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Clinical Trials: Humanitarian Medicine & Ethics


Source: Stanford University
To provide Therasphere treatment for patients diagnosed with unresectable liver cancer. Read More
Last Updated: 12 Oct 2016
Source: New York University School of Medicine
The MicroVention Low-profile Visualized Intraluminal Support (LVIS*) Device is intended for use with bare platinum embolic coils for the treatment of unruptured, wide neck (neck greater than or equal to 4 or a dome to neck ratio less than two), intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than or equal to 2.5mm and less than or equal to 4.5mm. Read More
Last Updated: 30 Aug 2016
Source: Vanderbilt University
The purpose of this study is to allow patients to undergo deep brain stimulation (DBS) surgery for the treatment of dystonia. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of the deep brain stimulator device in the treatment of this rare disorder. Use of DBS for dystonia is approved for humanitarian use by the FDA in the treatment of chronic, intractable (drug refractory) dystonia, including generalized and segmental ... Read More
Last Updated: 10 May 2016
Source: Hospital for Special Surgery, New York
The purpose of this study is to allow patients to undergo surgery with the SR™ MCP (Metacarpophalangeal) Implants for finger arthritis. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device. Read More
Last Updated: 17 Sep 2014
Source: Hospital for Special Surgery, New York
The purpose of this study is to allow patients to undergo surgery with the SR™ PIP (Proximal Interphalangeal) Implants for finger arthritis. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device Read More
Last Updated: 30 Aug 2015
Source: H. Lee Moffitt Cancer Center and Research Institute
This is not a research study. The purpose is to provide supervised access to TheraSphere® therapy at this institution. Read More
Last Updated: 07 Nov 2016
Source: Innovative Humanitarian Solutions
The purpose of this study is to determine whether antioxidant supplementation can have a positive health effect on patients suffering from Kashin-Beck disease. Read More
Last Updated: 11 Feb 2008
Source: Mayo Clinic
This registration is for clinical use of the FENIX, a Humanitarian Use Device (HUD) for fecal incontinence. This device is indicated for the treatment of fecal incontinence in patients who are not candidates for or have previously failed conservative treatment and less invasive therapy options (e.g. bulking agents, radiofrequency ablation, sacral nerve stimulation). Read More
Last Updated: 13 Jun 2016
Source: Ohio State University Comprehensive Cancer Center
This clinical trial studies radiolabeled glass beads (yttrium Y 90 glass microspheres) in treating patients with unresectable hepatocellular carcinoma. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be an effective treatment for liver cancer. Read More
Last Updated: 24 Mar 2015
Source: Carolinas Healthcare System
MDS Nordion's TheraSphere, Yttrium-90 glass microspheres has been approved as a Humanitarian device authorized by federal(USA)law for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma(HCC)who can have placement of appropriately positioned hepatic arterial catheters. Outcomes of this treatment protocol will be monitored and reported to the Carolinas HealthCare System ... Read More
Last Updated: 02 Feb 2015
Source: Synapse Biomedical
The purpose of this research study is to collect more information about the use, safety, and effectiveness of the NeuRx DPS® in ALS patients. Read More
Last Updated: 24 Jan 2017
Source: University of Pennsylvania
In a multicenter, randomized clinical trial of attitudes towards research participation, we will evaluate the ethics, effectiveness, and cost- effectiveness of three recruitment strategies for research participation in a large randomized controlled trial comparing two types of radiation therapy for non-small cell lung cancer. Read More
Last Updated: 03 Jan 2017
Source: Northwestern University
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery. PURPOSE: This phase II trial is studying how well radiolabeled glass beads work in treating patients with liver cancer that cannot be removed by surgery. Read More
Last Updated: 09 Oct 2016
Source: M.D. Anderson Cancer Center
This is not a research study. The goal of this treatment protocol is to learn more about the patient experience, including any reported side effects and possible benefit related to the use of the TheraSphere device for treatment of liver cancer. Because treatment using the TheraSphere device must be designed specifically for each patient, the treatment process will also be monitored. Read More
Last Updated: 26 Oct 2016
Source: InVivo Therapeutics
- To evaluate whether the Scaffold is safe and demonstrates probable benefit for the treatment of complete T2-T12/L1 spinal cord injury . - This is a Humanitarian Device Exemption (HDE) Probable Benefit Study to demonstrate safety and probable benefit in support of future studies and an HDE application with subsequent approval. Read More
Last Updated: 17 Jan 2017
Source: National Institutes of Health Clinical Center (CC)
This study will survey a random sample of 2,100 general medicine physicians in Europe and in the U.S. about ethical difficulties they face in their practice of medicine. The participants will complete a questionnaire designed to meet the following study objectives: - Identify the types of ethical dilemmas physicians report that they face in their practice and approaches they find helpful in responding to these situations - Determine what ethical ... Read More
Last Updated: 23 Jan 2017
Source: Columbia University
Enterra Therapy Gastric Simulation System (Enterra Therapy) is indicated for the treatment of patients with long term, uncontrolled (not helped by medication) nausea and vomiting from gastroparesis of diabetic or idiopathic origin. In March 2000, the Food and Drug Administration (FDA) gave approval of a humanitarian Device Exemption (HDE) of a Humanitarian Use Device (HUD) for Enterra Therapy Gastric electrical (GES) Simulation System. Although, there is ... Read More
Last Updated: 21 Jun 2016
Source: Synapse Biomedical
This post-approval study will follow 60 participants who have ALS, documented chronic hypoventilation, and bilateral phrenic nerve function, and who undergo the surgical implantation procedure to receive the NeuRx Diaphragm Pacing System device. Participants who are successfully implanted with the device will use it for daily diaphragm conditioning sessions. Participants will be followed for at least two years (until the last enrolled participant reaches the ... Read More
Last Updated: 11 Apr 2016
Source: Northwestern University
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery. PURPOSE: This phase II trial is studying how well radiolabeled glass beads work in treating patients with metastatic liver cancer that cannot be removed by surgery. Read More
Last Updated: 02 Jan 2017
Source: University of Texas Southwestern Medical Center
The US food and Drug Administration (FDA) originally approved INTACS prescription inserts in April 1999 for the correction of low levels of nearsightedness (-1.00 to -3.00 diopters). Additional clinical data have shown that INTACS are safe for the treatment of keratoconus, in July 2004, FDA approved INTACS inserts for the treatment of keratoconus as a Humanitarian Use Device (FDA approval letter attached). The statute and the implementing regulation of FDA ... Read More
Last Updated: 14 May 2014
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