Protrieve PROTECTOR Study
The purpose of the study is to collect information about how a medical device called Protrieve Sheath intreating deep vein thrombosis (DVT). The Protrieve Sheath is an FDA-cleared device to aid the insertion of catheters into blood vessels. TheProtrieve Sheath has a mesh funnel which expands and serves as a backstop as clot is removed by thetreatment catheter. In this study the Protrieve Sheath is being used in an experimental (investigational)manner to determine if it helps prevent a pulmonary embolism (PE) from occurring during the procedure.
A Study to Assess the Safety of Intratumoral Diffusing Alpha Radiation Emitters with Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer
This is a one-arm study testing whether the new treatment with Alpha DaRT (a medical device fitted inside the tumor that emits radiation), together with mFOLFIRINOX( a standard chemotherapy), is more effective and with fewer side effects in patients with advanced pancreatic cancer or those patients whose pancreatic cancer has spread from its primary location. Alpha DaRT is a medical device that emits radiations that help kill cancer cells. Patients will be divided into two groups based on whether their cancer has spread from its original location or has spread from its primary location to other distant parts of the body. Both these groups of patients will get thestandard chemotherapy and will have the study device called Alpha DaRT inserted into their tumor. The study team will take blood samples from all patients to see how they are doing . All patients will have special scans taken to see how their cancer is responding to the study treatment. All patients will be closely monitored for side effects and safety, and followed up to two years after the last treatment dose.
Monitoring and Prediction of Treatment Response in Crohn s Disease with Dual-Energy CT Enterography
This will be a quantitative, prospective study. Patients with small bowel Crohn’s will be enrolled in the study. Patients will undergo an initial DECTE prior to starting a new therapy as is already performed by standard of care. Following implementation of medical therapy, patients will undergo a follow-up DECTE 4 to 8 months later as is performed by standard of care. Medical therapies are at the discretion of the gastroenterologist caring for the patient as per standard of care. The iodine density will be determined and 3D iodine density maps will be created for each patient at the time of both DECTE examinations. We will be required to record patient name, MRN, accession number of each CT, patient age, gender, and clinical data including the Crohn’s disease activity index (CDAI), which is a calculated score based on a combination of clinical and laboratory values that do not involve PHI. PHI (MRN, accession number, name, dates of scans) will be used to identify patients for inclusion in the study and for comparison with follow-up imaging. All PHI will be removed at the earliest opportunity. The age, gender and initial clinical information will be recorded while first identifying patients. Clinical information will also be recorded at the time of follow-up CT. Following the 2nd DECTE, all PHI including MRN and accession number will be discarded. Each patient will be assigned a random identification number for anonymous image review. No link to PHI will be maintained.
The Prospective Natural History of Congenital Insensitivity to Pain with the Anhidrosis (CIPA)
The purpose of this study is to create a database of clinical information collected from you/your child’s medical chart on a yearly basis from patients with Congenital Insensitivity to Pain with Anhidrosis (CIPA). The study will document the clinical features of patients with CIPA overtime by storing their routine clinical test results in a central database. The study will involve collaborators at other specialist clinics around the world who follow/evaluate patients annually. Providing blood for future use is optional.
Cardiometabolic Comorbidity Burden and Vascular Health in Heart Failure with Preserved Ejection Fraction
The purpose of this research study is to investigate blood vessel wall function and genetic information (blueprints of your cells) in people with heart failure and preserved ejection fraction and determine the relationship between blood vessel wall function and health status. We hope to improve our understanding of heart failure to be able to develop new strategies to care for and treat people with this disease. We are asking you to take part in this research study because you have a medical condition being studied and/or are scheduled to have test/procedure.
DISCOVERY of Risk Factors for Type 2 Diabetes in Youth Study
Type 2 Diabetes (T2D) is a medical condition in which high blood sugars develop in the body. The DISCOVERY study team is doing this study to learn about things that put youth at risk for early onset of T2D. This study will help us develop future studies on how to prevent and treat youth-onset T2D. The DISCOVERY study will enroll and follow a large group of youth (about 3,600) at higher than average risk of developing T2D. They will be closely followed with measures that may predict the development of T2D as they go through puberty.
Glycemic and Cardiometabolic Biomarker improvements associated with reduction in air pollution exposure
In this research, we will conduct a double-blind, sham-controlled, randomized trial to examine the glycemic and cardiometabolic impact of air pollution exposure reduction using home portable air cleaners (PACs) in a cohort of 142 adult with prediabetes. This study will not evaluate the PAC or sham as medical devices in the context of this research; rather, the PAC and sham will be used per their commercialized indication as tools to standardize the conditions in order to measure the glycemic and cardiometabolic impact of reduced air pollution exposure.
Tuberous Sclerosis Complex Biosample Repository and Natural History Database Project
The purpose of the project is to learn more about tuberous sclerosis complex (TSC) which may lead to new treatments for conditions that affect different areas of the body such as the brain, kidney, lungs, and skin. The TSC Biosample Repository was established to provide a central biobank for the collection of blood, tissues, and cells from a vast number of individuals with TSC. The TSC Alliance Natural History Database, established in 2006 will serve as the central repository of de-identified clinical data associated with biosamples collected from individuals with TSC. The VARI Biorepository will distribute biosamples to researchers as approved by the TS Alliance.
Interferometric Near-infrared Spectroscopy (iNIRS) for non-invasive sensing of tissue blood flow and oxygenation
It has been challenging to diagnose diseases occurring deep within the human brain with portable and inexpensive medical imaging. While technologies such as Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) provide state-of-the-art imaging resolution, more portable, less invasive, and cheaper technologies are needed. This study will test a new non-invasive technology, called Interferometric Near-infrared Spectroscopy (iNIRS), that uses light to measure flow and oxygenation deep inside tissues. During the study, non-invasive optical monitoring of blood flow and other physiological parameters will be performed in participants as they perform simple tasks, or during physiological manipulations.
The ConsideRAte study. A multipart exploratory study to evaluate splenic nerve stimulation in patients with rheumatoid arthritis.
The ConsideRAte study This study will evaluate the safety, tolerability, and effects ofstimulating the splenic neurovascular bundle (NVB) with an activeimplantable medical device system. The study will consist of 4 studyperiods, including a Randomized Control Trial period (Period 1), anOpen Label period (Period 2), a Treat-to-target period (Period 3), and aLong-term Follow-up period (Period 4). Participants with activerheumatoid arthritis (RA) will receive an implantable system and,following a recovery period of at least 28 days after implant of thesystem, will be randomly assigned at Day 1 (of Period 1) to receiveeither active stimulation or sham-stimulation via this system for 12weeks (84 days). Day 1 assessments will be used as baseline.Summary of IB Version 2:Version 1, 16 Dec 2020 Initial ReleaseVersion 2, 23 Jul 2021 Add preclinical testing supporting increase target stimulation dose increase from 15 mA to 20 mACover Page, Headers, Table of Contents Updated version, DatePage 3 Updated Sponsor signatory to Chief Medical OfficerSection 2.4 Removed previous target amplitudeSection 2.7 Added brief description of preclinical study (2nd GLP study); brief conclusionsSection 6.1 Added mention of new GLP study and brief resultsFigure 20 Corrected max dose amplitude in from 15 mA to 20 mASection 9.2 Added brief description of the new preclinical study (GAL1063)Section 9.4 Added more detailed description and results of the new preclinical study (GAL1063)Table numbers and section numbers Adjusted tables numbers and section numbers to account for the section added to describe the new GLP studySection 13.1.5 Updated results and figures from the new GLP study (GAL1063)Section 13.5.2 Updated estimated nerve recruitment rates and figure at the new target amplitude (20 mA) Section 14 Appendix II Added background rationale for GAL1063 study. Change to IB Version 3: Version 1, 16 Dec 2020 Initial ReleaseVersion 2, 23 Jul 2021 Add preclinical testing supporting increase target stimulation dose increase from 15 mA to 20 mACover Page, Headers, Table of Contents Updated version, DatePage 3 Updated Sponsor signatory to Chief Medical OfficerSection 2.4 Removed previous target amplitudeSection 2.7 Added brief description of preclinical study (2nd GLP study); brief conclusionsSection 6.1 Added mention of new GLP study and brief resultsFigure 20 Corrected max dose amplitude in from 15 mA to 20 mASection 9.2 Added brief description of the new preclinical study (GAL1063)Section 9.4 Added more detailed description and results of the new preclinical study (GAL1063)Table numbers and section numbers Adjusted tables numbers and section numbers to account for the section added to describe the new GLP studySection 13.1.5 Updated results and figures from the new GLP study (GAL1063)Section 13.5.2 Updated estimated nerve recruitment rates and figure at the new target amplitude (20 mA) Section 14 Appendix II Added background rationale for GAL1063 study. Version 3; 22 Oct 2021 Revised to include new validation packaging results, and updated tables from V&V testingCover Page, Headers, Table of Contents Updated version, DateSection 11.1 Updated Table 14 to describe the correction for Failed package testing as complete. Updated Table 15 & 16 to describe the design changes for the packages that were re-tested, and results.Section 11.1.1 Updated Table 18 V&V testing table to include the GAL1063 GLP study and PASS criteria