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NCT ID: NCT01724580 No longer available - Clinical trials for Aicardi-Goutières Syndrome (AGS)

Compassionate Use Protocol for the Treatment of Autoinflammatory Syndromes

Start date: n/a
Phase:
Study type: Expanded Access

The Requesting Physician/Investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

NCT ID: NCT01701947 No longer available - Surgery Clinical Trials

HEMOLEVEN® Expanded Access Program Prevention of Surgical/Postpartum Hemorrhage Severe Inherited Factor XI Deficiency

EAP
Start date: n/a
Phase: N/A
Study type: Expanded Access

The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of administering selectively the missing factor outweigh the potential risks associated with the administration of fresh-frozen plasma.

NCT ID: NCT01659515 No longer available - Clinical trials for Infection Due to Resistant Organism

Arbekacin Treatment of Adult Patients With Infections Caused by Multidrug-resistant Bacteria

Start date: n/a
Phase:
Study type: Expanded Access

Arbekacin for the use of infection caused by multidrug-resistant organisms

NCT ID: NCT01626781 No longer available - Clinical trials for the Treatment Hand-foot Syndrome Patients With Gastrointestinal Tumors or Breast Cancer, Who Are Treated With Capecitabine

A Randomized, Open-label Phase III Trial of Mapisal® Versus an Urea Hand-foot Cream as Prophylaxis for Capecitabine-induced Hand-foot Syndrome in Patients With Gastrointestinal Tumors or Breast Cancer

PROCAPP
Start date: n/a
Phase: N/A
Study type: Expanded Access

The purpose of this study is the examination of Mapisal® versus urea hand-foot cream as prophylaxis for capecitabine-induced hand-foot syndrome (HFS) in patients with gastrointestinal tumors or breast cancer, to assess the efficacy of Mapisal®. Mapisal® is a medical device that is approved for the prophylaxis and treatment of HFS. Initial clinical data and case studies on the treatment and prophylaxis of Caelyx-induced HFS have been impressive. Because the pathomechanism of HFS caused by capecitabine is the same as for Caelyx-induced HFS, it is expected reason that administering Mapisal® should result in a significant reduction of HFS caused by capecitabine. The urea hand-foot cream was selected for the standard arm, because it is used commonly, is accepted by patients, and seems to have a positive influence on the severity of the HFS in the experience of many oncologists.

NCT ID: NCT01549548 No longer available - Clinical trials for Chronic Myeloid Leukemia

Compassionate Use Ponatinib

Start date: n/a
Phase: N/A
Study type: Expanded Access

The main purpose of this protocol is to provide expanded access to the study drug (Ponatinib/AP24534) for people with imatinib-, dasatinib-, and nilotinib- resistant/intolerant Philadelphia Chromosome Positive (Ph+) Leukemias. The other purpose of this protocol is to monitor the safety of the study drug in people with Ph+ Leukemias that have not responded to prior treatment.

NCT ID: NCT01461304 No longer available - Barth Syndrome Clinical Trials

Compassionate Use of Triheptanoin (C7) for Inherited Disorders of Energy Metabolism

Start date: n/a
Phase:
Study type: Expanded Access

This is a compassionate use study to allow patients already taking triheptanoin (C7) through previous studies to continue to receive the supplement. It will also allow triheptanoin supplementation in patients with qualifying disorders if they are failing conventional therapy.

NCT ID: NCT01378546 No longer available - Clinical trials for Lambert Eaton Myasthenic Syndrome (LEMS)

Treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) With 3, 4 DAP

Start date: May 2005
Phase: N/A
Study type: Expanded Access

Lambert Eaton Myasthenic Syndrome (LEMS) is rare neurological disorder that results in muscle weakness and limited reflex activity. More than half of LEMS cases are associated with a malignancy, usually small cell lung cancer, and tend to progress more quickly than cases not coupled with malignant cells. 3,4diaminopyridine (3,4DAP)is a drug that has been demonstrated to be effective in treating the weakness associated with LEMS as it increases strength and improves autonomic symptoms in LEMS patients. It is not currently approved by the FDA for use in the United States. The investigators plan to use 3,4DAP to treat patients with LEMS here at the Columbia University MDA/ALS Research Center.

NCT ID: NCT01373333 No longer available - Clinical trials for Lambert-Eaton Myasthenic Syndrome

Use Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic Syndrome

34-DAP
Start date: September 1997
Phase: N/A
Study type: Expanded Access

Compassionate use of orphan drug 3,4-Diaminopyridine(DAP) in Treatment of Lambert Eaton Myasthenic Syndrome (LEMS). 3,4-DAP is used to decrease the muscle weakness associated with LEMS and hopefully will decrease the need for prednisone and all other therapies that were previously required to control symptoms. How long a patient will take 3,4 DAP depends upon if he/she is seeing benefits from the medication or experiencing side effects that will prevent them from continuation in the study.

NCT ID: NCT01260779 No longer available - Clinical trials for Cutaneous or Subcutaneous Tumors Where There is no Comparable or Satisfactory

Expanded Access Protocol for PV-10 for Cutaneous or Subcutaneous Tumors

Start date: n/a
Phase: N/A
Study type: Expanded Access

This compassionate use protocol provides expanded access for investigational use of PV-10 in cancer patients who are not eligible for an existing PV-10 clinical trial, for whom there is no comparable or satisfactory approved alternative therapy and whom, in the opinion of the investigator, may benefit from PV-10 administration.

NCT ID: NCT01200017 No longer available - Clinical trials for Acute Myeloid Leukemia

Expanded Access Protocol (EAP) Using the CliniMACS® Device for Pediatric Haplocompatible Donor Stem Cell Transplant

Start date: n/a
Phase:
Study type: Expanded Access

This protocol provides expanded access to bone marrow transplants for children who lack a histocompatible (tissue matched) stem cell or bone marrow donor when an alternative donor (unrelated donor or half-matched related donor) is available to donate. In this procedure, some of the blood forming cells (the stem cells) are collected from the blood of a partially human leukocyte antigen (HLA) matched (haploidentical) donor and are transplanted into the patient (the recipient) after administration of a "conditioning regimen". A conditioning regimen consists of chemotherapy and sometimes radiation to the entire body (total body irradiation, or TBI), which is meant to destroy the cancer cells and suppress the recipient's immune system to allow the transplanted cells to take (grow). A major problem after a transplant from an alternative donor is increased risk of Graft-versus-Host Disease (GVHD), which occurs when donor T cells (white blood cells that are involved with the body's immune response) attack other tissues or organs like the skin, liver and intestines of the transplant recipient. In this study, stem cells that are obtained from a partially-matched donor will be highly purified using the investigational CliniMACS® stem cell selection device in an effort to achieve specific T cell target values. The primary aim of the study is to help improve overall survival with haploidentical stem cell transplant in a high risk patient population by limiting the complication of GVHD.