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Frank D'Amico

Publications and source records attributed to Frank D'Amico.

8 recordsLinked to original sources
PubMed2006

A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending. Part I: D-optimal design for characterization of powder mixing and preliminary spectral data evaluation.

Experimental design, multivariate data acquisition, and analysis in addition to real time monitoring and control through process analyzers, represent an integrated approach for implementation of Process Analytical Technology (PAT) in the pharmaceutical industry. This study, which is the first in a series of three parts, uses an experimental design approach to identify critical factors affecting powder blending. Powder mixtures composed of salicylic acid and lactose were mixed in an 8 qt. V-blender. D-optimal design was employed to characterize the blending process, by studying the effect of humidity, component concentration, and blender speed on mixing end point. Additionally, changes in particle size and density of powder mixtures were examined. A near-infrared (NIR) fiber-optic probe was used to monitor mixing, through multiple optical ports on the blender. Humidity, component concentration, and blender speed were shown to have a significant impact on the blending process. Furthermore, humidity and concentration had a significant effect on particle size and density of powder mixtures. NIRS was sensitive to changes in physicochemical properties of the mixtures, resulting from process variables. Proper selection of NIR spectral preprocessing is of ultimate importance for successful implementation of this technology in the monitoring and control of powder blending and is discussed.

Chemistry, Pharmaceutical↗
PubMed2005

Are antibiotics beneficial for patients with sinusitis complaints? A randomized double-blind clinical trial.

BACKGROUND: Sinusitis is the fifth most common reason for patients to visit primary care physicians, yet clinical outcomes relevant to patients are seldom studied. OBJECTIVE: To determine whether patients with purulent rhinitis, "sinusitis-type symptoms," improved with antibiotics. Second, to examine a clinical prediction rule to provide preliminary validation data. METHODS: Prospective clinical trial, with double-blinded placebo controlled randomization. The setting was a suburb of Washington, DC, from Oct 1, 2001, to March 31, 2003. All participants were 18 years or older, presenting to a family practice clinic with a complaint of sinusitis and with pus in the nasal cavity, facial pressure, or nasal discharge lasting longer than 7 days. The main outcome measures were resolution of symptoms within a 14-day follow-up period and the time to improvement (days). RESULTS: After exclusion criteria, 135 patients were randomized to either placebo (n=68) or amoxicillin (n=67) for 10 days. Intention-to-treat analyses showed that 32 (48%) of the amoxicillin group vs 25 (37%) of the placebo group (P=.26) showed complete improvement by the end of the 2-week follow-up period (relative risk=1.3; 95% confidence interval [CI], 0.87-1.94]). Although the rates of improvement were not statistically significantly different at the end of 2 weeks, the amoxicillin group improved significantly earlier, in the course of treatment, a median of 8 vs 12 days, than did the placebo group (P=.039). CONCLUSION: For most patients with sinusitis-type complaints, no improvement was seen with anti-biotics over placebo. For those who did improve, data suggested there is a subgroup of patients who may benefit from antibiotics.

Adult↗
PubMed2005

Do probiotics reduce adult lactose intolerance? A systematic review.

PURPOSE: To assess the efficacy of oral probiotics in adults with lactose intolerance through a systematic review of its effects on symptoms and breath hydrogen tests, and whether adding probiotics to nonfermented dairy products decreases lactose intolerance at that meal. METHODS: We searched randomized controlled trials published between 1966 and December 2002. Databases in the search strategy included Medline and AMED. We reviewed references of clinical trials and contacted authors of major articles and manufacturers of probiotic commercial products. Quality assessment was based on the McMaster guides and was performed by 5 independent reviewers. Data extraction was performed by 2 reviewers. RESULTS: A master list of 90 articles was compiled. Ten articles met inclusion and exclusion criteria and were consistent with our clinical question. Of the 9 studies that measured breath hydrogen, 3 were positive, 3 were negative, and 3 had both positive and negative results. Of the 7 studies that measured symptoms, 1 yielded positive results, 5 were negative, and 1 had both positive and negative outcomes. CONCLUSIONS: Probiotic supplementation in general did not alleviate the symptoms and signs of lactose intolerance in adults in this review. Some evidence suggests that specific strains, concentrations, and preparations are effective. Further clinical trials of specific strains and concentrations are necessary to delineate this potential therapeutic relationship.

Administration, Oral↗
PubMed2003

Does this patient have Parkinson disease?

CONTEXT: Diagnosis of Parkinson disease (PD) remains challenging. An accurate diagnosis is important because effective symptomatic treatment for PD is available. OBJECTIVE: To systematically review the literature for information on the precision and accuracy of the clinical examination for diagnosing PD. DATA SOURCES: MEDLINE database was searched for all English-language articles related to the diagnosis of PD published from January 1966 through April 2001. The reference lists of all articles retrieved were searched for additional relevant sources. STUDY SELECTION: Studies in which patients presented with 1 or more typical features of PD were included if the final diagnosis was confirmed by a suitable criterion standard and data could be extracted to determine the accuracy of 1 or more symptoms or signs. Variability in descriptions of symptoms and signs made it impossible to combine data across existing studies for most findings. DATA SYNTHESIS: We identified 6 studies that met our criteria. The positive (presence) likelihood ratios (LRs) for tremor as a symptom of PD ranged from 1.3 to 17 (range of negative [absence] LRs, 0.24 to 0.60). Tremor as a sign of PD produced a range of positive LRs from 1.3 to 1.5 (negative LRs, 0.47 to 0.61). Clinical features useful in the diagnosis of PD include a history of the combination of symptoms of rigidity and bradykinesia (positive LR, 4.5; negative LR, 0.12); a history of loss of balance (range of positive LRs, 1.6 to 6.6; range of negative LRs, 0.29 to 0.35), symptoms of micrographia (range of positive LRs, 2.8 to 5.9; range of negative LRs, 0.30 to 0.44), and a history of shuffling gait (range of positive LRs, 3.3 to 15; range of negative LRs, 0.32 to 0.50). Trouble with certain tasks such as turning in bed (positive LR, 13; negative LR, 0.56), opening jars (positive LR, 6.1; negative LR, 0.26), and rising from a chair (range of positive LRs, 1.9 to 5.2; range of negative LRs, 0.39 to 0.58). Useful signs include the glabella tap test (positive LR, 4.5; negative LR, 0.13), difficulty walking heel-to-toe (positive LR, 2.9; negative LR, 0.32), and rigidity (range of positive LRs, 0.53 to 2.8; range of negative LRs, 0.38 to 1.6). Significant selection bias was detected in all studies included for review. CONCLUSIONS: Symptoms of tremor, rigidity, bradykinesia, micrographia, shuffling gait, and difficulty with the tasks of turning in bed, opening jars, and rising from a chair should be carefully reviewed in all patients with suspected PD. The glabella tap and heel-to-toe tests also should be assessed.

Aged↗
PubMed2003

Association between tobacco use and metastatic neck disease.

OBJECTIVES/HYPOTHESIS: Tobacco has multiple effects on connective tissues that might affect tumor behavior. This study examined the association between tobacco use and tumor behavior (lymphatic metastasis and extracapsular spread) in head and neck cancers. STUDY DESIGN: Chart audit. METHODS: Medical records of patients from the Department of Otolaryngology, University of Pittsburgh Medical Center (Pittsburgh, PA) with oral cavity, pharyngeal, and laryngeal cancers who underwent neck dissection were reviewed focusing on their tobacco use habits, as well as the clinical and pathological criteria of primary tumors and cervical lymph nodes. Univariate and multivariate analyses were performed to study the significance between pathological and tobacco use variables. RESULTS: The study included 171 patients. Both univariate and multivariate analyses revealed significant associations between tobacco use and pathological findings. Cervical metastasis was observed in 100% of tobacco users and 54% of nonusers (P <.0001). Extracapsular spread was observed in 100% of tobacco users and 19% of nonusers (P <.0001). Tobacco use was independently associated with pathological nodal stage in multivariate analysis. Former users and light users of tobacco were not at reduced risk of cervical metastasis or extracapsular spread. CONCLUSIONS: The study demonstrates that tobacco use is a possible risk factor for cervical metastasis and extracapsular spread, which may be helpful information in planning therapy for patients with clinically staged node-negative necks.

Adult↗
PubMed2003

Clinical research in family medicine: quantity and quality of published articles.

BACKGROUND AND OBJECTIVES: Publication of clinical research in peer-reviewed journals is an important measure of scholarly productivity. This study determined the quantity and quality of original clinical research published by family physicians. METHODS: We surveyed clinical research papers published in the year 2000 in four leading family medicine research journals and research originating in a family practice institution but published in 16 non-family medicine journals. All were selected on the basis of relevance to family physicians and "impact factor." The relevance and validity of papers was assessed using previously established criteria. RESULTS: The survey of family medicine journals revealed a total of 170 original research articles. Ninety eight were from academic family practice programs, and the remaining 72 were from other medical specialties or health care institutions. Most of the papers were cross-sectional surveys. There were seven qualitative studies, six randomized controlled trials, and no systematic reviews from family practice programs in these journals. Eight of the articles were from practice-based research networks. A total of 79 articles were considered relevant or highly relevant, and 22 of these were also considered valid (Patient-oriented Evidence That Matters or POEMs). The survey of 16 non-family medicine journals revealed 37 clinical research papers: 16 surveys, nine prospective cohort studies, seven randomized controlled trials, three systematic reviews/meta-analysis, one qualitative study, and one case-control study. There were nine "highly relevant" papers--seven could be classified as POEMs. CONCLUSIONS: Most clinical family medicine research uses less-rigorous study designs, such as the cross-sectional survey. The majority of papers do not meet established criteria for relevance and validity. There are no standards or comparable studies to compare these results to prior years or to other disciplines.

Cross-Sectional Studies↗
PubMedDate not supplied

Metformin as treatment for overweight and obese adults: a systematic review.

PURPOSE: We wanted to determine whether metformin is an effective medication for treatment of overweight or obese adults who do not have diabetes mellitus or polycystic ovary syndrome (PCOS). METHODS: We searched MEDLINE (1966-2003), EMBASE (1986-2003), Allied and Complementary Medicine Database (1985-2003), International Pharmaceutical Abstracts (1970-2003), the Cochrane Library, American College of Physicians Journal Club, Database of Abstracts of Reviews of Effects, Cochrane Controlled Trials Register, MEDLINE In-Process & Other Non-Indexed Citations, reference lists of retrieved articles, and articles by selected authors and pharmaceutical manufacturers. Inclusion criteria were being obese or overweight determined by a BMI of 25 kg/m2 or greater or waist-to-hip ratio (WHR) of more than 0.8, metformin use, and aged 18 years or older. Exclusion criteria were a diagnosis of diabetes mellitus, polycystic ovarian syndrome or descriptors of polycystic ovarian syndrome, human immunodeficiency virus infection, and concomitant antipsychotic medications. Trials were graded on an 11-point Jadad scale. Only randomized controlled and blinded trials were accepted. Two reviewers independently extracted data from each trial. Primary outcomes measured were changes in BMI, WHR, and weight. RESULTS: Fifty-seven potentially relevant studies were initially identified; 48 were excluded because of lack of randomization, lack of blinding, failure to meet inclusion or exclusion criteria, inaccessible outcomes, or improper study design. Nine clinical trials met criteria for validity assessment. Four studies used the parameter of waist-to-hip ratio, 3 studies included BMI, and 8 used weight. Two of the 9 studies showed a small reduction in WHR. CONCLUSION: Insufficient evidence exists for the use of metformin as treatment of overweight or obese adults who do not have diabetes mellitus or polycystic ovary syndrome. Further studies are needed to answer this clinical question.

Adult↗