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NCT ID: NCT01130259 No longer available - Breast Cancer Clinical Trials

An Open-Label, Expanded Access Protocol of Iniparib Breast Cancer

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

The following trial is designed to offer pre-approval drug access to iniparib in combination with gemcitabine and carboplatin in order to provide potential clinical benefit to patients with ER-, PR-, and HER2-negative metastatic breast cancer. This follows an ongoing Phase 3, multi-center, open-label, randomized study of gemcitabine/carboplatin, with or without iniparib, in patients with ER-, PR-, and HER2-negative metastatic breast cancer (protocol 20090301). Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

NCT ID: NCT01151930 No longer available - Clinical trials for Malignant Solid Tumour

Long-Term Compassionate Use Study for Continued Administration of SCB01A-01

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

The primary objective is to characterize the safety profile of long-term exposure to SCB01A when administered to cancer subjects with advanced solid tumors. Furthermore, the efficacy profile will also be explored in this study.

NCT ID: NCT01194011 No longer available - Clinical trials for Valuable Suggestions to Improve Health Care Quality Transparent and Accessible Medical Care

Study on Nation-wide Health Care Quality Information Openness and Transparency Mechanism Establishment

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

Research objectives To provide people with sufficient information regarding health care and to improve its quality, this research endeavors to discuss the establishment of a health care information openness and transparency mechanism within the framework of the National Health Insurance system. This research also evaluates whether the transparency of health care quality information makes care givers provide better quality. Meanwhile, when appropriate information and quality index are presented to patients, patients shall have more knowledge about what they are dealing with, hence less misunderstanding between hospitals and patients would occur. Research Methods 1. To revise indicators based on international trends, related literature and the need of people. 2. To present 50 sets of quality indicator statistically on the website, and provide updated information about the first 10 sets. 3. To analyze and explain the outcome and purposes of the indicator to the public. 4. To estimate the possible trend for the coming year, and provide adaptive strategy. 5. To promote the website, and hold workshops in all six regions of Taiwan. 6. To make the website linked to the top 5 most populated official and unofficial websites. 7. To respond to questions on the forum of the website daily, and maintain the system, update the website regularly. 8. To complete the acceptability survey on health care institutions and people.

NCT ID: NCT01196208 No longer available - Clinical trials for Lymphoma, Non-Hodgkin

A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001

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

The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001

NCT ID: NCT01200017 No longer available - Clinical trials for Acute Myeloid Leukemia

Expanded Access Protocol (EAP) Using the CliniMACS® Device for Pediatric Haplocompatible Donor Stem Cell Transplant

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

This protocol provides expanded access to bone marrow transplants for children who lack a histocompatible (tissue matched) stem cell or bone marrow donor when an alternative donor (unrelated donor or half-matched related donor) is available to donate. In this procedure, some of the blood forming cells (the stem cells) are collected from the blood of a partially human leukocyte antigen (HLA) matched (haploidentical) donor and are transplanted into the patient (the recipient) after administration of a "conditioning regimen". A conditioning regimen consists of chemotherapy and sometimes radiation to the entire body (total body irradiation, or TBI), which is meant to destroy the cancer cells and suppress the recipient's immune system to allow the transplanted cells to take (grow). A major problem after a transplant from an alternative donor is increased risk of Graft-versus-Host Disease (GVHD), which occurs when donor T cells (white blood cells that are involved with the body's immune response) attack other tissues or organs like the skin, liver and intestines of the transplant recipient. In this study, stem cells that are obtained from a partially-matched donor will be highly purified using the investigational CliniMACS® stem cell selection device in an effort to achieve specific T cell target values. The primary aim of the study is to help improve overall survival with haploidentical stem cell transplant in a high risk patient population by limiting the complication of GVHD.

NCT ID: NCT01206504 No longer available - Clinical trials for West Nile Virus Infection

Expanded Access to MGAWN1 in Subjects With Suspected West Nile Neuroinvasive Disease; Suspected West Nile Virus Infection; or Substantial Accidental Exposure

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

This study will test an experimental drug called MGAWN1 for the treatment of West Nile infections.

NCT ID: NCT01210625 No longer available - Constipation Clinical Trials

Starch-entrapped Microspheres [Nutrabiotix Fiber] for Gut Health

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

The investigators hypothesize that daily oral intake of starch-entrapped alginate microspheres (called Nutrabiotix fiber) is well tolerated, exhibits no or minimal "typical" side effects of fiber (e.g. bloating, loose stool, flatulence), can be used as an ideal vehicle to deliver anti-oxidants/anti-inflammatory natural and synthetic substances/agents; and promote gut health by improving bowel habit, by changing the gut microbiota and increasing production of short chain fatty acids, especially butyrate, in the colon and decreasing production of protein putrification (prebiotic effects).

NCT ID: NCT01238276 No longer available - Diabetic Foot Ulcer Clinical Trials

Direct Antibiotic Delivery of Cefazolin Into Soft Tissue Infections Using Subcutaneous Injection and Ultrasonic Dispersion

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

This study focuses on a new drug delivery system (Direct Antibiotic Delivery) to treat soft tissue infections. In this study, cefazolin is delivered directly to the target tissues using subcutaneous injection of antibiotic solution and then dispersed using high-frequency external ultrasound. Using this system, a much higher concentration of antibiotic can be achieved than through traditional treatment methods. Unlike traditional delivery methods, Direct Antibiotic Delivery does not rely on blood supply and is beneficial for subjects with Diabetes or subjects who have received radiation therapy and blood supply is limited.

NCT ID: NCT01260779 No longer available - Clinical trials for Cutaneous or Subcutaneous Tumors Where There is no Comparable or Satisfactory

Expanded Access Protocol for PV-10 for Cutaneous or Subcutaneous Tumors

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

This compassionate use protocol provides expanded access for investigational use of PV-10 in cancer patients who are not eligible for an existing PV-10 clinical trial, for whom there is no comparable or satisfactory approved alternative therapy and whom, in the opinion of the investigator, may benefit from PV-10 administration.

NCT ID: NCT01279798 No longer available - Clinical trials for Non-small Cell Lung Cancer

Expanded Access Multicenter Study of Lucanix® (Belagenpumatucel-L)

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

This is an expanded access protocol designed to make Lucanix® available to subjects with advanced non-small cell lung cancer (NSCLC) who are not eligible for the Phase III Protocol, NR001-03. A total of 45 patients will be enrolled into the study.