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Biomedical subjects

G Putnam

Publications and source records attributed to G Putnam.

8 recordsLinked to original sources
PubMed2004

The sumatriptan/naratriptan aggregated patient (SNAP) database: aggregation, validation and application.

Pooled data from multiple clinical trials can provide information for medical decision-making that typically cannot be derived from a single clinical trial. By increasing the sample size beyond that achievable in a single clinical trial, pooling individual-patient data from multiple trials provides additional statistical power to detect possible effects of study medication, confers the ability to detect rare outcomes, and facilitates evaluation of effects among subsets of patients. Data from pharmaceutical company-sponsored clinical trials lend themselves to data-pooling, meta-analysis, and data mining initiatives. Pharmaceutical company-sponsored clinical trials are arguably among the most rigorously designed and conducted of studies involving human subjects as a result of multidisciplinary collaboration involving clinical, academic and/or governmental investigators as well as the input and review of medical institutional bodies and regulatory authorities. This paper describes the aggregation, validation and initial analysis of data from the sumatriptan/naratriptan aggregate patient (SNAP) database, which to date comprises pooled individual-patient data from 128 clinical trials conducted from 1987 to 1998 with the migraine medications sumatriptan and naratriptan. With an extremely large sample size (>28000 migraineurs, >140000 treated migraine attacks), the SNAP database allows exploration of questions about migraine and the efficacy and safety of migraine medications that cannot be answered in single clinical trials enrolling smaller numbers of patients. Besides providing the adequate sample size to address specific questions, the SNAP database allows for subgroup analyses that are not possible in individual trial analyses due to small sample size. The SNAP database exemplifies how the wealth of data from pharmaceutical company-sponsored clinical trials can be re-used to continue to provide benefit.

Clinical Trials as Topic↗
PubMed2002

Role of computerized tomography (CT) scan of the chest in patients with newly diagnosed head and neck cancers.

Chest metastases and second primaries are not uncommon in patients with head and neck cancer. Early detection of a second site of malignant disease may alter prognosis and management. This study assessed the diagnostic yield of chest radiographs compared with computerized tomography (CT) in a series of patients with head and neck cancer. Forty-four consecutive patients with a head and neck squamous cell carcinoma (SCC) attending the head and neck surgery department of Cumberland Infirmary, Carlisle, between January 2000 and December 2000 were included in this prospective study. Patients with lymphomas and localized cancers of the skin and lip were excluded. Thirty men and 14 women, with a mean age of 67 years, were assessed. All had chest radiographs and chest CT at the same time as the CT scan of the primary site. Only one patient had a true positive finding on chest radiograph. Five patients had an abnormal chest CT. Of these, two had multiple lung metastases, and another patient had biopsy-proved bronchogenic carcinoma and underwent surgical excision. The sensitivity and specificity of CT scan was 100% and 95%, as opposed to 33% and 97% for chest radiograph.

Aged↗
PubMed2001

Sumatriptan nasal spray and cognitive function during migraine: results of an open-label study.

OBJECTIVE: To examine measures of cognitive function during acute migraine, before and after treatment with sumatriptan nasal spray, 20 mg. BACKGROUND: Migraineurs frequently report symptoms of cognitive impairment during migraine. The efficacy of sumatriptan for treatment of migraine-related cognitive impairment is undocumented. METHODS: This open-label, single-attack study of 28 subjects used the Headache Care Center-Automated Neuropsychological Assessment Metrics, a computerized neuropsychological assessment battery, to measure cognitive function under three patient conditions: migraine-free, untreated migraine, and following sumatriptan (primary outcome). Headache response and pain-free response, percent effectiveness, and clinical disability were measured. RESULTS: Cognitive function (simple reaction time, sustained attention/concentration, working memory, visual-spatial processing) and alertness/fatigue were adversely affected during migraine compared with migraine-free performance (P<.05), and rapidly restored following sumatriptan nasal spray, 20 mg (P<.05). Headache and pain-free response were 86% and 68%, respectively, at 135 minutes postdose. Changes in migraine pain severity, clinical disability, and percent effectiveness following treatment with sumatriptan nasal spray, 20 mg, were significantly correlated with cognitive function measures across all subtests (P<.001). CONCLUSIONS: Sumatriptan nasal spray, 20 mg, restored migraine-related cognitive function and clinical disability.

Acute Disease↗
PubMed2001

Treatment of squamous cell carcinoma of the lip using Foscan-mediated photodynamic therapy.

Carcinoma of the lip is a common cancer of the head and neck area; its incidence is approximately one-quarter that for oral cavity cancers. It occurs most frequently on the lower lip of elderly males. This non-randomized Phase II study aimed to estimate the complete response (CR) rate to Foscan-mediated photodynamic therapy (Foscan-PDT) in patients with primary cancer of the lip, duration of CR, and the tolerability and safety of Foscan-PDT. Twenty-five patients with squamous cell carcinoma (SCC) of the lip (Tis, T1, T2/N0/M0) and Karnofsky status > or = 70 received 0.15 mg/kg Foscan intravenously, followed 4 days later by a single non-thermal illumination of the tumour (light dose 20 J/cm2, irradiance 100 mW/cm2, lambda=652 nm). Response was determined after 12 weeks and mean follow up is 424 days so far. After 12 weeks, 96% of cases (24/25) showed CR, and all CRs were confirmed by biopsy. The most common adverse event was swelling and local pain at the treatment site. Tumour recurrence was observed in two patients 4 and 18 months after PDT. One patient developed a single lymph node metastasis 7 months after therapy. Photosensitivity reactions occurred in five patients. The functional results were excellent in all patients without any signs of limited mouth opening or impaired lip closure. The cosmetic outcome was better than after surgical therapy. Foscan-PDT is an effective treatment modality for small primary tumours of the lips. Foscan-PDT yields complete response rates comparable to those published for surgery or radiotherapy without causing major toxicity. It allows preservation of form and function and does not compromise future treatment options for recurrent, residual or second primary disease.

Adult↗
PubMed1987

Therapeutic arterial embolisation of vascular lesions in the maxillofacial region.

The technique of therapeutic arterial embolisation involves the introduction of a thrombus-inducing material into the lumen of a blood vessel to occlude the vessel and reduce the blood supply to a lesion or to a specific part of the body. It is particularly useful in the maxillofacial region in the management of vascular lesions where marked diminution in blood flow can be achieved. This paper reviews the procedure and the materials for embolisation, and describes four patients for whom it was of considerable assistance.

Adolescent↗