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NCT ID: NCT01432301 Approved for marketing - Clinical trials for Toxicity Due to Chemotherapy

Uridine Triacetate as Antidote for Patients at Excess Risk of 5-FU Toxicity Due to Overdosage or Impaired Elimination

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

The purpose of this study is to provide emergency treatment of adult and pediatric patients: - Following a fluorouracil or capecitabine overdose regardless of the presence of symptoms or - Who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous systems, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.

NCT ID: NCT01464762 Approved for marketing - Tuberculosis Clinical Trials

Early Access of TMC207 in Patients With Extensively Drug Resistant or Pre-XDR Pulmonary Tuberculosis

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

The purpose of this is a study to provide early access of TMC207 to patients with pulmonary infection due to strains of Mycobacterium tuberculosis (M. tuberculosis) with resistance to isoniazid (INH), rifampin (RMP), and to a fluoroquinolone (FQ) and/or injectable second line tuberculosis (TB) drug (kanamycin, amikacin, or capreomycin) and who are unable/ineligible to participate in any other TMC207 study. In addition, information on safety and tolerability of TMC207 in combination with anti-TB drugs will be assessed and the results of microbiology assessments which are recommended to be performed during the early access study will be collected.

NCT ID: NCT01476163 Approved for marketing - Fabry Disease Clinical Trials

Physician Initiated Expanded Access Request for Migalastat in Individual Patients With Fabry Disease

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

This program allows physicians to request permission from Amicus Therapeutics (Amicus) for treatment access to migalastat hydrochloride (HCl) for specific adult patients with Fabry disease. Treatment is open label for 6 months with renewal every 6 months.

NCT ID: NCT01480128 Approved for marketing - Colon Neoplasms Clinical Trials

Multicenter Single-port Colectomy RCT

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

This clinical trial is going to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment, in terms of safety, efficacy, and cost. The investigators hypothesize that the single-port laparoscopic colectomy is not inferior to multiport laparoscopic colectomy.

NCT ID: NCT01579890 Approved for marketing - Clinical trials for Osteoarthritis of the Hand

Compassionate Use of Pennsaid Topical Lotion (Diclofenac) in Osteo or Rheumatoid Arthritis

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

This was a compassionate use, open treatment safety study of Pennsaid topical lotion (diclofenac) for osteo or rheumatoid arthritis.

NCT ID: NCT01592136 Approved for marketing - Clinical trials for Chronic Myeloid Leukemia (CML)

Expanded Access Program of Ponatinib

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

This protocol will allow expanded access of ponatinib to patients ≥18 years with chronic myeloid leukemia (CML) any phase or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) who have failed all available treatment options.

NCT ID: NCT01606982 Approved for marketing - Clinical trials for Metastatic Castration-Resistant Prostate Cancer

Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

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

The purpose of this treatment protocol is to provide expanded access to MDV3100 and monitor its safety in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy.

NCT ID: NCT01632826 Approved for marketing - Multiple Myeloma Clinical Trials

Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma

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

To provide pomalidomide access to relapsed/refractory multiple myeloma subjects with a likelihood of benefit from the pomalidomide treatment while the medication is not commercially available

NCT ID: NCT01683110 Approved for marketing - Clinical trials for Medullary Thyroid Cancer

Expanded Access of Cabozantinib in Medullary Thyroid Cancer

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

The objective of this study is to provide access to cabozantinib for eligible subjects with medullary thyroid cancer (MTC) pending approval of Exelixis' New Drug Application (NDA) by the FDA and commercial availability of cabozantinib.

NCT ID: NCT01764191 Approved for marketing - Cardiac Sarcoidosis Clinical Trials

18F-FDG PET Imaging in Cardiac Sarcoidosis

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

This study has been designed to provide patients suspected of having cardiac sarcoidosis (CS) with a potentially diagnostic 18F FDG PET/CT. CS is difficult to diagnose with currently available methods, therefore this project will allow access to 18F FDG PET/CT scanning, which may more accurately diagnose the presence of CS. This study will also provide additional data to further examine the effectiveness and safety profile of 18F FDG for this condition. Accurate and early detection is important to allow for better management of CS and improve patient care. The purpose of this study is to provide access to 18F-FDG PET/CT imaging in patients with clinical suspicion of cardiac sarcoidosis, and to collect additional data about the safety and effectiveness of 18F-FDG PET/CT in this patient population