patients with BCE is not known nor its association with their physical activity level (PAL). Therefore, the hypothesis of this study is that BD are effective in improving exercise capacity of patients with BCE. The authors also propose to characterize the respiratory mechanics of the patients with BCE and to evaluate their PAL and its association with quality of life, as secondary aims.