An Adaptive Phase 2/3 Multicenter Double-Blind Placebo-Controlled Randomized Parallel 3 Arm Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient s Calcific Aortic Valve Disease with Mild to Moderate Aortic Stenosis (EVOID-AS)
The primary objective of this study is to evaluate the efficacy of DA-1229 vs. placebo in reducing progression of aortic valve calcification in subjects with mild to moderate aortic stenosis.
An Adaptive Phase 2a/2b Randomized Double-Blind Placebo-Controlled Study of LY3871801 in Adult Participants with Moderately-to-Severely Active Rheumatoid Arthritis
This study is being done to see how safe an investigational drug is and how well it will work to help people with moderately to severely active rheumatoid arthritis (RA).
An Evaluation of Home Urinalysis Testing for Systemic Lupus Erythematosus (SLE) Patients at Elevated Risk for Developing Lupus Nephritis: A Pilot Stage and Randomized Controlled Study
Pilot Study: Feasibility, acceptability, and adaptation. We will produce a teaching video for home-based proteinuria testing that will instruct patients on how to collect a sample and evaluate the home colorimetric dipsticks (only protein, Siemens Albutrix).The urinalysis video planned, which will simply instruct the patients how to line up the dipsticks with the single protein color chart and match the color most closely corresponding to their urine. A scoring system will be explained, such that the color matching will be assigned as follows: negative = 1, trace = 2, +300 (.300g/l) = 3, 1.000g/l = 4, 3.000g/l = 5, 10.000g/l = 6.Following informed consent at their clinic visit, 18 participating patients will view the educational video, with available subtitles in all three languages (i.e., English, Spanish and Mandarin. The patient will have sufficient dipsticks to test the first morning void once weekly for a year (with weekly reminders via a text protocol) unless earlier intervention is required. For reporting the weekly score, the patient will be instructed to respond to the text they receive on the morning of the weekly dipstick check and enter the number corresponding to the color matching the dipstick, and indicate “period” if menstruating. If the score provided by the patient is 3 or greater for two consecutive weeks, the texting program will be programmed to alert the coordinator to call the patient and ask the patient come to the local laboratory for a formal UPCR. A UPCR of 0.5 or greater would trigger an immediate SOC visit with Drs. Buyon, Saxena, Belmont, or Izmirly. We will be using the HIPAA-compliant texting platform, SlickText, for patient communication. Participants will be able to send STOP message to opt out, and the only information included is their phone number. Additionally, they will be able to send TEAM message to receive a call from the coordinator if they encounter any difficulties. Each participant will receive texts in their preferred language. Feasibility for Stage 1 will be assessed quantitatively by the number of patients approached for the evaluation versus number willing to participate, with 70% participating as considered feasible. Acceptability will be determined if =80% of participants respond that they are at least moderately satisfied, using a brief Client Satisfaction Questionnaire. Data on adherence and implementation feasibility will be captured via SlickText (number of weeks returning a dipstick value divided by overall weeks, accommodating menstruation when urinalysis may not be completed, although patients will be instructed to collect the urine and record their period). Adherence of 75% will be considered successful. Further, we will aim to clinically validate the scores reported by patients who have a scheduled standard-of-care visit preferably on the same day as the weekly morning dipstick scoring is done; we will attempt to assure that patient score readings of 1 or 2 correspond to UPCR < 0.3. If we find errors, we will coach the patient and check their supply of dipsticks for deterioration. At the middle and end of the first year of the protocol, we will conduct debriefing interviews to evaluate the personal experiences and satisfaction with the intervention and modify the protocol accordingly. Clinical Trial To Follow: Implement a larger randomized controlled trial (RCT) among all eligible in the NYU Lupus Cohort (160 participating patients). Patients will be enrolled and randomized (1:1) to home testing intervention in addition to standard of care or standard of care only. Patients who have a scheduled standard-of-care visit preferably on the same day as the weekly morning dipstick scoring is done; we will attempt to assure that patient score readings of 1 or 2 correspond to UPCR < 0.3. The primary outcome will be that has a clinical indication for a kidney biopsy (UPCR 0.5 regardless of either de novo or relapsed disease), whether or not the patient actually undergoes the procedure.
An observational multi-center study to validate outcome measures for future clinical trials of Multiple System Atrophy (MSA)
The purpose of this research study is to develop and validate new methods to measure if a potential drug being tested in future clinical trials of patients with multiple system atrophy (MSA) is effective. These methods include a scale or questionnaire (“clinical outcome assessment” or COA), brain neuroimaging (magnetic resonance imaging or MRI) and biochemical biomarkers (blood or cerebrospinal fluid (CSF) samples).
An Open-Label Multi-Center Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes
This is an open label, multi-center, retrospective and prospective clinical study. Patients who are to undergo shoulder arthroplasty may be screened for participation. Likewise, patients who have previously undergone shoulder arthroplasty with the Equinoxe®, or other arthroplasty systems, may be screened for enrollment. This study may include patients from multiple centers, both US and international, undergoing hemi- or total shoulder joint replacement. Patients will be screened for enrollment based upon the inclusion and exclusion criteria described in the protocol.
AN OPEN-LABEL MULTICENTER STUDY OF LOXO-435 (LY3866288) IN ADVANCED SOLID TUMOR MALIGNANCIES WITH FGFR3 ALTERATIONS
This is a study of a drug called LOXO-435 for patients with advanced solid tumors, specifically focusing on metastatic urothelial cancer (mUC) that has a change in a gene called FGFR3. The study will be conducted in two phases. Phase 1a is the first part and will test different doses of LOXO-435 to determine its safety, how well it is accepted by the patient's body, how the body processes it (pharmacokinetics), and its initial effectiveness. This phase will include patients with any type of solid tumor that has an alteration in the FGFR3 gene or its related proteins. The goal is to find the recommended dose for the next phase. Phase 1b is the second part and will involve four groups of patients receiving the recommended dose from Phase 1a. These groups will include patients with urothelial cancer, either as a single treatment or in combination with pembrolizumab (another drug), as well as patients with other types of advanced solid tumors who will receive LOXO-435 alone. The purpose is to evaluate the effectiveness and safety of LOXO-435 in these specific patient groups.
An Open-Label Randomized Controlled Multi-Center Study of The Efficacy of Daromun (L19IL2 + L19TNF) Neoadjuvant Intratumoral Treatment Followed by Surgery and Adjuvant Therapy VS Surgery and Adjuvant Therapy in Clinical Stage IIIB/C/D Melanoma Patients
The primary objective of the study is to demonstrate that a neoadjuvant Daromun treatment followed by surgery and adjuvant therapy improves in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C/D melanoma patients with respect to the standard of care (surgery and adjuvant therapy).Primary endpoint of the study is recurrence free survival (RFS) in a time-to-event analysis in the Daromun plus surgery and adjuvant therapy treatment group (Arm 1) versus the surgery and adjuvant therapy control group (Arm 2). Analysis will be performed for the "Intention To Treat" population.
An Open-label Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination with Pembrolizumab Versus Treatment of Physician s Choice in Participants with HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer
This clinical study will evaluate MK-2870 either alone or in combination with pembrolizumab versus TPC in participants with HR+/HER2- (both HER2-zero and HER2-low) unresectable locally advanced or MBC, who have not been previously treatedwith chemotherapy in the metastatic setting.
An open-label randomized trial of zanidatamab with standard-of-care therapy against standard-of-care therapy alone for advanced HER2-positive biliary tract cancer (BTC)
This study is testing a new treatment called zanidatamab to see how well it works and how safe it is for people with a type of cancer called HER2-positive biliary tract cancer (BTC), which affects the gallbladder and bile ducts and cannot be removed by surgery or has spread to other parts of the body. Participants may receive up to two cycles of chemotherapy (cisplatin and gemcitabine, or “CisGem”) before being randomly assigned to one of two groups. In Group A, participants will get zanidatamab plus CisGem, with or without an immune therapy drug (like durvalumab or pembrolizumab). In Group B, participants will get CisGem, with or without the immune therapy drug. The treatment will continue until the cancer gets worse.
AN OPEN-LABEL TREATMENT WITH RANDOMIZATION OBSERVATION INVESTIGATOR-INITIATED STUDY ON THE DURATION AND EFFICACY OF JORNAY PM (METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES) ON ADULT ADHD SYMPTOMS AND EXECUTIVE FUNCTION AND EMOTIONAL REGULATION THROUGHOUT THE DAY INTO EARLY EVENING
The purpose of this research study is to examine the efficacy of Jornay PM on Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms and Executive Function throughout the day into early evening. This study will last approximately 11 weeks with will involve about 11 visits that are conducted both remote (WebEx/Telephone) and in the clinic.