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NCT ID: NCT01871233 No longer available - Clinical trials for Partial Onset Seizures

An Extended Access Program for Perampanel

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

The Extended Access Program (EAP) is a managed access programme for Perampanel. The main objective of this EAP is to ensure that patients participating in studies E2007-A001-207, E2007-G000-307, or E2007-G000-235 continue to have access to perampanel until such time perampanel tablets become commercially available for the treatment of Partial Onset Seizures (POS) in the country in which they reside. This EAP will consist of 2 phases: - Screening: The patient will start the program once the Screening assessments are completed and the patient is qualified for participation. - Treatment: Additional assessments, physical examinations, and dosage changes will be clinically determined by the treating physician. Patients will enter this program on the same dose of perampanel that they were receiving at the end of their participation in previous study. Doses of perampanel and of concomitant anti-epileptic drugs (AEDs) can be adjusted (i.e., added,removed, or changed in dose) based on clinical judgment. Treatment will be prescribed as long as clinically appropriate according to the judgement of the treating physician and the approved Summary of Product Characteristics (SmPC). The program will complete in a staggered fashion, country by country, as and when perampanel becomes commercially available for the treatment of POS in each country.

NCT ID: NCT01897740 No longer available - Clinical trials for Pulmonary Arterial Hypertension

Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With Sildenafil

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

The purpose of this study is to provide Sildenafil therapy for subjects who completed A1481156 study and are judged by the investigator to derive clinical benefit from continued treatment with Sildenafil, prior to reimbursement and availability for subjects in the Russian Federation.

NCT ID: NCT01908985 No longer available - Clinical trials for Refractory Open Angle Glaucoma

Ocular Fluorophotometry for Glaucoma Treated With Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU).

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

Monocentric prospective study conducted in two phases evaluating the secretion and elimination of aqueous humor by fluorophotometry in patients with glaucoma treated with cyclo-coagulation with ultrasound. Population selected: - Patients with refractory open angle glaucoma despite previous treatments currently validated for glaucoma. The purpose of our study is: - To evaluate the mechanism of action of glaucoma treatment by cyclo-coagulation with high intensity focused ultrasound in studying the secretion and elimination of aqueous humor by fluorophotometry. Planning: - First phase: 2 patients (feasibility study) If reduction of at least 10% of the flow of aqueous humor production at one month in the first two patients in the feasibility study, further in second phase. - Second phase: 6 patients

NCT ID: NCT01918514 No longer available - Pain Clinical Trials

The Effect of Adding Magnesium Sulfate to Standard Epidural and Interscalene Block in Treatment of Patients With Chronic Pain

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

Regional anesthesia is a safe, inexpensive technique, with the advantage of prolonged pain relief. In the pain clinic the investigators perform different injections as the standard treatment for chronic pain based on the diagnosis and indications. Local anesthetic like Bupivacaine with or without Steroids (Depo-medrol) is used for these injections. The investigators' goal is comparing pain control in different groups adding the magnesium sulfate 100mg to our compounds as an inexpensive, effective, and safe adjuvant to prolong the duration of analgesia and reduce the amount of narcotic dose.

NCT ID: NCT01931085 No longer available - Parasitic Disease Clinical Trials

Compassionate Use of Triclabendazole for the Treatment of Parasites (Prior to FDA Approval; Expanded Access Program)

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

Triclabendazole is a benzimidazole compound used as a systemic antihelmintic in veterinary practice. Triclabendazole is considered to be a second-line drug for parasites and is used when other preferred agents cannot be used because they are ineffective or because adverse reactions limit their use. Although Triclabendazole is widely used in developing countries for the treatment of parasites it is not approved by the FDA for this treatment in the US. It is currently being distributed in the US through a special arrangement with the FDA and the manufacturer on an individual patient approval basis. This arrangement requires that a single patient Investigational New Drug (IND) be obtained from FDA for each patient requiring Triclabendazole. Upon approval by FDA, the manufacturer (Novartis) will ship the drug directly to the prescribing physician.

NCT ID: NCT01945619 No longer available - CMV Infection Clinical Trials

Allogeneic Virus-Specific Cytotoxic T-Lymphocytes(CTL), Persistent/Recurrent Viral Infection Post-HSCT (EAP CHALLAH)

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

Subjects have a type of blood cell cancer, other blood disease or a genetic disease for which they received a stem cell transplant. After transplant while the immune system grows back the subjects have an infection with one or more of three viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV) or adenovirus - that has persisted or come back despite standard therapy. Adenovirus is a virus that causes symptoms of a common cold normally but can cause serious life-threatening infections in patients who have weak immune systems. It usually affects the lungs and can cause a very serious pneumonia, but it can also affect the gut, the liver, the pancreas and the eyes. CMV is a virus that can also cause serious infections in patients with suppressed immune systems. It usually affects the lungs and can cause a very serious pneumonia, but it can also affect the intestinal tract, the liver and the eyes. Approximately 2/3 of normal people harbor this virus in their body. In healthy people CMV rarely causes any problems because the immune system can keep it under control. If the subject and/or the subject's donor are positive for CMV, s/he is at risk of developing CMV disease while his/her immune system is weak post transplant. EBV is the virus that causes glandular fever or kissing disease. It is also normally controlled by a healthy immune system, but when the immune system is weak, it can cause fevers, enlarged lymph nodes and sometimes develop into a type of cancer called lymphoma. This treatment with specially trained T cells (called CTLs) has had activity against these viruses when the cells are made from the transplant donor. However, as it takes 2-3 months to make the cells, that approach is not practical when the subject already has an infection. We want to find out if we can use CTLs which have already been made from another donor that match the subject and his/her donor as closely as possible and if the CTLs will last in the body and have activity against these viruses. In a recent study these cells were given to 50 patients with viral infections post transplant and over 70% had a complete or partial response. The purpose of this study is to make CTL lines leftover from that previous study available to patients with viral infections that have not responded to standard treatments. These virus-specific CTLs are an investigational product not approved by the FDA.

NCT ID: NCT01947608 No longer available - Clinical trials for Non-small Cell Lung Cancer (NSCLC)

Expanded Treatment Protocol With LDK378 in ALK(+) NSCLC

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

Novartis-sponsored, open-label, multi-center, interventional ETP to provide LDK378 to patients with ALK (+)NSCLC, who have been pre-treated with an ALK inhibitor; except in countries where ALK inhibitors are not approved or available. The protocol will further evaluate the safety of LDK378 in patients with ALK(+) NSCLC.

NCT ID: NCT01949766 No longer available - Byler Disease Clinical Trials

Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease

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

This is a single patient compassionate use protocol to determine whether RAVICTI will improve bile flow in a subject who previously tolerated therapy with Buphenyl.

NCT ID: NCT01968655 No longer available - Clinical trials for Acquired Hemophilia A

Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies

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

To provide emergency access to OBI-1 for patients with Acquired Hemophilia and a serious bleeding episode who do not have access to an active clinical study site associated with the OBI-1-301 study.

NCT ID: NCT01980732 No longer available - Carcinoid Tumors Clinical Trials

68Ga DOTA-TATE PET/CT in Somatostatin Receptor Positive Tumors

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

The primary objective of the study is to evaluate 68Ga-DOTA TATE PET/CT for staging and monitoring response to chemotherapy in patients with carcinoid, neuroendocrine tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.