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Biomedical subjects

M Shulman

Publications and source records attributed to M Shulman.

At least 19 recordsLinked to original sources
PubMed2000

A phase I trial of solubilized DR2:MBP84-102 (AG284) in multiple sclerosis.

OBJECTIVE: To assess the safety, tolerability, and biologic and clinical activity of a solubilized complex comprised of human leukocyte antigen-DR2 with myelin basic protein84-102 (AG284)in patients with secondary progressive MS. BACKGROUND: Soluble species-specific major histocompatibility complex myelin basic protein91-103 complexes ameliorate disease in a dose-dependent manner when administered to SJL/J mice with chronic relapsing experimental allergic encephalomyelitis. Preincubation with AG284 reduces the proliferative response of a DR2-restricted, myelin basic protein84-102-reactive T cell clone, derived from a MS patient, to myelin basic protein84-102 in the presence of autologous antigen-presenting cells. METHODS: Thirty-three patients with secondary progressive MS were randomly assigned to receive three alternate day IV doses of AG284 or placebo in a double-masked dose escalation study. The primary outcome was safety and tolerability. Secondary outcomes included a comparison of pre- and post-treatment gadolinium-enhanced brain MRI activity, Kurtzke Expanded Disability Status Scale, and Nine Hole Peg Test scores. RESULTS: The frequency of adverse events was similar in the AG284 and placebo recipients. No significant treatment effect was detected by Expanded Disability Status Scale, Nine Hole Peg Test, or number of new gadolinium-enhancing MRI lesions. CONCLUSIONS: AG284 as administered during this study was safe and well tolerated. Further studies are warranted to determine the biologic activity and clinical efficacy of this potential treatment for MS.

Adult↗
PubMed2000

Comparison of epidural butamben to celiac plexus neurolytic block for the treatment of the pain of pancreatic cancer.

OBJECTIVE: To compare pain relief in metastatic pancreatic cancer patients between neurolytic celiac plexus block (NCPB) and epidural 5% butamben suspension (EBS), a material-based delivery system of a local anesthetic that produces a long-lasting differential nerve block. DESIGN: Open-label patient-selected parallel groups. SETTING: Urban tertiary care medical center. PATIENTS: Twenty-four adult patients with metastatic pancreatic cancer experiencing pain uncontrolled by systemic opioids who were referred to a multidisciplinary pain clinic for interventional therapy. INTERVENTIONS: Antecrural NCPB-block with ethanol and epidural 5% butamben suspension injections. MEASURES: Subjective global pain relief assessments on a 0-100% scale were made weekly for 4 weeks and then monthly. Change in opioid use postintervention. RESULTS: Eight patients had a single NCPB and three patients had two NCPB. Four of the former and two of the latter had successful pain relief defined to be a more than 75% reduction in pain when compared with pretreatment maintained for more than 4 weeks or until death (if less than 4 weeks). Thirteen patients received EBS in divided doses. Eleven patients received a cumulative EBS dose of 5 grams, one patient received a cumulative EBS dose of 2.5 grams, and one patient received a cumulative EBS dose of 8.75 grams. Nine of the eleven patients and each of the other two patients had successful pain relief. The overall incidence (85% EBS vs. 55% NCPB), the duration of successful pain relief, and the percent reduction in opioid use did not differ between the two groups. There were no serious complications. CONCLUSION: EBS appears to be a safe and effective alternative to NCPB in the treatment of pancreatic cancer pain.

Adult↗
PubMed1999

The FDA and regulatory issues in graft development.

Regulatory issues in graft development range from mundane to complex because of the extensive diversity in graft technology. This article, describes the regulatory differentiation between types of grafts, incorporating a description of the system for classifying devices by the Food and Drug Administration (FDA). Information relating to the need for and the regulation of clinical investigations of grafts is included. This discussion includes a description of the current work by the International Organization of Standards on endovascular devices. Finally, a contrast between clinical studies sponsored by manufacturers and individual clinical investigators is provided.

Blood Vessel Prosthesis↗
PubMed1994

Endogenous endophthalmitis due to Fusarium: case report and review.

Endogenous fungal endophthalmitis is being increasingly recognized in susceptible individuals. We report a case of endogenous endophthalmitis due to Fusarium solani that occurred as the sole clinical manifestation of fungal disease in an immunocompromised host. Four previously reported cases of endogenous fusarial endophthalmitis are also reviewed. Two of these patients had no underlying disease and presented with isolated endophthalmitis, while two other patients had acute leukemia and presented with multiple organ involvement due to Fusarium. All three patients with leukemia, including our patient, were severely neutropenic at the time of diagnosis. Two of these three patients had fungemia. MICs of amphotericin B for fungal isolates ranged from 0.14 to 10 micrograms/mL. Despite abatement of the endophthalmitis after antifungal therapy and vitrectomy, the prognosis for immunocompromised patients remains guarded because of underlying disease.

Aged↗
PubMed1992

Breast cancer. Importance of adequate surgical excision prior to radiotherapy in the local control of breast cancer in patients treated conservatively.

The extent of excision performed for mammary carcinoma prior to radiotherapy as a risk factor for local recurrence was studied in 503 patients. Three hundred twenty-three tumors (62%) were excised with a minimal rim of tissue (tumorectomy). One hundred forty-two patients (27%) had wide excision and 56 (11%) had quadrantectomy. Tumor stage, size, and radiation treatment were similar for all groups. Forty-one percent of tumorectomies had involved margins, and only 14% and 7% were involved in the wide excision and quadrantectomy groups, respectively. Local failure was 15% for tumorectomy, 7% for wide excision, and 5% for quadrantectomy. In T1 ductal carcinoma, only 4% of those with excisions greater than 5 cm had recurrences. Lesser excision had 20% recurrence. Extent of excision before radiotherapy is an important risk factor for recurrence. Failure was inversely proportional to the amount of breast tissue resected. Narrow excision should be discouraged since a larger tumor burden remains that may not be sterilized by radiation.

Adult↗
PubMed1990

Patterns and extent of isotype-specificity in the murine H chain switch DNA rearrangement.

We have analyzed the configuration of the H chain locus of 41 hybridomas by Southern blot analysis. Each H chain switch region was determined to be germ line, rearranged, or deleted. Including 13 previously analyzed hybridomas, 60% of those with rearrangements on both alleles showed a correlation of the two alleles, i.e., both the expressed and the nonexpressed alleles have rearranged to the same H chain constant region gene segment. When the two H chain alleles did not rearrange to the same gene, they often rearranged to neighboring H chain genes. These results support a role for isotype-specific factors in H chain switch recombination. The action of these isotype-specific factors may be propagated to some extent along the chromosome, which would lead to rearrangements to neighboring genes.

Alleles↗
PubMed1988

Novel application of video image processing to biochemical and antimicrobial susceptibility testing.

ALADIN (Analytab Products, Plainview, N.Y.) is an automated instrument that uses video imaging (computer-assisted guided video camera) for the determination of biochemical and antimicrobial susceptibility test reactions. This collaborative investigation compared video-generated results obtained with ALADIN with visually determined findings. Both approaches were used to view identical reactions. Overall agreement for biochemical and antimicrobial susceptibility tests was greater than 95%. This study demonstrates that video imaging is an acceptable approach for determining microbial responses to biochemical and antimicrobial agents and may provide, with appropriate computer modifications, more accurate and reproducible results than are possible by visual scrutiny.

Bacteria, Anaerobic↗
PubMed1988

Stimulation of rabbit lacrimal gland secretion with biologically active peptides.

To determine whether biologically active peptides can stimulate lacrimal gland secretion, we measured fluid and protein secretion from the cannulated lacrimal gland excretory duct of anesthetized rabbits after arterial injection of various peptides. Vasoactive intestinal peptide (VIP, 0.003-3 nmol) and porcine histidine isoleucine-containing peptide (PHI, 0.01-3 nmol) stimulated fluid and protein secretion in a dose-dependent manner. Cholecystokinin octapeptide (CCK-8, 0.01-3 nmol) stimulated fluid but not protein secretion. Neither bombesin nor eledoisin in doses as high as 3 nmol stimulated fluid or protein secretion. When combinations of high or low doses of VIP and the cholinergic agonist acetylcholine (ACh) were injected simultaneously, fluid and protein secretion was additive. We concluded that VIP and PHI stimulated secretion of lacrimal gland fluid and protein, CCK-8 stimulated secretion of fluid, and bombesin and eledoisin did not stimulate either fluid or protein secretion. VIP and ACh, both found in lacrimal gland nerve endings, stimulate lacrimal gland fluid and protein secretion by separate pathways.

Acetylcholine↗
PubMed1984

Monoclonal antibodies specific for murine IgM I. Characterization of antigenic determinants on the four constant domains of the mu heavy chain.

Seventeen monoclonal rat antibodies with specificities for mouse mu heavy chain recognize seven distinguishable determinants that are located on the four constant region domains. All determinants are present on secreted, intracellular and membrane bound IgM, and all but two are expressed on isolated mu heavy chain. One antibody, specific for a site in the first constant region domain, recognizes a determinant that is present on IgM of AKR, C3H/HeJ, C57BL/6J, SJL, DBA/2, BALB/c, NZB and CBA/J mouse strains, but not on IgM of A.TH, A/J and A.CA strains of mice.

Animals↗
PubMed1984

Postthoracotomy pain and pulmonary function following epidural and systemic morphine.

Thirty patients undergoing thoracotomy for lung resection were entered in a randomized, double-blind trial comparing the effects of epidural (E) versus intravenous (iv) morphine on postoperative pain and pulmonary function. Postoperatively the patients were given repeated doses of either 5.0 mg of morphine epidurally or 0.05-0.07 mg/kg morphine intravenously until there were no further spontaneous complaints of pain. Two, 8, and 24 h postoperatively, the following indices were measured: linear analogue pain score, somnolence score, vital signs, arterial PaO2, PaCO2, and pH, forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), and peak expiratory flow rate (PEFR). Patients receiving epidural morphine had significantly less pain at 2 h (P less than 0.01) and 8 h (P less than 0.004) postoperatively. There was no difference in vital signs except for significantly slower respiratory rates at 2 h (P less than 0.04), 8 h (P less than 0.02) and 24 h (P less than 0.01) in the epidural group. No significant differences occurred in the somnolence scores or blood-gas measurements, which were within normal limits.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1983

Intracisternal A-particle genes as movable elements in the mouse genome.

We analyzed two functionally defective mouse kappa light chain gene variants previously shown to contain novel insertions of repetitive DNA in their intervening sequences [Hawley, R. G., Shulman, M. J., Murialdo, H., Gibson, D. M. & Hozumi, N. (1982) Proc. Natl. Acad. Sci. USA 79, 7425-7429]. Heteroduplex analysis of the cloned genes shows that the insertions consist of intracisternal A-particle (IAP) genetic elements. Each insertion includes an IAP 5' long terminal repeat (LTR) sequence and extends to a characteristic IAP internal BamHI site where the IAP sequence is interrupted because the mutant genes were cloned from complete BamHI digests of the cellular DNAs. Restriction enzyme mapping indicates that the 5' LTR boundaries of the inserted IAP elements correspond closely to the previously determined rearrangement sites in the mutant genes. The IAP insertions in the two mutants can be distinguished by restriction-site differences and by the fact that one of them contains a deletion that is absent in the other. Nucleotide sequence data are presented for the LTRs of one full-length IAP gene copy randomly selected from a mouse genomic DNA library. These LTRs show many features typical of known integrated retroviral terminal repeat units, and the entire gene is bracketed by short direct repeats within the adjacent cellular DNA. Thus, the findings show that IAP genetic elements can appear in new locations in mouse cellular DNA and suggest that this may occur through a process of proviral insertion.

Animals↗
PubMed1983

The comparative activity of norfloxacin with other antimicrobial agents against Gram-positive and Gram-negative bacteria.

Norfloxacin (MK0366) displayed appreciable activity against the great majority of Gram-negative and Gram-positive bacteria. The minimum inhibitory concentration for 90% of isolates (MIC90) of the Enterobacteriaceae was 0.5 mg/l or less while for Campylobacter, Neisseria, Haemophilus MIC90s were 0.25 mg/l or less. Norfloxacin was also among the most active drugs tested against methicillin susceptible and resistant Staphylococcus aureus, Staph. epidermidis, enterococci and Pseudomonas aeruginosa with MIC90s between 0.5 and 4 mg/l.

Anti-Bacterial Agents↗
PubMed1983

Sodium thiosulfate disposition in humans: relation to sodium nitroprusside toxicity.

Thiosulfate concentrations and pharmacokinetics were studied in relation to sodium nitroprusside before, during, and after anesthesia. Normal thiosulfate concentrations were 1.13 +/- 0.11 mg/dl and 0.28 +/- 0.02 mg/dl in plasma and urine, respectively. Cholecystectomy patients had similar concentrations during surgery, with bile thiosulfate concentration of 13.72 +/- 2.95 mg/dl. Fasting patients and children had significantly higher plasma and urine thiosulfate concentrations. Over 99% of endogenous filtered thiosulfate was reabsorbed by the kidney in the average case. Coronary bypass patients had decreased plasma thiosulfate levels and increased excretion postoperatively. Disappearance of injected thiosulfate was biphasic; the distribution phase was dependent on the initial rate of injection, and the elimination phase depended on extracellular fluid turnover and renal excretion. Cholecystectomy patients on diuretics had a markedly increased rate of excretion, 56% within 100 min, versus normal subjects who excreted less than 50% in up to 18 h. In children, plasma thiosulfate did not change significantly, while blood cyanide concentration increased significantly during sodium nitroprusside administration and surgery. Thiosulfate did not change during recovery while cyanide decreased. Normal production of thiosulfate in humans may be limited; hence, continuous thiosulfate infusion may be required during sodium nitroprusside administration.

Adolescent↗
PubMed1983

Comparison of microtiter broth dilution and agar dilution methods for susceptibility testing of Eikenella corrodens.

Eikenella corrodens is a slow-growing, capnophilic, gram-negative rod which often grows poorly in liquid media. Consequently, the agar dilution technique is the method of choice for susceptibility testing of E. corrodens. We report a new microtiter broth dilution method for susceptibility testing of E. corrodens which compared favorably with results obtained by the agar dilution technique. Minimal bactericidal concentrations correlated well with minimal inhibitory concentrations.

Anti-Bacterial Agents↗