The Drug Product ZYN002 is a transdermal CBD gel. CBD is the primary non-euphoric cannabinoid contained in the Cannabis sativa L. plant. The CBD contained within ZYN002 is a pharmaceutically produced Active Pharmaceutical Ingredient (API) that is chemically identical to the CBD present in Cannabis. ZYN002 is currently being evaluated in clinical trials in children and adolescents with Fragile X Syndrome (FXS), autism spectrum disorder, 22q11.2 deletion syndrome, and developmental and epileptic encephalopathies. The safety and efficacy of ZYN002 in the treatment of behavioral symptoms in children and adolescents with FXS has been evaluated in three studies: Study ZYN2-CL-009, a completed open-label, multiple-center, multiple-dose study (n=20); Study ZYN2-CL-016, a completed randomized, double-blind, placebo-controlled, multiple-center study (n=212 randomized); and Study ZYN2-CL-017, an ongoing open-label extension and expanded access study to assess the long-term safety and tolerability of ZYN002 (n=240). The present protocol for ZYN2-CL-033 (RECONNECT) is designed to evaluate the efficacy and safety of ZYN002 for the treatment and behavioral symptoms in children and adolescents with genetic evidence of full mutation FXS. Qualified subjects that complete ZYN2-CL-033 will have the opportunity to roll over to the open label ZYN2-CL-017 study.
The purpose of this project is to study DNA and its connection to your health. DNA is in your blood, your saliva, and other tissues in your body. DNA is the unique instructions you are born with that tells your body how to work. By looking at DNA, you can learn information about your health, certain traits, and even your ancestral roots. DNA is also called your genetic information. DNA is mostly the same from person to person. But everyone's DNA is slightly different. We are still learning how DNA impacts health. This study will look at the DNA of many different people from many different backgrounds and compare it to information in their health records. The goal is to understand how learning about DNA can help improve health care for individuals, families, and the community.
Participants will provide a sample for DNA sequencing. Sequencing is the process of reading the letters of your DNA. This study may sequence your whole genome. Over time, you may be asked to provide additional samples for research purposes. The research team will collect health information about you from your medical record and may ask you questions about your health using surveys or other data collection method.
The purpose of this project is to study DNA and its connection to your health. DNA is in your blood, your saliva, and other tissues in your body. DNA is the unique instructions you are born with that tells your body how to work. By looking at DNA, you can learn information about your health, certain traits, and even your ancestral roots. DNA is also called your genetic information. DNA is mostly the same from person to person. But everyone's DNA is slightly different. We are still learning how DNA impacts health. This study will look at the DNA of many different people from many different backgrounds and compare it to information in their health records. The goal is to understand how learning about DNA can help improve health care for individuals, families, and the community.
Participants will provide a sample for DNA sequencing. Sequencing is the process of reading the letters of your DNA. This study may sequence your whole genome. Over time, you may be asked to provide additional samples for research purposes. The research team will collect health information about you from your medical record and may ask you questions about your health using surveys or other data collection method.
The purpose of this project is to study DNA and its connection to your health. DNA is in your blood, your saliva, and other tissues in your body. DNA is the unique instructions you are born with that tells your body how to work. By looking at DNA, you can learn information about your health, certain traits, and even your ancestral roots. DNA is also called your genetic information. DNA is mostly the same from person to person. But everyone's DNA is slightly different. We are still learning how DNA impacts health. This study will look at the DNA of many different people from many different backgrounds and compare it to information in their health records. The goal is to understand how learning about DNA can help improve health care for individuals, families, and the community.
Participants will provide a sample for DNA sequencing. Sequencing is the process of reading the letters of your DNA. This study may sequence your whole genome. Over time, you may be asked to provide additional samples for research purposes. The research team will collect health information about you from your medical record and may ask you questions about your health using surveys or other data collection method.
The purpose of this project is to study DNA and its connection to your health. DNA is in your blood, your saliva, and other tissues in your body. DNA is the unique instructions you are born with that tells your body how to work. By looking at DNA, you can learn information about your health, certain traits, and even your ancestral roots. DNA is also called your genetic information. DNA is mostly the same from person to person. But everyone's DNA is slightly different. We are still learning how DNA impacts health. This study will look at the DNA of many different people from many different backgrounds and compare it to information in their health records. The goal is to understand how learning about DNA can help improve health care for individuals, families, and the community.
Participants will provide a sample for DNA sequencing. Sequencing is the process of reading the letters of your DNA. This study may sequence your whole genome. Over time, you may be asked to provide additional samples for research purposes. The research team will collect health information about you from your medical record and may ask you questions about your health using surveys or other data collection method.
This study will recruit 2,634 participants,50 years of age or older, who have sustained a primary fragility fracture of the hip, femur, pelvis, clinical spine, humerus, or wrist in the last 12 months. Participants will be recruited from approximately 20 sites around the United States. Patients will be randomized to either continue treatment with "Augmented Fracture Liaison Service" or to continue with "Enhanced Usual Care." Both pathways incorporate patient education about the high risk of future fractures and available treatment approaches for fracture risk reduction. Patient education materials, in English or Spanish, will include information about fractures, bone health and osteoporosis, and will refer participants to resources to provide additional education on ways to reduce the risk of another fracture. Both arms of the study will be mailed education materials after enrollment. Study participation will consist of surveys over the course of 2 years, and a visit to a bone health specialist.