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NCT ID: NCT00177411 Withdrawn - Osteoporosis Clinical Trials

"PTHrP(1-36) IV Dose Escalation Study"

Start date: July 2005
Phase: Phase 1
Study type: Interventional

This is a single-blinded, one-treatment, combination dose escalation and pharmacokinetic study done in healthy volunteers. The investigators want to determine whether Parathyroid Hormone related Protein (1-36) [PTHrP(1-36)] shares anabolic properties with the only currently approved anabolic agent, parathyroid hormone(1-34) [PTH(1-34)], which stimulates both osteoblastic bone resorption and formation. In a previous study done by the investigators, postmenopausal osteoporotic women on estrogen received 6.56 mcg/kg PTHrP(1-36) subcutaneously for three months daily. They experiences a 4.7% increase in bone mineral density (BMD) of the lumbar spine when compared with those taking placebo. They also displayed an increase in serum osteocalcin, a marker of bone formation, with no change in several markers of bone resorption. It is believed that the rapid absorption and clearance of PTHrP(1-36) likely plays a central role in its anabolic effect In order to further assess absorption, we are combining both pharmacokinetic and dose escalation methods for studying intravenous PTHrP given via a one-time bolus injection. The purpose is to define the maximum safe dose and measure the pharmacokinetic parameters of a single intravenous dose of Parathyroid Hormone-related Protein (1-36)[PTHrP(1-36)]. The results will be useful in determining future treatment options for osteoporosis.

NCT ID: NCT00168051 Withdrawn - Hemophilia A Clinical Trials

Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A

Start date: April 2005
Phase: Phase 4
Study type: Interventional

The purpose of the study is to compare the pharmacokinetic parameters of ReFacto and Advate, using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma.

NCT ID: NCT00167791 Withdrawn - Clinical trials for End Stage Renal Disease

Rituximab Desensitization Therapy for Patients on the Waiting List for Kidney Transplant

Start date: July 2005
Phase: N/A
Study type: Interventional

This is a study of patients who have a high risk of kidney rejection before kidney transplant. The hypothesis is that treatment with a medication called rituximab will make it possible for them to receive a kidney transplant from a donor who previously did not present a good match.

NCT ID: NCT00167557 Withdrawn - Hepatitis C Clinical Trials

Orthotopic Liver Transplant (OLT) Recipients With Hepatitis C Virus (HCV) Under Preemptive Treatment

Start date: January 2005
Phase: Phase 4
Study type: Interventional

After a liver transplant, the hepatitis C virus (which destroyed one's own liver) eventually comes back. In many patients, this will eventually cause the loss of the new liver and can also confuse the doctors taking care of them because it is hard to tell the difference between one's body rejecting the new liver and hepatitis. This can cause serious treatment errors that can lead to more severe hepatitis or to rejection of the liver. Some of the drugs used to prevent rejection of one's new liver can cause the hepatitis to come back in a more severe form. This is especially true for the drugs known as corticosteroids. Right now, the only effective treatment against hepatitis C is a combination of two drugs called interferon and ribavirin. These drugs act by strengthening one's immune system to fight the virus and by directly reducing the reproduction of the virus. Because the treatment with these drugs is associated with many side effects, there is little experience with treating patients after liver transplantation with them. In the investigators' transplant program, they have decided to treat all patients with hepatitis C as early as possible after transplantation and to follow them closely for the development of hepatitis and side effects of the treatment. The investigators treat one's hepatitis as early as possible, before any actual damage has occurred in the new liver. This approach has been tried before but it has been hard to tell if it has worked or not. The main reason for failure was that many patients could not complete the treatment due to side effects. The investigators' purpose is to treat those side effects aggressively so that most patients can complete the treatment course. The purpose of this study is to collect all the data regarding the investigators' treatment protocol so that they will be able to learn if this form of treatment is beneficial. The study includes performing liver biopsies at scheduled times after one's liver transplant and for scheduled blood tests to see how much virus is still in the blood. If patients show signs that they are not responding to treatment they will be removed from the study.

NCT ID: NCT00167492 Withdrawn - Clinical trials for Liver Transplantation

Enteric Coated Myfortic for Liver Transplant Recipients

Start date: September 2005
Phase: Phase 4
Study type: Interventional

The purpose of this study is to replace the mycophenolate mofetil (Cellcept) which is our usual therapy after liver transplantation with sodium mycophenolic acid (Myfortic®) and to find out the effect this change may have on the development of side effects such as relief of gastrointestinal (stomach) problems. In the past we have had to stop Cellcept (our current drug) because of these side effects. We will also try to see if improved usage of this drug (Myfortic®) will allow us to use lower doses of other medications that lower your immune system. We will do some special tests on your blood to see if the amount of the drug is related with its effect on the immune system and side effects. Both Cellcept and Myfortic® are FDA approved medications although Myfortic® is not approved for use after liver transplantation. Myfortic® is really the same active drug as Cellcept® (Mycophenolic acid) but has been coated to prevent breakdown of the drug in the stomach and is made to lower the known gastrointestinal effects of Cellcept such as diarrhea, abdominal pain and nausea.

NCT ID: NCT00167440 Withdrawn - Low Cardiac Output Clinical Trials

Comparison of Techniques for Assessing Cardiac Output and Preload in Critically Ill Pediatric Patients

Start date: August 2004
Phase: Phase 3
Study type: Observational

Each year in the United States more than 30,000 children are admitted to intensive care units. The majority of these children have some degree of heart instability during their stay, yet there is currently no routine way to measure the actual amount of blood that the heart pumps. The ability to measure the amount of blood that the heart pumps accurately and easily at frequent intervals would be very helpful to the doctor caring for these children because many of them have poor heart function as a result of their illnesses. Current techniques used in adults to measure output of the heart are either not readily transferred to children or demand difficult invasive procedures. Because of this, the amount of blood that the heart pumps cannot be measured with enough frequency to help guide care. Despite this reality, accurate measurements of the amount of blood that the heart pumps in these patients at crucial points in their illnesses would allow for more accurate use of potentially harmful procedures and could possibly improve the outlook for these children. Likewise, being able to correctly measure blood volume could provide a better way to estimate the pressure on the heart and improve treatment. The purpose of this research study is to compare the accuracy of doctor estimates of heart output, and establish the usefulness of central blood volume measurements by PCOM (pediatric cardiac output measurements), a less invasive procedure

NCT ID: NCT00166686 Withdrawn - Clinical trials for Treatment-Related Cancer

Clonidine for Neurocognitive Sequelae

Start date: n/a
Phase: Phase 1/Phase 2
Study type: Interventional

The goals of the study are to determine the efficacy of clonidine in the treatment of children with neurocognitive sequelae following the therapy of long term malignancies. In addition, the study hopes to determine the long-term effect of clonidine on children's academic and psychosocial function.

NCT ID: NCT00166647 Withdrawn - Cancer Clinical Trials

Thiopurine Methyltransferase Polymorphisms Evaluation

Start date: February 2004
Phase: Phase 4
Study type: Observational

The purpose of the study is to determine the frequency of allelic variants in TPMT in the Hispanic population and to compare the frequency in the Hispanic population with the Caucasian Population.

NCT ID: NCT00163072 Withdrawn - Cachexia Clinical Trials

Pharmacokinetics and Safety of Transdermal Megestrol Acetate

Start date: October 2005
Phase: Phase 4
Study type: Interventional

Rationale: Megestrol acetate (Megace®) is a progestin analog that is FDA approved for the palliative treatment of breast and endometrial carcinoma. It is also commonly used as an appetite stimulant, particularly in HIV and cancer patients with poor appetite from their primary disease and/or their therapy. Megace is well absorbed orally, however, many patients, particularly younger ones have difficulty taking oral medications. Transdermal progestins are available and are FDA approved. For example, Ortho EvraTM is a transdermal contraceptive patch containing an estrogen (ethinyl estradiol) and a progestin (norelgestromin). Key Objectives: Compare the pharmacokinetics of orally administered vs. transdermal Megace and determine if there are any local side effects of the transdermal route.

NCT ID: NCT00161564 Withdrawn - Clinical trials for Idiopathic Thrombocytopenic Purpura (ITP)

A Trial to Treat Patients With ITP Who Do Not Achieve a Durable Response to Rituxan Alone

Start date: February 2004
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to compare the efficacy and safety of higher doses of rituximab to a combination of standard doses of Rituxan + CVP (Cyclophosphamide, Vincristine, and Prednisone) in patients with chronic Idiopathic Thrombocytopenic Purpura (ITP who did not respond to or relapsed after standard doses of rituximab.