Clinical trials programs

The National Cancer Institute (NCI) is the largest single sponsor of studies using anti-neoplastic agents with over 100 compounds currently in various stages of clinical testing. Most of the clinical trials are conducted by the NCI sponsored cooperative oncology groups and community oncology programs, cancer centers, and the pharmaceutical industry. These organizations conduct studies both independently as well as in a collaborative fashion.     

Genetic analysis of host responses in sepsis

During much of the past century, the microbe itself stood at the heart of microbial pathogenesis. Little thought was devoted to the host per se, though it was granted that differences in susceptibility to certain infections did exist between individuals, and between different ethnic groups. During the past 20 years, extraordinary strides in our grasp of mammalian genetics have made the host side of the equation far more approachable. A restricted collection of genes now presents itself as the likely repository for genetic differences that foretell susceptibility to infectious disease. The Toll-like receptors, of which 10 are presently known to exist in humans, offer an excellent example of this genetic reductionism, in that they embody the afferent component of the innate immune system, and strongly influence the containment of an infection from its earliest stages. The Toll-like receptors were identified as the culmination of a long and relentless inquiry into the yet-unsolved clinical problem of sepsis.     

Single parent women

Summary While there has been considerable interest in the problems of single parent families, no study has yet determined if the problems are due to increased risk of specific psychiatric disorders in single parents as compared to their married counterparts. Data collected as part of the National Institute of Mental Health Epidemiologic Catchment Area (ECA) Project are presented to compare the psychiatric as well as economic and social functioning of single vs. married parent women ages 18–44, based on a probability sample of members of the greater New Haven community. The major finding between groups is their relative similarity in psychiatric as well as social functioning. The major difference is economic. Single parents, both Black and White, more frequently are less educated and poorer. While many are on welfare, single compared to married female parents are more likely to be working and to report insufficient income to meet their needs. There are no appreciable differences in social contacts, use of health services or six-month prevalence rates of psychiatric disorders including major depression, alcohol or drug abuse. The data suggest that the problems faced by single parent women and their children may be a reflection of poverty and stress in families and not of psychiatric disorders or poor social relations in mothers.     

The role of medical comorbidity in outcome of major depression in primary care: the PROSPECT study.

OBJECTIVE: The authors described the influence of specific medical conditions on clinical remission and response of major depression (MDD) in a clinical trial evaluating a care-management intervention among older primary-care patients. METHODS: Adults age 60 years and older were randomly selected and screened for depression. Participants were randomly assigned to Usual Care or to an Intervention with a depression care-manager offering algorithm-based care for MDD. In all, 324 adults meeting criteria for MDD were included in these analyses. Remission and response was defined by a score on the Hamilton Rating Scale for Depression <10 and by a decrease from baseline of > or =50%, respectively. Medical comorbidity was ascertained through self-report. Cognitive impairment was defined by a score <24 on the Mini-Mental State Exam (MMSE). RESULTS: In Usual Care, rates of remission were faster in persons who reported atrial fibrillation (AF) than in persons who did not report AF and slower in persons who reported chronic pulmonary disease than in persons who did not report chronic pulmonary disease; rates of response were less stable in persons with MMSE <24 than in those with MMSE > or =24. In the Intervention condition, none of the specific chronic medical conditions were significantly associated with outcomes for MDD. CONCLUSIONS: Because disease-specific findings were observed in persons who received Usual Care but not in persons who received more intensive treatment in the Intervention condition, our results suggest that the association of medical comorbidity and treatment outcomes for MDD may be determined by the intensity of treatment for depression.     

Flavocoxid is as effective as naproxen for managing the signs and symptoms of osteoarthritis of the knee in humans: a short-term randomized,double-blind pilot study

Flavocoxid (Limbrel), a proprietary mixture of flavonoid molecules (baicalin and catechin), was tested against a traditional nonsteroidal anti-inflammatory drug, naproxen, for the management of the signs and symptoms of moderate osteoarthritis (OA) in humans. Discomfort and global disease activity were used as the primary end points, and safety assessments were also taken for both treatments as a secondary endpoint. In this double-blind study, 103 subjects were randomly assigned to receive either flavocoxid [500 mg twice daily (BID)] or naproxen (500 mg BID) in a 1-month onset of action trial. Outcome measures included the short Western Ontario and McMaster University Osteoarthritis Index, subject Visual Analogue Scale for discomfort and global response, and investigator Visual Analogue Scale for global response and fecal occult blood. Both flavocoxid and naproxen showed significant reduction in the signs and symptoms of knee OA (P ≤ .001). There were no statistically detectable differences between the flavocoxid and naproxen groups with respect to any of the outcome variables. Similarly, there were no statistically detectable differences between the groups with respect to any adverse event, although there was a trend toward a higher incidence of edema and nonspecific musculoskeletal discomfort in the naproxen group. In this short-term pilot study, flavocoxid was as effective as naproxen in controlling the signs and symptoms of OA of the knee and would present a safe and effective option for those individuals on traditional nonsteroidal anti-inflammatory drugs or cyclooxygenase-2 inhibitors. A low incidence of adverse events was reported for both groups.