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224 results

OCS Heart Perfusion Post-Approval Registry

The Organ Care System (OCS) Heart Perfusion Post-Approval Registry (OHP)
The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve donor-after-brain-death (DBD) and donation-after-circulatory-death (DCD) donor hearts.

Sub Category
Cardiothoracic Surgery

CentriMAG Failure to Wean Post Approval Study

As part of heart surgery, patients are put on cardiopulmonary bypass, a machine that temporarily takes over the function of the heart and lungs during surgery, maintaining circulation of blood and oxygen to the rest of the body. In some cases, patients are not able to get off bypass, and their heart is not able to spontaneously contract to allow for normal blood circulation. The CentriMag Circulatory Support System provides support to these patients, if needed. The CentriMag system, supports the heart and moves blood through the circulatory system until the patient’s heart recovers, is transplanted, or needs long term mechanical circulatory support. The purpose of this research study is to continue monitoring and collecting data for patients who require the CentriMag Circulatory Support System. The CentriMag Circulatory Support System has been approved by the FDA and is currently in commercial use. It is therefore not an investigational device. This study is required by the FDA for continued data collection for patients who are implanted with the device for up to 30 days post-explant or discharge, whichever time point is longer. If you are not able to be taken off the device, follow-up will last until start of anesthesia for another medical intervention (a heart transplant or long-term device).

Sub Category
Cardiothoracic Surgery

OCS™ Lung TOP Registry For Donor Lungs for Transplantation

The Organ Care System (OCS™) Lung Thoracic Organ Perfusion (TOP) Registry For Donor Lungs for Transplantation 
The purpose of this project is to monitor the performance of the OCS™ Lung System and to collect additional clinical data from patients transplanted with donor lungs preserved using the TransMedics OCS™ Lung System for preservation of donor lungs for transplantation.

Sub Category
Cardiothoracic Surgery

A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients with Resectable Brain Metastases

Comparing the Addition of Radiation Either Before or After Surgery for Patients With Brain Metastases
Protocol No
NRG-BN012
Sub Category
Breast Cancers, Early Phase/Multiple Disease Site Cancers, Thoracic Cancers, Sarcoma, Skin Cancers, Prostate and Urologic Cancers, Head and Neck Cancers, Gynecologic Cancers, Gastrointestinal Cancers, Endocrine Cancers

A Phase 1, Open-Label, Multicenter Study to Assess Safety, Tolerability, PK, and Efficacy of MK-1084 as Monotherapy and in Combination with Pembrolizumab in Subjects with KRASG12C Mutant Advanced Solid Tumors

This project is being done to test the safety and tolerability of MK-1084 alone in combination with pembrolizumab in patients with solid tumor cancers that have a mutated KRAS gene.
Protocol No
MERCK-MK1084-001
Sub Category
Breast Cancers, Early Phase/Multiple Disease Site Cancers, Thoracic Cancers, Sarcoma, Skin Cancers, Prostate and Urologic Cancers, Head and Neck Cancers, Gynecologic Cancers, Gastrointestinal Cancers, Eye/Orbital Cancers, Endocrine Cancers

A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of TST001 in Patients with Locally Advanced or Metastatic Solid Tumors

This project is being done to find out the highest tolerable dose of TST001 that can be given to patients when given via IV once every 2 or 3 weeks, what are the side effects, how much TST001 is in the blood at a specific times after dosing and how does the body get rid of it.
Protocol No
MABSPACE-TST001-1001
Sub Category
Breast Cancers, Early Phase/Multiple Disease Site Cancers, Thoracic Cancers, Sarcoma, Skin Cancers, Prostate and Urologic Cancers, Head and Neck Cancers, Gynecologic Cancers, Gastrointestinal Cancers, Eye/Orbital Cancers, Endocrine Cancers

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 Phase 1 study of orally administered VMD-928 in adult subjects with advanced solid tumors or lymphoma that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists
Protocol No
VMONCOLOGY-VMO-01C
Sub Category
Early Phase/Multiple Disease Site Cancers, Thoracic Cancers, Head and Neck Cancers, Gynecologic Cancers

A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 Monotherapy and HPN328 with Atezolizumab in Patients with Advanced Cancers Associated with Expression of Delta-like Canonical Notch Ligand 3 (DLL3)

Phase 1/2 open-label, multicenter study to evaluate the safety, PK, and pharmacodynamics of HPN328 in patients with SCLC or with advanced solid tumors associated with expression of DLL3. This study will be divided into 2 parts: Dose Escalation (Part 1) and Expansion (Part 2).
Protocol No
HARPOON-HPN328-4001
Sub Category
Early Phase/Multiple Disease Site Cancers, Thoracic Cancers

Phase 1b/2 Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of TAK-981 in Combination with Monoclonal Antibodies in Adult Patients with Relapsed and/or Refractory Multiple Myeloma

A Phase 1b/2 Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of TAK-981 in Combination With Monoclonal Antibodies in Adult Patients With Relapsed and/or Refractory Multiple Myeloma.
Protocol No
TAKEDA-TAK-981-1503
Sub Category
Hematologic/Blood Related Cancers, Early Phase/Multiple Disease Site Cancers

A Phase 1b/2a, Open-label, Dose-escalation Study of the Safety and Efficacy of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients with Relapsed or Refractory Systemic AL Amyloidosis

To assess the safety of STI-6129 in patients with relapse refractory (AL) Amyloidosis. To assess the efficacy of STI-6129 in the treatment of patients with R/R systemic AL Amyloidosis.
Protocol No
SORRENTO-STI-6129-001
Sub Category
Hematologic/Blood Related Cancers, Early Phase/Multiple Disease Site Cancers