Accelerated TMS for Depression and OCD

Repetitive transcranial magnetic stimulation (rTMS) is an FDA-cleared treatment for depression and obsessive compulsive disorder (OCD) that uses focused magnetic field pulses to stimulate target brain areas. Multiple brain targets in the prefrontal cortex have shown consistent evidence of treatment efficacy in both depression and OCD, but there are currently no established methods for selecting the optimal target site in individual patients.

Transoral Incisionless Fundoplication (TIF) Registry

This study is for men and women over 18 years of age who have suspected or known gastroesophageal reflux disease (GERD) or its associated complications, such as Barrett’s esophagus (a precancerous condition), or trouble swallowing due to esophagitis or scarring (stricture), who are undergoing diagnostic evaluation and treatment with Transoral Incisionless Fundoplication (TIF).  

A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS)

This clinical trial is to evaluate the experimental (investigational) study drug Volixibat in men or women who have been diagnosed with Cholestatic Pruritus (itching) with Primary Sclerosing Cholangitis (PSC). PSC is a disease of the bile ducts, which carry the digestive bile acid (used by the body to help with digestion) from your liver to your small intestine. In PSC, inflammation causes scars within the bile ducts. These scars make the ducts hard and narrow and gradually cause serious liver damage.

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr Adults (PREVENTABLE)

The purpose of PREVENTABLE is to learn if taking a statin could help older adults live well for longer by preventing dementia, disability, or heart disease.
   
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. This study seeks to assess the benefit of statins (Atorvastatin) for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events.
   

Training Video Library

The JCTO’s Quality Assurance Unit has developed a series of videos to help train and refresh clinical trial staff on the fundamentals of clinical research. Study teams have access to this library of YouTube videos via the links below and new staff are encouraged to review the content. Portions of this library were developed as a course companion for TWIST Jr, a course for those just beginning their work in clinical research. For more information about TWIST Jr. please reach out to JCTOQAU@med.cornell.edu

eSignature

The collection of signatures is a critical component of clinical research. Although this has been predominantly done with pen and paper, there is increasing need in the research community for processes that collect signatures digitally (eSignature). WCM currently supports one system, DocuSign, which is 21 CFR Part 11 compliant and therefore can be used to collect signatures on informed consent forms and essential regulatory documents (i.e. FDA Form 1572, financial disclosure forms, delegation of authority logs, etc.) for FDA-regulated studies.

Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed).

The Effects of Iron on Oxidative Stress and Alzheimer’s Disease Biomarkers in Amyloid-Positive and Negative Elderly Individuals

The purpose of this study is to investigate differences in iron in the brains of subjects with and without beta-amyloid deposition. Iron is an essential mineral in your body, and beta-amyloid is a protein associated with Alzheimer’s disease. Studies suggest that excess iron in the brain may be involved in processes that lead to Alzheimer's disease.

CSF Clearance in Sporadic Alzheimer’s Disease

We have developed and validated a non-invasive method to estimate the clearance of cerebrospinal fluid (CSF) from the brain. This study tests the hypothesis that reduced CSF clearance is predictive of a) future amyloid lesions, b) brain atrophy, and c) cognitive decline in healthy elderly adults or those with Mild Cognitive Impairment (MCI). 

 Measuring brain CSF clearance with novel, experimental imaging techniques may advance the understanding of Alzheimer’s disease (AD) progression at its earliest stages. 

VMO-01C: An Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 in Subjects with Solid Tumors or Lymphoma

This is a clinical trial for adults with cancer, which has continued to grow despite the treatments already received, because the standard drugs used to treat the disease are no longer working, because the tumor cells are resistant to available treatments, or subjects are not a candidate for or intolerant of other available treatments. The subjects with solid tumors and lymphoma are eligible for this trial.