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 comparative trial between oxytocin alone and dinoprostone for cervical ripening in unfavorable cervix pregnant women with 38 or more weeks of gestational age.
This is a prospective, randomized, double-blind, placebo-controlled study. In an initial phase, 100 patients with chronic low back pain will be included in this study. The patients will be recruited through magazines and newspapers to take part in a screening for treatment of low back pain. This screening will involve the evaluation of data such as history and physical examination to classify the patient in the group of nonspecific low back pain, excluding patients with neurological alterations and the so-called Red-Flags. Procedures After the initial screening the patients will undergo diagnostic blocks of the medial branch of lumbar vertebrae L2, L3, L4 , L5 and of the first sacral vertebra (S1) with lidocaine and control with distilled water. The patients that present more than 50% of pain improvement, evaluated by the Likert scale after 30 minutes will form the study group, while the patients that do not present pain improvement with lidocaine or that present pain improvement with distilled water will be excluded. The medial branch block consists of the insertion of a 90mm, 25-gauge needle through the skin with radioscopic control up to the medial branch topography. Infusion of 1ml of 2% lidocaine should be performed in each medial branch of the abovementioned vertebrae. Control is executed in the same manner yet with infusion of 1ml of distilled water. Through the use of the diagnostic block we will have 40 patients selected for the second phase of the study. Once defined the study group should be evaluated before the procedure through the Oswestry, Roland Morris, SF-36 and VAS questionnaires. In the second phase of the study the patients will be randomized. The random division into two groups will be performed through a computerized program of random numbers. The randomization result will be kept in matt sealed envelopes to guarantee secrecy of the allocation. The neurolysis procedure will be carried out in the first group, consisting of 20 patients, and the placebo or sham procedure with the second group, also with 20 patients. The neurolysis procedure will be carried out under sterile conditions, with the patient lying prone and with the neurotome insertion sites anesthetized with 2ml of 1% lidocaine. The neurotome (Smith & Nephew - RF) will be used for the procedure. The neurotome is a radiofrequency apparatus mounted on a 10cm electrode type 22 needle with a 5mm exposure tip. The neurotome should be introduced percutaneously in a manner similar to that adopted in the medial branch block through radioscopic control. The temperature of the electrode after its placement in the correct position is then raised to 80 °C for 90 seconds. Two neurotomies should be performed for each facet, one proximally and the other distally, due to double innervation of each facet. In the patients of the placebo group the procedure will be the same only the temperature of the neurotome will not be raised. This will be performed in a blind manner, as before starting the procedure, the surgeon will show the assistant who turns the device on or not the envelope containing the patient's group (placebo or neurotomy), yet the surgeon will not be informed whether the device has been turned on or not, having to perform the procedure in the same manner in both groups. The patients will then be reevaluated in the first month, 3 months after, 6 months after and 12 months after the procedure. The assessors will not be informed of the group to which the patient belongs, and the same scales performed in the preoperative period will be used here.
Fibromyalgia is a medical condition characterized by musculoskeletal pain, fatigue, sleep disturbances and depression. It affects population at a socioeconomically active age and represents a burden for the patients and the health care system due to its personal and functional implications. At this moment, there is no completely effective treatment for fibromyalgia, and acupuncture has been a promising alternative. This trial aims to evaluate if addition of acupuncture to standard care represents an improvement in comparison with standard care only. Thus, patients enrolled in this trial will be randomly allocated into one of two groups: group A, who besides standard treatment will receive 12 sessions of acupuncture; and group B, who will receive standard care with monthly orientation sessions for the same period. Patients will be evaluated at baseline, after completion of acupuncture treatment or orientation, and after an additional 12-week follow up. Evaluation will be based on diaries of pain and medication, and standard scales of pain, quality of life and disability.
The Observational Study in the "Real World" of Implantable Electronic Cardiac Devices will enable the construction of an electronic database with local access to clinical information, which will collect and disseminate epidemiologic data on demography, cardiovascular mortality and morbidity, and potential risk factors for a selected group of patients. These clinical variables will be analyzed against the data, as based in the programming of devices and the diagnostics. Approved descriptive statistics and analyses will be made available via Internet. The study will describe statistical indexes on sub-groups representing more than 10% of total of datasets. The study will be open to include any patient that had a Medtronic electronic device implanted, pacemakers, ICD, ICD with CRP. The study will be also adapted for devices implanted in the present and for devices to be implanted in patients in the future.
Intestinal absorption of levothyroxine (LT4) tablets depends on its dissolution in gastric acid secretion, which is reduced after bariatric interventions. Impaired LT4 absorption due to low gastric dissolution has been reported in patients with atrophic or chronic gastritis. The objective of this study is to evaluate the absorption of LT4 tablets in morbidly obese patients before and after Roux-en-Y bariatric surgery.
This study will evaluate the efficacy and safety of LCP-Tacro (tacrolimus) Tablets administered once-a-day compared to Prograf (tacrolimus) Capsules twice-a-day as immunosuppression for the prevention of organ rejection in newly transplanted adult kidney transplant recipients. Patients will be treated for a 12 month study period followed by a 12 month, blinded extension treatment period To show that LCP-Tacro Tablets are clinically similar to Prograf Capsules in the prevention of acute rejection.
The purpose of this study is to generate immunogenicity and safety data in preparation for efficacy studies in Latin America. Primary Objectives: - To describe the immune response to dengue viruses before and after each vaccination with CYD dengue vaccine. - To evaluate the safety of each vaccination with CYD dengue vaccine.
The aim of the present study was to carry out a pilot project comparing the effectiveness of two therapeutic approaches to temporomandibular disorders (TMDs) in adolescents. Eight female individuals diagnosed based on the Research Diagnosis Criteria for TMDs (RDC/TMD-axis 1)were randomly divided into two groups: 1) Massage therapy and muscle stretching (n=4); and 2) transcutaneous electrical nerve stimulation (TENS) (n=4). Regardless the treatment, ten sessions were held for each patient and two measurements (baseline and 10th session) were performed for the assessment of symptom evolution using a visual analog scale (VAS), maximum opening of the mouth (MOM) and pressure pain threshold (PPT). Statistical analysis wiil be carefully selected.
The aim of this study is to compare the incidence of tinnitus between mp3 users and non-users, aged between 15 and 30 years old. 100 patients will be recruited in Valença secondary schools. High frequency audiometry and otoacoustic emissions will be performed.Tinnitus patients will complete the Tinnitus Handicap Inventory questionnaire.
The purpose of this study is to evaluate prospectively whether concentrate fibrinogen reduces blood losses, transfusion requirements and occurrence of clinical complications compared to cryoprecipitate in children after cardiac surgery with pump.