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.
Scenario: spontaneous perineal laceration is an injury to the tissue in the perineum region, which can occur during vaginal delivery. The lesion can be classified into four degrees, according to the structures affected, with degrees one and two being more common. Some consequences may arise due to lacerations, such as perineal pain, genito-pelvic pain, in addition to infection, and dehiscence of the lesion, which may last up to one year after delivery. A laser is a form of non-ionizing radiation and when used in the repair process it is capable of generating analgesic, anti-inflammatory, and healing effects. Low-level laser treatment has been used in several areas, promoting cellular and vascular responses capable of accelerating the repair of injured tissue, in addition to pain relief and consequently capable of improving patients' quality of life. Objective: To determine the effects of low-power laser on the acceleration of the healing process and pain relief in primiparous women who had a spontaneous perineal tear, grade one and two, during normal delivery. Methods: a pilot randomized clinical trial will be carried out. Two groups will be divided randomly, one group will receive the application of the laser, and the second group the laser "sham". Data collection will be carried out at the LAbor and delivery rooms of the Instituto de Medicina Integral Prof. Fernando Figueira (IMIP). Primiparous women who had a spontaneous perineal tear, grades one and two, over 18 years of age or younger who are in charge, with a full-term pregnancy, single fetus, cephalic presentation, and who have been admitted to labor at the ANC will be included, excluding patients who are transferred to another sector, those that evolve to a cesarean section or need episiotomy or curettage and, in addition, the presence of infection during childbirth assistance, postpartum hemorrhage and suspected or diagnosed COVID-19. The laser will be applied at three predetermined moments: six hours, 24, and 48 hours after delivery. To evaluate the healing process a REEDA scale and a Peri-rule will be used. The assessment of pain intensity will be through the Visual Analogue Scale (VAS). Ethical Aspects: the research will be submitted to the IMIP Research Ethics Committee and data collection will begin after its approval. All data will be kept confidential and confidential, the participant will be asked to sign the Informed Consent Form before beginning any procedure.
The purpose of this study is to evaluate crovalimab for the treatment of a sickle cell pain crisis (also known as a VOE) that requires hospitalisation in adult and adolescent participants with SCD. The primary objective of this study is safety and will additionally evaluate pharmacokinetics (how crovalimab is processed by your body), pharmacodynamics (how your body reacts to crovalimab) and the preliminary efficacy of crovalimab compared with placebo.
Objective: To assess whether residents (R1, R2 or R3 according to the year of residency) of an orthopedic tertiary service, investigate, treat and / or refer the patient with an osteoporotic fracture to treat osteoporosis (OP) and whether this learning is improved over the years of residence. Methods: Residents answered diagnostic and therapeutic questions related to a clinical case of osteoporotic fracture (OF) in 4 scenarios, which were the initial care in the emergency room, at the time of discharge from hospital, during their outpatient return in 3 and 6 months. Answers were compared between years of residence.
Skin aging is an irreversible, slow and progressive process, being influenced mainly by age, but also by external factors such as ultraviolet radiation, smoking, alcohol, among others. Studies have shown benefits of photobiomodulation for facial rejuvenation, especially with the use of red LED. However, there is still a high level of variability in treatment parameters and frequency of application of FBM. The purpose of this study is to compare the effects of photobiomodulation with LED mask (660nm, 6.4 mW/cm², 2.67 J/cm², 5.02 mW, 21 min) on facial rejuvenation using 2 application frequencies: a group will receive 2 weekly applications for 4 weeks and another group will receive 3 weekly applications for the same period. A group with simulated photobiomodulation applied twice a week for 4 weeks will be used as a control. The treatment will be performed in female participants aged between 45 and 60 years. After a period of one month, the depth and width of wrinkles (assessment of face impressions by optical coherence tomography), evaluations of photographic images by specialists (Wrinkle Assessment Scale), as well as the quantitative analysis of the wrinkle size by the Image J software and the level of satisfaction of the participants (FACE-Q) will be compared with data collected before the start of the study. All data will be statistically analyzed according to their distribution, seeking a level of statistical significance of 5%.
Bacterial plaque-induced gingivitis is considered the most common oral disease in dentate individuals and the most frequent type of periodontal disease. Manual brushing is the most widely used method for mechanical plaque self-control and, consequently, prevention and treatment of gingivitis. The effectiveness of brushing, however, is questionable in interproximal areas. Thus, interdental cleaning is recognized as an essential part of maintaining gingival health and the most recommended interdental device is dental floss. However, there is weak scientific evidence available about the recommendation for daily flossing. The objective of this randomized blinded trial is to evaluate the efficacy and effectiveness of oral hygiene using soft toothbrush associated with dental floss versus soft toothbrush in maintaining the gingival condition in adults without loss of insertion. Seventy-six subjects with generalized gingivitis at proximal sites will be randomized into two experimental groups according to the use of dental floss: Manual toothbrushing group without the use of dental floss (without dental floss) and Group dental toothbrushing and dental flossing (dental floss). During a period of 8 weeks, the efficacy of the use of the toothbrush associated with the use of the dental floss will be evaluated. After this period, the baseline of the effectiveness study begins. After this period, the baseline of the effectiveness study begins. Participants will be followed up for another 12 months to evaluate the effectiveness of flossing. The parameters Index of Gingival Bleeding (GB) and Plaque Index (PI) will be evaluated at the baseline, 60, 120, 240 and 360 days. Descriptive analysis of GB and PI data will be performed using means, standard deviations and mean percentage of sites with different GB and PI scores. The differences in the means of GB and PI over time between groups and within the same group will be analyzed using the Poisson Multilevel Regression model. The main outcome will be the maintenance of the gingival condition. The difference in interventions will be compared using the chi-square test with significance level of 5%. Adults with less than 15% of sites with gingival bleeding will be considered healthy.
The objective of this observational study is to evaluate the seroprevalence of anti-AAV antibodies in subjects with Ornithine Transcarbamylase (OTC) deficiency, Glycogen Storage Disease Type Ia (GSDIa), and Wilson Disease
Introduction: The overactive bladder is a highly prevalent condition, which negatively impacts the quality of life and daily activities of women. Transcutaneous electrostimulation is currently a therapeutic alternative for urinary urgency symptoms. Although it can be applied to the sacral plexus or tibial nerve, the literature shows the effectiveness of these two modalities, in isolation, but there are few scientific studies that compare them as two therapeutic alternatives. Primary objective: to evaluate the efficacy between parascutaneous electrostimulation, tibial transcutaneous stimulation, and home protocol in the treatment of female overactive bladder. Methodology: This is a clinical trial, which will include women with a clinical complaint of overactive bladder, with or without urgency-incontinence, who will be randomized into 3 groups: transcutaneous parasacral electrostimulation (EETP), transcutaneous tibial electrostimulation (EETT) and a third group, home transcutaneous parasacral electrostimulation (EETPD), will consist of women who have financial difficulties or locomotion to attend the clinic.All groups, in the first session, will be guided to conduct behavioral therapy and will receive an educational booklet with guidelines. The equipment to be used will have a wave frequency of 10 Hz, a pulse width of 700 µs and a 20-minute session, with intensities according to the participant's tolerance. The intervention protocol of the EETP group is 30 sessions, three times a week, with an active electrode in the parasacral region. For EETT, 30 sessions will also be held, three times a week, with the electrode active in the tibial region. Participants will be captured at educational events held by the Pelvic Floor Service Center in Salvador and the metropolitan region. Participants will answer the basic anamnesis questionnaires, ICIQ-OAB, ROMA III criteria, Bristol scale, Hospital Anxiety and Depression Scale, Oswestry scale, Pittsburgh sleep quality index and Female Sexual Function Index. Then, the assessment of the bladder neck and the thickness of the bladder wall will be performed by 2D ultrasonography via suprapubic and intravaginal, following the assessment protocol described for the intervention groups. Primary outcomes: clinical improvement of symptoms, urinary frequency, episodes of urgent urinary incontinence, presence of adverse effects and constipation. Secondary outcomes: quality of life, sexual function, quality of sleep, anxiety and depression, muscle function (PERFECT and electromyography), lumbar-pelvic pain (pain intensity) and ultrasound. Participants will be followed for a minimum of 12 months to verify the long-term response, returning every 3 months. Expected results: The outpatient transcutaneous parasacral electrostimulation is expected to be superior when compared to the tibial transcutaneous electrostimulation in the resolution of the symptoms of the overactive female bladder.
The purpose of this study is to demonstrate non-inferiority (NI) in terms of humoral immune responses after 6 dose levels of Ad26.COV2.S.
The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.
Intraoperative methadone or fentanyl will be administered to patients submitted to kidney transplant surgery. Postoperative pain, analgesic consumption and side effects will be evaluated