Optic neuritis (ON) is a rare inflammatory disorder of the optic nerve that results in vision loss. It is characterized by rapid and variable vision loss, pain in, around and behind the eye, and changes in color vision. Subjects in this study will be followed for 12 months total and randomized in a 2:1 ratio to receive either an IV infusion medication or a placebo infusion. Low Contrast Visual Acuity will be tracked at 3 months. After 3 months, participants will continue the study
through Month 12 in the safety follow-up part of the study intended to provide longer
term safety information.

This study aims to determine if photo biostimulation with Nd-YAG laser improves wound healing following tooth extraction and alveolar ridge preservation. The impact of laser treatment on wound healing will be evaluated by levels of salivary inflammatory biomarkers, gingival wound size, and surveying for pain reduction and patient satisfaction. The intervention group will receive standard-of-care extraction and alveolar ridge preservation with adjunct Nd-YAG laser photobiostimulation on days 1, 3, and 7, while the control group will receive the standard-of-care extraction and alveolar ridge preservation only.

The purpose of this study is to learn more about long-term safety (good or bad effects) of avacopan and its efficacy (how well it is working) in treatment of antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis.

Avacopan is currently approved as an adjunctive (another treatment used along with primary treatment) treatment in adult people with severe active ANCA-associated vasculitis in the US and is also approved in the EU, Canada, Japan, and other countries.

In this study, avacopan will be compared with a placebo (a drug that looks likes the study medication but does not contain any medication). This is a randomized study, meaning that you will be assigned by chance (like flipping a coin) into a treatment group. You will have an equal chance of being placed in either of the 3 following groups: treatment with avacopan for 5 years in group A, or treatment with avacopan for 1 year followed by placebo for 4 years in group B, or treatment with placebo for 5 years in group C. The study is also a double-blinded study, meaning you and your study doctor will not know what you are receiving, the avacopan or placebo.

The study is sponsored by Amgen, Inc. Participation in the study will require 27 visits to the MUSC main campus over approximately 63 months, and visits will include the following procedures: blood draw, urine collection, physician-led assessments of your disease (for example physical exam and medical history review), and health questionnaires. You will also be provided with a paper diary to record any missed doses/overdoses of the study drug.

Compensation is available for participation.

This proposal is to contribute to data registry and sample bank called Pediatrics Biorepository for Gastroenterology Clinical Research. Samples collected in this study may be used for future research which plan to advance the state of science in the hopes to develop novel diagnostic approaches and identify therapeutic targets.

The purpose of this study is to determine if the investigational (not FDA approved) drug VIB4920 can be an effective treatment for patients with active Lupus Nephritis (LN).

This study will compare treatment with MMF (mycophenolate mofetil), Prednisone, plus the study medication VIB4920 to treatment with MMF and Prednisone alone.

Participants will have up to 15 scheduled visits that will involve routine monitoring of disease activity, up to two kidney biopsies, and blood and urine specimen collections. Participation in this study will last approximately 1 year and 2 months. Compensation is available for participation.

This is an exploratory study and the information obtained may lead to new findings regarding the inflammatory and neurodegenerative mechanisms in the progression of PD and help to develop new drugs to halt the disease progression. The study simply involves a one time blood draw.