This is a Phase 3 study. Phase 3 studies can involve testing a study drug in hundreds to thousands of people over several years. The main purpose of this study is to see if the study drug, Niraparib, works better than the comparator drug in people who have just been diagnosed with glioblastoma. The comparator drug is a type of chemotherapy commonly used to treat newly diagnosed glioblastoma.
This study includes:
• Phase 1, where subjects will take either the study drug or comparator drug. All participants will also receive radiotherapy in this phase. In this phase, there will be about 45 visits to the study center. The duration for this phase will last as long as the cancer does not get worse.
• Phase 2, where subjects will continue with the same drug given in Phase 1 without radiotherapy. In this phase there will be about 53 visits to the study center and participation in the study will last for 42 weeks.
There are four periods of the study, the screening period (last about 1 month), study treatment period (as long as desired or up to 8 months), safety follow-up period (1 month), and long-term follow up period (up to 5 years).
Some procedures in this study are blood tests, memory, speech and thinking test, ECG, tissue sample, bone marrow biopsy, and imaging test. Some risks include the cancer could get worse and there are risks associated with the study drugs (for example, low appetite, difficulty speaking, headaches, vomiting, nausea, diarrhea, etc.)

This study gives people who were part of an earlier Avalyn research protocol with inhaled pirfenidone versus placebo an opportunity to convert to open label or active investigational drug treatment. The goal is to continue learning additional safety and efficacy information in patients over a longer period of treatment time. Pulmonary fibrosis is a disorder with a poor prognosis that is often far worse than many cancers with limited treatment options. While this medication has yet to be proven effective, the safety profile currently is acceptable and the risks versus benefits favor offering this opportunity to patients with informed consent.

The GRIT-PKP2 study will evaluate the long-term safety and tolerability of LX2020 gene therapy for subjects with PKP2-ACM who have previously received an investigational study medication called LX2020. PKP2-ACM is an inherited heart condition which can cause heart muscle and electrical damage. Investigational means it is not approved for use by the Food and Drug Administration (FDA). There is no investigational treatment being administered in this study. The overall study duration is 4 years. The study consists of 7 visits: a rollover visit, an outpatient monitoring period, (5 visits, 18 months to 48 months after LX2020 administration in Study LX2020-01), and an end-of-study visit. Procedures and activities that subjects will undergo are: quality of life questionnaires, ECG, MRI, ultrasound, ECHO, collection of samples, remote cardiac monitoring, and collection of vital signs.

The purpose of this rollover study is to investigate the long-term safety of etavopivat in participants11 months of age and older with SCD or thalassaemia who have completed a treatment period in previous etavopivat studies (parent studies, see Section 4.1). Long-term clinical efficacy measures of etavopivat treatment will also be assessed. This study will also ensure that participants who are benefiting from etavopivat treatment have prolonged access to the drug in the time before it is commercially available in their country.

The goal of this observational study is to collect long-term safety and performance data for the use of the EndoForce System for connecting a hemodialysis graft to a vein in patients with End Stage Renal Disease. This is not an experimental procedure or an experimental therapy. This means that the study device has been approved by the FDA.

This study examines whether adding brief guided mindfulness exercises to accelerated Transcranial Magnetic Stimulation (TMS) treatment can help people with depression feel better and maintain those improvements longer. Participants will already be receiving accelerated intermittent theta-burst stimulation (aiTBS) as part of their clinical care. During the breaks between TMS sessions, they will have the option to listen to short, app-based mindfulness practices using the commercially available and free to participants Waking Up App. We will track whether this combined approach is practical, how easy participants find the meditations, and whether practicing mindfulness during treatment improves mood, well-being, or long-term recovery. The information gathered will help us design a larger study focused on improving the durability of TMS outcomes.

This study aims to create a long-term Ehlers-Danlos syndrome (EDS) biorepository and clinical research database to support gene and biomolecular discovery. The repository will serve as a sustainable resource for advancing EDS-related research by collecting both clinical data and biological samples. Participants who consent will be included in the EDS registry, which stores demographic and operative information, contact details, and biological specimens for current and future studies. Enrolled patients may also choose to be recontacted for future research opportunities. The database will link participants across specialties using identifiers such as name, date of birth, and medical record number. Data collected will include information from electronic health records, such as clinical notes, diagnoses, medications, labs, imaging, anthropometric measures, and procedure reports.

M1095-HS-303 is a Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe HS who were previously enrolled in a parental study.
Rollover to this OLE study will occur at the time of the End-of-Treatment (EOT) visit of the parental study. Upon enrollment into this study, each participant can continue to receive sonelokimab 120 mg every 4 weeks (Q4W) for up to 2 years, with a safety follow-up (SFU). Visit 8 weeks after the last dose of study treatment. Following successful training and supervision, sonelokimab will be self-administered by the participant (or caregiver if required) at home and at the study center.

Based on the research priorities identified by Cystic Fibrosis families and clinicians, the goal of the STOP PEDS randomized controlled trial is to evaluate the long- and short-term safety and efficacy of the antibiotic strategies in the management of outpatient Pulmonary Exacerbation in children with Cystic Fibrosis.

Study B7981028 is a Phase 3 long-term, double-blind extension study aimed at evaluating the safety and efficacy of ritlecitinib in participants with severe alopecia areata (AA). This study includes individuals who have completed previous ritlecitinib studies, B7981031 or B7981027, and are eligible to enroll in the B7981028 study. The research seeks to gather more comprehensive data on the treatment's effects over an extended period.