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CT Open to Enrollment

A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn’s Disease (Macaroni-23)

The purpose of this clinical research study is to see whether 2 investigational study drugs, Guselkumab and Mirikizumab, work in patients with Crohn’s disease (CD) who are 2 to 17 years of age at the time of joining the study.

Investigational means that these drugs are not approved by the U.S. Food and Drug Administration (FDA). 

An Open-Label, Multicenter, Extension Study for Patients Previously Enrolled in Studies With Pelabresib

This research study is for men and women who have been diagnosed with hematological or solid tumor indications or advanced malignancies and who participated previously in studies (a parent study) involving pelabresib, an experimental anti-cancer drug.

The Pain Identification and Communication Toolkit: A Training Program to Support Family Caregivers of Persons with Alzheimer’s Disease and Related Dementias

The purpose of this study is to compare the efficacy of the Pain Identification and Communication Toolkit (PICT) with a Health Promotion (HP) program.

Participants will be assigned to either the Pain Identification and Communication Toolkit (PICT/intervention) or Health Promotion (HP/attention control) group. There is an equal chance of being placed into either of the study groups, like flipping a coin.

A Phase 2 Study to Evaluate the Efficacy and Safety of Selinexor Monotherapy in Subjects with JAK Inhibitor-Naïve Myelofibrosis and Moderate Thrombocytopenia

The main purpose of this study with the corresponding optional expansion is to evaluate the efficacy of selinexor in JAKi-naïve participants with myelofibrosis (MF) and moderate thrombocytopenia based on spleen volume reduction (SVR). Additional efficacy and safety parameters will also be assessed during the study. The purpose of this research study is to see if Selinexor is an effective treatment for MF.

A Phase 1/Phase 2 Trial to Evaluate Safety, Immunogenicity and PSA Response of VTP-850 Prostate Cancer Immunotherapeutic in Men with Biochemical Recurrence after Definitive Local Therapy for Prostate Cancer

This is a multi-center Phase 1/2 clinical trial to evaluate the safety, prostate-specific antigen (PSA) response, and immunogenicity of the VTP850 prime-boost immunotherapeutic in men with biochemical recurrence of prostate cancer after definitive local therapy. 
   
VTP-850 is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration.

An Open-Label, Single-Center, Investigator Initiated Phase 1B Trial of E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas

The purpose of this study is to determine if endothelial cells derived from the human umbilical vein are safe for use in conjunction with fistulotomy for the treatment of simple anal fistulas. Endothelial cells are a special kind of cell in the body that line the inside surface of blood vessels. The goal of the study is to evaluate the preliminary safety of human umbilical vein cells in anal fistula healing.

A Safety and Effectiveness Prospective Blinded clinical study to validate xBar system as monitoring tool for anastomotic leaks detection

xBar is an investigational device intended for post-op monitoring of patients undergoing gastrointestinal (GI) surgery. The device is comprised of a surgical drain with embedded electrodes, connected to a small electronic device that records and relays data from the electrodes. The collected data is processed for early detection of complications.

Investigational means that xBar has not been approved by the U.S. Food and Drug Administration (FDA).

Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial (COSMID)

The COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is a pragmatic, patient-level randomized superiority trial of elective colectomy vs. best medical management for patients with quality of life (QoL) limiting diverticular disease. A parallel observational cohort will include those who are disinclined to have their treatment choice randomized but are willing to contribute information about their outcomes.

A Prospective, Multicenter, Randomized Clinical Investigation Evaluating GATT-Patch for Hemostasis during Minimally Invasive Liver and Gallbladder Surgery

This study is evaluating an investigational device (also known as the “study device”) called GATT-Patch as a possible management of minimal to moderate bleeding during liver surgery. An investigational device is one that has not been approved by the United States (US) Food and Drug Administration (FDA). 
   

Assessment of Colonic Oxygenation Utilizing Intra.OxTM

The purpose of this study is to calculate the amount of oxygen in bowel tissue with the ViOptix Intra.Ox™ device. The creation of a healthy and safe colorectal anastomosis, where the colon is attached to the remainder of the rectum after a portion of it has been removed, requires good blood supply and oxygenation to the bowel tissue. The device in this study is intended to non-invasively measure the percent of oxygen in the bowel tissue.