Assessment of the duration of protection in Campylobacter jejuni experimental infection in humans.

A human Campylobacter jejuni infection model provided controlled exposure to assess vaccine efficacy and investigate protective immunity for this important diarrheal pathogen. A well-characterized outbreak strain, C. jejuni 81-176, was investigated using a volunteer experimental infection model to evaluate the dose range and duration of protection.

beta-Blocker use in long-term dialysis patients: association with hospitalized heart failure and mortality.

Background: beta-Blockers have been shown to be beneficial in the treatment and prevention of heart failure (HF) in the general population, but they have not been assessed for their association with nonfatal HF in a nationally representative population of long-term dialysis patients.

Methods: We conducted a retrospective cohort study of 2550 patients enrolled in the US Renal Data System (USRDS) Wave 2 who were Medicare eligible at the start of the study. Analysis was stratified by the presence or absence of a known diagnosis of HF, and patients followed up until December 31, 2000.

Two studies evaluating the safety and immunogenicity of a live, attenuated Shigella flexneri 2a vaccine (SC602) and excretion of vaccine organisms in North American volunteers.

We report the first community-based evaluation of Shigella flexneri 2a strain SC602, a live, oral vaccine strain attenuated by deletion of the icsA (virG) plasmid virulence gene, given at 10(4) CFU. The primary objectives of this trial were to determine the safety and immunogenicity of the vaccine and to determine the duration of colonization. Four of 34 volunteers experienced transient fevers, and three reported diarrhea during the first 3 days of the study.

Arteriovenous fistula use and heart disease in long-term elderly hemodialysis patients: analysis of United States Renal Data System Dialysis Morbidity and Mortality Wave II.

Background: There are some concerns that arteriovenous fistula (AVF) use or other dialysis specific factors may exacerbate cardiovascular disease in long-term hemodialysis (HD) patients.

Methods: We performed a historical cohort study of the United States Renal Data System Dialysis Morbidity and Mortality Wave II study, limited to 993 patients who started HD in 1996 with valid information on vascular access and who were primarily eligible for Medicare at the start of the study. We assessed the association between hemodialysis vascular access and heart disease, defined as Medicare Claims for heart failure (HF, International Classification of Diseases (ICD9) code 428.

Body mass index, dialysis modality, and survival: analysis of the United States Renal Data System Dialysis Morbidity and Mortality Wave II Study.

Background: The impact of obesity on survival in end-stage renal disease (ESRD) patients as related to dialysis modality (i.e., a direct comparison of hemodialysis with peritoneal dialysis) has not been assessed adjusting for differences in medication use, follow-up > or =2 years, or accounting for changes in dialysis modality.

HIVAN and medication use in chronic dialysis patients in the United States: analysis of the USRDS DMMS Wave 2 study.

Background: The use and possible effects of factors known to improve outcomes in patients with human immunodeficiency virus associated nephropathy (HIVAN), namely of angiotensin converting enzyme inhibitors (ACE) and antiretroviral therapy, has not been reported for a national sample of dialysis patients.

Methods: We conducted a historical cohort study of the United States Renal Data System (USRDS) Dialysis Morbidity and Mortality Study (DMMS) Wave 2 to identify risk factors associated with increased mortality in these patients. Data were available for 3374 patients who started dialysis and were followed until March 2000.

Heart failure as a cause for hospitalization in chronic dialysis patients.

Background: Risk factors for heart failure (HF) have not been reported previously in a nationally representative sample of dialysis patients.

Methods: We conducted a historic cohort study of 1,995 patients enrolled in the US Renal Data System Dialysis Morbidity and Mortality Study Wave 2 who were Medicare eligible at the study start and were followed up until December 31, 1999, or receipt of a renal transplant. Cox regression analysis was used to model associations with time to first hospitalization for both recurrent and de novo HF (International Classification of Diseases, Ninth Revision code 428.

Survival by time of day of hemodialysis: analysis of United States Renal Data System Dialysis Morbidity and Mortality Waves III/IV.

Background: Whether morning shift hemodialysis is associated with improved survival in comparison to patients receiving afternoon shift hemodialysis has not been shown for a representative sample of US chronic hemodialysis patients.

Methods: We conducted a historical cohort study of a national database (US Renal Data System Dialysis Morbidity and Mortality Waves III/IV) of 6,939 patients who started hemodialysis therapy from January 1, 1990, through December 31, 1993. Patients were followed up through April 9, 2000, and censored at the time of change to a different modality, including transplantation.

Atrial fibrillation in chronic dialysis patients in the United States: risk factors for hospitalization and mortality.

Background: The incidence and risk factors for hospitalized atrial fibrillation have not been previously assessed in a national population of dialysis patients.

Methods: We analyzed the United States Renal Data System (USRDS) Dialysis Morbidity and Mortality Study (DMMS) Wave II in a historical cohort study of hospitalized atrial fibrillation. Data from 3374 patients who started dialysis in 1996 with valid follow-up times were available for analysis, censored at the time of renal transplantation and followed until November 2000.

Incident acute coronary syndromes in chronic dialysis patients in the United States.

Background: Patients on dialysis have a disproportionately high rate of cardiovascular disease (CVD). However, the incidence and risk factors for incident acute coronary syndromes (ACS) have not been previously assessed in dialysis patients.

Methods: We analyzed the United States Renal Data System (USRDS) Dialysis Morbidity and Mortality Study (DMMS) Wave II in a historical cohort study of ACS.

Safety, tolerability, and lack of antibody responses after administration of a PfCSP DNA malaria vaccine via needle or needle-free jet injection, and comparison of intramuscular and combination intramuscular/intradermal routes.

Introduction of a new vaccine requires choosing a delivery system that provides safe administration and the desired level of immunogenicity. The safety, tolerability, and immunogenicity of three monthly 2.5-mg doses of a PfCSP DNA vaccine were evaluated in healthy volunteers as administered intramuscularly (IM) by needle, IM by jet injection (Biojector or IM/intradermally (ID) by jet injection.

Scleroderma at end stage renal disease in the United States: patient characteristics and survival.

Background: The patient characteristics and mortality associated with scleroderma have not been characterized for a national sample of end stage renal disease (ESRD) patients.

Methods: 364,317 patients in the United States Renal Data System initiated on ESRD therapy between 1 January 1992 and 30 June 1997 with valid causes of ESRD were analyzed in an historical cohort study of scleroderma.

Results: Of the study population, 820 (0.