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NCT ID: NCT01776996 No longer available - Clinical trials for Infection, Human Immunodeficiency Virus

An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc

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

This is an open-label protocol designed to provide continued access to maraviroc to only those subjects who have completed previous studies of maraviroc and continue to receive clinical benefit.

NCT ID: NCT01777061 No longer available - Prostate Cancer Clinical Trials

Clinical Management Decisions for Recurrent Prostate Cancer Patients Based on [11C]Acetate PET Scan

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

When evaluating prostate cancer patients for recurrent disease, computed tomography (CT), and magnetic resonance imaging (MRI) are both highly sensitive methods for detecting lymph nodes, but are not specific as to whether the lymph nodes are malignant or benign. While positron emission tomography (PET) utilizing radioactive glucose (FDG) has revolutionized staging, restaging, and monitoring response to therapy in many prevalent cancers such as breast, colorectal, esophageal, head and neck, lung, lymphoma, and melanoma, findings with prostate cancer have proven less sensitive because prostate cancer has a lower avidity for glucose. A newer PET isotope, utilizing acetate that is incorporated into the cell membrane of rapidly proliferating cells, has shown greater sensitivity than FDG in detecting prostate cancer. This study will assess the clinical effectiveness of utilizing [11C]Acetate PET scans in identifying recurrent prostate cancer.

NCT ID: NCT01784562 No longer available - Clinical trials for Hypertension, Pulmonary

Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

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

The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.

NCT ID: NCT01784718 No longer available - Byler Disease Clinical Trials

Buphenyl Therapy for Byler's Disease

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

This is a single patient compassionate use protocol to determine whether Buphenyl (4-phenylbutyrate) will improve the poor bile flow associated with Byler Disease.

NCT ID: NCT01787136 No longer available - Clinical trials for Attention Deficit Hyperactivity Disorder

Dextromethorphan Added on for the Patients With ADHD

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

Dextromethorphan added on methylphenidate for the patients with attention deficit hyperactivity disorder

NCT ID: NCT01789151 No longer available - Clinical trials for Rheumatoid Arthritis

99m-Technetium- Glucosamine in Arthritis

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

Preliminary data following a pilot study from our institution confirms the ability of 99mTc-glucosamine (99mTc-ECDG) to differentiate between active, subclinical and quiescent disease in patients with rheumatoid arthritis, scleroderma lung, and vasculitis. We propose to extend these findings and further evaluate this imaging modality for its clinical utility, limitations, and application. An unacceptably high level of morbidity exists amongst patients suffering from rheumatic disease. This is often the result of mild disease being missed or misdiagnosed, and therapy inordinately delayed or inappropriate. The currently used therapeutic agents themselves have associated side-effects adding to unfavourable clinical outcomes. There is therefore a need for a superior, less expensive and more easily accessible imaging modality to assess the degree of inflammation to guide the clinician. Glucosamine is absorbed and metabolised in a manner not too dissimilar to that of glucose, and it can be readily labelled to form 99mTc-ECDG. Scans can be acquired within 3 hours of intravenous administration of this agent, accurately depicting sites of active inflammation/disease. HYPOTHESIS Glucose is a vital cellular substrate that accumulates at inflamed tissues because of the greater metabolic needs of the cells during active disease. Glucosamine, being an analogue of glucose, is metabolised more quickly in inflamed than non-inflamed tissue and thus 99mTc-ECDG scintigraphy like 18-Fluorodeoxyglucose (18FDG-PET) scintigraphy allows for detection of active inflammation. Unlike current bone scans this agent has the sensitivity to detect subclinical inflammatory disease that would in turn provide essential information to ensure accurate diagnosis and treatment.

NCT ID: NCT01797276 No longer available - Clinical trials for Mitochondrial Enzyme Deficiencies

Dichloroacetate Treatment of Congenital Lactic Acidosis Phase B: Expanded Access

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

Expanded access to DCA as continued treatment for congenital lactic acidosis.

NCT ID: NCT01834209 No longer available - Prostate Neoplasms Clinical Trials

A Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

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

The purpose of this study is to collect additional safety data during treatment with abiraterone acetate plus prednisone or prednisolone among adult participants with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC) who reside in areas in which abiraterone acetate is not yet available for this indication through local healthcare providers, and who are not eligible for enrollment into an available ongoing clinical study of abiraterone acetate.

NCT ID: NCT01835314 No longer available - Dravet Syndrome Clinical Trials

Compassionate Use of Stiripentol in Dravet Syndrome

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

Compassionate use of Stiripentol in Dravet Syndrome. This is a treatment protocol, not a research study, therefore children will only be monitored on a clinical basis for seizure improvement predominantly by parent and caregiver report.

NCT ID: NCT01838187 No longer available - Neuroblastoma Clinical Trials

Expanded Access Protocol Using 131I-MIBG Therapy +/- Vorinostat for Refractory Neuroblastoma, Pheochromocytoma, or Paraganglioma

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

Currently there is no known effective treatment for patients with advanced stage neuroblastoma who have relapsed or not responded to standard therapy. There is also no known effective treatment for patients with pheochromocytoma or paraganglioma who are less than 12 years of age. In previous studies that used 131I-MIBG as a potential anti-cancer therapy, a decrease in the size of tumors was seen in some of the children and adults. This research study will continue to evaluate the side effects of 131I-MIBG +/- Vorinostat when treating children and adults with neuroblastoma, pheochromocytoma, or paraganglioma. The 131I-MIBG compound is intended to work by selectively delivering the radioactive iodine to the tumor cells, which is then intended to result in their destruction. The purpose of this research study is to: - Make 131I-MIBG therapy available to patients with advanced neuroblastoma, pheochromocytoma, or paraganglioma - Further assess the side effects of 131I-MIBG therapy