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NCT ID: NCT01131247 Withdrawn - Clinical trials for Chronic Lymphocytic Leukemia (CLL)

PH2 Trial in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) With a Combination of Bendamustine & Ofatumumab

Start date: n/a
Phase: Phase 2
Study type: Interventional

Investigational Drugs: Ofatumumab (Azerra) + bendamustine (Trenda) Route of Administration: Intravenous (IV) Hypothesis: This study is designed to assess the toxicity and overall response rate. Ofatumumab is a fully human monoclonal antibody (A type of protein made in the laboratory that can bind to substances in the body, including tumor cells) that shows promising activity in the treatment of CLL as a single agent. It is thought that by combining it with Bendamustine, an FDA approved treatment for CLL, the effect on CLL will be greater than if Ofatumumab is given alone. Ofatumumab is FDA approved for the treatment of relapsed/refractory CLL. Participation: Approximately 37 relapsed/refractory CLL subjects will participate in this study over two years. Treatment Plan: A maximum of 6 cycles of treatment will be allowed. During day 1 of cycle 1 ofatumumab IV 300mg will be administered. On day 1 of all cycles ofatumumab treatment will be followed by bendamustine IV 90mg/m2. On day 2 of all cycles, bendamustine IV 90mg/m2 will be administered. On day 3 of all cycles, neulasta SQ 6mg will be given. On day 8 of cycle 1 only patients will receive ofatumumab IV 1000mg. During cycles 2 through 6 ofatumumab 1000mg will be given on day 1 only. Follow-up: Patients will be followed monthly for six months, then every three months for five years then annually thereafter.

NCT ID: NCT01130701 Withdrawn - Pancreatic Cancer Clinical Trials

A Pilot Study to Evaluate the Efficacy and Safety of Neoadjuvant Chemoradiotherapy With Capecitabine, . . .

PMABIIS
Start date: May 2010
Phase: Phase 2
Study type: Interventional

In this study, a new chemotherapeutic agent, panitumumab, will be tested in combination with another chemotherapeutic drug, capecitabine, along with external radiotherapy, to find out whether this combination is effective and safe to use before surgery.

NCT ID: NCT01130649 Withdrawn - Epilepsy Clinical Trials

Remote Tracking of Epilepsy Patients

Start date: July 2010
Phase: N/A
Study type: Observational

The investigators propose a novel method for tracking the seizure frequency, side effect burden, and medication compliance for patients with epilepsy. The investigators intend to utilize a table-top device currently for tracking other chronic disease to collect remote data from epilepsy patients. The hypothesis is that the use of this device will lead to better longterm treatment outcomes than the standard outpatient mechanism of following patients longitudinally.

NCT ID: NCT01130623 Withdrawn - Sarcoma Clinical Trials

A Phase I Study of Pazopanib as a Single Agent for Children With Refractory Solid Tumors

Start date: May 10, 2010
Phase: Phase 1
Study type: Interventional

Background: - Pazopanib, a drug that inhibits the growth of new blood vessels in tumors, was recently approved by the Food and Drug Administration to treat advanced kidney cancer in adults. Pazopanib has been used in only a small number of adults, and more research is needed on whether it is safe and effective to use in children. Researchers are interested in determining safe and effective treatment doses of pazopanib in children, and in other studies will examine which form of pazopanib treatment (tablet or liquid) is most effective and well tolerated. Objectives: - To determine a safe and effective dose of pazopanib to treat solid tumors in children. - To study the effects of pazopanib on blood cells, blood flow, and human development. Eligibility: - Children, adolescents, and young adults between 1 and 21 years of age who have been diagnosed with solid tumors that have not responded to treatment. Design: - Eligible participants will be screened with a physical examination, blood and tumor samples, and imaging studies. - Participants will receive pazopanib tablets for 28-day cycles of treatment. Pazopanib should be taken on an empty stomach, at least 1hour before or 2 hours after a meal. Participants may receive pazopanib for up to 24 cycles unless the tumor does not respond or participants develop serious side effects. - Blood samples will be taken on days 1, 15, 22, and 27 of the first cycle of pazopanib, with additional samples taken every 8 weeks during subsequent cycles. - An optional part of the study will collect additional blood samples at regular intervals for 24 hours after the first dose of pazopanib and at regular intervals after another dose during the second or third week of the first treatment cycle.

NCT ID: NCT01130324 Withdrawn - Pregnancy Clinical Trials

VIBATIV Pregnancy Registry

Start date: November 2009
Phase:
Study type: Observational [Patient Registry]

The purpose of this registry is to evaluate the outcome of pregnancy in women exposed to VIBATIV at any time during pregnancy. There are no mandated physician visits for the registry.

NCT ID: NCT01129947 Withdrawn - Clinical trials for Premature Ovarian Failure

The Use of DHEA in Women With Premature Ovarian Failure

Start date: May 2010
Phase: Phase 0
Study type: Interventional

DHEA supplementation has been used in women with infertility and diminished ovarian reserve. There is a small report in 5 women with POF that benefited from the use of DHEA over several months. The investigators aim to evaluate further the use of DHEA in women with Premature ovarian failure (POF).

NCT ID: NCT01128673 Withdrawn - Clinical trials for Hypoxic Ischemic Encephalopathy

MRI Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy(HIE)

Start date: May 2010
Phase: N/A
Study type: Observational

Hundreds of babies in the world are being treated with brain cooling to prevent brain injury after they lose oxygen at birth. This study will use the newly developed information from the magnet resonance image to determine the actual temperature of the brain. This will enable us to determine if the brain is being uniformly cooled and if techniques that provide cooling need to be changed to improve the injury prevention from cooling.

NCT ID: NCT01127672 Withdrawn - Plantar Fasciitis Clinical Trials

Treatment of Plantar Fasciitis With Platelet Rich Plasma

Start date: May 2010
Phase: N/A
Study type: Interventional

The purpose of this investigator-initiated study is to clinically evaluate the efficacy of a new treatment for plantar fasciitis. This treatment consists of a platelet rich plasma injection into the origin of the plantar fascia. It is thought that plasma rich plasma injection will dramatically improve outcomes for patients suffering from plantar fasciitis. Subjects will be randomized by choosing a slip of paper from an envelope. This process will randomize 25 patients to the experimental group, and 25 patients to the control. The experimental group will undergo a blood draw, allowing for an injection of platelet rich plasma into the origin of the plantar fascia. The control group will undergo a corticosteroid injection into the plantar fascia as the sole treatment. Patients will be followed for three months for pain, and will fill out questionnaires at the initial visit prior to receiving the injection, as well as six and twelve weeks post injection. These questionnaires will give insight into functionality and pain changes that the plantar fascia is experiencing due to treatment. Subjects will be outpatients. Subjects may include employees, students, minorities, and elderly, although no subsets of these will be formed. Subjects will be between 18 and 89 years of age. In total, subject participation will last approximately 3 months.

NCT ID: NCT01127334 Withdrawn - Clinical trials for Systolic Heart Failure

Pilot Study Using Echocardiography to Evaluate Patients With Heart Failure and Dyssynchrony Who Have a CRT-D Device

Start date: May 2010
Phase: N/A
Study type: Observational

Out of all the patients that receive a CRT-D ( a dual chamber pacemaker with defibrillator ) for cardiac resynchronization therapy there is approximately one-third that do not respond. We believe that by using a simple technique that includes routine echocardiography that are normally performed in these patients could help us better understand how to program their device to reach better optimization.

NCT ID: NCT01125501 Withdrawn - Metabolic Syndrome Clinical Trials

Protandim and the Metabolic Syndrome

Start date: April 2010
Phase: N/A
Study type: Interventional

Protandim will decrease markers of oxidative stress/inflammation in subjects with metabolic syndrome and proteomics will identify protein profiles that correlate with markers or/changes in oxidative stress.