Evergreen Park, Illinois
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
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
Effects of Home-based High-speed Bodyweight Resistance Training in Individual with Parkinson's Disease
The sample size calculation was performed considering the primary outcome measures bradykinesia (assessed using items 3.8, 3.9, 3.10, and 3.14 of the motor examination of the MDS-UPDRS) based on data provided by previous similar randomized controlled trial. The effect size for bradykinesia was derived from a previous study. In that study, the groups showed a difference in means of -2.3 (treatment effect), using a standard deviation of 2.5, a significance level (α) of 5% and a power of 0.80, a sample size of 40 participants are required. Assuming a dropout rate of 15%, a total of 46 participants will be recruited (23 per group). All statistical analyses will be performed by an independent examiner, blinded to the group allocation. All data analyses will be performed using SPSS for Windows (SPSS, Chicago, IL, USA). Descriptive statistics will be calculated for all outcomes. The effects of the interventions will be analyzed from the collected data using intention-to-treat. For dropouts, data from the last available assessment will be used for missed sessions. Two-way ANOVA with repeated measures will be used to evaluate the differences between groups, considering the time factor (pre-intervention, post-intervention, and follow-up), followed by post hoc test selected based on final sample size and in the assumption of equal of variance. If necessary, a similar nonparametric test will be used. The level of significance will be set at 5%.
Phase
N/ASpan
54 weeksSponsor
Federal University of Minas GeraisBelo Horizonte, Minas Gerais
Recruiting
LatAm-FINGERS Initiative for Cognitive Change
Today we know that 40% of dementia cases worldwide can be prevented through lifestyle modification. If we look at Latin America, this number is 56%. Latin America is a region with high-risk factors for dementia due to weakened socioeconomic infrastructure, an impoverished healthcare system, and low average education levels in the region. Additionally, we know that cardiovascular health is an important factor in the development of dementia. Under this scenario, LatAm-FINGERS is a multicenter study designed to prevent memory decline through lifestyle modification in people aged 60 to 77 at risk of dementia. Twelve Latin American countries are participating (Argentina, Bolivia, Brazil, Chile, Colombia, Dominican Republic, Mexico, Puerto Rico, Uruguay, Costa Rica, Ecuador, and Peru), with 100 individuals per center. These individuals are randomly assigned to two groups: (1) a group making systematic lifestyle changes (physical and cognitive training, implementation of the Mediterranean-dietary approach to stop hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) diet, socialization, and regular health check-ups) and (2) a group receiving regular health advice. The main objective of LatAm-FINGERS is to determine if this intervention is feasible in Latin America. Secondarily, we want to test if this lifestyle change can lead to improvements in participants' cognition over time (2 years). If successful, the results of this study will have large-scale implications for public policy regarding the standard of clinical care and prescriptive practices for a fast-growing and vulnerable population of older adults. LatAm-FINGERS is based on the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), which demonstrated that lifestyle modification promotes positive changes in memory and attention. Additionally, our study is aligned with the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER), which is conducting a similar intervention in the United States. This project is fully funded by the Alzheimer's Association.
Phase
N/ASpan
326 weeksSponsor
Fundación para la Lucha contra las Enfermedades Neurológicas de la InfanciaBelo Horizonte, Minas Gerais
Recruiting
Study of Plozasiran in Adults With Severe Hypertriglyceridemia
Phase
3Span
119 weeksSponsor
Arrowhead PharmaceuticalsBelo Horizonte, Minas Gerais
Recruiting
Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia
Phase
3Span
119 weeksSponsor
Arrowhead PharmaceuticalsBelo Horizonte, Minas Gerais
Recruiting
Belo Horizonte, Minas Gerais
Recruiting
Classifying for HER2 Dependence to De-Escalate Neoadjuvant Chemotherapy in Patients With HER2+ Early Breast Cancer Undergoing HER2 Double-Blockade
This is a nonrandomized phase II single arm study to assess de-escalation of chemotherapy in participants with HER2-positive early breast cancer undergoing neoadjuvant therapy with PHESGO™. Participants will be evaluated by central laboratory review for confirmation of selected biomarkers (pre-screening). Participants who meet the biomarker assessment criteria will follow the eligibility criteria assessment. Participants with HER2 positive disease that meet the eligibility criteria will be treated with neoadjuvant PHESGO™. A baseline PET/CT will be performed prior to start of PHESGO™ treatment. All participants will receive fixed-dose subcutaneous formulation with pertuzumab and trastuzumab (PHESGO™) every 21 days for 3 cycles to evaluate PET/CT response. After the 3rd cycle, participants achieving PET/CT response (defined in this trial as ≥40% reduction in the SUVMax as calculated by the formula SUVbaseline SUVresponse/SUVbaseline) will continue treatment with PHESGO™ for 5 additional cycles, completing 8 neoadjuvant cycles of PHESGO™. Participants without PET/CT response after 3rd cycle will be out of study and will receive treatment and surgery according to institutional standard of care. For this cohort of participant, data regarding treatment received, pCR status and outcomes will be collected. Definitive breast cancer surgery will be performed after the 8th cycle of therapy. After surgery, participants will receive adjuvant treatment according to their response. Participants achieving pCR will receive PHESGO™ alone as adjuvant treatment to complete a total of one year of therapy, thus receiving 10 cycles of adjuvant PHESGO™. Participants not achieving pCR will receive one of two adjuvant therapy options as per investigator's choice: (1) 14 cycles of trastuzumab emtansine (T-DM1), or (2) investigator's choice chemotherapy regimen (up to 6 cycles) plus 10 cycles of PHESGO™. Disease status and survival data collection will be abstracted from medical records for up to 5 years after surgery. Participants will be followed for recurrence and survival data with abstraction of data from medical records every 3 months in first year after surgery; every 4 months in second and third years; and then annually until five years. Medical procedures and therapies in the follow-up period are not a formal investigational part of this clinical trial and therefore will be performed according to the institutional standard of care.
Phase
2Span
374 weeksSponsor
Latin American Cooperative Oncology GroupBelo Horizonte, Minas Gerais
Recruiting
Telehealth Intervention Involving HEARTS Technical Package and Activity Monitor to Promote Physical Activity Post-stroke
Standard Operating Procedures: A non-probabilistic sample will be recruited from the community. Recruitment strategies include: referrals (e.g, phone numbers obtained from other research projects and university extension programs) and advertisements (e.g. physical folders distributed in public places, and electronic pamphlets published on social media). All subjects will be informed about the study procedures and will provide written consent. The feasibility outcomes will be identified considering the different phases of conducting the study. A trained researcher, blinded to the group allocation, will collect the sociodemographic, anthropometric, and clinical outcomes, in a university laboratory setting. Two independent examiners, blinded to the group allocation, will enter the data into a statistical software package, verify any missing or apparently wrong values. Original paper forms will be kept in a secure place. Electronic files will be available only to the research team. Analysis will be carried-out by a researcher, blinded to the group allocation. All individuals will receive an identification code to ensure anonymity. Statistical analyzes: All analyzes will be performed using SPSS (SPSS Inc., Chicago, IL, USA). Descriptive statistics will be calculated for all outcomes. The effect sizes will be calculated to determine the magnitude of within-groups and between-groups comparisons. The level of significance will be set at 5% and adjusted for multiple comparisons.
Phase
N/ASpan
97 weeksSponsor
Federal University of Minas GeraisBelo Horizonte, Minas Gerais
Recruiting
Effect of Treatments on Pain and Quality of Life in Individual With Burning Mouth Syndrome
Phase
4Span
100 weeksSponsor
Federal University of Minas GeraisBelo Horizonte, Minas Gerais
Recruiting