Needham, Massachusetts Clinical Trials

C Chong-Xian Pan, MD PhD

A Phase I Intravesical PPM Therapy for NMIBC

This clinical trial is to determine the safety and effectiveness of an investigational bladder cancer drug named "PLZ4-coated paclitaxel-loaded nanoscale micelle (PPM)." PPM is tiny particles that contain the chemotherapy drug paclitaxel. PLZ4 is a molecule that can possibly guide PPM to specifically target and deliver paclitaxel into and kill …

K Kierstyn Hayden

Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone

The purpose of the clinical study is to investigate whether the local delivery of bisphosphonate as a surgical adjuvant can decrease the chance of a giant cell tumor of bone coming back to the same location. The hypothesis is that the local administration of bisphosphonate will decrease the rate of …

V Victoria Staenglen

Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus

To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.

M Mariah Palmer

Fontan Udenafil Exercise Longitudinal Assessment Trial - 2

This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent who have had the Fontan procedure.

O Olga Taraschenko, MD, PhD

FIH Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy

This clinical trial is designed to test whether a single image-guided intracerebral administration of inhibitory nerve cells, called interneurons (NRTX-1001), into subjects with drug-resistant unilateral mesial temporal lobe epilepsy (MTLE), with or without mesial temporal sclerosis (MTS), is safe (frequency of adverse events) and effective (seizure frequency). NRTX-1001 comprises human …

Angiotensin-Neprilysin Inhibition in Hemodialysis Initiation

This randomized placebo-controlled clinical trial will evaluate the effect of sacubitril/valsartan (compared with placebo) on echocardiographic measures of hypervolemia, preservation of residual renal function, and key safety parameters in incident hemodialysis patients.

J Jonathan D Schoenfeld, MD, MPH

Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study

This research is being conducted to understand if treatment can be tailored for participants with HPV-related oropharynx cancers using both clinical features (stage of the tumor, smoking status) combined with an investigational HPV blood test. The names of the test and treatments involved in this study are: NavDx® HPV ctDNA …

B Belinda S Lennerz, MD PhD

Very Low Carbohydrate Diets and Glucagon Response in T1DM

Despite major technological advances, management of type one diabetes mellitus (T1D) remains suboptimal, putting millions of people at risk for immediate and long-term complications. After meals, a mismatch between carbohydrate absorption rate and insulin action typically leads to alternating periods of hyper- and hypoglycemia. A conceptually promising approach to control …

R Rosemary Smith, B.S.

Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder

Preliminary data have suggested that cannabidiol (CBD) may have a number of clinical benefits, including anti-anxiety and antidepressant properties. This study is a pilot open-label clinical trial assessing a custom-formulated high-CBD product over the course of 4 weeks in patients with bipolar disorder who experience anxiety.

D Dian Wang, MD

Proton or Photon RT for Retroperitoneal Sarcomas

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational intervention. Phase I studies also try to define the appropriate dose of the investigational therapy to use for further studies. "Investigational" means that the intervention is still being studied and that …