This multi-center, prospective, randomized, clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of the SelfWrap, a bioabsorbable perivascular wrap, for supporting surgically-created AVFs and using them for dialysis.
This study will involve approximately 200 participants. Half of the subjects in this trial will receive AVFs supported by the SelfWrap, while the other half will receive a traditional AVF alone. Participants will be followed for a duration of 36 months.
The purpose of this study is to determine the clinical efficacy of a novel, bioresorbable hydrogel sheet and wetting solution, VersaWrap®, in surgeries of the foot and ankle. This is a prospective, multi-center, controlled case series with patients identified by the Investigator in his practice. Patients who are scheduled to have procedures of the Achilles tendon will be reviewed to determine if they meet the inclusion/exclusion criteria. If eligible, patients may be enrolled in the study, and the operative surgeon will use VersaWrap® during the procedure. Patients are considered enrolled when VersaWrap® is placed intraoperatively. VersaWrap® has received its FDA 510(k) clearance. Enrollment is expected to take approximately 1-2 years. All subjects will be followed for 1 year post-operatively for a total study duration of approximately 3 years. Study follow-up visits will occur at 6 weeks, 3 months, 6 months, and 1 year after surgery. Patients enrolled in this study are receiving a standard of care surgical procedure (with or
without VersaWrap) and therefore there is no increased risk of the surgical procedure when participating in the study. The study collects patient data, and therefore there is a risk data privacy loss. Patients will also receive remuneration for their participation.
Ritlecitinib (PF 06651600) is an investigational drug (referred to as "study drug" from here on) and is being developed as possible study treatment for participants with non segmental vitiligo (both active and stable vitiligo). The study drug will be compared with a placebo to find out if the study drug is better than the placebo for the study treatment of vitiligo. After a screening period of up to 30 days, approximately 1000 eligible participants (Part Ia) will be randomized in a 3:1:1 ratio to ritlecitinib 100 mg QD (600 participants), ritlecitinib 50mg QD (200 participants), and placebo (200 participants) in the 52-week placebo-controlled treatment period. At Week 52, based how patients respond to the study drug will enter the 52 week extension period.
This study is an open label, Comparative Effectiveness Research study in patients who receive a heart transplant. Subjects will be enrolled into the study while under evaluation for heart transplantation or on the transplant waiting list prior to heart transplantation. All subjects will follow the center's standard of care surveillance schedule from transplant through 4 weeks post-transplantation. The study objective is to compare the effectiveness of rejection surveillance of heart transplant recipients with Prospera dd-cfDNA to rejection surveillance with endomyocardial biopsy (EMB) in the first post-transplant year.
The Prospera™ test is a non-invasive test intended to detect and quantify the fraction of donor-derived cell-free DNA (dd-cfDNA) to supplement management and surveillance of allograft rejection in patients who have undergone organ transplantation. The subjects may undergo blood draws, echocardiogrphys, medical history and physical exams, antibody testing, nuclear imaging, and MRI as apart of the study. The study period will be during the first 12 months post-transplant. Quality of life questionnaires will be completed at week 4, month 6 and month 12 post-transplant.
This is a prospective, multi-center, double-arm, randomized, single-blind, evaluator blinded clinical trial designed to assess the safety and efficacy of the SelfWrap for prophylactic treatment intended to improve clinical outcomes for CKD patients referred for vascular access creation surgery.
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with NASH/MASH cirrhosis and fibrosis stage 4.
The purpose of this study is to find out if the investigational drug/study medicine (omecamtiv mecarbil) can reduce the risk of the effects of heart failure (HF), hospitalization, transplantation, or death. It is hoped that the study medicine increases the heart's ability to pump blood throughout the body, but we need to learn more about its effect in patients who suffer the most from HF symptoms. "Investigational" means that the study medicine is still being tested in research studies and has not been approved by the U.S. Food and Drug Administration (FDA). The study drug will be taken by mouth twice daily.
Participation in this study will last for approximately 3 years, however, participation could last from a few weeks to a few years depending on your time of enrollment. These visits will include physical exams, blood draws, electrocardiograms (ECG), echocardiogram (Echo), blood draws, questionnaires along with receiving the study drug. Participants will receive the study drug and have a 2 week wash out period to ensure tolerance. From there, participants will be randomized to either the treatment group (and receive the medication) or the control group (and not receive the medication). The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like drawing straws). Neither the subject, nor the blinded study personnel will know which group subjects are in. Neither the subject nor the study doctor or study staff will decide what group subjects are assigned.