There are about 10004 clinical studies being (or have been) conducted in Brazil. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study designed to confirm the benefits of mepolizumab treatment on moderate or severe exacerbations in chronic obstructive pulmonary disease (COPD) participants given as an add on to their optimized maintenance COPD therapy. The maximum duration of participant participation is approximately 109 weeks, consisting of 2 screening visits (up to 3 weeks), a run-in period (up to 2 weeks), and an intervention period of at least 52 weeks and up to 104 weeks. 800 participants will be randomized in a 1:1 ratio to receive mepolizumab 100 milligrams (mg) or placebo every 4 weeks for at least 13 doses (52 weeks treatment period) up to a maximum of 26 doses (104 weeks treatment period). The number of randomized participants may increase up to approximately 1400.
With the aging population, a high prevalence of obesity, systemic arterial hypertension and diabetes mellitus, we are facing an increased incidence of elderly patients with chronic kidney disease (CKD) initiating renal replacement therapy. The correct diagnosis of CKD, the prognosis of the elderly patient with CKD, mainly comparing initiated dialysis vs. remaining in conservative treatment, the nutritional prognostic markers (sarcopenia), cardiovascular, mineral and bone metabolism, geriatric syndromes and sleep disorders are still debatable. Elderly patients are usually excluded from clinical trials and the scientific evidence is either scarce or based on retrospective data. Thus, the present study is a prospective cohort to evaluate the long-term evolution of patients ≥ 70 years with stage 4 or 5 CKD. The main outcomes are mortality and dialysis as a combined event. These endpoints will be correlated with independent parameters: Klotho, FGF23, nutrition and sleep quality. Confounders variables are cognition, depression, demographic, clinical and laboratory parameters, and daytime somnolence. Patients will be followed at the nephrology outpatient clinic of the Hospital das Clinicas, Universidade de Sao Paulo. The sample size was calculated to be 200 subjects. The summary methodology will include a broad geriatric assessment, cognition test, fragility, Charlson comorbidity scores, biochemical measurements of urea, creatinine, alkaline phosphatase, parathyroid hormone, calcium, phosphorus, vitamin D, vitamin B12, folic acid, thyroid hormones, hepatitis virus, serum albumin, albumin/creatinine ratio, protein/creatinine ratio, 24-h urinary protein, Epworth Sleepiness Scale, Pittsburgh questionnaire, segmental electric bioimpedance, and nutritional evaluation by 24h dietary interview.
Excessive fat mass (FM) contributes to changes in the strength and endurance of skeletal muscles. Mid-thigh muscle mass is approximately 2.5 times that of fat mass, but individuals who are obese have increased intra- (fat within muscle cells) and intermuscular fat (fat between muscle cells), establishing a negative influence on strength generation capacity and functional independence. The functional capacity of a skeletal muscle can be assessed based on the muscle's ability to produce strength. The relevance of this study is to identify/analyze the changes in segmental body composition (BC) which might better determine the association between fat free mass (FFM) of the lower limbs and maximum voluntary contraction (MVC), 36 months after bariatric surgery. This study was elaborated and will be performed at the Clinical Hospital in the Medical School of the University of Sao Paulo (HCFMUSP). The patients involved will receive the Informed Consent Form. The sample, consists of 155 adults selected at the ambulatory of the Bariatric and Metabolic Surgery Unit of the Department of Gastroenterology of HCFMUSP in the periods: preoperative, 6 and 36 months after surgery. Patients of both sexes, above 18 years of age, will undergo bariatric surgery performed at the institution. Adult patients over 60 years old, undergoing revision surgery and other surgical techniques will be excluded. Anthropometric variables will be obtained on the same day as the evaluation of BC by trained evaluators. The BC will be measured by In Body 230. BMI (kg/m2) shall be determined by dividing body weight (kg) by height (m) squared. Evaluation of Body Composition and Muscle Strength will be held between 8:00 am and 10:00 am in the Laboratory of Exercise and Movement Studies at the Institute of Orthopedics and Traumatology of FMUSP. BC measurements as FM (% and kg), FFM (% and kg), will be obtained by the indirect noninvasive method of electrical bioimpedance. The dynamometer will be used to evaluate muscle strength extension (Ext) and flexion (Flex) MVC torques for both legs will be carried. The MVC assessed variables should be absolute Ext and Flex torques (Nm), Ext and Flex torques relative to the body weight (Nm/Bw) and Ext and Flex torques relative to FFM (Nm/FFM).
The purpose of study is to evaluate if the addition of GSK3359609 to pembrolizumab as first-line treatment improves the efficacy of pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma/cancer (HNSCC).This is a randomized, double-blind, adaptive Phase II/III study comparing a combination of GSK3359609 inducible T cell co-stimulatory receptor (ICOS) agonist and pembrolizumab to pembrolizumab plus placebo in participants with programmed death receptor 1-ligand 1 (PD-L1) combined positive score (CPS) >=1 R/M HNSCC.
Progesterone (P4) is essential for the secretory development of endometrium and the maintenance of early pregnancy. In the luteal phase following controlled ovarian stimulation in in vitro fertilization (IVF) treatment, P4 profile is completely different from natural cycles (Fauser, 2002). Since the optimal luteal P4 levels are not well known, in normal IVF treatment a standard regime of exogenous P4 is given without considering the ovarian response for stimulation and the steroid levels in luteal phase. In 2005 Humaidan et al, showed that following the fresh embryo transfer, low luteal P4 levels (39 nmol/l) has a negative impact on ongoing pregnancy rates (Humaidan, 2005). In the following randomized controlled trials (RCTs), the use of exogenous human chorionic gonadotropin (hCG) after gonadotropin releasing hormone (GnRH) agonist trigger as a luteal phase support (Humaidan, 2010, 2013), the mid luteal P4 levels increased to 77-409 nmol/l and birth rates per transfer raised to %24. In the light of these, it is essential that the progesterone levels in luteal phase is above the certain threshold for induction of the normal secretory development of endometrium following the IVF treatment and for the maintenance of pregnancy. The implantation window is defined as that period when the uterus is receptive for implantation of the free-lying blastocyst. For maximal effectiveness of assisted reproductive technologies in women, it is important to know the optimal time for embryo transfer which implies a need to predict the period of uterine receptivity. Blood progesterone levels can be an indirect indication for implantation window and the embryo transfer timing. In a recent study by Vuong et al., marked inter-personal variation in early luteal circulating P4 levels have been reported following the same hCG trigger dose; since a freeze-all policy was adopted in that study, the inter-personal variation during the early luteal phase was entirely caused by differences in endogenous P4 production from the CL (Vuong, et al., 2020). In this study, almost one in five patients had already experienced a peak P4 concentration on OPU+2 day to OPU+3 day, and only one in seven had maximal concentrations on OPU+6 day, showing that a total of 85% of women experienced their highest P4 concentration before the period in which the peak was expected to be reached during a natural menstrual cycle (Andersen, et al., 2020). It is noteworthy that more than 40% of patients had a >50% decrease in P4 concentration between OPU+4 day and OPU+6 day; although exogenous P4 supplementation in women undergoing IVF will ameliorate this drop-in serum P4 to some extent, these findings clearly highlight the requirement for studies examining how the probability of achieving pregnancy in fresh cycles is affected by the timing and magnitude of the reduction in P4 concentrations (Vuong, et al., 2020). Variations in endogenous production might, in theory, originate from differences in "quality" of the CL as seen during the natural cycle (Hull, et al., 1982) and/or differences in serum concentrations of hCG during the early luteal phase used for triggering (Vuong, et al., 2020b). The aim of this study is two fold; i) to investigate the effect of early and mid luteal P4 levels on ongoing pregnancy rates and to determine the optimal luteal P4 levels in IVF cycles following the fresh blastocyst transfer in order to improve the reproductive outcomes, ii) to investigate the impact of serial P4 levels on OPU+3 and OPU+5 and delta P4 (ΔP4; as calculated by subtracting the P4 level on OPU+3 from the P4 level on OPU+5) on ongoing pregnancy rates.
This study aims to verify the impact of four speech therapy sessions on the Quality of Life of patients treated for malignant tongue and/or jaw cancer, using as measure specific questionnaires of speech and swallowing. The hypothesis is that after treatment with exercises and speech therapy guidance, patients will present better indicators on Quality of Life related to speech and swallowing.
B-cell maturation antigen (BCMA) is a target present on tumor cells in participants with multiple myeloma. Belantamab mafodotin (GSK2857916); is an antibody-drug conjugate (ADC) containing humanized anti-BCMA monoclonal antibody (mAb). This is a phase I/II, randomized, open-label, platform study designed to evaluate the effects of belantamab mafodotin in combination with other anti-cancer drugs in participants with relapsed/refractory multiple myeloma. The Platform design incorporates a single master protocol, where multiple treatment combinations, as sub-studies, will be evaluated simultaneously.
A randomized clinical trial will be conducted to evaluate the effectiveness of using the Swiss Ball as a resource that reduces the length of labor time. The study will be conducted in the Low Risk Labor and Delivery sector of (Instituto Materno Infantil Professor Fernando Figueira) IMIP, which has a team of obstetric nurses, medical coordination and physical therapy support. The study population will be composed of low risk parturients admitted to the sector. Parturients who meet the inclusion criteria after signing the Informed Consent Form will be allocated into two groups: Group A (experimental) and Group B (control). Group A will be encouraged to use the Swiss Ball through pelvic movements, and Group B will go through the usual routine. Study results will be evaluated by assistants during labor and immediately after delivery.
OBJECTIVE: To evaluate the effect of intervention by sending short text messages with a reminder of the time of medication use, compared to sending educational messages, on adherence to drug treatment in patients with hypertension. METHODOLOGY: Prospective, randomized, controlled, double-blind, parallel group study that will be performed in patients with hypertension seen at a community pharmacy in Brazil. The following groups will be compared: a) intervention group 1: 70 hypertensive patients registered for access to medication associated with usual care, in addition to text messages via mobile phone with educational information b) intervention group 2: 70 hypertensive patients registered for access to medications that will additionally receive text messages at the times indicated in the prescription for use of each indicated medication, in addition to educational information. After the washout period, the groups will have the active interventions changed for an additional 90 days. The proportion of adherent and non-adherent patients with and without controlled BP in both groups will be compared after the periods of application of the different interventions.
The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grfating (SAG). The specific aims of ROMA:Women are: Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grfating (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,000 women randomized 1:1 to MAG or SAG (690 from the parent ROMA trial + 1,310 from ROMA:Women). Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time. Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events. Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups. Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated. Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG. Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG. Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.