How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study.

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Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming

2017-09-18

Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. The setting for this research was a major academic institution in Beijing, China. The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive

Would Interstitial Fluid Flow be Responsible for Skeletal Maintenance in Tail-Suspended Rats?

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Li, Wen-Ting; Huang, Yun-Fei; Sun, Lian-Wen; Luan, Hui-Qin; Zhu, Bao-Zhang; Fan, Yu-Bo

2017-02-01

Despite the fast development of manned space flight, the mechanism and countermeasures of weightlessness osteoporosis in astronauts are still within research. It is accepted that unloading has been considered as primary factor, but the precise mechanism is still unclear. Since bone's interstitial fluid flow (IFF) is believed to be significant to nutrient supply and waste metabolism of bone tissue, it may influence bone quality as well. We investigated IFF's variation in different parts of body (included parietal bone, ulna, lumbar, tibia and tailbone) of rats using a tail-suspended (TS) system. Ten female Sprague-Dawley (SD) rats were divided into two groups: control (CON) and tail-suspension (TS) group. And after 21 days' experiment, the rats were injected reactive red to observe lacuna's condition under a confocal laser scanning microscope. The variations of IFF were analyzed by the number and area of lacuna. Volumetric bone mineral density (vBMD) and microarchitecture of bones were evaluated by micro-CT. The correlation coefficients between lacuna's number/area and vBMD were also analyzed. According to our experimental results, a 21 days' tail-suspension could cause a decrease of IFF in lumbar, tibia and tailbone and an increase of IFF in ulna. But in parietal bone, it showed no significant change. The vBMD and microarchitecture parameters also decreased in lumbar and tibia and increased in ulna. But in parietal bone and tailbone, it showed no significant change. And correlation analysis showed significant correlation between vBMD and lacuna's number in lumbar, tibia and ulna. Therefore, IFF decrease may be partly contribute to bone loss in tail-suspended rats, and it should be further investigated.

Defects in cortical microarchitecture among African-American women with type 2 diabetes.

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Yu, E W; Putman, M S; Derrico, N; Abrishamanian-Garcia, G; Finkelstein, J S; Bouxsein, M L

2015-02-01

Patients with type 2 diabetes mellitus (DM2) have increased fracture risk. We found that African-American women with DM2 have increased cortical porosity and lower cortical bone density at the radius than non-diabetic controls. These cortical deficits are associated with hyperglycemia and may contribute to skeletal fragility associated with DM2. Fracture risk is increased in patients with type 2 diabetes mellitus (DM2) despite normal areal bone mineral density (aBMD). DM2 is more common in African-Americans than in Caucasians. It is not known whether African-American women with DM2 have deficits in bone microstructure. We measured aBMD at the spine and hip by DXA, and volumetric BMD (vBMD) and microarchitecture at the distal radius and tibia by HR-pQCT in 22 DM2 and 78 non-diabetic African-American women participating in the Study of Women Across the Nation (SWAN). We also measured fasting glucose and HOMA-IR. Age, weight, and aBMD at all sites were similar in both groups. At the radius, cortical porosity was 26% greater, while cortical vBMD and tissue mineral density were lower in women with DM2 than in controls. There were no differences in radius total vBMD or trabecular vBMD between groups. Despite inferior cortical bone properties at the radius, FEA-estimated failure load was similar between groups. Tibia vBMD and microarchitecture were also similar between groups. There were no significant associations between cortical parameters and duration of DM2 or HOMA-IR. However, among women with DM2, higher fasting glucose levels were associated with lower cortical vBMD (r=-0.54, p=0.018). DM2 and higher fasting glucose are associated with unfavorable cortical bone microarchitecture at the distal radius in African-American women. These structural deficits may contribute to the increased fracture risk among women with DM2. Further, our results suggest that hyperglycemia may be involved in mechanisms of skeletal fragility associated with DM2.

Low volumetric BMD is linked to upper-limb fracture in pubertal girls and persists into adulthood: a seven-year cohort study.

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Cheng, Sulin; Xu, Leiting; Nicholson, Patrick H F; Tylavsky, Frances; Lyytikäinen, Arja; Wang, Qingju; Suominen, Harri; Kujala, Urho M; Kröger, Heikki; Alen, Markku

2009-09-01

The aetiology of increased incidence of fracture during puberty is unclear. This study aimed to determine whether low volumetric bone mineral density (vBMD) in the distal radius is associated with upper-limb fractures in growing girls, and whether any such vBMD deficit persists into adulthood. Fracture history from birth to 20 years was obtained and verified by medical records in 1034 Finnish girls aged 10-13 years. Bone density and geometry at distal radius, biomarkers and lifestyle/behavioural factors were assessed in a subset of 396 girls with a 7.5-year follow-up. We found that fracture incidence peaked during puberty (relative risk 3.1 at age of 8-14 years compared to outside this age window), and 38% of fractures were in the upper-limb. Compared to the non-fracture cohort, girls who sustained upper-limb fracture at ages 8-14 years had lower distal radial vBMD at baseline (258.9+/-37.5 vs. 287.5+/-34.1 mg/cm(3), p=0.001), 1-year (252.0+/-29.3 vs. 282.6+/-33.5 mg/cm(3), p=0.001), 2-year (258.9+/-32.2 vs. 289.9+/-40.1 mg/cm(3), p=0.003), and 7-year follow-ups (early adulthood, 307.6+/-35.9 vs. 343.6+/-40.9 mg/cm(3), p=0.002). There was a consistent trend towards larger bone cross-sectional area in the fracture cohort compared to non-fracture. In a logistic regression model, lower vBMD (p=0.001) was the only significant predictor of upper-limb fracture during the period of 8-14 years. Our results indicate that low BMD is an important factor underlying elevated upper-limb fracture risk during puberty, and that low BMD in pubertal girls with fracture persists into adulthood. Hence low vBMD during childhood is not a transient deficit. Methods to monitor vBMD and to maximise bone mineral accrual and reduce risks of falling in childhood should be developed.

Effects of total gastrectomy on plasma silicon and amino acid concentrations in men.

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Tatara, Marcin R; Krupski, Witold; Szpetnar, Maria; Dąbrowski, Andrzej; Bury, Paweł; Szabelska, Anna; Charuta, Anna; Boguszewska-Czubara, Anna; Maciejewski, Ryszard; Wallner, Grzegorz

2015-12-01

The aim of the study was to determine one-year effects of total gastrectomy on plasma silicon and free amino acid concentrations in patients and evaluate changes of volumetric bone mineral density (vBMD) in lumbar spine. Eight patients were enrolled to the control (CTR) group. Six patients subjected to total gastrectomy (GX group) were included to the experimental group. vBMD in trabecular and cortical bone was measured in lumbar vertebrae at baseline (before surgery) and one year later using quantitative computed tomography. Plasma concentrations of silicon and free amino acids were determined at baseline and one year later using photometric method and ion-exchange chromatography. Body weights within CTR and GX groups were not different after one-year follow-up when compared to the baseline values (P > 0.05). An average annual decrease of vBMD in the trabecular bone in the gastrectomized patients reached 15.0% in lumbar spine and was significantly different in comparison to the percentage changes observed in CTR group (P = 0.02). One-year percentage change of vBMD in the cortical bone in L1 and L2 has shown significantly decreased values by 10.5 and 9.1% in the GX group when compared to the percentage change observed in the controls (P silicon was significantly lowered by 26.7% one year after the total gastrectomy when compared to the baseline value (P = 0.009). Total gastrectomy in patients has induced severe osteoporotic changes in lumbar spine within one-year period. The observed osteoporotic changes were associated with decreased plasma concentration of silicon indicating importance of exocrine and endocrine functions of stomach for silicon homeostasis maintenance. Gastrectomy-induced bone loss was not related to decreased amino acid concentration in plasma obtained from overnight fasted patients. © 2015 by the Society for Experimental Biology and Medicine.

Bone Parameters in Anorexia Nervosa and Athletic Amenorrhea: Comparison of Two Hypothalamic Amenorrhea States.

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Kandemir, Nurgun; Slattery, Meghan; Ackerman, Kathryn E; Tulsiani, Shreya; Bose, Amita; Singhal, Vibha; Baskaran, Charumathi; Ebrahimi, Seda; Goldstein, Mark; Eddy, Kamryn; Klibanski, Anne; Misra, Madhusmita

2018-04-05

We have reported low bone mineral density (BMD), impaired bone structure, and increased fracture risk in anorexia nervosa (AN) and normal-weight, oligo-amenorrheic athletes (OA). However, data directly comparing compartment-specific bone parameters in AN, OA and controls are lacking. 426 females 14-21.9 years old were included; 231 AN, 94 OA and 101 normal-weight eumenorrheic controls. Dual energy x-ray absorptiometry was used to assess areal BMD (aBMD) of the whole body less head (WBLH), spine, and hip. High resolution peripheral quantitative CT was used to assess volumetric BMD (vBMD), bone geometry and structure at the non-weight bearing distal radius and weight-bearing distal tibia. AN had lower WBLH and hip aBMD Z-scores than OA and controls (p<0.0001). AN and OA had lower spine aBMD Z-scores than controls (p<0.01). At the radius, total and cortical vBMD, percent cortical area and thickness were lower in AN and OA vs. controls (p≤0.04); trabecular vBMD was lower in AN than controls. At the tibia, AN had lower measures for most parameters vs. OA and controls (p<0.05); OA had lower cortical vBMD than controls (p=0.002). AN and OA had higher fracture rates vs. controls. Stress fracture prevalence was highest in OA (p<0.0001); non-stress fracture prevalence was highest in AN (p<0.05). AN is deleterious to bone at all sites and both bone compartments. A high stress fracture rate in OA, who have comparable WBLH and hip aBMD measures to controls, indicates that BMD in these women may need to be even higher to avoid fractures.

Oropharyngeal Dysphagia in Dermatomyositis: Associations with Clinical and Laboratory Features Including Autoantibodies.

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Mugii, Naoki; Hasegawa, Minoru; Matsushita, Takashi; Hamaguchi, Yasuhito; Oohata, Sacihe; Okita, Hirokazu; Yahata, Tetsutarou; Someya, Fujiko; Inoue, Katsumi; Murono, Shigeyuki; Fujimoto, Manabu; Takehara, Kazuhiko

2016-01-01

Dysphagia develops with low frequency in patients with dermatomyositis. Our objective was to determine the clinical and laboratory features that can estimate the development of dysphagia in dermatomyositis. This study included 92 Japanese patients with adult-onset dermatomyositis. The associations between dysphagia and clinical and laboratory features including disease-specific autoantibodies determined by immunoprecipitation assays were analyzed. Videofluoroscopy swallow study (VFSS) was performed for all patients with clinical dysphagia (n = 13, 14.1%) but not for patients without clinical dysphagia. Typical findings of dysphagia (pharyngeal pooling, n = 11 and/or nasal regurgitation, n = 4) was detected by VFSS in all patients with clinical dysphagia. Eleven patients with dysphagia (84.6%) had anti-transcription intermediary factor 1γ (TIF-1γ) antibody. By univariate analysis, the average age and the male to female ratio, internal malignancy, and anti-TIF-1γ antibody were significantly higher and the frequency of interstitial lung diseases and manual muscle testing (MMT) scores of sternomastoid and dertoid muscles were significantly lower in patients with dysphagia than in patients without dysphagia. Among patients with anti-TIF-1γ antibody, the mean age, the ratios of male to female and internal malignancy were significantly higher and mean MMT scores of sternomastoid muscle were significantly lower in patients with dysphagia compared with patients without dysphagia. By multivariable analysis, the risk of dysphagia was strongly associated with the existence of internal malignancy and ant-TIF-1γ antibody and was also associated with reduced scores of manual muscle test of sternomastoid muscle. Dysphagia was markedly improved after the treatment against myositis in all 13 patients. These findings indicate that dysphagia can develop frequently in patients with internal malignancy, anti-TIF-1γ antibody, or severe muscle weakness of sternomastoid muscle.

The combination of structural parameters and areal bone mineral density improves relation to proximal femur strength. An in vitro study with high resolution peripheral quantitative computed tomography

DEFF Research Database (Denmark)

Hansen, Stinus; Beck Nielsen, Jens-Erik; Ahrberg, Fabian

2011-01-01

, volumetric BMD (vBMD), and microarchitectural parameters were obtained. In addition, aBMD by dual-energy X-ray absorptiometry (DXA) was performed at conventional hip regions and maximal compressive strength (MCS) was determined in a side-impact biomechanical test. Twelve cervical and 19 trochanteric...... fractures were confirmed. Geometry, vBMD, microarchitecture, and aBMD correlated significantly with MCS, with Spearman's correlation coefficients up to 0.77, 0.89, 0.90, and 0.85 (P ...

Integration of Medical Imaging Including Ultrasound into a New Clinical Anatomy Curriculum

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Moscova, Michelle; Bryce, Deborah A.; Sindhusake, Doungkamol; Young, Noel

2015-01-01

In 2008 a new clinical anatomy curriculum with integrated medical imaging component was introduced into the University of Sydney Medical Program. Medical imaging used for teaching the new curriculum included normal radiography, MRI, CT scans, and ultrasound imaging. These techniques were incorporated into teaching over the first two years of the…

Recreational football training decreases risk factors for bone fractures in untrained premenopausal women

DEFF Research Database (Denmark)

Helge, E W; Aagaard, P; Jakobsen, M D

2010-01-01

untrained Danish premenopausal women were randomized into two training groups (F and R) that trained 1.8+/-0.3 (+/-SD) and 1.9+/-0.3 h/week, respectively, and these groups were compared with an inactive control group (C). Jumping and dynamic muscle strength were tested and tibial vBMD was measured using...... peripheral quantitative computed tomography. Total vBMD in left and right tibia increased by 2.6+/-2.3% and 2.1+/-1.8% (P

Prior ankle fractures in postmenopausal women are associated with low areal bone mineral density and bone microstructure alterations.

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Biver, E; Durosier, C; Chevalley, T; Herrmann, F R; Ferrari, S; Rizzoli, R

2015-08-01

In a cross-sectional analysis in postmenopausal women, prior ankle fractures were associated with lower areal bone mineral density (BMD) and trabecular bone alterations compared to no fracture history. Compared to women with forearm fractures, microstructure alterations were of lower magnitude. These data suggest that ankle fractures are another manifestation of bone fragility. Whether ankle fractures represent fragility fractures associated with low areal bone mineral density (aBMD) and volumetric bone mineral density (vBMD) and/or bone microstructure alterations remains unclear, in contrast to the well-recognised association between forearm fractures and osteoporosis. The objective of this study was to investigate aBMD, vBMD and bone microstructure in postmenopausal women with prior ankle fracture in adulthood, compared with women without prior fracture or with women with prior forearm fractures, considered as typically of osteoporotic origin. In a cross-sectional analysis in the Geneva Retirees Cohort study, 63 women with ankle fracture and 59 with forearm fracture were compared to 433 women without fracture (mean age, 65 ± 1 years). aBMD was measured by dual-energy X-ray absorptiometry; distal radius and tibia vBMD and bone microstructure were measured by high-resolution peripheral quantitative computed tomography. Compared with women without fracture, those with ankle fractures had lower aBMD, radius vBMD (-7.9%), trabecular density (-10.7%), number (-7.3%) and thickness (-4.6%) and higher trabecular spacing (+14.5%) (P ankle fractures were 2.2 and 1.6, respectively, vs 2.2 and 2.7 for forearm fracture, respectively (P ≤ 0.001 for all). Compared to women with forearm fractures, those with ankle fractures had similar spine and hip aBMD, but microstructure alterations of lower magnitude. Women with ankle fractures have lower aBMD and vBMD and trabecular bone alterations, suggesting that ankle fractures are another manifestation of bone fragility.

Proximal Femur Volumetric Bone Mineral Density and Mortality: 13 Years of Follow-Up of the AGES-Reykjavik Study.

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Marques, Elisa A; Elbejjani, Martine; Gudnason, Vilmundur; Sigurdsson, Gunnar; Lang, Thomas; Sigurdsson, Sigurdur; Aspelund, Thor; Meirelles, Osorio; Siggeirsdottir, Kristin; Launer, Lenore; Eiriksdottir, Gudny; Harris, Tamara B

2017-06-01

Bone mineral density (BMD) has been linked to mortality, but little is known about the independent contribution of each endosteal bone compartment and also the rate of bone loss to risk of mortality. We examined the relationships between (1) baseline trabecular and cortical volumetric BMD (vBMD) at the proximal femur, and (2) the rate of trabecular and cortical bone loss and all-cause mortality in older adults from the AGES-Reykjavik study. The analysis of trabecular and cortical vBMD and mortality was based on the baseline cohort of 4654 participants (aged ≥66 years) with a median follow-up of 9.4 years; the association between rate of bone loss and mortality was based on 2653 participants with bone loss data (median follow-up of 5.6 years). Analyses employed multivariable Cox-proportional models to estimate hazard ratios (HRs) with time-varying fracture status; trabecular and cortical variables were included together in all models. Adjusted for important confounders, Cox models showed that participants in the lowest quartile of trabecular vBMD had an increased risk of mortality compared to participants in other quartiles (HR = 1.12; 95% confidence interval (CI), 1.01 to 1.25); baseline cortical vBMD was not related to mortality (HR = 1.08; 95% CI, 0.97 to 1.20). After adjustment for time-dependent fracture status, results were attenuated and not statistically significant. A faster loss (quartile 1 versus quartiles 2-4) in both trabecular and cortical bone was associated with higher mortality risk (HR = 1.37 and 1.33, respectively); these associations were independent of major potential confounders including time-dependent incident fractures (HR = 1.32 and 1.34, respectively). Overall, data suggest that faster bone losses over time in both the trabecular and cortical bone compartments are associated with mortality risk and that measurements of change in bone health may be more informative than single-point measurements in explaining mortality

Unique effects of energy versus estrogen deficiency on multiple components of bone strength in exercising women.

Science.gov (United States)

Southmayd, E A; Mallinson, R J; Williams, N I; Mallinson, D J; De Souza, M J

2017-04-01

Many female athletes are energy and/or estrogen deficient, but the independent effects on bone health have not been isolated. Energy deficiency was detrimental at the tibia while estrogen deficiency was detrimental at the radius. Nutrition must be considered alongside menstrual recovery when addressing compromised bone health in female athletes. The purpose of this study was to describe volumetric bone mineral density (vBMD), bone geometry, and estimated bone strength in exercising women (n = 60) grouped according to energy status (energy replete (EnR: n = 30) vs. energy deficient (EnD: n = 30)) and estrogen status (estrogen replete (E 2 R: n = 33) vs. estrogen deficient (E 2 D: n = 27)), resulting in four distinct groups: EnR + E 2 R (n = 17), EnR + E 2 D (n = 13), EnD + E 2 R (n = 16), EnD + E 2 D (n = 14). Energy status was determined using the ratio of measured to predicted resting energy expenditure (mREE/pREE). Estrogen status was based on self-reported menstrual status confirmed by daily evaluation of urinary estrone-1-glucoronide (E1G), pregnanediol glucuronide (PdG), and luteinizing hormone (LH). Eumenorrheic women were considered E 2 R, amenorrheic women were E 2 D, and oligomenorrheic women were categorized based on history of menses in the past year. Bone was assessed using peripheral quantitative computed tomography (pQCT). EnD women exhibited lower total vBMD, trabecular vBMD, cortical area, and BSI at the distal tibia and lower total vBMD, smaller cortical area and cortical thickness, and larger endosteal circumference at the proximal tibia compared to EnR women (p < 0.042). E 2 D women had lower total and cortical vBMD, larger total and trabecular area, and lower BSI at the distal radius and lower cortical vBMD at the proximal radius compared to E 2 R women (p < 0.023). Energy and estrogen interacted to affect total and trabecular area at the distal tibia (p < 0.021). Efforts to correct energy deficiency, which in turn may

Clinical and histopathological characteristics of cutaneous Leishmaniasis in Sanliurfa City of Turkey including Syrian refugees.

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Koçarslan, Sezen; Turan, Enver; Ekinci, Turan; Yesilova, Yavuz; Apari, Rabia

2013-01-01

The aim of our study was to investigate the clinical and histopathological characteristics of cutaneous leishmaniasis (CL) in the city of Sanliurfa in Turkey, where Syrian refugees also reside. At the Harran University Hospital outpatient clinics between 2012 and 2013, 54 CL cases, including 24 Syrian patients, underwent punch biopsy of the skin and/or a touch imprint. Patients in whom leishmania parasites were detected were included in the study. The clinical and histopathological data of the patients were obtained by a review of the patients' medical records. All the slides of each patient were re-evaluated histopathologically. Fifty-four cases (mean age; 17 ± 12 years), consisting of 32 males (59.3%) and 22 females (40.7%), were examined. The most common site of involvement was the face (63%). The most common presentation was noduloulcerative lesions (57.4%). Histopathologically, the majority of the cases exhibited hyperkeratosis, follicular plugging of the epidermis, chronic inflammatory infiltration, leishmania amastigotes and non-caseating granulomatous inflammation in the dermis. CL presents with a wide spectrum of expression, both clinically and histologically, and may mimic other inflammatory and neoplastic diseases. The diagnosis of CL relies on the identification of leishmania amastigotes in either a direct smear of the lesion or in a tissue section.

Association Between Insulin Resistance and Bone Structure in Nondiabetic Postmenopausal Women

DEFF Research Database (Denmark)

Shanbhogue, Vikram V; Finkelstein, Joel S; Bouxsein, Mary L

2016-01-01

computed tomography was used to assess bone density and microstructure at the distal radius and tibia. Fasting insulin and glucose was measured and insulin resistance was estimated using homeostasis model assessment of insulin resistance (HOMA-IR) with higher values indicating greater insulin resistance....... RESULTS: There was a negative association between HOMA-IR and bone size and a positive association between HOMA-IR and total vBMD, trabecular vBMD, trabecular thickness and cortical thickness at the radius and tibia. These relationships remained even after adjusting for body weight and other potential...

Clinical and histopathological characteristics of cutaneous Leishmaniasis in Sanliurfa City of Turkey including Syrian refugees

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Sezen Koçarslan

2013-01-01

Full Text Available Background: The aim of our study was to investigate the clinical and histopathological characteristics of cutaneous leishmaniasis (CL in the city of Sanliurfa in Turkey, where Syrian refugees also reside. Materials and Methods: At the Harran University Hospital outpatient clinics between 2012 and 2013, 54 CL cases, including 24 Syrian patients, underwent punch biopsy of the skin and/or a touch imprint. Patients in whom leishmania parasites were detected were included in the study. The clinical and histopathological data of the patients were obtained by a review of the patients′ medical records. All the slides of each patient were re-evaluated histopathologically. Results: Fifty-four cases (mean age; 17 ± 12 years, consisting of 32 males (59.3% and 22 females (40.7%, were examined. The most common site of involvement was the face (63%. The most common presentation was noduloulcerative lesions (57.4%. Histopathologically, the majority of the cases exhibited hyperkeratosis, follicular plugging of the epidermis, chronic inflammatory infiltration, leishmania amastigotes and non-caseating granulomatous inflammation in the dermis. Conclusion: CL presents with a wide spectrum of expression, both clinically and histologically, and may mimic other inflammatory and neoplastic diseases. The diagnosis of CL relies on the identification of leishmania amastigotes in either a direct smear of the lesion or in a tissue section.

Contemporary Aspects of Marketing in Clinical Trials Including Segments of IT and Technology Transfer

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Stamenovic, Milorad; Dobraca, Amra; Smajlovic, Mersiha

2018-01-01

Introduction: The aim of this paper is to present the marketing strategy and the application of management (marketing management) and advertising in order to increase the efficiency of innovative approach in clinical trials that include and involve the use of new technologies and transfer of technologies. Material and Methods: This paper has a descriptive character and represents a narrative review of the literature and new model implementation. Results: Marketing models are primarily used to improve the inclusion of a larger (and appropriate) number of patients, but they can be credited for the stay and monitoring of patients in the trial. Regulatory mechanisms play an important role in the application of various marketing strategies within clinical trials. The value for the patient as the most important stakeholder is defined in the field of clinical trials according to Kotler’s value model for the consumer. Conclusion: In order to achieve the best results it is important to adequately examine all the elements of clinical trials and apply this knowledge in creation of a marketing plan that will be made in accordance with the legal regulations defined globally and locally. In this paper, two challenges have been highlighted for the adequate application of marketing tools in the field of clinical trials, namely: defining business elements in order to provide an adequate marketing approach for clinical trials and technology transfer and ensuring uniformity and regulatory affirmation of marketing attitudes in clinical trials in all regions in which they are carried out in accordance with ICH-GCP and valid regulations. PMID:29719318

Contemporary Aspects of Marketing in Clinical Trials Including Segments of IT and Technology Transfer.

Science.gov (United States)

Stamenovic, Milorad; Dobraca, Amra; Smajlovic, Mersiha

2018-01-01

The aim of this paper is to present the marketing strategy and the application of management (marketing management) and advertising in order to increase the efficiency of innovative approach in clinical trials that include and involve the use of new technologies and transfer of technologies. This paper has a descriptive character and represents a narrative review of the literature and new model implementation. Marketing models are primarily used to improve the inclusion of a larger (and appropriate) number of patients, but they can be credited for the stay and monitoring of patients in the trial. Regulatory mechanisms play an important role in the application of various marketing strategies within clinical trials. The value for the patient as the most important stakeholder is defined in the field of clinical trials according to Kotler's value model for the consumer. In order to achieve the best results it is important to adequately examine all the elements of clinical trials and apply this knowledge in creation of a marketing plan that will be made in accordance with the legal regulations defined globally and locally. In this paper, two challenges have been highlighted for the adequate application of marketing tools in the field of clinical trials, namely: defining business elements in order to provide an adequate marketing approach for clinical trials and technology transfer and ensuring uniformity and regulatory affirmation of marketing attitudes in clinical trials in all regions in which they are carried out in accordance with ICH-GCP and valid regulations.

[The informed consent in international clinical trials including developing countries].

Science.gov (United States)

Montenegro Surís, Alexander; Monreal Agüero, Magda Elaine

2008-01-01

The informed consent procedure has been one of the most important controversies of ethical debates about clinical trials in developing countries. In this essay we present our recommendations about important aspects to consider in the informed consent procedure for clinical trials in developing countries. We performed a full publications review identified by MEDLINE using these terms combinations: informed consent, developing countries, less developed countries and clinical trials. To protect volunteers in less developed countries should be valuated the importance of the community in the informed consent proceeding. The signing and dating of the informed consent form is not always the best procedure to document the informed consent. The informed consent form should be written by local translators. Alternative medias of communications could be needed for communicatios of the information to volunteers. Comparing with developed countries the informed consent proceeding in clinical trials in developing countries frequently require additional efforts. The developing of pragmatic researches is needed to implement informed consent proceedings assuring subjects voluntarily in each developing country. The main aspects to define in each clinical trial for each country are the influence of the community, the effective communication of the information, the documentation of the informed consent and local authority's control.

Lower trabecular volumetric BMD at metaphyseal regions of weight-bearing bones is associated with prior fracture in young girls.

Science.gov (United States)

Farr, Joshua N; Tomás, Rita; Chen, Zhao; Lisse, Jeffrey R; Lohman, Timothy G; Going, Scott B

2011-02-01

Understanding the etiology of skeletal fragility during growth is critical for the development of treatments and prevention strategies aimed at reducing the burden of childhood fractures. Thus we evaluated the relationship between prior fracture and bone parameters in young girls. Data from 465 girls aged 8 to 13 years from the Jump-In: Building Better Bones study were analyzed. Bone parameters were assessed at metaphyseal and diaphyseal sites of the nondominant femur and tibia using peripheral quantitative computed tomography (pQCT). Dual-energy X-ray absorptiometry (DXA) was used to assess femur, tibia, lumbar spine, and total body less head bone mineral content. Binary logistic regression was used to evaluate the relationship between prior fracture and bone parameters, controlling for maturity, body mass, leg length, ethnicity, and physical activity. Associations between prior fracture and all DXA and pQCT bone parameters at diaphyseal sites were nonsignificant. In contrast, lower trabecular volumetric BMD (vBMD) at distal metaphyseal sites of the femur and tibia was significantly associated with prior fracture. After adjustment for covariates, every SD decrease in trabecular vBMD at metaphyseal sites of the distal femur and tibia was associated with 1.4 (1.1-1.9) and 1.3 (1.0-1.7) times higher fracture prevalence, respectively. Prior fracture was not associated with metaphyseal bone size (ie, periosteal circumference). In conclusion, fractures in girls are associated with lower trabecular vBMD, but not bone size, at metaphyseal sites of the femur and tibia. Lower trabecular vBMD at metaphyseal sites of long bones may be an early marker of skeletal fragility in girls. Copyright © 2011 American Society for Bone and Mineral Research.

Defining the bone morphometry, micro-architecture and volumetric density profile in osteopenic vs non-osteopenic adolescent idiopathic scoliosis.

Science.gov (United States)

Wang, Zhi-Wei; Lee, Wayne Yuk-Wai; Lam, Tsz-Ping; Yip, Benjamin Hon-Kei; Yu, Fiona Wai-Ping; Yu, Wing-Sze; Zhu, Feng; Ng, Bobby Kin-Wah; Qiu, Yong; Cheng, Jack Chun-Yiu

2017-06-01

Osteopenia has been widely reported in about 30 % of girls with adolescent idiopathic scoliosis (AIS). However, the bone quality profile of the 70 % non-osteopenic AIS defined by areal bone mineral density (BMD) with conventional dual-energy X-ray absorptiometry (DXA) has not been adequately studied. Our purpose was to verify whether abnormal volumetric BMD (vBMD) and bone structure (morphometry and micro-architecture) also existed in the non-osteopenic AIS when compared with matched controls using both DXA and high-resolution peripheral computed tomography (HR-pQCT). This was a case-control cross-sectional study. 257 AIS girls with a mean age of 12.7 (SD = 0.8) years old and 187 age- and gender-matched normal controls with an average age of 12.9 (SD = 0.5) years old were included. Areal BMD (aBMD) and bone quality were measured with standard DXA and HR-pQCT, respectively. The parameters of HR-pQCT could be categorized as bone morphometry, vBMD and bone micro-architecture. The results were compared between the osteopenic AIS and osteopenic control, and between the non-osteopenic AIS and non-osteopenic control. In addition to the lower aBMD and vBMD, osteopenic AIS showed significantly greater cortical perimeter and trabecular area than the osteopenic control even after adjustments of age (P architecture and volumetric density profile compared with their normal matched controls. The observed abnormalities were suggestive of decreased endocortical bone apposition or active endocortical resorption that could affect the mechanical bone strength in AIS. The underlying pathomechanism might be attributed to abnormal bone modeling/remodeling that could be associated with the etiopathogenesis of AIS.

The Benefits of Including Clinical Factors in Rectal Normal Tissue Complication Probability Modeling After Radiotherapy for Prostate Cancer

International Nuclear Information System (INIS)

Defraene, Gilles; Van den Bergh, Laura; Al-Mamgani, Abrahim; Haustermans, Karin; Heemsbergen, Wilma; Van den Heuvel, Frank; Lebesque, Joos V.

2012-01-01

Purpose: To study the impact of clinical predisposing factors on rectal normal tissue complication probability modeling using the updated results of the Dutch prostate dose-escalation trial. Methods and Materials: Toxicity data of 512 patients (conformally treated to 68 Gy [n = 284] and 78 Gy [n = 228]) with complete follow-up at 3 years after radiotherapy were studied. Scored end points were rectal bleeding, high stool frequency, and fecal incontinence. Two traditional dose-based models (Lyman-Kutcher-Burman (LKB) and Relative Seriality (RS) and a logistic model were fitted using a maximum likelihood approach. Furthermore, these model fits were improved by including the most significant clinical factors. The area under the receiver operating characteristic curve (AUC) was used to compare the discriminating ability of all fits. Results: Including clinical factors significantly increased the predictive power of the models for all end points. In the optimal LKB, RS, and logistic models for rectal bleeding and fecal incontinence, the first significant (p = 0.011–0.013) clinical factor was “previous abdominal surgery.” As second significant (p = 0.012–0.016) factor, “cardiac history” was included in all three rectal bleeding fits, whereas including “diabetes” was significant (p = 0.039–0.048) in fecal incontinence modeling but only in the LKB and logistic models. High stool frequency fits only benefitted significantly (p = 0.003–0.006) from the inclusion of the baseline toxicity score. For all models rectal bleeding fits had the highest AUC (0.77) where it was 0.63 and 0.68 for high stool frequency and fecal incontinence, respectively. LKB and logistic model fits resulted in similar values for the volume parameter. The steepness parameter was somewhat higher in the logistic model, also resulting in a slightly lower D 50 . Anal wall DVHs were used for fecal incontinence, whereas anorectal wall dose best described the other two endpoints. Conclusions

The Benefits of Including Clinical Factors in Rectal Normal Tissue Complication Probability Modeling After Radiotherapy for Prostate Cancer

Energy Technology Data Exchange (ETDEWEB)

Defraene, Gilles, E-mail: gilles.defraene@uzleuven.be [Radiation Oncology Department, University Hospitals Leuven, Leuven (Belgium); Van den Bergh, Laura [Radiation Oncology Department, University Hospitals Leuven, Leuven (Belgium); Al-Mamgani, Abrahim [Department of Radiation Oncology, Erasmus Medical Center - Daniel den Hoed Cancer Center, Rotterdam (Netherlands); Haustermans, Karin [Radiation Oncology Department, University Hospitals Leuven, Leuven (Belgium); Heemsbergen, Wilma [Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands); Van den Heuvel, Frank [Radiation Oncology Department, University Hospitals Leuven, Leuven (Belgium); Lebesque, Joos V. [Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands)

2012-03-01

Purpose: To study the impact of clinical predisposing factors on rectal normal tissue complication probability modeling using the updated results of the Dutch prostate dose-escalation trial. Methods and Materials: Toxicity data of 512 patients (conformally treated to 68 Gy [n = 284] and 78 Gy [n = 228]) with complete follow-up at 3 years after radiotherapy were studied. Scored end points were rectal bleeding, high stool frequency, and fecal incontinence. Two traditional dose-based models (Lyman-Kutcher-Burman (LKB) and Relative Seriality (RS) and a logistic model were fitted using a maximum likelihood approach. Furthermore, these model fits were improved by including the most significant clinical factors. The area under the receiver operating characteristic curve (AUC) was used to compare the discriminating ability of all fits. Results: Including clinical factors significantly increased the predictive power of the models for all end points. In the optimal LKB, RS, and logistic models for rectal bleeding and fecal incontinence, the first significant (p = 0.011-0.013) clinical factor was 'previous abdominal surgery.' As second significant (p = 0.012-0.016) factor, 'cardiac history' was included in all three rectal bleeding fits, whereas including 'diabetes' was significant (p = 0.039-0.048) in fecal incontinence modeling but only in the LKB and logistic models. High stool frequency fits only benefitted significantly (p = 0.003-0.006) from the inclusion of the baseline toxicity score. For all models rectal bleeding fits had the highest AUC (0.77) where it was 0.63 and 0.68 for high stool frequency and fecal incontinence, respectively. LKB and logistic model fits resulted in similar values for the volume parameter. The steepness parameter was somewhat higher in the logistic model, also resulting in a slightly lower D{sub 50}. Anal wall DVHs were used for fecal incontinence, whereas anorectal wall dose best described the other two endpoints

GWAS of clinically defined gout and subtypes identifies multiple susceptibility loci that include urate transporter genes

NARCIS (Netherlands)

Nakayama, A.; Nakaoka, H.; Yamamoto, K.; Sakiyama, M.; Shaukat, A.; Toyoda, Y.; Okada, Y.; Kamatani, Y.; Nakamura, T.; Takada, T.; Inoue, K.; Yasujima, T.; Yuasa, H.; Shirahama, Y.; Nakashima, H.; Shimizu, S.; Higashino, T.; Kawamura, Y.; Ogata, H.; Kawaguchi, M.; Ohkawa, Y.; Danjoh, I.; Tokumasu, A.; Ooyama, K.; Ito, T.; Kondo, T.; Wakai, K.; Stiburkova, B.; Pavelka, K.; Stamp, L.K.; Dalbeth, N.; Sakurai, Y.; Suzuki, H; Hosoyamada, M.; Fujimori, S.; Yokoo, T.; Hosoya, T.; Inoue, I.; Takahashi, A.; Kubo, M.; Ooyama, H.; Shimizu, T.; Ichida, K.; Shinomiya, N.; Merriman, T.R.; Matsuo, H.; Andres, M; Joosten, L.A.; Janssen, M.C.H.; Jansen, T.L.; Liote, F.; Radstake, T.R.; Riches, P.L.; So, A.; Tauches, A.K.

2017-01-01

OBJECTIVE: A genome-wide association study (GWAS) of gout and its subtypes was performed to identify novel gout loci, including those that are subtype-specific. METHODS: Putative causal association signals from a GWAS of 945 clinically defined gout cases and 1213 controls from Japanese males were

Accuracy of DXA scanning of the thoracic spine: cadaveric studies comparing BMC, areal BMD and geometric estimates of volumetric BMD against ash weight and CT measures of bone volume.

Science.gov (United States)

Sran, Meena M; Khan, Karim M; Keiver, Kathy; Chew, Jason B; McKay, Heather A; Oxland, Thomas R

2005-12-01

Biomechanical studies of the thoracic spine often scan cadaveric segments by dual energy X-ray absorptiometry (DXA) to obtain measures of bone mass. Only one study has reported the accuracy of lateral scans of thoracic vertebral bodies. The accuracy of DXA scans of thoracic spine segments and of anterior-posterior (AP) thoracic scans has not been investigated. We have examined the accuracy of AP and lateral thoracic DXA scans by comparison with ash weight, the gold-standard for measuring bone mineral content (BMC). We have also compared three methods of estimating volumetric bone mineral density (vBMD) with a novel standard-ash weight (g)/bone volume (cm3) as measured by computed tomography (CT). Twelve T5-T8 spine segments were scanned with DXA (AP and lateral) and CT. The T6 vertebrae were excised, the posterior elements removed and then the vertebral bodies were ashed in a muffle furnace. We proposed a new method of estimating vBMD and compared it with two previously published methods. BMC values from lateral DXA scans displayed the strongest correlation with ash weight (r=0.99) and were on average 12.8% higher (pBMC (AP or lateral) was more strongly correlated with ash weight than areal bone mineral density (aBMD; AP: r=0.54, or lateral: r=0.71) or estimated vBMD. Estimates of vBMD with either of the three methods were strongly and similarly correlated with volumetric BMD calculated by dividing ash weight by CT-derived volume. These data suggest that readily available DXA scanning is an appropriate surrogate measure for thoracic spine bone mineral and that the lateral scan might be the scan method of choice.

Quality of referral: What information should be included in a request for diagnostic imaging when a patient is referred to a clinical radiologist?

Science.gov (United States)

G Pitman, Alexander

2017-06-01

Referral to a clinical radiologist is the prime means of communication between the referrer and the radiologist. Current Australian and New Zealand government regulations do not prescribe what clinical information should be included in a referral. This work presents a qualitative compilation of clinical radiologist opinion, relevant professional recommendations, governmental regulatory positions and prior work on diagnostic error to synthesise recommendations on what clinical information should be included in a referral. Recommended requirements on what clinical information should be included in a referral to a clinical radiologist are as follows: an unambiguous referral; identity of the patient; identity of the referrer; and sufficient clinical detail to justify performance of the diagnostic imaging examination and to confirm appropriate choice of the examination and modality. Recommended guideline on the content of clinical detail clarifies when the information provided in a referral meets these requirements. High-quality information provided in a referral allows the clinical radiologist to ensure that exposure of patients to medical radiation is justified. It also minimises the incidence of perceptual and interpretational diagnostic error. Recommended requirements and guideline on the clinical detail to be provided in a referral to a clinical radiologist have been formulated for professional debate and adoption. © 2017 The Royal Australian and New Zealand College of Radiologists.

Adult-onset photosensitivity: clinical significance and epilepsy syndromes including idiopathic (possibly genetic) photosensitive occipital epilepsy.

Science.gov (United States)

Koutroumanidis, Michalis; Tsirka, Vasiliki; Panayiotopoulos, Chrysostomos

2015-09-01

To evaluate the clinical associations of adult-onset photosensitivity, we studied the clinical and EEG data of patients who were referred due to a possible first seizure and who had a photoparoxysmal response on their EEG. Patients with clinical evidence of photosensitivity before the age of 20 were excluded. Of a total of 30 patients, four had acute symptomatic seizures, two had vasovagal syncope, and 24 were diagnosed with epilepsy. Nine of the 24 patients had idiopathic (genetic) generalized epilepsies and predominantly generalized photoparoxysmal response, but also rare photically-induced seizures, while 15 had exclusively, or almost exclusively, reflex photically-induced occipital seizures with frequent secondary generalization and posterior photoparoxysmal response. Other important differences included a significantly older age at seizure onset and paucity of spontaneous interictal epileptic discharges in patients with photically-induced occipital seizures; only a quarter of these had occasional occipital spikes, in contrast to the idiopathic (genetic) generalized epilepsy patients with typically generalized epileptic discharges. On the other hand, both groups shared a positive family history of epilepsy, common seizure threshold modulators (such as tiredness and sleep deprivation), normal neurological examination and MRI, a generally benign course, and good response to valproic acid. We demonstrated that photosensitivity can first occur in adult life and manifest, either as idiopathic (possibly genetic) photosensitive occipital epilepsy with secondary generalization or as an EEG, and less often, a clinical/EEG feature of idiopathic (genetic) generalized epilepsies. Identification of idiopathic photosensitive occipital epilepsy fills a diagnostic gap in adult first-seizure epileptology and is clinically important because of its good response to antiepileptic drug treatment and fair prognosis.

Fix my child: The importance of including siblings in clinical assessments.

Science.gov (United States)

Farnfield, Steve

2017-07-01

This study examined concordance in the attachment strategies of school-aged siblings with reference to environmental risk in terms of poverty and maltreatment. It also investigated the effect of child maltreatment and maternal mental illness on children's psychosocial functioning in terms of the Dynamic-Maturational Model of Attachment and Adaptation (DMM) including unresolved trauma and the DMM Depressed modifier. The attachment strategies of 30 sibling pairs, aged 5-14 years, were assessed using the School-age Assessment of Attachment (SAA). Unlike most previous studies, this study included siblings from large families of two to six children. The main finding was that as environmental risk increases, the diversity of sibling attachment strategies decreases with greater recourse to the DMM Type A3-6 and A/C strategies. Unlike previous studies, the highest level of concordance was found in sibling pairs with the opposite gender. Boys whose mothers had a history of mental illness were significantly more likely than girls to be assessed with the DMM-depression modifier. As danger increases, children in the same family experience more of the same childhood. Further research should focus on single case, intra-familial studies to build a systemic model of the shared environment. Research should also evaluate the effects of environmental risk compared with size of the sibling group on children's attachment strategies. The clinical implications point to the importance of assessing all children in the family using a model built around functional formulation rather than diagnosing the symptoms of a particular child.

Association of Insulin Resistance with Bone Strength and Bone Turnover in Menopausal Chinese-Singaporean Women without Diabetes

Science.gov (United States)

Kalimeri, Maria; Leek, Francesca; Wang, Nan Xin; Koh, Huann Rong; Totman, John J.

2018-01-01

Insulin resistance (IR) is accompanied by increased areal or volumetric bone mineral density (aBMD or vBMD), but also higher fracture risk. Meanwhile, imbalances in bone health biomarkers affect insulin production. This study investigates the effect of IR on proximal femur and lumbar spine BMD, femoral neck bending, compressive and impact strength indices (Composite Strength Indices) and circulating levels of parathyroid hormone (PTH), C-telopeptide of Type I collagen (CTx-1) and 25(OH) Vitamin D3, in a cohort of 97 healthy, non-obese, menopausal Chinese-Singaporean women. Lumbar spine aBMD was inversely associated with IR and dependent on lean body mass (LBM) and age. No such associations were found for vBMD of the third lumbar vertebra, aBMD and vBMD of the proximal femur, or circulating levels of PTH, CTx-1 and 25(OH) Vitamin D3. Composite Strength Indices were inversely associated with IR and independent of LBM, but after adjusting for fat mass and age, this association remained valid only for the impact strength index. Composite Strength Indices were significantly lower in participants with a high degree of IR. Our findings on IR and Composite Strength Indices relationships were in agreement with previous studies on different cohorts, but those on IR and BMD associations were not. PMID:29710852

Association of Insulin Resistance with Bone Strength and Bone Turnover in Menopausal Chinese-Singaporean Women without Diabetes

Directory of Open Access Journals (Sweden)

Maria Kalimeri

2018-04-01

Full Text Available Insulin resistance (IR is accompanied by increased areal or volumetric bone mineral density (aBMD or vBMD, but also higher fracture risk. Meanwhile, imbalances in bone health biomarkers affect insulin production. This study investigates the effect of IR on proximal femur and lumbar spine BMD, femoral neck bending, compressive and impact strength indices (Composite Strength Indices and circulating levels of parathyroid hormone (PTH, C-telopeptide of Type I collagen (CTx-1 and 25(OH Vitamin D3, in a cohort of 97 healthy, non-obese, menopausal Chinese-Singaporean women. Lumbar spine aBMD was inversely associated with IR and dependent on lean body mass (LBM and age. No such associations were found for vBMD of the third lumbar vertebra, aBMD and vBMD of the proximal femur, or circulating levels of PTH, CTx-1 and 25(OH Vitamin D3. Composite Strength Indices were inversely associated with IR and independent of LBM, but after adjusting for fat mass and age, this association remained valid only for the impact strength index. Composite Strength Indices were significantly lower in participants with a high degree of IR. Our findings on IR and Composite Strength Indices relationships were in agreement with previous studies on different cohorts, but those on IR and BMD associations were not.

On exposure to anorexia nervosa, the temporal variation in axial and appendicular skeletal development predisposes to site-specific deficits in bone size and density: a cross-sectional study.

Science.gov (United States)

Seeman, E; Karlsson, M K; Duan, Y

2000-11-01

Skeletal development is heterogeneous. Throughout growth, bone size is more maturationally advanced than the mineral being accrued within its periosteal envelope; before puberty, appendicular growth is more rapid than axial growth; during puberty, appendicular growth slows and axial growth accelerates. We studied women with differing age of onset of anorexia nervosa to determine whether this temporal heterogeneity in growth predisposed to the development of deficits in bone size and volumetric bone mineral density (vBMD), which varied by site and severity depending on the age at which anorexia nervosa occurred. Bone size and vBMD of the third lumbar vertebra and femoral neck were measured using dual-energy X-ray absorptiometry in 210 women aged 21 years (range, 12-40 years) with anorexia nervosa. Results were expressed as age-specific SDs (mean +/- SEM). Bone width depended on the age of onset of anorexia nervosa; when the onset of anorexia nervosa occurred (1) before 15 years of age, deficits in vertebral body and femoral neck width did not differ (-0.77+/-0.27 SD and -0.55+/-0.17 SD, respectively); (2) between 15 and 19 years of age, deficits in vertebral body width (-0.95+/-0.16 SD) were three times the deficits in femoral neck width (-0.28+/-0.14 SD; p anorexia nervosa. No deficit in bone width was observed at the femoral neck. Deficits in vBMD at the vertebra and femoral neck were independent of the age of onset of anorexia nervosa but increased as the duration of anorexia nervosa increased, being about 0.5 SD lower at the vertebra than femoral neck. We infer that the maturational development of a region at the time of exposure to disease, and disease duration, determine the site, magnitude, and type of trait deficit in anorexia nervosa. Bone fragility due to reduced bone size and reduced vBMD in adulthood is partly established during growth.

Line probe assay for differentiation within Mycobacterium tuberculosis complex. Evaluation on clinical specimens and isolates including Mycobacterium pinnipedii

DEFF Research Database (Denmark)

Kjeldsen, Marianne Kirstine; Bek, Dorte; Rasmussen, Erik Michael

2009-01-01

A line probe assay (GenoType MTBC) was evaluated for species differentiation within the Mycobacterium tuberculosis complex (MTBC). We included 387 MTBC isolates, 43 IS6110 low-copy MTBC isolates, 28 clinical specimens with varying microscopy grade, and 30 isolates of non-tuberculous mycobacteria...

Analyses of musculoskeletal interactions in humans by quantitative computed tomography (QCT)

International Nuclear Information System (INIS)

Capiglioni, Ricardo; Cointry, Gustavo; Capozza, Ricardo; Gimenez, Carlos; Ferretti, Jose L.

2001-01-01

Bone and muscle cross-sectional properties were assessed by QCT at the L3 spinal level in normal women and men (n=93/5) aged 32-74 years and compared with the kyphosis angle (Ka) determined between T4 and T12 in lateral Rx's. The volumetric mineral density (vBMD) of trabecular bone, the bone mineral content (BMC) of the vertebral bodies and the fat-free areas of the peri spinal muscle (FFMA) varied in line and correlated negatively with the Ka. Multiple regression analyses showed that the trabecular vBMD and total BMC were the most significant independent determinants of the Ka, and that the FFMA and time since menopause were the only independent determinants of the bone properties, with no influence of the gender, age or anthropometric factors. (author)

Effects of Odanacatib on the Radius and Tibia of Postmenopausal Women

DEFF Research Database (Denmark)

Cheung, Am; Majumdar, S; Brixen, K

2014-01-01

results, odanacatib was superior to placebo with respect to increases in trabecular volumetric BMD (vBMD) and estimated compressive strength at the spine, and integral and trabecular vBMD and estimated strength at the hip. Here we report the results of HR-pQCT assessment. 214 postmenopausal women (mean.......64% and 2.66%). At the distal radius, odanacatib significantly improved trabecular thickness and BV/TV versus placebo. At a more proximal radial site, odanacatib attenuated the increase in cortical porosity seen with placebo (treatment difference= -7.7%, p = 0.066). At the distal tibia, odanacatib...... significantly improved trabecular number, separation, and BV/TV versus placebo. Safety and tolerability were similar between treatment groups. In conclusion, odanacatib increased cortical and trabecular density, cortical thickness, aspects of trabecular microarchitecture, and estimated strength at the distal...

GWAS of clinically defined gout and subtypes identifies multiple susceptibility loci that include urate transporter genes

OpenAIRE

Nakayama, Akiyoshi; Nakaoka, Hirofumi; Yamamoto, Ken; Sakiyama, Masayuki; Shaukat, Amara; Toyoda, Yu; Okada, Yukinori; Kamatani, Yoichiro; Nakamura, Takahiro; Takada, Tappei; Inoue, Katsuhisa; Yasujima, Tomoya; Yuasa, Hiroaki; Shirahama, Yuko; Nakashima, Hiroshi

2016-01-01

Objective A genome-wide association study (GWAS) of gout and its subtypes was performed to identify novel gout loci, including those that are subtype-specific. Methods Putative causal association signals from a GWAS of 945 clinically defined gout cases and 1213 controls from Japanese males were replicated with 1396 cases and 1268 controls using a custom chip of 1961 single nucleotide polymorphisms (SNPs). We also first conducted GWASs of gout subtypes. Replication with Caucasian and New Zeala...

Dutch guideline for clinical foetal-neonatal and paediatric post-mortem radiology, including a review of literature.

Science.gov (United States)

Sonnemans, L J P; Vester, M E M; Kolsteren, E E M; Erwich, J J H M; Nikkels, P G J; Kint, P A M; van Rijn, R R; Klein, W M

2018-06-01

Clinical post-mortem radiology is a relatively new field of expertise and not common practice in most hospitals yet. With the declining numbers of autopsies and increasing demand for quality control of clinical care, post-mortem radiology can offer a solution, or at least be complementary. A working group consisting of radiologists, pathologists and other clinical medical specialists reviewed and evaluated the literature on the diagnostic value of post-mortem conventional radiography (CR), ultrasonography, computed tomography (PMCT), magnetic resonance imaging (PMMRI), and minimally invasive autopsy (MIA). Evidence tables were built and subsequently a Dutch national evidence-based guideline for post-mortem radiology was developed. We present this evaluation of the radiological modalities in a clinical post-mortem setting, including MIA, as well as the recently published Dutch guidelines for post-mortem radiology in foetuses, neonates, and children. In general, for post-mortem radiology modalities, PMMRI is the modality of choice in foetuses, neonates, and infants, whereas PMCT is advised in older children. There is a limited role for post-mortem CR and ultrasonography. In most cases, conventional autopsy will remain the diagnostic method of choice. Based on a literature review and clinical expertise, an evidence-based guideline was developed for post-mortem radiology of foetal, neonatal, and paediatric patients. What is Known: • Post-mortem investigations serve as a quality check for the provided health care and are important for reliable epidemiological registration. • Post-mortem radiology, sometimes combined with minimally invasive techniques, is considered as an adjunct or alternative to autopsy. What is New: • We present the Dutch guidelines for post-mortem radiology in foetuses, neonates and children. • Autopsy remains the reference standard, however minimal invasive autopsy with a skeletal survey, post-mortem computed tomography, or post

Slowly progressive fluent aphasia; Clinical features and an imaging study including MRI, SPECT and PET

Energy Technology Data Exchange (ETDEWEB)

Sakurai, Yasuhisa; Momose, Toshimitsu; Watanabe, Toshiaki; Ishikawa, Takashi; Iwata, Makoto (Tokyo Univ. (Japan). Faculty of Medicine); Bando, Mitsuaki

1991-05-01

Three patients with slowly progressive fluent aphasia are reported. One of the patients presented with memory disturbance. They were characterized clinically by having selective deficits in vocabulary, which resulted in impairment of confrontation naming, and auditory comprehension. MRI showed an atrophy not only in the left temporal lobe (including the superior, middle and inferior temporal gyri), hippocampus, parahippocampual gyrus, and fusiform gyrus, but also in the left parietal lobe. I-123 IMP SPECT and F-18 FDG PET were used to determine regional cerebral blood flow and regional cerebral metabolic rate, respectively. In addition to the decreased tracer uptake in the left temporal and/or parietal lobe, a decreased uptake was seen in the bilateral basal ganglia, the inner side of the temporal lobe (including the bilateral hippocampus), the right anterior temporal lobe, and the left thalamus. These findings may deny the previous thought that lesions are localized in slowly progressive fluent aphasia. Furthermore, noticeable difficulty in naming, i.e., patients unable to recognize the right answer, are considered attributable to widespread lesions from the whole left temporal lobe, including the hippocampus, to the right temporal lobe. (N.K.).

Infection by rhinovirus: similarity of clinical signs included in the case definition of influenza IAn/H1N1.

Science.gov (United States)

de Oña Navarro, Maria; Melón García, Santiago; Alvarez-Argüelles, Marta; Fernández-Verdugo, Ana; Boga Riveiro, Jose Antonio

2012-08-01

Although new influenza virus (IAn/H1N1) infections are mild and indistinguishable from any other seasonal influenza virus infections, there are few data on comparisons of the clinical features of infection with (IAn/H1N1) and with other respiratory viruses. The incidence, clinical aspects and temporal distribution of those respiratory viruses circulating during flu pandemic period were studied. Respiratory samples from patients with acute influenza-like symptoms were collected from May 2009 to December 2009. Respiratory viruses were detected by conventional culture methods and genome amplification techniques. Although IAn/H1N1 was the virus most frequently detected, several other respiratory viruses co-circulated with IAn/H1N1 during the pandemic period, especially rhinovirus. The similarity between clinical signs included in the clinical case definition for influenza and those caused by other respiratory viruses, particularly rhinovirus, suggest that a high percentage of viral infections were clinically diagnosed as case of influenza. Our study offers useful information to face future pandemics caused by influenza virus, indicating that differential diagnoses are required in order to not overestimate the importance of the pandemic. Copyright © 2011 Elsevier España, S.L. All rights reserved.

Bone geometry, volumetric density, microarchitecture, and estimated bone strength assessed by HR-pQCT in Klinefelter syndrome

DEFF Research Database (Denmark)

Shanbhogue, Vikram V; Hansen, Stinus; Jørgensen, Niklas Rye

2014-01-01

Although the expected skeletal manifestations of testosterone deficiency in Klinefelter's syndrome (KS) are osteopenia and osteoporosis, the structural basis for this is unclear. The aim of this study was to assess bone geometry, volumetric bone mineral density (vBMD), microarchitecture...

Risk Stratification of Stress Fractures and Prediction of Return to Duty

Science.gov (United States)

2015-12-01

SUBJECT TERMS bone microarchitecture, HRpQCT, race, gender , sex, bone mineral density, vBMD, bone geometry, stress fracture 16. SECURITY...are collaborating with local sports medicine physicians, coaches, and athletic trainers to continue recruiting effectively (Task 3, objective 3). We

Clinical target volume delineation including elective nodal irradiation in preoperative and definitive radiotherapy of pancreatic cancer

Directory of Open Access Journals (Sweden)

Caravatta Luciana

2012-06-01

Full Text Available Abstract Background Radiotherapy (RT is widely used in the treatment of pancreatic cancer. Currently, recommendation has been given for the delineation of the clinical target volume (CTV in adjuvant RT. Based on recently reviewed pathologic data, the aim of this study is to propose criteria for the CTV definition and delineation including elective nodal irradiation (ENI in the preoperative and definitive treatment of pancreatic cancer. Methods The anatomical structures of interest, as well as the abdominal vasculature were identified on intravenous contrast-enhanced CT scans of two different patients with pancreatic cancer of the head and the body. To delineate the lymph node area, a margin of 10 mm was added to the arteries. Results We proposed a set of guidelines for elective treatment of high-risk nodal areas and CTV delineation. Reference CT images were provided. Conclusions The proposed guidelines could be used for preoperative or definitive RT for carcinoma of the head and body of the pancreas. Further clinical investigations are needed to validate the defined CTVs.

Subjective cognitive complaints included in diagnostic evaluation of dementia helps accurate diagnosis in a mixed memory clinic cohort

DEFF Research Database (Denmark)

Salem, L C; Vogel, Asmus Mejling; Ebstrup, J

2015-01-01

OBJECTIVE: Our objective was to examine the quantity and profile of subjective cognitive complaints in young patients as compared with elderly patients referred to a memory clinic. METHODS: Patients were consecutively recruited from the Copenhagen University Hospital Memory Clinic at Rigshospitalet....... In total, 307 patients and 149 age-matched healthy controls were included. Patients were classified in 4 diagnostic groups: dementia, mild cognitive impairment, affective disorders and no cognitive impairment. Subjective memory was assessed with subjective memory complaints (SMC) scale. Global cognitive...... with dementia have a significantly higher level and a different profile of subjective cognitive complaints as compared with elderly patients with dementia. Furthermore, young patients, diagnosed with an affective disorder, had the highest level of subjective cognitive complaints of all patients in a memory...

Increasing the number of unloading/reambulation cycles does not adversely impact body composition and lumbar bone mineral density but reduces tissue sensitivity

Science.gov (United States)

Gupta, Shikha; Manske, Sarah L.; Judex, Stefan

2013-11-01

A single exposure to hindlimb unloading leads to changes in body mass, body composition and bone, but the consequences of multiple exposures are not yet understood. Within a 18 week period, adult C57BL/6 male mice were exposed to 1 (1x-HLU), 2 (2x-HLU) or 3 (3x-HLU) cycles of 2 weeks of hindlimb unloading (HLU) followed by 4 weeks of reambulation (RA), or served as ambulatory age-matched controls. In vivo μCT longitudinally tracked changes in abdominal adipose and lean tissues, lumbar vertebral apparent volumetric bone mineral density (vBMD) and upper hindlimb muscle cross-sectional area before and after the final HLU and RA cycle. During the final HLU cycle, significant decreases in total adipose tissue and vertebral vBMD in the three experimental groups occurred such that there were no significant between-group differences at the beginning of the final RA cycle. However, the magnitude of the HLU induced losses diminished in mice undergoing their 2nd or 3rd HLU cycle. Irrespective of the number of HLU/RA cycles, total adipose tissue and vertebral vBMD recovered and were no different from age-matched controls after the final RA period. In contrast, upper hindlimb muscle cross-sectional area was significantly lower than controls in all unloaded groups after the final RA period. These results suggest that tissues in the abdominal region are more resilient to multiple bouts of unloading and more amenable to recovery during reambulation than the peripheral musculoskeletal system.

The Role of Body Weight on Bone in Anorexia Nervosa

DEFF Research Database (Denmark)

Frølich, Jacob; Hansen, Stinus; Winkler, Laura Al-Dakhiel

2017-01-01

Anorexia nervosa (AN) is associated with decreased bone mineral density and increased risk of fracture. The aim of this study was to assess bone geometry, volumetric bone mineral density (vBMD), trabecular microarchitecture and estimated failure load in weight-bearing vs. non-weight-bearing bones...

GWAS of clinically defined gout and subtypes identifies multiple susceptibility loci that include urate transporter genes.

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Nakayama, Akiyoshi; Nakaoka, Hirofumi; Yamamoto, Ken; Sakiyama, Masayuki; Shaukat, Amara; Toyoda, Yu; Okada, Yukinori; Kamatani, Yoichiro; Nakamura, Takahiro; Takada, Tappei; Inoue, Katsuhisa; Yasujima, Tomoya; Yuasa, Hiroaki; Shirahama, Yuko; Nakashima, Hiroshi; Shimizu, Seiko; Higashino, Toshihide; Kawamura, Yusuke; Ogata, Hiraku; Kawaguchi, Makoto; Ohkawa, Yasuyuki; Danjoh, Inaho; Tokumasu, Atsumi; Ooyama, Keiko; Ito, Toshimitsu; Kondo, Takaaki; Wakai, Kenji; Stiburkova, Blanka; Pavelka, Karel; Stamp, Lisa K; Dalbeth, Nicola; Sakurai, Yutaka; Suzuki, Hiroshi; Hosoyamada, Makoto; Fujimori, Shin; Yokoo, Takashi; Hosoya, Tatsuo; Inoue, Ituro; Takahashi, Atsushi; Kubo, Michiaki; Ooyama, Hiroshi; Shimizu, Toru; Ichida, Kimiyoshi; Shinomiya, Nariyoshi; Merriman, Tony R; Matsuo, Hirotaka

2017-05-01

A genome-wide association study (GWAS) of gout and its subtypes was performed to identify novel gout loci, including those that are subtype-specific. Putative causal association signals from a GWAS of 945 clinically defined gout cases and 1213 controls from Japanese males were replicated with 1396 cases and 1268 controls using a custom chip of 1961 single nucleotide polymorphisms (SNPs). We also first conducted GWASs of gout subtypes. Replication with Caucasian and New Zealand Polynesian samples was done to further validate the loci identified in this study. In addition to the five loci we reported previously, further susceptibility loci were identified at a genome-wide significance level (pgout cases, and NIPAL1 and FAM35A for the renal underexcretion gout subtype. While NIPAL1 encodes a magnesium transporter, functional analysis did not detect urate transport via NIPAL1, suggesting an indirect association with urate handling. Localisation analysis in the human kidney revealed expression of NIPAL1 and FAM35A mainly in the distal tubules, which suggests the involvement of the distal nephron in urate handling in humans. Clinically ascertained male patients with gout and controls of Caucasian and Polynesian ancestries were also genotyped, and FAM35A was associated with gout in all cases. A meta-analysis of the three populations revealed FAM35A to be associated with gout at a genome-wide level of significance (p meta =3.58×10 -8 ). Our findings including novel gout risk loci provide further understanding of the molecular pathogenesis of gout and lead to a novel concept for the therapeutic target of gout/hyperuricaemia. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Bone strength estimates relative to vertical ground reaction force discriminates women runners with stress fracture history.

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Popp, Kristin L; McDermott, William; Hughes, Julie M; Baxter, Stephanie A; Stovitz, Steven D; Petit, Moira A

2017-01-01

To determine differences in bone geometry, estimates of bone strength, muscle size and bone strength relative to load, in women runners with and without a history of stress fracture. We recruited 32 competitive distance runners aged 18-35, with (SFX, n=16) or without (NSFX, n=16) a history of stress fracture for this case-control study. Peripheral quantitative computed tomography (pQCT) was used to assess volumetric bone mineral density (vBMD, mg/mm 3 ), total (ToA) and cortical (CtA) bone areas (mm 2 ), and estimated compressive bone strength (bone strength index; BSI, mg/mm 4 ) at the distal tibia. ToA, CtA, cortical vBMD, and estimated strength (section modulus; Zp, mm 3 and strength strain index; SSIp, mm 3 ) were measured at six cortical sites along the tibia. Mean active peak vertical (pkZ) ground reaction forces (GRFs), assessed from a fatigue run on an instrumented treadmill, were used in conjunction with pQCT measurements to estimate bone strength relative to load (mm 2 /N∗kg -1 ) at all cortical sites. SSIp and Zp were 9-11% lower in the SFX group at mid-shaft of the tibia, while ToA and vBMD did not differ between groups at any measurement site. The SFX group had 11-17% lower bone strength relative to mean pkZ GRFs (phistory of stress fracture. Bone strength relative to load is also lower in this same region suggesting that strength deficits in the middle 1/3 of the tibia and altered gait biomechanics may predispose an individual to stress fracture. Copyright © 2016. Published by Elsevier Inc.

Relative contributions of lean and fat mass to bone strength in young Hispanic and non-Hispanic girls.

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Hetherington-Rauth, Megan; Bea, Jennifer W; Blew, Robert M; Funk, Janet L; Hingle, Melanie D; Lee, Vinson R; Roe, Denise J; Wheeler, Mark D; Lohman, Timothy G; Going, Scott B

2018-05-22

With the high prevalence of childhood obesity, especially among Hispanic children, understanding how body weight and its components of lean and fat mass affect bone development is important, given that the amount of bone mineral accrued during childhood can determine osteoporosis risk later in life. The aim of this study was to assess the independent contributions of lean and fat mass on volumetric bone mineral density (vBMD), geometry, and strength in both weight-bearing and non-weight-bearing bones of Hispanic and non-Hispanic girls. Bone vBMD, geometry, and strength were assessed at the 20% distal femur, the 4% and 66% distal tibia, and the 66% distal radius of the non-dominant limb of 326, 9- to 12-year-old girls using peripheral quantitative computed tomography (pQCT). Total body lean and fat mass were measured by dual-energy x-ray absorptiometry (DXA). Multiple linear regression was used to assess the independent relationships of fat and lean mass with pQCT bone measures while adjusting for relevant confounders. Potential interactions between ethnicity and both fat and lean mass were also tested. Lean mass was a significant positive contributor to all bone outcomes (p Lean mass is the main determinant of bone strength for appendicular skeletal sites. Fat mass contributes to bone strength in the weight-bearing skeleton but does not add to bone strength in non-weight-bearing locations and may potentially be detrimental. Bone vBMD, geometry, and strength did not differ between Hispanic and non-Hispanic girls; fat mass may be a stronger contributor to bone strength in weight-bearing bones of Hispanic girls compared to non-Hispanic. Copyright © 2018. Published by Elsevier Inc.

Rural versus nonrural differences in BMC, volumetric BMD, and bone size: a population-based cross-sectional study.

Science.gov (United States)

Specker, Bonny; Binkley, Teresa; Fahrenwald, Nancy

2004-12-01

Despite reports of lower fracture risk among rural versus urban populations, few studies have investigated rural versus urban differences in bone mineral content (BMC) and bone mineral density (BMD). Population differences in cross-sectional bone geometry and understanding lifestyle factors responsible for these differences may reveal insights into the reason for differences in fracture risk. We hypothesized that if lifestyle differences in bone mass, size, and geometry are a result of muscle strength, activity, or dietary differences, Hutterite and rural populations should have greater bone mass compared to nonrural populations. The study population consisted of 1189 individuals: 504 rural Hutterites (188 men), 349 rural individuals (>75% life farming, 184 men), and 336 nonrural individuals (never lived on farm, 134 men) aged 20 to 66 years. BMC, bone area, and areal BMD (aBMD) of the total body (TB), hip, femoral neck (FN), and spine by DXA; volumetric BMD (vBMD) and bone geometry at the 4% and 20% radius; polar stress strain index (pSSI), a measure of bone strength, at the 20% pQCT site; and strength, 7-day activity recall, and 24-h diet recall were collected and compared among groups. Hutterite women and men had greater grip strength compared to rural and nonrural populations (both, P BMC and areal size than the nonrural population, while Hutterites had greater BMC and areal size than rural population at some (TB, FN for females only), but not all (proximal hip), sites. Cortical vBMD was inversely associated with periosteal circumference at the 20% radius in women (r=-0.25, P BMC, aBMD, vBMD, or bone size.

[Anatomical study and clinical application of a leg flap pedicle-included with cutaneous nerve and its concomitant vessels].

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Liu, B; Hao, X; Goan, M

2000-05-01

To investigate the blood supply patterns and the clinical liability of a leg flap pedicle-included with cutaneous nerve and its concomitant vessels. Fresh cadaver legs with thirty-two in infants and two in adults were anatomically examined after the intravenous injection of the red Chlorinated Poly Vingl Choride (CPVC). Five patients with the soft tissue defects were selected for the treatment with the flap pedicle-included with the cutaneous nerve and its concomitant vessels. Four main cutaneous nerves were found in the leg after they perforated the deep fascia out. They were companioned with their concomitant vessels with different blood-supply pateeerns, which the upper part of the leg was in an axial pattern and the lower part was in a "chain-type anastomosing" pattern. Following the above-mentioned findings, five cases were successfully treated with this led flap. The leg flap should be designed along the cutaneous nerve and its concomitant vessels. When the flap is applied in the area of blood supply with "chain-type anastomosing" pattern, the deep fascia should also be included in the flap.

Should clinical case definitions of influenza in hospitalized older adults include fever?

Science.gov (United States)

Falsey, Ann R; Baran, Andrea; Walsh, Edward E

2015-08-01

Influenza is a major cause of morbidity and mortality in elderly persons. Fever is included in all standard definitions of influenza-like illness (ILI), yet older patients may have diminished febrile response to infection. Therefore, we examined the utility of various thresholds to define fever for case definitions of influenza in persons ≥ 65 years of age. Data from two prospective surveillance studies for respiratory viral infection in adults hospitalized with acute cardiopulmonary illnesses with or without fever were examined. The highest temperature reported prior to admission or measured during the first 24 h after admission was recorded. The diagnosis of influenza was made by a combination of viral culture, reverse-transcription polymerase chain reaction, antigen testing, and serology. A total of 2410 subjects (66% ≥ 65 years of age) were enrolled; 281 had influenza (261 influenza A, 19 influenza B, and one mixed influenza A and B). The commonly used definition of ILI (fever ≥ 37·8°C and cough) resulted in 57% sensitivity and 71% specificity in older adults. Receiver operating characteristic curves examining the various temperature thresholds combined with cough and/or sore throat showed the optimal balance between sensitivity and specificity to be 37·9°C (AUC 0·71) and 37·3°C (AUC 0·66), in younger and older persons, respectively. Clinical decision rules using the presence of cough and fever may be helpful when screening for influenza or empiric antiviral treatment when rapid influenza testing is not available; however, lower fever thresholds may be considered for elderly subjects. © 2015 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd.

Bone mineral density changes of lumbar spine and femur in osteoporotic patient treated with bisphosphonates and beta-hydroxy-beta-methylbutyrate (HMB): Case report.

Science.gov (United States)

Tatara, Marcin R; Krupski, Witold; Majer-Dziedzic, Barbara

2017-10-01

Currently available approaches to osteoporosis treatment include application of antiresorptive and anabolic agents influencing bone tissue metabolism. The aim of the study was to present bone mineral density (BMD) changes of lumbar spine in osteoporotic patient treated with bisphosphonates such as ibandronic acid and pamidronic acid, and beta-hydroxy-beta-methylbutyrate (HMB). BMD and volumetric BMD (vBMD) of lumbar spine were measured during the 6 year observation period with the use of dual-energy X-ray absorptiometry (DEXA) and quantitative computed tomography (QCT). The described case report of osteoporotic patient with family history of severe osteoporosis has shown site-dependent response of bone tissue to antiosteoporotic treatment with bisphosphonates. Twenty-five-month treatment with ibandronic acid improved proximal femur BMD with relatively poor effects on lumbar spine BMD. Over 15-month therapy with pamidronic acid was effective to improve lumbar spine BMD, while in the proximal femur the treatment was not effective. A total of 61-week long oral administration with calcium salt of HMB improved vBMD of lumbar spine in the trabecular and cortical bone compartments when monitored by QCT. Positive effects of nearly 2.5 year HMB treatment on BMD of lumbar spine and femur in the patient were also confirmed using DEXA method. The results obtained indicate that HMB may be applied for the effective treatment of osteoporosis in humans. Further studies on wider human population are recommended to evaluate mechanisms influencing bone tissue metabolism by HMB.

Normal tempo of bone formation in Turner syndrome despite signs of accelerated bone resorption

DEFF Research Database (Denmark)

Cleemann, Line Hartvig; Holm, Kirsten Bagge; Kobbernagel, Hanne

2011-01-01

Aims: To evaluate area bone mineral density (aBMD) and volumetric BMD (vBMD) by dual-energy X-ray absorptiometry, and relations to bone markers and hormones in adolescent women with Turner syndrome (TS). Methods: Cross-sectional study in TS patients (n = 37, 16.7 ± 3.4 years) and control group (n...

Normal Tempo of Bone Formation in Turner Syndrome despite Signs of Accelerated Bone Resorption

DEFF Research Database (Denmark)

Cleemann, Line; Holm, Kirsten; Kobbernagel, Hanne

2011-01-01

Aims: To evaluate area bone mineral density (aBMD) and volumetric BMD (vBMD) by dual-energy X-ray absorptiometry, and relations to bone markers and hormones in adolescent women with Turner syndrome (TS). Methods: Cross-sectional study in TS patients (n = 37, 16.7 ± 3.4 years) and control group (n...

Rate of Clinical Complete Response for 1 Year or More in Bone-Metastatic Breast Cancer after Comprehensive Treatments including Autologous Formalin-Fixed Tumor Vaccine.

Science.gov (United States)

Kuranishi, Fumito; Imaoka, Yuki; Sumi, Yuusuke; Uemae, Yoji; Yasuda-Kurihara, Hiroko; Ishihara, Takeshi; Miyazaki, Tsubasa; Ohno, Tadao

2018-01-01

No effective treatment has been developed for bone-metastatic breast cancer. We found 3 cases with clinical complete response (cCR) of the bone metastasis and longer overall survival of the retrospectively examined cohort treated comprehensively including autologous formalin-fixed tumor vaccine (AFTV). AFTV was prepared individually for each patient from their own formalin-fixed and paraffin-embedded breast cancer tissues. Three patients maintained cCR status of the bone metastasis for 17 months or more. Rate of cCR for 1 year or more appeared to be 15% (3/20) after comprehensive treatments including AFTV. The median overall survival time (60.0 months) and the 3- to 8-year survival rates after diagnosis of bone metastasis were greater than those of historical control cohorts in Japan (1988-2002) and in the nationwide population-based cohort study of Denmark (1999-2007). Bone-metastatic breast cancer may be curable after comprehensive treatments including AFTV, although larger scale clinical trial is required.

The relationship between the TMJ internal derangement state including rotational displacement and perforation and the clinical characteristics

International Nuclear Information System (INIS)

Jeong, Hwan Seok; You Dong Soo

1998-01-01

This study was designed to reveal the correlationship between the internal derangement state of TMJ and clinical characteristics including pain and mandibular dysfuntion. One hundred and twenty five subjects with TMJ signs and symptoms were chosen for two years. The level of pain and mandibular dysfuntion were evaluated by Visual Analog Scale (VAS) and Craniomandibular Index (CMI). The diagnostic categories of TMJ internal derangement were determined by arthrography and they included normal disc position, anterior disc displacement with reduction (ADDR), rotational disc displacement with reduction (RDDR), andterior disc displacement without reduction (ADDNR), and rotational disc displacement without reduction (RDDNR). Also disc perforation was used as a criteria to divide the diagnostic subgroups. The obtained results were as follows ; 1. The patient distribution of each group was 5 in normal disc position (4%), 40 in ADDR (32%), 30 in RDDR (24%), 34 in ADDNR (27%), and 16 in RDDNR (13%). 2. Perforation was observed in 8% of ADDR, 10% of RDDR, 32% of ADDNR, and 19% of RDDNR. 3. CMI of perforation group was higher than that of reduction or normal group(p 0.05).

Expansion of the clinical phenotype of the distal 10q26.3 deletion syndrome to include ataxia and hyperemia of the hands and feet.

Science.gov (United States)

Lacaria, Melanie; Srour, Myriam; Michaud, Jacques L; Doja, Asif; Miller, Elka; Schwartzentruber, Jeremy; Goldsmith, Claire; Majewski, Jacek; Boycott, Kym M

2017-06-01

Distal deletion of the long arm of chromosome 10 is associated with a dysmorphic craniofacial appearance, microcephaly, behavioral issues, developmental delay, intellectual disability, and ocular, urogenital, and limb abnormalities. Herein, we present clinical, molecular, and cytogenetic investigations of four patients, including two siblings, with nearly identical terminal deletions of 10q26.3, all of whom have an atypical presentation of this syndrome. Their prominent features include ataxia, mild-to-moderate intellectual disability, and hyperemia of the hands and feet, and they do not display many of the other features commonly associated with deletions of this region. These results point to a novel gene locus associated with ataxia and highlight the variability of the clinical presentation of patients with deletions of this region. © 2017 Wiley Periodicals, Inc.

Do we have to Include HCI Issues in Clinical Trials of Medical Devices?

DEFF Research Database (Denmark)

Nielsen, Lene; Christensen, Lars Rune; Sabers, Anne

2017-01-01

Digital devices play an important role in medical treatment and will in the future play a larger role in connection to cures of health-related issues. Traditionally medicine has been tested by clinical double blind, randomized trials to document the efficacy and safety profile. When it comes to t...

Rate of Clinical Complete Response for 1 Year or More in Bone-Metastatic Breast Cancer after Comprehensive Treatments including Autologous Formalin-Fixed Tumor Vaccine

Directory of Open Access Journals (Sweden)

Fumito Kuranishi

2018-01-01

Full Text Available Introduction. No effective treatment has been developed for bone-metastatic breast cancer. We found 3 cases with clinical complete response (cCR of the bone metastasis and longer overall survival of the retrospectively examined cohort treated comprehensively including autologous formalin-fixed tumor vaccine (AFTV. Patients and Methods. AFTV was prepared individually for each patient from their own formalin-fixed and paraffin-embedded breast cancer tissues. Results. Three patients maintained cCR status of the bone metastasis for 17 months or more. Rate of cCR for 1 year or more appeared to be 15% (3/20 after comprehensive treatments including AFTV. The median overall survival time (60.0 months and the 3- to 8-year survival rates after diagnosis of bone metastasis were greater than those of historical control cohorts in Japan (1988–2002 and in the nationwide population-based cohort study of Denmark (1999–2007. Conclusion. Bone-metastatic breast cancer may be curable after comprehensive treatments including AFTV, although larger scale clinical trial is required.

Identification of clinical isolates of Aspergillus, including cryptic species, by matrix assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS).

Science.gov (United States)

Vidal-Acuña, M Reyes; Ruiz-Pérez de Pipaón, Maite; Torres-Sánchez, María José; Aznar, Javier

2017-12-08

An expanded library of matrix assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS) has been constructed using the spectra generated from 42 clinical isolates and 11 reference strains, including 23 different species from 8 sections (16 cryptic plus 7 noncryptic species). Out of a total of 379 strains of Aspergillus isolated from clinical samples, 179 strains were selected to be identified by sequencing of beta-tubulin or calmodulin genes. Protein spectra of 53 strains, cultured in liquid medium, were used to construct an in-house reference database in the MALDI-TOF MS. One hundred ninety strains (179 clinical isolates previously identified by sequencing and the 11 reference strains), cultured on solid medium, were blindy analyzed by the MALDI-TOF MS technology to validate the generated in-house reference database. A 100% correlation was obtained with both identification methods, gene sequencing and MALDI-TOF MS, and no discordant identification was obtained. The HUVR database provided species level (score of ≥2.0) identification in 165 isolates (86.84%) and for the remaining 25 (13.16%) a genus level identification (score between 1.7 and 2.0) was obtained. The routine MALDI-TOF MS analysis with the new database, was then challenged with 200 Aspergillus clinical isolates grown on solid medium in a prospective evaluation. A species identification was obtained in 191 strains (95.5%), and only nine strains (4.5%) could not be identified at the species level. Among the 200 strains, A. tubingensis was the only cryptic species identified. We demonstrated the feasibility and usefulness of the new HUVR database in MALDI-TOF MS by the use of a standardized procedure for the identification of Aspergillus clinical isolates, including cryptic species, grown either on solid or liquid media. © The Author 2017. Published by Oxford University Press on behalf of The International Society for Human and Animal Mycology. All rights reserved. For

Principles of cobalt-60 teletherapy including an introduction to the compendium. Guidelines in clinical radiation oncology

International Nuclear Information System (INIS)

Mitchell, J.S.; Hlasivec, Z.

1984-01-01

It is generally accepted that the clinical radiotherapeutic oncologist must be a well educated doctor, with wide knowledge and experience, able to deal with the many difficult problems that can arise in connection with radiotherapy, curative, palliative or prophylactic. The management, treatment and care of the individual patient with malignant disease is a major task of medicine, requiring up-to-date knowledge in a number of rapidly advancing fields. To be efficient, it is essential for the clinical radiation oncologist to continue his education throughout his life, by reading the literature, attending lectures, conferences and advanced 'refresher' courses, and by visiting other centres. The clinical radiation oncologist will discover that it is wise, where at all possible, to spend a proportion of his time working with other specialists on clinical trials and research, with formal publication of the results. The disciplines of such work will deepen his understanding, not only of his own speciality, but of the whole field of oncology, and will further co-operation between the many different specialists on whose combined efforts the cure of each individual patient and the advances in the treatment of cancer must ultimately depend

Dermoscopic patterns in patients with a clinical diagnosis of onychomycosis-results of a prospective study including data of potassium hydroxide (KOH) and culture examination.

Science.gov (United States)

Jesús-Silva, Miriam América; Fernández-Martínez, Ramón; Roldán-Marín, Rodrigo; Arenas, Roberto

2015-04-01

Onychomycosis is the most common nail disease, representing 50% of cases affecting the nail apparatus. The diagnosis is made by clinical examination along with the KOH exam of the nail and culture of the sample. However, not all dermatologists have access to a mycology lab. To determine the correlation between KOH examination and dermoscopic patterns in patients with clinical diagnosis of onychomycosis. A descriptive, open, observational, prospective, cross-sectional study of 178 patients with clinical suspicion of onychomycosis was conducted. All patients underwent clinical examination, dermoscopy with a DermLite PHOTO dermatoscope (3Gen, San Juan Capistrano, CA, USA), KOH assessment and culture analysis. The most frequent dermoscopic patterns were identified and their correlation with the clinical subtype of onychomycosis was analyzed. The study included 178 patients with clinical suspicion of onychomycosis. Of these, 155 (87.1%) had positive direct KOH examination for onychomycosis. Eighty-seven patients (56.13%) presented with clinical onychomycosis pattern of total dystrophic onychomycosis (TDO), 67 (43.23%) with distal lateral subungual onychomycosis (DLSO), 1 (0.65%) with trachyonychia). Dermoscopic patterns of onychomycosis showed the following frequencies: the spiked pattern was present in 22 patients (14.19%), longitudinal striae pattern in 51 patients (32.9%) and linear edge pattern in 21 patients (13.55%). We identified a pattern described as "distal irregular termination" in 41 patients with TDO and 26 with DLSO. This is the fist study conducted in a Mexican population that uses dermoscopy as a diagnostic tool along with the KOH examination for the diagnosis of onychomycosis. Dermoscopy may be used as an important diagnostic tool when evaluating nail disease. However, it should not be used as the only diagnostic criteria for onychomycosis.

Alterations of bone density, microstructure, and strength of the distal radius in male patients with rheumatoid arthritis: a case-control study with HR-pQCT.

Science.gov (United States)

Zhu, Tracy Y; Griffith, James F; Qin, Ling; Hung, Vivian W; Fong, Tsz-Ning; Au, Sze-Ki; Li, Martin; Lam, Yvonne Yi-On; Wong, Chun-Kwok; Kwok, Anthony W; Leung, Ping-Chung; Li, Edmund K; Tam, Lai-Shan

2014-09-01

In this cross-sectional study, we investigated volumetric bone mineral density (vBMD), bone microstructure, and biomechanical competence of the distal radius in male patients with rheumatoid arthritis (RA). The study cohort comprised 50 male RA patients of average age of 61.1 years and 50 age-matched healthy males. Areal BMD (aBMD) of the hip, lumbar spine, and distal radius was measured by dual-energy X-ray absorptiometry. High-resolution peripheral quantitative computed tomography (HR-pQCT) of the distal radius provided measures of cortical and trabecular vBMD, microstructure, and biomechanical indices. aBMD of the hip but not the lumbar spine or ultradistal radius was significantly lower in RA patients than controls after adjustment for body weight. Total, cortical, and trabecular vBMD at the distal radius were, on average, -3.9% to -23.2% significantly lower in RA patients, and these differences were not affected by adjustment for body weight, testosterone level, or aBMD at the ultradistal radius. Trabecular microstructure indices were, on average, -8.1% (trabecular number) to 28.7% (trabecular network inhomogeneity) significantly inferior, whereas cortical pore volume and cortical porosity index were, on average, 80.3% and 63.9%, respectively, significantly higher in RA patients. RA patients also had significantly lower whole-bone stiffness, modulus, and failure load, with lower and more unevenly distributed cortical and trabecular stress. Density and microstructure indices significantly correlated with disease activity, severity, and levels of pro-inflammatory cytokines (interleukin [IL] 12p70, tumor necrosis factor, IL-6 and IL-1β). Ten RA patients had focal periosteal bone apposition most prominent at the ulnovolar aspect of the distal radius. These patients had shorter disease duration and significantly higher cortical porosity. In conclusion, HR-pQCT reveals significant alterations of bone density, microstructure, and strength of the distal radius in

Sequences of Regressions Distinguish Nonmechanical from Mechanical Associations between Metabolic Factors, Body Composition, and Bone in Healthy Postmenopausal Women.

Science.gov (United States)

Solis-Trapala, Ivonne; Schoenmakers, Inez; Goldberg, Gail R; Prentice, Ann; Ward, Kate A

2016-03-09

There is increasing recognition of complex interrelations between the endocrine functions of bone and fat tissues or organs. The objective was to describe nonmechanical and mechanical links between metabolic factors, body composition, and bone with the use of graphical Markov models. Seventy postmenopausal women with a mean ± SD age of 62.3 ± 3.7 y and body mass index (in kg/m 2 ) of 24.9 ± 3.8 were recruited. Bone outcomes were peripheral quantitative computed tomography measures of the distal and diaphyseal tibia, cross-sectional area (CSA), volumetric bone mineral density (vBMD), and cortical CSA. Biomarkers of osteoblast and adipocyte function were plasma concentrations of leptin, adiponectin, osteocalcin, undercarboxylated osteocalcin (UCOC), and phylloquinone. Body composition measurements were lean and percent fat mass, which were derived with the use of a 4-compartment model. Sequences of Regressions, a subclass of graphical Markov models, were used to describe the direct (nonmechanical) and indirect (mechanical) interrelations between metabolic factors and bone by simultaneously modeling multiple bone outcomes and their relation with biomarker outcomes with lean mass, percent fat mass, and height as intermediate explanatory variables. The graphical Markov models showed both direct and indirect associations linking plasma leptin and adiponectin concentrations with CSA and vBMD. At the distal tibia, lean mass, height, and adiponectin-UCOC interaction were directly explanatory of CSA (R 2 = 0.45); at the diaphysis, lean mass, percent fat mass, leptin, osteocalcin, and age-adiponectin interaction were directly explanatory of CSA (R 2 = 0.49). The regression models exploring direct associations for vBMD were much weaker, with R 2 = 0.15 and 0.18 at the distal and diaphyseal sites, respectively. Lean mass and UCOC were associated, and the global Markov property of the graph indicated that this association was explained by osteocalcin. This study, to our

Use of dual-energy computed tomography to measure skeletal-wide marrow composition and cancellous bone mineral density.

Science.gov (United States)

Arentsen, Luke; Hansen, Karen E; Yagi, Masashi; Takahashi, Yutaka; Shanley, Ryan; McArthur, Angela; Bolan, Patrick; Magome, Taiki; Yee, Douglas; Froelich, Jerry; Hui, Susanta K

2017-07-01

Temporal and spatial variations in bone marrow adipose tissue (MAT) can be indicative of several pathologies and confound current methods of assessing immediate changes in bone mineral remodeling. We present a novel dual-energy computed tomography (DECT) method to monitor MAT and marrow-corrected volumetric BMD (mcvBMD) throughout the body. Twenty-three cancellous skeletal sites in 20 adult female cadavers aged 40-80 years old were measured using DECT (80 and 140 kVp). vBMD was simultaneous recorded using QCT. MAT was further sampled using MRI. Thirteen lumbar vertebrae were then excised from the MRI-imaged donors and examined by microCT. After MAT correction throughout the skeleton, significant differences (p < 0.05) were found between QCT-derived vBMD and DECT-derived mcvBMD results. McvBMD was highly heterogeneous with a maximum at the posterior skull and minimum in the proximal humerus (574 and 0.7 mg/cc, respectively). BV/TV and BMC have a nearly significant correlation with mcvBMD (r = 0.545, p = 0.057 and r = 0.539, p = 0.061, respectively). MAT assessed by DECT showed a significant correlation with MRI MAT results (r = 0.881, p < 0.0001). Both DECT- and MRI-derived MAT had a significant influence on uncorrected vBMD (r = -0.86 and r = -0.818, p ≤ 0.0001, respectively). Conversely, mcvBMD had no correlation with DECT- or MRI-derived MAT (r = 0.261 and r = 0.067). DECT can be used to assess MAT while simultaneously collecting mcvBMD values at each skeletal site. MAT is heterogeneous throughout the skeleton, highly variable, and should be accounted for in longitudinal mcvBMD studies. McvBMD accurately reflects the calcified tissue in cancellous bone.

Adherence to antiretroviral therapy and clinical outcomes among young adults reporting high-risk sexual behavior, including men who have sex with men, in coastal Kenya.

Science.gov (United States)

Graham, Susan M; Mugo, Peter; Gichuru, Evanson; Thiong'o, Alexander; Macharia, Michael; Okuku, Haile S; van der Elst, Elise; Price, Matthew A; Muraguri, Nicholas; Sanders, Eduard J

2013-05-01

African men who have sex with men (MSM) face significant stigma and barriers to care. We investigated antiretroviral therapy (ART) adherence among high-risk adults, including MSM, participating in a clinic-based cohort. Survival analysis was used to compare attrition across patient groups. Differences in adherence, weight gain, and CD4 counts after ART initiation were assessed. Among 250 HIV-1-seropositive adults, including 108 MSM, 15 heterosexual men, and 127 women, patient group was not associated with attrition. Among 58 participants who were followed on ART, 40 % of MSM had less than 95 % adherence, versus 28.6 % of heterosexual men and 11.5 % of women. Although MSM gained less weight after ART initiation than women (adjusted difference -3.5 kg/year), CD4 counts did not differ. More data are needed on barriers to adherence and clinical outcomes among African MSM, to ensure that MSM can access care and derive treatment and prevention benefits from ART.

Methionine restriction alters bone morphology and affects osteoblast differentiation

Directory of Open Access Journals (Sweden)

Amadou Ouattara

2016-12-01

Full Text Available Methionine restriction (MR extends the lifespan of a wide variety of species, including rodents, drosophila, nematodes, and yeasts. MR has also been demonstrated to affect the overall growth of mice and rats. The objective of this study was to evaluate the effect of MR on bone structure in young and aged male and female C57BL/6J mice. This study indicated that MR affected the growth rates of males and young females, but not aged females. MR reduced volumetric bone mass density (vBMD and bone mineral content (BMC, while bone microarchitecture parameters were decreased in males and young females, but not in aged females compared to control-fed (CF mice. However, when adjusted for bodyweight, the effect of MR in reducing vBMD, BMC and microarchitecture measurements was either attenuated or reversed suggesting that the smaller bones in MR mice is appropriate for its body size. In addition, CF and MR mice had similar intrinsic strength properties as measured by nanoindentation. Plasma biomarkers suggested that the low bone mass in MR mice could be due to increased collagen degradation, which may be influenced by leptin, IGF-1, adiponectin and FGF21 hormone levels. Mouse preosteoblast cell line cultured under low sulfur amino acid growth media attenuated gene expression levels of Col1al, Runx2, Bglap, Alpl and Spp1 suggesting delayed collagen formation and bone differentiation. Collectively, our studies revealed that MR altered bone morphology which could be mediated by delays in osteoblast differentiation. Keywords: Methionine restriction, Aged mice, Micro-computed tomography, Nanoindentation, MC3T3-E1 subclone 4

Clinical Trials

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Full Text Available ... sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, ... and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including the NHLBI) usually ...

Clinical Trials

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Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ...

Risk Stratification of Stress Fractures and Prediction of Return-to-Duty

Science.gov (United States)

2016-12-01

mgh.harvard.edu; mbouxsei@bidmc.harvard.edu 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Massachusetts General Hospital AND...ADDRESS(ES) 8. PERFORMING ORGANIZATION REPORT NUMBER Boston, MA 02114-2554 9. SPONSORING / MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSOR...with recent stress fracture enrolled. 15. SUBJECT TERMS bone microarchitecture, HRpQCT, race, gender , sex, bone mineral density, vBMD, bone geometry

Perioperative brain damage after cardiovascular surgery; Clinical evaluation including CT scans

Energy Technology Data Exchange (ETDEWEB)

Maruyama, Michiyuki; Kuriyama, Yoshihiro; Sawada, Toru; Fujita, Tsuyoshi; Omae, T. (National Cardiovascular Center, Suita, Osaka (Japan))

1989-08-01

We examined 39 cases (1.6%) of post-operative brain damages out of 2,445 sequential cases of cardiovascular surgery in NCVC during past three years. In this study, we investigated clinical course and CT findings of each patient in details and analyzed the causes of the post operative brain damages. Of 39 cases, 23 (59%) were complicated with cerebral ischemia, 8 (21%) with subdural hematoma (SDH), 2 (5%) with intracranial hemorrhage (ICH) and 1 (2%) with subarachnoid hemorrhage (SAH), respectively. 5 cases (13%) had unclassified brain damages. In 23 cases of cerebral ischemia there were 5 cases of hypotension-induced ischemia, 4 cases of hypoxic encephalopathy, 3 cases of ischemia induced by intra-operative maneuvers, 3 cases of embolism after operation and a single case of 'microembolism'. Seven cases could not be classified into any of these categories. Duration of ECC was 169.9 {plus minus} 48.5 min on the average in patients with such brain damages as SDH, ICH, SAH and cardiogenic embolism, which were thought not to be related with ECC. On the other hand, that of the patients hypotensive ischemia or 'microembolism' gave an average value of 254.5 {plus minus} 96.8 min. And these patients were thought to have occurred during ECC. There was a statistically significant difference between these two mean values. (J.P.N.).

Diabetes Nutrition: Including Sweets in Your Meal Plan

Science.gov (United States)

Diabetes nutrition: Including sweets in your meal plan Diabetes nutrition focuses on healthy foods, but sweets aren't necessarily ... your meal plan. By Mayo Clinic Staff Diabetes nutrition focuses on healthy foods. But you can eat ...

Defining robustness protocols: a method to include and evaluate robustness in clinical plans

International Nuclear Information System (INIS)

McGowan, S E; Albertini, F; Lomax, A J; Thomas, S J

2015-01-01

We aim to define a site-specific robustness protocol to be used during the clinical plan evaluation process. Plan robustness of 16 skull base IMPT plans to systematic range and random set-up errors have been retrospectively and systematically analysed. This was determined by calculating the error-bar dose distribution (ebDD) for all the plans and by defining some metrics used to define protocols aiding the plan assessment. Additionally, an example of how to clinically use the defined robustness database is given whereby a plan with sub-optimal brainstem robustness was identified. The advantage of using different beam arrangements to improve the plan robustness was analysed. Using the ebDD it was found range errors had a smaller effect on dose distribution than the corresponding set-up error in a single fraction, and that organs at risk were most robust to the range errors, whereas the target was more robust to set-up errors. A database was created to aid planners in terms of plan robustness aims in these volumes. This resulted in the definition of site-specific robustness protocols. The use of robustness constraints allowed for the identification of a specific patient that may have benefited from a treatment of greater individuality. A new beam arrangement showed to be preferential when balancing conformality and robustness for this case. The ebDD and error-bar volume histogram proved effective in analysing plan robustness. The process of retrospective analysis could be used to establish site-specific robustness planning protocols in proton therapy. These protocols allow the planner to determine plans that, although delivering a dosimetrically adequate dose distribution, have resulted in sub-optimal robustness to these uncertainties. For these cases the use of different beam start conditions may improve the plan robustness to set-up and range uncertainties. (paper)

Defining robustness protocols: a method to include and evaluate robustness in clinical plans

Science.gov (United States)

McGowan, S. E.; Albertini, F.; Thomas, S. J.; Lomax, A. J.

2015-04-01

We aim to define a site-specific robustness protocol to be used during the clinical plan evaluation process. Plan robustness of 16 skull base IMPT plans to systematic range and random set-up errors have been retrospectively and systematically analysed. This was determined by calculating the error-bar dose distribution (ebDD) for all the plans and by defining some metrics used to define protocols aiding the plan assessment. Additionally, an example of how to clinically use the defined robustness database is given whereby a plan with sub-optimal brainstem robustness was identified. The advantage of using different beam arrangements to improve the plan robustness was analysed. Using the ebDD it was found range errors had a smaller effect on dose distribution than the corresponding set-up error in a single fraction, and that organs at risk were most robust to the range errors, whereas the target was more robust to set-up errors. A database was created to aid planners in terms of plan robustness aims in these volumes. This resulted in the definition of site-specific robustness protocols. The use of robustness constraints allowed for the identification of a specific patient that may have benefited from a treatment of greater individuality. A new beam arrangement showed to be preferential when balancing conformality and robustness for this case. The ebDD and error-bar volume histogram proved effective in analysing plan robustness. The process of retrospective analysis could be used to establish site-specific robustness planning protocols in proton therapy. These protocols allow the planner to determine plans that, although delivering a dosimetrically adequate dose distribution, have resulted in sub-optimal robustness to these uncertainties. For these cases the use of different beam start conditions may improve the plan robustness to set-up and range uncertainties.

Genotypic and phenotypic diversity of Ralstonia pickettii and Ralstonia insidiosa isolates from clinical and environmental sources including High-purity Water.

LENUS (Irish Health Repository)

Ryan, Michael P

2011-08-30

Abstract Background Ralstonia pickettii is a nosocomial infectious agent and a significant industrial contaminant. It has been found in many different environments including clinical situations, soil and industrial High Purity Water. This study compares the phenotypic and genotypic diversity of a selection of strains of Ralstonia collected from a variety of sources. Results Ralstonia isolates (fifty-nine) from clinical, industrial and environmental origins were compared genotypically using i) Species-specific-PCR, ii) PCR and sequencing of the 16S-23S rRNA Interspatial region (ISR) iii) the fliC gene genes, iv) RAPD and BOX-PCR and v) phenotypically using biochemical testing. The species specific-PCR identified fifteen out of fifty-nine designated R. pickettii isolates as actually being the closely related species R. insidiosa. PCR-ribotyping of the 16S-23S rRNA ISR indicated few major differences between the isolates. Analysis of all isolates demonstrated different banding patterns for both the RAPD and BOX primers however these were found not to vary significantly. Conclusions R. pickettii species isolated from wide geographic and environmental sources appear to be reasonably homogenous based on genotypic and phenotypic characteristics. R. insidiosa can at present only be distinguished from R. pickettii using species specific PCR. R. pickettii and R. insidiosa isolates do not differ significantly phenotypically or genotypically based on environmental or geographical origin.

Clinical efficacy of including capecitabine in neoadjuvant chemotherapy for breast cancer: a systematic review and meta-analysis of randomized controlled trials.

Directory of Open Access Journals (Sweden)

Qiuyun Li

Full Text Available BACKGROUND: Capecitabine has proven effective as a chemotherapy for metastatic breast cancer. Though several Phase II/III studies of capecitabine as neoadjuvant chemotherapy have been conducted, the results still remain inconsistent. Therefore, we performed a meta-analysis to obtain more precise understanding of the role of capecitabine in neoadjuvant chemotherapy for breast cancer patients. METHODS: The electronic database PubMed and online abstracts from ASCO and SABCS were searched to identify randomized clinical trials comparing neoadjuvant chemotherapy with or without capecitabine in early/operable breast cancer patients without distant metastasis. Risk ratios were used to estimate the association between capecitabine in neoadjuvant chemotherapy and various efficacy outcomes. Fixed- or random-effect models were adopted to pool data in RevMan 5.1. RESULTS: Five studies were included in the meta-analysis. Neoadjuvant use of capecitabine with anthracycline and/or taxane based therapy was not associated with significant improvement in clinical outcomes including: pathologic complete response in breast (pCR; RR = 1.10, 95% CI 0.87-1.40, p = 0.43, pCR in breast tumor and nodes (tnpCR RR = 0.99, 95% CI 0.83-1.18, p = 0.90, overall response rate (ORR; RR = 1.00, 95% CI 0.94-1.07, p = 0.93, or breast-conserving surgery (BCS; RR = 0.98, 95% CI 0.93-1.04, p = 0.49. CONCLUSIONS: Neoadjuvant treatment of breast cancer involving capecitabine did not significantly improve pCR, tnpCR, BCS or ORR. Thus adding capecitabine to neoadjuvant chemotherapy regimes is unlikely to improve outcomes in breast cancer patients without distant metastasis. Further research is required to establish the condition that capecitabine may be useful in breast cancer neoadjuvant chemotherapy.

Optimal use of MRI in clinical trials, clinical care and clinical registries of patients with rheumatoid arthritis

DEFF Research Database (Denmark)

Østergaard, Mikkel; Møller-Bisgaard, Signe

2014-01-01

the benefits of including MRI in treat-to-target strategies. The benefits of incorporating MRI into clinical registries are not yet known, but may include improved knowledge about the real-life advantages of MRI, as well as opportunities to develop better clinical and laboratory composite measures to monitor......Magnetic resonance imaging (MRI) clearly is more sensitive than clinical examination and conventional radiography (x-ray) for detection of inflammation (synovitis, bone marrow oedema (osteitis) and tenosynovitis) and damage (bone erosion and cartilage loss/joint space narrowing) in patients...... with rheumatoid arthritis (RA). The question is when and how MRI should be used. The present article reviews our knowledge about, and provides suggestions for, the use of MRI in clinical trials, clinical care and clinical registries. In clinical trials, the OMERACT RA MRI scoring system (RAMRIS) is a thoroughly...

Important clinical descriptors to include in the examination and assessment of patients with femoroacetabular impingement syndrome

DEFF Research Database (Denmark)

Reiman, M P; Thorborg, K; Covington, K

2017-01-01

PURPOSE: Determine which examination findings are key clinical descriptors of femoroacetabular impingement syndrome (FAIS) through use of an international, multi-disciplinary expert panel. METHODS: A three-round Delphi survey utilizing an international, multi-disciplinary expert panel operationally...

Occurance of Staphylococcus nepalensis strains in different sources including human clinical material.

Science.gov (United States)

Nováková, Dana; Pantůcek, Roman; Petrás, Petr; Koukalová, Dagmar; Sedlácek, Ivo

2006-10-01

Five isolates of coagulase-negative staphylococci were obtained from human urine, the gastrointestinal tract of squirrel monkeys, pig skin and from the environment. All key biochemical characteristics of the tested strains corresponded with the description of Staphylococcus xylosus species. However, partial 16S rRNA gene sequences obtained from analysed strains corresponded with those of Staphylococcus nepalensis reference strains, except for two strains which differed in one residue. Ribotyping with EcoRI and HindIII restriction enzymes, whole cell protein profile analysis performed by SDS-PAGE and SmaI macrorestriction analysis were used for more precise characterization and identification of the analysed strains. Obtained results showed that EcoRI and HindIII ribotyping and whole cell protein fingerprinting are suitable and reliable methods for the differentiation of S. nepalensis strains from the other novobiocin resistant staphylococci, whereas macrorestriction analysis was found to be a good tool for strain typing. The isolation of S. nepalensis is sporadic, and according to our best knowledge this study is the first report of the occurrence of this species in human clinical material as well as in other sources.

Clinical professional governance for detailed clinical models.

Science.gov (United States)

Goossen, William; Goossen-Baremans, Anneke

2013-01-01

This chapter describes the need for Detailed Clinical Models for contemporary Electronic Health Systems, data exchange and data reuse. It starts with an explanation of the components related to Detailed Clinical Models with a brief summary of knowledge representation, including terminologies representing clinic relevant "things" in the real world, and information models that abstract these in order to let computers process data about these things. Next, Detailed Clinical Models are defined and their purpose is described. It builds on existing developments around the world and accumulates in current work to create a technical specification at the level of the International Standards Organization. The core components of properly expressed Detailed Clinical Models are illustrated, including clinical knowledge and context, data element specification, code bindings to terminologies and meta-information about authors, versioning among others. Detailed Clinical Models to date are heavily based on user requirements and specify the conceptual and logical levels of modelling. It is not precise enough for specific implementations, which requires an additional step. However, this allows Detailed Clinical Models to serve as specifications for many different kinds of implementations. Examples of Detailed Clinical Models are presented both in text and in Unified Modelling Language. Detailed Clinical Models can be positioned in health information architectures, where they serve at the most detailed granular level. The chapter ends with examples of projects that create and deploy Detailed Clinical Models. All have in common that they can often reuse materials from earlier projects, and that strict governance of these models is essential to use them safely in health care information and communication technology. Clinical validation is one point of such governance, and model testing another. The Plan Do Check Act cycle can be applied for governance of Detailed Clinical Models

Molt performance and bone density of cortical, medullary, and cancellous bone in laying hens during feed restriction or alfalfa-based feed molt.

Science.gov (United States)

Kim, W K; Donalson, L M; Bloomfield, S A; Hogan, H A; Kubena, L F; Nisbet, D J; Ricke, S C

2007-09-01

A study was conducted to evaluate the effects of alfalfa-based molt diets on molting performance and bone qualities. A total of 36 Single Comb White Leghorn hens were used for the study. There were 6 treatments: pretrial control (PC), fully fed (FF), feed withdrawal (FW), 90% alfalfa:10% layer ration (A90), 80% alfalfa:20% layer ration (A80), and 70% alfalfa:30% layer ration (A70). For the PC treatment, hens were euthanized by CO(2) gas, and bones were collected before molt was initiated. At the end of the 9-d molt period, hens were euthanized, and femurs and tibias were collected to evaluate bone qualities by peripheral quantitative computed tomography, mechanical testing, and conventional ash weights. The hens fed alfalfa-based molt diets and FW stopped laying eggs within 5 d after molt started, and all hens in these groups had reduced ovary weights compared with those of the FF hens. In the FW and A90 groups, total femur volumetric bone mineral densities (vBMD) at the midshaft were significantly lower, but those of the A80 and A70 groups were not significantly different from the values for the PC and FF hens. In cortical bone density, the midshaft tibial vBMD were significantly higher for FF and A70 hens than for PC hens. The medullary bone densities at the midshaft femur or tibia of the FW, A90, A80, and A70 hens were reduced compared with those of the PC hens. Femur cancellous densities at the distal femur for the FW and A90 hens were significantly reduced compared with those of the PC and FF hens. The FW, A80, and A70 hens yielded significantly higher elastic moduli, and the A80 hens had higher ultimate stress compared with the PC hens, suggesting that the mechanical integrity of the midshaft bone was maintained even though the medullary vBMD was reduced. These results suggest that alfalfa-based molt diets exhibit molt performance similar to FW, that medullary and cancellous bones are labile bone compartments during molting, and that alfalfa-based molt diets

Clinical Immunology Review Series: an approach to the patient with recurrent orogenital ulceration, including Behçet's syndrome.

LENUS (Irish Health Repository)

Keogan, M T

2009-04-01

Patients presenting with recurrent orogenital ulcers may have complex aphthosis, Behçet\\'s disease, secondary complex aphthosis (e.g. Reiter\\'s syndrome, Crohn\\'s disease, cyclical neutropenia) or non-aphthous disease (including bullous disorders, erythema multiforme, erosive lichen planus). Behçet\\'s syndrome is a multi-system vasculitis of unknown aetiology for which there is no diagnostic test. Diagnosis is based on agreed clinical criteria that require recurrent oral ulcers and two of the following: recurrent genital ulcers, ocular inflammation, defined skin lesions and pathergy. The condition can present with a variety of symptoms, hence a high index of suspicion is necessary. The most common presentation is with recurrent mouth ulcers, often with genital ulcers; however, it may take some years before diagnostic criteria are met. All patients with idiopathic orogenital ulcers should be kept under review, with periodic focused assessment to detect evolution into Behçet\\'s disease. There is often a delay of several years between patients fulfilling diagnostic criteria and a diagnosis being made, which may contribute to the morbidity of this condition. Despite considerable research effort, the aetiology and pathogenesis of this condition remains enigmatic.

The effects of once-weekly teriparatide on hip structure and biomechanical properties assessed by CT

OpenAIRE

Ito, M.; Oishi, R.; Fukunaga, M.; Sone, T.; Sugimoto, T.; Shiraki, M.; Nishizawa, Y.; Nakamura, T.

2013-01-01

Summary Once-weekly administration of 56.5 μg teriparatide improved cortical bone parameters and biomechanical parameters at the proximal femur by CT geometry analysis. Introduction The aim of this study was to evaluate the effects of weekly administration of teriparatide [human PTH (1–34)] on bone geometry, volumetric bone mineral density (vBMD), and parameters of bone strength at the proximal femur which were longitudinally investigated using computed tomography (CT). Methods The subjects w...

Dataset for Phase I randomized clinical trial for safety and tolerability of GET 73 in single and repeated ascending doses including preliminary pharmacokinetic parameters.

Science.gov (United States)

Haass-Koffler, Carolina L; Goodyear, Kimberly; Long, Victoria M; Tran, Harrison H; Loche, Antonella; Cacciaglia, Roberto; Swift, Robert M; Leggio, Lorenzo

2017-12-01

The data in this article outline the methods used for the administration of GET 73 in the first time-in-human manuscript entitled "Phase I randomized clinical trial for the safety, tolerability and preliminary pharmacokinetics of the mGluR5 negative allosteric modulator GET 73 following single and repeated doses in healthy male volunteers" (Haass-Koffler et al., 2017) [1]. Data sets are provided in two different manners. The first series of tables provided includes procedural information about the experiments conducted. The next series of tables provided includes Pharmacokinetic (PK) parameters for GET 73 and its main metabolite MET 2. This set of data is comprised by two experiments: Experiment 1 references a single ascending dose administration of GET 73 and Experiment 2 references a repeated ascending dose administration of GET 73.

The DSM-5 Dimensional Anxiety Scales in a Dutch non-clinical sample: psychometric properties including the adult separation anxiety disorder scale.

Science.gov (United States)

Möller, Eline L; Bögels, Susan M

2016-09-01

With DSM-5, the American Psychiatric Association encourages complementing categorical diagnoses with dimensional severity ratings. We therefore examined the psychometric properties of the DSM-5 Dimensional Anxiety Scales, a set of brief dimensional scales that are consistent in content and structure and assess DSM-5-based core features of anxiety disorders. Participants (285 males, 255 females) completed the DSM-5 Dimensional Anxiety Scales for social anxiety disorder, generalized anxiety disorder, specific phobia, agoraphobia, and panic disorder that were included in previous studies on the scales, and also for separation anxiety disorder, which is included in the DSM-5 chapter on anxiety disorders. Moreover, they completed the Screen for Child Anxiety Related Emotional Disorders Adult version (SCARED-A). The DSM-5 Dimensional Anxiety Scales demonstrated high internal consistency, and the scales correlated significantly and substantially with corresponding SCARED-A subscales, supporting convergent validity. Separation anxiety appeared present among adults, supporting the DSM-5 recognition of separation anxiety as an anxiety disorder across the life span. To conclude, the DSM-5 Dimensional Anxiety Scales are a valuable tool to screen for specific adult anxiety disorders, including separation anxiety. Research in more diverse and clinical samples with anxiety disorders is needed. © 2016 The Authors International Journal of Methods in Psychiatric Research Published by John Wiley & Sons Ltd. © 2016 The Authors International Journal of Methods in Psychiatric Research Published by John Wiley & Sons Ltd.

Clinical Trials

Medline Plus

Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... include factors such as a patient's age and gender, the type and stage of disease, and whether ...

Bone geometry, strength, and muscle size in runners with a history of stress fracture.

Science.gov (United States)

Popp, Kristin L; Hughes, Julie M; Smock, Amanda J; Novotny, Susan A; Stovitz, Steven D; Koehler, Scott M; Petit, Moira A

2009-12-01

Our primary aim was to explore differences in estimates of tibial bone strength, in female runners with and without a history of stress fractures. Our secondary aim was to explore differences in bone geometry, volumetric density, and muscle size that may explain bone strength outcomes. A total of 39 competitive distance runners aged 18-35 yr, with (SFX, n = 19) or without (NSFX, n = 20) a history of stress fracture were recruited for this cross-sectional study. Peripheral quantitative computed tomography (XCT 3000; Orthometrix, White Plains, NY) was used to assess volumetric bone mineral density (vBMD, mg x mm(-3)), bone area (ToA, mm(2)), and estimated compressive bone strength (bone strength index (BSI) = ToA x total volumetric density (ToD(2))) at the distal tibia (4%). Total (ToA, mm(2)) and cortical (CoA, mm(2)) bone area, cortical vBMD, and estimated bending strength (strength-strain index (SSIp), mm(3)) were measured at the 15%, 25%, 33%, 45%, 50%, and 66% sites. Muscle cross-sectional area (MCSA) was measured at the 50% and 66% sites. Participants in the SFX group had significantly smaller (7%-8%) CoA at the 45%, 50%, and 66% sites (P stress fracture. However, the lower strength was appropriate for the smaller muscle size, suggesting that interventions to reduce stress fracture risk might be aimed at improving muscle size and strength.

Clinical Trials

Medline Plus

Full Text Available ... organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ...

Clinical Trials

Medline Plus

Full Text Available ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ... U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers ( ...

Intracellular activity of clinical concentrations of phenothiazines including thioridiazine against phagocytosed Staphylococcus aureus.

Science.gov (United States)

Ordway, Diane; Viveiros, Miguel; Leandro, Clara; Arroz, Maria Jorge; Amaral, Leonard

2002-07-01

The effect of thioridazine (TZ) was studied on the killing activity of human peripheral blood monocyte derived macrophages (HPBMDM) and of human macrophage cell line THP-1 at extracellular concentrations below those achievable clinically. These macrophages have nominal killing activity against bacteria and therefore, would not influence any activity that the compounds may have against intracellular localised Staphylococcus aureus. The results indicated that whereas TZ has an in vitro minimum inhibitory concentration (MIC) against the strains of S. aureus of 18, 0.1 mg/l of TZ in the medium completely inhibits the growth of S. aureus that has been phagocytosed by macrophages. The latter concentration was non-toxic to macrophages, did not cause cellular expression of activation marker CD69 nor induction of CD3+ T cell production of IFN-gamma, but blocked cellular proliferation and down-regulated the production of T cell-derived cytokines (IFN-gamma, IL-5). These results suggest that TZ induces intracellular bactericidal activities independent of the capacity to generate Type 1 responses against S. aureus.

The selective treatment of clinical mastitis based on on-farm culture results: II. Effects on lactation performance, including clinical mastitis recurrence, somatic cell count, milk production, and cow survival.

Science.gov (United States)

Lago, A; Godden, S M; Bey, R; Ruegg, P L; Leslie, K

2011-09-01

The objective of this multi-state, multi-herd clinical trial was to report on the efficacy of using an on-farm culture system to guide strategic treatment decisions in cows with clinical mastitis. The study was conducted in 8 commercial dairy farms ranging in size from 144 to 1,795 cows from Minnesota, Wisconsin, and Ontario, Canada. A total of 422 cows affected with mild or moderate clinical mastitis in 449 quarters were randomly assigned to either (1) a positive-control treatment program or (2) an on-farm culture-based treatment program. Quarter cases assigned to the positive-control group received immediate on-label intramammary treatment with cephapirin sodium. Quarters assigned to the culture-based treatment program were not treated until the results of on-farm culture were determined after 18 to 24h of incubation. Quarters in the culture-based treatment program that had gram-positive growth or a mixed infection were treated according to label instruction using intramammary cephapirin sodium. Quarters assigned to the culture-based treatment program that had gram-negative or no-growth did not receive intramammary therapy. It was already reported in a companion paper that the selective treatment of clinical mastitis based on on-farm culture results decreases antibiotic use by half and tends to decrease milk withholding time without affecting short-term clinical and bacteriological outcomes. The present article reports on long-term outcomes of the aforementioned study. No statistically significant differences existed between cases assigned to the positive-control program and cases assigned to the culture-based treatment program in risk and days for recurrence of clinical mastitis in the same quarter (35% and 78 d vs. 43% and 82 d), linear somatic cell count (4.2 vs. 4.4), daily milk production (30.0 vs. 30.7 kg), and risk and days for culling or death events (28% and 160 d vs. 32% and 137 d) for the rest of the lactation after enrollment of the clinical mastitis

Clinical proteomics

DEFF Research Database (Denmark)

Albrethsen, Jakob; Frederiksen, Hanne; Johannsen, Trine Holm

2018-01-01

Clinical proteomics aims to deliver cost-effective multiplexing of potentially hundreds of diagnostic proteins, including distinct protein isoforms. The analytical strategy known as targeted proteomics is particularly promising because it is compatible with robust mass spectrometry (MS)-platforms...... standards and calibrants. The present challenge is to examine if targeted proteomics of IGF-I can truly measure up to the routine performance that must be expected from a clinical testing platform.......Clinical proteomics aims to deliver cost-effective multiplexing of potentially hundreds of diagnostic proteins, including distinct protein isoforms. The analytical strategy known as targeted proteomics is particularly promising because it is compatible with robust mass spectrometry (MS......)-platforms already implemented in many clinical laboratories for routine quantitation of small molecules (i.e. uHPLC coupled to triple-quadrupole MS). Progress in targeted proteomics of circulating insulin-like growth factor 1 (IGF-I) have provided valuable insights about tryptic peptides, transitions, internal...

The clinical obesity maintenance model: an integration of psychological constructs including mood, emotional regulation, disordered overeating, habitual cluster behaviours, health literacy and cognitive function.

Science.gov (United States)

Raman, Jayanthi; Smith, Evelyn; Hay, Phillipa

2013-01-01

Psychological distress and deficits in executive functioning are likely to be important barriers to effective weight loss maintenance. The purpose of this paper is twofold. First, in the light of recent evidence in the fields of neuropsychology and obesity, particularly on the deficits in the executive function in overweight and obese individuals, a conceptual and theoretical framework of obesity maintenance is introduced by way of a clinical obesity maintenance model (COMM). It is argued that psychological variables, that of habitual cluster Behaviors, emotional dysregulation, mood, and health literacy, interact with executive functioning and impact on the overeating/binge eating behaviors of obese individuals. Second, cognizant of this model, it is argued that the focus of obesity management should be extended to include a broader range of maintaining mechanisms, including but not limited to cognitive deficits. Finally, a discussion on potential future directions in research and practice using the COMM is provided.

In vitro activity of Inula helenium against clinical Staphylococcus aureus strains including MRSA.

LENUS (Irish Health Repository)

O'Shea, S

2009-01-01

The present study aims to investigate the bactericidal activity (specifically antistaphylococcal) of Inula helenium. The antimicrobial activity of the extract is tested against 200 clinically significant Irish Staphylococcus aureus isolates consisting of methicillin-resistant (MRSA) and -sensitive (MSSA) S. aureus using a drop test method and a microbroth dilution method. The antibacterial effect is evaluated by measuring the area of the inhibition zone against the isolates. Results proved I. helenium to be 100% effective against the 200 staphylococci tested, with 93% of isolates falling within the ++ and +++ groups. The minimum bactericidal concentration of I. helenium was examined on a subset of isolates and values ranged from 0.9 mg\\/mL to 9.0 mg\\/mL. The extract was equally effective against antibiotic-resistant and -sensitive strains. This plant therefore possesses compounds with potent antistaphylococcal properties, which in the future could be used to complement infection control policies and prevent staphylococcal infection and carriage. This research supports other studies wherein herbal plants exhibiting medicinal properties are being examined to overcome the problems of antibiotic resistance and to offer alternatives in the treatment and control of infectious diseases.

Accelerated Evolution in Distinctive Species Reveals Candidate Elements for Clinically Relevant Traits, Including Mutation and Cancer Resistance.

Science.gov (United States)

Ferris, Elliott; Abegglen, Lisa M; Schiffman, Joshua D; Gregg, Christopher

2018-03-06

The identity of most functional elements in the mammalian genome and the phenotypes they impact are unclear. Here, we perform a genome-wide comparative analysis of patterns of accelerated evolution in species with highly distinctive traits to discover candidate functional elements for clinically important phenotypes. We identify accelerated regions (ARs) in the elephant, hibernating bat, orca, dolphin, naked mole rat, and thirteen-lined ground squirrel lineages in mammalian conserved regions, uncovering ∼33,000 elements that bind hundreds of different regulatory proteins in humans and mice. ARs in the elephant, the largest land mammal, are uniquely enriched near elephant DNA damage response genes. The genomic hotspot for elephant ARs is the E3 ligase subunit of the Fanconi anemia complex, a master regulator of DNA repair. Additionally, ARs in the six species are associated with specific human clinical phenotypes that have apparent concordance with overt traits in each species. Copyright © 2018 The Author(s). Published by Elsevier Inc. All rights reserved.

Accelerated Evolution in Distinctive Species Reveals Candidate Elements for Clinically Relevant Traits, Including Mutation and Cancer Resistance

Directory of Open Access Journals (Sweden)

Elliott Ferris

2018-03-01

Full Text Available The identity of most functional elements in the mammalian genome and the phenotypes they impact are unclear. Here, we perform a genome-wide comparative analysis of patterns of accelerated evolution in species with highly distinctive traits to discover candidate functional elements for clinically important phenotypes. We identify accelerated regions (ARs in the elephant, hibernating bat, orca, dolphin, naked mole rat, and thirteen-lined ground squirrel lineages in mammalian conserved regions, uncovering ∼33,000 elements that bind hundreds of different regulatory proteins in humans and mice. ARs in the elephant, the largest land mammal, are uniquely enriched near elephant DNA damage response genes. The genomic hotspot for elephant ARs is the E3 ligase subunit of the Fanconi anemia complex, a master regulator of DNA repair. Additionally, ARs in the six species are associated with specific human clinical phenotypes that have apparent concordance with overt traits in each species.

The Clinical Obesity Maintenance Model: An Integration of Psychological Constructs including Mood, Emotional Regulation, Disordered Overeating, Habitual Cluster Behaviours, Health Literacy and Cognitive Function

Directory of Open Access Journals (Sweden)

Jayanthi Raman

2013-01-01

Full Text Available Psychological distress and deficits in executive functioning are likely to be important barriers to effective weight loss maintenance. The purpose of this paper is twofold. First, in the light of recent evidence in the fields of neuropsychology and obesity, particularly on the deficits in the executive function in overweight and obese individuals, a conceptual and theoretical framework of obesity maintenance is introduced by way of a clinical obesity maintenance model (COMM. It is argued that psychological variables, that of habitual cluster Behaviors, emotional dysregulation, mood, and health literacy, interact with executive functioning and impact on the overeating/binge eating behaviors of obese individuals. Second, cognizant of this model, it is argued that the focus of obesity management should be extended to include a broader range of maintaining mechanisms, including but not limited to cognitive deficits. Finally, a discussion on potential future directions in research and practice using the COMM is provided.

Dataset for Phase I randomized clinical trial for safety and tolerability of GET 73 in single and repeated ascending doses including preliminary pharmacokinetic parameters

Directory of Open Access Journals (Sweden)

Carolina L. Haass-Koffler

2017-12-01

Full Text Available The data in this article outline the methods used for the administration of GET 73 in the first time-in-human manuscript entitled “Phase I randomized clinical trial for the safety, tolerability and preliminary pharmacokinetics of the mGluR5 negative allosteric modulator GET 73 following single and repeated doses in healthy male volunteers” (Haass-Koffler et al., 2017 [1]. Data sets are provided in two different manners. The first series of tables provided includes procedural information about the experiments conducted. The next series of tables provided includes Pharmacokinetic (PK parameters for GET 73 and its main metabolite MET 2. This set of data is comprised by two experiments: Experiment 1 references a single ascending dose administration of GET 73 and Experiment 2 references a repeated ascending dose administration of GET 73. Keywords: Glutamate receptor subtype 5 (mGlu5, Allosteric modulator, GET 73, Safety, Tolerability

Intralesional immunotherapy with tuberculin purified protein derivative (PPD) in recalcitrant wart: A randomized, placebo-controlled, double-blind clinical trial including an extra group of candidates for cryotherapy.

Science.gov (United States)

Amirnia, Mehdi; Khodaeiani, Effat; Fouladi, Daniel F; Masoudnia, Sima

2016-01-01

Due to paucity of randomized clinical trials, intralesional immunotherapy has not been yet accepted as a standard therapeutic method. To examine the efficacy and safety of intralesional immunotherapy with tuberculin purified protein derivative (PPD) for treating recalcitrant wart. In this randomized, placebo-controlled, double-blind clinical trial, a total of 69 patients with recalcitrant warts received either intralesional PPD antigen (n = 35) or intralesional saline (n = 34) for six times at 2-week intervals. A third group of candidates for cryotherapy (n = 33) was also included. The decrease in lesion size (good: complete response, intermediate: 50-99% improvement, poor: PPD patients; 0%, 14.7% and 85.3% of the placebo patients and 18.2%, 33.3% and 48.5% of the cryotherapy patients, respectively (PPD versus placebo: p PPD versus cryotherapy: p PPD group. The recurrence rate was 8.6%, 5.9% and 24.2% in the PPD, placebo and cryotherapy groups, respectively (p > 0.05). Intralesional immunotherapy with PPD antigen is highly effective and safe for treating recalcitrant warts. IRCT201407089844N3 in the Iranian Registry of Clinical Trials (IRCT).

Clinical Trials

Medline Plus

Full Text Available ... including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study explored ... risks. Other examples of clinical trials that test principles or strategies include studies that explore whether surgery ...

Managing clinical education through understanding key principles.

Science.gov (United States)

Cunningham, Joanne; Wright, Caroline; Baird, Marilyn

2015-01-01

Traditionally, a practicum facilitated the integration of on-campus learning and practical workplace training. Over the past 3 decades, an educative practicum has evolved that promotes clinical reasoning, including analytical and evaluative abilities, through reflective practice. Anecdotal evidence indicates that the delivery of clinical education within medical radiation science entry-level programs continues to vacillate between traditional practicums and the new reflective practicums. To review the literature about clinical education within the medical radiation sciences and identify key principles for practitioners seeking to reflect upon and improve their approach to teaching and supporting students in the clinical environment. A search of 3 major journal databases, Internet searches, and hand searches of reference lists were conducted to identify literature about clinical education in the medical radiation sciences from January 1, 2000, to December 31, 2012. Twenty-two studies were included in this review. The 5 key elements associated with clinical education include the clinical support model and quality, overcoming the theory-practice gap, learning outcomes and reliable and valid assessment, preparing and supporting students, and accommodating differing teaching and learning needs. Many factors influence the quality of clinical education, including the culture of the clinical environment and clinical leadership roles. Several approaches can help students bridge the theory-practice gap, including simulators, role-playing activities, and reflective journals. In addition, clinical educators should use assessment strategies that objectively measure student progress, and they should be positive role models for their students. The successful clinical education of students in the medical radiation sciences depends upon the systems, structures, and people in the clinical environment. Clinical education is accomplished through the collaborative efforts of the

Evaluation and comparison of multiple test methods, including real-time PCR, for Legionella detection in clinical specimens.

Directory of Open Access Journals (Sweden)

Adriana Peci

2016-08-01

Full Text Available Legionella is a gram-negative bacterium that can cause Pontiac fever, a mild upper respiratory infection and Legionnaire’s disease, a more severe illness. We aimed to compare the performance of urine antigen, culture and PCR test methods and to determine if sputum is an alternative to the use of more invasive bronchoalveolar lavage (BAL. Data for this study included specimens tested for Legionella at PHOL from January 1, 2010 to April 30, 2014, as part of routine clinical testing. We found sensitivity of UAT compared to culture to be 87%, specificity 94.7%, positive predictive value (PPV 63.8% and negative predictive value (NPV 98.5%. Sensitivity of UAT compared to PCR was 74.7%, specificity 98.3%, PPV 77.7% and NPV 98.1%. Of 146 patients who had a Legionella positive result by PCR, only 66(45.2% also had a positive result by culture. Sensitivity for culture was the same using either sputum or BAL (13.6%; sensitivity for PCR was 10.3% for sputum and 12.8% for BAL. Both sputum and BAL yield similar results despite testing methods (Fisher Exact p-values=1.0, for each test. In summary, all test methods have inherent weaknesses in identifying Legionella; thereforemore than one testing method should be used. Obtaining a single specimen type from patients with pneumonia limits the ability to diagnose Legionella, particularly when urine is the specimen type submitted. Given ease of collection, and similar sensitivity to BAL, clinicians are encouraged to submit sputum in addition to urine when BAL submission is not practical, from patients being tested for Legionella.

Law No.12.069 clinical analyses laboratories and radiological surgery it state included into retirement rules to workers from particularly establishment

International Nuclear Information System (INIS)

1953-01-01

It is declared understood in the pension laws that manage the Jubilations and Pensions Office of the Industry and Commerce the personnel that has lent or lend services in the Laboratories of Clinical analysis and in clinics radiological matters [es

Clinical Outcomes Used in Clinical Pharmacy Intervention Studies in Secondary Care

Directory of Open Access Journals (Sweden)

Lene Juel Kjeldsen

2017-05-01

Full Text Available The objective was to investigate type, frequency and result of clinical outcomes used in studies to assess the effect of clinical pharmacy interventions in inpatient care. The literature search using Pubmed.gov was performed for the period up to 2013 using the search phrases: “Intervention(s” and “pharmacist(s” and “controlled” and “outcome(s” or “effect(s”. Primary research studies in English of controlled, clinical pharmacy intervention studies, including outcome evaluation, were selected. Titles, abstracts and full-text papers were assessed individually by two reviewers, and inclusion was determined by consensus. In total, 37 publications were included in the review. The publications presented similar intervention elements but differed in study design. A large variety of outcome measures (135 had been used to evaluate the effect of the interventions; most frequently clinical measures/assessments by physician and health care service use. No apparent pattern was established among primary outcome measures with significant effect in favour of the intervention, but positive effect was most frequently related to studies that included power calculations and sufficient inclusion of patients (73% vs. 25%. This review emphasizes the importance of considering the relevance of outcomes selected to assess clinical pharmacy interventions and the importance of conducting a proper power calculation.

Use of an Objective Clinical Examination to Determine Clinical Competence.

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Dupras, Denise M.; Li, James T. C.

1995-01-01

A study investigated performance of 51 second-year internal medicine residents on an objective structured clinical examination and analyzed the test's role in evaluating clinical competence. The examination included nine physical diagnoses and several test-interpretation stations. Performance was analyzed statistically and correlated with…

Clinical Studies

DEFF Research Database (Denmark)

Pallesen, Ulla

universities and practicing dentists restore millions of teeth throughout the World with composite resin materials. Do we know enough about the clinical performance of these restorations over time? Numerous in vitro studies are being published on resin materials and adhesion, some of them attempting to imitate...... in vivo conditions. But real life is different and in vitro studies cannot include all variables. Only clinical studies can provide valid information on the clinical performance of restorations over time. What do we know about longevity of posterior resin restorations? What are the reasons for replacement...... and results from own up to 30-year prospective clinical university studies and practice based studies from Public Dental Health Service on the clinical performance of posterior composite resin restorations....

Evaluation and Comparison of Multiple Test Methods, Including Real-time PCR, for Legionella Detection in Clinical Specimens

Science.gov (United States)

Peci, Adriana; Winter, Anne-Luise; Gubbay, Jonathan B.

2016-01-01

Legionella is a Gram-negative bacterium that can cause Pontiac fever, a mild upper respiratory infection and Legionnaire’s disease, a more severe illness. We aimed to compare the performance of urine antigen, culture, and polymerase chain reaction (PCR) test methods and to determine if sputum is an acceptable alternative to the use of more invasive bronchoalveolar lavage (BAL). Data for this study included specimens tested for Legionella at Public Health Ontario Laboratories from 1st January, 2010 to 30th April, 2014, as part of routine clinical testing. We found sensitivity of urinary antigen test (UAT) compared to culture to be 87%, specificity 94.7%, positive predictive value (PPV) 63.8%, and negative predictive value (NPV) 98.5%. Sensitivity of UAT compared to PCR was 74.7%, specificity 98.3%, PPV 77.7%, and NPV 98.1%. Out of 146 patients who had a Legionella-positive result by PCR, only 66 (45.2%) also had a positive result by culture. Sensitivity for culture was the same using either sputum or BAL (13.6%); sensitivity for PCR was 10.3% for sputum and 12.8% for BAL. Both sputum and BAL yield similar results regardless testing methods (Fisher Exact p-values = 1.0, for each test). In summary, all test methods have inherent weaknesses in identifying Legionella; therefore, more than one testing method should be used. Obtaining a single specimen type from patients with pneumonia limits the ability to diagnose Legionella, particularly when urine is the specimen type submitted. Given ease of collection and similar sensitivity to BAL, clinicians are encouraged to submit sputum in addition to urine when BAL submission is not practical from patients being tested for Legionella. PMID:27630979

Clinical research informatics

CERN Document Server

Richesson, Rachel L

2012-01-01

This book provides foundational coverage of key areas, concepts, constructs, and approaches of medical informatics as it applies to clinical research activities, in both current settings and in light of emerging policies. The field of clinical research is fully characterized (in terms of study design and overarching business processes), and there is emphasis on information management aspects and informatics implications (including needed activities) within various clinical research environments. The purpose of the book is to provide an overview of clinical research (types), activities, and are

Research Areas - Clinical Trials

Science.gov (United States)

Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

Clinical multiphoton tomography and clinical two-photon microendoscopy

Science.gov (United States)

König, Karsten; Bückle, Rainer; Weinigel, Martin; Elsner, Peter; Kaatz, Martin

2009-02-01

We report on applications of high-resolution clinical multiphoton tomography based on the femtosecond laser system DermaInspectTM with its flexible mirror arm in Australia, Asia, and Europe. Applications include early detection of melanoma, in situ tracing of pharmacological and cosmetical compounds including ZnO nanoparticles in the epidermis and upper dermis, the determination of the skin aging index SAAID as well as the study of the effects of anti-aging products. In addition, first clinical studies with novel rigid high-NA two-photon 1.6 mm GRIN microendoscopes have been conducted to study the effect of wound healing in chronic wounds (ulcus ulcera) as well as to perform intrabody imaging with subcellular resolution in small animals.

Clinical Subtypes of Dementia with Lewy Bodies Based on the Initial Clinical Presentation.

Science.gov (United States)

Morenas-Rodríguez, Estrella; Sala, Isabel; Subirana, Andrea; Pascual-Goñi, Elba; Sánchez-Saudinós, MaBelén; Alcolea, Daniel; Illán-Gala, Ignacio; Carmona-Iragui, María; Ribosa-Nogué, Roser; Camacho, Valle; Blesa, Rafael; Fortea, Juan; Lleó, Alberto

2018-06-04

Dementia with Lewy bodies (DLB) is a heterogeneous disease in which clinical presentation, symptoms, and evolution widely varies between patients. To investigate the existence of clinical subtypes in DLB based on the initial clinical presentation. 81 patients with a clinical diagnosis of probable DLB were consecutively included. All patients underwent a neurological evaluation including a structured questionnaire about neuropsychiatric symptoms and sleep, an assessment of motor impairment (Unified Parkinson Disease Rating Scale subscale III), and a formal neuropsychological evaluation. Onset of core symptoms (hallucinations, parkinsonism, and fluctuations) and dementia were systematically reviewed from medical records. We applied a K-means clustering method based on the initial clinical presentation. Cluster analysis yielded three different groups. Patients in cluster I (cognitive-predominant, n = 46) presented more frequently with cognitive symptoms (95.7%, n = 44, p presented more frequently with psychotic symptoms (77.3%, n = 17), and had a shorter duration until the onset of hallucinations (p clinical DLB can be defined when considering the differential initial presentations. The proposed subtypes have distinct clinical profiles and progression patterns.

Effects of genes, sex, age, and activity on BMC, bone size, and areal and volumetric BMD.

Science.gov (United States)

Havill, Lorena M; Mahaney, Michael C; L Binkley, Teresa; Specker, Bonny L

2007-05-01

Quantitative genetic analyses of bone data for 710 inter-related individuals 8-85 yr of age found high heritability estimates for BMC, bone area, and areal and volumetric BMD that varied across bone sites. Activity levels, especially time in moderate plus vigorous activity, had notable effects on bone. In some cases, these effects were age and sex specific. Genetic and environmental factors play a complex role in determining BMC, bone size, and BMD. This study assessed the heritability of bone measures; characterized the effects of age, sex, and physical activity on bone; and tested for age- and sex-specific bone effects of activity. Measures of bone size and areal and volumetric density (aBMD and vBMD, respectively) were obtained by DXA and pQCT on 710 related individuals (466 women) 8-85 yr of age. Measures of activity included percent time in moderate + vigorous activity (%ModVig), stair flights climbed per day, and miles walked per day. Quantitative genetic analyses were conducted to model the effects of activity and covariates on bone outcomes. Accounting for effects of age, sex, and activity levels, genes explained 40-62% of the residual variation in BMC and BMD and 27-75% in bone size (all pBMC and cross-sectional area (CSA) at the 4% radius, but this was not observed among women (sex-by-activity interaction, both p vBMD (Cort-vBMD) than younger men, with minimal difference between low and high activity levels. Influence of activity was greater in older women: older women with low activity had lower Cort-vBMD than older men, but older women with high activity had higher Cort-vBMD than older men (age-by-sex-by-activity interaction, p=0.04). High heritability estimates for DXA and pQCT measures varied across bone sites. Percent time spent in moderate to vigorous activity had the most notable effect on bone, and in some cases, this effect was age or sex specific.

Fermented dairy products consumption is associated with attenuated cortical bone loss independently of total calcium, protein, and energy intakes in healthy postmenopausal women.

Science.gov (United States)

Biver, E; Durosier-Izart, C; Merminod, F; Chevalley, T; van Rietbergen, B; Ferrari, S L; Rizzoli, R

2018-05-03

A longitudinal analysis of bone microstructure in postmenopausal women of the Geneva Retirees Cohort indicates that age-related cortical bone loss is attenuated at non-bearing bone sites in fermented dairy products consumers, not in milk or ripened cheese consumers, independently of total energy, calcium, or protein intakes. Fermented dairy products (FDP), including yogurts, provide calcium, phosphorus, and proteins together with prebiotics and probiotics, all being potentially beneficial for bone. In this prospective cohort study, we investigated whether FDP, milk, or ripened cheese consumptions influence age-related changes of bone mineral density (BMD) and microstructure. Dietary intakes were assessed at baseline and after 3.0 ± 0.5 years with a food frequency questionnaire in 482 postmenopausal women enrolled in the Geneva Retirees Cohort. Cortical (Ct) and trabecular (Tb) volumetric (v) BMD and microstructure at the distal radius and tibia were assessed by high-resolution peripheral quantitative computerized tomography, in addition to areal (a) BMD and body composition by dual-energy X-ray absorptiometry, at the same time points. At baseline, FDP consumers had lower abdominal fat mass and larger bone size at the radius and tibia. Parathyroid hormone and β-carboxyterminal cross-linked telopeptide of type I collagen levels were inversely correlated with FDP consumption. In the longitudinal analysis, FDP consumption (mean of the two assessments) was associated with attenuated loss of radius total vBMD and of Ct vBMD, area, and thickness. There was no difference in aBMD and at the tibia. These associations were independent of total energy, calcium, or protein intakes. For other dairy products categories, only milk consumption was associated with lower decrease of aBMD and of failure load at the radius. In this prospective cohort of healthy postmenopausal women, age-related Ct bone loss was attenuated at non-bearing bone sites in FDP consumers, not in milk

Effect of growth hormone therapy and puberty on bone and body composition in children with idiopathic short stature and growth hormone deficiency.

Science.gov (United States)

Högler, Wolfgang; Briody, Julie; Moore, Bin; Lu, Pei Wen; Cowell, Christopher T

2005-11-01

The state of bone health and the effect of growth hormone (GH) therapy on bone and body composition in children with idiopathic short stature (ISS) are largely unknown. A direct role of GH deficiency (GHD) on bone density is controversial. Using dual-energy X-ray absorptiometry, this study measured total body bone mineral content (TB BMC), body composition, and volumetric bone mineral density (vBMD) at the lumbar spine (LS) and femoral neck (FN) in 77 children (aged 3-17 years) with ISS (n = 57) and GHD (n = 20). Fifty-five children (GHD = 13) receiving GH were followed over 24 months including measurement of bone turnover. At diagnosis, size-corrected TB BMC SDS was greater (P bone relation, as assessed by the BMC/lean mass (LTM) ratio SDS was not different between groups. During GH therapy, prepubertal GHD children gained more height (1.58 [0.9] SDS) and LTM (0.87 [0.63] SDS) compared to prepubertal ISS children (0.75 [0.27] and 0.17 [0.25] SDS, respectively). Percent body fat decreased in GHD (-5.94% [4.29]) but not in ISS children. Total body BMC accrual was less than predicted in all groups accompanied by an increase in bone turnover. Puberty led to the greatest absolute, but not relative, increments in weight, LTM, BMI, bone mass, and LSvBMD. Our results show that children with ISS and GHD differ in their response to GH therapy in anthropometry, body composition, and bone measures. Despite low vBMD values at diagnosis in both prepubertal groups, size-corrected regional or TB bone data were generally within the normal range and did not increase during GH therapy in GHD or ISS children. Growth hormone had great effects on the growth plate and body composition with subsequent gains in height, LTM, bone turnover, and bone mass accrual, but no benefit for volumetric bone density over 2 years.

Maintenance of Clinical Expertise and Clinical Research by the Clinical Professors at Gifu Pharmaceutical University.

Science.gov (United States)

Tachi, Tomoya; Noguchi, Yoshihiro; Teramachi, Hitomi

2017-01-01

The clinical professors at Gifu Pharmaceutical University (GPU) provide pharmaceutical services at GPU Pharmacy, Gifu University Hospital, and Gifu Municipal Hospital to keep their clinical skills up-to-date; they also perform clinical research in collaboration with many clinical institutes. The Laboratory of Clinical Pharmacy is part of the Department of Pharmacy Practice and Science, to which the clinical professors belong, and is composed of three clinical professors (a professor, an associate professor, and an assistant professor). The professor administers the GPU Pharmacy as its director, while the associate professor and assistant professor provide pharmaceutical services to patients at Gifu Municipal Hospital, and also provide practical training for students in the GPU Pharmacy. Collectively, they have performed research on such topics as medication education for students, clinical communication education, and analysis of clinical big data. They have also conducted research in collaboration with clinical institutes, hospitals, and pharmacies. Here, we introduce the collaborative research between the Laboratory of Clinical Pharmacy and Gifu Municipal Hospital. These studies include "Risk factors contributing to urinary protein expression resulting from bevacizumab combination chemotherapy", "Hyponatremia and hypokalemia as risk factors for falls", "Economic evaluation of adjustments of levofloxacin dosage by dispensing pharmacists for patients with renal dysfunction", and "Effect of patient education upon discharge for use of a medication notebook on purchasing over-the-counter drugs and health foods". In this symposium, we would like to demonstrate one model of the association and collaborative research between these clinical professors and clinical institutes.

Advances in Clinical Cardiology 2016: A Summary of the Key Clinical Trials.

Science.gov (United States)

Gray, Alastair; McQuillan, Conor; Menown, Ian B A

2017-07-01

The findings of many new cardiology clinical trials over the last year have been published or presented at major international meetings. This paper aims to describe and place in context a summary of the key clinical trials in cardiology presented between January and December 2016. The authors reviewed clinical trials presented at major cardiology conferences during 2016 including the American College of Cardiology (ACC), European Association for Percutaneous Cardiovascular Interventions (EuroPCR), European Society of Cardiology (ESC), European Association for the Study of Diabetes (EASD), Transcatheter Cardiovascular Therapeutics (TCT), and the American Heart Association (AHA). Selection criteria were trials with a broad relevance to the cardiology community and those with potential to change current practice. A total of 57 key cardiology clinical trials were identified for inclusion. Here we describe and place in clinical context the key findings of new data relating to interventional and structural cardiology including delayed stenting following primary angioplasty, contrast-induced nephropathy, management of jailed wires, optimal duration of dual antiplatelet therapy (DAPT), stenting vs bypass for left main disease, new generation stents (BioFreedom, Orsiro, Absorb), transcatheter aortic valve implantation (Edwards Sapien XT, transcatheter embolic protection), and closure devices (Watchman, Amplatzer). New preventative cardiology data include trials of bariatric surgery, empagliflozin, liraglutide, semaglutide, PCSK9 inhibitors (evolocumab and alirocumab), and inclisiran. Antiplatelet therapy trials include platelet function monitoring and ticagrelor vs clopidogrel for peripheral vascular disease. New data are also presented in fields of heart failure (sacubitril/valsartan, aliskiren, spironolactone), atrial fibrillation (rivaroxaban in patients undergoing coronary intervention, edoxaban in DC cardioversion), cardiac devices (implantable cardioverter

Using the Situated Clinical Decision-Making framework to guide analysis of nurses' clinical decision-making.

Science.gov (United States)

Gillespie, Mary

2010-11-01

Nurses' clinical decision-making is a complex process that holds potential to influence the quality of care provided and patient outcomes. The evolution of nurses' decision-making that occurs with experience has been well documented. In addition, literature includes numerous strategies and approaches purported to support development of nurses' clinical decision-making. There has been, however, significantly less attention given to the process of assessing nurses' clinical decision-making and novice clinical educators are often challenged with knowing how to best support nurses and nursing students in developing their clinical decision-making capacity. The Situated Clinical Decision-Making framework is presented for use by clinical educators: it provides a structured approach to analyzing nursing students' and novice nurses' decision-making in clinical nursing practice, assists educators in identifying specific issues within nurses' clinical decision-making, and guides selection of relevant strategies to support development of clinical decision-making. A series of questions is offered as a guide for clinical educators when assessing nurses' clinical decision-making. The discussion presents key considerations related to analysis of various decision-making components, including common sources of challenge and errors that may occur within nurses' clinical decision-making. An exemplar illustrates use of the framework and guiding questions. Implications of this approach for selection of strategies that support development of clinical decision-making are highlighted. Copyright © 2010 Elsevier Ltd. All rights reserved.

[Data-mining characteristics of adverse drug reactions and pharmacovi-gilance of Chinese patent drugs including Aconitum herbs].

Science.gov (United States)

Zhang, Xiao-Meng; Li, Fan; Zhang, Bing; Chen, Xiao-Fen; Piao, Jing-Zhu

2018-01-01

The common Aconitum herbs in clinical application mainly include Aconiti Radix(Chuanwu), Aconiti Kusnezoffii Radix(Caowu) and Aconiti Lateralis Radix Praeparaia(Fuzi), all of which have toxicity. Therefore, the safety of using Chinese patent drugs including Aconitum herbs has become an hot topic in clinical controversy. Based on the data-mining methods, this study explored the characteristics and causes of adverse drug reactions/events (ADR/ADE) of the Chinese patent drugs including Aconitum, in order to provide pharmacovigilance and rational drug use suggestions for clinical application. The detailed ADR/ADE reports about the Chinese patent drugs including Aconitum herbs were retrieved in the domestic literature databases since 1984 to now. The information extraction and data-mining were conducted based on the platforms of Microsoft office Excel 2016, Clementine 12.0 and Cytoscape 3.3.0. Finally, 78 detailed ADR/ADE reports involving a total of 30 varieties were included. 92.31% ADR/ADE were surely or likely led by the Chinese patent drugs including Aconitum, mostly involving multiple system/organ damages with good prognosis, and even 1 case of death. The incidence of included ADRs/ADEs was associated with various factors such as the patient idiosyncratic, drug toxicity, as well as clinical medication. The patient age was most closely related to ADR/ADEs, and those aged from 60 to 69 were more easily suffered from the ADRs/ADEs of Chinese patent drugs including Aconitum. The probability of ADR/ADEs for the drugs including Chuanwu or Caowu was greater than that of Fuzi, and the using beyond the instructions dose was the most important potential safety hazard in the clinical medication process. For the regular and characteristics of ADR/ADEs led by Chinese patent drugs including Aconitum, special attention shall be paid to the elder patients or with the patients with allergies; strictly control the dosage and course of treatment, strengthen the safety medication

Non-clinical influences on clinical decision-making: a major challenge to evidence-based practice

OpenAIRE

Hajjaj, FM; Salek, MS; Basra, MKA; Finlay, AY

2010-01-01

This article reviews an aspect of daily clinical practice which is of critical importance in virtually every clinical consultation, but which is seldom formally considered. Non-clinical influences on clinical decision-making profoundly affect medical decisions. These influences include patient-related factors such as socioeconomic status, quality of life and patient's expectations and wishes, physician-related factors such as personal characteristics and interaction with their professional co...

77 FR 49449 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

Science.gov (United States)

2012-08-16

... investigator initiated research. Topics for discussion include the following: (1) What FDA Expects in a...] Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...-sponsorship with the Society of Clinical Research Associates (SoCRA) is announcing a public workshop. The...

Clinical leadership in contemporary clinical practice: implications for nursing in Australia.

Science.gov (United States)

Davidson, P M; Elliott, D; Daly, J

2006-04-01

Leadership in the clinical practice environment is important to ensure both optimal patient outcomes and successive generations of motivated and enthusiastic clinicians. The present paper seeks to define and describe clinical leadership and identify the facilitators and barriers to clinical leadership. We also describe strategies to develop clinical leaders in Australia. Key drivers to the development of nursing leaders are strategies that recognize and value clinical expertise. These include models of care that highlight the importance of the nursing role; evidence-based practice and measurement of clinical outcomes; strategies to empower clinicians and mechanisms to ensure participation in clinical decision-making. Significant barriers to clinical leadership are organizational structures that preclude nurses from clinical decision making; the national shortage of nurses; fiscal constraints; absence of well evaluated models of care and trends towards less skilled clinicians. Systematic, strategic initiatives are required to nurture and develop clinical leaders. These strategies need to be collegial collaborations between the academic and health care sectors in order to provide a united voice for advancing the nursing profession.

Decision analysis. Clinical art or Clinical Science

Science.gov (United States)

1977-05-01

having helped some clients. Over the past half century, psychotherapy has faced a series of crises concerned with its transformation from an art to a...clinical science . These include validation of the effectiveness of various forms of therapy, validating elements of treatment programs and

[Support Team for Investigator-Initiated Clinical Research].

Science.gov (United States)

Fujii, Hisako

2017-07-01

Investigator-initiated clinical research is that in which investigators plan and carry out their own clinical research in academia. For large-scale clinical research, a team should be organized and implemented. This team should include investigators and supporting staff, who will promote smooth research performance by fulfilling their respective roles. The supporting staff should include project managers, administrative personnel, billing personnel, data managers, and clinical research coordinators. In this article, I will present the current status of clinical research support and introduce the research organization of the Dominantly Inherited Alzheimer Network (DIAN) study, an investigator-initiated international clinical research study, with particular emphasis on the role of the project management staff and clinical research coordinators.

Evaluating the MEDLINE Core Clinical Journals filter: data-driven evidence assessing clinical utility.

Science.gov (United States)

Klein-Fedyshin, Michele; Ketchum, Andrea M; Arnold, Robert M; Fedyshin, Peter J

2014-12-01

MEDLINE offers the Core Clinical Journals filter to limit to clinically useful journals. To determine its effectiveness for searching and patient-centric decision making, this study compared literature used for Morning Report in Internal Medicine with journals in the filter. An EndNote library with references answering 327 patient-related questions during Morning Report from 2007 to 2012 was exported to a file listing variables including designated Core Clinical Journal, Impact Factor, date used and medical subject. Bradford's law of scattering was applied ranking the journals and reflecting their clinical utility. Recall (sensitivity) and precision of the Core Morning Report journals and non-Core set was calculated. This study applied bibliometrics to compare the 628 articles used against these criteria to determine journals impacting decision making. Analysis shows 30% of clinically used articles are from the Core Clinical Journals filter and 16% of the journals represented are Core titles. When Bradford-ranked, 55% of the top 20 journals are Core. Articles sources used. Among the 63 Morning Report subjects, 55 have <50% precision and 41 have <50% recall including 37 subjects with 0% precision and 0% recall. Low usage of publications within the Core Clinical Journals filter indicates less relevance for hospital-based care. The divergence from high-impact medicine titles suggests clinically valuable journals differ from academically important titles. With few subjects demonstrating high recall or precision, the MEDLINE Core Clinical Journals filter may require a review and update to better align with current clinical needs. © 2014 John Wiley & Sons, Ltd.

Clinical review: Riedel's thyroiditis: a clinical review.

Science.gov (United States)

Hennessey, James V

2011-10-01

Riedel's thyroiditis is a rare inflammatory process involving the thyroid and surrounding cervical tissues and is associated with various forms of systemic fibrosis. Riedel's presentation is complex, including a thyroid mass associated with local symptoms, characteristic biochemical abnormalities such as hypocalcemia and hypothyroidism, as well as the involvement of a wide range of other organ systems. Diagnosis of Riedel's thyroiditis requires histopathological confirmation, but due to high complication rates, the role of surgical intervention is limited to airway decompression and diagnostic tissue retrieval. Unique among processes of the thyroid, Riedel's is commonly treated with long-term antiinflammatory medications to arrest progression and maintain a symptom-free course. Due to its rarity, Riedel's may not be immediately diagnosed, so clinicians benefit from recognizing the constellation of findings that should make prompt diagnosis possible. A review of print and electronic reviews was conducted. Source references were identified, and available literature was reviewed. A search of the PubMed database using the search term "Riedel's thyroiditis" was cross-referenced with associated clinical findings, systemic fibrosis diagnoses, and therapeutic search terms. Because most of the literature consisted of case reports and very small series, inclusion of identified articles was based on clinical descriptions of the subjects included and the criteria for diagnosis reported. More weight was attributed to series, using contemporary criteria for diagnosis. Case reports were included if the diagnosis was clear and clinical presentation was unique to illustrate the spectrum of disease. Because the majority of therapeutic intervention data were based upon case reports and very small series, an evidence-based approach was problematic, but information is presented as objectively and with as much balance as the limited quality of the data allows. Clinical awareness of the

Clinical Trials

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Full Text Available ... and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and ...

Clinical Trials

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Full Text Available ... study explored whether the benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials that test principles or strategies include studies that explore whether ...

A Clinical Evaluation of Definitive and Clinical Allergic Bronchopulmonary Mycosis

OpenAIRE

Matsuse, Hiroto; Nakata, Hiroko; Fukahori, Susumu; Tsuchida, Tomoko; Kawano, Tetsuya; Tomari, Shinya; Fukushima, Chizu; Matsuo, Nobuko; Asai, Sadahiro; Kohno, Shigeru

2006-01-01

Objective: The present study aims to overcome problems associated with the early diagnosis of allergic bronchopulmonary mycosis (ABPM) using the current criteria. Patients and Methods: Clinical features including radiographic findings from 10 patients with definitive ABPM based on the diagnostic criteria of Rosenberg-Patterson were compared with those from 9 patients with ABPM clinically diagnosed by respiratory allergy specialists. Results: ABPM should be considered in patients with peripher...

In Vitro Activity of the New Fluoroketolide Solithromycin (CEM-101) against a Large Collection of Clinical Neisseria gonorrhoeae Isolates and International Reference Strains, Including Those with High-Level Antimicrobial Resistance: Potential Treatment Option for Gonorrhea?

Science.gov (United States)

Golparian, Daniel; Fernandes, Prabhavathi; Ohnishi, Makoto; Jensen, Jörgen S.

2012-01-01

Gonorrhea may become untreatable, and new treatment options are essential. We investigated the in vitro activity of the first fluoroketolide, solithromycin. Clinical Neisseria gonorrhoeae isolates and reference strains (n = 246), including the two extensively drug-resistant strains H041 and F89 and additional isolates with clinical cephalosporin resistance and multidrug resistance, were examined. The activity of solithromycin was mainly superior to that of other antimicrobials (n = 10) currently or previously recommended for gonorrhea treatment. Solithromycin might be an effective treatment option for gonorrhea. PMID:22354296

77 FR 49448 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

Science.gov (United States)

2012-08-16

... include the following: (1) Are We There Yet?; (2) What FDA Expects in a Pharmaceutical Clinical Trial; (3) Medical Device Aspects of Clinical Research; (4) Adverse Event Reporting--Science, Regulation, Error, and...

CAUSES AND CLINICAL CHARACTERISTICS OF CHRONIC COR ...

African Journals Online (AJOL)

hi-tech

2004-04-04

Apr 4, 2004 ... Design: A hospital based cross-sectional study. Setting: Tikur Anbessa ... clinical, chest X-ray and electro-cardio graphic findings were included in the ... had a detailed clinical examination including a history of smoking and ...

Clinical radiology. A textbook including a review manual

International Nuclear Information System (INIS)

Felix, R.; Langer, R.; Langer, M.

1991-01-01

In this textbook, the emphasis is less on conventional X-ray techniques of proven value than on more recently developed methods of medical imaging like computed tomography and magnetic resonance tomography. The strategies currently followed in the initial diagnosis, rather than invariably relying on the X-ray methods of the past, are to an increasing extent based on innovative technologies. A considerable part of the textbook is basically an attempt at surveying the contributions of the individual radiologic and radionuclide methods to the establishment of a firm diagnosis. It is pointed out that one single method may provide just one single piece of information. Pathologic changes often can only be assessed in detail, if the individual results of various tests are assembled to make up a complete picture. A limited range of tools and basic reliance on one method alone may detract from diagnositc accuracy. (orig./MG) With 300 figs., 5 tabs [de

Clinical Trials

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Full Text Available ... offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including ... Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute of Health ...

Clinical Trials

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Full Text Available ... Events About NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory ... offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including ...

The surgery of peripheral nerves (including tumors)

DEFF Research Database (Denmark)

Fugleholm, Kåre

2013-01-01

Surgical pathology of the peripheral nervous system includes traumatic injury, entrapment syndromes, and tumors. The recent significant advances in the understanding of the pathophysiology and cellular biology of peripheral nerve degeneration and regeneration has yet to be translated into improved...... surgical techniques and better outcome after peripheral nerve injury. Decision making in peripheral nerve surgery continues to be a complex challenge, where the mechanism of injury, repeated clinical evaluation, neuroradiological and neurophysiological examination, and detailed knowledge of the peripheral...... nervous system response to injury are prerequisite to obtain the best possible outcome. Surgery continues to be the primary treatment modality for peripheral nerve tumors and advances in adjuvant oncological treatment has improved outcome after malignant peripheral nerve tumors. The present chapter...

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Full Text Available ... organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and ... how you feel. Some people will need to travel or stay in hospitals to take part in ...

Clinical Trials

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Full Text Available ... Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including ... our campus or trials NIH has sponsored at universities, medical centers, and hospitals. ClinicalTrials.gov View a ...

Clinical Trials

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Full Text Available ... groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments ... sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of ...

Clinical Trials

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Full Text Available ... sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and Veterans Affairs; ... age and frequency for doing screening tests, such as mammography; and compare two or more screening tests ...

Clinical Trials

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Full Text Available ... and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense ... FOIA) Accessibility Copyright and Usage No FEAR Act Grants and Funding Building 31 31 Center Drive Bethesda, ...

[The relevance of clinical risk management].

Science.gov (United States)

Gulino, Matteo; Vergallo, Gianluca Montanari; Frati, Paola

2011-01-01

Medical activity includes a risk of possible injury or complications for the patients, that should drive the Health Care Institutions to introduce and/ or improve clinical Risk management instruments. Although Italy is still lacking a National project of Clinical Risk Management, a number of efforts have been made by different Italian Regions to introduce instruments of risk management. In addition, most of National Health Care Institutions include actually a Department specifically in charge to manage the clinical risk. Despite the practical difficulties, the results obtained until now suggest that the risk management may represent a useful instrument to contribute to the reduction of errors in clinical conduct. Indeed, the introduction of adequate instruments of prevention and management of clinical risk may help to ameliorate the quality of health care Institution services.

SNP array analysis reveals novel genomic abnormalities including copy neutral loss of heterozygosity in anaplastic oligodendrogliomas.

Directory of Open Access Journals (Sweden)

Ahmed Idbaih

Full Text Available Anaplastic oligodendrogliomas (AOD are rare glial tumors in adults with relative homogeneous clinical, radiological and histological features at the time of diagnosis but dramatically various clinical courses. Studies have identified several molecular abnormalities with clinical or biological relevance to AOD (e.g. t(1;19(q10;p10, IDH1, IDH2, CIC and FUBP1 mutations.To better characterize the clinical and biological behavior of this tumor type, the creation of a national multicentric network, named "Prise en charge des OLigodendrogliomes Anaplasiques (POLA," has been supported by the Institut National du Cancer (InCA. Newly diagnosed and centrally validated AOD patients and their related biological material (tumor and blood samples were prospectively included in the POLA clinical database and tissue bank, respectively.At the molecular level, we have conducted a high-resolution single nucleotide polymorphism array analysis, which included 83 patients. Despite a careful central pathological review, AOD have been found to exhibit heterogeneous genomic features. A total of 82% of the tumors exhibited a 1p/19q-co-deletion, while 18% harbor a distinct chromosome pattern. Novel focal abnormalities, including homozygously deleted, amplified and disrupted regions, have been identified. Recurring copy neutral losses of heterozygosity (CNLOH inducing the modulation of gene expression have also been discovered. CNLOH in the CDKN2A locus was associated with protein silencing in 1/3 of the cases. In addition, FUBP1 homozygous deletion was detected in one case suggesting a putative tumor suppressor role of FUBP1 in AOD.Our study showed that the genomic and pathological analyses of AOD are synergistic in detecting relevant clinical and biological subgroups of AOD.

Impact of a pain protocol including hypnosis in major burns.

Science.gov (United States)

Berger, Mette M; Davadant, Maryse; Marin, Christian; Wasserfallen, Jean-Blaise; Pinget, Christophe; Maravic, Philippe; Koch, Nathalie; Raffoul, Wassim; Chiolero, René L

2010-08-01

Pain is a major issue after burns even when large doses of opioids are prescribed. The study focused on the impact of a pain protocol using hypnosis on pain intensity, anxiety, clinical course, and costs. All patients admitted to the ICU, aged >18 years, with an ICU stay >24h, accepting to try hypnosis, and treated according to standardized pain protocol were included. Pain was scaled on the Visual Analog Scale (VAS) (mean of daily multiple recordings), and basal and procedural opioid doses were recorded. Clinical outcome and economical data were retrieved from hospital charts and information system, respectively. Treated patients were matched with controls for sex, age, and the burned surface area. Forty patients were admitted from 2006 to 2007: 17 met exclusion criteria, leaving 23 patients, who were matched with 23 historical controls. Altogether patients were 36+/-14 years old and burned 27+/-15%BSA. The first hypnosis session was performed after a median of 9 days. The protocol resulted in the early delivery of higher opioid doses/24h (ppatient. A pain protocol including hypnosis reduced pain intensity, improved opioid efficiency, reduced anxiety, improved wound outcome while reducing costs. The protocol guided use of opioids improved patient care without side effects, while hypnosis had significant psychological benefits.

Reorganizing the General Clinical Research Center to improve the clinical and translational research enterprise.

Science.gov (United States)

Allen, David; Ripley, Elizabeth; Coe, Antoinette; Clore, John

2013-12-01

In 2010, Virginia Commonwealth University (VCU) was granted a Clinical and Translational Science Award which prompted reorganization and expansion of their clinical research infrastructure. A case study approach is used to describe the implementation of a business and cost recovery model for clinical and translational research and the transformation of VCU's General Clinical Research Center and Clinical Trials Office to a combined Clinical Research Services entity. We outline the use of a Plan, Do, Study, Act cycle that facilitated a thoughtful transition process, which included the identification of required changes and cost recovery processes for implementation. Through this process, the VCU Center for Clinical and Translational Research improved efficiency, increased revenue recovered, reduced costs, and brought a high level of fiscal responsibility through financial reporting.

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of rehabilitation interventions for osteoarthritis.

Science.gov (United States)

Fitzgerald, G K; Hinman, R S; Zeni, J; Risberg, M A; Snyder-Mackler, L; Bennell, K L

2015-05-01

A Task Force of the Osteoarthritis Research Society International (OARSI) has previously published a set of guidelines for the conduct of clinical trials in osteoarthritis (OA) of the hip and knee. Limited material available on clinical trials of rehabilitation in people with OA has prompted OARSI to establish a separate Task Force to elaborate guidelines encompassing special issues relating to rehabilitation of OA. The Task Force identified three main categories of rehabilitation clinical trials. The categories included non-operative rehabilitation trials, post-operative rehabilitation trials, and trials examining the effectiveness of devices (e.g., assistive devices, bracing, physical agents, electrical stimulation, etc.) that are used in rehabilitation of people with OA. In addition, the Task Force identified two main categories of outcomes in rehabilitation clinical trials, which include outcomes related to symptoms and function, and outcomes related to disease modification. The guidelines for rehabilitation clinical trials provided in this report encompass these main categories. The report provides guidelines for conducting and reporting on randomized clinical trials. The topics include considerations for entering patients into trials, issues related to conducting trials, considerations for selecting outcome measures, and recommendations for statistical analyses and reporting of results. The focus of the report is on rehabilitation trials for hip, knee and hand OA, however, we believe the content is broad enough that it could be applied to rehabilitation trials for other regions as well. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Personalizing medicine with clinical pharmacogenetics

Science.gov (United States)

Scott, Stuart A.

2012-01-01

Clinical genetic testing has grown substantially over the past 30 years as the causative mutations for Mendelian diseases have been identified, particularly aided in part by the recent advances in molecular-based technologies. Importantly, the adoption of new tests and testing strategies (e.g., diagnostic confirmation, prenatal testing, and population-based carrier screening) has often been met with caution and careful consideration before clinical implementation, which facilitates the appropriate use of new genetic tests. Although the field of pharmacogenetics was established in the 1950s, clinical testing for constitutional pharmacogenetic variants implicated in interindividual drug response variability has only recently become available to help clinicians guide pharmacotherapy, in part due to US Food and Drug Administration-mediated product insert revisions that include pharmacogenetic information for selected drugs. However, despite pharmacogenetic associations with adverse outcomes, physician uptake of clinical pharmacogenetic testing has been slow. Compared with testing for Mendelian diseases, pharmacogenetic testing for certain indications can have a lower positive predictive value, which is one reason for underutilization. A number of other barriers remain with implementing clinical pharmacogenetics, including clinical utility, professional education, and regulatory and reimbursement issues, among others. This review presents some of the current opportunities and challenges with implementing clinical pharmacogenetic testing. PMID:22095251

Gatekeepers for pragmatic clinical trials.

Science.gov (United States)

Whicher, Danielle M; Miller, Jennifer E; Dunham, Kelly M; Joffe, Steven

2015-10-01

To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the US clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This article provides a framework to help guide gatekeepers' decision-making related to the use of resources for pragmatic clinical trials. Relevant ethical considerations for gatekeepers include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers' decisions, including protection from harm and maximization of benefits; (2) advancement of organizational mission and values; and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers' actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding

Clinical neuropsychology in South Korea.

Science.gov (United States)

Kim, Myung-Sun; Chey, Jeanyung

2016-11-01

Clinical neuropsychology in South Korea, albeit its relatively short history, has advanced dramatically. We review a brief history and current status of clinical neuropsychology in South Korea. The history, the educational pathway, the training pathway, the certification process, and careers in clinical neuropsychology in South Korea are reviewed. We have reviewed the neuropsychological services, including assessment and treatment, research on neurological and psychiatric populations, and neuropsychology education and the requirements related to education, training, and board examinations of those providing neuropsychological services in South Korea. We also describe how the Korean Society for Neuropsychology Research, the first and only meeting for neuropsychologists in the country established in 1999, has played a major role in how clinical neuropsychology is practiced and developed as a professional field in South Korea. Clinical neuropsychology in South Korea has achieved major progress over just a quarter of a century, and its future is promising in light of the increasing demand for neuropsychological services and advances in neuroscience in the country. Challenges that the community of clinical neuropsychologists are currently facing in South Korea, including formalizing neuropsychological curriculum and training programs and developing advanced credentialing procedures, are discussed.

Non-clinical influences on clinical decision-making: a major challenge to evidence-based practice.

Science.gov (United States)

Hajjaj, F M; Salek, M S; Basra, M K A; Finlay, A Y

2010-05-01

This article reviews an aspect of daily clinical practice which is of critical importance in virtually every clinical consultation, but which is seldom formally considered. Non-clinical influences on clinical decision-making profoundly affect medical decisions. These influences include patient-related factors such as socioeconomic status, quality of life and patient's expectations and wishes, physician-related factors such as personal characteristics and interaction with their professional community, and features of clinical practice such as private versus public practice as well as local management policies. This review brings together the different strands of knowledge concerning non-clinical influences on clinical decision-making. This aspect of decision-making may be the biggest obstacle to the reality of practising evidence-based medicine. It needs to be understood in order to develop clinical strategies that will facilitate the practice of evidence-based medicine.

[Geographical differences in clinical characteristics and management of stable outpatients with coronary artery disease: comparison between the Italian and international population included in the Worldwide CLARIFY registry].

Science.gov (United States)

Pozzoli, Massimo; Tavazzi, Luigi

2014-04-01

Limited data are available regarding specific differences among countries in demographic and clinical characteristics and treatment of patients with stable coronary artery disease. CLARIFY is an international, prospective and longitudinal registry including more than 33 000 patients with stable coronary artery disease enrolled in 45 countries worldwide. Data were used to compare the characteristics of patients enrolled in Italy with those enrolled in Europe and in the rest of the world. Baseline data were available for 33 283 patients, 2112 of whom from Italy and 12 614 from the remaining western European countries. Italian patients were found to be older, more frequently smoker, hypertensive and with sedentary habits. In addition, they presented more frequently a history of myocardial infarction, carotid arterial disease and chronic obstructive pulmonary disease. In addition, when compared with patients of both European and international cohorts, more Italian patients had undergone coronary angiography and angioplasty. As far as treatment was concerned, a greater number of Italian patients were taking ivabradine, angiotensin-converting enzyme inhibitors and/or angiotensin receptor blockers, nitrates, thienopyridines, while those taking beta-blockers, calcium antagonists and other antianginal medications were fewer. Among ambulatory patients with stable coronary artery disease, there are important geographic differences in terms of risk factors, clinical characteristics, surgical and pharmacological treatment.

clinical: dementia

African Journals Online (AJOL)

have impairment on multiple cognitive domains, including attention, concentration, memory, executive function, motor functioning and speed of information processing, and sensory perceptual/motor skills deficits. The milder forms of HAND are easily missed. Diagnosis can be made on clinical grounds in the most severe ...

Lumbar foraminal stenosis, the hidden stenosis including at L5/S1.

Science.gov (United States)

Orita, Sumihisa; Inage, Kazuhide; Eguchi, Yawara; Kubota, Go; Aoki, Yasuchika; Nakamura, Junichi; Matsuura, Yusuke; Furuya, Takeo; Koda, Masao; Ohtori, Seiji

2016-10-01

In patients with lower back and leg pain, lumbar foraminal stenosis (LFS) is one of the most important pathologies, especially for predominant radicular symptoms. LFS pathology can develop as a result of progressing spinal degeneration and is characterized by exacerbation with foraminal narrowing caused by lumbar extension (Kemp's sign). However, there is a lack of critical clinical findings for LFS pathology. Therefore, patients with robust and persistent leg pain, which is exacerbated by lumbar extension, should be suspected of LFS. Radiological diagnosis is performed using multiple radiological modalities, such as magnetic resonance imaging, including plain examination and novel protocols such as diffusion tensor imaging, as well as dynamic X-ray, and computed tomography. Electrophysiological testing can also aid diagnosis. Treatment options include both conservative and surgical approaches. Conservative treatment includes medication, rehabilitation, and spinal nerve block. Surgery should be considered when the pathology is refractory to conservative treatment and requires direct decompression of the exiting nerve root, including the dorsal root ganglia. In cases with decreased intervertebral height and/or instability, fusion surgery should also be considered. Recent advancements in minimally invasive lumbar lateral interbody fusion procedures enable effective and less invasive foraminal enlargement compared with traditional fusion surgeries such as transforaminal lumbar interbody fusion. The lumbosacral junction can cause L5 radiculopathy with greater incidence than other lumbar levels as a result of anatomical and epidemiological factors, which should be better addressed when treating clinical lower back pain.

Distal radius plate of CFR-PEEK has minimal effect compared to titanium plates on bone parameters in high-resolution peripheral quantitative computed tomography: a pilot study.

Science.gov (United States)

de Jong, Joost J A; Lataster, Arno; van Rietbergen, Bert; Arts, Jacobus J; Geusens, Piet P; van den Bergh, Joop P W; Willems, Paul C

2017-02-27

Carbon-fiber-reinforced poly-ether-ether-ketone (CFR-PEEK) has superior radiolucency compared to other orthopedic implant materials, e.g. titanium or stainless steel, thus allowing metal-artifact-free postoperative monitoring by computed tomography (CT). Recently, high-resolution peripheral quantitative CT (HRpQCT) proved to be a promising technique to monitor the recovery of volumetric bone mineral density (vBMD), micro-architecture and biomechanical parameters in stable conservatively treated distal radius fractures. When using HRpQCT to monitor unstable distal radius fractures that require volar distal radius plating for fixation, radiolucent CFR-PEEK plates may be a better alternative to currently used titanium plates to allow for reliable assessment. In this pilot study, we assessed the effect of a volar distal radius plate made from CFR-PEEK on bone parameters obtained from HRpQCT in comparison to two titanium plates. Plates were instrumented in separate cadaveric human fore-arms (n = 3). After instrumentation and after removal of the plates duplicate HRpQCT scans were made of the region covered by the plate. HRpQCT images were visually checked for artifacts. vBMD, micro-architectural and biomechanical parameters were calculated, and compared between the uninstrumented and instrumented radii. No visible image artifacts were observed in the CFR-PEEK plate instrumented radius, and errors in bone parameters ranged from -3.2 to 2.6%. In the radii instrumented with the titanium plates, severe image artifacts were observed and errors in bone parameters ranged between -30.2 and 67.0%. We recommend using CFR-PEEK plates in longitudinal in vivo studies that monitor the healing process of unstable distal radius fractures treated operatively by plating or bone graft ingrowth.

Clinical heterogeneity in Fabry disease

Directory of Open Access Journals (Sweden)

G. N. Salogub

2015-01-01

Full Text Available Fabry disease is an X-linked, lysosomal storage disease (OMIM: 301500, caused by α-galactosidase A deficiency, resulting in accumulation of its substrates, glycosphingolipids, primarily – globotriaosylceramide, in the lysosomes of multiple cell types with multi-system clinical manifestations, even within the same family, including abnormalities of the central and peripheral nervous system, kidneys, heart, gastrointestinal tract, lungs, organ of vision. Clinical heterogeneity is often the reason of the delayed diagnosis. Nowadays enzyme replacement therapy has proved its efficiency in the treatment of Fabry disease. Including Fabry disease in the differential diagnosis of a large range of disorders is important because of its wide clinical heterogeneity and the possibility of an earlier intervention with a beneficial treatment.

Role Modeling for Clinical Educators.

Science.gov (United States)

Ettinger, Ellen Richter

1991-01-01

To become better role models, higher educators in institutions of clinical education should be conscious of the behaviors they demonstrate and the broad range of activities and attitudes that students observe and emulate, including clinical competence, professional demeanor, doctor-patient interactions, ethical values, and social consciousness.…

Visual Impairment/lntracranial Pressure Risk Clinical Care Data Tools

Science.gov (United States)

Van Baalen, Mary; Mason, Sara S.; Taiym, Wafa; Wear, Mary L.; Moynihan, Shannan; Alexander, David; Hart, Steve; Tarver, William

2014-01-01

Prior to 2010, several ISS crewmembers returned from spaceflight with changes to their vision, ranging from a mild hyperopic shift to frank disc edema. As a result, NASA expanded clinical vision testing to include more comprehensive medical imaging, including Optical Coherence Tomography and 3 Tesla Brain and Orbit MRIs. The Space and Clinical Operations (SCO) Division developed a clinical practice guideline that classified individuals based on their symptoms and diagnoses to facilitate clinical care. For the purposes of clinical surveillance, this classification was applied retrospectively to all crewmembers who had sufficient testing for classification. This classification is also a tool that has been leveraged for researchers to identify potential risk factors. In March 2014, driven in part by a more comprehensive understanding of the imaging data and increased imaging capability on orbit, the SCO Division revised their clinical care guidance to outline in-flight care and increase post-flight follow up. The new clinical guidance does not include a classification scheme

Clinical microbiology informatics.

Science.gov (United States)

Rhoads, Daniel D; Sintchenko, Vitali; Rauch, Carol A; Pantanowitz, Liron

2014-10-01

The clinical microbiology laboratory has responsibilities ranging from characterizing the causative agent in a patient's infection to helping detect global disease outbreaks. All of these processes are increasingly becoming partnered more intimately with informatics. Effective application of informatics tools can increase the accuracy, timeliness, and completeness of microbiology testing while decreasing the laboratory workload, which can lead to optimized laboratory workflow and decreased costs. Informatics is poised to be increasingly relevant in clinical microbiology, with the advent of total laboratory automation, complex instrument interfaces, electronic health records, clinical decision support tools, and the clinical implementation of microbial genome sequencing. This review discusses the diverse informatics aspects that are relevant to the clinical microbiology laboratory, including the following: the microbiology laboratory information system, decision support tools, expert systems, instrument interfaces, total laboratory automation, telemicrobiology, automated image analysis, nucleic acid sequence databases, electronic reporting of infectious agents to public health agencies, and disease outbreak surveillance. The breadth and utility of informatics tools used in clinical microbiology have made them indispensable to contemporary clinical and laboratory practice. Continued advances in technology and development of these informatics tools will further improve patient and public health care in the future. Copyright © 2014, American Society for Microbiology. All Rights Reserved.

Demystifying the reflective clinical journal

International Nuclear Information System (INIS)

Milinkovic, Danielle; Field, Nikki

2005-01-01

Student learning on clinical placement is a complex issue and cannot be defined solely by just doing things. Reflection during clinical practice is essential if the student is going to learn from the experience. Therefore it is important for educators to include as part of clinical education programs learning strategies that encourage reflection. The reflective clinical journal is an educational tool that is employed by the School of Medical Radiation Sciences at the University of Sydney to encourage reflection of undergraduate radiation therapy students whilst on clinical placement. This discussion paper explores the key concepts of reflection and the reflective clinical journal. Due to the paucity of information about this issue in radiation therapy the literature reviewed is from across all areas of the health sciences

Implementation and evaluation of Parkinson disease management in an outpatient clinical pharmacist-run neurology telephone clinic.

Science.gov (United States)

Stefan, Teodora Cristina; Elharar, Nicole; Garcia, Guadalupe

2018-05-01

Parkinson disease (PD) is a progressive, debilitating neurodegenerative disease that often requires complex pharmacologic treatment regimens. Prior to this clinic, there was no involvement of a clinical pharmacy specialist (CPS) in the outpatient neurology clinic at the West Palm Beach Veterans Affairs Medical Center. This was a prospective, quality-improvement project to develop a clinical pharmacist-run neurology telephone clinic and evaluate pharmacologic and nonpharmacologic interventions in an effort to improve the quality of care for patients with PD. Additionally, the CPS conducted medication education groups to 24 patients with PD and their caregivers, if applicable, at this medical center with the purpose of promoting patient knowledge and medication awareness. Medication management was performed via telephone rather than face to face. Only patients with a concomitant mental health diagnosis for which they were receiving at least one psychotropic medication were included for individual visits due to the established scope of practice of the CPS being limited to mental health and primary care medications. Data collection included patient and clinic demographics as well as pharmacologic and nonpharmacologic interventions made for patients enrolled from January 6, 2017, through March 31, 2017. A total of 49 pharmacologic and nonpharmacologic interventions were made for 10 patients. We successfully implemented and evaluated a clinical pharmacist-run neurology telephone clinic for patients with PD. Expansion of this clinic to patients with various neurological disorders may improve access to care using an innovative method of medication management expertise by a CPS.

Medical student resilience and stressful clinical events during clinical training.

Science.gov (United States)

Houpy, Jennifer C; Lee, Wei Wei; Woodruff, James N; Pincavage, Amber T

2017-01-01

Medical students face numerous stressors during their clinical years, including difficult clinical events. Fostering resilience is a promising way to mitigate negative effects of stressors, prevent burnout, and help students thrive after difficult experiences. However, little is known about medical student resilience. To characterize medical student resilience and responses to difficult clinical events during clinical training. Sixty-two third-year (MS3) and 55 fourth-year (MS4) University of Chicago medical students completed surveys in 2016 assessing resilience (Connor Davidson Resilience Scale, CD-RISC 10), symptoms of burnout, need for resilience training, and responses to difficult clinical events. Medical student mean resilience was lower than in a general population sample. Resilience was higher in males, MS4s, those without burnout symptoms, and students who felt able to cope with difficult clinical events. When students experienced difficult events in the clinical setting, the majority identified poor team dynamics among the most stressful, and agreed their wellbeing was affected by difficult clinical events. A majority also would prefer to discuss these events with their team later that day. Students discussed events with peers more than with attendings or residents. Students comfortable discussing stress and burnout with peers had higher resilience. Most students believed resilience training would be helpful and most beneficial during MS3 year. Clinical medical student resilience was lower than in the general population but higher in MS4s and students reporting no burnout. Students had some insight into their resilience and most thought resilience training would be helpful. Students discussed difficult clinical events most often with peers. More curricula promoting medical student resilience are needed.

Clinical applications of resting state functional connectivity

Directory of Open Access Journals (Sweden)

Michael D Fox

2010-06-01

Full Text Available During resting conditions the brain remains functionally and metabolically active. One manifestation of this activity that has become an important research tool is spontaneous fluctuations in the blood oxygen level dependent (BOLD signal of fMRI. The identification of correlation patterns in these spontaneous fluctuations has been termed resting state functional connectivity (fcMRI and has the potential to greatly increase the translation of fMRI into clinical care. In this article we review the advantages of the resting state signal for clinical applications including detailed discussion of signal to noise considerations. We include guidelines for performing resting state research on clinical populations, outline the different areas for clinical application, and identify important barriers to be addressed to facilitate the translation of resting state fcMRI into the clinical realm.

Feedback in Clinical Education, Part I: Characteristics of Feedback Provided by Approved Clinical Instructors

Science.gov (United States)

Nottingham, Sara; Henning, Jolene

2014-01-01

Context Providing students with feedback is an important component of athletic training clinical education; however, little information is known about the feedback that Approved Clinical Instructors (ACIs; now known as preceptors) currently provide to athletic training students (ATSs). Objective To characterize the feedback provided by ACIs to ATSs during clinical education experiences. Design Qualitative study. Setting One National Collegiate Athletic Association Division I athletic training facility and 1 outpatient rehabilitation clinic that were clinical sites for 1 entry-level master's degree program accredited by the Commission on Accreditation of Athletic Training Education. Patients or Other Participants A total of 4 ACIs with various experience levels and 4 second-year ATSs. Data Collection and Analysis Extensive field observations were audio recorded, transcribed, and integrated with field notes for analysis. The constant comparative approach of open, axial, and selective coding was used to inductively analyze data and develop codes and categories. Member checking, triangulation, and peer debriefing were used to promote trustworthiness of the study. Results The ACIs gave 88 feedback statements in 45 hours and 10 minutes of observation. Characteristics of feedback categories included purpose, timing, specificity, content, form, and privacy. Conclusions Feedback that ACIs provided included several components that made each feedback exchange unique. The ACIs in our study provided feedback that is supported by the literature, suggesting that ACIs are using current recommendations for providing feedback. Feedback needs to be investigated across multiple athletic training education programs to gain more understanding of certain areas of feedback, including frequency, privacy, and form. PMID:24143902

Microneedle delivery: clinical studies and emerging medical applications.

Science.gov (United States)

Pettis, Ronald J; Harvey, Alfred J

2012-03-01

The concept of microneedle drug delivery was described three decades ago; however, effective clinical demonstration has only occurred within the past 10-15 years. Substantial progress in microneedle design and fabrication including extensive in vitro, ex vivo, and in vivo preclinical evaluation with various drugs, vaccines and other agents has transpired over the last decade. In contrast with this large volume of preclinical data, there are relatively few published microneedle clinical studies. To date, the clinical investigative focus has included testing to reduce dermal barrier properties and enhance transdermal delivery; evaluation of enhanced vaccine antigenicity, including development of the first commercial microneedle product for intradermal influenza vaccination; evaluation of altered microneedle protein pharmacokinetics and pharmacodynamics, especially for insulin; and evaluation of the pain and other perceptions associated with microneedle usage. This review summarizes the various aspects of microneedle clinical evaluation to date and identifies areas requiring further clinical evaluation.

Clinical errors and medical negligence.

Science.gov (United States)

Oyebode, Femi

2013-01-01

This paper discusses the definition, nature and origins of clinical errors including their prevention. The relationship between clinical errors and medical negligence is examined as are the characteristics of litigants and events that are the source of litigation. The pattern of malpractice claims in different specialties and settings is examined. Among hospitalized patients worldwide, 3-16% suffer injury as a result of medical intervention, the most common being the adverse effects of drugs. The frequency of adverse drug effects appears superficially to be higher in intensive care units and emergency departments but once rates have been corrected for volume of patients, comorbidity of conditions and number of drugs prescribed, the difference is not significant. It is concluded that probably no more than 1 in 7 adverse events in medicine result in a malpractice claim and the factors that predict that a patient will resort to litigation include a prior poor relationship with the clinician and the feeling that the patient is not being kept informed. Methods for preventing clinical errors are still in their infancy. The most promising include new technologies such as electronic prescribing systems, diagnostic and clinical decision-making aids and error-resistant systems. Copyright © 2013 S. Karger AG, Basel.

Design of clinical trials for therapeutic cancer vaccines development.

Science.gov (United States)

Mackiewicz, Jacek; Mackiewicz, Andrzej

2009-12-25

Advances in molecular and cellular biology as well as biotechnology led to definition of a group of drugs referred to as medicinal products of advanced technologies. It includes gene therapy products, somatic cell therapeutics and tissue engineering. Therapeutic cancer vaccines including whole cell tumor cells vaccines or gene modified whole cells belong to somatic therapeutics and/or gene therapy products category. The drug development is a multistep complex process. It comprises of two phases: preclinical and clinical. Guidelines on preclinical testing of cell based immunotherapy medicinal products have been defined by regulatory agencies and are available. However, clinical testing of therapeutic cancer vaccines is still under debate. It presents a serious problem since recently clinical efficacy of the number of cancer vaccines has been demonstrated that focused a lot of public attention. In general clinical testing in the current form is very expensive, time consuming and poorly designed what may lead to overlooking of products clinically beneficial for patients. Accordingly regulatory authorities and researches including Cancer Vaccine Clinical Trial Working Group proposed three regulatory solutions to facilitate clinical development of cancer vaccines: cost-recovery program, conditional marketing authorization, and a new development paradigm. Paradigm includes a model in which cancer vaccines are investigated in two types of clinical trials: proof-of-principle and efficacy. The proof-of-principle trial objectives are: safety; dose selection and schedule of vaccination; and demonstration of proof-of-principle. Efficacy trials are randomized clinical trials with objectives of demonstrating clinical benefit either directly or through a surrogate. The clinical end points are still under debate.

Guideline-recommended therapy, including beta-blocker utilization, in patients with chronic heart failure: results from a Canadian community hospital heart function clinic

Directory of Open Access Journals (Sweden)

Heffernan M

2016-06-01

Full Text Available Michael Heffernan Division of Cardiology, Oakville Trafalgar Memorial Hospital, Oakville, ON, Canada Abstract: A comprehensive analysis of beta-blocker utilization and other guideline-recommended therapies for the treatment of chronic heart failure in a Canadian community hospital heart function clinic has not been undertaken and was, therefore, the focus of this study. The proportion of patients who would be potential candidates for ivabridine and sacubitril–valsartan therapy as a result of fulfilling the criteria for enrollment in either the Systolic Heart failure treatment with the If inhibitor ivabradine Trial (SHIFT study (left-ventricular ejection fraction [LVEF] >35%, sinus rhythm, New York Heart Association II–IV or the Prospective Comparison of angiotensin receptor-neprilysin inhibitor (ARNI with angiotensin-converting enzyme inhibitor (ACEI to determine impact on global Mortality and Morbidity in Heart Failure (PARADIGM-HF study (LVEF <40%, New York Heart Association II–IV, glomerular filtration rate >30 mL/min, was also assessed. A retrospective cross-sectional analysis was carried out in all 371 patients treated in this community heart function clinic for at least a 12-month period. The patients were elderly (mean age 74±13.3 years and predominately male (61.5% with symptomatic (82.5% moderate left-ventricular dysfunction (LVEF 45.4%±15.6%. A substantial proportion of the patients also had a diagnosis of atrial fibrillation (52.8%. The total use of beta blockers exceeded 87%, while 100% of patients without a documented contraindication or intolerance to a beta blocker received therapy. Adherence to other guideline-recommended pharmacotherapies specifically for heart failure with reduced left ventricular ejection was high: 86.1% of the eligible patients were treated with an ACEI/angiotensin receptor blocker and 61.9% received a mineralcorticoid receptor antagonist. We determined that 13.7% of the complement of this heart

Cancer clinical trials

International Nuclear Information System (INIS)

Scheurlen, A.; Kay, R.; Baum, M.

1988-01-01

This book contains the proceedings on Cancer clinical trials: A critical appraisal. Topics covered include: Scientific fundamentals; Heterogeneous treatment effects; On combining information: Historical controls, overviews, and comprehensive cohort studies; and assessment of quality of life

Fundamentals of clinical trials

CERN Document Server

Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

2015-01-01

This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

[Clinical stages of patients with Alzheimer disease treated in specialist clinics in Spain. The EACE study].

Science.gov (United States)

Alom Poveda, J; Baquero, M; González-Adalid Guerreiro, M

2013-10-01

The diagnostic paradigm of Alzheimer disease (AD) is changing; there is a trend toward diagnosing the disease in its early stages, even before the complete syndrome of dementia is apparent. The clinical stage at which AD is usually diagnosed in our area is unknown. Therefore, the purpose of this study is to describe the clinical stages of AD patients at time of diagnosis. Multicentre, observational and cross-sectional study. Patients with probable AD according to NINCDS-ARDRA criteria, attended in specialist clinics in Spain, were included in the study. We recorded the symptom onset to evaluation and symptom onset to diagnosis intervals and clinical status of AD (based on MMSE, NPI questionnaire, and CDR scale). Participants in this study included 437 specialists representing all of Spain's autonomous communities and a total of 1,707 patients, of whom 1,694 were included in the analysis. Mean MMSE score was 17.6±4.8 (95% CI:17.4-17.9). Moderate cognitive impairment (MMSE between 10 and 20) was detected in 64% of the patients, and severe cognitive impairment (MMSEde Neurología. Published by Elsevier Espana. All rights reserved.

06. Facilitating Collection of Research and Quality Data in Integrative Medicine Clinical Settings: Views From Academic, Health System and Private Clinics

Science.gov (United States)

Dolor, Rowena; Victorson, David; Amoils, Steve

2013-01-01

Focus Areas: Integrative Approaches to Care The purpose of this panel discussion is to share successful efforts from a practice-based research network (PBRN) including ten integrative medicine clinics. The BraveNet PBRN includes integrative medicine clinics with academic health centers, large health systems, and a stand-alone private practice clinic. While clinical care is prioritized across all of these centers, introducing research into clinical sites oriented to providing care poses challenges that vary by clinic environment. We will highlight some of the unique issues encountered when trying to standardize data collection in sites practicing a patient-centered, whole-systems approach to healing as well as the solutions used to overcome these issues. We will present some operational solutions and data collected from the PBRN's ongoing data registry, entitled PRIMIER. The panel will engage attendees in a dialogue centering on potential for future analyses of existing results, ideas for possible upcoming studies, and creative ways to expand the PBRN data registry to include additional sites that may have expertise and interest in participating.

A Call to Include Severe Combined Immunodeficiency in Newborn Screening Program

Directory of Open Access Journals (Sweden)

Raz Somech

2014-01-01

Full Text Available Quantification of the T cell receptor excision circles (TRECs has recently emerged as a useful non-invasive clinical and research tool to investigate thymic activity. It allows the identification of T cell production by the thymus. Quantification of TREC copies has recently been implemented as the preferred test to screen neonates with severe combined immunodeficiency (SCID or significant lymphopenia. Neonatal genetic screening for SCID is highly important in countries with high rates of consanguinous marriages, such as Israel, and can be used for early diagnosis, enabling prompt therapeutic intervention that will save lives and improve the outcome of these patients. TREC measurement is also applicable in clinical settings where T cell immunity is involved, including any T cell immunodeficiencies, HIV infection, the aging process, autoimmune diseases, and immune reconstitution after bone marrow transplantation.

Overgeneral autobiographical memory bias in clinical and non-clinical voice hearers.

Science.gov (United States)

Jacobsen, Pamela; Peters, Emmanuelle; Ward, Thomas; Garety, Philippa A; Jackson, Mike; Chadwick, Paul

2018-03-14

Hearing voices can be a distressing and disabling experience for some, whilst it is a valued experience for others, so-called 'healthy voice-hearers'. Cognitive models of psychosis highlight the role of memory, appraisal and cognitive biases in determining emotional and behavioural responses to voices. A memory bias potentially associated with distressing voices is the overgeneral memory bias (OGM), namely the tendency to recall a summary of events rather than specific occasions. It may limit access to autobiographical information that could be helpful in re-appraising distressing experiences, including voices. We investigated the possible links between OGM and distressing voices in psychosis by comparing three groups: (1) clinical voice-hearers (N = 39), (2) non-clinical voice-hearers (N = 35) and (3) controls without voices (N = 77) on a standard version of the autobiographical memory test (AMT). Clinical and non-clinical voice-hearers also completed a newly adapted version of the task, designed to assess voices-related memories (vAMT). As hypothesised, the clinical group displayed an OGM bias by retrieving fewer specific autobiographical memories on the AMT compared with both the non-clinical and control groups, who did not differ from each other. The clinical group also showed an OGM bias in recall of voice-related memories on the vAMT, compared with the non-clinical group. Clinical voice-hearers display an OGM bias when compared with non-clinical voice-hearers on both general and voices-specific recall tasks. These findings have implications for the refinement and targeting of psychological interventions for psychosis.

Clinical epidemiology.

Science.gov (United States)

Martin, S W; Bonnett, B

1987-06-01

Rational clinical practice requires deductive particularization of diagnostic findings, prognoses, and therapeutic responses from groups of animals (herds) to the individual animal (herd) under consideration This process utilizes concepts, skills, and methods of epidemiology, as they relate to the study of the distribution and determinants of health and disease in populations, and casts them in a clinical perspective.We briefly outline diagnostic strategies and introduce a measure of agreement, called kappa, between clinical diagnoses. This statistic is useful not only as a measure of diagnostic accuracy, but also as a means of quantifying and understanding disagreement between diagnosticians. It is disconcerting to many, clinicians included, that given a general deficit of data on sensitivity and specificity, the level of agreement between many clinical diagnoses is only moderate at best with kappa values of 0.3 to 0.6.Sensitivity, specificity, pretest odds, and posttest probability of disease are defined and related to the interpretation of clinical findings and ancillary diagnostic test results. An understanding of these features and how they relate to ruling-in or ruling-out a diagnosis, or minimizzing diagnostic errors will greatly enhance the diagnostic accuracy of the practitioner, and reduce the frequency of clinical disagreement. The approach of running multiple tests on every patient is not only wasteful and expensive, it is unlikely to improve the ability of the clinician to establish the correct diagnosis.We conclude with a discussion of how to decide on the best therapy, a discussion which centers on, and outlines the key features of, the well designed clinical trial. Like a diagnosis, the results from a clinical trial may not always be definitive, nonetheless it is the best available method of gleaning information about treatment efficacy.

Developing standard transmission system for radiology reporting including key images

International Nuclear Information System (INIS)

Kim, Seon Chil

2007-01-01

Development of hospital information system and Picture Archiving Communication System is not new in the medical field, and the development of internet and information technology are also universal. In the course of such development, however, it is hard to share medical information without a refined standard format. Especially in the department of radiology, the role of PACS has become very important in interchanging information with other disparate hospital information systems. A specific system needs to be developed that radiological reports are archived into a database efficiently. This includes sharing of medical images. A model is suggested in this study in which an internal system is developed where radiologists store necessary images and transmit them is the standard international clinical format, Clinical Document Architecture, and share the information with hospitals. CDA document generator was made to generate a new file format and separate the existing storage system from the new system. This was to ensure the access to required data in XML documents. The model presented in this study added a process where crucial images in reading are inserted in the CDA radiological report generator. Therefore, this study suggests a storage and transmission model for CDA documents, which is different from the existing DICOM SR. Radiological reports could be better shared, when the application function for inserting images and the analysis of standard clinical terms are completed

Clinical mastitis in ewes; bacteriology, epidemiology and clinical features

Directory of Open Access Journals (Sweden)

Kvitle Bjørg

2007-09-01

Full Text Available Abstract Background Clinical mastitis is an important disease in sheep. The objective of this work was to identify causal bacteria and study certain epidemiological and clinical features of clinical mastitis in ewes kept for meat and wool production. Methods The study included 509 ewes with clinical mastitis from 353 flocks located in 14 of the 19 counties in Norway. Clinical examination and collection of udder secretions were carried out by veterinarians. Pulsed-field gel electrophoresis (PFGE was performed on 92 Staphylococcus aureus isolates from 64 ewes. Results and conclusion S. aureus was recovered from 65.3% of 547 clinically affected mammary glands, coagulase-negative staphylococci from 2.9%, enterobacteria, mainly Escherichia coli, from 7.3%, Streptococcus spp. from 4.6%, Mannheimia haemolytica from 1.8% and various other bacteria from 4.9%, while no bacteria were cultured from 13.2% of the samples. Forty percent of the ewes with unilateral clinical S. aureus mastitis also had a subclinical S. aureus infection in the other mammary gland. Twenty-four of 28 (86% pairs of S. aureus isolates obtained from clinically and subclinically affected mammary glands of the same ewe were indistinguishable by PFGE. The number of identical pairs was significantly greater than expected, based on the distribution of different S. aureus types within the flocks. One-third of the cases occurred during the first week after lambing, while a second peak was observed in the third week of lactation. Gangrene was present in 8.8% of the clinically affected glands; S. aureus was recovered from 72.9%, Clostridium perfringens from 6.3% and E. coli from 6.3% of the secretions from such glands. This study shows that S. aureus predominates as a cause of clinical ovine mastitis in Norway, also in very severe cases. Results also indicate that S. aureus is frequently spread between udder halves of infected ewes.

Two-dimensional analysis of motion artifacts, including flow effects

International Nuclear Information System (INIS)

Litt, A.M.; Brody, A.S.; Spangler, R.A.; Scott, P.D.

1990-01-01

The effects of motion on magnetic resonance images have been theoretically analyzed for the case of a point-like object in simple harmonic motion and for other one-dimensional trajectories. The authors of this paper extend this analysis to a generalized two-dimensional magnetization with an arbitrary motion trajectory. The authors provide specific solutions for the clinically relevant cases of the cross-sections of cylindrical objects in the body, such as the aorta, which has a roughly one-dimensional, simple harmonic motion during respiration. By extending the solution to include inhomogeneous magnetizations, the authors present a model which allows the effects of motion artifacts and flow artifacts to be analyzed simultaneously

Clinical spectrum of onchodermatitis

International Nuclear Information System (INIS)

Bari, A.U.

2007-01-01

To describe the frequency and to see various dermatological presentations of onchocerciasis in black Africans of Sierra Leone. Local black patients of all age groups, attending dermatology outpatient department of Pak Field Hospital (established as a part of UN peacekeeping mission in Sierra Leone) with clinical diagnosis of onchodermatitis, based on symptomatology and morphological features of the disease, were included. UN troops were excluded. Laboratory investigations including blood complete picture and skin snips were carried out in all patients. Skin biopsy and nodule biopsy was performed in selected cases. Skin manifestations were recorded and categorized into various clinical patterns, i.e. acute, chronic, lichenified, onchocercoma, etc. Data was analyzed by using descriptive statistics in Instat. A total of 3011 patients, belonging to different local tribes, having a variety of skin disorders, were seen during the study period. One hundred and eighty-seven (6.2%) patients were found to have onchodermatitis. Patients were of all ages and both sexes, their ages ranging from 1 month to 73 years. Gender ratio was almost equal. A whole clinical spectrum of onchodermatitis was observed, chronic papular onchodermatitis being the most common pattern. Onchodermatitis with a large spectrum of clinical manifestations was seen in black Africans of the eastern part of Sierra Leone. (author)

Positron emission tomography clinical practice

CERN Document Server

Valk, Peter E; Bailey, Dale L; Townsend, David W; Maisey, Michael N

2006-01-01

This book provides a contemporary reference to the science, technology and clinical applications of PET and PET/CT. The opening chapters summarize the scientific aspects of PET and PET/CT including physics, instrumentation, radiation dosimetry and radiation protection. A chapter on normal variants in FDG PET imaging serves as an introduction to the clinical chapters, which cover oncology applications and have been updated to include the impact of FDG PET/CT imaging in oncology. The book concludes with chapters on the use of PET and PET/CT in cardiology and neurology and PET imaging of infectio

Clinical governance and external audit.

Science.gov (United States)

Glazebrook, S G; Buchanan, J G

2001-01-01

This paper describes a model of clinical governance that was developed at South Auckland Health during the period 1995 to 2000. Clinical quality and safety are core objectives. A multidisciplinary Clinical Board is responsible for the development and publicising of sound clinical policies together with monitoring the effects of their implementation on quality and safety. The Clinical Board has several committees, including an organization-wide Continuous Quality Improvement Committee to enhance the explicit nature of the quality system in terms of structure, staff awareness and involvement, and to develop the internal audit system. The second stream stems from the Chief Medical Officer and clinical directors in a clinical management sense. The Audit Committee of the Board of Directors covers both clinical and financial audit. The reporting lines back to that committee are described and the role of the external auditor of clinical standards is explained. The aim has been to create a supportive culture where quality initiatives and innovation can flourish, and where the emphasis is not on censure but improvement.

Tools in a clinical information system supporting clinical trials at a Swiss University Hospital.

Science.gov (United States)

Weisskopf, Michael; Bucklar, Guido; Blaser, Jürg

2014-12-01

Issues concerning inadequate source data of clinical trials rank second in the most common findings by regulatory authorities. The increasing use of electronic clinical information systems by healthcare providers offers an opportunity to facilitate and improve the conduct of clinical trials and the source documentation. We report on a number of tools implemented into the clinical information system of a university hospital to support clinical research. In 2011/2012, a set of tools was developed in the clinical information system of the University Hospital Zurich to support clinical research, including (1) a trial registry for documenting metadata on the clinical trials conducted at the hospital, (2) a patient-trial-assignment-tool to tag patients in the electronic medical charts as participants of specific trials, (3) medical record templates for the documentation of study visits and trial-related procedures, (4) online queries on trials and trial participants, (5) access to the electronic medical records for clinical monitors, (6) an alerting tool to notify of hospital admissions of trial participants, (7) queries to identify potentially eligible patients in the planning phase as trial feasibility checks and during the trial as recruitment support, and (8) order sets to facilitate the complete and accurate performance of study visit procedures. The number of approximately 100 new registrations per year in the voluntary trial registry in the clinical information system now matches the numbers of the existing mandatory trial registry of the hospital. Likewise, the yearly numbers of patients tagged as trial participants as well as the use of the standardized trial record templates increased to 2408 documented trial enrolments and 190 reports generated/month in the year 2013. Accounts for 32 clinical monitors have been established in the first 2 years monitoring a total of 49 trials in 16 clinical departments. A total of 15 months after adding the optional feature of

Genome-wide association study of clinically defined gout identifies multiple risk loci and its association with clinical subtypes

OpenAIRE

Matsuo, Hirotaka; Yamamoto, Ken; Nakaoka, Hirofumi; Nakayama, Akiyoshi; Sakiyama, Masayuki; Chiba, Toshinori; Takahashi, Atsushi; Nakamura, Takahiro; Nakashima, Hiroshi; Takada, Yuzo; Danjoh, Inaho; Shimizu, Seiko; Abe, Junko; Kawamura, Yusuke; Terashige, Sho

2015-01-01

Objective Gout, caused by hyperuricaemia, is a multifactorial disease. Although genome-wide association studies (GWASs) of gout have been reported, they included self-reported gout cases in which clinical information was insufficient. Therefore, the relationship between genetic variation and clinical subtypes of gout remains unclear. Here, we first performed a GWAS of clinically defined gout cases only. Methods A GWAS was conducted with 945 patients with clinically defined gout and 1213 contr...

Credentialing for participation in clinical trials

International Nuclear Information System (INIS)

Followill, David S.; Urie, Marcia; Galvin, James M.; Ulin, Kenneth; Xiao, Ying; FitzGerald, Thomas J.

2012-01-01

The National Cancer Institute (NCI) clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based clinical trial processes for improvements in patient care. The cooperative groups are undergoing a transformation process to launch, conduct, and publish clinical trials more rapidly. Institutional participation in clinical trials can be made more efficient and include the expansion of relationships with international partners. This paper reviews the current processes that are in use in radiation therapy trials and the importance of maintaining effective credentialing strategies to assure the quality of the outcomes of clinical trials. The paper offers strategies to streamline and harmonize credentialing tools and processes moving forward as the NCI undergoes transformative change in the conduct of clinical trials.

Credentialing for participation in clinical trials

Energy Technology Data Exchange (ETDEWEB)

Followill, David S. [Radiological Physics Center, Department of Radiation Physics, University of Texas MD Anderson Cancer Center, Houston, TX (United States); Urie, Marcia [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Galvin, James M. [Department of Radiation Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States); Radiation Therapy Oncology Group, Philadelphia, PA (United States); Ulin, Kenneth [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Department of Radiation Oncology, University of Massachusetts Medical School, Worcester, MA (United States); Xiao, Ying [Department of Radiation Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States); Radiation Therapy Oncology Group, Philadelphia, PA (United States); FitzGerald, Thomas J., E-mail: dfollowi@mdanderson.org [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Department of Radiation Oncology, University of Massachusetts Medical School, Worcester, MA (United States)

2012-12-26

The National Cancer Institute (NCI) clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based clinical trial processes for improvements in patient care. The cooperative groups are undergoing a transformation process to launch, conduct, and publish clinical trials more rapidly. Institutional participation in clinical trials can be made more efficient and include the expansion of relationships with international partners. This paper reviews the current processes that are in use in radiation therapy trials and the importance of maintaining effective credentialing strategies to assure the quality of the outcomes of clinical trials. The paper offers strategies to streamline and harmonize credentialing tools and processes moving forward as the NCI undergoes transformative change in the conduct of clinical trials.

[Research activity in clinical biochemistry].

Science.gov (United States)

Jørgensen, Henrik L; Larsen, Birger; Ingwersen, Peter; Rehfeld, Jens F

2008-09-01

Quantitative bibliometric measurements of research activity are frequently used, e.g. for evaluating applicants for academic positions. The purpose of this investigation is to assess research activity within the medical speciality of Clinical Biochemistry by comparing it with a matched control group from other medical specialities in Denmark. A list of all physicians registered in Denmark (23,127 persons) was drawn from the database "Laeger.dk". Of these, 5,202 were generalists (not included) while 11,691 were from other specialities. Of the 126 specialists from Clinical Biochemistry, 57 fulfilled the inclusion criteria. Each of these 57 was matched according to medical title with two randomly chosen specialists from other specialities, totaling 114. Using Medline and the Web of Science, the number of publications and the number of citations were then ascertained. 25% of the 11,691 specialists held a PhD degree or doctoral degree, DMSci, (Clinical Biochemistry: 61%). The 171 specialists included in the study had 9,823 papers in Medline and 10,140 papers in the Web of Science. The number of Medline papers per specialist was 71 for Clinical Biochemistry compared to 51 for the control group. The number of citations per specialist was 1,844 for Clinical Biochemistry compared to 816 for the control group. The top ten H-indices (of which 8 were in Clinical Biochemistry) ranged from 30 to 69. Both the number of papers and the number of citations were higher for Clinical Biochemistry than for the control group. The difference was most pronounced among professors.

Clinical Research Careers: Reports from a NHLBI Pediatric Heart Network Clinical Research Skills Development Conference

Science.gov (United States)

Lai, Wyman W.; Richmond, Marc; Li, Jennifer S.; Saul, J. Philip; Mital, Seema; Colan, Steven D.; Newburger, Jane W.; Sleeper, Lynn A.; McCrindle, Brain W.; Minich, L. LuAnn; Goldmuntz, Elizabeth; Marino, Bradley S.; Williams, Ismee A.; Pearson, Gail D.; Evans, Frank; Scott, Jane D.; Cohen, Meryl S.

2013-01-01

Background Wyman W. Lai, MD, MPH, and Victoria L. Vetter, MD, MPH. The Pediatric Heart Network (PHN), funded under the U.S. National Institutes of Health-National Heart, Lung, and Blood Institute (NIH–NHLBI), includes two Clinical Research Skills Development (CRSD) Cores, which were awarded to The Children's Hospital of Philadelphia and to the Morgan Stanley Children's Hospital of New York–Presbyterian. To provide information on how to develop a clinical research career to a larger number of potential young investigators in pediatric cardiology, the directors of these two CRSD Cores jointly organized a one-day seminar for fellows and junior faculty from all of the PHN Core sites. The participants included faculty members from the PHN and the NHLBI. The day-long seminar was held on April 29, 2009, at the NHLBI site, immediately preceding the PHN Steering Committee meeting in Bethesda, MD. Methods The goals of the seminar were 1) to provide fellows and early investigators with basic skills in clinical research 2) to provide a forum for discussion of important research career choices 3) to introduce attendees to each other and to established clinical researchers in pediatric cardiology, and 4) to publish a commentary on the future of clinical research in pediatric cardiology. Results The following chapters are compilations of the talks given at the 2009 PHN Clinical Research Skills Development Seminar, published to share the information provided with a broader audience of those interested in learning how to develop a clinical research career in pediatric cardiology. The discussions of types of clinical research, research skills, career development strategies, funding, and career management are applicable to research careers in other areas of clinical medicine as well. Conclusions The aim of this compilation is to stimulate those who might be interested in the research career options available to investigators. PMID:21167335

Pre-clinical and clinical development of the first placental malaria vaccine

DEFF Research Database (Denmark)

Pehrson, Caroline; Salanti, Ali; Theander, Thor G

2017-01-01

the condition.  Areas covered: Pub Med was searched using the broad terms 'malaria parasite placenta' to identify studies of interactions between parasite and host, 'prevention of placental malaria' to identify current strategies to prevent placental malaria, and 'placental malaria vaccine' to identify pre-clinical...... vaccine development. However, all papers from these searches were not systematically included.  Expert commentary: The first phase I clinical trials of vaccines are well underway. Trials testing efficacy are more complicated to carry out as only women that are exposed to parasites during pregnancy...

Pediatric Clinical Trials Conducted in South Korea from 2006 to 2015: An Analysis of the South Korean Clinical Research Information Service, US ClinicalTrials.gov and European Clinical Trials Registries.

Science.gov (United States)

Choi, Sheung-Nyoung; Lee, Ji-Hyun; Song, In-Kyung; Kim, Eun-Hee; Kim, Jin-Tae; Kim, Hee-Soo

2017-12-01

The status of pediatric clinical trials performed in South Korea in the last decade, including clinical trials of drugs with unapproved indications for children, has not been previously examined. The aim was to provide information regarding the current state of pediatric clinical trials and create a basis for future trials performed in South Korea by reviewing three databases of clinical trials registrations. We searched for pediatric clinical studies (participants South Korea between 2006 and 2015 registered on the Clinical Research Information Service (CRIS), ClinicalTrials.gov, and the European Clinical Trials Registry (EuCTR). Additionally, we reviewed whether unapproved indications were involved in each trial by comparing the trials with a list of authorized trials provided by the Ministry of Food and Drug Safety (MFDS). The primary and secondary outcomes were to determine the change in number of pediatric clinical trials with unapproved indications over time and to assess the status of unauthorized pediatric clinical trials from the MFDS and the publication of articles after these clinical trials, respectively. We identified 342 clinical studies registered in the CRIS (n = 81), ClinicalTrials.gov (n = 225), and EuCTR (n = 36), of which 306 were reviewed after excluding duplicate registrations. Among them, 181 studies were interventional trials dealing with drugs and biological agents, of which 129 (71.3%) involved unapproved drugs. Of these 129 trials, 107 (82.9%) were authorized by the MFDS. Pediatric clinical trials in South Korea aiming to establish the safety and efficacy of drugs in children are increasing; however, non-MFDS-authorized studies remain an issue.

ACCP Clinical Pharmacist Competencies.

Science.gov (United States)

Saseen, Joseph J; Ripley, Toni L; Bondi, Deborah; Burke, John M; Cohen, Lawrence J; McBane, Sarah; McConnell, Karen J; Sackey, Bryan; Sanoski, Cynthia; Simonyan, Anahit; Taylor, Jodi; Vande Griend, Joseph P

2017-05-01

The purpose of the American College of Clinical Pharmacy (ACCP) is to advance human health by extending the frontiers of clinical pharmacy. Consistent with this mission and its core values, ACCP is committed to ensuring that clinical pharmacists possess the knowledge, skills, attitudes, and behaviors necessary to deliver comprehensive medication management (CMM) in team-based, direct patient care environments. These components form the basis for the core competencies of a clinical pharmacist and reflect the competencies of other direct patient care providers. This paper is an update to a previous ACCP document and includes the expectation that clinical pharmacists be competent in six essential domains: direct patient care, pharmacotherapy knowledge, systems-based care and population health, communication, professionalism, and continuing professional development. Although these domains align with the competencies of physician providers, they are specifically designed to better reflect the clinical pharmacy expertise required to provide CMM in patient-centered, team-based settings. Clinical pharmacists must be prepared to complete the education and training needed to achieve these competencies and must commit to ongoing efforts to maintain competence through ongoing professional development. Collaboration among stakeholders will be needed to ensure that these competencies guide clinical pharmacists' professional development and evaluation by educational institutions, postgraduate training programs, professional societies, and employers. © 2017 Pharmacotherapy Publications, Inc.

Clinical pharmacology in Russia-historical development and current state.

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Zagorodnikova Goryachkina, Ksenia; Burbello, Aleksandra; Sychev, Dmitry; Frolov, Maxim; Kukes, Vladimir; Petrov, Vladimir

2015-02-01

Clinical pharmacology in Russia has long history and is currently active, but rather unrecognized internationally. It is governmentally approved as a teaching/scientific specialty since 1983 and as a medical specialty since 1997. Courses of clinical pharmacology are included in the undergraduate curricula in the 5th and/or 6th year of education at all medical schools in the Russian Federation. Postgraduate education includes initial specialization in internal medicine with further residency in clinical pharmacology. Governmental legislation recommends that every healthcare institution has either a department or a single position of clinical pharmacologist. Major routine duties include information about and monitoring of medication use, consultations in difficult clinical situations, pharmacogenetic counseling, therapeutic drug monitoring, pharmacovigilance, and participation in drug and therapeutics (formulary) committees. There are official experts in clinical pharmacology in Russia responsible for coordinating relevant legislative issues. The chief expert clinical pharmacologist represents the discipline directly at the Ministry of Health. Research in clinical pharmacology in Russia is extensive and variable, but only some of it is published internationally. Russia is a participant of international societies of clinical pharmacology and therapeutics and collaboration is actively ongoing. There are still certain problems related to the development of the discipline in Russia-some healthcare institutions do not see the need for clinical pharmacology. However, the number of clinical pharmacologists in Russia is increasing as well as their role in physicians' education, national healthcare, and research.

Xq28 duplications including MECP2 in five females: Expanding the phenotype to severe mental retardation.

Science.gov (United States)

Bijlsma, E K; Collins, A; Papa, F T; Tejada, M I; Wheeler, P; Peeters, E A J; Gijsbers, A C J; van de Kamp, J M; Kriek, M; Losekoot, M; Broekma, A J; Crolla, J A; Pollazzon, M; Mucciolo, M; Katzaki, E; Disciglio, V; Ferreri, M I; Marozza, A; Mencarelli, M A; Castagnini, C; Dosa, L; Ariani, F; Mari, F; Canitano, R; Hayek, G; Botella, M P; Gener, B; Mínguez, M; Renieri, A; Ruivenkamp, C A L

2012-06-01

Duplications leading to functional disomy of chromosome Xq28, including MECP2 as the critical dosage-sensitive gene, are associated with a distinct clinical phenotype in males, characterized by severe mental retardation, infantile hypotonia, progressive neurologic impairment, recurrent infections, bladder dysfunction, and absent speech. Female patients with Xq duplications including MECP2 are rare. Only recently submicroscopic duplications of this region on Xq28 have been recognized in four females, and a triplication in a fifth, all in combination with random X-chromosome inactivation (XCI). Based on this small series, it was concluded that in females with MECP2 duplication and random XCI, the typical symptoms of affected boys are not present. We present clinical and molecular data on a series of five females with an Xq28 duplication including the MECP2 gene, both isolated and as the result of a translocation, and compare them with the previously reported cases of small duplications in females. The collected data indicate that the associated phenotype in females is distinct from males with similar duplications, but the clinical effects may be as severe as seen in males. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

Clinical outcomes for young people with screening-detected and clinically-diagnosed rheumatic heart disease in Fiji.

Science.gov (United States)

Engelman, Daniel; Mataika, Reapi L; Ah Kee, Maureen; Donath, Susan; Parks, Tom; Colquhoun, Samantha M; Carapetis, Jonathan R; Kado, Joseph H; Steer, Andrew C

2017-08-01

Echocardiographic screening is under consideration as a disease control strategy for rheumatic heart disease (RHD). However, clinical outcomes of young people with screening-detected RHD are unknown. We aimed to describe the outcomes for a cohort with screening-detected RHD, in comparison to patients with clinically-diagnosed RHD. A retrospective cohort study included all young people with screening-detected RHD in the Central Division of Fiji in the primary cohort. Screen-negative and clinically-diagnosed comparison groups were matched 1:1 to the primary cohort. Data were collected on mortality, clinical complications and healthcare utilisation from the electronic and paper health records and existing databases. Seventy participants were included in each group. Demographic characteristics of the groups were similar (median age 11years, 69% female, median follow-up 7years). There were nine (12.9%) RHD-related deaths in the clinically-diagnosed group and one (1.4%) in the screening-detected group (Incident Rate Ratio: 9.6, 95% CI 1.3-420.6). Complications of RHD were observed in 39 (55.7%) clinically-diagnosed cases, four (20%) screening-detected cases and one (1.4%) screen-negative case. There were significant differences in the cumulative complication curves of the groups (pFiji. The prognosis of clinically-diagnosed RHD remains poor, with very high mortality and complication rates. Further studies in other settings will inform RHD screening policy. Comprehensive control strategies are required for disease prevention. Copyright © 2017 Elsevier B.V. All rights reserved.

Growth/differentiation factor-5: pre-clinical and clinical evaluations of periodontal regeneration and alveolar augmentation--review.

Science.gov (United States)

Lee, Jaebum; Wikesjö, Ulf M E

2014-08-01

Growth/differentiation factor-5 (GDF-5) plays critical roles in mesenchymal cell differentiation and stimulates human periodontal ligament cell proliferation. Potentially, GDF-5 may also play roles in wound healing including periodontal regeneration and alveolar augmentation. The objective of this review was to provide up-to-date information from pre-clinical/clinical studies evaluating GDF-5 for these indications. A comprehensive search using PubMed and Google search engines was conducted to identify reports on GDF-5 applied to periodontal and alveolar indications. Two reviewers independently screened the titles and abstracts from a total of 479 reports. Full-length articles of 17 pre-clinical and four clinical studies were selected and reviewed. Canine-, porcine- and non-human primate-based models as well as human clinical trials were used in the evaluation of GDF-5 in support of periodontal regeneration and alveolar augmentation. An absorbable collagen sponge (ACS), β-tricalcium phosphate (β-TCP) and a poly(lactic-co-glycolic) acid (PLGA) were evaluated as candidate carriers for GDF-5 using various dose and healing intervals demonstrating significantly enhanced periodontal regeneration/alveolar augmentation including cementum, periodontal ligament and alveolar bone with limited, if any, adverse effects. Growth/differentiation factor-5 supports periodontal regeneration/alveolar augmentation without aberrant healing events documented in qualified pre-clinical models and clinical pilot studies. In perspective, GDF-5 appears a promising technology for periodontal regeneration/alveolar augmentation. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Antimicrobial susceptibility and antibiotic resistance gene transfer analysis of foodborne, clinical, and environmental Listeria spp. isolates including Listeria monocytogenes.

Science.gov (United States)

Bertsch, David; Muelli, Mirjam; Weller, Monika; Uruty, Anaïs; Lacroix, Christophe; Meile, Leo

2014-02-01

The aims of this study were to assess antibiotic resistance pheno- and genotypes in foodborne, clinical, and environmental Listeria isolates, as well as to elucidate the horizontal gene transfer potential of detected resistance genes. A small fraction of in total 524 Listeria spp. isolates (3.1%) displayed acquired antibiotic resistance mainly to tetracycline (n = 11), but also to clindamycin (n = 4) and trimethoprim (n = 3), which was genotypically confirmed. In two cases, a tetracycline resistance phenotype was observed together with a trimethoprim resistance phenotype, namely in a clinical L. monocytogenes strain and in a foodborne L. innocua isolate. Depending on the applied guidelines, a differing number of isolates (n = 2 or n = 20) showed values for ampicillin that are on the edge between intermediate susceptibility and resistance. Transferability of the antibiotic resistance genes from the Listeria donors, elucidated in vitro by filter matings, was demonstrated for genes located on transposons of the Tn916 family and for an unknown clindamycin resistance determinant. Transfer rates of up to 10(-5) transconjugants per donor were obtained with a L. monocytogenes recipient and up to 10(-7) with an Enterococcus faecalis recipient, respectively. Although the prevalence of acquired antibiotic resistance in Listeria isolates from this study was rather low, the transferability of these resistances enables further spread in the future. This endorses the importance of surveillance of L. monocytogenes and other Listeria spp. in terms of antibiotic susceptibility. © 2014 The Authors. MicrobiologyOpen published by John Wiley & Sons Ltd.

Yeast identification in routine clinical microbiology laboratory and its clinical relevance

Directory of Open Access Journals (Sweden)

S Agarwal

2011-01-01

Full Text Available Rapid identification of yeast infections is helpful in prompt appropriate antifungal therapy. In the present study, the usefulness of chromogenic medium, slide culture technique and Vitek2 Compact (V2C has been analysed. A total of 173 clinical isolates of yeast species were included in the study. An algorithm to identify such isolates in routine clinical microbiology laboratory was prepared and followed. Chromogenic medium was able to identify Candida albicans, C. tropicalis, C. krusei, C. parapsilosis and Trichosporon asahii. Chromogenic medium was also helpful in identifying "multi-species" yeast infections. The medium was unable to provide presumptive identification of C. pelliculosa, C. utilis, C. rugosa, C. glabrata and C. hemulonii. Vitek 2 compact (V2C differentiated all pseudohypae non-producing yeast species. The algorithm followed was helpful in timely presumptive identification and final diagnosis of yeast infections, including multi-species yeast infections.

Clinical biochemistry education in Spain.

Science.gov (United States)

Queraltó, J M

1994-12-31

Clinical biochemistry in Spain was first established in 1978 as an independent specialty. It is one of several clinical laboratory sciences specialties, together with haematology, microbiology, immunology and general laboratory (Clinical analysis, análisis clinicos). Graduates in Medicine, Pharmacy, Chemistry and Biological Sciences can enter post-graduate training in Clinical Chemistry after a nation-wide examination. Training in an accredited Clinical Chemistry department is 4 years. A national committee for medical and pharmacist specialties advises the government on the number of trainees, program and educational units accreditation criteria. Technical staff includes nurses and specifically trained technologists. Accreditation of laboratories is developed at different regional levels. The Spanish Society for Clinical Biochemistry and Molecular Pathology (SECQ), the national representative in the IFCC, has 1600 members, currently publishes a scientific journal (Química Clinica) and a newsletter. It organizes a continuous education program, a quality control program and an annual Congress.

Marfan syndrome with a complex chromosomal rearrangement including deletion of the FBN1 gene

Directory of Open Access Journals (Sweden)

Colovati Mileny ES

2012-01-01

Full Text Available Abstract Background The majority of Marfan syndrome (MFS cases is caused by mutations in the fibrillin-1 gene (FBN1, mapped to chromosome 15q21.1. Only few reports on deletions including the whole FBN1 gene, detected by molecular cytogenetic techniques, were found in literature. Results We report here on a female patient with clinical symptoms of the MFS spectrum plus craniostenosis, hypothyroidism and intellectual deficiency who presents a 1.9 Mb deletion, including the FBN1 gene and a complex rearrangement with eight breakpoints involving chromosomes 6, 12 and 15. Discussion This is the first report of MFS with a complex chromosome rearrangement involving a deletion of FBN1 and contiguous genes. In addition to the typical clinical findings of the Marfan syndrome due to FBN1 gene haploinsufficiency, the patient presents features which may be due to the other gene deletions and possibly to the complex chromosome rearrangement.

Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262): clinical effectiveness systematic review and economic model.

Science.gov (United States)

Archer, Rachel; Tappenden, Paul; Ren, Shijie; Martyn-St James, Marrissa; Harvey, Rebecca; Basarir, Hasan; Stevens, John; Carroll, Christopher; Cantrell, Anna; Lobo, Alan; Hoque, Sami

2016-05-01

Ulcerative colitis (UC) is the most common form of inflammatory bowel disease in the UK. UC can have a considerable impact on patients' quality of life. The burden for the NHS is substantial. To evaluate the clinical effectiveness and safety of interventions, to evaluate the incremental cost-effectiveness of all interventions and comparators (including medical and surgical options), to estimate the expected net budget impact of each intervention, and to identify key research priorities. Peer-reviewed publications, European Public Assessment Reports and manufacturers' submissions. The following databases were searched from inception to December 2013 for clinical effectiveness searches and from inception to January 2014 for cost-effectiveness searches for published and unpublished research evidence: MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library including the Cochrane Systematic Reviews Database, Cochrane Controlled Trials Register, Database of Abstracts of Reviews of Effects, the Health Technology Assessment database and NHS Economic Evaluation Database; ISI Web of Science, including Science Citation Index, and the Conference Proceedings Citation Index-Science and Bioscience Information Service Previews. The US Food and Drug Administration website and the European Medicines Agency website were also searched, as were research registers, conference proceedings and key journals. A systematic review [including network meta-analysis (NMA)] was conducted to evaluate the clinical effectiveness and safety of named interventions. The health economic analysis included a review of published economic evaluations and the development of a de novo model. Ten randomised controlled trials were included in the systematic review. The trials suggest that adult patients receiving infliximab (IFX) [Remicade(®), Merck Sharp & Dohme Ltd (MSD)], adalimumab (ADA) (Humira(®), AbbVie) or golimumab (GOL) (Simponi(®), MSD) were more likely to

Clinical trials in orthopaedics and the future direction of clinical investigations for femoroacetabular impingement

DEFF Research Database (Denmark)

Clohisy, John C; Kim, Young-Jo; Lurie, Jon

2013-01-01

to be further defined. To date, clinical research reports have included primarily surgical case series. Future clinical investigations are needed to establish improved clinical evidence to guide patient care. Most urgent is the need to better understand the potential role of standardized nonsurgical treatment......Femoroacetabular impingement (FAI) represents a heterogeneous group of disorders that affect a diverse patient population. The natural history of the disease, the role of nonsurgical management, the indications for surgery, optimal surgical techniques, and the predictors of treatment outcomes need...... options for FAI and to define the predictors of surgical and nonsurgical outcomes. Future randomized controlled trials and large observational cohort studies targeted at these clinical research deficiencies will strengthen the evidence and improve informed decision making regarding the management...

Bone Status Among Patients With Nonsurgical Hypoparathyroidism, Autosomal Dominant Hypocalcaemia, and Pseudohypoparathyroidism: A Cohort Study.

Science.gov (United States)

Underbjerg, Line; Malmstroem, Sofie; Sikjaer, Tanja; Rejnmark, Lars

2018-03-01

Nonsurgical hypoparathyroidism (Ns-HypoPT) and pseudohypoparathyroidism (PHP) are both rare diseases, characterized by hypocalcemia. In Ns-HypoPT, PTH levels are low, whereas patients with PHP often have very high levels due to receptor-insensitivity to PTH (PTH-resistance). Accordingly, we hypothesized that indices of bone turnover and bone mineralization/architecture are similar in Ns-HypoPT and PHP despite marked differences in PTH levels. We studied 62 patients with Ns-HypoPT and 31 with PHP as well as a group of age- and sex-matched healthy controls. We found a significantly higher areal BMD (aBMD) by DXA among patients with Ns-HypoPT, both compared with PHP and the background population. Compared with Ns-HypoPT, PHP patients had significantly lower total and trabecular volumetric BMD (vBMD) assessed by quantitative computed tomography (QCT) scans at the spine and hip. High-resolution peripheral quantitative computed tomography (HRpQCT) scans showed a lower trabecular area and vBMD as well as a lower trabecular number at the tibia in PHP compared to Ns-HypoPT and matched controls. In PHP, PTH levels correlated with levels of markers of bone formation (osteocalcin, bone-specific alkaline phosphatase, P1NP), and bone resorption (CTx). In adult males, levels of bone markers were significantly higher in PHP compared with Ns-HypoPT. Levels of procalcitonin and calcitonin were significantly higher in PHP compared with Ns-HypoPT. In conclusion, indices of bone turnover, density, and microarchitecture differ between patients with Ns-HypoPT and PHP. Our data suggest that patients with PHP do not have a complete skeletal resistance to PTH and that the effects of chronically high PTH levels in PHP are mostly confined to the trabecular tissue. © 2017 American Society for Bone and Mineral Research. © 2017 American Society for Bone and Mineral Research.

The VITRO Score (Von Willebrand Factor Antigen/Thrombocyte Ratio as a New Marker for Clinically Significant Portal Hypertension in Comparison to Other Non-Invasive Parameters of Fibrosis Including ELF Test.

Directory of Open Access Journals (Sweden)

Stephanie Hametner

Full Text Available Clinically significant portal hypertension (CSPH, defined as hepatic venous pressure gradient (HVPG ≥10 mmHg, causes major complications. HVPG is not always available, so a non-invasive tool to diagnose CSPH would be useful. VWF-Ag can be used to diagnose. Using the VITRO score (the VWF-Ag/platelet ratio instead of VWF-Ag itself improves the diagnostic accuracy of detecting cirrhosis/ fibrosis in HCV patients.This study tested the diagnostic accuracy of VITRO score detecting CSPH compared to HVPG measurement.All patients underwent HVPG testing and were categorised as CSPH or no CSPH. The following patient data were determined: CPS, D'Amico stage, VITRO score, APRI and transient elastography (TE.The analysis included 236 patients; 170 (72% were male, and the median age was 57.9 (35.2-76.3; 95% CI. Disease aetiology included ALD (39.4%, HCV (23.4%, NASH (12.3%, other (8.1% and unknown (11.9%. The CPS showed 140 patients (59.3% with CPS A; 56 (23.7% with CPS B; and 18 (7.6% with CPS C. 136 patients (57.6% had compensated and 100 (42.4% had decompensated cirrhosis; 83.9% had HVPG ≥10 mmHg. The VWF-Ag and the VITRO score increased significantly with worsening HVPG categories (P<0.0001. ROC analysis was performed for the detection of CSPH and showed AUC values of 0.92 for TE, 0.86 for VITRO score, 0.79 for VWF-Ag, 0.68 for ELF and 0.62 for APRI.The VITRO score is an easy way to diagnose CSPH independently of CPS in routine clinical work and may improve the management of patients with cirrhosis.

Efficient design of clinical trials and epidemiological research: is it possible?

Science.gov (United States)

Lauer, Michael S; Gordon, David; Wei, Gina; Pearson, Gail

2017-08-01

Randomized clinical trials and large-scale, cohort studies continue to have a critical role in generating evidence in cardiovascular medicine; however, the increasing concern is that ballooning costs threaten the clinical trial enterprise. In this Perspectives article, we discuss the changing landscape of clinical research, and clinical trials in particular, focusing on reasons for the increasing costs and inefficiencies. These reasons include excessively complex design, overly restrictive inclusion and exclusion criteria, burdensome regulations, excessive source-data verification, and concerns about the effect of clinical research conduct on workflow. Thought leaders have called on the clinical research community to consider alternative, transformative business models, including those models that focus on simplicity and leveraging of digital resources. We present some examples of innovative approaches by which some investigators have successfully conducted large-scale, clinical trials at relatively low cost. These examples include randomized registry trials, cluster-randomized trials, adaptive trials, and trials that are fully embedded within digital clinical care or administrative platforms.

Clinical validation of the Tempus xO assay

Science.gov (United States)

Beaubier, Nike; Tell, Robert; Huether, Robert; Bontrager, Martin; Bush, Stephen; Parsons, Jerod; Shah, Kaanan; Baker, Tim; Selkov, Gene; Taxter, Tim; Thomas, Amber; Bettis, Sam; Khan, Aly; Lau, Denise; Lee, Christina; Barber, Matthew; Cieslik, Marcin; Frankenberger, Casey; Franzen, Amy; Weiner, Ali; Palmer, Gary; Lonigro, Robert; Robinson, Dan; Wu, Yi-Mi; Cao, Xuhong; Lefkofsky, Eric; Chinnaiyan, Arul; White, Kevin P.

2018-01-01

We have developed a clinically validated NGS assay that includes tumor, germline and RNA sequencing. We apply this assay to clinical specimens and cell lines, and we demonstrate a clinical sensitivity of 98.4% and positive predictive value of 100% for the clinically actionable variants measured by the assay. We also demonstrate highly accurate copy number measurements and gene rearrangement identification. PMID:29899824

Implementing Clinical Research Using Factorial Designs: A Primer.

Science.gov (United States)

Baker, Timothy B; Smith, Stevens S; Bolt, Daniel M; Loh, Wei-Yin; Mermelstein, Robin; Fiore, Michael C; Piper, Megan E; Collins, Linda M

2017-07-01

Factorial experiments have rarely been used in the development or evaluation of clinical interventions. However, factorial designs offer advantages over randomized controlled trial designs, the latter being much more frequently used in such research. Factorial designs are highly efficient (permitting evaluation of multiple intervention components with good statistical power) and present the opportunity to detect interactions amongst intervention components. Such advantages have led methodologists to advocate for the greater use of factorial designs in research on clinical interventions (Collins, Dziak, & Li, 2009). However, researchers considering the use of such designs in clinical research face a series of choices that have consequential implications for the interpretability and value of the experimental results. These choices include: whether to use a factorial design, selection of the number and type of factors to include, how to address the compatibility of the different factors included, whether and how to avoid confounds between the type and number of interventions a participant receives, and how to interpret interactions. The use of factorial designs in clinical intervention research poses choices that differ from those typically considered in randomized clinical trial designs. However, the great information yield of the former encourages clinical researchers' increased and careful execution of such designs. Copyright © 2017. Published by Elsevier Ltd.

Clinical and microbiological characteristics of Nocardiosis including those caused by emerging Nocardia species in Taiwan, 1998-2008.

Science.gov (United States)

Tan, C-K; Lai, C-C; Lin, S-H; Liao, C-H; Chou, C-H; Hsu, H-L; Huang, Y-T; Hsueh, P-R

2010-07-01

The genus of Nocardia is rapidly expanding and the species distribution varies with different geographical locations. We retrospectively reviewed the laboratory records of the bacteriology laboratory at National Taiwan University Hospital from January 1998 to June 2008 to identify patients with nocardiosis. During the study period, 164 isolates of Nocardia spp. were identified from 134 patients but only 113 patients had Nocardia infection. Nocardia brasiliensis (n = 54) was the most common pathogen, followed by N. asteroides (n = 36), N. farcinica (n = 7), N. flavorosea (n = 4), N. otitidiscaviarum (n = 3), N. nova (n = 3), N. beijingensis (n = 2) and one each of N. puris, N. jinanensis and N. takedensis. The major types of infection were cutaneous infection (56.6%), pulmonary infection (33.6%) and disseminated infection (7.1%). Eighty-eight patients received sulfonamide-containing antibiotic and eight of 100 patients with available data on outcomes died during the episode of nocardiosis. In conclusion, the clinical and microbiological manifestations of Nocardiosis vary with the different Nocardia species. Accurate identification of the species is crucial to make the diagnosis.

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of lifestyle diet and exercise interventions for osteoarthritis.

Science.gov (United States)

Messier, S P; Callahan, L F; Golightly, Y M; Keefe, F J

2015-05-01

The objective was to develop a set of "best practices" for use as a primer for those interested in entering the clinical trials field for lifestyle diet and/or exercise interventions in osteoarthritis (OA), and as a set of recommendations for experienced clinical trials investigators. A subcommittee of the non-pharmacologic therapies committee of the OARSI Clinical Trials Working Group was selected by the Steering Committee to develop a set of recommended principles for non-pharmacologic diet/exercise OA randomized clinical trials. Topics were identified for inclusion by co-authors and reviewed by the subcommittee. Resources included authors' expert opinions, traditional search methods including MEDLINE (via PubMed), and previously published guidelines. Suggested steps and considerations for study methods (e.g., recruitment and enrollment of participants, study design, intervention and assessment methods) were recommended. The recommendations set forth in this paper provide a guide from which a research group can design a lifestyle diet/exercise randomized clinical trial in patients with OA. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Ginger for Prevention of Antituberculosis-induced Gastrointestinal Adverse Reactions Including Hepatotoxicity: A Randomized Pilot Clinical Trial.

Science.gov (United States)

Emrani, Zahra; Shojaei, Esphandiar; Khalili, Hossein

2016-06-01

In this study, the potential benefits of ginger in preventing antituberculosis drug-induced gastrointestinal adverse reactions including hepatotoxicity have been evaluated in patients with tuberculosis. Patients in the ginger and placebo groups (30 patients in each group) received either 500 mg ginger (Zintoma)(®) or placebo one-half hour before each daily dose of antituberculosis drugs for 4 weeks. Patients' gastrointestinal complaints (nausea, vomiting, dyspepsia, and abdominal pain) and antituberculosis drug-induced hepatotoxicity were recorded during the study period. In this cohort, nausea was the most common antituberculosis drug-induced gastrointestinal adverse reactions. Forty eight (80%) patients experienced nausea. Nausea was more common in the placebo than the ginger group [27 (90%) vs 21 (70%), respectively, p = 0.05]. During the study period, 16 (26.7%) patients experienced antituberculosis drug-induced hepatotoxicity. Patients in the ginger group experienced less, but not statistically significant, antituberculosis drug-induced hepatotoxicity than the placebo group (16.7% vs 36.7%, respectively, p = 0.07). In conclusion, ginger may be a potential option for prevention of antituberculosis drug-induced gastrointestinal adverse reactions including hepatotoxicity. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Learning for clinical leadership.

Science.gov (United States)

Cook, Michael J; Leathard, Helen L

2004-11-01

Clinical leadership has been acclaimed widely as a major factor influencing the quality of patient care but research has revealed a paucity of preparation for this significant role. Leadership literature has rarely addressed clinical leadership specifically or referred to the difficulties in characterizing effective clinical leaders. The research informing this paper focused on clinical leadership and identified five attributes of effective clinical leaders: creativity, highlighting, influencing, respecting, and supporting. Effective clinical leaders adopted a transformational leadership style and improved care, through others, by including transformational (soft) knowledge as an integral part of their effective practice repertoire. Phronesis is introduced as practical wisdom that is gained through immersion in relevant experience, and as an essential element of preparation for clinical nursing leadership practice. It is argued, that learning to transform care requires opportunities to work within an environment that engenders and supports aspiring leaders. The paper describes the research process, elucidates the attributes through illustrative examples from the research data, and discusses an emergent educational strategy for the development of these attributes by clinicians in their practice environments. The paper also describes the application of this research through an interdisciplinary programme for staff leading teams in both health and social services sectors.

Patient engagement in clinical trials: The Clinical Trials Transformation Initiative's leadership from theory to practical implementation.

Science.gov (United States)

Patrick-Lake, Bray

2018-02-01

Patient engagement is an increasingly important aspect of successful clinical trials. Over the past decade, as patient group involvement in clinical trials has continued to increase and diversify, the Clinical Trials Transformation Initiative has not only recognized the crucial role patients play in improving the clinical trial enterprise but also made a deep commitment to help grow and shape the emerging field of patient engagement. This article describes the evolution of patient engagement including the origins of the patient engagement movement; barriers to successful engagement and remaining challenges to full and valuable collaboration between patient groups and trial sponsors; and Clinical Trials Transformation Initiative's role in influencing the field through organizational practices, formal project work and resulting recommendations, and external advocacy efforts.

Clinical Databases for Chest Physicians.

Science.gov (United States)

Courtwright, Andrew M; Gabriel, Peter E

2018-04-01

A clinical database is a repository of patient medical and sociodemographic information focused on one or more specific health condition or exposure. Although clinical databases may be used for research purposes, their primary goal is to collect and track patient data for quality improvement, quality assurance, and/or actual clinical management. This article aims to provide an introduction and practical advice on the development of small-scale clinical databases for chest physicians and practice groups. Through example projects, we discuss the pros and cons of available technical platforms, including Microsoft Excel and Access, relational database management systems such as Oracle and PostgreSQL, and Research Electronic Data Capture. We consider approaches to deciding the base unit of data collection, creating consensus around variable definitions, and structuring routine clinical care to complement database aims. We conclude with an overview of regulatory and security considerations for clinical databases. Copyright © 2018 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

Clinical reasoning: concept analysis.

Science.gov (United States)

Simmons, Barbara

2010-05-01

This paper is a report of a concept analysis of clinical reasoning in nursing. Clinical reasoning is an ambiguous term that is often used synonymously with decision-making and clinical judgment. Clinical reasoning has not been clearly defined in the literature. Healthcare settings are increasingly filled with uncertainty, risk and complexity due to increased patient acuity, multiple comorbidities, and enhanced use of technology, all of which require clinical reasoning. Data sources. Literature for this concept analysis was retrieved from several databases, including CINAHL, PubMed, PsycINFO, ERIC and OvidMEDLINE, for the years 1980 to 2008. Rodgers's evolutionary method of concept analysis was used because of its applicability to concepts that are still evolving. Multiple terms have been used synonymously to describe the thinking skills that nurses use. Research in the past 20 years has elucidated differences among these terms and identified the cognitive processes that precede judgment and decision-making. Our concept analysis defines one of these terms, 'clinical reasoning,' as a complex process that uses cognition, metacognition, and discipline-specific knowledge to gather and analyse patient information, evaluate its significance, and weigh alternative actions. This concept analysis provides a middle-range descriptive theory of clinical reasoning in nursing that helps clarify meaning and gives direction for future research. Appropriate instruments to operationalize the concept need to be developed. Research is needed to identify additional variables that have an impact on clinical reasoning and what are the consequences of clinical reasoning in specific situations.

Characterization of Vibrio cholerae O1 El Tor Biotype Variant Clinical Isolates from Bangladesh and Haiti, Including a Molecular Genetic Analysis of Virulence Genes ▿

Science.gov (United States)

Son, Mike S.; Megli, Christina J.; Kovacikova, Gabriela; Qadri, Firdausi; Taylor, Ronald K.

2011-01-01

Vibrio cholerae serogroup O1, the causative agent of the diarrheal disease cholera, is divided into two biotypes: classical and El Tor. Both biotypes produce the major virulence factors toxin-coregulated pilus (TCP) and cholera toxin (CT). Although possessing genotypic and phenotypic differences, El Tor biotype strains displaying classical biotype traits have been reported and subsequently were dubbed El Tor variants. Of particular interest are reports of El Tor variants that produce various levels of CT, including levels typical of classical biotype strains. Here, we report the characterization of 10 clinical isolates from the International Centre for Diarrhoeal Disease Research, Bangladesh, and a representative strain from the 2010 Haiti cholera outbreak. We observed that all 11 strains produced increased CT (2- to 10-fold) compared to that of wild-type El Tor strains under in vitro inducing conditions, but they possessed various TcpA and ToxT expression profiles. Particularly, El Tor variant MQ1795, which produced the highest level of CT and very high levels of TcpA and ToxT, demonstrated hypervirulence compared to the virulence of El Tor wild-type strains in the infant mouse cholera model. Additional genotypic and phenotypic tests were conducted to characterize the variants, including an assessment of biotype-distinguishing characteristics. Notably, the sequencing of ctxB in some El Tor variants revealed two copies of classical ctxB, one per chromosome, contrary to previous reports that located ctxAB only on the large chromosome of El Tor biotype strains. PMID:21880975

Is medical perspective on clinical governance practices associated with clinical units’ performance and mortality? A cross-sectional study through a record-linkage procedure

Directory of Open Access Journals (Sweden)

Guido Sarchielli

2016-07-01

Full Text Available Objective: Assessment of the knowledge and application as well as perceived utility by doctors of clinical governance tools in order to explore their impact on clinical units’ performance measured through mortality rates and efficiency indicators. Methods: This research is a cross-sectional study with a deterministic record-linkage procedure. The sample includes n = 1250 doctors (n = 249 chiefs of clinical units; n = 1001 physicians working in six public hospitals located in the Emilia-Romagna Region in Italy. Survey instruments include a checklist and a research-made questionnaire which were used for data collection about doctors’ knowledge and application as well as perceived utility of clinical governance tools. The analysis was based on clinical units’ performance indicators which include patients’ mortality, extra-region active mobility rate, average hospital stay, bed occupancy, rotation and turnover rates, and the comparative performance index as efficiency indicators. Results: The clinical governance tools are known and applied differently in all the considered clinical units. Significant differences emerged between roles and organizational levels at which the medical leadership is carried out. The levels of knowledge and application of clinical governance practices are correlated with the clinical units’ efficiency indicators (bed occupancy rate, bed turnover interval, and extra-region mobility. These multiple linear regression analyses highlighted that the clinical governance knowledge and application is correlated with clinical units’ mortality rates (odds ratio, −8.677; 95% confidence interval, −16.654, −0.700. Conclusion: The knowledge and application, as well as perceived utility by medical professionals of clinical governance tools, are associated with the mortality rates of their units and with some efficiency indicators. However, the medical frontline staff seems to not consider homogeneously useful

Clinical variability of Waardenburg-Shah syndrome in patients with proximal 13q deletion syndrome including the endothelin-B receptor locus.

Science.gov (United States)

Tüysüz, Beyhan; Collin, Anna; Arapoğlu, Müjde; Suyugül, Nezir

2009-10-01

Waardenburg-Shah syndrome (Waardenburg syndrome type IV-WS4) is an auditory-pigmentary disorder that combines clinical features of pigmentary abnormalities of the skin, hair and irides, sensorineural hearing loss, and Hirschsprung disease (HSCR). Mutations in the endothelin-B receptor (EDNRB) gene on 13q22 have been found to cause this syndrome. Mutations in both alleles cause the full phenotype, while heterozygous mutations cause isolated HSCR or HSCR with minor pigmentary anomalies and/or sensorineural deafness. We investigated the status of the EDNRB gene, by FISH analysis, in three patients with de novo proximal 13q deletions detected at cytogenetic analysis and examined the clinical variability of WS4 among these patients. Chromosome 13q was screened with locus specific FISH probes and breakpoints were determined at 13q22.1q31.3 in Patients 1 and 3, and at 13q21.1q31.3 in Patient 2. An EDNRB specific FISH probe was deleted in all three patients. All patients had common facial features seen in proximal 13q deletion syndrome and mild mental retardation. However, findings related to WS4 were variable; Patient 1 had hypopigmentation of the irides and HSCR, Patient 2 had prominent bicolored irides and mild bilateral hearing loss, and Patient 3 had only mild unilateral hearing loss. These data contribute new insights into the pathogenesis of WS4.

Computerized Clinical Simulations.

Science.gov (United States)

Reinecker, Lynn

1985-01-01

Describes technique involved in designing a clinical simulation problem for the allied health field of respiratory therapy; discusses the structure, content, and scoring categories of the simulation; and provides a sample program which illustrates a programming technique in BASIC, including a program listing and a sample flowchart. (MBR)

African Journal of Clinical and Experimental Microbiology ...

African Journals Online (AJOL)

Author Guidelines. Aims and scope. African Journal of Clinical and Experimental Microbiology is the official Journal of African Society for Clinical Microbiology. It publishes original research papers in all aspects of Medical Microbiology, including Bacteriology, Virology Rickettsiology and Chlamydiology, Mycology, ...

Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262): clinical effectiveness systematic review and economic model.

OpenAIRE

Archer, R.; Tappenden, P.; Ren, S.; Martyn-St James, M.; Harvey, R.; Basarir, H.; Stevens, J.; Carroll, C.; Cantrell, A.; Lobo, A.; Hoque, S.

2016-01-01

BACKGROUND: Ulcerative colitis (UC) is the most common form of inflammatory bowel disease in the UK. UC can have a considerable impact on patients' quality of life. The burden for the NHS is substantial. OBJECTIVES: To evaluate the clinical effectiveness and safety of interventions, to evaluate the incremental cost-effectiveness of all interventions and comparators (including medical and surgical options), to estimate the expected net budget impact of each intervention, and to identify key re...

Developing Federal Clinical Care Recommendations for Women.

Science.gov (United States)

Godfrey, Emily M; Tepper, Naomi K; Curtis, Kathryn M; Moskosky, Susan B; Gavin, Loretta E

2015-08-01

The provision of family planning services has important health benefits for the U.S. Approximately 25 million women in the U.S. receive contraceptive services annually and 44 million make at least one family planning-related clinical visit each year. These services are provided by private clinicians, as well as publicly funded clinics, including specialty family planning clinics, health departments, Planned Parenthoods, community health centers, and primary care clinics. Recommendations for providing quality family planning services have been published by CDC and the Office of Population Affairs of the DHHS. This paper describes the process used to develop the women's clinical services portion of the new recommendations and the rationale underpinning them. The recommendations define family planning services as contraceptive care, pregnancy testing and counseling, achieving pregnancy, basic infertility care, sexually transmitted disease services, and preconception health. Because many women who seek family planning services have no other source of care, the recommendations also include additional screening services related to women's health, such as cervical cancer screening. These clinical guidelines are aimed at providing the highest-quality care and are designed to establish a national standard for family planning in the U.S. Published by Elsevier Inc.

Comprehensive brachytherapy physical and clinical aspects

CERN Document Server

Baltas, Dimos; Meigooni, Ali S; Hoskin, Peter J

2013-01-01

Modern brachytherapy is one of the most important oncological treatment modalities requiring an integrated approach that utilizes new technologies, advanced clinical imaging facilities, and a thorough understanding of the radiobiological effects on different tissues, the principles of physics, dosimetry techniques and protocols, and clinical expertise. A complete overview of the field, Comprehensive Brachytherapy: Physical and Clinical Aspects is a landmark publication, presenting a detailed account of the underlying physics, design, and implementation of the techniques, along with practical guidance for practitioners. Bridging the gap between research and application, this single source brings together the technological basis, radiation dosimetry, quality assurance, and fundamentals of brachytherapy. In addition, it presents discussion of the most recent clinical practice in brachytherapy including prostate, gynecology, breast, and other clinical treatment sites. Along with exploring new clinical protocols, ...

Cerebellar abnormalities contribute to disability including cognitive impairment in multiple sclerosis.

Directory of Open Access Journals (Sweden)

Katrin Weier

Full Text Available The cerebellum is known to be involved not only in motor but also cognitive and affective processes. Structural changes in the cerebellum in relation to cognitive dysfunction are an emerging topic in the field of neuro-psychiatric disorders. In Multiple Sclerosis (MS cerebellar motor and cognitive dysfunction occur in parallel, early in the onset of the disease, and the cerebellum is one of the predilection sites of atrophy. This study is aimed at determining the relationship between cerebellar volumes, clinical cerebellar signs, cognitive functioning and fatigue in MS. Cerebellar volumetry was conducted using T1-weighted MPRAGE magnetic resonance imaging of 172 MS patients. All patients underwent a clinical and brief neuropsychological assessment (information processing speed, working memory, including fatigue testing. Patients with and without cerebellar signs differed significantly regarding normalized cerebellar total volume (nTCV, normalized brain volume (nBV and whole brain T2 lesion volume (LV. Patients with cerebellar dysfunction likewise performed worse in cognitive tests. A regression analysis indicated that age and nTCV explained 26.3% of the variance in SDMT (symbol digit modalities test performance. However, only age, T2 LV and nBV remained predictors in the full model (r(2 = 0.36. The full model for the prediction of PASAT (Paced Auditory Serial Addition Test scores (r(2 = 0.23 included age, cerebellar and T2 LV. In the case of fatigue, only age and nBV (r(2 = 0.17 emerged as significant predictors. These data support the view that cerebellar abnormalities contribute to disability, including cognitive impairment in MS. However, this contribution does not seem to be independent of, and may even be dominated by wider spread MS pathology as reflected by nBV and T2 LV.

Evaluation Apprehension and Impression Management in Clinical Medical Education.

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McGaghie, William C

2018-05-01

Historically, clinical medical education has relied on subjective evaluations of students and residents to judge their clinical competence. The uncertainty associated with these subjective clinical evaluations has produced evaluation apprehension among learners and attempts to manage one's professional persona (impression management) among peers and supervisors. Such behavior has been documented from antiquity through the Middle Ages to the present, including in two new qualitative studies in this issue of Academic Medicine on the social psychology of clinical medical education. New approaches to medical education, including competency-based education, mastery learning, and assessment methods that unite evaluation and education, are slowly changing the culture of clinical medical education. The author of this Invited Commentary argues that this shift will bring greater transparency and accountability to clinical medical education and gradually reduce evaluation apprehension and the impression management motives it produces.

Concept-Based Learning in Clinical Experiences: Bringing Theory to Clinical Education for Deep Learning.

Science.gov (United States)

Nielsen, Ann

2016-07-01

Concept-based learning is used increasingly in nursing education to support the organization, transfer, and retention of knowledge. Concept-based learning activities (CBLAs) have been used in clinical education to explore key aspects of the patient situation and principles of nursing care, without responsibility for total patient care. The nature of best practices in teaching and the resultant learning are not well understood. The purpose of this multiple-case study research was to explore and describe concept-based learning in the context of clinical education in inpatient settings. Four clinical groups (each a case) were observed while they used CBLAs in the clinical setting. Major findings include that concept-based learning fosters deep learning, connection of theory with practice, and clinical judgment. Strategies used to support learning, major teaching-learning foci, and preconditions for concept-based teaching and learning will be described. Concept-based learning is promising to support integration of theory with practice and clinical judgment through application experiences with patients. [J Nurs Educ. 2016;55(7):365-371.]. Copyright 2016, SLACK Incorporated.

Whole body MRI, including diffusion-weighted imaging in follow-up of patients with testicular cancer.

Science.gov (United States)

Mosavi, Firas; Laurell, Anna; Ahlström, Håkan

2015-11-01

Whole body (WB) magnetic resonance imaging (MRI), including diffusion-weighted imaging (DWI) has become increasingly utilized in cancer imaging, yet the clinical utility of these techniques in follow-up of testicular cancer patients has not been evaluated. The purpose of this study was to evaluate the feasibility of WB MRI with continuous table movement (CTM) technique, including multistep DWI in follow-up of patients with testicular cancer. WB MRI including DWI was performed in follow-up of 71 consecutive patients (median age, 37 years; range 19-84) with histologically confirmed testicular cancer. WB MRI protocol included axial T1-Dixon and T2-BLADE sequences using CTM technique. Furthermore, multi-step DWI was performed using b-value 50 and 1000 s/mm(2). One criterion for feasibility was patient tolerance and satisfactory image quality. Another criterion was the accuracy in detection of any pathological mass, compared to standard of reference. Signal intensity in DWI was used for evaluation of residual mass activity. Clinical, laboratory and imaging follow-up were applied as standard of reference for the evaluation of WB MRI. WB MRI was tolerated in nearly all patients (69/71 patients, 97%) and the image quality was satisfactory. Metal artifacts deteriorated the image quality in six patients, but it did not influence the overall results. No case of clinical relapse was observed during the follow-up time. There was a good agreement between conventional WB MRI and standard of reference in all patients. Three patients showed residual masses and DWI signal was not restricted in these patients. Furthermore, DWI showed abnormally high signal intensity in a normal-sized retroperitoneal lymph node indicating metastasis. The subsequent (18)F-FDG PET/CT could verify the finding. WB MRI with CTM technique including multi-step DWI is feasible in follow-up of patients with testicular cancer. DWI may contribute to important added-value data to conventional MRI sequences

Clinical applications of PET/CT

International Nuclear Information System (INIS)

Le Ngoc Ha

2011-01-01

The purpose of this article is to review the evolution of PET, PET/CT focusing on the technical aspects, PET radiopharmaceutical developments and current clinical applications as well. The newest technologic advances have been reviewed, including improved crystal design, acquisition modes, reconstruction algorithms, etc. These advancements will continue to improve contrast, decrease noise, and increase resolution. Combined PET/CT system provides faster attenuation correction and useful anatomic correlation to PET functional information. A number of new radiopharmaceuticals used for PET imaging have been developed, however, FDG have been considered as the principal PET radiotracer. The current clinical applications of PET and PET/CT are widespread and include oncology, cardiology and neurology. (author)

Cancer clinical trials in persons with HIV infection.

Science.gov (United States)

Little, Richard F

2017-01-01

The era of modern HIV therapeutics is well underway. The cancer and infectious disease epidemiology of HIV disease has markedly altered as populations are availed to the benefits of antiretroviral therapy (ARV). The types of cancers occurring among those with HIV infection has broadened but the case burden in absolute numbers is very low relative to the background population. There are fewer incident cases of the AIDS-defining cancers (aggressive B-cell lymphomas, Kaposi's sarcoma, and cervical cancer). There is an increased risk for certain non-AIDS-defining cancers, but these occur somewhat sporadically relative to clinical trial enrollment. The changing epidemiology of cancer in HIV poses challenges as well as opportunities for participation of persons with HIV in cancer therapy clinical trials. There are excellent examples of cancer trials that inform cancer therapy for patients with HIV infection. Examples include those from HIV-specific trials and from trials mainly focused on the background population that included patients with HIV infection. Interpretation of clinical trials to guide therapy for those with HIV infection and cancer largely depends on data that does not include HIV-infected patients. The ability to extend clinical trial findings to populations not included in clinical trials remains problematic for a variety of populations, including those with HIV or AIDS. Careful prioritization of studies designed to bridge this gap is needed. However, there are published studies that serve as excellent examples bridging these gaps and the portfolio of cancer therapy trials underway will inform HIV and cancer better than at any time in the past.

Clinical supervisors' perceived needs for teaching communication skills in clinical practice.

Science.gov (United States)

Perron, N Junod; Sommer, J; Hudelson, P; Demaurex, F; Luthy, C; Louis-Simonet, M; Nendaz, M; De Grave, W; Dolmans, D; van der Vleuten, C P M

2009-07-01

Lack of faculty training is often cited as the main obstacle to post-graduate teaching in communication skills. To explore clinical supervisors' needs and perceptions regarding their role as communication skills trainers. Four focus group discussions were conducted with clinical supervisors from two in-patient and one out-patient medical services from the Geneva University Hospitals. Focus groups were audio taped, transcribed verbatim and analyzed in a thematic way using Maxqda software for qualitative data analysis. Clinical supervisors said that they frequently addressed communication issues with residents but tended to intervene as rescuers, clinicians or coaches rather than as formal instructors. They felt their own training did not prepare them to teach communication skills. Other barriers to teach communication skills include lack of time, competing demands, lack of interest and experience on the part of residents, and lack of institutional priority given to communication issues. Respondents expressed a desire for experiential and reflective training in a work-based setting and emphasised the need for a non-judgmental learning atmosphere. Results suggest that organisational priorities, culture and climate strongly influence the degree to which clinical supervisors may feel comfortable to teach communication skills to residents. Attention must be given to these contextual factors in the development of an effective communication skills teaching program for clinical supervisors.

Clinical characteristics and management of children with ...

African Journals Online (AJOL)

reflux (VUR), including the clinical characteristics and management. Summary background data The association ... different clinical characteristics compared with the other two groups of patients with high-grade VUR. .... way ANOVA test; while qualitative data were analyzed using Chi square. The difference was considered.

Transforming practice into clinical scholarship.

Science.gov (United States)

Limoges, Jacqueline; Acorn, Sonia

2016-04-01

The aims of this paper were to explicate clinical scholarship as synonymous with the scholarship of application and to explore the evolution of scholarly practice to clinical scholarship. Boyer contributed an expanded view of scholarship that recognized various approaches to knowledge production beyond pure research (discovery) to include the scholarship of integration, application and teaching. There is growing interest in using Boyer's framework to advance knowledge production in nursing but the discussion of clinical scholarship in relation to Boyer's framework is sparse. Discussion paper. Literature from 1983-2015 and Boyer's framework. When clinical scholarship is viewed as a synonym for Boyer's scholarship of application, it can be aligned to this well established framework to support knowledge generated in clinical practice. For instance, applying the three criteria for scholarship (documentation, peer review and dissemination) can ensure that the knowledge produced is rigorous, available for critique and used by others to advance nursing practice and patient care. Understanding the differences between scholarly practice and clinical scholarship can promote the development of clinical scholarship. Supporting clinical leaders to identify issues confronting nursing practice can enable scholarly practice to be transformed into clinical scholarship. Expanding the understanding of clinical scholarship and linking it to Boyer's scholarship of application can assist nurses to generate knowledge that addresses clinical concerns. Further dialogue about how clinical scholarship can address the theory-practice gap and how publication of clinical scholarship could be expanded given the goals of clinical scholarship is warranted. © 2016 John Wiley & Sons Ltd.

Clinical reasoning of nursing students on clinical placement: Clinical educators' perceptions.

Science.gov (United States)

Hunter, Sharyn; Arthur, Carol

2016-05-01

Graduate nurses may have knowledge and adequate clinical psychomotor skills however they have been identified as lacking the clinical reasoning skills to deliver safe, effective care suggesting contemporary educational approaches do not always facilitate the development of nursing students' clinical reasoning. While nursing literature explicates the concept of clinical reasoning and develops models that demonstrate clinical reasoning, there is very little published about nursing students and clinical reasoning during clinical placements. Semi-structured interviews were conducted with ten clinical educators to gain an understanding of how they recognised, developed and appraised nursing students' clinical reasoning while on clinical placement. This study found variability in the clinical educators' conceptualisation, recognition, and facilitation of students' clinical reasoning. Although most of the clinical educators conceptualised clinical reasoning as a process those who did not demonstrated the greatest variability in the recognition and facilitation of students' clinical reasoning. The clinical educators in this study also described being unable to adequately appraise a student's clinical reasoning during clinical placement with the use of the current performance assessment tool. Copyright © 2016 Elsevier Ltd. All rights reserved.

Use of an Objective Structured Clinical Examination in Clinical Nurse Specialist Education.

Science.gov (United States)

Cuevas, Heather E; Timmerman, Gayle M

2016-01-01

Helping patients maximize their potential using expert coaching to facilitate lifestyle change is an important practice area for clinical nurse specialists (CNSs). The purpose is to determine the usefulness of objective structured clinical examinations (OSCEs) for evaluating CNS students' coaching competencies in the context of facilitating lifestyle change. Despite the use of OSCEs to assess competencies in clinical skills (eg, performance of procedures, decision making), its potential for evaluating coaching competencies for lifestyle change has not been demonstrated. We developed 4 OSCEs dealing with coaching patients in exercise, weight loss, stress reduction, or nonpharmacologic management of hyperlipidemia. Evaluation criteria included (1) approach to the patient, (2) information gathering, (3) motivational interviewing, and (4) management (medical and behavioral strategies). Student performance ranged from highly organized with proficient coaching skills to disorganized and focused solely on clinical management and prescriptive communication. Student responses were positive. Objective structured clinical examinations were highly useful for evaluating CNS students' coaching competencies for lifestyle change. Using OSCEs early in the semester to provide students feedback on their performance and again at the end to determine improvement optimizes use of this teaching strategy.

European AIDS Clinical Society (EACS) guidelines for the clinical management and treatment of HIV-infected adults

DEFF Research Database (Denmark)

Clumeck, N; Pozniak, A; Raffi, F

2008-01-01

A working group of the European AIDS Clinical Society (EACS) have developed these guidelines for European clinicians to help them in the treatment of adults with HIV infection. This third version of the guidelines includes, as new topics, the assessment of patients at initial and subsequent clinic...... virological failure and the treatment of HIV during pregnancy. In Europe, there is a wide range of clinical practices in antiretroviral therapy depending on various factors such as drug registration, national policies, local availability, reimbursement and access to treatment. These can vary greatly from one...

How Exemplary Inpatient Teaching Physicians Foster Clinical Reasoning.

Science.gov (United States)

Houchens, Nathan; Harrod, Molly; Fowler, Karen E; Moody, Stephanie; Saint, Sanjay

2017-09-01

Clinical reasoning is a crucial component of training in health professions. These cognitive skills are necessary to provide quality care and avoid diagnostic error. Much previous literature has focused on teaching clinical reasoning in nonclinical environments and does not include learner reflections. The authors sought to explore, through multiple perspectives including learners, techniques used by exemplary inpatient clinician-educators for explicitly cultivating clinical reasoning. The authors conducted (2014-2015) a multisite, exploratory qualitative study examining how excellent clinician-educators foster clinical reasoning during general medicine rounds. This was accomplished through interviews of educators, focus group discussions with learners, and direct observations of clinical teaching. The authors reviewed field notes and transcripts using techniques of thematic analysis. Twelve clinician-educators, 57 current learners, and 26 former learners participated in observations and interviews. The techniques and behaviors of educators were categorized into 4 themes, including 1) emphasizing organization and prioritization, 2) accessing prior knowledge, 3) thinking aloud, and 4) analyzing the literature. The findings of this comprehensive study both confirm strategies found in previous literature and provide novel approaches. This is the first study to incorporate the perspectives of learners. Educators' techniques and behaviors, identified through direct observation and supported by reflections from the entire team, can inform best practices for the teaching of clinical reasoning. Copyright © 2017 Elsevier Inc. All rights reserved.

Clinical arthrography

International Nuclear Information System (INIS)

Arndt, R.; Horns, J.W.; Gold, R.H.; Blaschke, D.D.

1985-01-01

This book deals with the method and interpretation of arthrography of the shoulder, knee, ankle, elbow, hip, wrist, and metacarpophalangeal, interphalangeal, and temporomandibular joints. The emphasis is on orthopaedic disorders, usually of traumatic origin, which is in keeping with the application of arthrography in clinical practice. Other conditions, such as inflammatory and degenerative diseases, congenital disorders and, in the case of the hip, arthrography of reconstructive joint surgery, are included. Each chapter is devoted to one joint and provides a comprehensive discussion on the method of arthrography, including single and double contrast techniques where applicable, normal radiographic anatomy, and finally, the interpretation of the normal and the abnormal arthrogram

Clinical indications of prolactin radioimmunoassay

International Nuclear Information System (INIS)

Lengyel, A.M.J.; Vieira, J.G.H.; Zanella, M.R.; Zampieri, M.; Chacra, A.R.

1980-01-01

Is a review is presented of the main clinical uses of prolactin measurements, including the galactorrhea-amenorrhea syndrome, an experiment employing the prolactin radioimmunoassay is related. (Author) [pt

Clinical effectiveness of garlic (Allium sativum).

Science.gov (United States)

Pittler, Max H; Ernst, Edzard

2007-11-01

The objective of this review is to update and assess the clinical evidence based on rigorous trials of the effectiveness of garlic (A. sativum). Systematic searches were carried out in Medline, Embase, Amed, the Cochrane Database of Systematic Reviews, Natural Standard, and the Natural Medicines Comprehensive Database (search date December 2006). Our own files, the bibliographies of relevant papers and the contents pages of all issues of the review journal FACT were searched for further studies. No language restrictions were imposed. To be included, trials were required to state that they were randomized and double blind. Systematic reviews and meta-analyses of garlic were included if based on the results of randomized, double-blind trials. The literature searches identified six relevant systematic reviews and meta-analysis and double-blind randomized trials (RCT) that were published subsequently. These relate to cancer, common cold, hypercholesterolemia, hypertension, peripheral arterial disease and pre-eclampsia. The evidence based on rigorous clinical trials of garlic is not convincing. For hypercholesterolemia, the reported effects are small and may therefore not be of clinical relevance. For reducing blood pressure, few studies are available and the reported effects are too small to be clinically meaningful. For all other conditions not enough data are available for clinical recommendations.

Food allergy: a clinician's criteria for including sera in a serum bank.

Science.gov (United States)

Ballmer-Weber, B K; Fernández-Rivas, M

2008-10-01

Safety assessment for genetically-engineered crop plants includes assessment for allergic responses. To facilitate this assessment, serum banks should contain well-characterised sera from patients with confirmed food allergies. A serum is defined as well-characterised if it is taken from a patient who has a convincing history of allergic responses to a known allergen or an allergen-containing food, a positive skin prick test (or elevated IgE response), and a positive response in a clinical food challenge.

Marking out the clinical expert/clinical leader/clinical scholar: perspectives from nurses in the clinical arena.

Science.gov (United States)

Mannix, Judy; Wilkes, Lesley; Jackson, Debra

2013-01-01

Clinical scholarship has been conceptualised and theorised in the nursing literature for over 30 years but no research has captured nurses' clinicians' views on how it differs or is the same as clinical expertise and clinical leadership. The aim of this study was to determine clinical nurses' understanding of the differences and similarities between the clinical expert, clinical leader and clinical scholar. A descriptive interpretative qualitative approach using semi-structured interviews with 18 practising nurses from Australia, Canada and England. The audio-taped interviews were transcribed and the text coded for emerging themes. The themes were sorted into categories of clinical expert, clinical leader and clinical scholarship as described by the participants. These themes were then compared and contrasted and the essential elements that characterise the nursing roles of the clinical expert, clinical leader and clinical scholar were identified. Clinical experts were seen as linking knowledge to practice with some displaying clinical leadership and scholarship. Clinical leadership is seen as a positional construct with a management emphasis. For the clinical scholar they linked theory and practice and encouraged research and dissemination of knowledge. There are distinct markers for the roles of clinical expert, clinical leader and clinical scholar. Nurses working in one or more of these roles need to work together to improve patient care. An 'ideal nurse' may be a blending of all three constructs. As nursing is a practice discipline its scholarship should be predominantly based on clinical scholarship. Nurses need to be encouraged to go beyond their roles as clinical leaders and experts to use their position to challenge and change through the propagation of knowledge to their community.

Clinical grade adult stem cell banking.

Science.gov (United States)

Thirumala, Sreedhar; Goebel, W Scott; Woods, Erik J

2009-07-01

There has been a great deal of scientific interest recently generated by the potential therapeutic applications of adult stem cells in human care but there are several challenges regarding quality and safety in clinical applications and a number of these challenges relate to the processing and banking of these cells ex-vivo. As the number of clinical trials and the variety of adult cells used in regenerative therapy increases, safety remains a primary concern. This has inspired many nations to formulate guidelines and standards for the quality of stem cell collection, processing, testing, banking, packaging and distribution. Clinically applicable cryopreservation and banking of adult stem cells offers unique opportunities to advance the potential uses and widespread implementation of these cells in clinical applications. Most current cryopreservation protocols include animal serum proteins and potentially toxic cryoprotectant additives (CPAs) that prevent direct use of these cells in human therapeutic applications. Long term cryopreservation of adult stem cells under good manufacturing conditions using animal product free solutions is critical to the widespread clinical implementation of ex-vivo adult stem cell therapies. Furthermore, to avoid any potential cryoprotectant related complications, reduced CPA concentrations and efficient post-thaw washing to remove CPA are also desirable. The present review focuses on the current strategies and important aspects of adult stem cell banking for clinical applications. These include current good manufacturing practices (cGMPs), animal protein free freezing solutions, cryoprotectants, freezing & thawing protocols, viability assays, packaging and distribution. The importance and benefits of banking clinical grade adult stem cells are also discussed.

Why providers participate in clinical trials: considering the National Cancer Institute's Community Clinical Oncology Program.

Science.gov (United States)

McAlearney, Ann Scheck; Song, Paula H; Reiter, Kristin L

2012-11-01

The translation of research evidence into practice is facilitated by clinical trials such as those sponsored by the National Cancer Institute's Community Clinical Oncology Program (CCOP) that help disseminate cancer care innovations to community-based physicians and provider organizations. However, CCOP participation involves unsubsidized costs and organizational challenges that raise concerns about sustained provider participation in clinical trials. This study was designed to improve our understanding of why providers participate in the CCOP in order to inform the decision-making process of administrators, clinicians, organizations, and policy-makers considering CCOP participation. We conducted a multi-site qualitative study of five provider organizations engaged with the CCOP. We interviewed 41 administrative and clinician key informants, asking about what motivated CCOP participation, and what benefits they associated with involvement. We deductively and inductively analyzed verbatim interview transcripts, and explored themes that emerged. Interviewees expressed both "altruistic" and "self-interested" motives for CCOP participation. Altruistic reasons included a desire to increase access to clinical trials and feeling an obligation to patients. Self-interested reasons included the desire to enhance reputation, and a need to integrate disparate cancer care activities. Perceived benefits largely matched expressed motives for CCOP participation, and included internal and external benefits to the organization, and quality of care benefits for both patients and participating physicians. The motives and benefits providers attributed to CCOP participation are consistent with translational research goals, offering evidence that participation can contribute value to providers by expanding access to innovative medical care for patients in need. Copyright © 2012 Elsevier Inc. All rights reserved.

Perspectives on Clinical Informatics: Integrating Large-Scale Clinical, Genomic, and Health Information for Clinical Care

Directory of Open Access Journals (Sweden)

In Young Choi

2013-12-01

Full Text Available The advances in electronic medical records (EMRs and bioinformatics (BI represent two significant trends in healthcare. The widespread adoption of EMR systems and the completion of the Human Genome Project developed the technologies for data acquisition, analysis, and visualization in two different domains. The massive amount of data from both clinical and biology domains is expected to provide personalized, preventive, and predictive healthcare services in the near future. The integrated use of EMR and BI data needs to consider four key informatics areas: data modeling, analytics, standardization, and privacy. Bioclinical data warehouses integrating heterogeneous patient-related clinical or omics data should be considered. The representative standardization effort by the Clinical Bioinformatics Ontology (CBO aims to provide uniquely identified concepts to include molecular pathology terminologies. Since individual genome data are easily used to predict current and future health status, different safeguards to ensure confidentiality should be considered. In this paper, we focused on the informatics aspects of integrating the EMR community and BI community by identifying opportunities, challenges, and approaches to provide the best possible care service for our patients and the population.

Pressure Ulcers in Adults: Prediction and Prevention. Clinical Practice Guideline Number 3.

Science.gov (United States)

Agency for Health Care Policy and Research (DHHS/PHS), Rockville, MD.

This package includes a clinical practice guideline, quick reference guide for clinicians, and patient's guide to predicting and preventing pressure ulcers in adults. The clinical practice guideline includes the following: overview of the incidence and prevalence of pressure ulcers; clinical practice guideline (introduction, risk assessment tools…

An overview of clinical governance policies, practices and initiatives.

Science.gov (United States)

Braithwaite, Jeffrey; Travaglia, Joanne F

2008-02-01

To map the emergence of, and define, clinical governance; to discuss current best practices, and to explore the implications of these for boards of directors and executives wishing to promote a clinical governance approach in their health services. Review and analysis of the published and grey literature on clinical governance from 1966 to 2006. Medline and CINAHL databases, key journals and websites were systematically searched. Central issues were identified in the literature as key to effective clinical governance. These include: ensuring that links are made between health services' clinical and corporate governance; the use of clinical governance to promote quality and safety through a focus on quality assurance and continuous improvement; the creation of clinical governance structures to improve safety and quality and manage risk and performance; the development of strategies to ensure the effective exchange of data, knowledge and expertise; and the sponsoring of a patient-centred approach to service delivery. A comprehensive approach to clinical governance necessarily includes the active participation of boards and executives in sponsoring and promoting clinical governance as a quality and safety strategy. Although this is still a relatively recent development, the signs are promising.

Marking out the clinical expert/clinical leader/clinical scholar: perspectives from nurses in the clinical arena

Science.gov (United States)

2013-01-01

Background Clinical scholarship has been conceptualised and theorised in the nursing literature for over 30 years but no research has captured nurses’ clinicians’ views on how it differs or is the same as clinical expertise and clinical leadership. The aim of this study was to determine clinical nurses’ understanding of the differences and similarities between the clinical expert, clinical leader and clinical scholar. Methods A descriptive interpretative qualitative approach using semi-structured interviews with 18 practising nurses from Australia, Canada and England. The audio-taped interviews were transcribed and the text coded for emerging themes. The themes were sorted into categories of clinical expert, clinical leader and clinical scholarship as described by the participants. These themes were then compared and contrasted and the essential elements that characterise the nursing roles of the clinical expert, clinical leader and clinical scholar were identified. Results Clinical experts were seen as linking knowledge to practice with some displaying clinical leadership and scholarship. Clinical leadership is seen as a positional construct with a management emphasis. For the clinical scholar they linked theory and practice and encouraged research and dissemination of knowledge. Conclusion There are distinct markers for the roles of clinical expert, clinical leader and clinical scholar. Nurses working in one or more of these roles need to work together to improve patient care. An ‘ideal nurse’ may be a blending of all three constructs. As nursing is a practice discipline its scholarship should be predominantly based on clinical scholarship. Nurses need to be encouraged to go beyond their roles as clinical leaders and experts to use their position to challenge and change through the propagation of knowledge to their community. PMID:23587282

Redesigning a clinical mentoring program for improved outcomes in the clinical training of clerks

Directory of Open Access Journals (Sweden)

Chia-Der Lin

2015-09-01

Full Text Available Introduction: Mentorship has been noted as critical to medical students adapting to clinical training in the medical workplace. A lack of infrastructure in a mentoring program might deter relationship building between mentors and mentees. This study assessed the effect of a redesigned clinical mentoring program from the perspective of clerks. The objective was to assess the benefits of the redesigned program and identify potential improvements. Methods: A redesigned clinical mentoring program was launched in a medical center according to previous theoretical and practical studies on clinical training workplaces, including the elements of mentor qualifications, positive and active enhancers for mentor–mentee relationship building, the timing of mentoring performance evaluation, and financial and professional incentives. A four-wave web survey was conducted, comprising one evaluation of the former mentoring program and three evaluations of the redesigned clinical mentoring program. Sixty-four fifth-year medical students in clerkships who responded to the first wave and to at least two of the three following waves were included in the study. A structured and validated questionnaire encompassing 15 items on mentor performance and the personal characteristics of the clerks was used. Mixed linear models were developed for repeated measurements and to adjust for personal characteristics. Results: The results revealed that the redesigned mentoring program improved the mentors’ performance over time for most evaluated items regarding professional development and personal support provided to the mentees. Conclusions: Our findings serve as an improved framework for the role of the institution and demonstrate how institutional policies, programs, and structures can shape a clinical mentoring program. We recommend the adoption of mentorship schemes for other cohorts of medical students and for different learning and training stages involved in becoming a

Redesigning a clinical mentoring program for improved outcomes in the clinical training of clerks

Science.gov (United States)

Lin, Chia-Der; Lin, Blossom Yen-Ju; Lin, Cheng-Chieh; Lee, Cheng-Chun

2015-01-01

Introduction Mentorship has been noted as critical to medical students adapting to clinical training in the medical workplace. A lack of infrastructure in a mentoring program might deter relationship building between mentors and mentees. This study assessed the effect of a redesigned clinical mentoring program from the perspective of clerks. The objective was to assess the benefits of the redesigned program and identify potential improvements. Methods A redesigned clinical mentoring program was launched in a medical center according to previous theoretical and practical studies on clinical training workplaces, including the elements of mentor qualifications, positive and active enhancers for mentor–mentee relationship building, the timing of mentoring performance evaluation, and financial and professional incentives. A four-wave web survey was conducted, comprising one evaluation of the former mentoring program and three evaluations of the redesigned clinical mentoring program. Sixty-four fifth-year medical students in clerkships who responded to the first wave and to at least two of the three following waves were included in the study. A structured and validated questionnaire encompassing 15 items on mentor performance and the personal characteristics of the clerks was used. Mixed linear models were developed for repeated measurements and to adjust for personal characteristics. Results The results revealed that the redesigned mentoring program improved the mentors’ performance over time for most evaluated items regarding professional development and personal support provided to the mentees. Conclusions Our findings serve as an improved framework for the role of the institution and demonstrate how institutional policies, programs, and structures can shape a clinical mentoring program. We recommend the adoption of mentorship schemes for other cohorts of medical students and for different learning and training stages involved in becoming a physician. PMID

Clinical status and philosophy of clinical care of radionuclide-treated beagles

International Nuclear Information System (INIS)

MacMillan, K.; Holbrook, C.; White, R.; Chrisp, C.

1975-01-01

A manual for therapy of beagles is reviewed. The following protocol is outlined and described: antibiotic therapy, chemotherapy for neoplasms, hormone therapy, nutritional therapy, radiation therapy, steroid therapy, and miscellaneous treatments. The manual also includes sections on diagnosis and discussions of individual cases. Tables summarizing clinical cases seen during 1974 are presented

Clinical Decision Support (CDS) Inventory

Data.gov (United States)

U.S. Department of Health & Human Services — The Clinical Decision Support (CDS) Inventory contains descriptions of past and present CDS projects across the Federal Government. It includes Federal projects,...

The clinical reasoning process in randomized clinical trials with patients with non-specific neck pain is incomplete: A systematic review.

Science.gov (United States)

Maissan, Francois; Pool, Jan; de Raaij, Edwin; Mollema, Jürgen; Ostelo, Raymond; Wittink, Harriet

2018-06-01

Primarily to evaluate the completeness of the description of the clinical reasoning process in RCTs with patients with non-specific neck pain with an argued or diagnosed cause i.e. an impairment or activity limitation. Secondly, to determine the association between the completeness of the clinical reasoning process and the degree of risk of bias. Pubmed, Cinahl and PEDro were systematically searched from inception to July 2016. RCTs (n = 122) with patients with non-specific neck pain receiving physiotherapy treatment published in English were included. Data extraction included study characteristics and important features of the clinical reasoning process based on the Hypothesis-Oriented Algorithm for Clinicians II (HOAC II)]. Thirty-seven studies (30%) had a complete clinical reasoning process of which 8 (6%) had a 'diagnosed cause' and 29 (24%) had an 'argued cause'. The Spearmans rho association between the extent of the clinical reasoning process and the risk of bias was -0.2. In the majority of studies (70%) the described clinical reasoning process was incomplete. A very small proportion (6%) had a 'diagnosed cause'. Therefore, a better methodological quality does not necessarily imply a better described clinical reasoning process. Copyright © 2018 Elsevier Ltd. All rights reserved.

Changes in information behavior in clinical teams after introduction of a clinical librarian service

Science.gov (United States)

Urquhart, Christine; Turner, Janet; Durbin, Jane; Ryan, Jean

2007-01-01

Objectives: The eighteen-month evaluation of a clinical librarian project (October 2003–March 2005) conducted in North Wales, United Kingdom (UK) assessed the benefits of clinical librarian support to clinical teams, the impact of mediated searching services, and the effectiveness of information skills training, including journal club support. Methods: The evaluation assessed changes in teams' information-seeking behavior and their willingness to delegate searching to a clinical librarian. Baseline (n = 69 responses, 73% response rate) and final questionnaire (n = 57, 77% response rate) surveys were complemented by telephone and face-to-face interviews (n = 33) among 3 sites served. Those attending information skills training sessions (n = 130) completed evaluations at the session and were surveyed 1 month after training (n = 24 questionnaire responses, n = 12 interviews). Results: Health professionals in clinical teams reported that they were more willing to undertake their own searching, but also more willing to delegate some literature searching, than at the start of the project. The extent of change depended on the team and the type of information required. Information skills training was particularly effective when organized around journal clubs. Conclusions: Collaboration with a clinical librarian increased clinician willingness to seek information. Clinical librarian services should leverage structured training opportunities such as journal clubs. PMID:17252062

[Historic Development of Clinical Biology Laboratories in Luxembourg].

Science.gov (United States)

Wennig R; Humbel R-L

2014-01-01

After a short overview on the development of diagnostic tools in clinical biology at an international level from Antiquity towards today, a history of the clinical biology including public and private institutions in Luxembourg will be outlined.

Clinical neurogenetics: autosomal dominant spinocerebellar ataxia.

Science.gov (United States)

Shakkottai, Vikram G; Fogel, Brent L

2013-11-01

The autosomal dominant spinocerebellar ataxias are a diverse and clinically heterogeneous group of disorders characterized by degeneration and dysfunction of the cerebellum and its associated pathways. Clinical and diagnostic evaluation can be challenging because of phenotypic overlap among causes, and a stratified and systematic approach is essential. Recent advances include the identification of additional genes causing dominant genetic ataxia, a better understanding of cellular pathogenesis in several disorders, the generation of new disease models that may stimulate development of new therapies, and the use of new DNA sequencing technologies, including whole-exome sequencing, to improve diagnosis. Copyright © 2013 Elsevier Inc. All rights reserved.

Clinical neurogenetics: neuropathic lysosomal storage disorders.

Science.gov (United States)

Pastores, Gregory M; Maegawa, Gustavo H B

2013-11-01

The lysosomal storage disorders are a clinically heterogeneous group of inborn errors of metabolism, associated with the accumulation of incompletely degraded macromolecules within several cellular sites. Affected individuals present with a broad range of clinical problems, including hepatosplenomegaly and skeletal dysplasia. Onset of symptoms may range from birth to adulthood. Most are associated with neurologic features. Later-onset forms are often misdiagnosed as symptoms, which might include psychiatric manifestations, are slowly progressive, and may precede other neurologic or systemic features. Symptomatic care, which remains the mainstay for most subtypes, can lead to significant improvement in quality of life. Copyright © 2013 Elsevier Inc. All rights reserved.

Types of Cancer Clinical Trials

Science.gov (United States)

Information about the several types of cancer clinical trials, including treatment trials, prevention trials, screening trials, supportive and palliative care trials. Each type of trial is designed to answer different research questions.

Clinical leadership and nursing explored: A literature search.

Science.gov (United States)

Stanley, David; Stanley, Karen

2017-10-27

To explore what we know of the concept of clinical leadership and what the term means. Clues to the definition of clinical leadership, the attributes of effective and less effective clinical leaders, models of clinical leadership and the barriers that hinder clinical leadership development were explored. While nursing leadership and healthcare leadership are terms that have been evident in nursing and health industry literature for many decades, clinical leadership is a relatively new term and is may still be misunderstood. A search was undertaken of formal and informal literature using a library database and a range of search engines for the words "clinical leadership" and "clinical leadership in nursing." In each case, the full search parameters were employed with searches between 1974-2016. Full-text articles were requested, and English was the preferred language. In total, 3,259 publications were located through seven database search tools, although these included a large number of duplications. Following further informal searches and removing irrelevant material, 27 research or literature review focused papers were retained that included 17 qualitative studies, one quantitative study, one mixed method study, one Delphi study and two that compared other research studies. As well, five literature reviews were retained in the synthesis. The data synthesis resulted five categories: definitions of clinical leadership, characteristics most likely or least associated with clinical leadership, models applied to clinical leadership and limits to clinical leadership development. Clinical leaders are recognised for having their values and beliefs parallel their actions and interventions. They are found across the spectrum of health organisations, often at the highest level for clinical interaction, but not commonly at the highest management level in a ward or unit team and they are seen in all clinical environments. Clinical Leadership and an understanding on how

Quality of clinical trials: A moving target

Science.gov (United States)

Bhatt, Arun

2011-01-01

Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials. PMID:22145122

OARSI Clinical Trials Recommendations: Soluble biomarker assessments in clinical trials in osteoarthritis.

Science.gov (United States)

Kraus, V B; Blanco, F J; Englund, M; Henrotin, Y; Lohmander, L S; Losina, E; Önnerfjord, P; Persiani, S

2015-05-01

The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials and their utility at five stages, including preclinical development and phase I to phase IV trials. As demonstrated by this summary, biomarkers can provide value at all stages of therapeutics development. When resources permit, we recommend collection of biospecimens in all OA clinical trials for a wide variety of reasons but in particular, to determine whether biomarkers are useful in identifying those individuals most likely to receive clinically important benefits from an intervention; and to determine whether biomarkers are useful for identifying individuals at earlier stages of OA in order to institute treatment at a time more amenable to disease modification. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Lesbian, gay, bisexual, transgender content on reproductive endocrinology and infertility clinic websites.

Science.gov (United States)

Wu, Harold Y; Yin, Ophelia; Monseur, Brent; Selter, Jessica; Collins, Lillian J; Lau, Brandyn D; Christianson, Mindy S

2017-07-01

To assess geographical distribution and practice characteristics of fertility clinics inclusive of lesbian, gay, bisexual, and transgender (LGBT) patients. Cross-sectional analysis. Not applicable. None. None. Prevalence and geographical distribution of fertility clinic websites with LGBT-specific content, indicated by keywords and home page cues specific to the LGBT patient population. Assessment of relationship between LGBT-specific content and clinic characteristics, including U.S. region, clinic size, private versus academic setting, and state-mandated fertility insurance coverage. Of 379 websites analyzed, 201 (53%) contained LGBT content. Clinics with the highest proportion of LGBT website content were in the Northeast (59/82, 72%) and West (63/96, 66%), while the lowest proportion was in the Midwest (29/74, 39%) and South (50/127, 39%). Most frequently used terms included lesbian (72%), LGBT/LGBTQ (69%), and gay (68%), while less used terms included trans/transgender (32%) and bisexual (15%). Larger clinic size was associated with LGBT-specific website content (odds ratio, 4.42; 95% confidence interval, 2.07-9.67). Practice type and state-mandated fertility insurance coverage were not associated with a clinic website having LGBT content. Over half of Society for Assisted Reproductive Technology member fertility clinics included LGBT content on their websites, yet those in the Midwest and South were significantly less likely to do so. Predictive factors for having LGBT website content included location in northeastern and western regions and increasing clinic size. Further studies are needed to evaluate whether inclusion of LGBT content on clinic websites impacts use of reproductive services by the LGBT patient population. Copyright © 2017 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Marking out the clinical expert/clinical leader/clinical scholar: perspectives from nurses in the clinical arena

OpenAIRE

Mannix, Judy; Wilkes, Lesley; Jackson, Debra

2013-01-01

Background Clinical scholarship has been conceptualised and theorised in the nursing literature for over 30?years but no research has captured nurses? clinicians? views on how it differs or is the same as clinical expertise and clinical leadership. The aim of this study was to determine clinical nurses? understanding of the differences and similarities between the clinical expert, clinical leader and clinical scholar. Methods A descriptive interpretative qualitative approach using semi-struct...

[Research activity in clinical biochemistry

DEFF Research Database (Denmark)

Jorgensen, H.L.; Larsen, B.; Ingwersen, P.

2008-01-01

BACKGROUND: Quantitative bibliometric measurements of research activity are frequently used, e.g. for evaluating applicants for academic positions. The purpose of this investigation is to assess research activity within the medical speciality of Clinical Biochemistry by comparing it with a matched...... Clinical Biochemistry, 57 fulfilled the inclusion criteria. Each of these 57 was matched according to medical title with two randomly chosen specialists from other specialities, totaling 114. Using Medline and the Web of Science, the number of publications and the number of citations were then ascertained....... RESULTS: 25% of the 11,691 specialists held a PhD degree or doctoral degree, DMSci, (Clinical Biochemistry: 61%). The 171 specialists included in the study had 9,823 papers in Medline and 10,140 papers in the Web of Science. The number of Medline papers per specialist was 71 for Clinical Biochemistry...

[Research activity in clinical biochemistry

DEFF Research Database (Denmark)

Jorgensen, H.L.; Larsen, B.; Ingwersen, P.

2008-01-01

Clinical Biochemistry, 57 fulfilled the inclusion criteria. Each of these 57 was matched according to medical title with two randomly chosen specialists from other specialities, totaling 114. Using Medline and the Web of Science, the number of publications and the number of citations were then ascertained......BACKGROUND: Quantitative bibliometric measurements of research activity are frequently used, e.g. for evaluating applicants for academic positions. The purpose of this investigation is to assess research activity within the medical speciality of Clinical Biochemistry by comparing it with a matched....... RESULTS: 25% of the 11,691 specialists held a PhD degree or doctoral degree, DMSci, (Clinical Biochemistry: 61%). The 171 specialists included in the study had 9,823 papers in Medline and 10,140 papers in the Web of Science. The number of Medline papers per specialist was 71 for Clinical Biochemistry...

International collaboration including patients is essential to develop new therapies for patients with myositis.

Science.gov (United States)

Lundberg, Ingrid E; Vencovsky, Jiri

2017-05-01

To discuss the needs for international collaborations between investigators in different disciplines working with myositis and with patients with myositis. Recent advances in detection of several myositis-specific autoantibodies that are associated with distinct clinical phenotypes, will enable studies in new well defined clinically homogenous subgroups of myositis This is likely to lead to development of new information on molecular pathogenesis that might be different in different myositis subgroups. Subgrouping patients according to autoantibody profile may also be important to assess outcome, to identify prognostic biomarkers and in clinical trials. As these are rare disorders international collaboration is essential to enrol large enough cohorts of the subgroups. To facilitate such collaboration we have developed a web-based international myositis register, www.euromyositis.eu, which includes validated outcome measures and patient reported outcome measures. This register is to support research but also to support decision-making in the clinic. We welcome investigators to join the Euromyositis register. Myositis is a heterogeneous disorder with varying treatment response and outcome. There is a high unmet need for new therapies which can only be achieved by increased knowledge on molecular disease mechanisms. Subgrouping patients according to autoantibody profile may be a new way forward to get a better understanding on disease mechanisms and to develop novel therapies.

Characteristics of adults with anxiety or depression treated at an internet clinic: comparison with a national survey and an outpatient clinic.

Science.gov (United States)

Titov, Nickolai; Andrews, Gavin; Kemp, Alice; Robinson, Emma

2010-05-28

There is concern that people seeking treatment over the Internet for anxiety or depressive disorders may not resemble the general population or have less severe disorders than patients attending outpatient clinics or cases identified in community surveys. Thus the response to treatment in Internet based trials might not generalize. We reviewed the characteristics of applicants to an Australian Internet-based treatment clinic for anxiety and depression, and compared this sample with people from a national epidemiological survey and a sample of patients at a specialist outpatient anxiety and depression clinic. Participants included 774 volunteers to an Internet clinic, 454 patients at a specialist anxiety disorders outpatient clinic, and 627 cases identified in a national epidemiological survey. Main measures included demographic characteristics, and severity of symptoms as measured by the Kessler 10-Item scale (K-10), the 12-item World Health Organisation Disability Assessment Schedule second edition (WHODAS-II), the Penn State Worry Questionnaire (PSWQ), the Body Sensations Questionnaire (BSQ), the Automatic Cognitions Questionnaire (ACQ), the Social Interaction Anxiety Scale (SIAS) and the Social Phobia Scale (SPS). The severity of symptoms of participants attending the two clinics was similar, and both clinic samples were more severe than cases in the epidemiological survey. The Internet clinic and national samples were older and comprised more females than those attending the outpatient clinic. The Internet clinic sample were more likely to be married than the other samples. The Internet clinic and outpatient clinic samples had higher levels of educational qualifications than the national sample, but employment status was similar across groups. The Internet clinic sample have disorders as severe as those attending an outpatient clinic, but with demographic characteristics more consistent with the national sample. These data indicate that the benefits of Internet

Characteristics of adults with anxiety or depression treated at an internet clinic: comparison with a national survey and an outpatient clinic.

Directory of Open Access Journals (Sweden)

Nickolai Titov

2010-05-01

Full Text Available There is concern that people seeking treatment over the Internet for anxiety or depressive disorders may not resemble the general population or have less severe disorders than patients attending outpatient clinics or cases identified in community surveys. Thus the response to treatment in Internet based trials might not generalize.We reviewed the characteristics of applicants to an Australian Internet-based treatment clinic for anxiety and depression, and compared this sample with people from a national epidemiological survey and a sample of patients at a specialist outpatient anxiety and depression clinic. Participants included 774 volunteers to an Internet clinic, 454 patients at a specialist anxiety disorders outpatient clinic, and 627 cases identified in a national epidemiological survey. Main measures included demographic characteristics, and severity of symptoms as measured by the Kessler 10-Item scale (K-10, the 12-item World Health Organisation Disability Assessment Schedule second edition (WHODAS-II, the Penn State Worry Questionnaire (PSWQ, the Body Sensations Questionnaire (BSQ, the Automatic Cognitions Questionnaire (ACQ, the Social Interaction Anxiety Scale (SIAS and the Social Phobia Scale (SPS.The severity of symptoms of participants attending the two clinics was similar, and both clinic samples were more severe than cases in the epidemiological survey. The Internet clinic and national samples were older and comprised more females than those attending the outpatient clinic. The Internet clinic sample were more likely to be married than the other samples. The Internet clinic and outpatient clinic samples had higher levels of educational qualifications than the national sample, but employment status was similar across groups.The Internet clinic sample have disorders as severe as those attending an outpatient clinic, but with demographic characteristics more consistent with the national sample. These data indicate that the benefits

Core competencies in clinical neuropsychology training across the world.

Science.gov (United States)

Hessen, Erik; Hokkanen, Laura; Ponsford, Jennie; van Zandvoort, Martine; Watts, Ann; Evans, Jonathan; Haaland, Kathleen Y

2018-05-01

This work aimed to review main competency requirements from training models in countries with well-established specialties in clinical neuropsychology and to extract core competencies that likely will apply to clinical neuropsychologists regardless of regional and cultural context. We reviewed standards for post-graduate training in clinical neuropsychology from countries in Europe, Australia, and North America based on existing literature, presentations at international conferences, and from description of the training models from national psychological or neuropsychological associations. Despite differences, the reviewed models share similar core competencies considered necessary for a specialty in clinical neuropsychology: (1) In-depth knowledge of general psychology including clinical psychology (post-graduate level), ethical, and legal standards. (2) Expert knowledge about clinically relevant brain-behavioral relationships. (3) Comprehensive knowledge about, and skills in, related clinical disciplines. (4) In-depth knowledge about and skills in neuropsychological assessment, including decision-making and diagnostic competency according to current classification of diseases. (5) Competencies in the area of diversity and culture in relation to clinical neuropsychology. (6) Communication competency of neuropsychological findings and test results to relevant and diverse audiences. (7) Knowledge about and skills in psychological and neuropsychological intervention, including treatment and rehabilitation. All the models have undergone years of development in accordance with requirements of national health care systems in different parts of the world. Despite differences, the common core competency requirements across different regions of the world suggest generalizability of these competencies. We hope this summary can be useful as countries with less established neuropsychology training programs develop their models.

OARSI Clinical Trials Recommendations: Hand imaging in clinical trials in osteoarthritis.

Science.gov (United States)

Hunter, D J; Arden, N; Cicuttini, F; Crema, M D; Dardzinski, B; Duryea, J; Guermazi, A; Haugen, I K; Kloppenburg, M; Maheu, E; Miller, C G; Martel-Pelletier, J; Ochoa-Albíztegui, R E; Pelletier, J-P; Peterfy, C; Roemer, F; Gold, G E

2015-05-01

Tremendous advances have occurred in our understanding of the pathogenesis of hand osteoarthritis (OA) and these are beginning to be applied to trials targeted at modification of the disease course. The purpose of this expert opinion, consensus driven exercise is to provide detail on how one might use and apply hand imaging assessments in disease modifying clinical trials. It includes information on acquisition methods/techniques (including guidance on positioning for radiography, sequence/protocol recommendations/hardware for MRI); commonly encountered problems (including positioning, hardware and coil failures, sequences artifacts); quality assurance/control procedures; measurement methods; measurement performance (reliability, responsiveness, validity); recommendations for trials; and research recommendations. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Clinical neuropsychology in Israel: history, training, practice and future challenges.

Science.gov (United States)

Vakil, Eli; Hoofien, Dan

2016-11-01

This is an invited paper for a special issue on international perspectives on training and practice in clinical neuropsychology. We provide a review of the status of clinical neuropsychology in Israel, including the history of neuropsychological, educational, and accreditation requirements to become a clinical neuropsychologist and to practice clinical neuropsychology. The information is based primarily on the personal knowledge of the authors who have been practicing clinical neuropsychology for over three decades and hold various administrative and academic positions in this field. Second, we conducted three ad hoc surveys among clinical and rehabilitation psychologists; heads of academic programs for rehabilitation and neuropsychology; and heads of accredited service providers. Third, we present a literature review of publications by clinical neuropsychologists in Israel. Most of the clinical neuropsychologists are graduates of either rehabilitation or clinical training programs. The vast majority of neuropsychologists are affiliated with rehabilitation psychology. The training programs (2-3 years of graduate school) provide solid therapeutic and diagnostic skills to the students. Seventy-five percent of the participants in this survey are employed at least part-time by public or state-funded institutions. Israeli neuropsychologists are heavily involved in case management, including vocational counseling, and rehabilitation psychotherapy. Conclusions and future goals: Although clinical neuropsychologists in Israel are well educated and valued by all health professionals, there are still several challenges that must be addressed in order to further advance the field and the profession. These included the need for Hebrew-language standardized and normalized neuropsychological tests and the application of evidence-based interventions in neuropsychological rehabilitation.

Effectiveness of a Simulated Clinical Examination in the Assessment of the Clinical Competencies of Entry-Level Trainees in a Family Medicine Residency Programme

Science.gov (United States)

Curran, Vernon R.; Butler, Roger; Duke, Pauline; Eaton, William H.; Moffatt, Scott M.; Sherman, Greg P.; Pottle, Madge

2012-01-01

Clinical competence is a multidimensional concept and encompasses a variety of skills including procedural, problem-solving and clinical judgement. The initial stages of postgraduate medical training are believed to be a particularly important time for the development of clinical skill competencies. This study reports on an evaluation of a…

Leveraging electronic health records for clinical research.

Science.gov (United States)

Raman, Sudha R; Curtis, Lesley H; Temple, Robert; Andersson, Tomas; Ezekowitz, Justin; Ford, Ian; James, Stefan; Marsolo, Keith; Mirhaji, Parsa; Rocca, Mitra; Rothman, Russell L; Sethuraman, Barathi; Stockbridge, Norman; Terry, Sharon; Wasserman, Scott M; Peterson, Eric D; Hernandez, Adrian F

2018-04-30

Electronic health records (EHRs) can be a major tool in the quest to decrease costs and timelines of clinical trial research, generate better evidence for clinical decision making, and advance health care. Over the past decade, EHRs have increasingly offered opportunities to speed up, streamline, and enhance clinical research. EHRs offer a wide range of possible uses in clinical trials, including assisting with prestudy feasibility assessment, patient recruitment, and data capture in care delivery. To fully appreciate these opportunities, health care stakeholders must come together to face critical challenges in leveraging EHR data, including data quality/completeness, information security, stakeholder engagement, and increasing the scale of research infrastructure and related governance. Leaders from academia, government, industry, and professional societies representing patient, provider, researcher, industry, and regulator perspectives convened the Leveraging EHR for Clinical Research Now! Think Tank in Washington, DC (February 18-19, 2016), to identify barriers to using EHRs in clinical research and to generate potential solutions. Think tank members identified a broad range of issues surrounding the use of EHRs in research and proposed a variety of solutions. Recognizing the challenges, the participants identified the urgent need to look more deeply at previous efforts to use these data, share lessons learned, and develop a multidisciplinary agenda for best practices for using EHRs in clinical research. We report the proceedings from this think tank meeting in the following paper. Copyright © 2018 Elsevier, Inc. All rights reserved.

Why Providers Participate in Clinical Trials: Considering the National Cancer Institute’s Community Clinical Oncology Program

Science.gov (United States)

McAlearney, Ann Scheck; Song, Paula H.; Reiter, Kristin L.

2012-01-01

Background The translation of research evidence into practice is facilitated by clinical trials such as those sponsored by the National Cancer Institute’s Community Clinical Oncology Program (CCOP) that help disseminate cancer care innovations to community-based physicians and provider organizations. However, CCOP participation involves unsubsidized costs and organizational challenges that raise concerns about sustained provider participation in clinical trials. Objectives This study was designed to improve our understanding of why providers participate in the CCOP in order to inform the decision-making process of administrators, clinicians, organizations, and policy-makers considering CCOP participation. Research Methods We conducted a multi-site qualitative study of five provider organizations engaged with the CCOP. We interviewed 41 administrative and clinician key informants, asking about what motivated CCOP participation, and what benefits they associated with involvement. We deductively and inductively analyzed verbatim interview transcripts, and explored themes that emerged. Results Interviewees expressed both “altruistic” and “self-interested” motives for CCOP participation. Altruistic reasons included a desire to increase access to clinical trials and feeling an obligation to patients. Self-interested reasons included the desire to enhance reputation, and a need to integrate disparate cancer care activities. Perceived benefits largely matched expressed motives for CCOP participation, and included internal and external benefits to the organization, and quality of care benefits for both patients and participating physicians. Conclusion The motives and benefits providers attributed to CCOP participation are consistent with translational research goals, offering evidence that participation can contribute value to providers by expanding access to innovative medical care for patients in need. PMID:22925970

Developments in statistical evaluation of clinical trials

CERN Document Server

Oud, Johan; Ghidey, Wendimagegn

2014-01-01

This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.

Oligotrophic bacteria isolated from clinical materials.

OpenAIRE

Tada, Y; Ihmori, M; Yamaguchi, J

1995-01-01

Oligotrophic bacteria (oligotrophs) are microorganisms that grow in extremely nutritionally deficient conditions in which the concentrations of organic substances are low. Many oligotrophic bacteria were isolated from clinical materials including urine, sputum, swabbings of the throat, vaginal discharges, and others. Seventy-seven strains of oligotrophic bacteria from 871 samples of clinical material were isolated. A relatively higher frequency of isolation of oligotrophic bacteria was shown ...

Evaluating critical thinking in clinical practice.

Science.gov (United States)

Oermann, M H

1997-01-01

Although much has been written about measurement instruments for evaluating critical thinking in nursing, this article describes clinical evaluation strategies for critical thinking. Five methods are discussed: 1) observation of students in practice; 2) questions for critical thinking, including Socratic questioning; 3) conferences; 4) problem-solving strategies; and 5) written assignments. These methods provide a means of evaluating students' critical thinking within the context of clinical practice.

Mycobacteria of clinical interest

International Nuclear Information System (INIS)

Casal, M.

1986-01-01

This book is based upon a symposium on mycobacteria of clinical interest. Due to the multidisciplinary participation of, among others, microbiologists, clinicians, immunologists and epidemiologists, a very wide and thorough presentation of the present state of clinical research in this field is ensured. Topics of particular interest included in this volume were the new antimicrobial agents active against mycobacteria; new therapeutic possibilities; a system of rapid diagnosis of tuberculosis and mycobacteriosis; mycobacteriosis in AIDS; progress in immunopathology of tuberculosis and leprosy; progress in bacteriology and vaccination in leprosy; progress in immunological diagnosis and new epidemiological biovars of M. tuberculosis. (Auth.)

Clinical imaging of the pancreas

International Nuclear Information System (INIS)

May, G.; Gardiner, R.

1987-01-01

Featuring more than 300 high-quality radiographs and scan images, clinical imaging of the pancreas systematically reviews all appropriate imaging modalities for diagnosing and evaluating a variety of commonly encountered pancreatic disorders. After presenting a succinct overview of pancreatic embryology, anatomy, and physiology, the authors establish the clinical indications-including postoperative patient evaluation-for radiologic examination of the pancreas. The diagnostic capabilities and limitations of currently available imaging techniques for the pancreas are thoroughly assessed, with carefully selected illustrations depicting the types of images and data obtained using these different techniques. The review of acute and chronic pancreatitis considers the clinical features and possible complications of their variant forms and offers guidance in selecting appropriate imaging studies

Clinical Reasoning in Medicine: A Concept Analysis

Directory of Open Access Journals (Sweden)

Shahram Yazdani

2018-01-01

Full Text Available Background: Clinical reasoning plays an important role in the ability of physicians to make diagnoses and decisions. It is considered the physician’s most critical competence, but it is an ambiguous conceptin medicine that needs a clear analysis and definition. Our aim was to clarify the concept of clinical reasoning in medicine by identifying its components and to differentiate it from other similar concepts.It is necessary to have an operational definition of clinical reasoning, and its components must be precisely defined in order to design successful interventions and use it easily in future research.Methods: McKenna’s nine-step model was applied to facilitate the clarification of the concept of clinical reasoning. The literature for this concept analysis was retrieved from several databases, including Scopus, Elsevier, PubMed, ISI, ISC, Medline, and Google Scholar, for the years 1995– 2016 (until September 2016. An extensive search of the literature was conducted using the electronic database. Accordingly, 17 articles and one book were selected for the review. We applied McKenna’s method of concept analysis in studying clinical reasoning, so that definitional attributes, antecedents, and consequences of this concept were extracted.Results: Clinical reasoning has nine major attributes in medicine. These attributes include: (1 clinical reasoning as a cognitive process; (2 knowledge acquisition and application of different types of knowledge; (3 thinking as a part of the clinical reasoning process; (4 patient inputs; (5 contextdependent and domain-specific processes; (6 iterative and complex processes; (7 multi-modal cognitive processes; (8 professional principles; and (9 health system mandates. These attributes are influenced by the antecedents of workplace context, practice frames of reference, practice models of the practitioner, and clinical skills. The consequences of clinical reasoning are the metacognitive improvement of

Reporting and evaluation of HIV-related clinical endpoints in two multicenter international clinical trials

DEFF Research Database (Denmark)

Lifson, A; Rhame, F; Bellosa, W

2006-01-01

adjudication between reviewers before diagnostic certainty was assigned. CONCLUSION: Important requirements for HIV trials using clinical endpoints include objective definitions of "confirmed" and "probable," a formal reporting process with adequate information and supporting source documentation, evaluation......PURPOSE: The processes for reporting and review of progression of HIV disease clinical endpoints are described for two large phase III international clinical trials. METHOD: SILCAAT and ESPRIT are multicenter randomized HIV trials evaluating the impact of interleukin-2 on disease progression...... and death in HIV-infected patients receiving antiretroviral therapy. We report definitions used for HIV progression of disease endpoints, procedures for site reporting of such events, processes for independent review of reported events by an Endpoint Review Committee (ERC), and the procedure...

2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology.

Science.gov (United States)

Neuss, Michael N; Gilmore, Terry R; Belderson, Kristin M; Billett, Amy L; Conti-Kalchik, Tara; Harvey, Brittany E; Hendricks, Carolyn; LeFebvre, Kristine B; Mangu, Pamela B; McNiff, Kristen; Olsen, MiKaela; Schulmeister, Lisa; Von Gehr, Ann; Polovich, Martha

2016-12-01

Purpose To update the ASCO/Oncology Nursing Society (ONS) Chemotherapy Administration Safety Standards and to highlight standards for pediatric oncology. Methods The ASCO/ONS Chemotherapy Administration Safety Standards were first published in 2009 and updated in 2011 to include inpatient settings. A subsequent 2013 revision expanded the standards to include the safe administration and management of oral chemotherapy. A joint ASCO/ONS workshop with stakeholder participation, including that of the Association of Pediatric Hematology Oncology Nurses and American Society of Pediatric Hematology/Oncology, was held on May 12, 2015, to review the 2013 standards. An extensive literature search was subsequently conducted, and public comments on the revised draft standards were solicited. Results The updated 2016 standards presented here include clarification and expansion of existing standards to include pediatric oncology and to introduce new standards: most notably, two-person verification of chemotherapy preparation processes, administration of vinca alkaloids via minibags in facilities in which intrathecal medications are administered, and labeling of medications dispensed from the health care setting to be taken by the patient at home. The standards were reordered and renumbered to align with the sequential processes of chemotherapy prescription, preparation, and administration. Several standards were separated into their respective components for clarity and to facilitate measurement of adherence to a standard. Conclusion As oncology practice has changed, so have chemotherapy administration safety standards. Advances in technology, cancer treatment, and education and training have prompted the need for periodic review and revision of the standards. Additional information is available at http://www.asco.org/chemo-standards .

Predictors of clinical outcome following lumbar disc surgery

DEFF Research Database (Denmark)

Hebert, Jeffrey J; Fritz, Julie; Koppenhaver, S.L.

2016-01-01

scheduled for first time, single-level lumbar discectomy. Participants underwent a standardized preoperative evaluation including real-time ultrasound imaging assessment of lumbar multifidus function, and an 8-week postoperative rehabilitation programme. Clinical outcome was defined by change in disability....... CONCLUSIONS: Information gleaned from the clinical history and physical examination helps to identify patients more likely to succeed with lumbar disc surgery. While this study helps to inform clinical practice, additional research confirming these results is required prior to confident clinical...

[Advances of Molecular Diagnostic Techniques Application in Clinical Diagnosis.

Science.gov (United States)

Ying, Bin-Wu

2016-11-01

Over the past 20 years,clinical molecular diagnostic technology has made rapid development,and became the most promising field in clinical laboratory medicine.In particular,with the development of genomics,clinical molecular diagnostic methods will reveal the nature of clinical diseases in a deeper level,thus guiding the clinical diagnosis and treatments.Many molecular diagnostic projects have been routinely applied in clinical works.This paper reviews the advances on application of clinical diagnostic techniques in infectious disease,tumor and genetic disorders,including nucleic acid amplification,biochip,next-generation sequencing,and automation molecular system,and so on.

IncobotulinumtoxinA in clinical literature.

Science.gov (United States)

Lorenc, Z Paul; Kenkel, Jeffrey M; Fagien, Steven; Hirmand, Haideh; Nestor, Mark S; Sclafani, Anthony P; Sykes, Jonathan M; Waldorf, Heidi A

2013-03-01

IncobotulinumtoxinA is the third neurotoxin type A to be approved for aesthetic use in the United States. Because incobotulinumtoxinA has been in use in Europe for some time, the clinical literature is fairly replete with references to its properties and characteristics, as well as its safety and efficacy. In North America, 2 pivotal trials, referred to as GL-1 and GL-2, investigated the safety and efficacy of incobotulinumtoxinA in the glabellar region; both are currently in press with another journal. Other published studies of incobotulinumtoxinA are also described in depth in this article, including reports on aesthetic indications, diffusion, therapeutic indications, and studies pertaining to the preclinical and clinical pharmacology of incobotulinumtoxinA. Topics addressed include potency variability, mean concentration, stability and dissociation, and endopeptide immunoassay.

A systematic review of clinical audit in companion animal veterinary medicine.

Science.gov (United States)

Rose, Nicole; Toews, Lorraine; Pang, Daniel S J

2016-02-26

Clinical audit is a quality improvement process with the goal of continuously improving quality of patient care as assessed by explicit criteria. In human medicine clinical audit has become an integral and required component of the standard of care. In contrast, in veterinary medicine there appear to have been a limited number of clinical audits published, indicating that while clinical audit is recognised, its adoption in veterinary medicine is still in its infancy. A systematic review was designed to report and evaluate the veterinary literature on clinical audit in companion animal species (dog, cat, horse). A systematic search of English and French articles using Proquest Dissertations and Theses database (February 6, 2014), CAB Abstracts (March 21, 2014 and April 4, 2014), Scopus (March 21, 2014), Web of Science Citation index (March 21, 2014) and OVID Medline (March 21, 2014) was performed. Included articles were those either discussing clinical audit (such as review articles and editorials) or reporting parts of, or complete, audit cycles. The majority of articles describing clinical audit were reviews. From 89 articles identified, twenty-one articles were included and available for review. Twelve articles were reviews of clinical audit in veterinary medicine, five articles included at least one veterinary clinical audit, one thesis was identified, one report was of a veterinary clinical audit website and two articles reported incomplete clinical audits. There was no indication of an increase in the number of published clinical audits since the first report in 1998. However, there was evidence of article misclassification, with studies fulfilling the criteria of clinical audit not appropriately recognised. Quality of study design and reporting of findings varied considerably, with information missing on key components, including duration of study, changes in practice implemented between audits, development of explicit criteria and appropriate statistical

The clinical nurse educator as leader.

Science.gov (United States)

Adelman-Mullally, Theresa; Mulder, Cindy K; McCarter-Spalding, Deborah E; Hagler, Debra A; Gaberson, Kathleen B; Hanner, Mary Beth; Oermann, Marilyn H; Speakman, Elizabeth T; Yoder-Wise, Patricia S; Young, Patricia K

2013-01-01

The National League for Nursing recognizes leadership as an important aspect of the educator role. The purpose of this article is to describe leadership in the context of clinical nursing education and how clinical nurse educators enact leadership. The article identifies particular nursing practice skills and strengths that clinicians bring to nursing education that enhance leadership knowledge, skills, and abilities. After review of several leadership models, we identified five overarching themes that demonstrate how clinical nurse educators exemplify the various models including role modeling, providing vision, helping students to learn, challenging the system or status quo, and seeking relational integrity. We explicate the themes with examples affirming the leadership potential of clinical nurse educators, and suggest ways in which nursing faculty members and administrators might draw on the leadership capital of clinical nurse educators. Copyright © 2012 Elsevier Ltd. All rights reserved.

Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)

DEFF Research Database (Denmark)

Kubiak, Christine; de Andres-Trelles, Fernando; Kuchinke, Wolfgang

2009-01-01

in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching...... with cell therapy, etc.); diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.); and epidemiology studies. Our classification...

Database on veterinary clinical research in homeopathy.

Science.gov (United States)

Clausen, Jürgen; Albrecht, Henning

2010-07-01

The aim of the present report is to provide an overview of the first database on clinical research in veterinary homeopathy. Detailed searches in the database 'Veterinary Clinical Research-Database in Homeopathy' (http://www.carstens-stiftung.de/clinresvet/index.php). The database contains about 200 entries of randomised clinical trials, non-randomised clinical trials, observational studies, drug provings, case reports and case series. Twenty-two clinical fields are covered and eight different groups of species are included. The database is free of charge and open to all interested veterinarians and researchers. The database enables researchers and veterinarians, sceptics and supporters to get a quick overview of the status of veterinary clinical research in homeopathy and alleviates the preparation of systematical reviews or may stimulate reproductions or even new studies. 2010 Elsevier Ltd. All rights reserved.

Clinical Practice in Portuguese Sexology.

Science.gov (United States)

Alarcão, Violeta; Ribeiro, Sofia; Almeida, Joana; Giami, Alain

2017-11-17

Few studies explore the clinicians' knowledge, attitudes, and practices regarding sexuality, despite their role in the sexual-health socialization process. This study focuses on Portuguese sexologists engaged in clinical practice. It aims to characterize sexologists' sex education and training and their clinical practices, including diagnostic and therapeutic approaches. This research followed the methodology of an European survey on sexology as a profession (Euro-Sexo). From the 91 respondents who completed questionnaires, 51 (56%) were active in clinical practice. Results indicate that the Portuguese clinical sexologist is significantly older, predominantly male, has had training in sexology, performs more scientific research, and is more engaged in teaching activities when compared to nonclinical working sexologists. This article describes the main sexual problems presented by patients to Portuguese clinical sexologists and highlights differences in the professional groups and approaches toward treating these problems by medical doctors and nonmedical professionals. Results reinforce the idea that there are intra-European differences in the educational background of sexologists and reveal important variations in Portuguese sexologists' education, training, and clinical practice. The representations and practices of the sexologists in Portugal, as in other European countries, are embedded in cultural scenarios and sexual cultures, with implications for the clinical practice.

A Quality Model to Select Patients in Cupping Therapy Clinics: A New Tool for Ensuring Safety in Clinical Practice.

Science.gov (United States)

Aboushanab, Tamer; AlSanad, Saud

2018-06-08

Cupping therapy is a popular treatment in various countries and regions, including Saudi Arabia. Cupping therapy is regulated in Saudi Arabia by the National Center for Complementary and Alternative Medicine (NCCAM), Ministry of Health. The authors recommend that this quality model for selecting patients in cupping clinics - first version (QMSPCC-1) - be used routinely as part of clinical practice and quality management in cupping clinics. The aim of the quality model is to ensure the safety of patients and to introduce and facilitate quality and auditing processes in cupping therapy clinics. Clinical evaluation of this tool is recommended. Continued development, re-evaluation and reassessment of this tool are important. Copyright © 2018. Published by Elsevier B.V.

Clinical EPR: Unique Opportunities and Some Challenges

Science.gov (United States)

Swartz, Harold M.; Williams, Benjamin B.; Zaki, Bassem I.; Hartford, Alan C.; Jarvis, Lesley A.; Chen, Eunice; Comi, Richard J.; Ernstoff, Marc S.; Hou, Huagang; Khan, Nadeem; Swarts, Steven G.; Flood, Ann B.; Kuppusamy, Periannan

2014-01-01

Electron paramagnetic resonance (EPR) spectroscopy has been well established as a viable technique for measurement of free radicals and oxygen in biological systems, from in vitro cellular systems to in vivo small animal models of disease. However, the use of EPR in human subjects in the clinical setting, although attractive for a variety of important applications such as oxygen measurement, is challenged with several factors including the need for instrumentation customized for human subjects, probe and regulatory constraints. This paper describes the rationale and development of the first clinical EPR systems for two important clinical applications, namely, measurement of tissue oxygen (oximetry), and radiation dose (dosimetry) in humans. The clinical spectrometers operate at 1.2 GHz frequency and use surface loop resonators capable of providing topical measurements up to 1 cm depth in tissues. Tissue pO2 measurements can be carried out noninvasively and repeatedly after placement of an oxygen-sensitive paramagnetic material (currently India ink) at the site of interest. Our EPR dosimetry system is capable of measuring radiation-induced free radicals in the tooth of irradiated human subjects to determine the exposure dose. These developments offer potential opportunities for clinical dosimetry and oximetry, which include guiding therapy for individual patients with tumors or vascular disease, by monitoring of tissue oxygenation. Further work is in progress to translate this unique technology to routine clinical practice. PMID:24439333

Transition rates from schizotypal disorder to psychotic disorder for first-contact patients included in the OPUS trial. A randomized clinical trial of integrated treatment and standard treatment

DEFF Research Database (Denmark)

Nordentoft, Merete; Thorup, Anne; Petersen, Lone

2006-01-01

Only a few randomized clinical trials have tested the effect on transition rates of intervention programs for patients with sub-threshold psychosis-like symptoms.......Only a few randomized clinical trials have tested the effect on transition rates of intervention programs for patients with sub-threshold psychosis-like symptoms....

Implant rehabilitation of the atrophic edentulous maxilla including immediate fixed provisional restoration without the use of bone grafting: a review of 1-year outcome data from a long-term prospective clinical trial.

Science.gov (United States)

Toljanic, Joseph A; Baer, Russell A; Ekstrand, Karl; Thor, Andreas

2009-01-01

The literature suggests that predictable integration can be achieved when dental implant placement is combined with immediate fixed provisional restoration in a variety of clinical situations. Fewer data are available, however, regarding outcomes for immediate provisional restoration of implants in the edentulous maxilla. This report presents 1-year data acquired from a long-term prospective clinical trial designed to assess outcomes following the immediate provisional fixed restoration of implants in the atrophic edentulous maxilla without the use of bone augmentation. Fifty-one subjects diagnosed with an atrophic edentulous maxilla received a total of 306 implants (six implants per subject) followed by fixed provisional restoration within 24 hours of implant placement. No subjects underwent grafting to enhance bone volume in preparation for implant treatment. Data acquired included bone quantity and quality, implant dimensions, implant locations, and implant placement stability. Subjects returned for 1-year follow-up examinations to assess implant integration and restoration function. Periapical radiographs were obtained and compared to baseline images to assess marginal bone height maintenance. At the 3-month follow-up examination, 294 of 306 implants placed in 51 subjects were found to be integrated. This represents a cumulative implant survival rate of 96%. At the 1-year follow-up examination, mean marginal bone loss of 0.5 mm was noted, with no further loss of implants. These results support the contention that predictable long-term outcomes may be obtained for the atrophic edentulous maxilla when treated with an implant rehabilitation protocol that includes immediate fixed provisional restoration without the use of bone grafting. This strategy offers a promising treatment alternative for the patient with an atrophic edentulous maxilla.

Self-rehabilitation of acquired brain injury patients including neglect and attention deficit disorder with a tablet game in a clinical setting

DEFF Research Database (Denmark)

Knoche, Hendrik; Hald, Kasper; Richter, Dorte

2017-01-01

We designed and evaluated a whack-a-mole (WAM) style game (see Figure 1) in a clinical randomized controlled trial (RCT) with reminder-assisted but self-initiated use over the period of a month with 43 participants from a post-lesion pool. While game play did not moderate rehabilitative progress ...... beneficial to their rehabilitation and attributed gains in the attention training properties of the game. The game showed potential for bedside assessment, insight support, and motivation by providing knowledge about rehabilitative progress....

Clinical practice recommendations for depression.

Science.gov (United States)

Malhi, G S; Adams, D; Porter, R; Wignall, A; Lampe, L; O'Connor, N; Paton, M; Newton, L A; Walter, G; Taylor, A; Berk, M; Mulder, R T

2009-01-01

To provide clinically relevant evidence-based recommendations for the management of depression in adults that are informative, easy to assimilate and facilitate clinical decision making. A comprehensive literature review of over 500 articles was undertaken using electronic database search engines (e.g. MEDLINE, PsychINFO and Cochrane reviews). In addition articles, book chapters and other literature known to the authors were reviewed. The findings were then formulated into a set of recommendations that were developed by a multidisciplinary team of clinicians who routinely deal with mood disorders. The recommendations then underwent consultative review by a broader advisory panel that included experts in the field, clinical staff and patient representatives. The clinical practice recommendations for depression (Depression CPR) summarize evidence-based treatments and provide a synopsis of recommendations relating to each phase of the illness. They are designed for clinical use and have therefore been presented succinctly in an innovative and engaging manner that is clear and informative. These up-to-date recommendations provide an evidence-based framework that incorporates clinical wisdom and consideration of individual factors in the management of depression. Further, the novel style and practical approach should promote uptake and implementation.

Clinical outcome of pediatric collagenous gastritis: case series and review of literature.

Science.gov (United States)

Hijaz, Nadia Mazen; Septer, Seth Steven; Degaetano, James; Attard, Thomas Mario

2013-03-07

Collagenous gastritis (CG) is characterized by patchy subepithelial collagen bands. Effective treatment and the clinical and histological outcome of CG in children are poorly defined. The aim of this study is to summarize the published literature on the clinical outcome and response to therapy of pediatric CG including two new cases. We performed a search in Pubmed, OVID for related terms; articles including management and clinical and/or endo-histologic follow up information were included and abstracted. Reported findings were pooled in a dedicated database including the corresponding data extracted from chart review in our patients with CG. Twenty-four patients were included (17 females) with a mean age of 11.7 years. The clinical presentation included iron deficiency anemia and dyspepsia. The reported duration of follow up (in 18 patients) ranged between 0.2-14 years. Despite most subjects presenting with anemia including one requiring blood transfusion, oral iron therapy was only documented in 12 patients. Other treatment modalities were antisecretory measures in 13 patients; proton pump inhibitors (12), or histamine-2 blockers (3), sucralfate (5), prednisolone (6), oral budesonide in 3 patients where one received it in fish oil and triple therapy (3). Three (13%) patients showed no clinical improvement despite therapy; conversely 19 out of 22 were reported with improved symptoms including 8 with complete symptom resolution. Spontaneous clinical resolution without antisecretory, anti-inflammatory or gastroprotective agents was noted in 5 patients (4 received only supplemental iron). Follow up endo-histopathologic data (17 patients) included persistent collagen band and stable Mononuclear cell infiltrate in 12 patients with histopathologic improvement in 5 patients. Neither collagen band thickness nor mononuclear cell infiltrate correlated with clinical course. Intestinal metaplasia and endocrine cell hyperplasia were reported (1) raising the concern of long

Sustainable development of a GCP-compliant clinical trials platform in Africa: the malaria clinical trials alliance perspective.

Science.gov (United States)

Ogutu, Bernhards R; Baiden, Rita; Diallo, Diadier; Smith, Peter G; Binka, Fred N

2010-04-20

The Malaria Clinical Trials Alliance (MCTA), a programme of INDEPTH network of demographic surveillance centres, was launched in 2006 with two broad objectives: to facilitate the timely development of a network of centres in Africa with the capacity to conduct clinical trials of malaria vaccines and drugs under conditions of good clinical practice (GCP); and to support, strengthen and mentor the centres in the network to facilitate their progression towards self-sustaining clinical research centres. Sixteen research centres in 10 African malaria-endemic countries were selected that were already working with the Malaria Vaccine Initiative (MVI) or the Medicines for Malaria Venture (MMV). All centres were visited to assess their requirements for research capacity development through infrastructure strengthening and training. Support provided by MCTA included: laboratory and facility refurbishment; workshops on GCP, malaria diagnosis, strategic management and media training; and training to support staff to undertake accreditation examinations of the Association of Clinical Research Professionals (ACRP). Short attachments to other network centres were also supported to facilitate sharing practices within the Alliance. MCTA also played a key role in the creation of the African Media & Malaria Research Network (AMMREN), which aims to promote interaction between researchers and the media for appropriate publicity and media reporting of research and developments on malaria, including drug and vaccine trials. In three years, MCTA strengthened 13 centres to perform GCP-compliant drug and vaccine trials, including 11 centres that form the backbone of a large phase III malaria vaccine trial. MCTA activities have demonstrated that centres can be brought up to GCP compliance on this time scale, but the costs are substantial and there is a need for further support of other centres to meet the growing demand for clinical trial capacity. The MCTA experience also indicates that

Orthokeratology: clinical utility and patient perspectives

Directory of Open Access Journals (Sweden)

Charm J

2017-02-01

Full Text Available Jessie Charm Sight Enhancement Center, Hong Kong Special Administrative Region Abstract: Orthokeratology (ortho-k is a special rigid contact lens worn at night to achieve myopic reduction and control. This review provides an overview on prescribing ortho-k, including clinical consideration on patient aspect and lens design; its clinical outcomes; and clinical efficacy and safety. Patient satisfaction was summarized. In order to achieve long-term healthy ortho-k treatment, it requires both patient and practitioners’ care and rapport to maintain good ocular health and lens conditions. Keywords: orthokeratology, efficacy, patient satisfaction, myopic reduction, myopic control

Understanding clinical reasoning in osteopathy: a qualitative research approach

OpenAIRE

Grace, Sandra; Orrock, Paul; Vaughan, Brett; Blaich, Raymond; Coutts, Rosanne

2016-01-01

Background Clinical reasoning has been described as a process that draws heavily on the knowledge, skills and attributes that are particular to each health profession. However, the clinical reasoning processes of practitioners of different disciplines demonstrate many similarities, including hypothesis generation and reflective practice. The aim of this study was to understand clinical reasoning in osteopathy from the perspective of osteopathic clinical educators and the extent to which it wa...

Biomedical applications of mass spectrometry. Clinical uses of stable isotopes

International Nuclear Information System (INIS)

Krahmer, U.I.; McCloskey, J.A.

1978-01-01

The review covers typical or important examples of stable isotope usage in clinical fields during the period since the last triennial mass spectrometry conference in 1973. Items are included which involve uses of stable isotopes in human or clinically oriented studies, including measurements carried out on materials of human origin. 163 references. (U.K.)

A predictive approach to selecting the size of a clinical trial, based on subjective clinical opinion.

Science.gov (United States)

Spiegelhalter, D J; Freedman, L S

1986-01-01

The 'textbook' approach to determining sample size in a clinical trial has some fundamental weaknesses which we discuss. We describe a new predictive method which takes account of prior clinical opinion about the treatment difference. The method adopts the point of clinical equivalence (determined by interviewing the clinical participants) as the null hypothesis. Decision rules at the end of the study are based on whether the interval estimate of the treatment difference (classical or Bayesian) includes the null hypothesis. The prior distribution is used to predict the probabilities of making the decisions to use one or other treatment or to reserve final judgement. It is recommended that sample size be chosen to control the predicted probability of the last of these decisions. An example is given from a multi-centre trial of superficial bladder cancer.

The clinical effects of Kinesio® Tex taping: A systematic review.

Science.gov (United States)

Morris, D; Jones, D; Ryan, H; Ryan, C G

2013-05-01

Kinesio(®) Tex tape (KTT) is used in a variety of clinical settings. The purpose of this study was to investigate the effect of KTT from randomized controlled trials (RCTs) in the management of clinical conditions. A systematic literature search of CINAHL; MEDLINE; OVID; AMED; SCIENCE DIRECT; PEDRO; www.internurse.com; SPORT DISCUS; BRITISH NURSING INDEX; www.kinesiotaping.co.uk; www.kinesiotaping.com; COCHRANE CENTRAL REGISTER OF CLINICAL TRIALS; and PROQUEST was performed up to April 2012. The risk of bias and quality of evidence grading was performed using the Cochrane collaboration methodology. Eight RCTs met the full inclusion/exclusion criteria. Six of these included patients with musculoskeletal conditions; one included patients with breast-cancer-related lymphedema; and one included stroke patients with muscle spasticity. Six studies included a sham or usual care tape/bandage group. There was limited to moderate evidence that KTT is no more clinically effective than sham or usual care tape/bandage. There was limited evidence from one moderate quality RCT that KTT in conjunction with physiotherapy was clinically beneficial for plantar fasciitis related pain in the short term; however, there are serious questions around the internal validity of this RCT. There currently exists insufficient evidence to support the use of KTT over other modalities in clinical practice.

Clinical laboratory waste management in Shiraz, Iran.

Science.gov (United States)

Askarian, Mehrdad; Motazedian, Nasrin; Palenik, Charles John

2012-06-01

Clinical laboratories are significant generators of infectious waste, including microbiological materials, contaminated sharps, and pathologic wastes such as blood specimens and blood products. Most waste produced in laboratories can be disposed of in the general solid waste stream. However, improper management of infectious waste, including mixing general wastes with infectious wastes and improper handling or storage, could lead to disease transmission. The aim of this study was to assess waste management processes used at clinical laboratories in Shiraz, Iran. One hundred and nine clinical laboratories participated In this cross sectional study, Data collection was by questionnaire and direct observation. Of the total amount of waste generated, 52% (by weight) was noninfectious domestic waste, 43% was non-sharps infectious waste and 5% consisted of sharps. There was no significant relationship between laboratory staff or manager education and the score for quality of waste collection and disposal at clinical laboratories. Improvements in infectious waste management processes should involve clearer, more uniformly accepted definitions of infectious waste and increased staff training.

Clinical and MRI evaluation of tuberculous meningitis

International Nuclear Information System (INIS)

Jiang Chunjing; Shu Jiner; Chen Jian; Sheng Sanlan; Lu Jinhua; Cai Xiaoxiao; Li Huimin

2010-01-01

Objective: To evaluate the relationship of clinical and magnetic resonance imaging (MRI) findings in patients with tuberculous meningitis (TBM), and to improve the understanding of TBM. Methods: The clinical and MRI findings in 42 patients with confirmed TBM were analyzed retrospectively. MRI examination was performed using a 1 Tesla system, including SE T 1 WI and T 2 WI. Intravenous contrast was injected in 29 patients, and follow-up scans were performed on 17 patients. Results: Of 24 patients with early TBM, MRI was abnormal in 5(21%) with slight Tl-hypointense meningeal (4) or ependymal thickening (1). MRI on 33/35 (94%) patients with late stage TBM was abnormal with T 1 hypointensity and T 2 hyperintensity including meningeal thickening (19), mild surrounding brain edema (10), nodules (11), tuberculoma (5) and abscess (2). There was significant plaque-like, nodular or rim enhancement with surrounding brain edema. Conclusion: Tuberculous meningitis has minimal clinical and MRI findings in the early phase and significant clinical and MRI findings in the late phase. The enhanced scan may help to detect the abnormality. (authors)

The Racial, Cultural and Social Makeup of Hispanics as a potential Profile Risk for Intensifying the Need for Including this Ethnic Group in Clinical Trials.

Science.gov (United States)

López-Candales, Angel; Aponte Rodríguez, Jaime; Harris, David

2015-01-01

Hypertension not only is the most frequently listed cause of death worldwide; but also a well-recognized major risk factor for cardiovascular disease and stroke. Based on the latest published statistics published by the American Heart Association, hypertension is very prevalent and found in one of every 3 US adults. Furthermore, data from NHANES 2007 to 2010 claims that almost 6% of US adults have undiagnosed hypertension. Despite this staggering statistic, previous US guidelines for the prevention, detection, and treatment of hypertension (The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure 7 [JNC 7]), released in 2003, stated that; "unfortunately, sufficient numbers of Mexican Americans and other Hispanic Americans... have not been included in most of the major clinical trials to allow reaching strong conclusions about their responses to individual antihypertensive therapies." However, the recently published JNC 8 offers no comment regarding recommendations or guideline treatment suggestions on Hispanics. The purpose of this article not only is to raise awareness of the lack of epidemiological data and treatment options regarding high blood pressure in the US Hispanic population; but also to make a case of the racial, cultural and social makeup of this ethnic group that places them at risk of cardiovascular complications related to hypertension.

The Consistency Between Clinical and Electrophysiological Diagnoses

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Esra E. Okuyucu

2009-09-01

Full Text Available OBJECTIVE: The aim of this study was to provide information concerning the impact of electrophysiological tests in the clinical management and diagnosis of patients, and to evaluate the consistency between referring clinical diagnoses and electrophysiological diagnoses. METHODS: The study included 957 patients referred to the electroneuromyography (ENMG laboratory from different clinics with different clinical diagnoses in 2008. Demographic data, referring clinical diagnoses, the clinics where the requests wanted, and diagnoses after ENMG testing were recorded and statistically evaluated. RESULTS: In all, 957 patients [644 (67.3% female and 313 (32.7% male] were included in the study. Mean age of the patients was 45.40 ± 14.54 years. ENMG requests were made by different specialists; 578 (60.4% patients were referred by neurologists, 122 (12.8% by orthopedics, 140 (14.6% by neurosurgeons, and 117 (12.2% by physical treatment and rehabilitation departments. According to the results of ENMG testing, 513 (53.6% patients’ referrals were related to their referral diagnosis, whereas 397 (41.5% patients had normal ENMG test results, and 47 (4.9% patients had a diagnosis that differed from the referring diagnosis. Among the relation between the referral diagnosis and electrophysiological diagnosis according to the clinics where the requests were made, there was no statistical difference (p= 0.794, but there were statistically significant differences between the support of different clinical diagnoses, such as carpal tunnel syndrome, polyneuropathy, radiculopathy-plexopathy, entrapment neuropathy, and myopathy based on ENMG test results (p< 0.001. CONCLUSION: ENMG is a frequently used neurological examination. As such, referrals for ENMG can be made to either support the referring diagnosis or to exclude other diagnoses. This may explain the inconsistency between clinical referring diagnoses and diagnoses following ENMG

Electronic cigarettes and nicotine clinical pharmacology

OpenAIRE

Schroeder, Megan J; Hoffman, Allison C

2014-01-01

Objective To review the available literature evaluating electronic cigarette (e-cigarette) nicotine clinical pharmacology in order to understand the potential impact of e-cigarettes on individual users, nicotine dependence and public health. Methods Literature searches were conducted between 1 October 2012 and 30 September 2013 using key terms in five electronic databases. Studies were included in the review if they were in English and publicly available; non-clinical studies, conference abst...

Nocardial mycetoma: Diverse clinical presentations

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Sharma Nand

2008-01-01

Full Text Available Nocardia spp are gram-positive, aerobic, acid-fast bacteria which exist as saprophytes in nature. Invasive disseminated infections are particularly common in immunocompromised or debilitated hosts. Superficial infections with Nocardia spp occur as a result of local trauma and contamination of the wound. Clinically, it presents as acute infection (abscesses or cellulitis, mycetoma, or sporotrichoid infection. Differential diagnosis includes eumycetoma, chromomycosis, blastomycosis, coccidioidomycosis, sporotrichosis, tuberculosis, botryomycosis, syphilis, yaws, and neoplasia. Its diagnosis is confirmed by demonstrating the causative organism in exudates (as granules, tissue specimens, or cultures. Early diagnosis will obviate need for drastic surgical measures as early institution of chemotherapy is effective in most patients. However, its diagnosis is often delayed due to diverse clinical presentations and for want of clinical suspicion, particularly in non-endemic areas. This paper presents 4 clinical forms of this not so uncommon disease, emphasizing the importance of high index of clinical suspicion, especially in non-endemic regions; and the significance of repeated examination of exudates for Nocardia granules for an early diagnosis.

PROFAM expands Mexican family planning clinics.

Science.gov (United States)

1983-01-01

Mexico's private, nonprofit social marketing company, known as PROFAM, intends to expand its family planning clinics to marginal urban areas. The clinics are part of PROFAM's push to diversify social marketing outlets for contraceptive products and other birth control methods. PROFAM expects to establish 3 new clinics, possibly including a pregnancy test laboratory, a small 1-doctor clinic, and a large clinic housing an operating room. 1 clinic will be located outside the Mexico City area, the program's traditional boundaries. The company currently runs 2 small clinics and a pregnancy testing laboratory in Ciudad Netzahualcoyti, a community of 3.5 million on Mexico City's outskirts. PROFAM recently obtaine d government approval to sell condoms in food stores, which should increase distribtuion and sales. Currently, the company sells over 1 million high quality, lubricated condoms each month, accounting for over half of the Mexican market. Distribution covers 85% of the country's drugstore. Program setbacks occurred in 1981, when the Mexican government cancelled PROFAM's sales permits for all contraceptive products except condoms. Cancelled products included an oral contraceptive and 3 vaginal spermicides. These 4 products had provided nearly 100,000 couple years of protection in 1979 and an estimated 120,000 CYP 1980. During 1979 and 1980, condoms provided about 27,000 and 60,000 CYP, respectively. PROFAM had relied heavily on the pill and spermicides because its early studies showed condoms had a negative image in Mexico, due largely to the product's association with extramarital affairs. To counter this, PROFAM launched a widespread, free product sampling program in 1979, along with a continuing educational and advertising drive. Subsequent consumer surveys revealed a marked increase in product acceptance, with PROFAM's condom becoming the most widely known brand available in Mexico.

[The future of clinical laboratory database management system].

Science.gov (United States)

Kambe, M; Imidy, D; Matsubara, A; Sugimoto, Y

1999-09-01

To assess the present status of the clinical laboratory database management system, the difference between the Clinical Laboratory Information System and Clinical Laboratory System was explained in this study. Although three kinds of database management systems (DBMS) were shown including the relational model, tree model and network model, the relational model was found to be the best DBMS for the clinical laboratory database based on our experience and developments of some clinical laboratory expert systems. As a future clinical laboratory database management system, the IC card system connected to an automatic chemical analyzer was proposed for personal health data management and a microscope/video system was proposed for dynamic data management of leukocytes or bacteria.

Heart Failure: From Research to Clinical Practice.

Science.gov (United States)

Islam, Md Shahidul

2018-01-01

"Heart failure: from research to clinical practice", a collection of selected reviews, which comes out also as a book, covers essentially all important aspects of heart failure, including the pathogenesis, clinical features, biomarkers, imaging techniques, medical treatment and surgical treatments, use of pacemakers and implantable cardioverter defibrillators, and palliative care. The reviews include essential background information, state of the art, critical and in-depth analysis, and directions for future researches for elucidation of the unresolved issues. Everyone interested in heart failure is expected to find this compilation helpful for a deeper understanding of some of the complex issues.

Guide to clinical PET in oncology: Improving clinical management of cancer patients

International Nuclear Information System (INIS)

2008-10-01

Positron emission tomography (PET) has an approximately 50 year-history. It was developed as a tool of medical science to quantitatively measure metabolic rates of bio-substances in vivo and in particular the number of receptors in neuroscience. Until the late 1990s PET was, in most cases, research oriented activity. In 2001, positron emission tomography/X ray computed tomography (PET/CT) hybrid imaging system became commercially available. An era of clinical PET then emerged, in which PET images were utilized for clinical practice in the treatment and diagnosis of cancer patients. PET imaging could recognize areas of abnormal metabolic behaviour of cancers in vivo, and the addition of CT imaging underlines the site of malignancy. More accurate and precise interpretation of cancer lesions can therefore be performed by PET/CT imaging than PET or CT imaging alone. Clinical PET, in particular with fluorine-18-fluorodeoxyglucose ( 18 F-FDG), has already proven itself to have considerable value in oncology. The indications include malignant lymphoma and melanoma, head and neck cancers, oesophageal cancer, breast cancer, lung cancer and colorectal cancer, and it is still being expanded. The roles of clinical PET could be for 1) preoperative staging of cancers, 2) differentiation between residual tumour and scarring, 3) demonstration of suspected recurrences, 4) monitoring response to therapy, 5) prognosis and 6) radiotherapy treatment planning. Clinical PET can be used to illustrate exactly which treatment should be applied for a cancer patient as well as where surgeons should operate and where radiation oncologists should target radiation therapy. An almost exponential rise in the introduction of clinical PET, as well as the installation of PET/CT has been seen throughout the world. Clinical PET is currently viewed as the most powerful diagnostic tool in its field. This IAEA-TECDOC presents an overview of clinical PET for cancer patients and a relevant source of

Real-world cure rates for hepatitis C virus treatments that include simeprevir and/or sofosbuvir are comparable to clinical trial results.

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Bichoupan, Kian; Tandon, Neeta; Crismale, James F; Hartman, Joshua; Del Bello, David; Patel, Neal; Chekuri, Sweta; Harty, Alyson; Ng, Michel; Sigel, Keith M; Bansal, Meena B; Grewal, Priya; Chang, Charissa Y; Leong, Jennifer; Im, Gene Y; Liu, Lawrence U; Odin, Joseph A; Bach, Nancy; Friedman, Scott L; Schiano, Thomas D; Perumalswami, Ponni V; Dieterich, Douglas T; Branch, Andrea D

2017-11-12

To assess the real-world effectiveness and cost of simeprevir (SMV), and/or sofosbuvir (SOF)-based therapy for chronic hepatitis C virus (HCV) infection. The real-world performance of patients treated with SMV/SOF ± ribavirin (RBV), SOF/RBV, and SOF/RBV with pegylated-interferon (PEG) were analyzed in a consecutive series of 508 patients with chronic HCV infection treated at a single academic medical center. Patients with genotypes 1 through 4 were included. Rates of sustained virological response - the absence of a detectable serum HCV RNA 12 wk after the end of treatment [sustained virological response (SVR) 12] - were calculated on an intention-to-treat basis. Costs were calculated from the payer's perspective using Medicare/Medicaid fees and Redbook Wholesale Acquisition Costs. Patient-related factors associated with SVR12 were identified using multivariable logistic regression. SVR12 rates were as follows: 86% (95%CI: 80%-91%) among 178 patients on SMV/SOF ± RBV; 62% (95%CI: 55%-68%) among 234 patients on SOF/RBV; and 78% (95%CI: 68%-86%) among 96 patients on SOF/PEG/RBV. Mean costs-per-SVR12 were $174442 (standard deviation: ± $18588) for SMV/SOF ± RBV; $223003 (± $77946) for SOF/RBV; and $126496 (± $31052) for SOF/PEG/RBV. Among patients on SMV/SOF ± RBV, SVR12 was less likely in patients previously treated with a protease inhibitor [odds ratio (OR): 0.20, 95%CI: 0.06-0.56]. Higher bilirubin (OR: 0.47, 95%CI: 0.30-0.69) reduced the likelihood of SVR12 among patients on SOF/RBV, while FIB-4 score ≥ 3.25 reduced the likelihood of SVR12 (OR: 0.18, 95%CI: 0.05-0.59) among those on SOF/PEG/RBV. SVR12 rates for SMV and/or SOF-based regimens in a diverse real-world population are comparable to those in clinical trials. Treatment failure accounts for 27% of costs.

Effectiveness of nurse-led clinics on service delivery and clinical outcomes in adults with chronic ear, nose and throat complaints: a systematic review.

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Whiteford, Caroline; White, Sarahlouise; Stephenson, Matthew

2016-04-01

Ear, nose and throat complaints are very common and can cause significant disruption to patients' lives. Many conditions are of a chronic nature and are not currently managed in a timely manner by general practitioners in the community. This may be due to a lack of specialized knowledge, necessary diagnostic equipment or time for lengthy patient education on management of their condition. A nurse-led model of care may be an effective alternative. To examine the effectiveness of nurse-led clinics on adults with chronic ear, nose and throat complaints. Adult patients, aged 18 years and older, attending ear, nose and throat clinics, regardless of the complaint. Nurse-led care in general practice and acute care in which the nurse was identified as taking a lead role in the care of the patients with chronic ear, nose and throat complaints. General practitioner-led care, or ear, nose and throat consultant-led care, sometimes described as "standard care". Service delivery outcomes, clinical and health outcomes and financial outcomes. Any relevant quantitative studies published in English between 1980 and 2013 were considered. A standardized three-step search strategy aimed to find both published and unpublished studies. Databases searched include PubMed, CINAHL, Cochrane Library (CENTRAL), Scopus, Embase, MedNar and ProQuest Theses and Dissertations. Methodological validity was assessed independently by two reviewers using standardized critical appraisal instruments from the Joanna Briggs Institute. Due to methodological heterogeneity of the included studies, no statistical pooling was possible and all results are presented narratively. The search identified 13,536 titles, of which 20 potentially relevant articles were retrieved. Of these 20, 17 were excluded following full-text review leaving three studies that were assessed for methodological quality and included in the review. Service delivery outcome findings were that patient satisfaction was equal or higher and

Diagnosis and clinical management of urinary tract infection

OpenAIRE

Heilberg, Ita Pfeferman; Schor, Nestor

2003-01-01

A review about recent aspects on diagnosis and clinical management of urinary tract infection (UTI) is presented. There is a wide variation in clinical presentation of UTI which include different forms as cystitis, pyelonephritis, urethral syndrome and the clinical relevance of asymptomatic bacteriuria and low-count bacteriuria that must be distinguished from contamination. Pathogenetic aspects concerning bacterial virulence as well as host factors in susceptibility to UTI as urinary tract ob...

Quality of clinical trials: A moving target

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Arun Bhatt

2011-01-01

Full Text Available Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.

Skin symptoms in four ectodermal dysplasia syndromes including two case reports of Rapp-Hodgkin-Syndrome.

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Knaudt, Björn; Volz, Thomas; Krug, Markus; Burgdorf, Walter; Röcken, Martin; Berneburg, Mark

2012-01-01

The skin, hair and nail changes in four distinct ectodermal dysplasia syndromes are compared and reviewed. These syndromes comprise Christ-Siemens-Touraine syndrome; ectrodactyly, ectodermal dysplasia and cleft lip/palate syndrome; ankyloblepharon-ectodermal defects-cleft lip/palate syndrome and Rapp-Hodgkin syndrome. A comprehensive overview of the dermatological signs and symptoms in these syndromes was generated from the database of the Ectodermal Dysplasia Network Germany, the clinical findings in the patients seen in our department and an extensive review of the literature. The findings included abnormalities of skin, sweating, hair and nails. These clinical findings are discussed in relation to the underlying molecular defects known to play a role in these four ectodermal dysplasia syndromes.

Thymic hyperplasia - clinical course and imaging diagnostic

International Nuclear Information System (INIS)

Drebov, R.; Panov, M.; Totev, M.; Deliverski, T.; Tcandev, I.; Velkovski, I.

2006-01-01

The real thymic hyperplasia is benign disease sometimes simulating malignant tumours. The aim of this study is to analyse the clinical symptoms of real thymic hyperplasia and the results from imaging diagnostic based on our clinical material. Clinical material include 27 children, aged from two months to 15 years, admitted in department of thoracic surgery, for a period of 20 years (1985 - 2004). We retrospectively analyze the clinical signs and results from X-ray investigation, CT (Siemens Somatom DRG and Philips Secura) and echocardiography (Acuson TX, 5 and 7 MHz). We discuss the diagnostic value of different methods as well as typical and atypical findings. (authors)

Basic and clinical immunology

Science.gov (United States)

Chinen, Javier; Shearer, William T.

2003-01-01

Progress in immunology continues to grow exponentially every year. New applications of this knowledge are being developed for a broad range of clinical conditions. Conversely, the study of primary and secondary immunodeficiencies is helping to elucidate the intricate mechanisms of the immune system. We have selected a few of the most significant contributions to the fields of basic and clinical immunology published between October 2001 and October 2002. Our choice of topics in basic immunology included the description of T-bet as a determinant factor for T(H)1 differentiation, the role of the activation-induced cytosine deaminase gene in B-cell development, the characterization of CD4(+)CD25(+) regulatory T cells, and the use of dynamic imaging to study MHC class II transport and T-cell and dendritic cell membrane interactions. Articles related to clinical immunology that were selected for review include the description of immunodeficiency caused by caspase 8 deficiency; a case series report on X-linked agammaglobulinemia; the mechanism of action, efficacy, and complications of intravenous immunoglobulin; mechanisms of autoimmunity diseases; and advances in HIV pathogenesis and vaccine development. We also reviewed two articles that explore the possible alterations of the immune system caused by spaceflights, a new field with increasing importance as human space expeditions become a reality in the 21st century.

Role perceptions of nurse clinical research coordinators

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Jones CT

2013-09-01

Full Text Available Carolynn Thomas Jones, Lynda L Wilson School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA Abstract: Nursing roles in clinical research have evolved in the last 3 decades and include diverse responsibilities and job titles. Nurse clinical research coordinators’ (NCRCs roles include study planning, implementation, participant recruitment and retention, assessment of participants’ responses to clinical protocols, data management, and evaluation. The purpose of this study was to examine NCRCs’ perceptions of 59 specific clinical research activities that have been proposed as a taxonomy of NCRC activities. Participants were asked to check whether each of the 59 activities is being performed, and whether those activities should be performed, by NCRCs. The sample included 61 NCRCs who were attending the annual meeting of the International Association of Clinical Research Nurses. The percentage of respondents who indicated that the 59 activities are being performed by NCRCs at their sites ranged from 55%–98.4%. The percentage of respondents who indicated that the 59 activities should be performed by NCRCs ranged from 61.7%–88.5%. There were eight activities that fewer than 70% of the respondents reported should be performed by NCRCs. Chi-square analyses were conducted to determine whether there was a difference in the distribution of responses to the “are performed” versus “should be performed” responses for each of the 59 activities. There were significant differences in the distributions for 49 of the activities. The percentage of nurses responding “are performed” was higher than the percentage of responses to the “should be performed” items for 41 of these 49 activities. Findings suggest that further research is needed to validate the extent to which the taxonomy of clinical research nurse (CRN roles is a valid reflection of the actual practice of NCRCs, and also to explore reasons for the

Community to clinic navigation to improve diabetes outcomes

Directory of Open Access Journals (Sweden)

Nancy E. Schoenberg

2017-03-01

Full Text Available Rural residents experience rates of Type 2 Diabetes Mellitus (T2DM that are considerably higher than their urban or suburban counterparts. Two primary modifiable factors, self-management and formal clinical management, have potential to greatly improve diabetes outcomes. “Community to Clinic Navigation to Improve Diabetes Outcomes,” is the first known randomized clinical trial pilot study to test a hybrid model of diabetes self-management education plus clinical navigation among rural residents with T2DM. Forty-one adults with T2DM were recruited from two federally qualified health centers in rural Appalachia from November 2014–January 2015. Community health workers provided navigation, including helping participants understand and implement a diabetes self-management program through six group sessions and, if needed, providing assistance in obtaining clinic visits (contacting providers' offices for appointments, making reminder calls, and facilitating transportation and dependent care. Pre and post-test data were collected on T2DM self-management, physical measures, demographics, psychosocial factors, and feasibility (cost, retention, and satisfaction. Although lacking statistical significance, some outcomes indicate trends in positive directions, including diet, foot care, glucose monitoring, and physical health, including decreased HbA1c and triglyceride levels. Process evaluations revealed high levels of satisfaction and feasibility. Due to the limited intervention dose, modest program expenditures (~$29,950, and a severely affected population most of whom had never received diabetes education, outcomes were not as robust as anticipated. Given high rates of satisfaction and retention, this culturally appropriate small group intervention holds promise for hard to reach rural populations. Modifications should include expanded recruitment venues, sample size, intervention dosage and longer term assessment.

A descriptive survey investigating pre-registration student nurses' perceptions of clinical skill development in clinical placements.

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Stayt, Louise C; Merriman, Clair

2013-04-01

Clinical skill development is essential to nurse education. Clinical skills are frequently taught in higher education institutions using clinical simulation. It is unclear if clinical skills are subsequently consolidated and developed in clinical placements. The aim of this survey was to evaluate pre-registration student nurses perceptions of the frequency of opportunities to practise, the level of supervision and assessment of, clinical skills in their clinical placements. This was a cross-sectional survey design using an online, self-report questionnaire including a Likert-type scale and open ended comments. Four hundred and twenty one students, from all year groups, from a university in the south of England on a wide variety of clinical placements participated. Participants evaluated the frequency of opportunity to practise, level of supervision and assessment of and feedback on performance of specific clinical skills. Clinical skills evaluated were measurement of vital signs, aseptic non-touch technique, assisting with eating and drinking, and assisting with comfort and hygiene. Data were analysed utilising Statistical Package for the Social Sciences Version 19. The frequency of opportunities to practise skills in clinical placement was variable with some participants reporting that they never had opportunity to practise essential skills. Similarly the level of supervision and assessment was also inconsistent suggesting that participants frequently practised clinical skills unsupervised without being assessed as competent. Inconsistencies in clinical skill development may lead to graduates who are not work ready and as a result, insufficient clinical competence potentially leads to unsafe practice and poor patient care. This calls for stronger partnerships between educators and clinical areas and the prioritisation of mentor preparation and education as well as organisational support in terms of mentor workload planning. Copyright © 2012 Elsevier Ltd. All

Comparison of mania patients suitable for treatment trials versus clinical treatment.

Science.gov (United States)

Talamo, Alessandra; Baldessarini, Ross J; Centorrino, Franca

2008-08-01

It remains uncertain whether bipolar disorder (BPD) patients in randomized-controlled trials (RCTs) are sufficiently representative of clinically encountered patients as to guide clinical-therapeutic practice. We complied inclusion/exclusion criteria by frequency from reports of 21 RCTs for mania, and applied them in a pilot study of patients hospitalized for DSM-IV BPD manic/mixed states to compare characteristics and clinical responses of patients who did versus did not meet exclusion criteria. From 27 initially identified inclusion/exclusion criteria ranked by citation frequency, we derived six inclusion, and 10 non-redundant-exclusion factors. Of 67 consecutive patients meeting inclusion criteria, 15 (22.4%) potential "research subjects" met all 10 exclusion criteria. The remaining 52 "clinical patients" differed markedly on exclusion criteria, including more psychiatric co-morbidity, substance abuse, involuntary hospitalization, and suicide attempts or violence, but were otherwise similar. In both groups responses to clinically determined inpatient treatments were similar, including improvement in mania ratings. Based on applying reported inclusion/exclusion criteria for RCTs to a pilot sample of hospitalized-manic patients, those likely to be included in modern RCTs were similar to patients who would be excluded, most notably in short-term antimanic-treatment responses. The findings encourage further comparisons of subjects included/excluded from RCTs to test potential clinical generalizability of research findings. The pilot study is limited in numbers and exposure times with which to test for the minor differences between "research subjects" and "clinical patients." (c) 2008 John Wiley & Sons, Ltd.

Real-time enrollment dashboard for multisite clinical trials

Directory of Open Access Journals (Sweden)

William A. Mattingly

2015-10-01

Conclusion: We have designed and implemented a visualization dashboard for managing multi-site clinical trial enrollment in two community acquired pneumonia studies. Information dashboards are useful for clinical trial management. They can be used in a standalone trial or can be included into a larger management system.

Clinical Presentation of Epilepsy among Adult Sudanese Epileptic ...

African Journals Online (AJOL)

Objective: To study the pattern of clinical presentation of epilepsy among adult Sudanese epileptic patients. Methods: 120 patients with epilepsy were included in a prospective cross-sectional study. Setting: The study was conducted at Sheik Mohamed Kheir Friday Epileptic Clinic .Duration: May 2003 Oct 2006. Results: ...

Ambulatory Blood Pressure Monitoring – Clinical Practice Recommendations

Directory of Open Access Journals (Sweden)

Katalin Mako

2016-09-01

Full Text Available Ambulatory blood pressure monitoring (ABPM became a subject of considerable scientific interest. Due to the increasing use of the ABPM in everyday clinical practice it is important that all the users have a correct knowledge on the clinical indications, the methodology of using the device including some technical issues and the interpretation of results. In the last years several guidelines and position papers have been published with recommendations for the monitoring process, reference values, for clinical practice and research. This paper represents a summary of the most important aspects related to the use of ABPM in daily practice, being a synthesis of recommendations from the recent published guidelines and position papers. This reference article presents the practical and technical issues of ABPM, the use of this method in special situations, the clinical interpretation of measured values including the presentation of different ABPM patterns, derived parameters, the prognostic significance and the limitations of this method.

Clinical Core Competency Training for NASA Flight Surgeons

Science.gov (United States)

Polk, J. D.; Schmid, Josef; Hurst, Victor, IV; Doerr, Harold K.; Doerr, Harold K.

2007-01-01

Introduction: The cohort of NASA flight surgeons (FS) is a very accomplished group with varied clinical backgrounds; however, the NASA Flight Surgeon Office has identified that the extremely demanding schedule of this cohort prevents many of these physicians from practicing clinical medicine on a regular basis. In an effort to improve clinical competency, the NASA FS Office has dedicated one day a week for the FS to receive clinical training. Each week, an FS is assigned to one of five clinical settings, one being medical patient simulation. The Medical Operations Support Team (MOST) was tasked to develop curricula using medical patient simulation that would meet the clinical and operational needs of the NASA FS Office. Methods: The MOST met with the Lead FS and Training Lead FS to identify those core competencies most important to the FS cohort. The MOST presented core competency standards from the American Colleges of Emergency Medicine and Internal Medicine as a basis for developing the training. Results: The MOST identified those clinical areas that could be best demonstrated and taught using medical patient simulation, in particular, using high fidelity human patient simulators. Curricula are currently being developed and additional classes will be implemented to instruct the FS cohort. The curricula will incorporate several environments for instruction, including lab-based and simulated microgravity-based environments. Discussion: The response from the NASA FS cohort to the initial introductory class has been positive. As a result of this effort, the MOST has identified three types of training to meet the clinical needs of the FS Office; clinical core competency training, individual clinical refresher training, and just-in-time training (specific for post-ISS Expedition landings). The MOST is continuing to work with the FS Office to augment the clinical training for the FS cohort, including the integration of Web-based learning.

Scholarly productivity for nursing clinical track faculty.

Science.gov (United States)

Tschannen, Dana; Anderson, Christine; Strobbe, Stephen; Bay, Esther; Bigelow, April; Dahlem, Chin Hwa Gina Y; Gosselin, Ann K; Pollard, Jennifer; Seng, Julia S

2014-01-01

Recent years have yielded substantial advancement by clinical track faculty in cohort expansion and collective contributions to the discipline of nursing. As a result, standards for progression and promotion for clinical faculty need to be more fully developed, articulated, and disseminated. Our school formed a task force to examine benchmarks for the progression and promotion of clinical faculty across schools of nursing, with the goal of guiding faculty, reviewers, and decision makers about what constitutes excellence in scholarly productivity. Results from analyses of curriculum vitae of clinical professors or associate professors at six universities with high research activity revealed a variety of productivity among clinical track members, which included notable diversity in the types of scholarly products. Findings from this project help quantify types of scholarship for clinical faculty at the time of promotion. This work provides a springboard for greater understanding of the contributions of clinical track faculty to nursing practice. Copyright © 2014 Elsevier Inc. All rights reserved.

Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings.

Science.gov (United States)

Mtove, George; Kimani, Joshua; Kisinza, William; Makenga, Geofrey; Mangesho, Peter; Duparc, Stephan; Nakalembe, Miriam; Phiri, Kamija S; Orrico, Russell; Rojo, Ricardo; Vandenbroucke, Pol

2018-03-22

Multinational clinical trials are logistically complex and require close coordination between various stakeholders. They must comply with global clinical standards and are accountable to multiple regulatory and ethical bodies. In resource-limited settings, it is challenging to understand how to apply global clinical standards to international, national, and local factors in clinical trials, making multiple-level stakeholder engagement an important element in the successful conduct of these clinical trials. During the planning and implementation of a large multinational clinical trial for intermittent preventive treatment of malaria in pregnancy in resource-limited areas of sub-Saharan Africa, we encountered numerous challenges, which required implementation of a range of engagement measures to ensure compliance with global clinical and regulatory standards. These challenges included coordination with ongoing global malaria efforts, heterogeneity in national regulatory structures, sub-optimal healthcare infrastructure, local practices and beliefs, and perspectives that view healthcare providers with undue trust or suspicion. In addition to engagement with international bodies, such as the World Health Organization, the Malaria in Pregnancy Consortium, the Steve Biko Centre for Bioethics, and the London School of Hygiene and Tropical Medicine, in order to address the challenges just described, Pfizer Inc. and Medicines for Malaria Venture (the "Sponsoring Entities" for these studies) and investigators liaised with national- and district-level stakeholders such as health ministers and regional/local community health workers. Community engagement measures undertaken by investigators included local meetings with community leaders to explain the research aims and answer questions and concerns voiced by the community. The investigators also engaged with family members of prospective trial participants in order to be sensitive to local practices and beliefs. Engagement

Advancing the educational and career pathway for clinical trials nurses.

Science.gov (United States)

Scott, Kathleen; White, Kathryn; Roydhouse, Jessica K

2013-04-01

Clinical trials nurses play a pivotal role in the conduct of clinical research, but the educational and career pathway for these nurses remains unclear. This article reports findings from a survey of nurses working in cancer clinical trials research in Australia. Most participants held postgraduate qualifications (42 of 61); however, clinical trials education was primarily attained through short professional development courses. Interest in pursuing trial-specific postgraduate education was high, but barriers were identified, including cost, time, and unclear benefit for career advancement. Job titles varied substantially, which is indicative of an unclear employment pathway. These findings suggest that initiatives to improve the educational and career pathway for clinical trials nurses are needed and should include the following: formal educational preparation, greater consistency in employment status, and clearer career progression. These strategies should be underpinned by broad professional recognition of the clinical trials nurse as a specialized nursing role. Copyright 2013, SLACK Incorporated.

Improving the accuracy of self-assessment of practical clinical skills using video feedback--the importance of including benchmarks.

Science.gov (United States)

Hawkins, S C; Osborne, A; Schofield, S J; Pournaras, D J; Chester, J F

2012-01-01

Isolated video recording has not been demonstrated to improve self-assessment accuracy. This study examines if the inclusion of a defined standard benchmark performance in association with video feedback of a student's own performance improves the accuracy of student self-assessment of clinical skills. Final year medical students were video recorded performing a standardised suturing task in a simulated environment. After the exercise, the students self-assessed their performance using global rating scales (GRSs). An identical self-assessment process was repeated following video review of their performance. Students were then shown a video-recorded 'benchmark performance', which was specifically developed for the study. This demonstrated the competency levels required to score full marks (30 points). A further self-assessment task was then completed. Students' scores were correlated against expert assessor scores. A total of 31 final year medical students participated. Student self-assessment scores before video feedback demonstrated moderate positive correlation with expert assessor scores (r = 0.48, p benchmark performance demonstration, self-assessment scores demonstrated a very strong positive correlation with expert scores (r = 0.83, p benchmark performance in combination with video feedback may significantly improve the accuracy of students' self-assessments.

42 CFR 409.10 - Included services.

Science.gov (United States)

2010-10-01

... an inpatient of a participating hospital or of a participating CAH or, in the case of emergency... practitioner and clinical nurse specialist services, as defined in section 1861(s)(2)(K)(ii) of the Act. (6...

Discovering Related Clinical Concepts Using Large Amounts of Clinical Notes.

Science.gov (United States)

Ganesan, Kavita; Lloyd, Shane; Sarkar, Vikren

2016-01-01

The ability to find highly related clinical concepts is essential for many applications such as for hypothesis generation, query expansion for medical literature search, search results filtering, ICD-10 code filtering and many other applications. While manually constructed medical terminologies such as SNOMED CT can surface certain related concepts, these terminologies are inadequate as they depend on expertise of several subject matter experts making the terminology curation process open to geographic and language bias. In addition, these terminologies also provide no quantifiable evidence on how related the concepts are. In this work, we explore an unsupervised graphical approach to mine related concepts by leveraging the volume within large amounts of clinical notes. Our evaluation shows that we are able to use a data driven approach to discovering highly related concepts for various search terms including medications, symptoms and diseases.

Discovering Related Clinical Concepts Using Large Amounts of Clinical Notes

Directory of Open Access Journals (Sweden)

Kavita Ganesan

2016-01-01

Full Text Available The ability to find highly related clinical concepts is essential for many applications such as for hypothesis generation, query expansion for medical literature search, search results filtering, ICD-10 code filtering and many other applications. While manually constructed medical terminologies such as SNOMED CT can surface certain related concepts, these terminologies are inadequate as they depend on expertise of several subject matter experts making the terminology curation process open to geographic and language bias. In addition, these terminologies also provide no quantifiable evidence on how related the concepts are. In this work, we explore an unsupervised graphical approach to mine related concepts by leveraging the volume within large amounts of clinical notes. Our evaluation shows that we are able to use a data driven approach to discovering highly related concepts for various search terms including medications, symptoms and diseases.

β-Thalassemia Intermedia: A Clinical Perspective

Science.gov (United States)

Musallam, Khaled M.; Taher, Ali T.; Rachmilewitz, Eliezer A.

2012-01-01

Our understanding of the molecular and pathophysiological mechanisms underlying the disease process in patients with β-thalassemia intermedia has substantially increased over the past decade. Earlier studies observed that patients with β-thalassemia intermedia experience a clinical-complications profile that is different from that in patients with β-thalassemia major. In this article, a variety of clinical morbidities are explored, and their associations with the underlying disease pathophysiology and risk factors are examined. These involve several organs and organ systems including the vasculature, heart, liver, endocrine glands, bone, and the extramedullary hematopoietic system. The effects of some therapeutic interventions on the development of clinical complications are also discussed. PMID:22762026

The detection, diagnosis, therapy, and pre-clinical biology of breast cancer

International Nuclear Information System (INIS)

1978-01-01

The Cancergram covers clinical aspects of cancers of the mammary glands, the fat pads and the supporting tissues. Abstracts included concern certain specific types of neoplasms which occur in the breast, and in ancillary tissues related to the breast (axillary lymph nodes, etc.). Also included are selected studies on receptors and the physiological aspects of lactation, pregnancy, and ontogeny related to cancer of the breast. The topic includes clinically relevant aspects of the prevention, detection, diagnosis, evaluation, and therapy of breast cancer. With certain exceptions, pre-clinical studies of tissue culture systems or animal model studies which are not directly related to primary human disease are excluded

Shared governance in a clinic system.

Science.gov (United States)

Meyers, Michelle M; Costanzo, Cindy

2015-01-01

Shared governance in health care empowers nurses to share in the decision-making process, which results in decentralized management and collective accountability. Share governance practices have been present in hospitals since the late 1970s. However, shared governance in ambulatory care clinics has not been well established. The subjects of this quality project included staff and administrative nurses in a clinic system. The stakeholder committee chose what model of shared governance to implement and educated clinic staff. The Index of Professional Nursing Governance measured a shared governance score pre- and postimplementation of the Clinic Nursing Council. The Clinic Nursing Council met bimonthly for 3 months during this project to discuss issues and make decisions related to nursing staff. The Index of Professional Nursing Governance scores indicated traditional governance pre- and postimplementation of the Clinic Nursing Council, which is to be expected. The stakeholder committee was beneficial to the initial implementation process and facilitated staff nurse involvement. Shared governance is an evolutionary process that develops empowered nurses and nurse leaders.

Clinical Correlates of Computationally Derived Visual Field Defect Archetypes in Patients from a Glaucoma Clinic.

Science.gov (United States)

Cai, Sophie; Elze, Tobias; Bex, Peter J; Wiggs, Janey L; Pasquale, Louis R; Shen, Lucy Q

2017-04-01

To assess the clinical validity of visual field (VF) archetypal analysis, a previously developed machine learning method for decomposing any Humphrey VF (24-2) into a weighted sum of clinically recognizable VF loss patterns. For each of 16 previously identified VF loss patterns ("archetypes," denoted AT1 through AT16), we screened 30,995 reliable VFs to select 10-20 representative patients whose VFs had the highest decomposition coefficients for each archetype. VF global indices and patient ocular and demographic features were extracted retrospectively. Based on resemblances between VF archetypes and clinically observed VF patterns, hypotheses were generated for associations between certain VF archetypes and clinical features, such as an association between AT6 (central island, representing severe VF loss) and large cup-to-disk ratio (CDR). Distributions of the selected clinical features were compared between representative eyes of certain archetypes and all other eyes using the two-tailed t-test or Fisher exact test. 243 eyes from 243 patients were included, representative of AT1 through AT16. CDR was more often ≥ 0.7 among eyes representative of AT6 (central island; p = 0.002), AT10 (inferior arcuate defect; p = 0.048), AT14 (superior paracentral defect; p = 0.016), and AT16 (inferior paracentral defect; p = 0.016) than other eyes. CDR was more often 6D (p = 0.069). Shared clinical features between computationally derived VF archetypes and clinically observed VF patterns support the clinical validity of VF archetypal analysis.

A nurse- and pharmacist-led treatment advice clinic for patients attending an HIV outpatient clinic.

Science.gov (United States)

Griffiths, C; Miles, K; Aldam, D; Cornforth, D; Minton, J; Edwards, S; Williams, I

2007-05-01

This paper is a report of a study to map care pathways, examine the approach of different treatment advisors and explore the acceptability of a nurse- and pharmacist-led treatment advice clinic in order to aid decision-making for the future development and evaluation of the clinic. High levels of adherence to antiretroviral drugs are a prerequisite for a successful and durable virological and immunological response to HIV. Treatment guidelines acknowledge that adherence is a process, not a single event, and that adherence support must be integrated into clinical follow-up for all patients receiving these drugs. Data were collected between September 2004 and January 2005 through 17 consultation observations and 10 patient interviews in a specialist treatment advice clinic located within a central London HIV outpatient clinic providing care for over 2200 patients, of whom more than 1300 are taking highly active antiretroviral therapy. The nurses and pharmacist had similar consultation approaches, although follow-up care varied in extent. Benefits of the clinic approach included permitting patients to observe real tablets, tailoring regimens to lifestyles and telephone follow-up. These factors, particularly telephone support, were perceived by patients to assist with adherence. The role of telephone support, perceived to assist with initial adherence, requires further investigation. Future work is also needed to explore the health economics of this approach and to determine the actual impact of the clinic on clinical and adherence outcomes.

Delineation of a new chromosome 20q11.2 duplication syndrome including the ASXL1 gene

DEFF Research Database (Denmark)

Avila, Magali; Kirchhoff, Eva Maria; Marle, Nathalie

2013-01-01

We report on three males with de novo overlapping 7.5, 9.8, and 10 Mb duplication of chromosome 20q11.2. Together with another patient previously published in the literature with overlapping 20q11 microduplication, we show that such patients display common clinical features including metopic ridg...

Association of genital mycoplasmas including Mycoplasma genitalium in HIV infected men with nongonococcal urethritis attending STD & HIV clinics.

Science.gov (United States)

Manhas, Ashwini; Sethi, Sunil; Sharma, Meera; Wanchu, Ajay; Kanwar, A J; Kaur, Karamjit; Mehta, S D

2009-03-01

Acute nongonococcal urethritis (NGU) is one of the commonest sexually transmitted infections affecting men. The role of genital mycoplasmas including Mycoplasma genitalium in HIV infected men with NGU is still not known. The aim of this study was to determine the isolation pattern/detection of genital mycoplasma including M. genitalium in HIV infected men with NGU and to compare it with non HIV infected individuals. One hundred male patients with NGU (70 HIV positive, 30 HIV negative) were included in the study. Urethral swabs and urine samples obtained from patients were subjected to semi-quantitative culture for Mycoplasma hominis and Ureaplasama urealyticum, whereas M. genitalium was detected by PCR from urine. The primers MgPa1 and MgPa3 were selected to identify 289 bp product specific for M. genitalium. Chalmydia trachomatis antigen detection was carried out by ELISA. M. genitalium and M. hominis were detected/isolated in 6 per cent of the cases. M. genitalium was more common amongst HIV positive cases (7.1%) as compared to HIV negative cases (3.3%) but difference was not statistically significant. Co-infection of C. trachomatis and U. urealyticum was found in two HIV positive cases whereas, C. trachomatis and M. hominis were found to be coinfecting only one HIV positive individual. M. genitalium was found to be infecting the patients as the sole pathogen. Patients with NGU had almost equal risk of being infected with M. genitalium, U. urealyticum or M. hominis irrespective of their HIV status. M.genitalium constitutes one of the important causes of NGU besides other genital mycoplasmas.

Assessing clinical reasoning abilities of medical students using clinical performance examination

Directory of Open Access Journals (Sweden)

Sunju Im

2016-03-01

Full Text Available Purpose: The purpose of this study is to investigate the reliability and validity of new clinical performance examination (CPX for assessing clinical reasoning skills and evaluating clinical reasoning ability of the students. Methods: Third-year medical school students (n=313 in Busan-Gyeongnam consortium in 2014 were included in the study. One of 12 stations was developed to assess clinical reasoning abilities. The scenario and checklists of the station were revised by six experts. Chief complaint of the case was rhinorrhea, accompanied by fever, headache, and vomiting. Checklists focused on identifying of the main problem and systematic approach to the problem. Students interviewed the patient and recorded subjective and objective findings, assessments, plans (SOAP note for 15 minutes. Two professors assessed students simultaneously. We performed statistical analysis on their scores and survey. Results: The Cronbach α of subject station was 0.878 and Cohen κ coefficient between graders was 0.785. Students agreed on CPX as an adequate tool to evaluate students’ performance, but some graders argued that the CPX failed to secure its validity due to their lack of understanding the case. One hundred eight students (34.5% identified essential problem early and only 58 (18.5% performed systematic history taking and physical examination. One hundred seventy-three of them (55.3% communicated correct diagnosis with the patient. Most of them had trouble in writing SOAP notes. Conclusion: To gain reliability and validity, interrater agreement should be secured. Students' clinical reasoning skills were not enough. Students need to be trained on problem identification, reasoning skills and accurate record-keeping.

Clinical review: Ethnic differences in bone mass--clinical implications.

Science.gov (United States)

Leslie, William D

2012-12-01

Differences in bone mineral density (BMD) as assessed with dual-energy x-ray absorptiometry are observed between geographic and ethnic groups, with important implications in clinical practice. PubMed was employed to identify relevant studies. A review of the literature was conducted, and data were summarized and integrated. The available data highlight the complex ethnic variations in BMD, which only partially account for observed variations in fracture rates. Factors contributing to ethnic differences include genetics, skeletal size, body size and composition, lifestyle, and social determinants. Despite BMD differences, the gradient of risk for fracture from BMD and other clinical risk factors appears to be similar across ethnic groups. Furthermore, BMD variation is greater within an ethnic population than between ethnic populations. New imaging technologies have identified ethnic differences in bone geometry, volumetric density, microarchitecture, and estimated bone strength that may contribute to a better understanding of ethnic differences in fracture risk. Factors associated with ethnicity affect BMD and fracture risk through direct and indirect mechanisms.

Crescentic glomerulonephritis: A clinical and histomorphological analysis of 46 cases

Directory of Open Access Journals (Sweden)

Ruchika Gupta

2011-01-01

Full Text Available Background: Crescentic glomerulonephritis (CrGN, defined as crescents involving more than 50% of the glomeruli, includes pauci-immune, immune complex-mediated and anti-glomerular basement membrane disease. Objectives: The present study was aimed at evaluating the various clinical, biochemical and histological parameters in CrGN with respect to these categories and clinical outcome. Materials and Methods: Renal biopsies diagnosed as CrGN between Jan 2008 and Feb 2010 were included. Clinical and laboratory parameters were retrieved along with the therapeutic approach and clinical outcome, wherever available. Renal biopsy slides were evaluated for various glomerular, tubulo-interstitial and arteriolar features. Appropriate statistical tests were applied for significance. Results: A total of 46 cases of CrGN were included; majority (71.7% of cases were pauci-immune (PI while 28.3% were immune complex-mediated (IC. Among clinical features, gender ratio was significantly different between PI and IC groups (P = 0.006. The various histological parameters, including proportion of cellular crescents, tuft necrosis and Bowman′s capsule rupture, were similar in both the groups. Four unusual associations, including idiopathic membranoproliferative glomerulonephritis (MPGN, multibacillary leprosy, acute lymphoblastic leukemia and C1q nephropathy were detected. Adequate follow-up information was available in 21 (46% of the patients. Of these, 11 (52.4% were dialysis-dependent at the last follow-up. Adult patients required renal replacement therapy more frequently than pediatric cases (P = 0.05. Presence of arteriolar fibrinoid necrosis also showed association with poor clinical outcome (P = 0.05. Conclusions: Crescentic glomerulonephritis remains one of the main causes of acute renal failure with histological diagnosis. Immunohistologic examination is essential for accurate classification into one of the three categories. This condition should be considered

Infrastructure resources for clinical research in amyotrophic lateral sclerosis.

Science.gov (United States)

Sherman, Alexander V; Gubitz, Amelie K; Al-Chalabi, Ammar; Bedlack, Richard; Berry, James; Conwit, Robin; Harris, Brent T; Horton, D Kevin; Kaufmann, Petra; Leitner, Melanie L; Miller, Robert; Shefner, Jeremy; Vonsattel, Jean Paul; Mitsumoto, Hiroshi

2013-05-01

Clinical trial networks, shared clinical databases, and human biospecimen repositories are examples of infrastructure resources aimed at enhancing and expediting clinical and/or patient oriented research to uncover the etiology and pathogenesis of amyotrophic lateral sclerosis (ALS), a rapidly progressive neurodegenerative disease that leads to the paralysis of voluntary muscles. The current status of such infrastructure resources, as well as opportunities and impediments, were discussed at the second Tarrytown ALS meeting held in September 2011. The discussion focused on resources developed and maintained by ALS clinics and centers in North America and Europe, various clinical trial networks, U.S. government federal agencies including the National Institutes of Health (NIH), the Agency for Toxic Substances and Disease Registry (ATSDR) and the Centers for Disease Control and Prevention (CDC), and several voluntary disease organizations that support ALS research activities. Key recommendations included 1) the establishment of shared databases among individual ALS clinics to enhance the coordination of resources and data analyses; 2) the expansion of quality-controlled human biospecimen banks; and 3) the adoption of uniform data standards, such as the recently developed Common Data Elements (CDEs) for ALS clinical research. The value of clinical trial networks such as the Northeast ALS (NEALS) Consortium and the Western ALS (WALS) Consortium was recognized, and strategies to further enhance and complement these networks and their research resources were discussed.

Toward an Ecological Perspective of Resident Teaching Clinic

Science.gov (United States)

Smith, C. Scott; Francovich, Chris; Morris, Magdalena; Hill, William; Langlois-Winkle, Francine; Rupper, Randall; Roth, Craig; Wheeler, Stephanie; Vo, Anthony

2010-01-01

Teaching clinic managers struggle to convert performance data into meaningful behavioral change in their trainees, and quality improvement measures in medicine have had modest results. This may be due to several factors including clinical performance being based more on team function than individual action, models of best practice that are…

Epidemiological and clinical aspects of ear nose and throat ...

African Journals Online (AJOL)

Introduction: sensorineural emergencies (SNE) are rare clinical situations. Few patients consult early explaining subsequent difficulty in having accurate data and management. Three clinical conditions are considered SNE in otolaryngology; they include sudden sensorineural hearing loss (SSHL), Bell's palsy and acute ...

Clinimetrics and clinical psychometrics: macro- and micro-analysis.

Science.gov (United States)

Tomba, Elena; Bech, Per

2012-01-01

Clinimetrics was introduced three decades ago to specify the domain of clinical markers in clinical medicine (indexes or rating scales). In this perspective, clinical validity is the platform for selecting the various indexes or rating scales (macro-analysis). Psychometric validation of these indexes or rating scales is the measuring aspect (micro-analysis). Clinical judgment analysis by experienced psychiatrists is included in the macro-analysis and the item response theory models are especially preferred in the micro-analysis when using the total score as a sufficient statistic. Clinical assessment tools covering severity of illness scales, prognostic measures, issues of co-morbidity, longitudinal assessments, recovery, stressors, lifestyle, psychological well-being, and illness behavior have been identified. The constructive dialogue in clinimetrics between clinical judgment and psychometric validation procedures is outlined for generating developments of clinical practice in psychiatry. Copyright © 2012 S. Karger AG, Basel.

Clinical trial network for the promotion of clinical research for rare diseases in Japan: muscular dystrophy clinical trial network.

Science.gov (United States)

Shimizu, Reiko; Ogata, Katsuhisa; Tamaura, Akemi; Kimura, En; Ohata, Maki; Takeshita, Eri; Nakamura, Harumasa; Takeda, Shin'ichi; Komaki, Hirofumi

2016-07-11

Duchenne muscular dystrophy (DMD) is the most commonly inherited neuromuscular disease. Therapeutic agents for the treatment of rare disease, namely "orphan drugs", have recently drawn the attention of researchers and pharmaceutical companies. To ensure the successful conduction of clinical trials to evaluate novel treatments for patients with rare diseases, an appropriate infrastructure is needed. One of the effective solutions for the lack of infrastructure is to establish a network of rare diseases. To accomplish the conduction of clinical trials in Japan, the Muscular dystrophy clinical trial network (MDCTN) was established by the clinical research group for muscular dystrophy, including the National Center of Neurology and Psychiatry, as well as national and university hospitals, all which have a long-standing history of research cooperation. Thirty-one medical institutions (17 national hospital organizations, 10 university hospitals, 1 national center, 2 public hospitals, and 1 private hospital) belong to this network and collaborate to facilitate clinical trials. The Care and Treatment Site Registry (CTSR) calculates and reports the proportion of patients with neuromuscular diseases in the cooperating sites. In total, there are 5,589 patients with neuromuscular diseases in Japan and the proportion of patients with each disease is as follows: DMD, 29 %; myotonic dystrophy type 1, 23 %; limb girdle muscular dystrophy, 11 %; Becker muscular dystrophy, 10 %. We work jointly to share updated health care information and standardized evaluations of clinical outcomes as well. The collaboration with the patient registry (CTSR), allows the MDCTN to recruit DMD participants with specific mutations and conditions, in a remarkably short period of time. Counting with a network that operates at a national level is important to address the corresponding national issues. Thus, our network will be able to contribute with international research activity, which can lead to

The preanalytic phase in veterinary clinical pathology.

Science.gov (United States)

Braun, Jean-Pierre; Bourgès-Abella, Nathalie; Geffré, Anne; Concordet, Didier; Trumel, Cathy

2015-03-01

This article presents the general causes of preanalytic variability with a few examples showing specialists and practitioners that special and improved care should be given to this too often neglected phase. The preanalytic phase of clinical pathology includes all the steps from specimen collection to analysis. It is the phase where most laboratory errors occur in human, and probably also in veterinary clinical pathology. Numerous causes may affect the validity of the results, including technical factors, such as the choice of anticoagulant, the blood vessel sampled, and the duration and conditions of specimen handling. While the latter factors can be defined, influence of biologic and physiologic factors such as feeding and fasting, stress, and biologic and endocrine rhythms can often not be controlled. Nevertheless, as many factors as possible should at least be documented. The importance of the preanalytic phase is often not given the necessary attention, although the validity of the results and consequent clinical decision making and medical management of animal patients would likely be improved if the quality of specimens submitted to the laboratory was optimized. © 2014 American Society for Veterinary Clinical Pathology.

Building an engaged workforce at Cleveland Clinic

Directory of Open Access Journals (Sweden)

Patrnchak JM

2013-05-01

Full Text Available Joseph M PatrnchakCleveland Clinic, Cleveland, OH, USAAbstract: Employee engagement is widely recognized as a critical factor in organizational performance. This article examines an ongoing cultural development initiative at Cleveland Clinic designed to significantly increase employee engagement. Key components of this initiative include the introduction of serving leadership, new caregiver wellness and recognition programs, “Cleveland Clinic Experience” training focused on the institution’s core mission, and changes in the institutional vocabulary. Since 2008, the results include a dramatic improvement in engagement, as measured by the Gallup Q12 survey, with parallel improvements in patient satisfaction, as measured by the clinic's scores on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS survey. In addition to a discussion of the key components of the clinic’s engagement initiative, the article provides a partial review of the literature focused on employee engagement as well as a summary of “lessons learned” that may serve as a guide for others facing the challenge of increasing employee engagement in large, mature health care institutions.Keywords: health care, employee engagement, culture change, hospital performance, patient satisfaction

Clinical Research Informatics for Big Data and Precision Medicine.

Science.gov (United States)

Weng, C; Kahn, M G

2016-11-10

To reflect on the notable events and significant developments in Clinical Research Informatics (CRI) in the year of 2015 and discuss near-term trends impacting CRI. We selected key publications that highlight not only important recent advances in CRI but also notable events likely to have significant impact on CRI activities over the next few years or longer, and consulted the discussions in relevant scientific communities and an online living textbook for modern clinical trials. We also related the new concepts with old problems to improve the continuity of CRI research. The highlights in CRI in 2015 include the growing adoption of electronic health records (EHR), the rapid development of regional, national, and global clinical data research networks for using EHR data to integrate scalable clinical research with clinical care and generate robust medical evidence. Data quality, integration, and fusion, data access by researchers, study transparency, results reproducibility, and infrastructure sustainability are persistent challenges. The advances in Big Data Analytics and Internet technologies together with the engagement of citizens in sciences are shaping the global clinical research enterprise, which is getting more open and increasingly stakeholder-centered, where stakeholders include patients, clinicians, researchers, and sponsors.

Clinics of ocular tuberculosis.

Science.gov (United States)

Gupta, Vishali; Shoughy, Samir S; Mahajan, Sarakshi; Khairallah, Moncef; Rosenbaum, James T; Curi, Andre; Tabbara, Khalid F

2015-02-01

Ocular tuberculosis is an extrapulmonary tuberculous condition and has variable manifestations. The purpose of this review is to describe the clinical manifestations of ocular tuberculosis affecting the anterior and posterior segments of the eye in both immunocompetent and immunocompromised patients. Review of literature using Pubmed database. Mycobacterium tuberculosis may lead to formation of conjunctival granuloma, nodular scleritis, and interstitial keratitis. Lacrimal gland and orbital caseating granulomas are rare but may occur. The intraocular structures are also a target of insult by M. tuberculosis and may cause anterior granulomatous uveitis, anterior and posterior synechiae, secondary glaucoma, and cataract. The bacillus may involve the ciliary body, resulting in the formation of a localized caseating granuloma. Posterior segment manifestations include vitritis, retinal vasculitis, optic neuritis, serpiginous-like choroiditis, choroidal tubercules, subretinal neovascularization, and, rarely, endophthalmitis. The recognition of clinical signs of ocular tuberculosis is of utmost importance as it can provide clinical pathway toward tailored investigations and decision making for initiating anti-tuberculosis therapy.

Teaching clinical reasoning to medical students.

Science.gov (United States)

Gay, Simon; Bartlett, Maggie; McKinley, Robert

2013-10-01

Keele Medical School's new curriculum includes a 5-week course to extend medical students' consultation skills beyond those historically required for competent inductive diagnosis. Clinical reasoning is a core skill for the practice of medicine, and is known to have implications for patient safety, yet historically it has not been explicitly taught. Rather, it has been assumed that these skills will be learned by accumulating a body of knowledge and by observing expert clinicians. This course aims to assist students to develop their own clinical reasoning skills and promote their greater understanding of, and potential to benefit from, the clinical reasoning skills of others. The course takes place in the fourth or penultimate year, and is integrated with students' clinical placements, giving them opportunities to practise and quickly embed their learning. This course emphasises that clinical reasoning extends beyond initial diagnosis into all other aspects of clinical practice, particularly clinical management. It offers students a variety of challenging and interesting opportunities to engage with clinical reasoning across a wide range of clinical practice. It addresses bias through metacognition and increased self-awareness, considers some of the complexities of prescribing and non-pharmacological interventions, and promotes pragmatic evidence-based practice, information management within the consultation and the maximising of patient adherence. This article describes clinical reasoning-based classroom and community teaching. Early evaluation suggests that students value the course and benefit from it. © 2013 John Wiley & Sons Ltd.

Effect of Objective Structured Clinical Examination on Nursing Students' Clinical Skills

Directory of Open Access Journals (Sweden)

Seyedeh Narjes Mousavizadeh

2018-01-01

Full Text Available Considering the daily increasing changes in clinical training approaches, the necessity of using new evaluation methods in proportion with these approaches is also becoming more and more obvious for measuring all of the cognitive, emotional and psychomotor dimensions of students. The present study was designed and conducted for reviewing the effect of objective structured clinical examination method on the clinical skills of nursing students. In this quasi-experimental study, 48 nursing students have participated that were randomly assigned to two groups of intervention and control. The intervention group students were evaluated at the end of educational period of their clinical skills and principles course using objective structured clinical examination (OSCE. The OSCE included five core skills in this course: assessing and fulfilling patients’ basic needs, dressing up, injectable drug therapy, noninjectable drug therapy, infection control. The control group students were evaluated using the routine method. Both groups of students were followed up in the next semester and were compared in terms of learning enhancement in these five skills. Evaluation of procedures was based on valid and reliable check-lists made by the researcher. Results were analyzed using descriptive and inferential statistics (Chi-square, independent and paired T tests. The mean score of the final evaluation in the intervention group was significantly higher than that of the control group (P= 0.000. Final evaluation scores of the intervention group students showed a better performance than their previous semester (P= 0.000, while the final evaluation scores of the control group students showed a lack of progress in their skills (P<0.05. It seems that this evaluation method also is a support for students' learning and resulted in improvement of clinical skills among them. Accordingly, it is recommended that nursing education centers apply this method to assess students�

Doripenem: position in clinical practice.

Science.gov (United States)

Dedhia, Harakh V; McKnight, Richard

2009-06-01

Doripenem is a novel carbapenem with a broad spectrum of activity against Gram-positive pathogens, anerobes and Gram-negative bacteria, including Pseudomonas aeruginosa. Doripenem exhibits rapid bactericidal activity with two- to fourfold lower MIC values for Gram-negative bacteria, compared with other carbapenems such as imipenem. Doripenem is approved for the treatment of complicated intra-abdominal infection and urinary tract infections. It has been successfully used in the treatment of nosocomial and ventilator-associated pneumonia. It has a potential to be the drug of choice for these conditions. This evaluation focuses on the general review of the drug, including mechanisms of resistance, clinical efficacy and the position of doripenem in clinical practice. Stability against numerous beta-lactamases, low adverse-event potential and more potent in vitro and possibly in vivo activity against P. aeruginosa and Acinetobacter baumanni compared with existing carbapenems are attractive features.

Mobile clinics for women's and children's health.

Science.gov (United States)

Abdel-Aleem, Hany; El-Gibaly, Omaima M H; El-Gazzar, Amira F E-S; Al-Attar, Ghada S T

2016-08-11

The accessibility of health services is an important factor that affects the health outcomes of populations. A mobile clinic provides a wide range of services but in most countries the main focus is on health services for women and children. It is anticipated that improvement of the accessibility of health services via mobile clinics will improve women's and children's health. To evaluate the impact of mobile clinic services on women's and children's health. For related systematic reviews, we searched the Database of Abstracts of Reviews of Effectiveness (DARE), CRD; Health Technology Assessment Database (HTA), CRD; NHS Economic Evaluation Database (NHS EED), CRD (searched 20 February 2014).For primary studies, we searched ISI Web of Science, for studies that have cited the included studies in this review (searched 18 January 2016); WHO ICTRP, and ClinicalTrials.gov (searched 23 May 2016); Cochrane Central Register of Controlled Trials (CENTRAL), part of The Cochrane Library. www.cochranelibrary.com (including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register) (searched 7 April 2015); MEDLINE, OvidSP (searched 7 April 2015); Embase, OvidSP (searched 7 April 2015); CINAHL, EbscoHost (searched 7 April 2015); Global Health, OvidSP (searched 8 April 2015); POPLINE, K4Health (searched 8 April 2015); Science Citation Index and Social Sciences Citation Index, ISI Web of Science (searched 8 April 2015); Global Health Library, WHO (searched 8 April 2015); PAHO, VHL (searched 8 April 2015); WHOLIS, WHO (searched 8 April 2015); LILACS, VHL (searched 9 April 2015). We included individual- and cluster-randomised controlled trials (RCTs) and non-RCTs. We included controlled before-and-after (CBA) studies provided they had at least two intervention sites and two control sites. Also, we included interrupted time series (ITS) studies if there was a clearly defined point in time when the intervention occurred and at least three data points

'Cloud computing' and clinical trials: report from an ECRIN workshop.

Science.gov (United States)

Ohmann, Christian; Canham, Steve; Danielyan, Edgar; Robertshaw, Steve; Legré, Yannick; Clivio, Luca; Demotes, Jacques

2015-07-29

Growing use of cloud computing in clinical trials prompted the European Clinical Research Infrastructures Network, a European non-profit organisation established to support multinational clinical research, to organise a one-day workshop on the topic to clarify potential benefits and risks. The issues that arose in that workshop are summarised and include the following: the nature of cloud computing and the cloud computing industry; the risks in using cloud computing services now; the lack of explicit guidance on this subject, both generally and with reference to clinical trials; and some possible ways of reducing risks. There was particular interest in developing and using a European 'community cloud' specifically for academic clinical trial data. It was recognised that the day-long workshop was only the start of an ongoing process. Future discussion needs to include clarification of trial-specific regulatory requirements for cloud computing and involve representatives from the relevant regulatory bodies.

The effect of a preanaesthesia clinic consultation on adult patient ...

African Journals Online (AJOL)

reduce anxiety however current studies on anxiety and the preanaesthesia clinic have not quantified this reduction. Objective: ... Disadvantages of the preoperative clinic may include ad- ditional consultation costs and longer hospital waiting.

Challenges in Measuring Benefit of Clinical Research Training Programs--the ASH Clinical Research Training Institute Example.

Science.gov (United States)

Sung, Lillian; Crowther, Mark; Byrd, John; Gitlin, Scott D; Basso, Joe; Burns, Linda

2015-12-01

The American Society of Hematology developed the Clinical Research Training Institute (CRTI) to address the lack of training in patient-oriented research among hematologists. As the program continues, we need to consider metrics for measuring the benefits of such a training program. This article addresses the benefits of clinical research training programs. The fundamental and key components are education and mentorship. However, there are several other benefits including promotion of collaboration, job and advancement opportunities, and promotion of work-life balance. The benefits of clinical research training programs need to be measured so that funders and society can judge if they are worth the investment in time and resources. Identification of elements that are important to program benefit is essential to measuring the benefit of the program as well as program planning. Future work should focus on the constructs which contribute to benefits of clinical research training programs such as CRTI.

Highly effective cystic fibrosis clinical research teams: critical success factors.

Science.gov (United States)

Retsch-Bogart, George Z; Van Dalfsen, Jill M; Marshall, Bruce C; George, Cynthia; Pilewski, Joseph M; Nelson, Eugene C; Goss, Christopher H; Ramsey, Bonnie W

2014-08-01

Bringing new therapies to patients with rare diseases depends in part on optimizing clinical trial conduct through efficient study start-up processes and rapid enrollment. Suboptimal execution of clinical trials in academic medical centers not only results in high cost to institutions and sponsors, but also delays the availability of new therapies. Addressing the factors that contribute to poor outcomes requires novel, systematic approaches tailored to the institution and disease under study. To use clinical trial performance metrics data analysis to select high-performing cystic fibrosis (CF) clinical research teams and then identify factors contributing to their success. Mixed-methods research, including semi-structured qualitative interviews of high-performing research teams. CF research teams at nine clinical centers from the CF Foundation Therapeutics Development Network. Survey of site characteristics, direct observation of team meetings and facilities, and semi-structured interviews with clinical research team members and institutional program managers and leaders in clinical research. Critical success factors noted at all nine high-performing centers were: 1) strong leadership, 2) established and effective communication within the research team and with the clinical care team, and 3) adequate staff. Other frequent characteristics included a mature culture of research, customer service orientation in interactions with study participants, shared efficient processes, continuous process improvement activities, and a businesslike approach to clinical research. Clinical research metrics allowed identification of high-performing clinical research teams. Site visits identified several critical factors leading to highly successful teams that may help other clinical research teams improve clinical trial performance.

Juvenile myoclonic epilepsy: clinical and EEG features

DEFF Research Database (Denmark)

Pedersen, S B; Petersen, K A

1998-01-01

We aimed to characterize the clinical profile and EEG features of 43 patients with juvenile myoclonic epilepsy. In a retrospective design we studied the records of, and re-interviewed, 43 patients diagnosed with JME from the epilepsy clinic data base. Furthermore, available EEGs were re...... were sleep deprivation (84%), stress (70%), and alcohol consumption (51%). EEG findings included rapid spike-wave and polyspike-wave....

Clinical significance of anaplasia in childhood rhabdomyosarcoma

OpenAIRE

Sidhom, Iman; El Nadi, Enas; Taha, Hala; Elkinaai, Naglaa; Zaghloul, Mohamed S.; Younes, Alaa; Labib, Rania; Sabry, Mohamed

2015-01-01

Background: The presence of anaplastic features has been known to correlate with poor clinical outcome in various pediatric malignancies, including Wilms tumor and medulloblastoma but not in rhabdomyosarcoma. Aim: Aim was to study the frequency of anaplasia at presentation in childhood rhabdomyosarcoma and its relationship to clinical and pathological characteristics as well as to outcome. Patients and Methods: Anaplasia was retrospectively assessed in 105 consecutive pediatric rhabdomy...

Juvenile myoclonic epilepsy: clinical and EEG features

DEFF Research Database (Denmark)

Pedersen, S B; Petersen, K A

1998-01-01

We aimed to characterize the clinical profile and EEG features of 43 patients with juvenile myoclonic epilepsy. In a retrospective design we studied the records of, and re-interviewed, 43 patients diagnosed with JME from the epilepsy clinic data base. Furthermore, available EEGs were re-evaluated...... were sleep deprivation (84%), stress (70%), and alcohol consumption (51%). EEG findings included rapid spike-wave and polyspike-wave....

iPSCs: A Minireview from Bench to Bed, including Organoids and the CRISPR System

Directory of Open Access Journals (Sweden)

Andrés Javier Orqueda

2016-01-01

Full Text Available When Dolly the sheep was born, the first probe into an adult mammalian genome traveling back in time and generating a whole new animal appeared. Ten years later, the reprogramming process became a defined method of producing induced pluripotent stem cells (iPSCs through the overexpression of four transcription factors. iPSCs are capable of originating virtually all types of cells and tissues, including a whole new animal. The reprogramming strategies based on patient-derived cells should make the development of clinical applications of cell based therapy much more straightforward. Here, we analyze the current state, opportunities, and challenges of iPSCs from bench to bed, including organoids and the CRISPR system.

Veterinary clinical nutrition: success stories: an overview.

Science.gov (United States)

Davies, Mike

2016-08-01

In this overview of success stories in veterinary clinical nutrition topics in cats and dogs reviewed include the dietary management of chronic kidney disease, dissolution of urinary tract uroliths by dietary modification, the recognition that taurine and L-carnitine deficiencies can cause dilated cardiomyopathy; that clinical signs associated with feline hyperthyroidism (caused by a benign adenoma) can be controlled by a low-iodine diet alone; that dietary management of canine osteoarthritis can also reduce non-steroidal anti-inflammatory drug doses; and that disease-free intervals and survival times can be statistically longer in dogs with Stage III lymphoma managed with diet. As we discover more about nutrigenetics and nutrigenomics, and as we expand our basic understanding of idiopathic diseases we are bound to identify more nutritionally related causes, and be able to develop novel dietary strategies to manage disease processes, including the formulation of diets designed to alter gene expression to obtain beneficial clinical outcomes.

Disorganization at the stage of schizophrenia clinical outcome: Clinical-biological study.

Science.gov (United States)

Nestsiarovich, A; Obyedkov, V; Kandratsenka, H; Siniauskaya, M; Goloenko, I; Waszkiewicz, N

2017-05-01

According to the multidimensional model of schizophrenia, three basic psychopathological dimensions constitute its clinical structure: positive symptoms, negative symptoms and disorganization. The latter one is the newest and the least studied. Our aim was to discriminate disorganization in schizophrenia clinical picture and to identify its distinctive biological and socio-psychological particularities and associated genetic and environmental factors. We used SAPS/SANS psychometrical scales, scales for the assessment of patient's compliance, insight, social functioning, life quality. Neuropsychological tests included Wisconsin Card Sorting Test (WCST), Stroop Color-Word test. Neurophysiological examination included registration of P300 wave of the evoked cognitive auditory potentials. Environmental factors related to patient's education, family, surrounding and nicotine use, as well as subjectively significant traumatic events in childhood and adolescence were assessed. Using PCR we detected SNP of genes related to the systems of neurotransmission (COMT, SLC6A4 and DRD2), inflammatory response (IL6, TNF), cellular detoxification (GSTM1, GSTT1), DNA methylation (MTHFR, DNMT3b, DNMT1). Disorganization is associated with early schizophrenia onset and history of psychosis in family, low level of insight and compliance, high risk of committing delicts, distraction errors in WCST, lengthened P300 latency of evoked cognitive auditory potentials, low-functional alleles of genes MTHFR (rs1801133) and DNMT3b (rs2424913), high level of urbanicity and psychotraumatic events at early age. Severe disorganization at the stage of schizophrenia clinical outcome is associated with the set of specific biological and social-psychological characteristics that indicate its epigenetic nature and maladaptive social significance. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Clinical presentation of familial exudative vitreoretinopathy.

Science.gov (United States)

Ranchod, Tushar M; Ho, Lawrence Y; Drenser, Kimberly A; Capone, Antonio; Trese, Michael T

2011-10-01

To describe the clinical characteristics, staging and presentation of patients with familial exudative vitreoretinopathy (FEVR) in our clinical practice over the last 25 years. Case series, retrospective review. We included 273 eyes of 145 patients. Data collected from charts included gender, gestational age at birth, birthweight, age at presentation, referring diagnosis, family history, prior ocular surgery, and clinical presentation in each eye. Eyes with invasive posterior segment procedures before initial presentation were excluded. Demographics on presentation and clinical staging. Patients were slightly male predominant (57%) with a mean birthweight of 2.80 kg (range, 740 g-4.76 kg), mean gestational age of 37.8 weeks (range, 25-42), and mean age at presentation of almost 6 years (range, presentation, gestational age, and birthweight. Although a positive family history on presentation may support the diagnosis of FEVR, a negative family history is of little help. The majority of retinal folds extended radially in the temporal quadrants, but radial folds were seen in almost all quadrants. Fellow eyes demonstrated a wide variation in symmetry. The presentation of FEVR may mimic the presentation of other pediatric and adult vitreoretinal disorders, and careful examination is often crucial in making the diagnosis of FEVR. The authors have no proprietary or commercial interest in any of the materials discussed in this article. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

fMRI. Basics and clinical applications. 2. ed.

Energy Technology Data Exchange (ETDEWEB)

Ulmer, Stephan [Medizinisch Radiologisces Institut (MRI), Zuerich (Switzerland); Universitaetsklinikum Schleswig-Holstein, Kiel (Germany). Inst. fuer Neuroradiologie; Jansen, Olav (eds.) [Universitaetsklinikum Schleswig-Holstein, Kiel (Germany). Inst. fuer Neuroradiologie

2013-11-01

State of the art overview of fMRI. Covers technical issues, methods of statistical analysis, and the full range of clinical applications. Revised and expanded edition including discussion of novel aspects of analysis and further important applications. Includes comparisons with other brain mapping techniques and discussion of potential combined uses. Since functional MRI (fMRI) and the basic method of BOLD imaging were introduced in 1993 by Seiji Ogawa, fMRI has evolved into an invaluable clinical tool for routine brain imaging, and there have been substantial improvements in both the imaging technique itself and the associated statistical analysis. This book provides a state of the art overview of fMRI and its use in clinical practice. Experts in the field share their knowledge and explain how to overcome diverse potential technical barriers and problems. Starting from the very basics on the origin of the BOLD signal, the book covers technical issues, anatomical landmarks, the full range of clinical applications, methods of statistical analysis, and special issues in various clinical fields. Comparisons are made with other brain mapping techniques, such as DTI, PET, TMS, EEG, and MEG, and their combined use with fMRI is also discussed. Since the first edition, original chapters have been updated and new chapters added, covering both novel aspects of analysis and further important clinical applications.

A Leadership Education and Development Program for Clinical Nurses.

Science.gov (United States)

Fitzpatrick, Joyce J; Modic, Mary Beth; Van Dyk, Jennifer; Hancock, K Kelly

2016-11-01

The Leadership Education and Development (LEAD) Program was designed to transform care at the bedside by empowering clinical nurses as leaders. The heart of LEAD was enhancing communication skills of clinical nurses with clinical colleagues and, most importantly, patients and families. Key concepts of leadership/management were included: personal awareness, personal leadership skills/abilities, leading change, leading others individually and in teams, enhancing the patient/provider experience, and the leadership role in outcomes management. A quantitative, longitudinal, survey design was used with 2 cohorts. The program consisted of six 4-hour sessions for 3 to 6 months. Leadership practices were measured before program implementation, at the end of the program, and 3 months after program completion. There were significant increases in leadership practices sustained 3 months after program completion. A range of other outcome measures was included. There is a need for additional leadership development programs for clinical nurses.

Clinical, laboratory, and hemostatic findings in cats with naturally occurring sepsis.

Science.gov (United States)

Klainbart, Sigal; Agi, Limor; Bdolah-Abram, Tali; Kelmer, Efrat; Aroch, Itamar

2017-11-01

OBJECTIVE To characterize clinical and laboratory findings in cats with naturally occurring sepsis, emphasizing hemostasis-related findings, and evaluate these variables for associations with patient outcomes. DESIGN Prospective, observational, clinical study. ANIMALS 31 cats with sepsis and 33 healthy control cats. PROCEDURES Data collected included history; clinical signs; results of hematologic, serum biochemical, and hemostatic tests; diagnosis; and outcome (survival vs death during hospitalization or ≤ 30 days after hospital discharge). Differences between cats with and without sepsis and associations between variables of interest and death were analyzed statistically. RESULTS The sepsis group included cats with pyothorax (n = 10), septic peritonitis (7), panleukopenia virus infection (5), bite wounds (5), abscesses and diffuse cellulitis (3), and pyometra (1). Common clinical abnormalities included dehydration (21 cats), lethargy (21), anorexia (18), pale mucous membranes (15), and dullness (15). Numerous clinicopathologic abnormalities were identified in cats with sepsis; novel findings included metarubricytosis, hypertriglyceridemia, and high circulating muscle enzyme activities. Median activated partial thromboplastin time and plasma D-dimer concentrations were significantly higher, and total protein C and antithrombin activities were significantly lower, in the sepsis group than in healthy control cats. Disseminated intravascular coagulopathy was uncommon (4/22 [18%] cats with sepsis). None of the clinicopathologic abnormalities were significantly associated with death on multivariate analysis. CONCLUSIONS AND CLINICAL RELEVANCE Cats with sepsis had multiple hematologic, biochemical, and hemostatic abnormalities on hospital admission, including several findings suggestive of hemostatic derangement. Additional research including larger numbers of cats is needed to further investigate these findings and explore associations with outcome.

Clinical simulation as an evaluation method in health informatics

DEFF Research Database (Denmark)

Jensen, Sanne

2016-01-01

Safe work processes and information systems are vital in health care. Methods for design of health IT focusing on patient safety are one of many initiatives trying to prevent adverse events. Possible patient safety hazards need to be investigated before health IT is integrated with local clinical...... work practice including other technology and organizational structure. Clinical simulation is ideal for proactive evaluation of new technology for clinical work practice. Clinical simulations involve real end-users as they simulate the use of technology in realistic environments performing realistic...... tasks. Clinical simulation study assesses effects on clinical workflow and enables identification and evaluation of patient safety hazards before implementation at a hospital. Clinical simulation also offers an opportunity to create a space in which healthcare professionals working in different...

Models of clinical reasoning with a focus on general practice: A critical review.

Science.gov (United States)

Yazdani, Shahram; Hosseinzadeh, Mohammad; Hosseini, Fakhrolsadat

2017-10-01

Diagnosis lies at the heart of general practice. Every day general practitioners (GPs) visit patients with a wide variety of complaints and concerns, with often minor but sometimes serious symptoms. General practice has many features which differentiate it from specialty care setting, but during the last four decades little attention was paid to clinical reasoning in general practice. Therefore, we aimed to critically review the clinical reasoning models with a focus on the clinical reasoning in general practice or clinical reasoning of general practitioners to find out to what extent the existing models explain the clinical reasoning specially in primary care and also identity the gaps of the model for use in primary care settings. A systematic search to find models of clinical reasoning were performed. To have more precision, we excluded the studies that focused on neurobiological aspects of reasoning, reasoning in disciplines other than medicine decision making or decision analysis on treatment or management plan. All the articles and documents were first scanned to see whether they include important relevant contents or any models. The selected studies which described a model of clinical reasoning in general practitioners or with a focus on general practice were then reviewed and appraisal or critics of other authors on these models were included. The reviewed documents on the model were synthesized. Six models of clinical reasoning were identified including hypothetic-deductive model, pattern recognition, a dual process diagnostic reasoning model, pathway for clinical reasoning, an integrative model of clinical reasoning, and model of diagnostic reasoning strategies in primary care. Only one model had specifically focused on general practitioners reasoning. A Model of clinical reasoning that included specific features of general practice to better help the general practitioners with the difficulties of clinical reasoning in this setting is needed.

Models of clinical reasoning with a focus on general practice: a critical review

Directory of Open Access Journals (Sweden)

SHAHRAM YAZDANI

2017-10-01

Full Text Available Introduction: Diagnosis lies at the heart of general practice. Every day general practitioners (GPs visit patients with a wide variety of complaints and concerns, with often minor but sometimes serious symptoms. General practice has many features which differentiate it from specialty care setting, but during the last four decades little attention was paid to clinical reasoning in general practice. Therefore, we aimed to critically review the clinical reasoning models with a focus on the clinical reasoning in general practice or clinical reasoning of general practitioners to find out to what extent the existing models explain the clinical reasoning specially in primary care and also identity the gaps of the model for use in primary care settings Methods: A systematic search to find models of clinical reasoning were performed. To have more precision, we excluded the studies that focused on neurobiological aspects of reasoning, reasoning in disciplines other than medicine decision making or decision analysis on treatment or management plan. All the articles and documents were first scanned to see whether they include important relevant contents or any models. The selected studies which described a model of clinical reasoning in general practitioners or with a focus on general practice were then reviewed and appraisal or critics of other authors on these models were included. The reviewed documents on the model were synthesized Results: Six models of clinical reasoning were identified including hypothetic-deductive model, pattern recognition, a dual process diagnostic reasoning model, pathway for clinical reasoning, an integrative model of clinical reasoning, and model of diagnostic reasoning strategies in primary care. Only one model had specifically focused on general practitioners reasoning. Conclusion: A Model of clinical reasoning that included specific features of general practice to better help the general practitioners with the difficulties

Clinical management of soft tissue sarcomas

International Nuclear Information System (INIS)

Pinedo, H.M.; Verweij, J.

1986-01-01

This book is concerned with the clinical management of soft tissue sarcomas. Topics covered include: Radiotherapy; Pathology of soft tissue sarcomas; Surgical treatment of soft tissue sarcomas; and Chemotherapy in advanced soft tissue sarcomas

Pediatric pancreas transplantation, including total pancreatectomy with islet autotransplantation.

Science.gov (United States)

Bondoc, Alexander J; Abu-El-Haija, Maisam; Nathan, Jaimie D

2017-08-01

Unlike other solid-organ transplants, whole pancreas transplantation in children is relatively rare, and it occurs more frequently in the context of multivisceral or composite organ transplantation. Because children only infrequently suffer severe sequelae of type 1 diabetes mellitus, pancreas transplantation is rarely indicated in the pediatric population. More commonly, pediatric pancreas transplant occurs in the setting of incapacitating acute recurrent or chronic pancreatitis, specifically islet autotransplantation after total pancreatectomy. In this clinical scenario, total pancreatectomy removes the nidus of chronic pain and debilitation, while autologous islet transplantation aims to preserve endocrine function. The published experiences with pediatric total pancreatectomy with islet autotransplantation (TPIAT) in children has demonstrated excellent outcomes including liberation from chronic opioid use, as well as improved mental and physical quality of life with good glycemic control. Given the complexity of the operation, risk of postoperative complication, and long-term physiologic changes, appropriate patient selection and comprehensive multidisciplinary care teams are critical to ensuring optimal outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

A Visualization of Evolving Clinical Sentiment Using Vector Representations of Clinical Notes.

Science.gov (United States)

Ghassemi, Mohammad M; Mark, Roger G; Nemati, Shamim

2015-09-01

Our objective in this paper was to visualize the evolution of clinical language and sentiment with respect to several common population-level categories including: time in the hospital, age, mortality, gender and race. Our analysis utilized seven years of unstructured free text notes from the Multiparameter Intelligent Monitoring in Intensive Care (MIMIC) database. The text data was partitioned by category and used to generate several high dimensional vector space representations. We generated visualizations of the vector spaces using Distributed Stochastic Neighbor Embedding (tSNE) and Principal Component Analysis (PCA). We also investigated representative words from clusters in the vector space. Lastly, we inferred the general sentiment of the clinical notes toward each parameter by gauging the average distance between positive and negative keywords and all other terms in the space. We found intriguing differences in the sentiment of clinical notes over time, outcome, and demographic features. We noted a decrease in the homogeneity and complexity of clusters over time for patients with poor outcomes. We also found greater positive sentiment for females, unmarried patients, and patients of African ethnicity.

Advances in clinical study of curcumin.

Science.gov (United States)

Yang, Chunfen; Su, Xun; Liu, Anchang; Zhang, Lin; Yu, Aihua; Xi, Yanwei; Zhai, Guangxi

2013-01-01

Curcumin has been estimated as a potential agent for many diseases and attracted great attention owing to its various pharmacological activities, including anti-cancer, and anti-inflammatory. Now curcumin is being applied to a number of patients with breast cancer, rheumatoid arthritis, Alzheimer's disease, colorectal cancer, psoriatic, etc. Several clinical trials have stated that curcumin is safe enough and effective. The objective of this article was to summarize the clinical studies of curcumin, and give a reference for future studies.

Teamwork and Clinical Error Reporting among Nurses in Korean Hospitals

OpenAIRE

Jee-In Hwang, PhD; Jeonghoon Ahn, PhD

2015-01-01

Purpose: To examine levels of teamwork and its relationships with clinical error reporting among Korean hospital nurses. Methods: The study employed a cross-sectional survey design. We distributed a questionnaire to 674 nurses in two teaching hospitals in Korea. The questionnaire included items on teamwork and the reporting of clinical errors. We measured teamwork using the Teamwork Perceptions Questionnaire, which has five subscales including team structure, leadership, situation monitori...

Electrochemical Sensors for Clinic Analysis

Directory of Open Access Journals (Sweden)

Guang Li

2008-03-01

Full Text Available Demanded by modern medical diagnosis, advances in microfabrication technology have led to the development of fast, sensitive and selective electrochemical sensors for clinic analysis. This review addresses the principles behind electrochemical sensor design and fabrication, and introduces recent progress in the application of electrochemical sensors to analysis of clinical chemicals such as blood gases, electrolytes, metabolites, DNA and antibodies, including basic and applied research. Miniaturized commercial electrochemical biosensors will form the basis of inexpensive and easy to use devices for acquiring chemical information to bring sophisticated analytical capabilities to the non-specialist and general public alike in the future.

42 CFR 485.638 - Conditions of participation: Clinical records.

Science.gov (United States)

2010-10-01

... participation: Clinical records. (a) Standard: Records system—(1) The CAH maintains a clinical records system in..., readily accessible, and systematically organized. (4) For each patient receiving health care services, the CAH maintains a record that includes, as applicable— (i) Identification and social data, evidence of...

Knowledge Creation in Clinical Product Development Management Research

DEFF Research Database (Denmark)

Karlsson, Christer; Sköld, Martin

2012-01-01

This paper explores the clinical approach to management research and positions it in relation to other similar approaches. It achieves this by pointing out the most important historical milestones in the development of such approaches. The literature on the approach is mapped, including that on t......This paper explores the clinical approach to management research and positions it in relation to other similar approaches. It achieves this by pointing out the most important historical milestones in the development of such approaches. The literature on the approach is mapped, including...... of the approaches, the paper discusses the research issues to which clinical research is relevant and how the research framework should be designed, then practical issues relating to how to approach the study objects, the design of the research instruments, and the conducting of the field research. Finally...

Clinical trial participation. Viewpoints from racial/ethnic groups.

Science.gov (United States)

Roberson, N L

1994-11-01

Racial/ethnic groups' participation in clinical trials is a relatively new area of research that warrants attention. Although racial/ethnic groups have been included in experimental studies since the 1940s, they were not included in significant numbers in clinical trials for cancer. Clinical trials play a dominant role in clinical oncology. Despite this state-of-the-art cancer treatment, however, there is mounting concern that this scientific progress is not being shared equitably by all segments of the U.S. population. There is underrepresentation of members of racial/ethnic groups in cancer clinical trials, which suggests that participation may be a critical issue. Unfortunately, little is known or documented about these groups' participation in clinical trials. This paper discusses racial/ethnic groups' views and opinions about clinical trial participation. Diagnostic research was conducted as a beginning phase to investigate this new area of research. African Americans, Hispanics, and Native Americans in three Buffalo, New York, communities were selected as study subjects. Data were collected via telephone surveys. Qualitative methods were employed for data analysis and reporting. Findings showed that study subjects knew little about cancer clinical trials and basically had no opportunity to participate. They believed that participation in clinical trials could be beneficial. In each of the three groups, however, there were cultural factors believed to influence participation. A primary concern was "mistrust of white people" and the feeling of being treated like "guinea pigs." Based on study findings, it was evident that recruitment for improving participation requires strategic planning that involves participants representative of the study population. To yield results, the plan should be tailored to the target group, presented as a credible study, designed to reflect trust in the medical care team, and implemented through a continuous educational process.

Clinical outcomes research in gynecologic oncology.

Science.gov (United States)

Melamed, Alexander; Rauh-Hain, J Alejandro; Schorge, John O

2017-09-01

Clinical outcomes research seeks to understand the real-world manifestations of clinical care. In particular, outcomes research seeks to reveal the effects of pharmaceutical, procedural, and structural aspects of healthcare on patient outcomes, including mortality, disease control, toxicity, cost, and quality of life. Although outcomes research can utilize interventional study designs, insightful use of observational data is a defining feature of this field. Many questions in gynecologic oncology are not amenable to investigation in randomized clinical trials due to cost, feasibility, or ethical concerns. When a randomized trial is not practical or has not yet been conducted, well-designed observational studies have the potential to provide the best available evidence about the effects of clinical care. Such studies may use surveys, medical records, disease registries, and a variety of administrative data sources. Even when a randomized trial has been conducted, observational studies can be used to estimate the real-world effect of an intervention, which may differ from the results obtained in the controlled setting of a clinical trial. This article reviews the goals, methodologies, data sources, and limitations of clinical outcomes research, with a focus on gynecologic oncology. Copyright © 2017. Published by Elsevier Inc.

Clinical practice recommendations for bipolar disorder.

Science.gov (United States)

Malhi, G S; Adams, D; Lampe, L; Paton, M; O'Connor, N; Newton, L A; Walter, G; Taylor, A; Porter, R; Mulder, R T; Berk, M

2009-01-01

To provide clinically relevant evidence-based recommendations for the management of bipolar disorder in adults that are informative, easy to assimilate and facilitate clinical decision-making. A comprehensive literature review of over 500 articles was undertaken using electronic database search engines (e.g. MEDLINE, PsychINFO and Cochrane reviews). In addition articles, book chapters and other literature known to the authors were reviewed. The findings were then formulated into a set of recommendations that were developed by a multidisciplinary team of clinicians who routinely deal with mood disorders. These preliminary recommendations underwent extensive consultative review by a broader advisory panel that included experts in the field, clinical staff and patient representatives. The clinical practice recommendations for bipolar disorder (bipolar CPR) summarise evidence-based treatments and provide a synopsis of recommendations relating to each phase of the illness. They are designed for clinical use and have therefore been presented succinctly in an innovative and engaging manner that is clear and informative. These up-to-date recommendations provide an evidence-based framework that incorporates clinical wisdom and consideration of individual factors in the management of bipolar disorder. Further, the novel style and practical approach should promote their uptake and implementation.

Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)

LENUS (Irish Health Repository)

Kubiak, Christine

2009-10-16

Abstract Background Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. Methods In order to summarise the current situation in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching an agreement on a common classification was the initial step in the development of the survey. Results The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials with cell therapy, etc.); diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.); and epidemiology studies. Our classification was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising. Conclusion The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and simplification of the

Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN

Directory of Open Access Journals (Sweden)

Sanz Nuria

2009-10-01

Full Text Available Abstract Background Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. Methods In order to summarise the current situation in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching an agreement on a common classification was the initial step in the development of the survey. Results The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials with cell therapy, etc.; diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.; and epidemiology studies. Our classification was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising. Conclusion The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and

Teaching clinical reasoning by making thinking visible: an action research project with allied health clinical educators.

Science.gov (United States)

Delany, Clare; Golding, Clinton

2014-01-30

Clinical reasoning is fundamental to all forms of professional health practice, however it is also difficult to teach and learn because it is complex, tacit, and effectively invisible for students. In this paper we present an approach for teaching clinical reasoning based on making expert thinking visible and accessible to students. Twenty-one experienced allied health clinical educators from three tertiary Australian hospitals attended up to seven action research discussion sessions, where they developed a tentative heuristic of their own clinical reasoning, trialled it with students, evaluated if it helped their students to reason clinically, and then refined it so the heuristic was targeted to developing each student's reasoning skills. Data included participants' written descriptions of the thinking routines they developed and trialed with their students and the transcribed action research discussion sessions. Content analysis was used to summarise this data and categorise themes about teaching and learning clinical reasoning. Two overriding themes emerged from participants' reports about using the 'making thinking visible approach'. The first was a specific focus by participating educators on students' understanding of the reasoning process and the second was heightened awareness of personal teaching styles and approaches to teaching clinical reasoning. We suggest that the making thinking visible approach has potential to assist educators to become more reflective about their clinical reasoning teaching and acts as a scaffold to assist them to articulate their own expert reasoning and for students to access and use.

Features of the Clinical Course of Adrenal Incidentalomas

Directory of Open Access Journals (Sweden)

G.A. Alimukhamedova

2014-03-01

Full Text Available The objective of the study was to examine the clinical features of adrenal incidentalomas. 98 clinical observations of patients with adrenal incidentalomas receiving in- and out-patient treatment in the clinic of Republican Specialized Scientific and Practical Medical Centre of Endocrinology of Ministry of Healthcare of Republic of Uzbekistan were analyzed. Of them, 51 % — males, 49 % — females. General clinical observation included: thorough gaining of complaints; anamnesis morbi and vitae; assessment of somatic and endocrine statuses; clinical examination with measurement of blood pressure and body mass index; urinalysis; biochemical blood analysis. In addition, all patients underwent complete blood count with determination of blood potassium, sodium, chlorine, lipid profile, fasting blood glucose and oral glucose tolerance test, creatinine and urea; hormonal blood tests, including studies of plasma aldosterone and plasma renin activity in a horizontal position, adrenocorticotropic hormone, blood cortisol, as well as the daily excretion of catecholamines with urine. For topical diagnosis we used ultrasound, CT of adrenals. It was found that adrenal incidentalomas were detected in 37.8 % as a result of searching for the reason of arterial hypertension, in 23.5 % — of obesity and hypothalamus dysfunction, in 14.2 % — in abdominal pathology, in 12.2 % — of non-specific complaints, in 8.1 % — in exclusion of adrenal diseases, and in 4 % — in clinical supervision. Clinically they are characterized with nonspecific features with predominance of arterial hypertension (76.5 %, which is associated with adrenal pathology only 18.4 % of cases. Analysis of metabolic disorders revealed clinically significant changes as well. Of 98 examined patients, 70 % had metabolic disorders.

Hospital clinical pharmacy services in Vietnam.

Science.gov (United States)

Trinh, Hieu T; Nguyen, Huong T L; Pham, Van T T; Ba, Hai L; Dong, Phuong T X; Cao, Thao T B; Nguyen, Hanh T H; Brien, Jo-Anne

2018-04-07

Background Clinical pharmacy is key to the quality use of medicines. While there are different approaches in different countries, international perspectives may inform health service development. The Vietnamese Ministry of Health introduced a legal regulation of clinical pharmacy services in December 2012. Objective To describe the services, and to explore reported barriers and facilitators in implementing clinical pharmacy activities in Vietnamese hospitals after the introduction of Vietnamese Ministry of Health legal regulation. Setting Thirty-nine hospitals in Hanoi, Vietnam, including 22 provincial and 17 district hospitals. Method A mixed methods study was utilized. An online questionnaire was sent to the hospitals. In-depth interviews were conducted with pairs of nominated pharmacists at ten of these hospitals. The questionnaire focused on four areas: facilities, workforce, policies and clinical pharmacy activities. Main outcome measure Proportion of clinical pharmacy activities in hospitals. Themes in clinical pharmacy practice. Results 34/39 (87%) hospitals had established clinical pharmacy teams. Most activities were non-patient-specific (87%) while the preliminary patient-specific clinical pharmacy services were available in only 8/39 hospitals (21%). The most common non-patient-specific activities were providing medicines information (97%), reporting adverse drug reactions (97%), monitoring medication usage (97%). The patient specific activities varied widely between hospitals and were ad hoc. The main challenges reported were: lack of workforce and qualified clinical pharmacists. Conclusion While most hospitals had hospital-based pharmacy activities, the direct patient care was limited. Training, education and an expanded work forces are needed to improve clinical pharmacy services.

Considerations for Clinical Neuropsychological Evaluation in Amyotrophic Lateral Sclerosis.

Science.gov (United States)

Woolley, Susan C; Rush, Beth K

2017-11-01

The clinical neuropsychologist has the opportunity to be uniquely involved in the evaluation and treatment of individuals with amyotrophic lateral sclerosis (ALS). We review the current literature that defines cognitive and behavioral symptoms in ALS, including current knowledge of the neuropathological and genetic underpinning for these symptoms. There are unique considerations for clinical neuropsychological evaluation and clinical research in ALS and we highlight these in this review. Specifically, we shed light on special factors that contribute to our understanding of cognitive and behavioral impairment in ALS, including co-morbid symptoms, differential diagnosis, and considerations for longitudinal tracking of phenotypes. We discuss the rationale for proposing a specific approach to such as cognitive screening, test selection, response modality consideration, and test-retest intervals. With this didactic overview, the clinical neuropsychologist has the potential to learn more about the heterogeneous presentation of motor and neuropsychological symptoms in ALS. Furthermore, the reader has the opportunity to understand what it takes to develop a valid assessment approach particularly when the phenotype of ALS remains undefined in some regards. This clinical practice review sets the stage for the clinical neuropsychologist to further contribute to our clinical and scientific understanding of ALS and cognition. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Participation in HIV research: the importance of clinic contact factors.

Science.gov (United States)

Worthington, Catherine A; Gill, M John

2008-08-01

Recruiting minority populations living with HIV to many types of clinic-based HIV research is a concern. This study examined an expanded range of predictors of HIV research participation (clinic contact, clinical, and personal characteristics) to investigate observed ethnocultural differences in HIV research participation. Research participation was defined as participation in any of diagnostic, pathogenesis, drug trial or survey research. Logistic regression modeling was used to predict research participation of 657 eligible patients (93% of the patient population) who began care between January 1997 and the end of September 2003 at a regional outpatient HIV care program in Calgary, Canada. Approximately one third (32%) were non-white, including 18% Aboriginal, 9% black, 4% Asian, and 1% Hispanic individuals. Twenty-nine percent (187/657) of the patients participated in at least one study of any kind. Multivariate analysis indicated that the strongest predictors of any research participation (including diagnostic, pathogenesis, drug trial, or survey studies) are clinical (including nadir CD4 count [odds ratio {OR} = 0.132, p percentage of appointments kept [OR = 1.022, p service use shown by these groups that may influence research participation. To attract under researched populations, attention should shift from the "who" of research participation to the "how" of clinical interactions.

Combining areal DXA bone mineral density and vertebrae postero-anterior width improves the prediction of vertebral strength

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Taton, Grzegorz; Rokita, Eugeniusz [Jagiellonian University Medical College, Department of Biophysics, Krakow (Poland); Wrobel, Andrzej [Jagiellonian University, Institute of Physics, Krakow (Poland); Korkosz, Mariusz [Jagiellonian University Medical College, Department of Internal Medicine and Gerontology, Division of Rheumatology, Krakow (Poland)

2013-12-15

Areal bone mineral density (aBMD) measured by dual-energy X-ray absorptiometry (DXA) is an important determinant of bone strength (BS), despite the fact that the correlation between aBMD and BS is relatively weak. Parameters that describe BS more accurately are desired. The aim of this study was to determine whether the geometrical corrections applied to aBMD would improve its ability for BS prediction. We considered new parameters, estimated from a single DXA measurement, as well as BMAD (bone mineral apparent density) reported in the literature. In vitro studies were performed with the L3 vertebrae from 20 cadavers, which were studied with DXA and quantitative computed tomography (QCT). A mechanical strength assessment was carried out. Two new parameters were introduced: vBMD{sub min} = (aBMD)/(W{sub PA}{sup min}) and vBMD{sub av} = (aBMD)/(W{sub PA}{sup av}) (W{sub PA}{sup min} - minimal vertebral body width in postero-anterior (PA) view, W{sub PA}{sup av} - average PA vertebral body width). Volumetric BMD measured by QCT (vBMD), aBMD, BMAD, vBMD{sub min}, and vBMD{sub av} were correlated to ultimate load and ultimate stress (P{sub max}) to find the best predictor of vertebrae BS. The coefficients of correlation between P{sub max} and vBMD{sub min}, vBMD{sub av}, as well as BMAD, were r = 0.626 (p = 0.005), r = 0.610 (p = 0.006) and r = 0.567 (p = 0.012), respectively. Coefficients for vBMD and aBMD are r = 0.648 (p = 0.003) and r = 0.511 (p = 0.03), respectively. Our results showed that aBMD normalized by vertebrae dimensions describes vertebrae BS better than aBMD alone. The considered indices vBMD{sub av}, vBMD{sub min}, and BMAD can be measured in routine PA DXA and considerably improve BS variability prediction. vBMD{sub min} is superior compared to vBMD{sub av} and BMAD. (orig.)

Recombinant human parathyroid hormone (PTH 1-34) and low-intensity pulsed ultrasound have contrasting additive effects during fracture healing.

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Warden, Stuart J; Komatsu, David E; Rydberg, Johanna; Bond, Julie L; Hassett, Sean M

2009-03-01

Fracture healing is thought to be naturally optimized; however, recent evidence indicates that it may be manipulated to occur at a faster rate. This has implications for the duration of morbidity associated with bone injuries. Two interventions found to accelerate fracture healing processes are recombinant human parathyroid hormone [1-34] (PTH) and low-intensity pulsed ultrasound (LIPUS). This study aimed to investigate the individual and combined effects of PTH and LIPUS on fracture healing. Bilateral midshaft femur fractures were created in Sprague-Dawley rats, and the animals treated 7 days/week with PTH (10 microg/kg) or a vehicle solution. Each animal also had one fracture treated for 20 min/day with active-LIPUS (spatial-averaged, temporal-averaged intensity [I(SATA)]=100 mW/cm(2)) and the contralateral fracture treated with inactive-LIPUS (placebo). Femurs were harvested 35 days following injury to permit micro-computed tomography, mechanical property and histological assessments of the fracture calluses. There were no interactions between PTH and LIPUS indicating that their effects were additive rather than synergistic. These additive effects were contrasting with LIPUS primarily increasing total callus volume (TV) without influencing bone mineral content (BMC), and PTH having the opposite effect of increasing BMC without influencing TV. As a consequence of the effect of LIPUS on TV but not BMC, it decreased volumetric bone mineral density (vBMD) resulting in a less mature callus. The decreased maturity and persistence of cartilage at the fracture site when harvested offset any beneficial mechanical effects of the increased callus size with LIPUS. In contrast, the effect of PTH on callus BMC but not TV resulted in increased callus vBMD and a more mature callus. This resulted in PTH increasing fracture site mechanical strength and stiffness. These data suggest that PTH may have utility in the treatment of acute bone fractures, whereas LIPUS at an I(SATA) of

Wound care clinical pathway: a conceptual model.

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Barr, J E; Cuzzell, J

1996-08-01

A clinical pathway is a written sequence of clinical processes or events that guides a patient with a defined problem toward an expected outcome. Clinical pathways are tools to assist with the cost-effective management of clinical outcomes related to specific problems or disease processes. The primary obstacles to developing clinical pathways for wound care are the chronic natures of some wounds and the many variables that can delay healing. The pathway introduced in this article was modeled upon the three phases of tissue repair: inflammatory, proliferative, and maturation. This physiology-based model allows clinicians to identify and monitor outcomes based on observable and measurable clinical parameters. The pathway design, which also includes educational and behavioral outcomes, allows the clinician to individualize the expected timeframe for outcome achievement based on individual patient criteria and expert judgement. Integral to the pathway are the "4P's" which help standardize the clinical processes by wound type: Protocols, Policies, Procedures, and Patient education tools. Four categories into which variances are categorized based on the cause of the deviation from the norm are patient, process/system, practitioner, and planning/discharge. Additional research is warranted to support the value of this clinical pathway in the clinical arena.

Understanding clinical reasoning in osteopathy: a qualitative research approach.

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Grace, Sandra; Orrock, Paul; Vaughan, Brett; Blaich, Raymond; Coutts, Rosanne

2016-01-01

Clinical reasoning has been described as a process that draws heavily on the knowledge, skills and attributes that are particular to each health profession. However, the clinical reasoning processes of practitioners of different disciplines demonstrate many similarities, including hypothesis generation and reflective practice. The aim of this study was to understand clinical reasoning in osteopathy from the perspective of osteopathic clinical educators and the extent to which it was similar or different from clinical reasoning in other health professions. This study was informed by constructivist grounded theory. Participants were clinical educators in osteopathic teaching institutions in Australia, New Zealand and the UK. Focus groups and written critical reflections provided a rich data set. Data were analysed using constant comparison to develop inductive categories. According to participants, clinical reasoning in osteopathy is different from clinical reasoning in other health professions. Osteopaths use a two-phase approach: an initial biomedical screen for serious pathology, followed by use of osteopathic reasoning models that are based on the relationship between structure and function in the human body. Clinical reasoning in osteopathy was also described as occurring in a number of contexts (e.g. patient, practitioner and community) and drawing on a range of metaskills (e.g. hypothesis generation and reflexivity) that have been described in other health professions. The use of diagnostic reasoning models that are based on the relationship between structure and function in the human body differentiated clinical reasoning in osteopathy. These models were not used to name a medical condition but rather to guide the selection of treatment approaches. If confirmed by further research that clinical reasoning in osteopathy is distinct from clinical reasoning in other health professions, then osteopaths may have a unique perspective to bring to multidisciplinary

Satisfaction and improvement of clinical experiment of student radiotechnologists

International Nuclear Information System (INIS)

Lyu, Kwang Yeul; Kim, Hyun Soo

2006-01-01

Clinical experiment is a set of experience to help student acquire technic, attitude and knowledge by participating in the clinical work. The radiotechnologists who are employed in departments of radiology serve as clinical instructors. Their responsibilities include teaching students them to become competent radiotechnologist. Clinical instructors often have no formal preparation in teaching student. The purpose of this study is to review some principals that will help clinical instructors support and foster the professional development of student radiotechnologists. The clinical instructor should be able to identify the qualities of instructor, the characteristics of feedback and use facilitation skills when is evaluated student performance. And the survey was performed to evaluate the satisfaction of student participated in clinical experiment, the purpose of this research is to fine the problems and improvements in clinical experiment of student radiotechnologist in Korea

Prevalence and concordance between the clinical and the post-mortem diagnosis of dementia in a psychogeriatric clinic.

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Grandal Leiros, B; Pérez Méndez, L I; Zelaya Huerta, M V; Moreno Eguinoa, L; García-Bragado, F; Tuñón Álvarez, T; Roldán Larreta, J J

The aim of our study is to describe the types of dementia found in a series of patients and to estimate the level of agreement between the clinical diagnosis and post-mortem diagnosis. We conducted a descriptive analysis of the prevalence of the types of dementia found in our series and we established the level of concordance between the clinical and the post-mortem diagnoses. The diagnosis was made based on current diagnostic criteria. 114 cases were included. The most common clinical diagnoses both at a clinical and autopsy level were Alzheimer disease and mixed dementia but the prevalence was quite different. While at a clinical level, prevalence was 39% for Alzheimer disease and 18% for mixed dementia, in the autopsy level, prevalence was 22% and 34%, respectively. The agreement between the clinical and the autopsy diagnoses was 62% (95% CI 53-72%). Almost a third of our patients were not correctly diagnosed in vivo. The most common mistake was the underdiagnosis of cerebrovascular pathology. Copyright © 2016 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

Clinical outcomes of endovascularly managed iatrogenic renal hemorrhages

International Nuclear Information System (INIS)

Chiramel, George Koshy; Keshava, Shyamkumar Nidugala; Moses, Vinu; Kekre, Nitin; Tamilarasi, V; Devasia, Anthony

2015-01-01

To evaluate the effectiveness of endovascular management in iatrogenic renal injuries with regard to clinical status on follow-up and requirements for repeat angiography and embolization. This retrospective study included patients who were referred for endovascular management of significant hemorrhage following an iatrogenic injury. Data was recorded from the Picture Archiving and Communication system (PACS) and electronic medical records. The site and type of iatrogenic injury, imaging findings, treatment, angiography findings, embolization performed, clinical status on follow-up, and requirement for repeat embolization were recorded. The outcomes were clinical resolution, nephrectomy, or death. Clinical findings were recorded on follow-up visits to the clinic. Statistical analysis was performed using descriptive statistics. Seventy patients were included in this study between January 2000 and June 2012. A bleeding lesion (a pseudoaneurysm or arteriovenous fistula) was detected during the first angiogram in 55 patients (78.6%) and was selectively embolized. Fifteen required a second angiography as there was no clinical improvement and five required a third angiography. Overall, 66 patients (94.3%) showed complete resolution and 4 patients (5.7%) died. Three patients (4.3%) underwent nephrectomy for clinical stabilization even after embolization. There were no major complications. The two minor complications resolved spontaneously. Angiography and embolization is the treatment of choice in iatrogenic renal hemorrhage. Upto 20% of initial angiograms may not reveal the bleed and repeat angiography is required to identify a recurrent or unidentified bleed. The presence of multiple punctate bleeders on angiography suggests an enlarging subcapsular hematoma and requires preoperative embolization and nephrectomy

Factors for incomplete adherence to antiretroviral therapy including drug refill and clinic visits among older adults living with human immunodeficiency virus - cross-sectional study in South Africa.

Science.gov (United States)

Barry, Abbie; Ford, Nathan; El-Khatib, Ziad

2018-03-01

To assess adherence outcomes to antiretroviral therapy (ART) of recipients ≥50 years in Soweto, South Africa. This was a secondary data analysis for a cross-sectional study at two HIV clinics in Soweto. Data on ART adherence and covariates were gathered through structured interviews with HIV 878 persons living with HIV (PLHIV) receiving ART. Logistic regression analysis was used to assess associations. PLHIV ≥50 years (n = 103) were more likely to miss clinic visits during the last six months than PLHIV aged 25-49 (OR 2.15; 95%CI 1.10-4.18). PLHIV ≥50 years with no or primary-level education were less likely to have missed a clinic visit during the last six months than PLHIV with secondary- or tertiary-level education in the same age category (OR 0.3; 95%CI 0.1-1.1), as were PLHIV who did not disclose their status (OR 0.2; 95%CI 0-1.1). There was no evidence of increased risk for non-adherence to ART pills and drug refill visits among older PLHIV. Missing a clinic visit was more common among older PLHIV who were more financially vulnerable. Further studies are needed to verify these findings and identify new risk factors associated with ART adherence. © 2017 John Wiley & Sons Ltd.

Understanding Egorrhea from Cultural-Clinical Psychology

Directory of Open Access Journals (Sweden)

Jun eSasaki

2013-11-01

Full Text Available Based on his observations in Japanese clinical settings, Fujinawa (1972 conceptualized egorrhea syndrome, which includes symptoms such as olfactory reference syndrome, fear of eye-to-eye confrontation, delusions of sleep talking, delusions of soliloquy, and thought broadcasting. The key feature of this syndrome is self-leakage, a perceived sense that one’s personal internal information, such as feelings and thoughts, are leaking out. To reach a more comprehensive understanding of egorrhea, this paper aims to present general overview and reconsider the phenomenon of self-leakage using cultural-clinical psychology as a framework. First, the symptoms of egorrhea are reviewed in relation to other related psychopathologies such as social anxiety disorder (SAD and taijin kyofusho (TKS, as well as schizophrenia. Second, a series of empirical studies conducted using Japanese non-clinical samples are summarized. The results of these studies form the basis for subsequent discussions, which incorporates the cultural-clinical psychology perspective proposed by Ryder, Ban, Chentsova-Dutton (2011. This paper ends with a general discussion regarding implications for research and clinical practice.

Evidence-based clinical practice guidelines for chronic pancreatitis 2015.

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Ito, Tetsuhide; Ishiguro, Hiroshi; Ohara, Hirotaka; Kamisawa, Terumi; Sakagami, Junichi; Sata, Naohiro; Takeyama, Yoshifumi; Hirota, Morihisa; Miyakawa, Hiroyuki; Igarashi, Hisato; Lee, Lingaku; Fujiyama, Takashi; Hijioka, Masayuki; Ueda, Keijiro; Tachibana, Yuichi; Sogame, Yoshio; Yasuda, Hiroaki; Kato, Ryusuke; Kataoka, Keisho; Shiratori, Keiko; Sugiyama, Masanori; Okazaki, Kazuichi; Kawa, Shigeyuki; Tando, Yusuke; Kinoshita, Yoshikazu; Watanabe, Mamoru; Shimosegawa, Tooru

2016-02-01

Chronic pancreatitis is considered to be an irreversible progressive chronic inflammatory disease. The etiology and pathology of chronic pancreatitis are complex; therefore, it is important to correctly understand the stage and pathology and provide appropriate treatment accordingly. The newly revised Clinical Practice Guidelines of Chronic Pancreatitis 2015 consist of four chapters, i.e., diagnosis, staging, treatment, and prognosis, and includes a total of 65 clinical questions. These guidelines have aimed at providing certain directions and clinically practical contents for the management of chronic pancreatitis, preferentially adopting clinically useful articles. These revised guidelines also refer to early chronic pancreatitis based on the Criteria for the Diagnosis of Chronic Pancreatitis 2009. They include such items as health insurance coverage of high-titer lipase preparations and extracorporeal shock wave lithotripsy, new antidiabetic drugs, and the definition of and treatment approach to pancreatic pseudocyst. The accuracy of these guidelines has been improved by examining and adopting new evidence obtained after the publication of the first edition.

Perspective: Recommendations for benchmarking pre-clinical studies of nanomedicines

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Dawidczyk, Charlene M.; Russell, Luisa M.; Searson, Peter C.

2015-01-01

Nanoparticle-based delivery systems provide new opportunities to overcome the limitations associated with traditional small molecule drug therapy for cancer, and to achieve both therapeutic and diagnostic functions in the same platform. Pre-clinical trials are generally designed to assess therapeutic potential and not to optimize the design of the delivery platform. Consequently, progress in developing design rules for cancer nanomedicines has been slow, hindering progress in the field. Despite the large number of pre-clinical trials, several factors restrict comparison and benchmarking of different platforms, including variability in experimental design, reporting of results, and the lack of quantitative data. To solve this problem, we review the variables involved in the design of pre-clinical trials and propose a protocol for benchmarking that we recommend be included in in vivo pre-clinical studies of drug delivery platforms for cancer therapy. This strategy will contribute to building the scientific knowledge base that enables development of design rules and accelerates the translation of new technologies. PMID:26249177

Clinical and histopathological differential diagnosis of eosinophilic pustular folliculitis.

Science.gov (United States)

Fujiyama, Toshiharu; Tokura, Yoshiki

2013-06-01

Eosinophilic pustular folliculitis (EPF) is an inflammatory disease characterized by repeated pruritic follicular papules and pustules arranged in arcuate plaques, and folliculotropic infiltration of eosinophils. The diagnosis of EPF is occasionally difficult and problematic because EPF may share the clinical appearance and histological findings with other diseases. Moreover, EPF has several clinical subtypes, including the classical type, infantile type and immunosuppression-associated type. Because the therapies of EPF are relatively specific as compared to eczematous disorders, accurate diagnosis is essential for the management of EPF. Clinical differential diagnoses include tinea, acne, rosacea, eczematous dermatitis, granuloma faciale, autoimmune annular erythema, infestations and pustular dermatosis. Histologically, cutaneous diseases with eosinophilic infiltrates can be differentially diagnosed. Follicular mucinosis, mycosis fungoides and other cutaneous T-cell lymphomas are the most important differential diagnoses both clinically and histopathologically. It should be kept in mind particularly that the initial lesions of cutaneous T-cell lymphoma resemble EPF. © 2013 Japanese Dermatological Association.

Spontaneous Pneumomediastinum: Case Presentation to a College Student Health Clinic

Science.gov (United States)

Spotts, P. Hunter

2017-01-01

The author describes a case of spontaneous pneumomediastinum (SPM) in a 19-year-old man presenting to a college student health clinic. The author also provides a review on SPM, including clinical manifestations, diagnostic evaluation, and management.

Building sustainable multi-functional prospective electronic clinical data systems.

Science.gov (United States)

Randhawa, Gurvaneet S; Slutsky, Jean R

2012-07-01

A better alignment in the goals of the biomedical research enterprise and the health care delivery system can help fill the large gaps in our knowledge of the impact of clinical interventions on patient outcomes in the real world. There are several initiatives underway to align the research priorities of patients, providers, researchers, and policy makers. These include Agency for Healthcare Research and Quality (AHRQ)-supported projects to build flexible prospective clinical electronic data infrastructure that meet the needs of these diverse users. AHRQ has previously supported the creation of 2 distributed research networks as a new approach to conduct comparative effectiveness research (CER) while protecting a patient's confidential information and the proprietary needs of a clinical organization. It has applied its experience in building these networks in directing the American Recovery and Reinvestment Act funds for CER to support new clinical electronic infrastructure projects that can be used for several purposes including CER, quality improvement, clinical decision support, and disease surveillance. In addition, AHRQ has funded a new Electronic Data Methods forum to advance the methods in clinical informatics, research analytics, and governance by actively engaging investigators from the American Recovery and Reinvestment Act-funded projects and external stakeholders.

Clinical observation of radiation urinary bladder disease

International Nuclear Information System (INIS)

Jin Yuke; Liu Libo; Zhang Haiying; Liang Shuo; Chen Dawei; Wu Zhenfeng; Dong Lihua; Lu Xuejun

2004-01-01

Objective: Clinical characteristic, diagnosis and treatment of radiation urinary bladder disease induced by radiation therapy for cancers in the pelvis were inquired into for providing diagnostic basis. Methods: Statistical analysis for the clinical cases was carried out. Results: The incidence of radiation bladder diseases induced by radiation therapy of cervix cancer are about 0.8%-2.96%, with an average of 2.14%. Radiation bladder disease is divided into acute radiation cystitis, chronic radiation cystitis and radiation vesical fistula. Chronic radiation cystitis is seen most often in the clinic and its main clinical symptom is painless macroscopic hematuria, which is again subdivided into slight and severe degrees. Diagnosis should include history of exposure to radiation, which dose exceed the dose threshold, and typical clinical characteristics. Conclusion: The characteristics, types and diagnostic basis of radiation urinary bladder disease analyzed in this study can provide the reference for drawing up diagnostic standard

Clinical presentation and imaging of a rare case of Tarsal Tuberculosis.

Science.gov (United States)

Kapetanakis, Stylianos; Chourmouzi, Danai; Papadopoulou, Elissavet; Oikonomou, Dimitrios; Gkantsinikoudis, Nikolaos

2018-02-01

A 43-year-old woman arrived to emergency unit of our hospital, referring intense deteriorated pain and swelling of midfoot. Rapid clinical evolvement of osteoarticular tuberculosis represents a potential clinical scenario. Clinicians should always include foot tuberculosis in differential diagnosis, in cases of severe clinical and radiological manifestations.

Clinical presentation and evaluation of dermatomyositis

Directory of Open Access Journals (Sweden)

Umaima Marvi

2012-01-01

Full Text Available Dermatomyositis (DM is a chronic inflammatory disorder of the skin and muscles. Evidence supports that DM is an immune-mediated disease and 50-70% of patients have circulating myositis-specific auto-antibodies. Gene expression microarrays have demonstrated upregulation of interferon signaling in the muscle, blood, and skin of DM patients. Patients with classic DM typically present with symmetric, proximal muscle weakness, and skin lesions that demonstrate interface dermatitis on histopathology. Evaluation for muscle inflammation can include muscle enzymes, electromyogram, magnetic resonance imaging, and/or muscle biopsy. Classic skin manifestations of DM include the heliotrope rash, Gottron′s papules, Gottron′s sign, the V-sign, and shawl sign. Additional cutaneous lesions frequently observed in DM patients include periungual telangiectasias, cuticular overgrowth, "mechanic′s hands", palmar papules overlying joint creases, poikiloderma, and calcinosis. Clinically amyopathic DM is a term used to describe patients who have classic cutaneous manifestations for more than 6 months, but no muscle weakness or elevation in muscle enzymes. Interstitial lung disease can affect 35-40% of patients with inflammatory myopathies and is often associated with the presence of an antisynthetase antibody. Other clinical manifestations that can occur in patients with DM include dysphagia, dysphonia, myalgias, Raynaud phenomenon, fevers, weight loss, fatigue, and a nonerosive inflammatory polyarthritis. Patients with DM have a three to eight times increased risk for developing an associated malignancy compared with the general population, and therefore all patients with DM should be evaluated at the time of diagnosis for the presence of an associated malignancy. This review summarizes the immunopathogenesis, clinical manifestations, and evaluation of patients with DM.

Radiogenomics: predicting clinical normal tissue radiosensitivity

DEFF Research Database (Denmark)

Alsner, Jan

2006-01-01

Studies on the genetic basis of normal tissue radiosensitivity, or  'radiogenomics', aims at predicting clinical radiosensitivity and optimize treatment from individual genetic profiles. Several studies have now reported links between variations in certain genes related to the biological response...... to radiation injury and risk of normal tissue morbidity in cancer patients treated with radiotherapy. However, after these initial association studies including few genes, we are still far from being able to predict clinical radiosensitivity on an individual level. Recent data from our own studies on risk...

A Clinical Approach to Vulvar Ulcers.

Science.gov (United States)

Stewart, Kristen M A

2017-09-01

This article discusses the differential diagnosis of vulvar ulcers and describes a general clinical approach to this common but nonspecific examination finding. The differential diagnosis includes sexually and nonsexually transmitted infections, dermatitides, trauma, neoplasms, hormonally induced ulcers, and drug reactions. Patient history and physical examination provide important clues to the cause of a vulvar ulcer. However, laboratory testing is usually required for accurate diagnosis because the clinical presentation is often nonspecific and may be atypical due to secondary conditions. Copyright © 2017 Elsevier Inc. All rights reserved.

Clinical trials integrity: a CRO perspective.

Science.gov (United States)

Beach, J E

2001-01-01

When contract research organizations (CROs) were first formed, pharmaceutical companies outsourced to them only certain aspects of the conduct of their clinical trials. At first CROs were highly specialized entities, providing, for example, either biostatistical advice, clinical research associates who monitored investigational sites for regulatory compliance, or regulatory support. Gradually, full service CROs emerged, offering a full range of services for clinical trials, including the selection of investigators and investigational sites, assistance with patient recruitment, safety surveillance and reporting, site audits, and data management and biostatistics. This evolving relationship between CROs and the pharmaceutical and medical device industries has resulted in CROs assuming more and more of the regulatory and ethical risks and responsibilities inherent in the conduct of clinical trials. In this full service role, CROs, unlike sponsors, are not interested in the outcome of study, but like sponsors, are subject to heavy regulation by the federal government, must follow applicable state laws, must respect international guidelines, and are obliged to follow their own operating procedures. Moreover, they are judged by the industry on the basis of the scope and quality of services provided, including the degree of adherence to the research protocol, regulatory requirements, and timelines; the quality of the professional working relationships with investigators and institutions, both academic and community-based; and the validity of the data. Further, CROs are subject to comprehensive audits by sponsoring companies, FDA, and other regulatory authorities. For all these reasons, CROs are being tasked with strict vigilance of all stages of the clinical trial process to ensure that the laws, regulations, and industry standards designed for the protection of human subjects and data integrity are maintained.

Clinical pharmacogenetics implementation: approaches, successes, and challenges.

Science.gov (United States)

Weitzel, Kristin W; Elsey, Amanda R; Langaee, Taimour Y; Burkley, Benjamin; Nessl, David R; Obeng, Aniwaa Owusu; Staley, Benjamin J; Dong, Hui-Jia; Allan, Robert W; Liu, J Felix; Cooper-Dehoff, Rhonda M; Anderson, R David; Conlon, Michael; Clare-Salzler, Michael J; Nelson, David R; Johnson, Julie A

2014-03-01

Current challenges exist to widespread clinical implementation of genomic medicine and pharmacogenetics. The University of Florida (UF) Health Personalized Medicine Program (PMP) is a pharmacist-led, multidisciplinary initiative created in 2011 within the UF Clinical Translational Science Institute. Initial efforts focused on pharmacogenetics, with long-term goals to include expansion to disease-risk prediction and disease stratification. Herein we describe the processes for development of the program, the challenges that were encountered and the clinical acceptance by clinicians of the genomic medicine implementation. The initial clinical implementation of the UF PMP began in June 2012 and targeted clopidogrel use and the CYP2C19 genotype in patients undergoing left heart catheterization and percutaneous-coronary intervention (PCI). After 1 year, 1,097 patients undergoing left heart catheterization were genotyped preemptively, and 291 of those underwent subsequent PCI. Genotype results were reported to the medical record for 100% of genotyped patients. Eighty patients who underwent PCI had an actionable genotype, with drug therapy changes implemented in 56 individuals. Average turnaround time from blood draw to genotype result entry in the medical record was 3.5 business days. Seven different third party payors, including Medicare, reimbursed for the test during the first month of billing, with an 85% reimbursement rate for outpatient claims that were submitted in the first month. These data highlight multiple levels of success in clinical implementation of genomic medicine. © 2014 Wiley Periodicals, Inc.

Clinical Linguistics--Retrospect and Prospect.

Science.gov (United States)

Grunwell, Pamela

In the past 20 years, linguistics has gained a prominent position in speech and language pathology in Britain, evolving into a new field, clinical linguistics. It includes three related areas of activity: training of speech pathologists/therapists; professional practice; and research. Linguistics and speech/language pathology have developed as…

How do Patients Experience Consultations in an Outpatient AF-clinic?

DEFF Research Database (Denmark)

Thrysøe, Lars

Background / Introduction Studies indicates that patients with atrial fibrillation have a lower QoL compared to patients with other heart diseases. They meet some kind of neglect from the health society and some delay in treatment and care initiation. The interdisciplinary AF-outpatient clinic...... at Odense University Hospital, Denmark, was established marts 2012, and has in order to qualify patient treatment and care. The aim of the current project is to evaluate the clinic. Purpose / research questions How do patient and relatives experience consultations in AF-clinic? (Phase I) How do QoL develop...... over time? (Phase II) What economic consequences can be derived from the AF-clinic? (Phase III) Methods The first research question (Phase I) includes 14 patients, and will be answered by fieldwork and interviews. Afterwards, the ongoing Phase II includes 150 patients who reply the same questionnaire...

Clinical management of patients with hyperthyroidism

International Nuclear Information System (INIS)

Cooper, D.S.; Ridgway, E.C.

1985-01-01

The clinical management of the hyperthyroid patient is controversial, because there is no perfect treatment. Factors that influence the choice of therapy include the patient's age, sex, and type of hyperthyroidism, as well as patient and physician preference

Clinical Application of Pharmacogenetics: Where are We Now?

Science.gov (United States)

2014-01-01

Pharmacogenetic (PGx) testing has the potential to improve drug therapy in an individual by informing appropriate drug dosing or drug selection in order to maximize efficacy and safety. Although multiple studies have illustrated the potential benefits of such testing when applied to specific drugs across a broad range of therapy areas, the uptake of PGx testing in routine clinical practice has been relatively limited. Implementation appears to be hampered by the absence of sufficiently strong evidence linking the results of testing with actionable benefits in terms of clinical outcomes. Meanwhile, there are now adequate data to allow dosing recommendations as have been developed by bodies including the Dutch Pharmacogenetics Working Group (DPWG) and the Clinical Pharmacogenetics Implementation Consortium (CPIC) in several settings, including TPMT/thiopurines, CYP2C19/clopidogrel, CYP2D6/codeine, VKORC1-CYP2C9/warfarin, HLA-B*5701/abacavir, SLCO1B1/simvastatin and HLAB*5801/allopurinol. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT) have also recently initiated surveys in order to better understand the extent of, and the role played by, PGx testing in clinical practice. This should help identify where further training and education may be beneficial. To this end, in collaboration with ESPT, the IFCC Pharmacogenetic Laboratory Network has now been formed, with the aim of improving the uptake and quality of PGx testing. PMID:27683445

Overview on Clinical Relevance of Intra-Tumor Heterogeneity.

Science.gov (United States)

Stanta, Giorgio; Bonin, Serena

2018-01-01

Today, clinical evaluation of tumor heterogeneity is an emergent issue to improve clinical oncology. In particular, intra-tumor heterogeneity (ITH) is closely related to cancer progression, resistance to therapy, and recurrences. It is interconnected with complex molecular mechanisms including spatial and temporal phenomena, which are often peculiar for every single patient. This review tries to describe all the types of ITH including morphohistological ITH, and at the molecular level clonal ITH derived from genomic instability and nonclonal ITH derived from microenvironment interaction. It is important to consider the different types of ITH as a whole for any patient to investigate on cancer progression, prognosis, and treatment opportunities. From a practical point of view, analytical methods that are widely accessible today, or will be in the near future, are evaluated to investigate the complex pattern of ITH in a reproducible way for a clinical application.

Overview on Clinical Relevance of Intra-Tumor Heterogeneity

Directory of Open Access Journals (Sweden)

Giorgio Stanta

2018-04-01

Full Text Available Today, clinical evaluation of tumor heterogeneity is an emergent issue to improve clinical oncology. In particular, intra-tumor heterogeneity (ITH is closely related to cancer progression, resistance to therapy, and recurrences. It is interconnected with complex molecular mechanisms including spatial and temporal phenomena, which are often peculiar for every single patient. This review tries to describe all the types of ITH including morphohistological ITH, and at the molecular level clonal ITH derived from genomic instability and nonclonal ITH derived from microenvironment interaction. It is important to consider the different types of ITH as a whole for any patient to investigate on cancer progression, prognosis, and treatment opportunities. From a practical point of view, analytical methods that are widely accessible today, or will be in the near future, are evaluated to investigate the complex pattern of ITH in a reproducible way for a clinical application.

Predicting clinical decline in progressive agrammatic aphasia and apraxia of speech.

Science.gov (United States)

Whitwell, Jennifer L; Weigand, Stephen D; Duffy, Joseph R; Clark, Heather M; Strand, Edythe A; Machulda, Mary M; Spychalla, Anthony J; Senjem, Matthew L; Jack, Clifford R; Josephs, Keith A

2017-11-28

To determine whether baseline clinical and MRI features predict rate of clinical decline in patients with progressive apraxia of speech (AOS). Thirty-four patients with progressive AOS, with AOS either in isolation or in the presence of agrammatic aphasia, were followed up longitudinally for up to 4 visits, with clinical testing and MRI at each visit. Linear mixed-effects regression models including all visits (n = 94) were used to assess baseline clinical and MRI variables that predict rate of worsening of aphasia, motor speech, parkinsonism, and behavior. Clinical predictors included baseline severity and AOS type. MRI predictors included baseline frontal, premotor, motor, and striatal gray matter volumes. More severe parkinsonism at baseline was associated with faster rate of decline in parkinsonism. Patients with predominant sound distortions (AOS type 1) showed faster rates of decline in aphasia and motor speech, while patients with segmented speech (AOS type 2) showed faster rates of decline in parkinsonism. On MRI, we observed trends for fastest rates of decline in aphasia in patients with relatively small left, but preserved right, Broca area and precentral cortex. Bilateral reductions in lateral premotor cortex were associated with faster rates of decline of behavior. No associations were observed between volumes and decline in motor speech or parkinsonism. Rate of decline of each of the 4 clinical features assessed was associated with different baseline clinical and regional MRI predictors. Our findings could help improve prognostic estimates for these patients. © 2017 American Academy of Neurology.

Deliverable 6.2 - Software: upgraded MC simulation tools capable of simulating a complete in-beam ET experiment, from the beam to the detected events. Report with the description of one (or few) reference clinical case(s), including the complete patient model and beam characteristics

CERN Document Server

The ENVISION Collaboration

2014-01-01

Deliverable 6.2 - Software: upgraded MC simulation tools capable of simulating a complete in-beam ET experiment, from the beam to the detected events. Report with the description of one (or few) reference clinical case(s), including the complete patient model and beam characteristics

Building the Clinical Bridge: An Australian Success

Directory of Open Access Journals (Sweden)

Marianne Wallis

2012-01-01

Full Text Available Nursing effectiveness science includes primary, secondary, and translational, clinically focused research activities which aim to improve patient or client outcomes. It is imperative, for the successful conduct of a program of nursing effectiveness science, that a clinical bridge is established between academic and healthcare service facilities. An Australian example of the development of a robust clinical bridge through the use of jointly funded positions at the professorial level is outlined. In addition, an analysis of the practical application of Lewin’s model of change management and the contribution of both servant and transformational leadership styles to the bridge building process is provided.

Factors Associated with Veterinary Clinical Faculty Attrition.

Science.gov (United States)

Furr, Martin

Faculty attrition and recruitment for veterinary clinical faculty positions have been reported as significant problems in veterinary medical education. To investigate the factors that may be important in veterinary clinical faculty retention, the perceptions and views of veterinary clinical academic faculty were determined using a web-distributed electronic survey. Responses were dichotomized by whether the respondent had or had not left an academic position and were analyzed for their association with faculty attrition. A total of 1,226 responses were recorded, and results demonstrated that factors other than compensation were associated with veterinary clinical faculty attrition, including departmental culture, work-life balance, and recognition and support of clinical medicine by the administration. Forty-four percent of respondents who had held a faculty appointment reported leaving academia either voluntarily or for non-voluntary reasons such as failure to achieve tenure, retirement, or having their position closed. Attention to correcting deficiencies in workplace culture and professional rewards could be a beneficial means by which to decrease the faculty attrition rates currently observed in clinical academic veterinary medicine.

Moving oncolytic viruses into the clinic: clinical-grade production, purification, and characterization of diverse oncolytic viruses

Directory of Open Access Journals (Sweden)

Guy Ungerechts

2016-01-01

Full Text Available Oncolytic viruses (OVs are unique anticancer agents based on their pleotropic modes of action, which include, besides viral tumor cell lysis, activation of antitumor immunity. A panel of diverse viruses, often genetically engineered, has advanced to clinical investigation, including phase 3 studies. This diversity of virotherapeutics not only offers interesting opportunities for the implementation of different therapeutic regimens but also poses challenges for clinical translation. Thus, manufacturing processes and regulatory approval paths need to be established for each OV individually. This review provides an overview of clinical-grade manufacturing procedures for OVs using six virus families as examples, and key challenges are discussed individually. For example, different virus features with respect to particle size, presence/absence of an envelope, and host species imply specific requirements for measures to ensure sterility, for handling, and for determination of appropriate animal models for toxicity testing, respectively. On the other hand, optimization of serum-free culture conditions, increasing virus yields, development of scalable purification strategies, and formulations guaranteeing long-term stability are challenges common to several if not all OVs. In light of the recent marketing approval of the first OV in the Western world, strategies for further upscaling OV manufacturing and optimizing product characterization will receive increasing attention.

Moving oncolytic viruses into the clinic: clinical-grade production, purification, and characterization of diverse oncolytic viruses.

Science.gov (United States)

Ungerechts, Guy; Bossow, Sascha; Leuchs, Barbara; Holm, Per S; Rommelaere, Jean; Coffey, Matt; Coffin, Rob; Bell, John; Nettelbeck, Dirk M

2016-01-01

Oncolytic viruses (OVs) are unique anticancer agents based on their pleotropic modes of action, which include, besides viral tumor cell lysis, activation of antitumor immunity. A panel of diverse viruses, often genetically engineered, has advanced to clinical investigation, including phase 3 studies. This diversity of virotherapeutics not only offers interesting opportunities for the implementation of different therapeutic regimens but also poses challenges for clinical translation. Thus, manufacturing processes and regulatory approval paths need to be established for each OV individually. This review provides an overview of clinical-grade manufacturing procedures for OVs using six virus families as examples, and key challenges are discussed individually. For example, different virus features with respect to particle size, presence/absence of an envelope, and host species imply specific requirements for measures to ensure sterility, for handling, and for determination of appropriate animal models for toxicity testing, respectively. On the other hand, optimization of serum-free culture conditions, increasing virus yields, development of scalable purification strategies, and formulations guaranteeing long-term stability are challenges common to several if not all OVs. In light of the recent marketing approval of the first OV in the Western world, strategies for further upscaling OV manufacturing and optimizing product characterization will receive increasing attention.

Clinical photography among African cleft caregivers

Directory of Open Access Journals (Sweden)

Peter Babatunde Olaitan

2011-01-01

Full Text Available Objective: The aim of this paper is to document the practice of photography among clinicians whose daily work depends and is influenced so much by medical photography. Materials and Methods: Questionnaires documenting the bio data, place of practice, and experience of cleft caregivers with clinical photography were distributed. Knowledge of rules guiding clinical photography and adherence to them were also asked. Types of camera used were documented and knowledge of the value of clinical photographs were also inquired. Results: Plastic surgeons constitute the highest proportion of 27 (38.6%, followed by Oral and Maxillofacial surgeons with 14 (20.0%. Twenty one (30.0% of the respondents always, 21 (30.0% often, 12 (17.1% frequently, while 9 respondents sometimes took photographs of their patients. Suggested uses of clinical photographs included training, 52 (74.3%, education, 51 (72.9%, medicolegal, 44 (62.9% and advertisement, 44 (62.9% among others. Twenty two (31.4% did not know that there were standard guidelines for taking clinical photographs. Twenty three (32.9% of them did not seek the consent of the patients before taking clinical photographs. Conclusion: While the practice of clinical photography is high among African cleft caregivers, there is a need for further education on the issues of standard rules and obtaining consent from patients.