Campina Grande

This research aims to compare the effects of implantable Gestrinone pellets and oral Dienogest tablets in treating symptoms related to endometriosis. The study involves adult women aged 18 to 45 years who are pre-menopausal and seeking treatment for endometriosis. The trial is a randomized controlled clinical phase 4 study designed to evaluate how these two therapies impact pain and lesion regression associated with endometriosis. Participants will be randomly assigned to one of two groups: one group will receive 1.6 mg/kg of Gestrinone pellets implanted under the skin in the gluteal region, while the other group will take 2 mg of oral Dienogest daily. Follow-up visits are scheduled at 1 week, and 1, 3, 6, 9, and 12 months after starting treatment to monitor effects and changes. During the study, researchers will assess the severity of menstrual pain, pain during intercourse, and non-cyclical pelvic pain using verbal and visual scales at multiple time points up to 12 months. They will also evaluate uterine bleeding, systemic effects through blood tests, changes in endometriosis lesions and endometrial thickness by ultrasound, body composition, quality of life, and sexual function. The study uses validated statistical methods to analyze the data and monitor safety throughout the 12-month period.

This research aims to evaluate whether lowering blood phosphate levels in people with end-stage kidney disease (ESKD) who are on dialysis can reduce the risk of death or major heart-related events compared to maintaining higher phosphate levels. The study also looks at whether lowering phosphate improves physical health, fatigue, quality of life, patient satisfaction, and itching, as well as whether it is cost-effective. Hyperphosphatemia, or high phosphate in the blood, is common in ESKD and linked to higher death risk, but there is no strong trial evidence that lowering phosphate improves important patient outcomes. Participants will be randomly assigned to one of two groups: an intensive phosphate target group aiming to keep serum phosphate at or below 1.50 mmol/L using phosphate-lowering medications, or a liberal phosphate target group aiming for a higher phosphate range of 2.0 to 2.5 mmol/L. In the liberal group, all phosphate-lowering drugs at baseline will be stopped and only restarted if phosphate rises above 2.5 mmol/L. Medication choice and doses will be based on physicians' and participants' decisions to meet target levels. The trial is multinational and will include 3600 adults on dialysis. During the study, researchers will track major outcomes including cardiovascular death or serious heart and artery events over 5 years. They will also assess physical health, quality of life using the EQ5D-5L questionnaire, fatigue, itching, and overall survival. The study involves monitoring serum phosphate levels and medication use, and measuring cost-effectiveness of the treatment strategies. Participants will be followed closely to understand the safety and impact of the phosphate targets on their health and well-being.