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NCT ID: NCT01297933 Approved for marketing - Clinical trials for Short Bowel Syndrome

Compassionate Use of Omegaven for Pediatric Patients With Parenteral Nutrition Associated Liver Disease

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

A compassionate use protocol to provide Omegaven to pediatric patients with parenteral nutrition (PN) dependence and parenteral nutrition associated liver disease (PNALD).

NCT ID: NCT01220531 Approved for marketing - DiGeorge Syndrome Clinical Trials

Thymus Transplantation Safety-Efficacy

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

Complete DiGeorge anomaly (cDGA) is a disorder in which there is no thymus function. With no thymus function, bone marrow stem cells do not develop into educated T cells, which fight infection. Without successful treatment, patients with cDGA must remain in reverse isolation to prevent infection and subsequent death. Cultured thymus tissue with and without immunosuppression (drugs given before and after implantation) has resulted in the development of good T cell function in subjects with complete DiGeorge anomaly. This expanded access study continues cultured thymus tissue safety and efficacy research for the treatment of complete DiGeorge anomaly. Eligible participants receive cultured thymus tissue. Immune function testing is continued for one year post-implantation.

NCT ID: NCT01217697 Approved for marketing - Clinical trials for Urogenital Neoplasms

Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer

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

The purpose of this study is to collect additional safety information on abiraterone acetate administered with prednisone to patients with metastatic castration-resistant prostate cancer (CRPC).

NCT ID: NCT01160250 Approved for marketing - Clinical trials for Basal Cell Carcinoma

A Study of Vismodegib (GDC-0449) in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

Start date: July 2010
Phase: Phase 4
Study type: Expanded Access

This is an open-label, non-comparative, multicenter, expanded access study of Vismodegib (GDC-0449) in patients with locally advanced basal cell carcinoma (BCC) or metastatic BCC (mBCC) who are otherwise without satisfactory treatment options.

NCT ID: NCT01076517 Approved for marketing - Liver Cancer Clinical Trials

A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma

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

To provide Therasphere treatment for patients diagnosed with unresectable liver cancer.

NCT ID: NCT00954460 Approved for marketing - Clinical trials for Gaucher Disease, Type 1

Treatment Protocol of Velaglucerase Alfa for Patients With Type 1 Gaucher Disease

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

Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside accumulates within macrophages leading to cellular engorgement, organomegaly, and organ system dysfunction. The purpose of this treatment protocol is to observe the safety of velaglucerase alfa in patients with type 1 Gaucher disease who are either treatment naive (newly diagnosed) or who are currently being treated with the Enzyme Replacement Therapy (ERT) imiglucerase.

NCT ID: NCT00948948 Approved for marketing - Clinical trials for Breast Reconstruction

Mentor Adjunct Study for Silicone Gel-Filled Mammary Prosthesis

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

Mentor is undertaking a five-year prospective clinical study designed to collect safety data associated with the implantation of its gel-filled mammary prostheses. This study is an "adjunct" study, which will encompass clinical reviews of reconstructive cases in all patients who meet clinical and regulatory criteria for breast reconstruction with gel-filled mammary prostheses. This "adjunct" study will be accomplished under a limited clinical protocol in which specific parameters will be required but with controls somewhat less stringent than those normally required in Investigational Device Exemption (IDE) Trials.

NCT ID: NCT00918424 Approved for marketing - Epilepsy Clinical Trials

Long Term Study of the Safety of OXC XR as in Pediatric Epilepsy Subjects

Start date: June 2009
Phase: N/A
Study type: Expanded Access

Follow-on study to continue evaluation of the safety of OXC XR as adjunctive therapy in pediatric epilepsy

NCT ID: NCT00906984 Approved for marketing - Clinical trials for Hepatocellular Carcinoma

TheraSphere® for Treatment of Unresectable Hepatocellular Carcinoma

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

The purpose of this protocol is to provide TheraSphere treatment for patients with liver cancer who cannot be treated by surgery. The effect on the tumor and any side effects of TheraSphere treatment will be examined. This study will provide supervised and limited access to TheraSphere treatment at University California Irvine Medical Center. TheraSphere is a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors. When Y-90 is incorporated into very tiny glass beads (TheraSphere), it can be injected to the liver through blood vessels supplying the liver. This allows a large dose of radiation to be delivered to the tumor with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue. The radiation from TheraSphere is contained within the body and becomes minimally active within 7 days after treatment due to physical decay. The glass beads remain in the body, but do not cause any health problems. TheraSphere has been approved for use in the treatment of liver cancer in the United States by the Food and Drug Administration on a limited basis.

NCT ID: NCT00889135 Approved for marketing - Clinical trials for Dopamine Beta Hydroxylase (DBH) Deficiency

Long Term Treatment With L-DOPS

Start date: September 2004
Phase: N/A
Study type: Expanded Access

This study is designed to supply L-DOPS (droxidopa) on a long term basis to patients with a genetic form of profound orthostatic hypotension, most commonly DBH deficiency. It also allows us to collect medical history information on this small population of patients that would allow us to determine if there are any complications from this type of treatment.