St Jouan Des Guerets, France
Efficacy and Safety of Gonioscopy Assisted Transluminal Trabeculotomy in Patients with Primary Open-angle Glaucoma and Cataract.
Phase
N/ASpan
199 weeksSponsor
Faculdade de Ciências Médicas de Minas GeraisBelo Horizonte, Minas Gerais
Recruiting
A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors
Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong life and control disease-related symptoms. In this study, participants with relapsed/refractory (R/R) CLL who were previously exposed to a BTKi and a BCL2i will receive BGB-16673 or the investigator's choice of idelalisib plus rituximab (for CLL only) or bendamustine plus rituximab or venetoclax plus rituximab retreatment. The main purpose of this study is to compare the length of time that participants live without their CLL or SLL worsening between those participants who receive BGB-16673 versus the investigator's choice of treatment (idelalisib plus rituximab or bendamustine plus rituximab, or venetoclax plus rituximab). Approximately 250 participants will be included in this study around the world. Participants will be randomly allocated to receive either BGB-16673 or the investigator's choice of treatment.
Phase
3Span
253 weeksSponsor
BeiGeneBelo Horizonte
Recruiting
A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis
Phase
3Span
312 weeksSponsor
Bristol-Myers SquibbBelo Horizonte, Minas Gerais
Recruiting
Belo Horizonte, Minas Gerais
Recruiting
Belo Horizonte, Minas Gerais
Recruiting
Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)
Phase
3Span
214 weeksSponsor
Alpine Immune Sciences Inc, A Subsidiary of VertexBelo Horizonte
Recruiting
Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
Phase
3Span
362 weeksSponsor
Eli Lilly and CompanyBelo Horizonte, Minas Gerais
Recruiting
Effect of Training and Use of Cane on Gait in Individuals With Parkinson's Disease
A non-probabilistic sample will be recruited from the community. Individuals will be included according to the following criteria: age ≥ 40 years; diagnosis of idiopathic PD confirmed by a neurologist; classification between stages II to IV of the modified Hoehn & Yahr Scale (HY); use of anti-parkinsonian medication with stable pharmacological therapy for at least 6 months; ability to walk independently in a 14-meter corridor with a walking speed ≤ 1.1 m/s (defined to screen individuals with gait impairments); ability to use a single-point cane during walking correctly and safely without regular use of any type of assistive device since the diagnosis of PD. Individuals with cognitive impairment, using deep brain stimulation, or who present any other condition that may compromise the test performance will be excluded. Two individuals with PD were involved as collaborators in this study to contribute to the relevance of the research through the inclusion of patient perspectives. After baseline assessments individuals will be randomly allocated into the experimental and control groups. After allocation, all individuals will be instructed to maintain their usual healthcare routines. Individuals in the experimental group will receive cane usage training, provided in four sessions lasting 40 minutes each, spaced over a period of 15 to 22 days. Additionally, they will be instructed and encouraged to use the cane in their daily mobility activities, both indoors and outdoors, starting from the first day of training. To monitor adherence, individuals will receive a diary to record on which occasions and for how long they used the cane during gait activities. To enhance adherence, participants will receive telephone follow-ups between sessions aimed at monitoring and encouraging device use. Individuals will be re-evaluated after the end of the training sessions. After revaluation, the canes will be left with participants who will be instructed as follows: "Feel free to use the cane at any time as needed." Another diary will be provided for the participant to record the use of the device after the end of the intervention. To ensure a comparable amount of attention received, individuals in the control group will receive an intervention involving global stretching of the upper and lower limbs and health education. The intervention will be provided in four sessions lasting 40 minutes each, spaced for 15 to 22 days. Additionally, individuals allocated to the control group will be instructed not to start using any assistive device during the study period and encouraged to perform stretching daily at home from the first day of training. To monitor adherence, individuals will receive a diary to record stretching exercises performed daily. To enhance adherence, participants will receive telephone follow-ups between sessions aimed at monitoring and encouraging the performance of the stretching exercises.The intervention will be offered by the same physiotherapist responsible for training the experimental group. Individuals will be re-evaluated after the end of the training sessions. After revaluation, the participants will be instructed as follows: "Feel free to continue stretching exercises and use the health information discussed as needed." Another diary will be provided for the participant to record the stretching exercises performed after the end of the intervention. The primary outcomes is gait speed. Secondary outcomes include gait confidence, cadence, step length, functional mobility, freezing of gait , fear of falls, and satisfaction with the use of a cane. Adverse events will be monitored throughout the intervention. They are defined as any unexpected medical issue related to the intervention-such as pain, falls, or exercise intolerance-that requires hospitalization or additional treatment. The sample size was calculated based on a clinically meaningful difference of 0.22 m/s and a standard deviation of 0.15 m/s in the 10MWT for individuals with PD. With a 5% significance level and 80% power, 18 participants were required. Considering a 30% dropout rate, the final sample size was set at 26 (13 per group). However, this study will utilize an adaptive design and the sample size will be re-estimated using the effect sizes from the current study and recruitment will be adjusted accordingly. Between-group differences will be measured using a two-way repeated measures ANOVA, considering baseline, post-intervention, and follow-up assessments, following both intention-to-treat and per-protocol approaches (α=0.05).
Phase
N/ASpan
74 weeksSponsor
Federal University of Minas GeraisBelo Horizonte, Minas Gerais
Recruiting
Belo Horizonte
Recruiting
An Ophthalmic Safety Study in Patients With Breast Cancer
This is a multicentre study assessing the ophthalmic safety in patients who are participating in a qualifying study. The study will include two cohorts of at least 60 individuals each. To be able to account for events associated with aging, worsening of pre-existing conditions, etc., ophthalmic study assessments will be performed in parallel in two cohorts at the same timepoints. The duration of the study assessment period will be approximately 12 months. Longer duration of the study would result in additional patient burden.
Phase
N/ASpan
122 weeksSponsor
AstraZenecaBelo Horizonte
Recruiting