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This protocol allows for the treatment of pediatric patients, male and female, between the ages of 2 months and 17 years. Patients must have failed steroid treatment for Grade B-D acute GVHD.
PURPOSE - HYPOTHESIS: Children with unilateral congenital urine flow impairment, who require surgery, have abnormal 24-hour ambulatory blood pressure measurements. OBJECTIVES: To Measure 24-hour ambulatory blood pressure in children who have unilateral hydronephrosis or multicystic-dysplastic kidneys. To compare these blood pressure measurements between the children who require surgical correction and those who do not need surgical correction. BACKGROUND: With the introduction of ultrasound examinations of pregnant women, previously undetected abnormalities in the fetus are being detected. Dilatation of the kidney caused by congenital unilateral impairment to the urine flow either partial, presenting as unilateral hydronephrosis or complete, as seen in children with multicystic-dysplastic kidneys, id a common finding affecting approximately 1: 1,500 pregnancies (Cendron et al 1994). The majority of infants do not require surgery, with only 25% needing surgery by 18 months of age (Ransley 1991). However, i8n a few. There is an increase in renal dilatation which ultimately results in a reduction in renal function. The decision to operate is dependent on changes in renal pelvic diameter observed on serial ultrasound scans and on renal function. This process is often lengthy an requ8ires numerous scans, which can be upsetting for parents and child. M<any techniques have been used to identify, early, those patients who will require surgery. These have included: Intra-0renal pressure measurements, renal function, and calyceal diameter (Feung L 1997). To date, none have shown to be better than ultrasound (Dhillion HK 1998). Ambulatory blood pressure monitoring measures the blood pressure multiple times during a predefined period. It, therefore, more accurately reflects the continuous nature of blood pressure during both awake and sleep periods (Sorof JM 2001). Consequently, it may detect abnormalities in blood pressure that are missed on a single reading. This has been shown in the one previous study investigating ambulatory blood pressure and patient with multicystic dysplastic kidneys (Seeman T et al Eur J Pediatr 2001). In this study, 20% of the children studied had abnormal results when ambulatory blood pressure was monitored.
Congenital diaphragmatic hernia is an anatomically simple birth defect in which contents of the fetal abdomen migrate into the chest due to incomplete formation of the diaphragm. Herniation of viscera into the chest prevents the fetal lungs from developing and growing to normal size. In the most severe cases, there is significant morbidity and mortality at birth. For these fetuses, fetal intervention may improve outcomes by enabling the lungs to grow enough in utero that they are capable of sustaining life after birth. This unblinded, non-randomized trial will assess the safety and efficacy of the use of the Goldvalve balloon and MiniTorquer microcatheter to perform percutaneous temporary tracheal occlusion to treat severe CDH in utero. The primary outcome variable will be fetal lung growth due to successful 'plugging/unplugging' of the trachea, as determined by serial lung-head ratio (LHR) measurements. Secondary outcome variables include maternal, fetal and neonatal variables, specifically neonatal survival at 90 days of life. For infants who survive beyond 90 days post-delivery, their families will be offered follow-up (up to 2 years of age and possibly beyond) in the Long-term Infant-to-Adult Follow-up Evaluation (LIFE) Clinic at UCSF.
The primary reason for this study is to further assess safety and efficacy data of the bortezomib/melphalan/prednisone (BMP) regimen in previously untreated and transplant ineligible multiple myeloma patients
Following the discovery of tumor-specific frequencies in patients with advanced cancer, compassionate treatment with tumor-specific frequencies administered at levels that are significantly below the levels generated by cell phone will be offered to patients with limited therapeutic options.
This protocol allows for the treatment of patients, male and female, between the ages of 18 years and 70 years. Patients must have failed to respond to steroid treatment for Grade C-D acute GVHD.
VTI had established other clinical protocols to study the effects of ELAD® plus standard therapy compared with standard therapy alone in patients with acute on chronic (AOCH) (VTI-201, VTI-206) and fulminant hepatic failure (FHF) (VTI-202) and acute alcoholic hepatitis (AAH). However, liver failure (LF) patients who do not qualify for other protocols may benefit from ELAD use. In order to accommodate physician requests for the use of ELAD in LF patients who do not qualify for open Protocols, without the need to resort to individual Emergency Use INDs for each case, VTI has developed a Treatment Protocol with Cost Recovery to provide for expanded access to ELAD for those with LF. This uncontrolled Treatment Protocol has been designed to provide expanded access to ELAD in subjects with LF while assuring that sufficient data are collected to adequately monitor ELAD safety when used in this setting at multiple centers in the United States.
Fish oil therapy may decrease the incidence of cardiac arrhythmias. This study will test whether pre-treatment with fish oils before catheter ablation of atrial fibrillation decreases the early post operative occurrence of atrial fibrillation.
Clofazimine has shown effectiveness in the treatment of leprosy for many years. The World Health Organization and the National Hansen's Disease Program consider clofazamine to be standard therapy for treatment of multibacillary leprosy. In recent years, the availability of the drug has become limited and is currently available only under a research protocol and is considered "investigational." Use of Clofazamine in patients presenting with lepromatous leprosy is necessary for patients exhibiting nerve involvement or lesions resistant to other therapies. This drug will be used prospectively for patients who require treatment of leprosy as deemed appropriate by a Kaiser Permanente Southern California physician.
The purpose of this study is to provide sildenafil therapy to patients who completed the A1481244 study for the treatment of PAH, and reside in Brazilian States where Revatio™ is not supplied by Health Secretary, and are judged by the Investigator to derive clinical benefit from continued treatment with Sildenafil. It will be supplied until patient gets access to Sildenafil through Brazilian State Health Secretary from where patient resides.