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.
BACKGROUND: Gastric cancer is one of the most common cancers and is one of the most deadly cancers. Most patients have advanced disease and should receive first-line trastuzumab-associated chemotherapy when the biopsy is positive for immunocytochemical expression and / or HER2 gene amplification. A study conducted by our group noted that there may be disagreement in HER2 expression between circulating tumor cells (CTCs) and tumor tissue. However, the effectiveness of using anti-HER2 treatment when only CTC express HER2 is unknown. The present study aims to evaluate the expression of HER2 in patients with relapsed or metastatic gastric cancer and what would be the efficacy of adding trastuzumab to chemotherapy when tumor tissue is negative for HER2, but there is expression of this gene in CTCs. OBJECTIVES: The primary objectives are to evaluate HER2 expression in circulating tumor cells of relapsed or metastatic gastric cancer patients with negative HER2 expression on tissue biopsy and response to standard treatment with combined anti-HER2 chemotherapy in this population. Secondary objectives are to assess the prognostic impact of HER2 positivity on circulating tumor cells in advanced gastric tumors and to evaluate HER2 expression in CTCs at the time of treatment progression. METHODS: The investigators will prospectively evaluate HER2 expression in CTC and its response to treatment with standard chemotherapy and addition of trastuzumab in patients with relapsed or metastatic gastric cancer with positive expression of HER2 only in CTC. HER2 expression in tissue and in CTC will be evaluated by immunocytochemistry. Descriptive statistics will be used to report the results of categorical and continuous variables, and respective dispersion measures. Time-to-event variables will be reported in Kaplan Meyer medians and curves. EXPECTED RESULTS: Upon completion of the study the investigators expect to show the frequency of HER2 expression in this specific population, higher radiological response rate with trastuzumab combination compared to chemotherapy alone, determine the prognostic impact associated with HER2 expression in CTCs and show the frequency of HER2 expression in CTCs at the time of study treatment progression. This study may open a new opportunity for anti-HER2 treatment for gastric cancer patients.
Given the lack of studies in the literature associating the use of acupuncture and sliding suction cup in patients with advanced knee osteoarthritis, the objective of this study is to evaluate the benefits of this association in patients of the Institute of Orthopedics and Traumatology outpatient clinic of the University of São Paulo while awaiting surgical treatment of knee osteoarthritis as a method of pain relief, limb function improvement and quality of life.
Randomised Clinical Study to evaluate the efficacy of tilapia skin as an occlusive biological dressing on palatal wound healing after free gingival graft harvesting.
This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who participated in a prior clinical trial with linerixibat (BAT117123 [NCT01899703], 201000 GLIMMER [NCT02966834] (group 1) or 212620 GLISTEN [NCT00210418]) (group 2). All participants will receive open-label linerixibat for the duration of the study. The study duration is expected to last until the study's end or until linerixibat can be lawfully made available to participants. However, the total duration of study participation will vary by participant depending upon the time of entry relative to study end in their respective country.
Erector spinae plane block (ESP block) was first described by Forero et al for the treatment of neuropathic chest pain. Total hip arthroplasty is a surgery with a high potential for severe postoperative pain, and greater attention should be paid to postoperative analgesia. There are multiple forms of postoperative analgesia for total hip arthroplasty, such as subarachnoid morphine, femoral nerve block, obturator and lateral femoral cutaneous block, lumbar plexus block, continuous epidural block, and "3 in 1" block, for example. ESP (LESP) block has emerged based on the same principle as the ESP block in the thoracic region. So far, to the best of our knowledge, there are only a few case reports that evidence its use for hip surgery analgesia. This study aimed to study the local anesthetic dispersion and the mechanism of action of the blockade. An experimental, analytical and prospective study will be carried out in which eight fresh adult human cadavers will be selected and injected with 20 ml of 0.01% methylene blue solution at L4 level. The injection will be performed with a Quincke 20G 100-150mm ultrasound-guided needle with a low-frequency curvilinear transducer (4-8 MHz - SonoSite) in the plane between the transverse process of L4 and the spinal erector muscle, bilaterally in each cadaver. by the same operator. After injection of the solution, the cadavers will be submitted to posterior lumbar region dissection by an anatomist and analyzed the dispersion and impregnation of the blue solution.
To investigate the efficacy of the footstrike pattern transition from rearfoot to midfoot / forefoot pattern compared to lower limb muscle strengthening exercises and lumbar spine region on decreasing the intensity of chronic musculoskeletal pain in cadets from Naval School. Methods: A randomized controlled trial with blind evaluator and allocation of participants in three parallel groups will be performed. Participating in the study, 81 cadets of the Naval Academy of Rio de Janeiro, between 18 and 24 years of age with chronic musculoskeletal pain in the lower limbs or in the lumbar region and who have the rearfoot as footstrike pattern. Participants will be randomly assigned into the following groups: (1) footstrike pattern transition from rearfoot to midfoot / forefoot; (2) muscle strengthening of the lower limbs and lower back; and (3) usual treatment group. Primary treatment outcomes will be pain and specific disability measured twelve weeks after randomization. Secondary treatment outcomes will be pain and specific disability measured six and nine months after randomization. An intention-to-treat analysis will be performed using mixed linear models to compare outcomes between groups.
The purpose of this study is to determine the effects of early intervention (placement into foster care, and a caregiving training) on physical, cognitive, social and brain development and psychiatric symptomatology in children place in out-of-home care.
OBJECTIVES: To assess the effect of concurrent training (CT) of an eight-week on strength, power and cardiorespiratory fitness on muscle condition, balance, load distribution in the lower limbs and aerobic capacity in patients with unilateral transtibial amputation (UTA). MATERIAL AND METHODS: Twenty-six individuals with prosthesis over 3-months were selected. Patients were randomly divided into two groups. Group 1 (n = 17) denominated UTA who performed the evaluation and training recommended by the prosthesis (bodybuilding vs. aerobic interval-training on the exercise cycle ergometer). Group 2 (n = 9) denominated untrained unilateral transtibial (UUT) amputees who after the evaluation were not included for the recommended training. All patients were evaluated at the baseline time of randomization and eight weeks after
The preparation of ICU Diary, conducted by the Hospital care team towards the patient, has been suggested as an effective and low-cost strategy to enhance the patient's experience in the intensive care unit, as well as to prevent anxiety, depression and Posttraumatic Stress Disorder (PTSD). New-found researches in Brazilian ICUs indicates the pervasiveness of these symptoms in patients who have been hospitalized in the unit, however, there are no randomized trials that evaluate the impact of Diaries in the Brazilian context. The aim is to explore the effects of providing an ICU Diary in the symptoms of anxiety, depression and PTSD within patients who were hospitalized in the unit. Refers to a randomized controlled trial that is being conducted in two ICUs in a general-purpose hospital in Porto Alegre, Brazil.
This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered on Day 1 (D1) at every 3 weeks (Q3W) schedule. Pomalidomide will be administered daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first.