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Researchers are evaluating the safety and effectiveness of subcutaneous immunotherapy in people aged 12 to 65 who have allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, sensitized to cupressaceae and grass pollens. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to compare active treatments with a placebo over an 18-month period. The study focuses on reducing symptoms and medication use during the pollen seasons of cupressaceae (January to March) and grasses (May to June). Participants will receive one of three treatments: two different doses of purified and polymerized allergen extracts from a mix of grasses and cupressaceae, or a placebo that looks the same but contains no active ingredients. These treatments are given as subcutaneous injections. Each participant will be treated and monitored for 18 months, covering multiple pollen seasons with continuous dosing. During the study, participants will track their symptoms and medication use daily using an electronic diary on their smartphone. Researchers will assess combined symptom and medication scores to measure treatment effects during pollen seasons. Safety and adherence will be monitored throughout the 18 months. The study involves 180 participants and includes various clinical assessments to ensure accurate evaluation of treatment impact and participant wellbeing.

Age: 12Years - 65YearsAll GendersPhase 3
27 locations
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Actively Recruiting

Breast cancer remains the leading cancer affecting women worldwide, with many survivors facing serious side effects from treatment such as muscle loss, fatigue, and reduced physical ability. Researchers are exploring melatonin, a natural hormone with antioxidant and anti-inflammatory properties, to see if it can help improve physical function and quality of life in women over 60 years old who have survived breast cancer. This study focuses on the effects of melatonin combined with a physical exercise program to understand its potential benefits in this population. Participants are divided into two groups: one receiving 6 mg of melatonin daily through capsules and the other receiving a placebo that looks similar to melatonin capsules. Both groups follow a supervised physical training program suited to their age and abilities for 10 weeks. Various tests are conducted before and after the intervention to measure muscle damage, hormone levels, antioxidant capacity, physical performance, body measurements, and quality of life. Throughout the 10-week study, researchers assess participants' blood markers like Irisin and Sestrin-2 on the first day and after supplementation. Physical performance tests include handgrip strength and other functional assessments. Quality of life is evaluated with questionnaires covering physical and psychological health, social relationships, and environment. The study lasts about 10 weeks, during which participants are closely monitored to understand melatonin's impact when combined with exercise.

Age: 60Years - 80YearsFEMALEPhase Not Applicable
1 location
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