Sample - Clinical Study - English into Brazilian Portuguese

Details of procedures:

You/your child will be first asked to sign this Informed Consent document before you/your child take part in this study.  During this Extension Study, you/your child will receive xxxxxx treatment once every week. You/your child will be weighed prior to each infusion to determine the amount of medication you/your child will receive.  The study drug solution will be given through a needle or catheter into you/your child’s vein. The infusion will take approximately four hours, and may be decreased to a minimum of two hours following the completion of the initial five extension study infusions, as tolerated. The tests and procedures (outlined below) will be carried out at certain time points throughout the study to determine the long-term safety and effectiveness of this treatment.

The following is a description of the examinations you/your child will be required to participate in during the duration of the study. The schedules of these tests are listed after their description.

Pulmonary function testing: You/your child will be asked to blow as hard as you/your child can into a mouthpiece that is connected to a machine that measures the total amount of air in the  lungs and how quickly you/your child can fill and blow out this air.

Six minute walk test: You/your child will be asked to walk (in a designated hospital area) for 6 minutes to determine your/your child’s endurance by measuring total distance traveled.

Sleep study: You/your child will be observed for at least 5 hours during a night sleep to monitor how your/your child’s breathing is affected by MPS I.

Joint range of motion: A physiotherapist will be used to record the range of motion of your/your child’s shoulders, elbows, hips, and knees.

Blood and urine collection: Approximately 50 mls (1 cup) of urine will be collected and will be used to measure urine mucopolysaccharides.

Questionnaires/Diaries:  You/your child will fill out a series of questionnaires which measure your/your child’s quality of life and activity level.

Details of procedures:

You/your child will be first asked to sign this Informed Consent document before you/your child take part in this study.  During this Extension Study, you/your child will receive xxxxxx treatment once every week. You/your child will be weighed prior to each infusion to determine the amount of medication you/your child will receive.  The study drug solution will be given through a needle or catheter into you/your child’s vein. The infusion will take approximately four hours, and may be decreased to a minimum of two hours following the completion of the initial five extension study infusions, as tolerated. The tests and procedures (outlined below) will be carried out at certain time points throughout the study to determine the long-term safety and effectiveness of this treatment.

The following is a description of the examinations you/your child will be required to participate in during the duration of the study. The schedules of these tests are listed after their description.

Pulmonary function testing: You/your child will be asked to blow as hard as you/your child can into a mouthpiece that is connected to a machine that measures the total amount of air in the  lungs and how quickly you/your child can fill and blow out this air.

Six minute walk test: You/your child will be asked to walk (in a designated hospital area) for 6 minutes to determine your/your child’s endurance by measuring total distance traveled.

Sleep study: You/your child will be observed for at least 5 hours during a night sleep to monitor how your/your child’s breathing is affected by MPS I.

Joint range of motion: A physiotherapist will be used to record the range of motion of your/your child’s shoulders, elbows, hips, and knees.

Blood and urine collection: Approximately 50 mls (1 cup) of urine will be collected and will be used to measure urine mucopolysaccharides.

Questionnaires/Diaries:  You/your child will fill out a series of questionnaires which measure your/your child’s quality of life and activity level.