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NCT ID: NCT00633373 No longer available - Lung Transplant Clinical Trials

Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

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

Currently there are no approved therapies for lung transplant recipients in the United States (US). Treatment with CIS following lung transplantation has previously been demonstrated to result in a clinically meaningful improvement in survival and chronic rejection-free survival compared to placebo, but additional data supporting its use is needed prior to Food and Drug Administration (FDA) approval. This treatment use protocol is a mechanism for providing eligible lung transplant recipients early access to CIS in advance of FDA approval.

NCT ID: NCT00636259 No longer available - Clinical trials for Adenocarcinoma of the Prostate

Casodex 150-mg Compassionate Use Trial for Subjects With Prostate Cancer

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

This study provides compassionate use of bicalutamide (Casodex) at a 150-mg dose for subjects with prostate cancer prior to it becoming commercially available. The patient will receive bicalutamide 150-mg as long as the physician feels that the subject is benefiting from this therapy and safety information is provided regularly to AstraZeneca. Treatment will be discontinued after bicalutamide 150-mg becomes commercially available.

NCT ID: NCT00642057 No longer available - Clinical trials for Hyperkinetic Movement Disorders

Compassionate Use of Tetrabenazine in the Treatment of Abnormal Movements

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

Although the results of studies looking at tetrabenazine have shown its effectiveness in the management of hyperkinetic(too much) movement disorders, it has not been made available in the U.S. The drug must be obtained from Cambridge Laboratories, the distributor, using an individual IND (#16,161). The cost of the drug is passed on to the patient. The purpose of the protocol is to provide an efficacious drug, with few side effects, in an attempt to get rid of a variety of incapacitating dyskinesias (abnormal movements).

NCT ID: NCT00655252 No longer available - Clinical trials for Metastatic Renal Cell Cancer

Expanded Access Study of RAD001 in Metastatic Renal Cell Cancer Patients Who Are Intolerant of or Who Have Failed Despite Prior Vascular Endothelial Growth Factor Therapy

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

This expanded access study is designed to provide RAD001 to patients with MRCC who are without satisfactory treatment alternatives, until RAD001 becomes commercially available.

NCT ID: NCT00660556 No longer available - Pain Clinical Trials

ARCHIMEDES Compassionate Use Supplement

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

The purpose of this Compassionate Use Supplement to the IDE Protocol is to assure and monitor the safety of six Subjects (in the United States) implanted with ARCHIMEDES until all remaining implanted pumps are explanted.

NCT ID: NCT00669357 No longer available - Clinical trials for Severe Biventricular End Stage Heart Disease

AbioCor Implantable Replacement Heart

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

Abiocor is a post market approval study for an Implantable Replacement Heart. This post approval study is currently on hold.

NCT ID: NCT00701168 No longer available - Neoplasm Metastasis Clinical Trials

Therasphere® for Treatment of Unresectable Primary Liver Cancer and Metastatic Liver Cancer

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

The purpose of this protocol is to provide supervised and limited access to Therasphere® treatment for patients with primary liver cancer and chemotherapy refractory liver metastasis who cannot be treated by surgical removal of the affected part of the liver. Patient response to treatment and any side effects of Therasphere® treatment will be examined.

NCT ID: NCT00704925 No longer available - Clinical trials for Lambert Eaton Myasthenic Syndrome

Treatment of Lambert-Eaton Syndrome With 3,4 DAP

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

A new drug called 3,4-Diaminopyridine (3,4-DAP) is currently under investigation for treatment of the symptoms of Lambert-Eaton Myasthenic Syndrome (LEMS). This is an expanded access trial, which means that although data from this study will be collected and reported to the US Food and Drug Administration (FDA)and the drug manufacturer, this is not a formal study of drug in LEMS. If you decide volunteer, you will be evaluated by a neurologist to determine your eligibility to receive 3, 4-DAP by a review of your medical history, medication regimen (the medications you are taking) and a neurological examination. If you are a female of child-bearing potential, a serum pregnancy test will be done to ensure that you are not pregnant. Once it is determined that this treatment is appropriate for your care, you will begin taking 3, 4 DAP by mouth in slowly increasing doses. Treatment will begin with 5mg three times a day, as clinically needed, and if tolerated. You will be monitored for strength and side effects by routine clinic visits at initial intervals of once a month, increasing to intervals of every 12 months as permitted. Blood will be drawn (approximately 1 tablespoon) at every clinic visit or as often as the investigator deems necessary to assess your liver/kidney function and blood counts. You will have an EKG (a test to see how your heart is functioning) at your first study visit, after 6 months of taking 3,4 DAP and again every 2 years. Treatment will be continued indefinitely if a good clinical response is achieved. This study is planned to last indefinitely. The dosage of 3, 4DAP is individually adjusted. The usual range is 10-15 mg 3-4 times per day for the full effect and will increase by 50% every two weeks to 10-15 mg three to six times a day, as needed and if tolerated. Dosages above the full effect level will not provide an additional benefit and should not be used. 3, 4 DAP is a convulsant (causes seizures). A total of 100 mg/day is the maximum dosage allowed.

NCT ID: NCT00719225 No longer available - Clinical trials for Renal Transplantation

A Belatacept Compassionate Use Study for Patients With a Kidney Transplant

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

To make belatacept available for recipients of a renal allograft who are currently intolerant to or have contraindications to CNIs and/or m-TOR inhibitors and are either: - unable to construct an adequate immunosuppression regimen due to nonrenal toxicity / contraindication (and withdrawing the causative agent would lead to renal graft loss) OR - at imminent risk of losing the allograft kidney due to nephrotoxicity and have no other options for renal replacement therapy

NCT ID: NCT00720603 No longer available - Multiple Myeloma Clinical Trials

This is a Multi-center, Single Arm, Open Label Study Intended to Provide Expanded Access to Plerixafor for Patients With Non-Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM) Who Are to Receive Treatment With an Autologous Peripheral Stem Cell Transplant.

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

The purpose of this program is to provide expanded access to plerixafor for patients with NHL, HD, or MM who are to receive treatment with an autologous peripheral stem cell transplant.