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NCT ID: NCT02859558 Active, not recruiting - HIV-1 Infection Clinical Trials

Early ART to Limit Infection and Establishment of Reservoir

EARLIER
Start date: January 2017
Phase: Phase 2
Study type: Interventional

The study was done to: - Start antiretroviral therapy (ART) early in those recently or acutely infected with HIV-1 - See how starting ART as soon as the infection is found affects the amount of HIV-1 in blood and how well the body fights the HIV-1 infection - Look at the amount of HIV-1 DNA (genetic material for HIV-1) seen in CD4+ T-cells (infection-fighting cells in blood) after 48 weeks of ART - See how early treatment for HIV affects the numbers of HIV-1 infection fighting cells (CD4+ and CD8+ T-cells) in blood

NCT ID: NCT02854254 Active, not recruiting - Clinical trials for Congestive Heart Failure

Peripherally Inserted Central Catheter Use for Dobutamine Infusion in Heart Failure Patients

DOBUTAPICC
Start date: December 2012
Phase: N/A
Study type: Interventional

In decompensation of heart failure, it may occur low cardiac output. For patients in this situation, the use of inotropic may be necessary. Prolonged intravenous infusion of inotropic agents can lead to phlebitis in peripherally venous access. On the other hand, central venous access presents complications inherent in the procedure. The peripherally inserted central catheter (PICC) may be an option in this situation. The present research project is a randomized clinical trial to evaluate the incidence of phlebitis by using the PICC in comparison to the peripheral venous access. The criteria for inclusion are: advanced congestive heart failure, in use of intravenous inotropic; platelets > 50.000 mm3 and left ventricular ejection fraction (LVEF) < 0.45. Patients will be randomized to receive the PICC or keep the peripheral venous access. The main outcome will be the occurrence of phlebitis. The sample size will be of 40 patients for each group (PICC and control). The data will be analyzed by logistic regression. Will be considered significant P 0.05.

NCT ID: NCT02852486 Active, not recruiting - Clinical trials for Leukemia, Chronic Myeloid

Study of Imatinib Discontinuation in Chronic Myeloid Leukemia With Deep Molecular Response

EDI-PIO
Start date: June 22, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate treatment-free remission after imatinib discontinuation in patients with chronic myeloid leukemia with deep molecular response. Before discontinuation, patients will receive pioglitazone associated with imatinib during 3 months.

NCT ID: NCT02809092 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Interleukin-21 (IL-21)- Expanded Natural Killer Cells for Induction of Acute Myeloid Leukemia

Start date: April 1, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Relapsed acute myeloblastic leukemia (AML) requires remission prior to allogeneic Hematopoietic Stem Cell Transplant (HSCT) for optimal survival, but is a disease with poor response to chemotherapy. Human leukocyte antigen (HLA) haploidentical, Natural killer (NK) enriched peripheral blood cell infusions have shown safety in patients with poor prognosis AML. Though not powered for such an assessment, this trial showed a promising but not statistically significant trend in remission rate. NK cell therapy was limited by small numbers of NK cells attainable through leukapheresis. We have now demonstrated that large numbers of NK cells can be propagated ex vivo from a small volume blood draw, obviating the need for donor leukapheresis. The purpose of this trial is to determine the feasibility and maximum tolerated dose of expanded NK cells and estimate the toxicity of treating relapsed/refractory AML with fludarabine + high-dose cytarabine + G-CSF (FLAG) chemotherapy followed by haploidentical expanded natural killer (NK) cells. The first NK cell dosing cohort will be well below the currently-established safe dose of pheresis-derived NK cells, as expanded NK cells may have increased toxicity because of their activated phenotype. In order to avoid accruing patients at suboptimal doses, a dose escalation schema based on the principles of an accelerated titration design is used in this study to allow expeditious advancement up to the current safe dose of NK cells.

NCT ID: NCT02807818 Active, not recruiting - Child Development Clinical Trials

A Home Visiting Program for Pregnant Youth to Promote Early Brain Development

Start date: June 2015
Phase: N/A
Study type: Interventional

Home visiting programs for pregnant women aiming to improve mother-infant relationship has received worldwide attention in the past 30 years. These programs are considered an important strategy to improve women's health during pregnancy, aside from improving child's birthing conditions and allowing parents access to tools which will nurture and properly stimulate their baby, thus promoting emotional and cognitive development. Objectives: The "Nurse home visitation program for pregnant youth" aims to promote infant´s healthy development, from pregnancy to the first months of life, in a high-risk population. Methods: Eighty young pregnant women aged between 14 and 20 years were randomly allocated to the intervention or to usual prenatal care program. The "Nurse home visitation program for pregnant youth" was developed based on Albert Bandura's theory of self-efficacy, on Urie Bronfenbrenner´s bioecological model, which recognizes the importance of individual and family inclusion in various contexts of social life, on John Bowlby and Mary Ainsworth evolutionary theories of attachment, which involves the care practitioner addressing issues such as environmental health, life course and parenting, bond between mother and infant, and infant´s social and cognitive development. Neuropsychomotor development will be assessed at 3, 6 and 12 months using the Bayley Scale of Infant Development. Brain development will be assessed via electroencephalography at 6 and 12 months.

NCT ID: NCT02807012 Active, not recruiting - Stroke Clinical Trials

Nursing Home Care Intervention Post Stroke

SHARE
Start date: May 2016
Phase: N/A
Study type: Interventional

Associated with the worsening of functional capacity of older adult and the lack of guidance on how to care of them after stroke, the family caregiver starts to fell burden related to the care, and the quality of life was affected by that burden. Besides that, the older adult began to use more frequently health services and had more hospitalizations by preventable conditionals with adequate care. The aim of this study is to evaluate the effectiveness of educational interventions of care at home provide by nurses to family caregivers of older adult with stroke after hospital discharge, compared with usual care guidelines or no guidance, in one month follow up. The family caregivers of older adults post stroke with the first functional sequel from the Clinical Hospital of Porto Alegre (HCPA) will participate in the study. The intervention will involve the systematic monitoring of nurses through home visits (HVs) during one month. Thus, will instrumentalize the family caregiver to care of older adult with stoke according the protocol developed in a research group and the needs of care of them. The control group won't receive the home visits and could have or not the usual care guidelines provide by health services that have access.

NCT ID: NCT02795910 Active, not recruiting - Hypertension Clinical Trials

Integrated Primary Care for Diabetes and Cardiovascular Disease

PACKBrazDCVD
Start date: April 1, 2017
Phase: N/A
Study type: Interventional

This study will evaluate a complex intervention based on a patient management tool (PMT), combined with educational outreach to primary care doctors, nurses and other health workers, in the Brazilian city of Florianopolis. The intervention is aimed at improving the quality of primary health care and health outcomes, in adults with diabetes and cardiovascular disease (CVD). The effectiveness of the intervention will be assessed by randomly allocating 48 primary care clinics to receive the intervention or not, and comparing patient and clinic level endpoints that reflect the health and quality of care provided over the following year. About 11000 patients known to have been diagnosed with diabetes mellitus and 32000 with CVD (defined as having a diagnosis of hypertension, ischemic heart disease, heart failure or cerebrovascular disease) in participating clinics will be included in the study. About 7800 of them have diagnoses of both CVD and stroke. The primary endpoints will be 1. Number of participants in whom at least one of the following tests was recorded: body mass index, plasma glucose, serum cholesterol, electrocardiogram, and 2. in participants with a diagnosis of hypertension recorded previously, average systolic blood pressure recorded. Secondary endpoints will include the individual components of the composite scores, health measures (hospital admissions and deaths), and indicators of appropriate diagnosis of comorbid conditions such as depression. Eligible patients will be identified and outcomes measured using electronic medical records.

NCT ID: NCT02789202 Active, not recruiting - Dental Caries Clinical Trials

Diammine Silver Fluoride in Arresting Enamel Caries Lesions on Babies' Occlusal Surfaces

Start date: October 2014
Phase: N/A
Study type: Interventional

This study aims to verify the actual possibility of using silver diammine fluoride (SDF) in arresting enamel caries lesions on occlusal surfaces of primary molars in babies. Besides, the cost-efficacy and also parental acceptability of using SDF will be evaluated. For this, 100 babies 1-3 years will be examined and treated in a mobile dental unit, which will temporarily be parked in public schools of Barueri, Sao Paulo, Brazil. The caries diagnosis will be conducted using the International Caries Detection and Assessment System (ICDAS). Babies with initial lesions will be randomized concerning the treatment in Group A (SDF) and Group B (fluoride varnish). Participants will be examined in the baseline and followed by 6, 12, 18 and 24 months. As primary outcome, caries progression into dentine will be considered. Acceptability reported by parents after treatments, the time and estimated money spent for treating will also be collected. Social and biological data that could be related to efficacy of techniques will be also collected. Multilevel analyses will be performed to check which technique will be most effective and possible factors associated to its efficacy. Discomfort, acceptability and costs will be compared between/among the approaches used to arrest enamel caries lesions.

NCT ID: NCT02786186 Active, not recruiting - Psoriasis Clinical Trials

A Registry of Patients With Moderate to Severe Plaque Psoriasis

PURE
Start date: December 23, 2015
Phase:
Study type: Observational [Patient Registry]

The main purpose of the current study will be to provide real - world evidence regarding the safety and effectiveness of secukinumab in the management of patients with moderate to severe chronic plaque psoriasis.

NCT ID: NCT02783092 Active, not recruiting - Epilepsy Clinical Trials

A Double-Blind Trial to Evaluate Efficacy and Safety of Cannabidiol as an add-on Therapy for Treatment in Refractory Epilepsy

Start date: January 9, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of the adjuvant use of cannabidiol administered twice daily in doses of 5-25 mg/kg/day through the proportion of responsive patients; that is, participants with at least 50% decrease in the frequency of epileptic seizures in the last month of the trial relative to baseline (pretreatment with AEDs only). Primary end point(s): Rate of responsive patients; that is, participants with at least 50% decrease in the frequency of epileptic seizures in the last month of the trial relative to baseline (pretreatment with AEDs only).