The key points to remember about abobotulinumtoxinA are as follows:BoNTA-ABO (abobotulinumtoxinA [Dysport]; Medicis Aesthetics, Scottsdale, AZ) and BoNTA-ONA (onabotulinumtoxin A [Botox Cosmetic]; Allergan, Irvine, CA) are both derivatives of botulinum toxin A produced from different strains of the bacterium Clostridium botulinum through proprietary manufacturing processes, and both are approved by the US Food and Drug Administration (FDA).BoNTA-ABO and BoNTA-ONA, which
Alan Matarasso; David Shafer
Despite extensive clinical experience and published data regarding botulinum toxin, questions remain about the clinical substitution\\u000a of one botulinum toxin formulation for another. In the case of Dysport® and Botox®, doseequivalence ratios ranging from 1:1 to 6:1 (Dysport:Botox) have been advocated. This dose-ranging, electroneurographic\\u000a study investigated the dose equivalence, diffusion characteristics (spread) and safety of these two type-A toxins in
Kai Wohlfarth; Imke Schwandt; Florian Wegner; Tim Jürgens; Götz Gelbrich; Armin Wagner; Ulrich Bogdahn; Wilhelm Schulte-Mattler
OBJECTIVEThis study was designed to establish whether a ratio of three units of Dysport® is equivalent to one unit of Botox® for the treatment of cervical dystonia.METHODSPatients with predominantly rotational cervical dystonia, and a minimum of four previous Botox treatments, were randomised to receive either the clinically indicated dose of Botox or three times that dose in Dysport units. Study
T Odergren; H Hjaltason; S Kaakkola; G Solders; J Hanko; C Fehling; R J Marttila; H Lundh; S Gedin; I Westergren; A Richardson; C Dott; H Cohen
Is efficacy of repeated intradetrusor botulinum toxin type A (Dysport ® ) injections dose dependent? Clinical and urodynamic results after four injections in patients with drug-resistant neurogenic detrusor overactivity
Objective To assess the effects of two different doses of botulinum toxin A (Dysport®: 500 and 1,000 IU) injected repeatedly into the bladder for the treatment of neurogenic detrusor overactivity (NDO) in terms\\u000a of safety, durability, and improvement of continence status and urodynamic parameters.\\u000a \\u000a \\u000a \\u000a Patients and methods In this study we analyzed the effects of successive doses of 500 or 1,000 IU of Dysport®, endoscopically
Ibrahim Fathi Ghalayini; Mohammed A. Al-Ghazo; Ziad Ali Elnasser
Objectives To compare the clinical characteristics and the long-term outcome of a large series of patients with blepharospasm (BS) treated\\u000a with the two most used brands of BoNT-A over the last 15 years. Methods We have reviewed the clinical charts of 128 patients with BS who received botulinum neurotoxin (BoNT) in 1341 treatments\\u000a (Botox in 1009, Dysport in 332) over the
A. R. Bentivoglio; A. Fasano; T. Ialongo; F. Soleti; S. Lo Fermo; A. Albanese
Background and purpose: To review the clinical characteristics and the long-term outcome of patients with hemifacial spasm (HFS) who received botulinum neurotoxin (BoNT) over the past 10 years. Results: A total of 108 patients received 665 treat- ments. Mean latency of clinical effect was 5.4 ± 5.3 days for Botox and 4.9 ± 4.6 days for Dysport (P > 0.05).
A. R. Bentivoglio; A. Fasano; T. Ialongo; F. Soleti; S. Lo Fermo; A. Albanese
Objectives: Botulinum toxin type A is a potent neuromuscular paralyzing agent used in various disorders including cervical dystonia. Two preparations of botulinum toxin are now commercially available ( Dysport and Botox), but much controversy remains about their respective potencies. The aim of the study was to compare the efficacy of Botox with two different ratios of Dysport.Methods: A double blind,
D Ranoux; C Gury; J Fondarai; J L Mas; M Zuber
Treatment with botulinum toxin-A is recommended as first-line treatment for cervical dystonia (CD). In clinical practice many factors appear to influence dose adjustment and the retreatment regimen; however, there is little information available in the literature regarding the evolution of dosing over treatment cycles. We report on two similarly designed, long-term, multicenter, open-label extension studies of Dysport for the treatment of CD, which followed 500 U fixed-dose placebo-controlled trials. Both studies specified a fixed 500 U dose for the first open-label treatment cycle, with dose adjustment in subsequent treatment cycles according to the clinical response. These analyses include 218 patients who entered the two studies; doses in the subsequent treatment cycles ranged between 250 and 1,000 U. During open-label treatment, all treatment cycles resulted in improvements in mean Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total scores. However, increasing the dose of Dysport above the initial 500 U dose was not observed to result in an incremental improvement in response as measured by the TWSTRS. No individual patient characteristic was found to reliably predict the use of higher doses at each treatment cycle. Dysport was generally well tolerated with no major differences in the incidence of adverse events (AEs) observed with different doses. Dysphagia was considered an AE of special interest and dysphagia data from the open-label studies were combined with two Phase II studies. Analysis of this enhanced database indicates that unilateral injections of >150 U into the sternocleidomastoid muscle is associated with a higher dysphagia risk. Thus, limiting the dose in the sternocleidomastoid may help reduce the incidence of dysphagia. PMID:22878514
Hauser, Robert A; Truong, Daniel; Hubble, Jean; Coleman, Chandra; Beffy, Jean-Luc; Chang, Stephen; Picaut, Philippe
Botox® and Dysport® are the preparations of botulinum neurotoxin most widely used for therapeutic purposes. Several studies have addressed the\\u000a topic of the equivalency ratio (D\\/B ratio) to be used in clinical practice and whether a reliable value exists is still a\\u000a matter of debate. To this purpose, we ideated a novel paradigm by retrospectively examining the patients affected by
Anna Rita Bentivoglio; Tàmara Ialongo; Francesco Bove; Francesca De Nigris; Alfonso Fasano
Botulinum toxin is considered the treatment of choice for hemifacial spasm (HFS) and reinnervation synkinesias (RS). We present\\u000a 133 patients with HFS (n = 97) and RS (n = 36) who have been treated with either Botox® (n = 78) or Dysport® (n = 55) exclusively for 6 years (range 2–12 years). The Botox® dose was 21 ± 8 MU, the Dysport® dose 46 ± 22 MU. The therapeutic effect started after 7.1 ± 2.3 days and lasted for
Katja Kollewe; Bahram Mohammadi; Reinhard Dengler; Dirk Dressler
Botox(®) and Dysport(®) are the preparations of botulinum neurotoxin most widely used for therapeutic purposes. Several studies have addressed the topic of the equivalency ratio (D/B ratio) to be used in clinical practice and whether a reliable value exists is still a matter of debate. To this purpose, we ideated a novel paradigm by retrospectively examining the patients affected by hemifacial spasm and blepharospasm. We compared the pairs of treatments with a switch from one brand to the other undergone by the same patient in consecutive sessions with overlapping clinical outcome. Out of 2006 treatments, we found 51 treatment pairs. D/B ratio was extremely variable (range 1.2-13.3) and in most cases (65%) it was between 1:3 and 1:5. In conclusion, even if the 1:4 ratio might be reliable for clinical purpose, a true bioequivalence between Dysport(®) and Botox(®) might not exist due to the intrinsic difference in their pharmacokinetic properties. PMID:21710123
Bentivoglio, Anna Rita; Ialongo, Tàmara; Bove, Francesco; De Nigris, Francesca; Fasano, Alfonso
Botulinum toxin is considered the treatment of choice for hemifacial spasm (HFS) and reinnervation synkinesias (RS). We present 133 patients with HFS (n = 97) and RS (n = 36) who have been treated with either Botox (n = 78) or Dysport (n = 55) exclusively for 6 years (range 2-12 years). The Botox dose was 21 +/- 8 MU, the Dysport dose 46 +/- 22 MU. The therapeutic effect started after 7.1 +/- 2.3 days and lasted for 12.5 +/- 3.9 weeks. It was stable throughout the observation period in 85% of all patients. Adverse effects occurred in 5.4% of injection series. No patient terminated treatment because of unsatisfactory results. Secondary therapy failure did not occur. With an effective conversion ratio of Botox:Dysport = 1:2.56 there were no differences between both drugs with respect to therapeutic efficacy and adverse effects thus confirming the hypothesis that there may not be intrinsic differences between both products. PMID:20437061
Kollewe, Katja; Mohammadi, Bahram; Dengler, Reinhard; Dressler, Dirk
OBJECTIVETo define a safe and effective dose of Dysport for treating hip adductor spasticity.METHODSPatients with definite or probable multiple sclerosis, and disabling spasticity affecting the hip adductor muscles of both legs, were randomised to one of four treatment groups. Dysport (500, 1000, or 1500 Units), or placebo was administered by intramuscular injection to these muscles. Patients were assessed at entry,
N Hyman; M Barnes; B Bhakta; A Cozens; M Bakheit; B Kreczy-Kleedorfer; W Poewe; J Wissel; P Bain; S Glickman; A Sayer; A Richardson; C Dott
OBJECTIVETo describe the long term efficacy and side effects of the treatment of hemifacial spasm with Dysport and to evaluate two different sites of injection to hopefully reduce side effects.METHODSThis study was designed as a prospective descriptive study. Injections were made subcutaneously around the eye. Peak improvement was subjectively assessed by using a visual analogue scale and reported in percentages
Suthipun Jitpimolmard; Somsak Tiamkao; Malinee Laopaiboon
Objective: To compare the effect of equivalent doses in two different volumes of botulinum toxin type A (Dysport) on gastrocnemius spasticity.Design: Single-blind, randomized, controlled trial.Setting: Hospital rehabilitation departmentSubjects: Twenty-two children with spastic diplegic or quadriplegic cerebral palsy.Intervention: High (500 U\\/5 mL) and low (500 U\\/1 mL)-volume preparations of Dysport were injected into the gastrocnemius muscles, each child randomly receiving one
Gwo-Chi Hu; Yao-Chia Chuang; Jen-Pei Liu; Kuo-Liong Chien; Yi-Min Chen; Ying-Fang Chen
Chemodervation with abobotulinum toxin A (Dysport) and botulinum toxin type A (Botox) is finding an expanding role in functional and cosmetic cases. We describe the use of chemodenervation with abobotulinum toxin A for functional corneal protection in two cases and botulinum toxin type A for facial symmetry after Bell's palsy in one patient. The first case is a 75-year-old female with a nonhealing corneal erosion in her right eye secondary to epithelial basement membrane corneal dystrophy who underwent injection of 24 units of abobotulinum toxin A to the right Muller's muscle and levator palpebrae superioris to induce a protective ptosis. The second case is a 40-year-old male with corneal decompensation in the right eye after penetrating keratoplasty who underwent similar injection at both sites. The third case is a 46-year-old Asian female with history of Bell's palsty affecting her right side and causing mild left eyelid retraction who was injected 3 units of botulinum toxin type A to her Muller's muscle for lid positioning. Chemodenervation is used in these cases to purposefully induce ptosis by careful injection to Muller's muscle and the levator palpebrae superioris for functional and cosmetic purposes. PMID:20724861
Reddy, Usha P; Woodward, Julie A
Background: There are several commercially available neurotoxins to improve facial aesthetics, but few prospective, randomized trials have been conducted without commercial support to compare these agents.Objectives: The authors present the results of a study examining and comparing the effects of onabotulinumtoxinA (BoNT-ONA; Botox, Allergan, Inc., Irvine, California) and abobotulinumtoxinA (BoNT-ABO; Dysport, Ipsen Ltd, Slough, UK).Methods: The authors enrolled 53 patients
Basil M. Michaels; George A. Csank; Gabriel E. Ryb; Frederick N. Eko; Abigail Rubin
Efficacy and safety of a single botulinum type A toxin complex treatment (Dysport ®) for the relief of upper back myofascial pain syndrome: Results from a randomized double-blind placebo-controlled multicentre study
Botulinum type A toxin (BoNT-A) has antinociceptive and muscle-relaxant properties and may help relieve the symptoms of myofascial pain syndrome. In this study we evaluated the efficacy and tolerability of BoNT-A (Dysport®) in patients with myofascial pain syndrome of the upper back. We conducted a prospective, randomized, double-blind, placebo-controlled, 12-week, multicentre study. Patients with moderate-to-severe myofascial pain syndrome affecting cervical
Hartmut Göbel; Axel Heinze; Gerhard Reichel; Harald Hefter; Reiner Benecke
Botulinum toxin type A is a 150?kD protein produced by Clostridium botulinum, which exists in a complex with up to six additional proteins. The ability of botulinum toxin to inhibit acetylcholine release at the neuromuscular junction has been exploited for use in medical conditions characterized by muscle hyperactivity. As such, botulinum toxin is widely recommended by international treatment guidelines for movement disorders and it has a plethora of other clinical and cosmetic indications. The chronic nature of these conditions requires repeated injections of botulinum toxin, usually every few months. Multiple injections can lead to secondary treatment failure in some patients that may be associated with the production of neutralizing antibodies directed specifically against the neurotoxin. However, the presence of such antibodies does not always render patients non-responsive. The reported prevalence of immunoresistance varies greatly, depending on factors such as study design and treated indication. This review presents what is currently known about the immunogenicity of botulinum toxin and how this impacts upon patient non-response to treatment. The complexing proteins may act as adjuvants and stimulate the immune response. Their role and that of neutralizing and non-neutralizing antibodies in the response to botulinum toxin is discussed, together with an assessment of current neutralizing antibody measurement techniques. Botulinum toxin preparations with different compositions and excipients have been developed. The major commercially available preparations of botulinum toxin are Botox (onabotulinumtoxin A; Allergan, Inc., Ireland), Dysport (abobotulinumtoxin A; Ipsen Ltd, UK), and Xeomin (incobotulinumtoxin A; botulinum toxin type A [150?kD], free from complexing proteins; NT 201; Merz Pharmaceuticals GmbH, Germany). The new preparations of botulinum toxin aim to minimize the risk of immunoresistance in patients being treated for chronic clinical conditions. PMID:22385408
Two reports have shown a Japanese preparation of botulinum toxin type F (BTX-F) to be an effective alternative for patients with torticollis who develop clinical resistance to botulinum toxin type A (BTX-A). A group of patients with torticollis, comprising five secondary non-responders and one primary non-responder, were treated with a preparation of BTX-F produced in the UK (Speywood Pharmaceuticals). A low dose of BTX-F (220 mouse units (MU) in total) was given into clinically affected neck muscles, followed six weeks later by an injection of a total of 520 MU. Antibodies to BTX-A (mouse protection assay) were present in all secondary non-responders but not in the primary non-responder. No patients developed atrophy after injection of Dysport BTX-A (40 MU) into the left extensor digitorum brevis muscle whereas pronounced atrophy occurred in all patients after injection of 40 MU of BTX-F into the right extensor digitorum brevis muscle. Three patients improved subjectively after treatment with 220 MU BTX-F and five (all secondary non-responders) after the subsequent dose of 520 MU (two considerably), with reduced Tsui scores, but group scores were only significantly changed after the higher dose. The primary non-responder remained unchanged after both doses of BTX-F. One patient reported mild dysphagia with 520 MU BTX-F. Mean duration of improvement with 520 MU BTX-F was five (range 4-6)weeks. Thus BTX-F provides benefit for BTX-A non-responders with few side effects but for a shorter period than BTX-A, possibly due to relative underdosing. As with BTX-A, biological sensitivity to BTX-F does not necessarily predict a clinical response. Images
Sheean, G L; Lees, A J
Assessment of the health status of animals through measurement of cellular, biochemical, and macromolecular constituents in blood, secretions, and excretions has been variously referred to as clinical chemistry, clinical biochemistry, or clinical pathology. he genesis of this dis...
Botulinum neurotoxin A was the first developed for therapeutic and then esthetic uses, Botox first and then Dysport. These two products differ on a few points, explaining their nonequivalence of units: American and British tests of the mouse LD50 units based on solutions that were not identical and 500microg vs 150microg serum albumin dose in the excipient. The neurotoxin- accessory protein complexes were also different: 900 kDa homogeneous for Botox, 500 kDa heterogeneous for Dysport, giving greater diffusion for Dysport, but this is under debate and could result from an excessive conversion ratio. Clinical comparative studies, often with weak methodology, have defined an ideal ratio between these two products, guaranteeing efficacy, but without an overly pronounced diffusion. In the first publications for neurological and ophthalmological indications, the conversion ratio between Dysport and Botox was high, 4:1, and sometimes higher. However, today, particularly for cosmetic indications, the trend is toward a much lower ratio, 2.5:1, or perhaps less for dyshidrosis. This lower ratio has an economic incidence: Dysport is less expensive and therefore more competitive. The price of Dysport's cosmetic product, Azzalure, compared to the price of Vistabel, which is Botox's cosmetic presentation, has not yet been defined in France. The other A toxins, Xeomin, and the Asian toxins, MyoBloc (botulinum toxin type B), tested compared to Botox, have a slightly lower efficacy. PMID:19576490
... Clinical Pharmacology, Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling (PDF - 363KB), Draft Guidance ... More results from www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances
The injection of Clostridium botulinum type A neurotoxins is among the most commonly performed cosmetic procedures, both in the U.S. and worldwide. The U.S. Food and Drug Administration (FDA) approval of a new botulinum neurotoxin type A in April 2009 (BoNT-A, Dysport, Medicis, Scottsdale, AZ-hereafter referred to as "Dysport") has broadened the neurotoxin market and provides new therapeutic alternatives to practitioners. The introduction of this product raises questions about how to best use it. In this supplement, the authors address critical similarities and differences between onabotulinumtoxinA (Botox, Allergan, Irvine, CA--hereafter referred to as "Botox") and abobotulinumtoxinA (Dysport). The authors also provide practical guidelines for the use of Dysport based on clinical experience and peer-reviewed, published clinical trials. In the authors' opinion, Botox and Dysport can be used for similar "on-" and "off-label" applications. Judicious use of either product requires an understanding of how the two products differ in order to avoid side effects and achieve optimal results. Common Questions: Are these two toxins the same or different and how? How are inter-product "unit" conversions addressed? Does injection technique differ? Does one product result in greater adverse events? Does one product last longer or "diffuse" better than the other? What other toxins can be expected on the market in the future? PMID:20361474
Hexsel, Doris; Spencer, James M; Woolery-Lloyd, Heather; Gilbert, Erin
... Clinical / Medical, Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention (PDF - 265KB), Draft Guidance, 03 ... More results from www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances
This interactive feature addresses the diagnosis or management of a clinical case. A case vignette is followed by specific clinical options, neither of which can be considered either correct or incorrect. In short essays, experts in the field then argue for each of the options. Readers can participate in forming community opinion by choosing one of the options and, if they like, providing their reasons.
Although creatine supplementation (CS) is typically considered in the context of sports supplementation, a continually expanding\\u000a body of research literature is examining the potential clinical and therapeutic potential of CS. Aspects of clinical use seem\\u000a obvious, to enhance muscle performance in conditions of sarcopenia, for muscular rehabilitation following injury, and for\\u000a inborn errors of metabolism. In addition, the effects of
Joseph P. Weir
Alcohol is the most consumed substance in France. Nine percent of French people are present with alcohol misuse (abuse and dependence). Early screening of alcohol misuse can be identified in clinical, biological or social fields. Minimal guidance is effective even at an early stage of alcohol misuse. Currently, clinical population presenting with alcohol dependence presents most frequently a polyconsumption (association of alcohol-tobacco-cannabis). Psychiatric comorbidities must be screened and systematically distinguished from induced psychiatric disorders. Medically assisted alcohol withdrawal remains consensual and effective. It combines hydration, benzodiazepines and thiamine. Strategies against alcoholism relapse use better evaluated psychotherapies (as behavioral and cognitive therapies) and the development of new pharmacological treatments. PMID:23069232
Cottencin, Olivier; Guardia, Dewi; Karila, Laurent; Rolland, Benjamin
Clinical research has focused on autoimmune disease (AID) for a couple of decades. More sensitive and specific methods have been developed for neuroimmunological research. Gamma fraction bands (bands separated by electrophoresis and visualized by amino black staining) and IgG fraction bands (bands separated by iso-electric focusing and visualized by immunostaining) are used instead of oligoclonal bands. Myasthenia gravis (MG) mainly
Xian-hao Xu; Hua Zhang; Hong Guo; Xiu-yun Wang; Hong Sun; Xiong Han; Bao-lin Li; Feng-zhen Pang; Hong Wang; Shi-Guang Wen; Yun Jiang; Min-xun Tan
Since the introduction, in 1982, of a Biomagnetic facility in the clinical environment, efforts were concentrated to investigate whether magnetocardiography could really provide new information of potential diagnostic use, even avoiding electromagnetic shielding to facilitate simultaneous biomagnetic and conventional cardiac investigations, including cardiac catheterization for invasive electrophysiological procedures. More than350 patients have been magnetically investigated using a single-channel second-order gradiometer.
Riccardo R. Fenici; Guido Melillo; Mariella Masselli
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.
Arndt, R.; Horns, J.W.; Gold, R.H.; Blaschke, D.D.
Study design and methods of the BoTULS trial: a randomised controlled trial to evaluate the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A
Background Following a stroke, 55–75% of patients experience upper limb problems in the longer term. Upper limb spasticity may cause pain, deformity and reduced function, affecting mood and independence. Botulinum toxin is used increasingly to treat focal spasticity, but its impact on upper limb function after stroke is unclear. The aim of this study is to evaluate the clinical and cost effectiveness of botulinum toxin type A plus an upper limb therapy programme in the treatment of post stroke upper limb spasticity. Methods Trial design : A multi-centre open label parallel group randomised controlled trial and economic evaluation. Participants : Adults with upper limb spasticity at the shoulder, elbow, wrist or hand and reduced upper limb function due to stroke more than 1 month previously. Interventions : Botulinum toxin type A plus upper limb therapy (intervention group) or upper limb therapy alone (control group). Outcomes : Outcome assessments are undertaken at 1, 3 and 12 months. The primary outcome is upper limb function one month after study entry measured by the Action Research Arm Test (ARAT). Secondary outcomes include: spasticity (Modified Ashworth Scale); grip strength; dexterity (Nine Hole Peg Test); disability (Barthel Activities of Daily Living Index); quality of life (Stroke Impact Scale, Euroqol EQ-5D) and attainment of patient-selected goals (Canadian Occupational Performance Measure). Health and social services resource use, adverse events, use of other antispasticity treatments and patient views on the treatment will be compared. Participants are clinically reassessed at 3, 6 and 9 months to determine the need for repeat botulinum toxin type A and/or therapy. Randomisation : A web based central independent randomisation service. Blinding : Outcome assessments are undertaken by an assessor who is blinded to the randomisation group. Sample size : 332 participants provide 80% power to detect a 15% difference in treatment successes between intervention and control groups. Treatment success is defined as improvement of 3 points for those with a baseline ARAT of 0–3 and 6 points for those with ARAT of 4–56. Trial registration ISRCTN78533119 EudraCT 2004-002427-40 CTA 17136/0230/001 Funding National Institute for Health Research, Health Technology Assessment Programme. Ipsen Ltd provide botulinum toxin type A (Dysport®).
Rodgers, Helen; Shaw, Lisa; Price, Christopher; van Wijck, Frederike; Barnes, Michael; Graham, Laura; Ford, Gary; Shackley, Phil; Steen, Nick
Study design and methods of the BoTULS trial: a randomised controlled trial to evaluate the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A.
BACKGROUND: Following a stroke, 55-75% of patients experience upper limb problems in the longer term. Upper limb spasticity may cause pain, deformity and reduced function, affecting mood and independence. Botulinum toxin is used increasingly to treat focal spasticity, but its impact on upper limb function after stroke is unclear.The aim of this study is to evaluate the clinical and cost effectiveness of botulinum toxin type A plus an upper limb therapy programme in the treatment of post stroke upper limb spasticity. METHODS: Trial design: A multi-centre open label parallel group randomised controlled trial and economic evaluation. Participants: Adults with upper limb spasticity at the shoulder, elbow, wrist or hand and reduced upper limb function due to stroke more than 1 month previously. Interventions: Botulinum toxin type A plus upper limb therapy (intervention group) or upper limb therapy alone (control group).Outcomes: Outcome assessments are undertaken at 1, 3 and 12 months. The primary outcome is upper limb function one month after study entry measured by the Action Research Arm Test (ARAT). Secondary outcomes include: spasticity (Modified Ashworth Scale); grip strength; dexterity (Nine Hole Peg Test); disability (Barthel Activities of Daily Living Index); quality of life (Stroke Impact Scale, Euroqol EQ-5D) and attainment of patient-selected goals (Canadian Occupational Performance Measure). Health and social services resource use, adverse events, use of other antispasticity treatments and patient views on the treatment will be compared. Participants are clinically reassessed at 3, 6 and 9 months to determine the need for repeat botulinum toxin type A and/or therapy.Randomisation : A web based central independent randomisation service. Blinding: Outcome assessments are undertaken by an assessor who is blinded to the randomisation group. Sample size: 332 participants provide 80% power to detect a 15% difference in treatment successes between intervention and control groups. Treatment success is defined as improvement of 3 points for those with a baseline ARAT of 0-3 and 6 points for those with ARAT of 4-56. TRIAL REGISTRATION: ISRCTN78533119 Eudra CT 2004-002427-40 CTA 17136/0230/001 FUNDING: National Institute for Health Research, Health Technology Assessment Programme. Ipsen Ltd provide botulinum toxin type A (Dysport(R)). PMID:18947418
Rodgers, Helen; Shaw, Lisa; Price, Christopher; van Wijck, Frederike; Barnes, Michael; Graham, Laura; Ford, Gary; Shackley, Phil; Steen, Nick
Clinical neuropsychology is developing into a professional specialty with training and credentialing criteria. This has implications for the roles clinical psychologists. It may no longer be responsible or ethical for the general clinical psychologist to ...
L. I. Cripe
Protein-losing enteropathy (PLE) is a rare complication of a variety of intestinal disorders characterized by an excessive loss of proteins into the gastrointestinal tract due to impaired integrity of the mucosa. The clinical presentation of patients with PLE is highly variable, depending upon the underlying cause, but mainly consists of edema due to hypoproteinemia. While considering PLE, other causes of hypoproteinemia such as malnutrition, impaired synthesis, or protein loss through other organs like the kidney, liver, or skin, have to be excluded. The disorders causing PLE can be divided into those due to protein loss from intestinal lymphatics, like primary intestinal lymphangiectasia or congenital heart disease and those with protein loss due to an inflamed or abnormal mucosal surface. The diagnosis is confirmed by increased fecal concentrations of alpha-1-antitrypsin. After PLE is diagnosed, the underlying cause should be identified by stool cultures, serologic evaluation, cardiac screening, or radiographic imaging. Treatment of PLE consists of nutrition state maintenance by using a high protein diet with supplement of fat-soluble vitamins. In patients with lymphangiectasia, a low fat with medium chain triglycerides (MCT) diet should be prescribed. Besides dietary adjustments, appropriate treatment for the underlying etiology is necessary and supportive care to avoid complications of edema. PLE is a rare complication of various diseases, mostly gastrointestinal or cardiac conditions that result into loss of proteins in the gastrointestinal tract. Prognosis depends upon the severity and treatment options of the underlying disease.
Braamskamp, Marjet J. A. M.; Dolman, Koert M.
We have experienced a significant change into ‘the way we practice’ since we stepped into the area of clinical research. The training in good clinical practice (GCP) made us capable of imparting the excellence. We describe the experience of our journey from clinical practice to clinical research.
Fulwani, Mahesh; Pardeshi, Raviraj
Text VersionClinical Chemistry and Clinical Toxicology Devices Panel Meeting April 25, 2013 Panel Discussion Questions Session III - Isoniazid Test Strips ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials
... The main components of a clinical protocol are described in Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance (PDF - 262KB ... More results from www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved
Text Version... Clinical Chemistry and Clinical Toxicology Devices Panel Methotrexate Test Systems, Phencyclidine (PCP) Test Systems, Isoniazid Test Strips ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials
Tests the feasibility of an outreach clinical librarian service in an acute hospital setting, providing quality filtered research evidence at the point of clinical need. The design was based on a six-month pilot with professional librarians attending clinical meetings responding to information needs raised there by providing appraised summaries of the published evidence, with full text and bibliographic material as
Claire J. Honeybourne; Janet Harrison
A randomized clinical trial (RCT) is currently the strongest method for evaluating interventions in clinical practice. RCTs also provide the politically most powerful form of evidence. However it is not necessarily agreed what constitutes an RCT. This editorial explores what might be included within the rubric of ‘randomized clinical trial' (and randomized controlled trial) by considering the reasons for using
Derick T Wade
Clinical science research incorporates the fields of clinical investigation and health services research. With a focus on the use of either human specimens or subjects, clinical investigation research projects translate knowledge gained from basic science research based on animal models for disease. The goal of clinical investigation is to develop new prevention, intervention, and therapeutic approaches to improve patient clinical
Frederick L. Grover; A. Laurie Shroyer
A clinical practice guideline can be implemented using a guideline execution engine. The engine can interpret the clinical practice guideline, obtain medical data stored in a clinical information system (CIS), and implement an action in response to execut...
B. Wu C. Taunk D. R. Berg J. M. Thrun P. Ram R. M. Abarbanel
... in Clinical Trials: About Clinical Trials In This Topic About Clinical Trials Risks and Benefits Terms to ... for More Information National Institute on Aging Related Topics Talking with Your Doctor Taking Medicines The information ...
|What is it like to be a clinical educator? How do clinical educators experience and describe their continuing journey of becoming a clinical educator? Within the model developed in this research, dimensions of being a clinical educator were identified. These dimensions include (a) having a sense of self (and the impact of bringing self into the…
Higgs, Joy; Mcallister, Lindy
In summary, culture-based therapy and severity levels are key to management of clinical mastitis. Antibiotic therapy should be strongly considered for gram-positive clinical mastitis. Antibiotic therapy is not necessary for mild-to-moderate gram-negative clinical mastitis. Antibiotic therapy is warranted for practically all severe clinical mastitis as well as fluids and anti-inflammatory drugs. Clinical mastitis cases due to yeast and fungal pathogens or no growth isolates do not warrant antibiotic therapy. PMID:22664208
Roberson, Jerry R
Clinical integration has vaulted from idea to imperative, thanks in part to the new health reform law. This first installment of H&HN's series on the implications of the law looks at two health systems at very different points on the path to clinical integration. PMID:20575345
Since direct patient care is only one of the many fields of clinical pharmacologists world wide, the contribution of the discipline to the provision of healthcare is frequently underestimated. Besides therapeutic monitoring and pharmacogenetic services, particularly drug information services run by clinical pharmacology departments have been established in many countries. Despite the fact that electronic prescribing support may prevent physicians from major medication errors due to drug-drug interactions and inadequate dosages, a substantial number of questions addressed to drug information services include clinical expertise and judgement. Furthermore, a high number of requests deal with adverse drug interactions and involve requests for alternative drugs in the individual clinical context. Using information technology, an international web-based clinical pharmacology service using existing knowledge databases seems to be a promising option to demonstrate the excellence of the discipline. PMID:23640193
Thürmann, Petra A
This cross-sectional research used a qualitative questionnaire to explore clinical competence in nursing. The aim was to look for evidence of how clinical competence showed itself in practice. In the research, the views from both education and working life are combined to broadly explore and describe clinical competence from the perspective of students, clinical preceptors and teachers. The questions were formulated on how clinical competence is characterised and experienced, what contributes to it and how it is maintained, and on the relation between clinical competence and evidence-based care. The answers were analysed by inductive content analysis. The results showed that clinical competence in practice is encountering, knowing, performing, maturing and improving. Clinical competence is an ongoing process, rather than a state and manifests itself in an ontological and a contextual dimension. PMID:22059740
Lejonqvist, Gun-Britt; Eriksson, Katie; Meretoja, Riitta
... However, they felt that the tests should be used in conjunction with other traditional risk assessment tools and clinical judgment. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/medicaldevices
Background: Rofecoxib is a member of a subgroup of nonsteroidal anti-inflammatory drugs (NSAIDs) known as cyclooxygenase-2 (COX-2)—selective inhibitors. It has been studied in adult and elderly patients in a number of painful conditions (primary dysmenorrhea, acute pain after dental and orthopedic surgery, osteoarthritis [OA], and rheumatoid arthritis).Objective: This review discusses the clinical pharmacology of and clinical experience with rofecoxib, and
Arthur L. Weaver
Reference clinical data interchange standards defined by CDISC (Clinical Data Interchange Standards Consortium), we developed clinical data management system with distributed system architecture which can be executed on different platforms for high performance. This system consists mainly of study management module, data capture module, data management module and security module. Besides, web-based approach changes the traditional client\\/server design pattern for
Lingli Fu; Sheng Ding; Tao Chen
The role of sibutramine as an effective adjunct to diet and exercise in weight management programmes has been proven in clinical trials. Although the reality of managing obesity in clinical practice is very different from that of a controlled clinical trial, there is good evidence that sibutramine is an easy-to-use and highly effective additional therapy when used in everyday practice
The number of clinical applications for PET continues to increase, particularly in the field of oncology. In parallel with\\u000a this is a growth in the number of centers that are able to provide a clinical PET or PET\\/CT service. The vast majority of\\u000a clinical PET applications are oncological in nature but there are also important neurological and cardiological applications.
Gary J. R. Cook
|Discusses important issues concerning the design of student health clinics, including convenient access, privacy and security, showers and sinks, durability and safety, and special considerations. (EV)|
Jelliffe, James H.; Schipp, Michael K.
Discusses important issues concerning the design of student health clinics, including convenient access, privacy and security, showers and sinks, durability and safety, and special considerations. (EV)
Jelliffe, James H.; Schipp, Michael K.
Thyroid Cancer - Featured Clinical Trials The following list shows Featured Clinical Trials for a specific type of cancer. You may also want to view: Multiple Cancer Types - Featured Clinical Trials Supportive Care - Featured Clinical Trials Related
Recently, interest in consultation training has begun to grow in the literature after a long period of neglect. Although a case has been made in the literature for improving the clinical supervision of consultation skills, the process of supervising the development of consultation skills continues to receive little attention. In this article, strategies for clinical supervision of consultation skills will
Katurah Cramer; Sylvia Rosenfield
Clinical analysis requires methods of high reliability. The importance of immunosensors in clinical analysis is discussed. Due to the fact that the construction of immunosensors plays a very important role in their response characteristics, different types of immunosensor designs are highlighted. The performances of immunosensors are discussed taking into account the type of transducer utilized for construction. PMID:11225777
Stefan, R I; van Staden, J F; Aboul-Enein, H Y
This book presents clinical applications of magnetic resonance imaging with a strong clinical orientation. Covers technique, instrumentation, and contrast agents. Describes MRI of the neck, brain, heart, spine, TMJ and orbit, chest abdomen, pelvis, and the joints. Also includes a high field atlas of the central nervous system.
Brady, T.J.; Edelman, R.R.
TQM principles change the work environment so that point-of-service personnel can improve health care delivery to patients. The clinical pathway process starts with the principles of TQM. In the era of managed care, health care resources can be managed effectively using a clinical pathway. The multidisciplinary team has the opportunity to improve the health care services provided to patients. PMID:9847822
Leininger, S M
Four cases of coma, clinically typed as hypoglycaemic but without low blood sugar levels are presented. The clinical picture was rapidly normalised by immediate infusion with hypertonic glucosate. A tentative pathogenetic hypothesis is proposed and the Yager and Young "non-hypoglycaemia" syndrome is once more discussed. PMID:6521946
Petrella, V; Silvera, F; Massara, G
Ximelagatran is a novel oral anticoagulant belonging to a class of drugs known as direct thrombin inhibitors. Numerous recent large-scale, randomised controlled clinical trials have given the drug a large clinical platform. These include data on the thromboprophylaxis of venous thromboembolism following major orthopaedic surgery and knee arthroscopy, as well as in the treatment of deep vein thrombosis and prevention
C. J. Boos; A. Hinton; G. Y. H. Lip
|The scalar electrocardiogram (ECG) is one of the most important and commonly used clinical tools in medicine. A detailed description of the recordings of cardiac electrical activity made by the ECG is presented, and the vast numbers of uses made with the data provided by this diagnostic tool are cited. Clinical applications of the ECG are listed.…
Brammell, H. L.; Orr, William
Although yohimbine (YOH) has been available for the treatment of male erectile dysfunction (ED) for longer than Viagra®, there is a perception that little is known about the clinical performance of the drug. This review attempts, by comprehensive analysis of the literature, to cover the clinical, pharmacological, and therapeutic profiles of YOH, relevant to its potential utility in the management
S. William Tam; Manuel Worcel; Michael Wyllie
SUMMARY. Clinical reasoning is reviewed with respect to the historical and continuing need for critical inquiry skills, the hypothetico-deductive basis of sound reasoning, factors influencing therapists' reasoning, and ways of promoting critical yet creative reasoning. The importance of clinicians' organisation of biomedical and clinical knowledge and the inclusion of the patient in the problem solving and decision making processes are
Drug development is a lengthy, costly, and complex process, with clinical trials essential for characterizing dosing, safety, and efficacy in treated populations. After regulatory approval, aggressive marketing ensures that most drugs are used by a broad spectrum of ages, genders, races, and ethnic groups. Unfortunately, not all groups are adequately represented in clinical trials; adolescents are commonly overlooked. This commentary
ClinicalTrials.gov provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The U.S. National Institutes of Health (NIH), through its National Library of Medi...
An informal clinical ethics committee was set up to advise on ethical problems in prenatal diagnosis in Leeds. It was used twice in six months but was not called on again in the subsequent year, and we describe this experience. In North America similar committees are often used to advise on clinical moral dilemmas, and we review the published evidence from there and discuss some of the advantages and problems. Our committee's advice may have altered clinicians' actions considerably, but perhaps doctors in Britain are not yet ready to surrender this aspect of clinical autonomy.
Thornton, J. G.; Lilford, R. J.
Midwifery is a practical facet of the health sciences that emphasizes professional competence-oriented teaching and learning. Cognitive and practical processes integrate and build midwifery student professional knowledge, attitudes, and skills. Clinical education is a teaching method and strategy used to prepare midwifery students for professional practice. Midwifery clinical teaching plans are designed using literature review, expert opinions, and student comments and determine total required hours and caseloads. Midwifery clinical teaching activities and methods promote self-reflection, childbirth education fundamentals, learning by role model observation, and learning role function through overseas observership programs. This paper discusses midwifery education dilemmas and coping methods in Taiwan. PMID:23729338
Kao, Chien-Huei; Gau, Meei-Ling
Clinical information systems are the computer and information systems used by health care personnel to facilitate patient care. These systems have evolved from financial systems to true patient care systems with variable levels of functionality. Early systems provided laboratory and radiology results, and modern systems now provide copies of the radiology images and decision support for therapeutic orders. The rapidly changing technological infrastructure has created barriers to implementation of the electronic medical record, while coding schemes continue to be refined to enable data access and aggregate data analysis. Further refinement of clinical information systems is required before the potential value of these systems is realized in the clinical management of patients. PMID:10688384
Hardin, W D
TNF inhibitors are currently considered both effective and cost-effective in patients with active rheumatoid arthritis (RA), particularly in patients who have not responded fully to methotrexate. There is substantial doubt about the cost-effectiveness of TNF inhibitors as initial treatment for active RA. New data from the National Data Bank for Rheumatic Diseases now question the current consensus in methotrexate failures. The data suggest that in routine clinical practice TNF inhibitors provide only modest incremental benefits over best conventional therapy. If confirmed, these observational studies suggest that the economic argument underpinning the widespread use of TNF inhibitors in established RA is unsustainable.
... in Clinical Trials and Gender Analysis of Data in Biologic Product Applications A research study funded by the FDA Office of Women's Health; ... More results from www.fda.gov/biologicsbloodvaccines/developmentapprovalprocess/investigationalnewdrugindordeviceexemptionideprocess
This document describes the logistical considerations for voluntary, large-scale, post-event smallpox vaccination clinics. This example model may be used to supplement other state and local vaccination planning considerations for responding to a smallpox ...
The objectives of the project are new and rapid methods for detecting, isolating and characterizing either new viruses which may appear or known viruses, viral antigens, and antibodies to known pathogenic viruses which can be used clinically. During Phase...
N. G. Anderson
This research proposed a system, which integrated the complete patient information, including the medical images, for assisting orthopedics clinic diagnosis. The system concurrently operated with legacy systems and conformed itself to correspond with the ...
S. Tang Y. Huang M. Hsiao T. Lee S. Young
Clinical skills units offer exciting and innovative ways of learning about clinical skills. Links between theoretical knowledge and clinical practice are appropriate for both undergraduate and postgraduate training. Students and doctors can practice and acquire technical and examination skills in a standardised and protected environment without being concerned about the distress such learning may cause real patients. Models and simulators used in skills units are being developed to keep pace with demand, with a corresponding increase in standards of quality and durability. As undergraduate medical courses respond to the demands of modern clinical practice the use of such facilities will increase. This paper describes the functions of skills units and provides practical examples of educational strategies in use. Images p731-a p731-b p731-c p731-d
Text Version... and 95% CI for the comparison between MTS ... Shire felt no meaningful comparisons of treatment ... Clinical Trials to Estimate and Compare Incidence ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess
The paper proposes that the Navy develop an Aviation Clinical Psychology (ACP) program that would complement the Flight Surgeon Program by providing mental health services tailored to the aviation community. Using a community psychology model, it is argue...
J. B. Parker
An attempt to assess the first decade of clinical biofeedback research and practice is presented. Scientifically, there are three major problems which the field must address: first, the problem of models or theoretical orientations; second, the problem of...
W. J. Ray
Leprosy is a chronic infectious peripheral neuropathy caused by Mycobacterium leprae. The different clinical presentations of the disease are determined by the quality of the host immune response. Early detection of leprosy and treatment by multidrug therapy are the most important steps in preventing deformity and disability. Thus the early recognition of the clinical leprosy presentation is essential. Mononeuritis, mononeuritis multiplex (MM), polyneuritis (MM summation) are the most frequent. The frequent anesthetic skin lesions are absent in the pure neuritic leprosy presentation form. Isolated peripheral nerve involvement is common, including the cranial ones. Arthritic presentation is occasionally seen, usually misdiagnosed as rheumatoid arthritis. Attention should be given to autonomic dysfunctions in leprosy. There are clinical presentations with severe neuropathic pain - painful small-fiber neuropathy. Leprous late-onset neuropathy (LLON) clinical presentation should be considered facing a patient who develop an inflammatory neuropathy many years after a previous skin leprosy treatment. PMID:24141500
Nascimento, Osvaldo J M
Researchers from a diverse array of scientific disciplines have focused and continue to focus on opportunities and areas for responsible clinical research involving the possible beneficial health effects of “probiotics.” Investigators and researchers should be aware that not all clinical research involving probiotics reasonably falls within the requirements of the “investigational new drug” (IND) rubric administered and enforced by the US Food and Drug Administration. In determining whether an IND application is required before a clinical study may lawfully commence, investigators and researchers as well as institutional review boards should consider the regulatory classification, e.g., “drug,” “new drug,” “food,” “food additive,” “dietary supplement,” etc. that applies to the substance under investigation. A potential probiotic product can fall along a continuum of regulatory classifications, each having implications on the nature and degree of regulatory requirements for clinical research and, ultimately, for claim substantiation and market access.
Degnan, Fred H.
... Although "new" may imply "better," it is not known whether the potential medical treatment offers benefit to patients until clinical research on that ... More results from www.fda.gov/drugs/developmentapprovalprocess/conductingclinicaltrials
Simulators are no replacement for patients in surgical learning. Live patients are required for teaching clinical signs and skills. Large numbers of students, a relative lack of motivation, a decreasing number of common cases, unwilling patients, differences in language, etc., make clinical teaching in India a bitter problem. Because patient-related problems are important, surgical training using models can help students to gain effective control over surgical signs and skills. PMID:9614730
... Roster of the Clinical Chemistry and Clinical Toxicology Devices Panel. Purpose: The Committee reviews and evaluates ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/medicaldevices
Abstract I call attention to the metapsychology of sense, and the role sense plays-phenomenologically and symbolically-in the life of the clinician and the group. Each group member asserts influence in taking a role as the perceiver and the perceived, the senser and the sensed. We reach for sense, for without sense reference, we cannot grasp or even talk about psychic reality. It serves as sign and symbol, as metaphor, analogy, illustration, and model. Sense fixes experience yet may fixate experience and interfere with developing abstract thoughts. Clinical vignettes illustrate how the leader may utilize his or her particular clinical sensibility to reach the group and focus attention, to link sense to psychic qualities: to the personality of the members, the group culture and process, and the live clinical interaction. PMID:24004010
Billow, Richard M
The National Institutes of Health (NIH) has a long-standing commitment to neuropathy research. From 2005-2009, the NIH has committed US $115 million each year. A collaborative effort between researchers and patients can accelerate the translation of pre-clinical discoveries into better treatments for neuropathy patients. Clinical trials are needed to test these new treatments, but they can only be implemented in a timely fashion if patients with neuropathies are willing to participate. This perspective focuses on the value of having various outlets for informing both the patients and the physicians about existing clinical research opportunities and on the potential benefit of establishing patient registries to help with trial recruitment. Once data have been collected, there is a need to broadly share the data in order to inform future trials, and a first step would be to harmonize data collection by using Common Data Elements (CDEs). PMID:22548622
Abstract Drug development continues to face challenges to successfully progress the most promising drug candidates through the stages of clinical trials. Given the increasing cost to develop a drug, methods are required to characterise early drug efficacy and safety. Imaging techniques are increasingly used in oncological clinical trials to provide evidence for decision making. With the application of conventional morphological imaging techniques and standardised response criteria based on tumour size measurements, imaging continues to be used to define key study end points. However, functional imaging techniques are likely to play an important role in the evaluation of novel therapeutics, although how these methods are to be optimally applied has yet to be clearly established. The specific challenges of standardising multi-centre imaging in the context of clinical trials are highlighted, including the processes for image acquisition, data analysis and radiological review.
The Mayo Clinic offers a wide range of outreach services for the general public, including websites providing basic information about cancer, smoking cessation techniques, and others. Their online Fitness Center website will be a real boon to anyone who is looking to pick up some basic fitness awareness, learn about strength training, or read up on sports nutrition. First-time visitors can start by reading through the "Fitness Basics" area, which answers common questions like "Why exercise?" and also provides information on getting warmed up before exercising. Visitors can also sign up for the Mayo Clinic's free e-newsletter, "Housecall".
In the United Kingdom 20% of consultants and 23% of senior registrars are female. A questionnaire sent to female clinical oncologists revealed that 90% have full-time contracts, although 36% had spent time in part-time training. Sixty-seven per cent of the total have children and the husbands of 51% of the 74% who are married are doctors. Twenty-four per cent believe they have experienced sexual discrimination in clinical oncology and 10% believe they have failed to be appointed to a post because of their gender. Problems highlighted were of inadequate funding for locums to cover maternity leave and poor child care facilities. PMID:8481366
Junor, E; Barrett, J
A clinical trial was conducted in mentally subnormal children and normal subjects with varied mental stress. The results showed good improvement in the behavior, attention span and memory in mentally subnormal children. In students, it reduces irritability, and they were stress-free and comfortable during the examinations. In the group of patients with hypertension, diabetes and psychoneurotic illnesses, subjects reported a
Listeria monocytogenes is an uncommon cause of illness in the general population. However, this bacterium is an important cause of severe infections in neonates, pregnant women, the elderly, transplant recipients and other patients with impaired cell-mediated immunity. Various clinical syndromes due to L. monocytogenes have been described such as sepsis, central nervous system infections, endocarditis, gastroenteritis and localized infections. A
|In mental health, family, and community counseling settings, master's-level counselors engage in unstructured clinical interviewing to develop diagnoses based on the "Diagnostic and Statistical Manual of Mental Disorders" (4th ed., text rev.; "DSM-IV-TR"; American Psychiatric Association, 2000). Although counselors receive education about…
Jones, Karyn Dayle
Neuroprotection is a therapeutic approach that aims to prevent neuronal degeneration and loss of function. Research has focused on developing neuroprotective agents for the therapy of various degenerative diseases, including Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, and glaucoma. Clinical trials for the evaluation of neuroprotective agents pose unique challenges in terms of experimental design and data interpretation. In order
Scott M. Whitcup
Clinical definitions of melioidosis and inhalation-acquired melioidosis (Burkholderia pseudomallei infection) are described together with the evidence used to develop these definitions. Such definitions support accurate public health reporting, preparedness planning for deliberate B. pseudomallei release, design of experimental models, and categorization of naturally acquired melioidosis. PMID:23468355
Cheng, Allen C; Currie, Bart J; Dance, David A B; Funnell, Simon G P; Limmathurotsakul, Direk; Simpson, Andrew J H; Peacock, Sharon J
|Recent importance placed upon efficacy research has spawned the development of the Communication Sciences and Disorders Clinical Trials Research Group (CSDRG). This group, funded by the National Institutes of Health (NIH), was organized by the American Speech Language and Hearing Association to address the need for more treatment efficacy…
Logemann, Jeri A.
Clinical trials are designed to test whether a drug is safe for humans, and whether the drug is effective in treating human diseases or conditions. Although the drug has generally gone through extensive animal testing before the trial begins, animal trials cannot always predict how new medicines will affect humans. Even the most painstaking tests with animals give only approximate
Tom Hollon; Miriam Komaromy
Text Version... DC 9/12/2002 10/22/2002 OAI AGREN STUART MD FAMILY ALLERGY CLINIC 3048 E BASELINE RD MESA AZ 1/18/2005 1/24/2005 VAI ... More results from www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation
Bonded retainers have become a very important retention appliance in orthodontic treatment. They are popular because they are considered reliable, independent of patient cooperation, highly efficient, easy to fabricate, and almost invisible. Of these traits, reliability is the subject of this clinical study. A total of 549 patients with retainers were analyzed with regard to wearing time, extension of the
Dietmar Segner; Bettina Heinrici
Text Version... applicant initiated, as part their clinical development plan, an ... Germany A/California/7/2009 (H1N1) Met criteria ... For the site in the US, 589 subjects ... More results from www.fda.gov/downloads/biologicsbloodvaccines/vaccines
Lymphadenopathy is a common clinical finding and is frequently benign. Warning signs suggestive of a malig- nant etiology include lymph nodes >2 cm in size, supra- clavicular location, and generalized lymphadenopathy associated with hepatosplenomegaly or systemic symp- toms. A metastatic solid tumor is always in the differential diagnosis of localized lymphadenopathy, particularly in older individuals. In the case of more
JENNIFER R. BROWN; ARTHUR T. SKARIN
Hypnosis is an increasingly popular clinical intervention. The number of training courses in hypnosis is growing each year. Research on hypnosis training appears to show that limited exposure to training, as is typical in the common 3 to 5 day format of mass training, produces limited results. Only when training is extended over time do the…
Horevitz, Richard P.
Background: A recurrent episode of diverticulitis is a new distinct episode of acute inflammation after a period of complete remission of symptoms. Outdated literature suggested a high recurrence rate (>40%) and a worse clinical presentation with less chance of conservative treatment. More recent studies showed a more benign course with no need toward an aggressive policy of treatment. Methods: We
Gian Andrea Binda; Antonio Amato; Alberto Serventi; Alberto Arezzo
Violence touches the lives of many in our society. When people are victim- ized by violent crime, the general public assumes that the victim could have been spared if the perpetrator had been identified as potentially dan- gerous by mental health agents. Yet the prediction of dangerousness remains an inexact science and depends upon many complex factors. Clinical Assessment of
Georges-Franck Pinard; Linda Pagani
Abstract Objective To assess residents’ clinical questions, where they get their answers, the utility of those answers, and if an evidence-based medicine (EBM) workshop improves the use of evidence-based electronic resources. Design Prospective observational cohort study. Setting Urban family medicine teaching clinics in Edmonton, Alta, in 2007. Participants First- and second-year family medicine residents training in the family medicine teaching units. Methods An observer recorded clinical questions posed by residents in clinic, the resources used to answer these questions, and how residents thought the answers modified practice. Resources were categorized broadly as colleagues, electronic, or paper. Answer utility was ranked in decreasing order as large change, small change, confirmed, expanded knowledge, or no help. Use of resources was compared before and after an EBM workshop, and between residents under normal supervision and those in semi-independent clinics. Results Thirty-eight residents from 5 sites were observed addressing 325 questions in 114 clinical half-day sessions (420 patients). Residents had 0.8 questions per patient and answered 83.4% of questions with 1 resource (range 1 to 6). Residents made 406 attempts to answer questions, using colleagues 65.5% of the time (93.6% were preceptors), electronic resources 20.7% of the time, and paper resources 13.8% of the time. Answers from colleagues were least likely to require secondary resources (F test, P < .001). The utility of answers from colleagues (F test, P = .002) was superior to that of answers from electronic resources, and this difference remained significantly higher in sensitivity analysis. The EBM workshop training did not influence electronic resource use (17.8% before and 15.1% after, Fisher-Freeman-Halton test, P = .18), but semi-independence from preceptors increased the use of electronic resources from 16.5% to 51.0% (Fisher-Freeman-Halton test, P < .001). Conclusion Residents have many questions during clinical practice. Preceptors were used more commonly than all other resources combined and were the most dependable resource for residents to obtain answers. Although an EBM workshop was not associated with increased use of electronic evidence-based resources, semi-independent work appeared to be.
Allan, G. Michael; Ma, Victoria; Aaron, Sarah; Vandermeer, Ben; Manca, Donna; Korownyk, Christina
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.
Ghrelin as a human natural hormone is involved in fundamental regulatory processes of eating and energy balance. Ghrelin signals the nutrient availability from the gastrointestinal tract to the central nervous system, up-regulates food intake and lowers energy expenditure mainly through hypothalamic mediators acting both centrally and peripherally including the gastrointestinal tract (motility, epithelium), promotes both neuro-endocrine and inflammatory signals to increase skeletal muscle growth and decrease protein breakdown, and increases lipolysis while body fat utilization is reduced. Ghrelin does more to exert its probably sentinel role around "human energy": it influences through mainly extra-hypothalamic actions the hedonic and incentive value of food, mood and anxiety, sleep-wake regulation, learning and memory, and neurogenesis. Recently numerous ghrelin gene-derived peptides were discovered, demonstrating the complexity within the ghrelin/ghrelin receptor axis. For clinical applications, not only the natural ghrelin and its slice variants, but also several modified or artificial molecules acting at ghrelin-associated receptors were and are developed. Current clinical applications are limited to clinical studies, focusing mainly on cachexia in chronic heart failure, COPD, cancer, endstage- renal-disease or cystic fibrosis, but also on frailty in elderly, gastrointestinal motility (e.g., gastroparesis, functional dyspepsia, postoperative ileus), after curative gastrectomy, anorexia nervosa, growth hormone deficient patients, alcohol craving, sleep-wake regulation (e.g. major depression), or sympathetic nervous activity in obesity. The results of completed, preliminary studies support the clinical potential of ghrelin, ghrelin gene-derived peptides, and artificial analogues, suggesting that larger clinical trials are demanded to move ghrelin towards an available and reimbursed pharmaceutical intervention. PMID:22632860
Four common mistakes can easily thwart clinical integration: Assuming that EHR adoption is the cornerstone of successful integration; Delaying the development of ambulatory services that support clinical integration; Believing that knowledge of clinical integration initiatives will passively diffuse through the ranks; Attaching too much weight to Federal Trade Commission/Department of Justice approval of a clinical integration model. PMID:23173368
The incidence of obesity has increased dramatically during recent decades. Obesity increases the risk for metabolic and cardiovascular diseases and may therefore contribute to premature death. With increasing fat mass, secretion of adipose tissue derived bioactive molecules (adipokines) changes towards a pro-inflammatory, diabetogenic and atherogenic pattern. Adipokines are involved in the regulation of appetite and satiety, energy expenditure, activity, endothelial function, hemostasis, blood pressure, insulin sensitivity, energy metabolism in insulin sensitive tissues, adipogenesis, fat distribution and insulin secretion in pancreatic ?-cells. Therefore, adipokines are clinically relevant as biomarkers for fat distribution, adipose tissue function, liver fat content, insulin sensitivity, chronic inflammation and have the potential for future pharmacological treatment strategies for obesity and its related diseases. This review focuses on the clinical relevance of selected adipokines as markers or predictors of obesity related diseases and as potential therapeutic tools or targets in metabolic and cardiovascular diseases.
Much more is known about attitudes toward mental illness and social stigma, the viscious cycle of its consequences and how to fight the social stigma in public, but much less is known about how to combat the stigma and self stigma in clinical practice. Stigma theories have not been enough to understand the feelings and experience of people with mental illness. Conceptual framework that understands stigma as consisting of difficulties of knowledge (ignorance or misinformation), problems of attitudes (prejudice), and problems of behaviour (discrimination) have not o been enough to understand stigma dynamics in the patient therapist interaction. Understanding the psychodynamic aspects of internalized stereotype of mental illness in the patient- therapist relationship may improve our competency to deal with stigma and self stigma in clinical practice. PMID:23995176
Better outcomes for chronic diseases remain elusive because success depends on events outside the control of the health care system: patients’ ability to mange their health behaviors and chronic diseases. Among the most powerful influences on self-management are the social and environmental constraints on healthy living, yet the clinical response to these environmental determinants is poorly developed. A potential approach for addressing social determinants in practice, as well as planning and evaluating community responses, is the capability framework. Defined as the real opportunity to achieve a desired lifestyle, capability focuses attention on the material conditions that constrain real opportunity and how opportunity emerges from the interaction between personal resources and the social environment. Using examples relevant to chronic disease and behavior change, we discuss the clinical application of the capability framework.
Ferrer, Robert L.; Carrasco, Alejandra Varela
This book demonstrates how clinical engineering has applied engineering principles to the development and use of complex medical devices for the diagnosis and treatment of the sick and injured. It discusses the proper utilization of medical devices and equipment in the health-care industry and provides understanding of complex engineering systems, and their uses in the modern hospital or other health-care facility.
Since 1989, eight new antiepileptic drugs (AEDs) have been licensed for clinical use. Levetiracetam is the latest to be licensed and is used as adjunctive therapy for the treatment of adult patients with partial seizures with or without secondary generalisation that are refractory to other established first-line AEDs. Pharmacokinetic studies of levetiracetam have been conducted in healthy volunteers, in adults, children and elderly patients with epilepsy, and in patients with renal and hepatic impairment. After oral ingestion, levetiracetam is rapidly absorbed, with peak concentration occurring after 1.3 hours, and its bioavailability is >95%. Co-ingestion of food slows the rate but not the extent of absorption. Levetiracetam is not bound to plasma proteins and has a volume of distribution of 0.5-0.7 L/kg. Plasma concentrations increase in proportion to dose over the clinically relevant dose range (500-5000 mg) and there is no evidence of accumulation during multiple administration. Steady-state blood concentrations are achieved within 24-48 hours. The elimination half-life in adult volunteers, adults with epilepsy, children with epilepsy and elderly volunteers is 6-8, 6-8, 5-7 and 10-11 hours, respectively. Approximately 34% of a levetiracetam dose is metabolised and 66% is excreted in urine unmetabolised; however, the metabolism is not hepatic but occurs primarily in blood by hydrolysis. Autoinduction is not a feature. As clearance is renal in nature it is directly dependent on creatinine clearance. Consequently, dosage adjustments are necessary for patients with moderate to severe renal impairment. To date, no clinically relevant pharmacokinetic interactions between AEDs and levetiracetam have been identified. Similarly, levetiracetam does not interact with digoxin, warfarin and the low-dose contraceptive pill; however, adverse pharmacodynamic interactions with carbamazepine and topiramate have been demonstrated. Overall, the pharmacokinetic characteristics of levetiracetam are highly favourable and make its clinical use simple and straightforward. PMID:15301575
Patsalos, Philip N
Exposure to plants is very common, through leisure or professional activity. In addition, plant products and botanic extracts are increasingly present in the environment. Cutaneous adverse reactions to plants and their derivatives occur fairly frequently, and establishing the correct diagnosis is not always easy. The astute clinician relies on a detailed history and a careful skin examination to substantiate his opinion. This article reviews the characteristic clinical patterns of phyto- and phytophotodermatitis and some less common presentations. PMID:19580924
\\u000a Venomous animals occur in numerous phyla and present a great diversity of taxa, toxins, targets, clinical effects and outcomes.\\u000a Venomous snakes are the most medically significant group globally and may injure >1.25 million humans annually, with up to\\u000a 100 000 deaths and many more cases with long-term disability. Scorpion sting is the next most important cause of envenoming,\\u000a but significant
Clinical pharmacokinetics of homoharringtonine (HHT) were studied in eight patients who received uniformly labeled HHT at 3-4 mg\\/m2 (150 mu Ci) by continuous 6-hour infusion. The drug and metabolites were quantified by radiochemical and high-performance liquid chromatographic techniques. Computerized nonlinear least-square regression and curve stripping were used to characterize HHT and total (Â³H)HHT equivalent pharmacokinetics. Unchanged HHT in the plasma
N. Savaraj; K. Lu; I. Dimery; L. G. Feun; M. Burgess; M. Keating; T. L. Loo
The inhibition of the renin–angiotensin system is one of the most commonly utilized ways to lower blood pressure in patients\\u000a with arterial hypertension. Up till now, angiotensin-converting enzyme inhibitors as well as angiotensin receptor blockers\\u000a are the established inhibitors of this system, and both classes are used in clinical routine. There is a wealth of information\\u000a about those classes, which
Dirk Westermann; Roland Schmieder; Heinz-Peter Schultheiss; Carsten Tschöpe
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies knowledge area of Prous Science Integrity(R), the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: AdGVVEGF121.10, anakinra, andolast, anidulafungin, APC-2059, l-arginine hydrochloride, aripiprazole, arzoxifene hydrochloride, asimadoline; Bexarotene, bimatoprost, bimosiamose, bizelesin, BMS-188667, botulinum toxin type B, bromfenac sodium, bryostatin 1; Cannabidiol, cariporide mesilate, CCI-1004, CDP-571, cerivastatin sodium, clevudine; Dalbavancin, darbepoetin alfa, decitabine, deligoparin sodium, diethylnorspermine, drotrecogin alfa (activated), DTaP-HBV-IPV/Hib-vaccine; E-5564, eculizumab, edodekin alfa, emtricitabine, enfuvirtide, (-)-epigallocatechin gallate, eplerenone, esomeprazole magnesium, etaquine, etoricoxib, ezetimibe; Fesoterodine, fipamezole hydrochloride, fondaparinux sodium, fosamprenavir calcium, frovatriptan, fulvestrant; Gadofosveset sodium, galiximab, ghrelin (human), glufosfamide; Homoharringtonine; Idraparinux sodium, imatinib mesylate, INS-37217; KRN-7000; L-651582, lafutidine, lanthanum carbonate, lenercept, levetiracetam, lusupultide; Magnesium sulfate, melatonin, mepolizumab, midostaurin, morphine hydrochloride, mozavaptan; Natalizumab, nesiritide; OPC-51803, oregovomab, oritavancin; Peginterferon alfa-2(a), pleconaril, plevitrexed, prasterone, pregabalin; Ranibizumab, Ro-31-7453, roxifiban acetate, rubitecan; SCV-07, SHL-749, sho-saiko-to, soblidotin, solifenacin succinate; Tegaserod maleate, telithromycin, tenecteplase, theraCIM, tipifarnib, travoprost; Valdecoxib, vardenafil hydrochloride hydrate, voriconazole; Ximelagatran; Ziprasidone hydrochloride, ZYC-00101. PMID:12851663
Bayes, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 166Ho-DOTMP 5A8; A-179578, abetimus sodium, adefovir dipivoxil, AGI-1067, AIDSVAX gp120 B/B, AK-602, alefacept alemtuzumab, aliskiren fumarate, ALVAC vCP1433, ALVAC vCP1452, anecortave acetate, arzoxifene hydrochloride, atazanavir sulfate, atlizumab, avasimibe; Binodenoson, BMS-488043; Choriogonadotropin alfa, ciclesonide, COL-1621, CVT-3146, CVT-E002, Cypher; Daptomycin, darbepoetin alfa, darunavir, D-D4FC, deferasirox, desloratadine, desmoteplase, duloxetine hydrochloride, DX-9065a; E-5564, efalizumab, emfilermin, emivirine, emtricitabine, enfuvirtide, estradiol acetate, ezetimibe; Frovatriptan; Gallium maltolate, gefitinib; HIV-1 Immunogen, human insulin; Iguratimod, IL-4/IL-13 Trap, imatinib mesylate, inhaled insulin, insulin glargine, irofulven, ISS-1018, ivabradine hydrochloride; Lutropin alfa; Melatonin; Nesiritide; O6-Benzylguanine, omapatrilat, oritavancin, ospemifene; Parecoxib sodium, peginterferon alfa-2a, pexelizumab, pimecrolimus, pirfenidone, pramlintide acetate, prasterone sulfate PT-141; Rasburicase, razaxaban hydrochloride, recombinant malaria vaccine, rhBMP-2/ACS, roflumilast, rosiglitazone maleate/metformin hydrochloride, rotavirus vaccine; SCH-D, sitaxsentan sodium, solifenacin succinate; Targinine hydrochloride, taxus, TER-199, tramadol hydrochloride/acetaminophen; Valdecoxib, valganciclovir hydrochloride, vatalanib succinate, VEG Trap(R1R2); Ximelagatran; Yttrium Y90 Epratuzumab. PMID:15319808
Bayes, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies Knowledge Area of Prous Science Integrity(R), the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 3,4-DAP; Adefovir dipivoxil, ADL-10-0101, alefacept, alemtuzumab, alosetron hydrochloride, ALT-711, aprepitant, atazanavir sulfate, atlizumab, atvogen; Bortezomib; CETP vaccine, clevudine, crofelemer; DAC:GLP-1, darbepoetin alfa, decitabine, drotrecogin alfa (activated), DX-9065a; E-7010, edodekin alfa, emivirine, emtricitabine, entecavir, erlosamide, erlotinib hydrochloride, everolimus, exenatide; Fondaparinux sodium, frovatriptan, fulvestrant; Gemtuzumab ozogamicin, gestodene; Homoharringtonine, human insulin; Imatinib mesylate, indiplon, indium 111 (111In) ibritumomab tiuxetan, inhaled insulin, insulin detemir, insulin glargine, ivabradine hydrochloride; Lanthanum carbonate, lapatinib, LAS-34475, levetiracetam, liraglutide, lumiracoxib; Maxacalcitol, melagatran, micafungin sodium; Natalizumab, NSC-640488; Oblimersen sodium; Parecoxib sodium, PEG-filgrastim, peginterferon alfa-2(a), peginterferon alfa-2b, pexelizumab, pimecrolimus, pleconaril, pramlintide acetate, pregabalin, prucalopride; rAHF-PFM, Ranelic acid distrontium salt, ranolazine, rDNA insulin, recombinant human soluble thrombomodulin, rhGM-CSF, roxifiban acetate, RSD-1235, rubitecan, ruboxistaurin mesilate hydrate; SC-51, squalamine; Tegaserod maleate, telbivudine, tesaglitazar, testosterone gel, tezosentan disodium, tipranavir; Vatalanib succinate; Ximelagatran; Yttrium 90 (90Y) ibritumomab tiuxetan; Zoledronic acid monohydrate. PMID:14671684
Bayés, M; Rabasseda, X; Prous, J R
There is much neurological literature on clinical, pathological, technical aspects of diagnostic or therapeutic aspects, however there are few articles about clinical-neurological reasoning. This paper analyzes the psychological processes by which neurologists solve complicated diagnostic problems. Clinicians can use a variety of reasoning, such as model (pattern), exhaustive, probabilistic, deterministic (categorical), and hypothetical-deductive reasoning mechanisms. The neurologist must be aware of what kind of reasoning is being used at a given time as well as the errors that can occur. Most of these errors are found in the probabilistic setting and can be grouped into three categories: representativeness errors, availability or adjustment and anchoring biases. Most of them occur due to an inadequate intuitive judgement by the physician to handle the probabilities. There are other sources of error, related with the diagnostic process or with the environmental circumstances in which they develop. The most important ones as well as their theoretical and practical implications are described. In the evidence based medicine era, it is important for the clinical neurologists to be aware of this terminology and concepts for an adequate practice of neurology. PMID:15372335
Diaz Guzmán, J
Abstract Problem addressed The growing number of elderly patients with multiple chronic conditions presents an urgent challenge in primary care. Current practice models are not well suited to addressing the complex health care needs of this patient population. Objective of program The primary objective of the IMPACT (Interprofessional Model of Practice for Aging and Complex Treatments) clinic was to design and evaluate a new interprofessional model of care for community-dwelling seniors with complex health care needs. A secondary objective was to explore the potential of this new model as an interprofessional training opportunity. Program description The IMPACT clinic is an innovative new model of interprofessional primary care for elderly patients with complex health care needs. The comprehensive team comprises family physicians, a community nurse, a pharmacist, a physiotherapist, an occupational therapist, a dietitian, and a community social worker. The model is designed to accommodate trainees from each discipline. Patient appointments are 1.5 to 2 hours in length, during which time a diverse range of medical, functional, and psychosocial issues are investigated by the full interprofessional team. Conclusion The IMPACT model is congruent with ongoing policy initiatives in primary care reform and enhanced community-based care for seniors. The clinic has been pilot-tested in 1 family practice unit and modeled at 3 other sites with positive feedback from patients and families, clinicians, and trainees. Evaluation data indicate that interprofessional primary care models hold great promise for the growing challenge of managing complex chronic disease.
Tracy, C. Shawn; Bell, Stephanie H.; Nickell, Leslie A.; Charles, Jocelyn; Upshur, Ross E.G.
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies knowledge area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 2F5, 2G12, abetimus sodium, ABI-007, adalimumab, adefovir dipivoxil, AE-941, alefacept, altropane, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, aminopterin, anakinra, aprinocarsen sodium, atazanavir, atlizumab, atomoxetine hydrochloride; B7-1 vaccine, bevacizumab, biricodar dicitrate, BMS-188667, brasofensine sulfate, bryostatin 1; cantuzumab mertansine, CHS-828, cinacalcet hydrochloride, cipamfylline, creatine, CVT-3146; darbepoetin alfa, DITPA, drotrecogin alfa (activated), duloxetine hydrochloride; edatrexate, efalizumab, ENMD-0997, epoetin, erlosamide, esomeprazole magnesium, etiprednol dicloacetate, etoricoxib, everolimus, ezetimibe; fampridine, fenretinide, FTY-720; IGF-I/IGFBP-3, IL-1 cytokine trap, ilodecakin, interferon beta, ISIS-104838, ISIS-2503, ISIS-5132, ivabradine hydrochloride; lafutidine, lanthanum carbonate, l-Arginine hydrochloride, LEA29Y, lerdelimumab, levetiracetam, levobupivacaine hydrochloride, levosimendan, lopinavir; melagatran, mibefradil hydrochloride, miglustat, morphine-6-glucuronide; nesiritide; omalizumab, omapatrilat; p24-VLP, parecoxib sodium, peginterferon alfa-2a, peginterferon alfa-2b, pegsunercept, pitavastatin calcium, plevitrexed, prasterone, pregabalin, PRO-2000, prucalopride; rapacuronium bromide, rebimastat, RGA-0853, rubitecan, ruboxistaurin mesilate hydrate, RWJ-67657; S-16020-2, sarizotan, SLV-306, stiripentol; TA-CIN, tenecteplase, teriparatide, tezacitabine, tipifarnib, trabectedin, troglitazone; valdecoxib, vardenafil; Z-338, ziconotide. PMID:12808477
Bayes, M; Rabasseda, X; Prous, J R
This article provides an ethical critique of the Good Clinical Practice (GCP) and Declaration of Helsinki (DoH) documents. While the previous criticisms of GCP are entirely correct, there is much more wrong with the document than has previously been acknowledged, including a circular definition and an astonishing vagueness about ethical principles. In addition to its failure to provide adequate ethical protection of participants, the procedurally dense nature of GCP lends itself to a box-ticking culture where important ethical issues are overlooked because they are not 'mentioned on the form'. In contrast, the DoH is a much more effective ethical document, but actually goes too far in one respect. It transpires that the best ethical guidelines for clinical research would be neither over-prescriptive in regard to particular ethical issues (as the DoH is) nor neglectful of them (as GCP is); correctly framed ethical principles will provide sufficient protection to participants while also ensuring a culture of ethicovigilance in clinical trials. PMID:22506737
Shaw, David; McMahon, Alex
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abetimus sodium, adalimumab, alefacept, alemtuzumab, almotriptan, AMGN-0007, anakinra, anti-CTLA-4 Mab, L-arginine hydrochloride, arzoxifene hydrochloride, astemizole, atazanavir sulfate, atlizumab; Belimumab, BG-9928, binodenoson, bosentan, botulinum toxin type B, bovine lactoferrin, BufferGel; Caspofungin acetate, ciclesonide,cilomilast, ciluprevir, clofarabine, CVT-3146; Darbepoetin alfa, desloratadine, diflomotecan, doripenem, dronedarone hydrochloride, drotrecogin alfa (activated), DT388-GM-CSF, duloxetine hydrochloride, E-5564, efalizumab, enfuvirtide, esomeprazole magnesium, estradiol acetate, ETC-642, exenatide, exisulind, ezetimib; Febuxostat; Gallium maltolate, ganirelix acetate, garenoxacin mesilate, gefitinib; H11, HuMax; IL-15, IDD-1, IGIV-C, imatinib mesylate, ISIS-14803, ITF-1697, ivabradine hydrochloride; KRN-5500; L-365260, levetiracetam, levosimendan, licofelone, linezolid, LJP-1082, lopinavir lumiracoxib; MCC-478, melatonin, morphine hydrochloride, morphine-6-glucuronide, moxidectin; N-Acetylcarnosine, natalizumab, NM-702, NNC-05-1869, NSC-703940; Ocinaplon OM-89, omalizumab, omeprazole/ sodium bicarbonate, OPC-28326, ospemifene; PEG-filgrastim peginterferon alfa-2a, pegsunercept, pirfenidone, pralmorelin, pregabalin; Recombinant glucagon-like peptide-1 (7-36) amide, repifermin, RSD-1235; S-8184, selodenoson, sodium dichloroacetate, suberanilohydroxamic acid; TAS-102, terfenadine, teriparatide, tipranavir troxacitabine; Ximelagatran; YM-337. PMID:14735233
Bayés, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies knowledge area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abacavir sulfate, abciximab, acetylcysteine, adefovir dipivoxil, alfuzosin hydrochloride, aliskiren fumarate, alosetron hydrochloride, amlodipine besilate, apomorphine hydrochloride, atazanavir, atorvastatin, atorvastatin calcium, atrasentan; Basiliximab, beraprost sodium, bevacizumab, bivalirudin, botulinum toxin type A, botulinum toxin type B; Celecoxib, cetuximab, cilansetron, cilomilast; Daclizumab, darbepoetin alfa, docetaxel, duloxetine hydrochloride; Efalizumab, efavirenz, eletriptan,, entecavir, eplerenone, epoetin alfa, eptifibatide, esomeprazole magnesium. ezetimibe; Filgrastim, finasteride, fluvastatin sodium, follitropin alfa; Gemcitabine, gemeprost, ghrelin (human); HE-2000; Infliximab, 111In-Pentetreotide, interferon alfa-2 alpha, interferon alfa-2 beta, interferon beta-1 alpha, irbesartan, irinotecan hydrochloride; Ketamine hydrochloride; L-778123, lafutidine, lamivudine, lamivudine/zidovudine, latanoprost, letrozole, licofelone, lopinavir, losartan potassium, loxiglumide, lubeluzole; Magnesium sulfate, MeGLA, meloxicam, mycophenolate mofetil; NBI-6024, nelfinavir mesilate, nesiritide, nevirapine, niacin, NN-2211; Octreotide, orlistat; PC-515, peginterferon alfa-2 alpha, peginterferon alfa-2b, pemetrexed disodium, pibrozelesin hydrochloride, pimagedine, pirfenidone, pitavastatin calcium, premarin/trimegestone, prucalopride; Rabeprazole sodium; reboxetine, risedronate sodium, ritonavir, rituximab, rofecoxib, roflumilast, rosuvastatin calcium; Sertraline, sibutramine hydrochloride monohydrate, sildenafil citrate, spironolactone, stavudine; Tacrolimus, tadalafil, tamsulosin hydrochloride, tenecteplase, thalidomide, travoprost; Valsartan; Zoledronic acid monohydrate. PMID:12500432
Bayés, M; Rabasseda, X; Prous, J R
Despite being the most significant consumers of health care resources and medications worldwide, recent international research has highlighted the under-representation of older participants from clinical trials. This creates problems for physicians as the patients seen in clinical practice are not representative of those on which medical treatments and interventions have been trialled, and we need to consider whether results (both negative and positive) from these trials are applicable to these patients. Our aim was to gauge whether exclusion of older people was prevalent in research proposals submitted to Dublin teaching hospitals. We audited all clinical research proposals submitted to the Research Ethics committee (REC) covering the teaching hospitals attached to Trinity College Dublin (TCD) from July 2008 to July 2011 inclusive, recording exclusion of patients based on an arbitrary upper age limit. Of the 226 relevant trials studied, 31(13.7%) excluded participants based solely on an arbitrary upper age limit. 22 (9.8%) of the relevant trials were submitted by geriatricians, none of which excluded patients based solely on age. Over 50% (12 of 22) trials submitted by neurology/psychiatry excluded patients based on an upper age limit. The mean upper age limit used over all trials as a cut-off was 69.2 years of age. As well as this, the majority of the remaining trials also contained other exclusion criteria, especially those based on cognitive function which further limited participation of older people. While we found that a significant proportion of clinical trials submitted to the TCD REC still excluded patients based arbitrarily on an upper age limit, participation rates of older people seem to be higher in this Irish centre than that seen in international trials. Significant room for improvement still remains however and there needs to be a promotion of greater awareness of the need for developing, testing and licensing medicines so that it mirrors the consumer groups in which they will be used. Increased input from geriatricians around the testing and licensing of medicines, and in licensing agencies, would greatly help in this regard. It is both unhelpful for optimal healthcare as well as fundamentally unjust to exclude participants from clinical research based solely on an arbitrary age limit. PMID:23240288
Briggs, R; Robinson, S; O'Neill, D
Text Version... Public Health Service Brief Summary of the Clinical Chemistry and Clinical Toxicology Devices Panel Meeting – April 25, 2013 Introduction: ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity. prous.com. This issue focuses on the following selection of drugs: ABX-IL-8, Acclaim, adalimumab, AGI-1067, alagebrium chloride, alemtuzumab, Alequel, Androgel, anti-IL-12 MAb, AOD-9604, aripiprazole, atomoxetine hydrochloride; Biphasic insulin aspart, bosentan, botulinum toxin type B, bovine lactoferrin, brivudine; Cantuzumab mertansine, CB-1954, CDB-4124, CEA-TRICOM, choriogonadotropin alfa, cilansetron, CpG-10101, CpG-7909, CTL-102, CTL-102/CB-1954; DAC:GRF, darbepoetin alfa, davanat-1, decitabine, del-1 Genemedicine, dexanabinol, dextofisopam, dnaJP1, dronedarone hydrochloride, dutasteride; Ecogramostim, eletriptan, emtricitabine, EPI-hNE-4, eplerenone, eplivanserin fumarate, erlotinib hydrochloride, ertapenem sodium, escitalopram oxalate, esomeprazole magnesium, etoricoxib, ezetimibe; Falecalcitriol, fingolimod hydrochloride; Gepirone hydrochloride; HBV-ISS, HSV-2 theracine, human insulin; Imatinib mesylate, Indiplon, insulin glargine, ISAtx-247; L612 HuMAb, levodopa/carbidopa/entacapone, lidocaine/prilocaine, LL-2113AD, lucinactant, LY-156735; Meclinertant, metelimumab, morphine hydrochloride, morphine-6-glucuronide; Natalizumab, nimotuzumab, NX-1207, NYVAC-HIV C; Omalizumab, onercept, osanetant; PABA, palosuran sulfate, parathyroid hormone (human recombinant), parecoxib sodium, PBI-1402, PCK-3145, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pemetrexed disodium, pimecrolimus, PINC, pregabalin; Ramelteon, rasagiline mesilate, rasburicase, rimonabant hydrochloride, RO-0098557, rofecoxib, rosiglitazone maleate/metformin hydrochloride; Safinamide mesilate, SHL-749, sitaxsentan sodium, sparfosic acid, SprayGel, squalamine, St. John's Wort extract, synthetic human secretin; Taxus, telavancin hydrochloride, telithromycin, temoporfin, tenofovir disoproxil fumarate, tenofovir disoproxil fumarate/emtricitabine, teriparatide, testosterone gel, TG-1024, tirapazamine, travoprost, travoprost/timolol; Valdecoxib, valganciclovir hydrochloride, voriconazole; Ximelagatran. PMID:15834452
Bayés, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 101M, 166Ho-DOTMP, 3-AP; Abatacept, abetimus sodium, ACR-16, adefovir dipivoxil, alefacept, AMD-070, aminolevulinic acid hexyl ester, anatumomab mafenatox, anti-CTLA-4 MAb, antigastrin therapeutic vaccine, AP-12009, AP-23573, APC-8024, aripiprazole, ATL-962, atomoxetine hydrochloride; Bevacizumab, bimatoprost, bortezomib, bosentan, BR-1; Calcipotriol/betamethasone dipropionate, cinacalcet hydrochloride, clofazimine, colchicine, cold-adapted influenza vaccine trivalent, CRM197; Desloratadine, desoxyepothilone B, diethylhomospermine; Edodekin alfa, efalizumab, elcometrine, eletriptan, enfuvirtide, entecavir, EP-2101, eplerenone, erlotinib hydrochloride, etoricoxib, everolimus, exherin, ezetimibe; Febuxostat, fluorescein lisicol, fosamprenavir calcium, frovatriptan; Hemoglobin raffimer, HSPPC-96, human insulin; Imatinib mesylate, insulin detemir, insulin glargine, IRX-2, istradefylline, IV gamma-globulin, ixabepilone; Kahalalide F; L-759274, levodopa/carbidopa/entacapone, licofelone, lonafarnib, lopinavir, lurtotecan, LY-156735; MAb G250, mecasermin, melatonin, midostaurin, muraglitazar; Nesiritide, nitronaproxen; O6-Benzylguanine, olmesartan medoxomil, olmesartan medoxomil/hydrochlorothiazide, omapatrilat, oral insulin; Parecoxib sodium, PCK-3145, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ ribavirin, pemetrexed disodium, peptide YY3-36, PG-CPT, phenoxodiol, pimecrolimus, posaconazole; Rasagiline mesilate, rDNA insulin, RG228, rimonabant hydrochloride, rosuvastatin calcium, rotigotine hydrochloride; S-3304, safinamide mesilate, salcaprozic acid sodium salt, SDZ-SID-791, SGN-30, soblidotin, squalamine; Telmisartan/hydrochlorothiazide, testosterone gel, TF(c)-KLH conjugate vaccine, TH-9507, theraloc, tipifarnib, tocilizumab, travoprost; ValboroPro, valdecoxib, veglin, voriconazole; Ximelagatran. PMID:15538546
Bayes, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abiraterone acetate, Ad5CMV-p53, adefovir dipivoxil, AE-941, ambrisentan, aripiprazole, atomoxetine hydrochloride, atrasentan; BCH-10618, bimatoprost, BMS-184476, BMS-275183, BMS-387032, botulinum toxin type B, BR-1, BR96-Doxorubicin; Capravirine, caspofungin acetate, cinacalcet hydrochloride; Darbepoetin alfa, desloratadine, dextrin sulfate, DJ-927, duloxetine hydrochloride; Elacridar, emtricitabine, eplerenone, ertapenem sodium, escitalopram oxalate, ESP-24217, etoricoxib, exenatide, ezetimibe; Ferumoxtran-10, fondaparinux sodium, fosamprenavir calcium; GS-7904L, GW-5634; HMN-214, human insulin; IC-14, imatinib mesylate, indiplon, insulin glargine, insulinotropin, iseganan hydrochloride; Lanthanum carbonate, L-Arginine hydrochloride, LEA29Y, lenalidomide, LE-SN38, lestaurtinib, L-MDAM, lometrexol, lopinavir, lopinavir/ritonavir; Magnesium sulfate, maraviroc, mepolizumab, metreleptin, milataxel, MNA-715, morphine hydrochloride; Nesiritide, neutrophil-inhibitory factor, NK-911; Olanzapine/fluoxetine hydrochloride, olmesartan medoxomil, omalizumab, ortataxel, oxycodone hydrochloride/ibuprofen; Panitumumab, patupilone, PC-515, PD-MAGE-3 Vaccine, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ ribavirin, pemetrexed disodium, pimecrolimus, prasugrel, pregabalin, PRO-2000; Rosuvastatin calcium, RPR-113090; sabarubicin hydrochloride, safinamide mesilate, SB-715992, sitaxsentan sodium, soblidotin, synthadotin; Tadalafil, taltobulin, temsirolimus, tenofovir disoproxil fumarate, tenofovir disoproxil fumarate/emtricitabine, testosterone gel, tigecycline, tipranavir, tirapazamine, trabectedin, travoprost; UCN-01; Vardenafil hydrochloride hydrate; XB-947; Yttrium 90 (90Y) ibritumomab tiuxetan. PMID:15605126
Bayés, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abarelix, ABX-EGF, ademetionine, agomelatine, AMGN-0007, 9-aminocamptothecin, AN-9, anecortave acetate, anidulafungin, AOD-9604, apolizumab, apomate, L-arginine hydrochloride, arzoxifene hydrochloride; Bevacizumab, BP-897, BufferGel; Capravirine, carboxyamidotriazole, carnosine, CC-4047, CEP-701, cerivastatin sodium, clofarabine, conivaptan hydrochloride, CP-461, CS-003; Daptomycin, darifenacin, decitabine, deferasirox, duloxetine hydrochloride; Eberconazole, Ecyd, efalizumab, eglumegad hydrate, EMD-72000, (-)-epigallocatechin gallate, exatecan mesilate, exenatide; Fampridine, fenretinide, ferumoxtran-10; Gadofosveset sodium, garenoxacin mesilate, genistein, glutamine, GPI-15715; Hexyl insulin M2, human insulin, HYB-165; Indisulam, irofulven; KRN-5500, L-796568, laurocapram, lidocaine/prilocaine, lonafarnib, lotrafiban; Melagatran, melatonin, 2-methoxyestradiol, metreleptin, motexafin gadoliniu, motexafin lutetium; Natalizumab, nelarabine, NO-aspirin, NSC-683864; ONO-6126; Pemetrexed disodium, pexelizumab, pirfenidone, PncCRM9, polyglutamate paclitaxel, pramlintide acetate pregabalin, PRO-2000; Ragaglitazar, ramelteon, rasagiline mesilate, rDNA insulin, recombinant glucagon-like peptide-1 (7-36) amide, recombinant human parathyroid hormone (1-84), reolysin RG228, roflumilast, roxifiban acetate, RPI-4610, rubitecan; Safinamide mesilate, solifenacin succinate, SRL-172; T-138067, tafenoquine succinate, tecadenoson, TER-286, tesaglitazar, tetrathiomolybdate, tezosentan disodium, TheraCIM, tigecycline, tipifarnib, tolvaptan, trabectedin, tributyrin, trimegestone, troxacitabine; UCN-01, urokinase alfa; Vinflunine, viscum fraxini 2; Xcellerated T cells, ximelagatran. PMID:14685303
Bayes, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Thomson Reuters Integrity(SM), the drug discovery and development portal, http://www.thomsonreutersintegrity.com. This issue focuses on the following selection of drugs: Abatacept, Adalimumab, AdCD40L, Adefovir, Aleglitazar, Aliskiren fumarate, AM-103, Aminolevulinic acid methyl ester, Amlodipine, Anakinra, Aprepitant, Aripiprazole, Atazanavir sulfate, Axitinib; Belimumab, Bevacizumab, Bimatoprost, Bortezomib, Bupropion/naltrexone; Calcipotriol/betamethasone dipropionate, Certolizumab pegol, Ciclesonide, CYT-997; Darbepoetin alfa, Darunavir, Dasatinib, Desvenlafaxine succinate, Dexmethylphenidate hydrochloride cogramostim; Eltrombopag olamine, Emtricitabine, Escitalopram oxalate, Eslicarbazepine acetate, Eszopiclone, Etravirine, Everolimus-eluting coronary stent, Exenatide, Ezetimibe; Fenretinide, Filibuvir, Fludarabine; Golimumab; Hepatitis B hyperimmunoglobulin, HEV-239, HP-802-247, HPV-16/18 AS04, HPV-6/11/16/18, Human albumin, Human gammaglobulin; Imatinib mesylate, Inotuzumab ozogamicin, Invaplex 50 vaccine; Lapatinib ditosylate, Lenalidomide, Liposomal doxorubicin, Lopinavir, Lumiliximab, LY-686017; Maraviroc, Mecasermin rinfabate; Narlaprevir; Ocrelizumab, Oral insulin, Oritavancin, Oxycodone hydrochloride/naloxone; Paclitaxel-eluting stent, Palonosetron hydrochloride, PAN-811, Paroxetine, Pazopanib hydrochloride, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Pitavastatin calcium, Posaconazole, Pregabalin, Prucalopride succinate; Raltegravir potassium, Ranibizumab, RHAMM R3 peptide, Rosuvastatin calcium; Salclobuzic acid sodium salt, SCY-635, Selenate sodium, Semapimod hydrochloride, Silodosin, Siltuximab, Silybin, Sirolimus-eluting stent, SIR-Spheres, Sunitinib malate; Tapentadol hydrochloride, Tenofovir disoproxil fumarate, Tocilizumab, Tositumomab/iodine (I131) tositumomab, Trabectedin, TransVax™ hepatitis C vaccine; Ustekinumab; V-260, Valspodar, Varenicline tartrate, VCL-IPT1, Vildagliptin, VRC-HIVADV014-00-VP, VRC-HIVDNA009-00-VP, VRC-HIVDNA016-00-VP; Yttrium 90 (90Y) ibritumomab tiuxetan, Yttrium Y90 Epratuzumab; Zibotentan, Zotarolimus-eluting stent. PMID:21225019
Tomillero, A; Moral, M A
Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: ABT-510, adalimumab, alefacept, ambrisentan, aminolevulinic acid methyl ester, armodafinil, aselizumab, asenapine maleate, azelnidipine; Bevacizumab, bexarotene, bimosiamose, biphasic insulin aspart, bortezomib, bosentan, BQ-123; C340, cannabidiol, caspofungin acetate, CC-4047, certolizumab pegol, cetuximab, ciclesonide, cilansetron, Cypher; Dabigatran etexilate, darbepoetin alfa, darifenacin hydrobromide, desloratadine, dexosome vaccine (melanoma), dimethyl fumarate, dronabinol/cannabidiol, drospirenone, drospirenone/estradiol, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Efalizumab, eglumetad hydrate, emoxipin hydrochloride, eplerenone, erlotinib hydrochloride, escitalopram oxalate, etonogestrel/ethinylestradiol; Garenoxacin mesilate, gamma-hydroxybutyrate sodium, gefitinib; H5N1 pandemic influenza vaccine, human growth hormone-(177-191), human insulin; Indacaterol, INKP-100, INKP-102, insulin glargine, i.v. gamma-globulin; KLH; Lapatinib, L-arginine hydrochloride, lasofoxifene tartrate, levocetirizine, licochalcone A, LMI vaccine, lomefloxacin, lubiprostone, lumiracoxib; Miglustat, mycograb; Natalizumab, NCX-4016, nortopixantrone hydrochloride; Olmesartan medoxomil, omalizumab, oral insulin, OrM3; Parathyroid hormone (human recombinant), parecoxib sodium, PCK-3145, PEG-filgrastim, peginterferon alfa-2a, pemetrexed disodium, pexelizumab, photochlor, pimecrolimus, pneumococcal 7-valent conjugate vaccine, polyphenon E; R-126638, R-411, resveratrol, roflumilast, RS-86, ruboxistaurin mesilate hydrate, rupatadine fumarate; Sipuleucel-T, somatropin, St. John's Wort extract; Tadalafil, Taxus, telbivudine, telithromycin, temsirolimus, teriparatide, teverelix, tigecycline, tiotropium bromide, tolterodine, tolvaptan, treprostinil sodium, typhoid vaccine; Vardenafil hydrochloride hydrate, vildagliptin, voriconazole; Ximelagatran; Zanolimumab, zileuton. PMID:16541195
Bayés, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com This issue focuses on the following selection of drugs: A-007, A6, adalimumab, adenosine triphosphate, alefacept, alemtuzumab, AllerVax Ragweed, amphora, anakinra, angiotensin-(1-7), anidulafungin, apomine, aripiprazole, atomoxetine hydrochloride, avanafil; BAL-8557, becatecarin, bevacizumab, biphasic insulin aspart, BMS-188797, bortezomib, bosentan, botulinum toxin type B, brivudine; Calcipotriol/betamethasone dipropionate, caspofungin acetate, catumaxomab, certolizumab pegol, cetuximab, CG-0070, ciclesonide, cinacalcet hydrochloride, clindamycin phosphate/benzoyl peroxide, cryptophycin 52, Cypher; Dabigatran etexilate, darapladib, darbepoetin alfa, decitabine, deferasirox, desloratadine, dexanabinol, dextromethorphan/quinidine sulfate, DMF, drotrecogin alfa (activated), duloxetine hydrochloride; E-7010, edaravone, efalizumab, emtricitabine, entecavir, eplerenone, erlotinib hydrochloride, escitalopram oxalate, estradiol valerate/dienogest, eszopiclone, exenatide, ezetimibe; Fondaparinux sodium, fulvestrant; Gefitinib, gestodene, GYKI-16084; Hyaluronic acid, hydralazine hydrochloride/isosorbide dinitrate; Imatinib mesylate, indiplon, insulin glargine; Juzen-taiho-to; Lamivudine/zidovudine/abacavir sulfate, L-arginine hydrochloride, lasofoxifene tartrate, L-BLP-25, lenalidomide, levocetirizine, levodopa/carbidopa/entacapone, lexatumumab, lidocaine/prilocaine, lubiprostone, lumiracoxib; MAb-14.18, mitoquidone; Natalizumab, neridronic acid, neuradiab; Olpadronic acid sodium salt, omalizumab; p53-DC vaccine, parathyroid hormone (human recombinant), peginterferon alfa-2a, peginterferon alfa-2b, pemetrexed disodium, perifosine, pimecrolimus, prasterone, prasugrel, PRO-2000, Pseudostat; R24, rasburicase, RHAMM R3 peptide, rilonacept, rosuvastatin calcium, rotavirus vaccine, rufinamide; Sabarubicin hydrochloride, SHL-749, sirolimus-eluting stent, SLx-2101, sodium butyrate, sorafenib, SU-6668; TachoSil, tadalafil, taxus, tegaserod maleate, telbivudine, tenofovir disoproxil fumarate, teriparatide, tetramethylpyrazine, teverelix, tiotropium bromide, tipifarnib, tirapazamine, tolvaptan, TransvaxTM hepatitis C vaccine, treprostinil sodium; Valganciclovir hydrochloride, valsartan/amlodipine, vandetanib, vardenafil hydrochloride hydrate, vatalanib succinate, veglin, voriconazole; Yttrium 90 (90Y) ibritumomab tiuxetan; Zileuton, zotarolimus, zotarolimus-eluting stent. PMID:17003851
Bayes, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Intergrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 249553, 2-Methoxyestradiol; Abatacept, Adalimumab, Adefovir dipivoxil, Agalsidase beta, Albinterferon alfa-2b, Aliskiren fumarate, Alovudine, Amdoxovir, Amlodipine besylate/atorvastatin calcium, Amrubicin hydrochloride, Anakinra, AQ-13, Aripiprazole, AS-1404, Asoprisnil, Atacicept, Atrasentan; Belimumab, Bevacizumab, Bortezomib, Bosentan, Botulinum toxin type B, Brivaracetam; Catumaxomab, Cediranib, Cetuximab, cG250, Ciclesonide, Cinacalcet hydrochloride, Curcumin, Cypher; Darbepoetin alfa, Denosumab, Dihydrexidine; Eicosapentaenoic acid/docosahexaenoic acid, Entecavir, Erlotinib hydrochloride, Escitalopram oxalate, Etoricoxib, Everolimus, Ezetimibe; Febuxostat, Fenspiride hydrochloride, Fondaparinux sodium; Gefitinib, Ghrelin (human), GSK-1562902A; HSV-tk/GCV; Iclaprim, Imatinib mesylate, Imexon, Indacaterol, Insulinotropin, ISIS-112989; L-Alanosine, Lapatinib ditosylate, Laropiprant; Methoxy polyethylene glycol-epoetin-beta, Mipomersen sodium, Motexafin gadolinium; Natalizumab, Nimotuzumab; OSC, Ozarelix; PACAP-38, Paclitaxel nanoparticles, Parathyroid Hormone-Related Protein-(1-36), Pasireotide, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Picoplatin, Pimecrolimus, Pitavastatin calcium, Plitidepsin; Ranelic acid distrontium salt, Ranolazine, Recombinant human relaxin H2, Regadenoson, RFB4(dsFv)-PE38, RO-3300074, Rosuvastatin calcium; SIR-Spheres, Solifenacin succinate, Sorafenib, Sunitinib malate; Tadalafil, Talabostat, Taribavirin hydrochloride, Taxus, Temsirolimus, Teriparatide, Tiotropium bromide, Tipifarnib, Tirapazamine, Tocilizumab; UCN-01, Ularitide, Uracil, Ustekinumab; V-260, Vandetanib, Vatalanib succinate, Vernakalant hydrochloride, Vorinostat; YM-155; Zileuton, Zoledronic acid monohydrate. PMID:18200333
Bayés, M; Rabasseda, X; Prous, J R
Neuroferritinopathy is an autosomal dominant basal ganglia disease with iron accumulation caused by a mutation of the gene encoding ferritin light polypeptide (FTL). Six pathogenic mutations in the FTL gene have so far been reported. One such mutation was found in a Japanese family, thus suggesting that a new mutation in the FTL gene can therefore occur anywhere in the world. The typical clinical features of neuroferritinopathy are dystonia (especially orofacial dystonia related to speech and leading to dysarthrophonia) and involuntary movement, but such features vary greatly among the affected individuals. The findings of excess iron storage and cystic changes involving the globus pallidus and the putamen on brain MRI. and low serum ferritin levels are characteristic in neuroferritinopathy. Brain histochemistry shows abnormal aggregates of ferritin and iron throughout the central nervous system. Iron atoms are stored in the central cavity of the ferritin polymer and the E-helices of ferritin play an important role in maintaining the central cavity. A mutation in exon 4 of the FTL gene is known to alter the structure of E-helices, thereby leading to the release of free iron and excessive oxidative stress. Iron depletion therapy by iron chelation in symptomatic patients has not been shown to be beneficial, however before the nset of clinical symptoms, such a treatment strategy may still have some benefit. Neuroferritinopathy should therefore be considered in all patients presenting with basal ganglia disorders of unknown origin. These characteristic MRI findings may help to differentiate neuroferritinopathy from other diseases showing similar clinical features. PMID:19594102
Ohta, Emiko; Nagasaka, Takamura; Shindo, Kazumasa; Toma, Shinobu; Nagasaka, Kaori; Miwa, Michiaki; Takiyama, Yoshihisa; Shiozawa, Zenji
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies Knowledge Area of Prous Science Integrity(R), the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Activated protein C concentrate, Ad-CD154, Adeno-Interferon gamma, alemtuzumab, APC-8024, 9-aminocamptothecin, aprepitant, l-arginine hydrochloride, aripiprazole, arsenic trioxide, asimadoline; O6-Benzylguanine, bevacizumab, Bi-20, binodenoson, biphasic insulin aspart, bivatuzumab, 186Re-bivatuzumab, BMS-181176, bosentan, botulinum toxin type B, BQ-123, bryostatin 1; Carboxy- amidotriazole, caspofungin acetate, CB-1954, CC-4047, CDP-860, cerivastatin sodium, clevidipine, CTL-102; 3,4-DAP, darbepoetin alfa, decitabine, desloratadine, DHA-paclitaxel, duloxetine hydrochloride; Efalizumab, EGF vaccine, eletriptan, eniluracil, ENMD-0997, eplerenone, eplivanserin, erlosamide, ertapenem sodium, escitalopram oxalate, esomeprazole magnesium, eszopiclone, everolimus, exatecan mesilate, exenatide, ezetimibe; Fondaparinux sodium, FR-901228, FTY-720; Gefitinib, gemtuzumab ozogamicin, gepirone hydrochloride; Hexyl insulin M2, human insulin; Imatinib mesylate, insulin detemir, insulin glargine, iodine (I131) tositumomab, ISV-205, ivabradine hydrochloride, ixabepilone; Levetiracetam, levocetirizine, linezolid, liposomal NDDP, lonafarnib, lopinavir, LY-156735; Mafosfamide cyclohexylamine salt, magnesium sulfate, maxacalcitol, meclinertant, melagatran, melatonin, MENT, mepolizumab, micafungin sodium, midostaurin, motexafin gadolinium; Nesiritide, NS-1209, NSC-601316, NSC-683864; Osanetant; Palonosetron hydrochloride, parecoxib sodium, pegaptanib sodium, peginterferon alfa-2a, peginterferon alfa-2b, pegylated OB protein, pemetrexed disodium, perillyl alcohol, picoplatin, pimecrolimus, pixantrone maleate, plevitrexed, polyglutamate paclitaxel, posurdex, pramlintide acetate, prasterone, pregabalin; Rasburicase, rimonabant hydrochloride, rostaporfin, rosuvastatin calcium; SDZ-SID-791, sibrotuzumab, sorafenib, SU-11248; Tadalafil, targinine, tegaserod maleate, telithromycin, TheraCIM, tigecycline, tiotropium bromide, tipifarnib, tirapazamine, treprostinil sodium; Valdecoxib, Valganciclovir hydrochloride, Vardenafil hydrochloride hydrate; Ximelagatran; Zofenopril calcium, Zoledronic acid monohydrate. PMID:15071612
Bayés, M; Rabasseda, X; Prous, J R
The renewal of the philosophical debate in psychiatry is one exciting news of recent years. However, its use in psychopharmacology may be problematic, ranging from self-confinement into the realm of values (which leaves the evidence-based domain unchallenged) to complete rejection of scientific evidence. In this paper philosophy is conceived as a conceptual audit of clinical psychopharmacology. Its function is to criticise the epistemological and methodological problems of current neopositivist, ingenuously realist and evidence-servant psychiatry from within the scientific stance and with the aim of aiding psychopharmacologists in practicing a more self-aware, critical and possibly useful clinical practice. Three examples are discussed to suggest that psychopharmacological practice needs conceptual clarification. At the diagnostic level it is shown that the crisis of the current diagnostic system and the problem of comorbidity strongly influence psychopharmacological results, new conceptualizations more respondent to the psychopharmacological requirements being needed. Heterogeneity of research samples, lack of specificity of psychotropic drugs, difficult generalizability of results, need of a phenomenological study of drug-induced psychopathological changes are discussed herein. At the methodological level the merits and limits of evidence-based practice are considered, arguing that clinicians should know the best available evidence but that guidelines should not be constrictive (due to several methodological biases and rhetorical tricks of which the clinician should be aware, sometimes respondent to extra-scientific, economical requests). At the epistemological level it is shown that the clinical stance is shaped by implicit philosophical beliefs about the mind/body problem (reductionism, dualism, interactionism, pragmatism), and that philosophy can aid physicians to be more aware of their beliefs in order to choose the most useful view and to practice coherently. In conclusion, psychopharmacologists already use methodological audit (e.g. statistical audit); similarly, conceptual clarification is needed in both research planning/evaluation and everyday psychopharmacological practice. PMID:23470600
Monotherapy of epilepsy is usually preferable to polytherapy for a variety of reasons. However, investigational or newer antiepileptic drugs (AEDs) are typically evaluated as add-on therapy in patients with refractory seizures. Because coadministered drugs are subject to drug interactions, add-on trials of AEDs do not necessarily address the utility of a new AED as monotherapy or its use in patients with newly diagnosed epilepsy, in whom monotherapy is usually sufficient. Monotherapy clinical trials are difficult to design because randomizing epilepsy patients to placebo or pseudoplacebo is considered unethical, and results from active-drug noninferiority designs are difficult to interpret. Active-drug superiority designs have been developed in an attempt to provide useful information about the monotherapeutic efficacy of new AEDs. The conversion to monotherapy trial design, introduced in the late 1970s, provides for initial add-on of an investigational agent to a preexisting drug in patients with uncontrolled seizures, followed by gradual discontinuation of the preexisting treatment and an eventual monotherapy phase of the investigational agent. Conversion to monotherapy trials are typically of short duration and have been criticized for failing to provide adequate time for titration to optimal dose, an inability to examine tolerance development or long-term safety, and possibly placing enrolled patients at increased risk for morbidity, but they have been used to obtain data about monotherapy efficacy sufficient for regulatory authority approval. Relevant clinical trial data are needed to guide treatment choices in patients who have failed previous monotherapy. To date, large-scale prospective trials comparing monotherapy with old and new AEDs have not shown superior efficacy of the new AEDs but have demonstrated their better tolerability and safety. It is hoped that use of appropriately designed monotherapy clinical trials will help to identify a new generation of AEDs in the future for monotherapy in epilepsy patients. PMID:18071154
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Know- ledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: ABI-007, Ad.Egr.TNF.11D, adefovir dipivoxil, AdPEDF.11, AES-14, albumex, alefacept, alemtuzumab, aliskiren fumarate, alvimopan hydrate, aAminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, anakinra, anti-IL-12 MAb, aprepitant, atazanavir sulfate, atrasentan, avanafil; Banoxantrone, BG-12, bimatoprost, bortezomib, bosentan; Calcipotriol/betamethasone dipropionate, caspofungin acetate, CBT-1, ciclesonide, clofarabine, conivaptan hydrochloride, CpG-7909, C-Vax, Cypher; DA-8159, DAC:GLP-1, darbepoetin alfa, darifenacin, duloxetine hydrochloride; Eculizumab, efalizumab, efaproxiral sodium, EGF vaccine, eletriptan, epratuzumab, erlotinib hydrochloride, escitalopram oxalate, ETC-642, etoricoxib, everolimus, exenatide; Gefitinib, IV gamma-globulin; Human insulin, gamma-hydroxybutyrate sodium; IDN-6556, iguratimod, imatinib mesylate, indiplon, ixabepilone; Laquinimod, LB-80380, lidocaine/prilocaineliraglutide, lopinavir, lopinavir/ritonavir, lucinactant; MAb-14.18, melatonin, MLN-591-DM1; NC-531, neridronic acid, nesiritide, neutrophil-inhibitory factor, niacin/lovastatin; Oblimersen sodium, olcegepant, oral Insulin, ORV-105; Palonosetron hydrochloride, PAmAb, pegaptanib sodium, peginterferon alfa-2a, pegvisomant, perifosine, pexelizumab, phenoxodiol, phenserine tartrate, pimecrolimus, pramlintide acetate, pregabalin, PRO-542, prostate cancer vaccine, PT-141; Ramelteon, rasagiline mesilate, rDNA insulin, reslizumab, rh-Lactoferrin, ribamidine hydrochloride, rosuvastatin calcium; S-8184l, SC-1, sorafenib, St. John's Wort extract, SU-11248; Taxus, telbivudine, tenofovir disoproxil fumarate, teriparatide, testosterone gel, tezosentan disodium, tipifarnib, tolvaptan, trabectedin, travoprost, travoprost/timolol, treprostinil sodium; Vardenafil hydrochloride hydrate; Xcellerated T cells, XR-5944; Yttrium 90 (90Y) ibritumomab tiuxetan; Ziconotide. PMID:15349141
Bayes, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abetimus sodium, Ad5-FGF4, adeno-Interferon gamma, AE-941, AERx, alemtuzumab, alicaforsen sodium, almotriptan, alpharadin, anakinra, anatumomab mafenatox, ANG-453, anti-CTLA-4 Mab, AP-12009, aprepitant, aripiprazole, arsenic trioxide, astemizole, atlizumab, atomoxetine hydrochloride; Bevacizumab, BG-9928, BMS-188667, botulinum toxin type B, BufferGel; Caffeine, CDP-870, cetuximab, cilomilast, ciluprevir, clofarabine, continuous erythropoiesis receptor activator, CP-461; Darbepoetin alfa, deferasirox, desloratadine, desoxyepothilone B, diflomotecan, dolasetron, drotrecogin alfa (activated), duloxetine hydrochloride; ED-71, efalizumab, efaproxiral sodium, EKB-569, eletriptan, EMD-72000, enfuvirtide, erlotinib hydrochloride, escitalopram oxalate, etoricoxib; Fampridine, ferumoxytol, fondaparinux sodium; Gadofosveset sodium, gastrazole, gefitinib, gemtuzumab ozogamicin, gepirone hydrochloride glutamine; hLM609, HSPPC-96, human insulin; IDD-1, imatinib mesylate, indisulam, inhaled insulin, ixabepilone; Keratinocyte growth factor; Lapatinib, laquinimod, LDP-02, LE-SN38, levetiracetam, levosimendan, licofelone, liposomal doxorubicin, liposomal NDDP, lopinavir, lumiracoxib, LY-156735; Morphine hydrochloride, morphine-6-glucuronide, motexafin gadolinium, MS-27-275, MVA-5T4, MVA-Muc1-IL-2; Nemifitide ditriflutate, neridronic acid nitronaproxen, NSC-683864, NSC-703940, NVP-LAF-237; Oblimersen sodium, ocinaplon, oncomyc-NG, OPC-28326, ortataxel, ospemifene; Palonosetron hydrochloride, PEG-filgrastim peginterferon alfa-2(a), peginterferon alfa-2b, pegsunercept, pemetrexed disodium, pregabalin, prilocaine, pyridoxamine; RDP-58, recombinant glucagon-like peptide-1 (7-36) amide, recombinant human ApoA-I milano/phospholipid complex; SB-715992, soblidotin, sodium dichloroacetate, St. John's Wort extract; TAS-102, terfenadine, TG-1024, TG-5001, 4'-Thio-ara-C, tipranavir, topixantrone hydrochloride, trabectedin, transdermal selegiline, trimethoprim, troxacitabine, TT-232; Vatalanib succinate, vinflunine; Ximelagatran; Ziprasidone hydrochloride, Zoledronic acid monohydrate. PMID:14988742
Bayés, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: AAV1/SERCA2a, Abacavir sulfate/lamivudine, Adalimumab, Aliskiren fumarate, Ambrisentan, Aripiprazole, AT-7519, Atazanavir sulfate, Atomoxetine hydrochloride, Azacitidine, Azelnidipine; Besifloxacin hydrochloride, Bevacizumab, Bioabsorbable everolimus-eluting coronary stent, Bortezomib, Bosentan, Budesonide/formoterol fumarate; CAIV-T, Carisbamate, Casopitant mesylate, Certolizumab pegol, Cetuximab, Ciclesonide, Ciprofloxacin/dexamethasone, CTCE-9908; Dalcetrapib, Darunavir, Deferasirox, Desloratadine, Disitertide, Drotrecogin alfa (activated), DTA-H19, Duloxetine hydrochloride, Dutasteride; Ecogramostim, Efalizumab, Emtricitabine, Eribulin mesilate, Escitalopram oxalate, Eszopiclone, EUR-1008, Everolimus-eluting coronary stent, Exenatide; Fampridine, Fluticasone furoate, Formoterol fumarate/fluticasone propionate, Fosamprenavir calcium, Fulvestrant; Gabapentin enacarbil, GS-7904L; HPV-6/11/16/18, Human Secretin, Hydralazine hydrochloride/isosorbide dinitrate; Imatinib mesylate, Imexon, Inalimarev/Falimarev, Indacaterol, Indacaterol maleate, Inhalable human insulin, Insulin detemir, Insulin glargine, Ixabepilone; L-Alanosine, Lapatinib ditosylate, Lenalidomide, Levocetirizine dihydrochloride, Liraglutide, Lisdexamfetamine mesilate, Lopinavir, Loratadine/montelukast sodium, Lutropin alfa; MeNZB, Mepolizumab, Micafungin sodium, Morphine hydrochloride; Nabiximols, Nikkomycin Z; Olmesartan medoxomil, Omalizumab; Paclitaxel-eluting stent, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Perifosine, PF-489791, Plitidepsin, Posaconazole, Pregabalin; QAX-576; Raltegravir potassium, Ramelteon, Rasagiline mesilate, Recombinant human relaxin H2, rhGAD65, Rivaroxaban, Rosuvastatin calcium, Rotigotine; Saxagliptin, SCH-530348, Sirolimus-eluting stent, SLIT-amikacin, Sorafenib, Sotrastaurin, SR-16234, Sulforaphane; Tadalafil, Tanespimycin, Tapentadol hydrochloride, Teriparatide, Tesofensine, Tiotropium bromide, Tipifarnib, Tirapazamine, TMC-207, Tocilizumab, Tolvaptan, Tosedostat, Treprostinil sodium; Ustekinumab; Varespladib methyl, Vicriviroc, Vildagliptin, Vildagliptin/metformin hydrochloride, Volociximab, Voriconazole; Ziconotide, Ziprasidone hydrochloride. PMID:19907722
Tomillero, A; Moral, M A
Because the symptom of fatigue is often vague, clinical evaluation requires the consideration of distinct features such as timing, precipitants, presence of libido, sleep quality, exercise capacity, and sedation. Fatigue has dimensions of affect and tolerability. In chronic illness, it is helpful to consider mood, physical conditioning, course of predictable treatment consequences, postural hypotension, and the well-being of caretakers. The differential diagnosis of acute and chronic fatigue is considered. Chronic fatigue of unknown etiology is placed in historical context, and an approach to the complexities of providing continuing evaluation and care is discussed.
Greenberg, Donna B.
Dyslexia is characterized by a severe, persistent reading disorder occurring in an intelligent child. In the large field of learning disabilities, dyslexia is related to a cerebral dysfunction well described with Imagery and genetic studies. Nevertheless the diagnosis of dyslexia cannot be done by another way than clinical symptoms. Optimizing the management of children with dyslexia is a critical issue and is now possible, thanks to the improvement of neurosciences data and the mobilization of the key stakeholders. The knowledge of the precise symptoms is essential in order to lead the child's doctor able to improve coordination and harmonization of teaching and care and guidance of parents. PMID:21074390
Billard, C; Delteil-Pinton, F
Comfrey has a centuries-old tradition as a medicinal plant. Today, multiple randomized controlled trials have demonstrated the efficacy and safety of comfrey preparations for the topical treatment of pain, inflammation and swelling of muscles and joints in degenerative arthritis, acute myalgia in the back, sprains, contusions and strains after sports injuries and accidents, also in children aged 3 or 4 and over. This paper provides information on clinical trials and non-interventional studies published on comfrey to date and further literature, substantiating the fact that topical comfrey preparations are a valuable therapy option for the treatment of painful muscle and joint complaints. PMID:22359388
Comfrey has a centuries-old tradition as a medicinal plant. Today, multiple randomized controlled trials have demonstrated the efficacy and safety of comfrey preparations for the topical treatment of pain, inflammation and swelling of muscles and joints in degenerative arthritis, acute myalgia in the back, sprains, contusions and strains after sports injuries and accidents, also in children aged 3 or 4 and over. This paper provides information on clinical trials and non-interventional studies published on comfrey to date and further literature, substantiating the fact that topical comfrey preparations are a valuable therapy option for the treatment of painful muscle and joint complaints. Copyright © 2012 John Wiley & Sons, Ltd.
Monitoring tests form an increasing proportion of the workload in clinical biochemistry and biochemists can help by providing clinicians with information about the variability and precision of tests, the time frame for pharmacodynamic stabilisation after a treatment change, and the frequency of testing. This paper outlines the phases of monitoring, and how to decide if monitoring is beneficial, which test to use for monitoring, when a change in the test result indicates a need for the change in treatment and the length of testing intervals. We conclude with some recommendations for biochemists for future areas of research and advice that can be given to clinicians.
Doust, Jenny; Glasziou, Paul
Tonsillopharyngitis is an extremely common infection seen in adults and children. Although the symptoms and signs of this disease are usually sufficient to make a diagnosis, it is often difficult to make a distinction between bacterial and viral etiology on clinical grounds alone. The complications of tonsillopharyngitis may be classified into suppurative and nonsuppurative complications. The nonsuppurative complications include scarlet fever, acute rheumatic fever, and post-streptococcal glomerulonephritis. Suppurative complications include peritonsillar, parapharyngeal, and retropharyngeal cellulites and/or abscess. Features suggestive of viral bacterial (GABHS) etiologies, the medical and surgical guidelines for managing tonsillopharyngitis, and its complications are highlighted in this article. PMID:16089240
Tewfik, Ted L; Al Garni, Mohamed
Friedreich ataxia is the most common autosomal recessive ataxia. It is a progressive neurodegenerative disorder, typically with onset before 20 years of age. Signs and symptoms include progressive ataxia, ascending weakness and ascending loss of vibration and joint position senses, pes cavus, scoliosis, cardiomyopathy, and arrhythmias. There are no disease-modifying medications to either slow or halt the progression of the disease, but research investigating therapies to increase endogenous frataxin production and decrease the downstream consequences of disrupted iron homeostasis is ongoing. Clinical trials of promising medications are underway, and the treatment era of Friedreich ataxia is beginning. PMID:24176426
|A plan was developed to assure equivalency of clinical education among the medical laboratory technician (MLT) programs affiliated with Sandhills Community College. The plan was designed by faculty to monitor the quality of clinical courses offered by the clinical affiliates. The major strategies were to develop competencies, slide/tape modules,…
Davis, Judith A.
As a first step in the development of a competency-based clinical toxicology clerkship, a set of terminal behavioral objectives were developed that reflect the anticipated role that clinical pharmacists should play as part of the clinical toxicology team. The evaluation approaches used at the University of Utah are presented. (LBH)
Veltri, Joseph C.; And Others
|As a first step in the development of a competency-based clinical toxicology clerkship, a set of terminal behavioral objectives were developed that reflect the anticipated role that clinical pharmacists should play as part of the clinical toxicology team. The evaluation approaches used at the University of Utah are presented. (LBH)|
Veltri, Joseph C.; And Others
|Objective: The authors describe the first 6 months of a dialectical behavior therapy (DBT) clinic operated by trainees in a general adult psychiatry residency program. The purpose of this report is to provide a model for the creation and maintenance of a formalized resident DBT clinic. Methods: Residents participated in the DBT clinic, attended a…
Lajoie, Travis; Sonkiss, Joshua; Rich, Anne
|Describes a new approach to clinical reasoning education called clinical reasoning theater (CRT). With students as the audience, the doctor's clinical reasoning skills are modeled in CRT when he or she thinks aloud during conversations with the patient. Preliminary results of students' evaluations of the relevance of CRT reveal that they…
Borleffs, Jan C. C.; Custers, Eugene J. F. M.; van Gijn, Jan; ten Gate, Olle Th. J.
ContextThe use of botulinum toxin A (BoNTA) in the treatment of lower urinary tract dysfunction has expanded in recent years and the off-licence usage list includes neurogenic detrusor overactivity (NDO), idiopathic detrusor overactivity (IDO), painful bladder syndrome (PBS), and lower urinary tract symptoms resulting from bladder outflow obstruction (BOO) or detrusor sphincter dyssynergia (DSD). There are two commonly used preparations
Altaf Mangera; Karl-Erik Andersson; Apostolos Apostolidis; Chris Chapple; Prokar Dasgupta; Antonella Giannantoni; Stavros Gravas; Stephan Madersbacher
Neuroferritinopathy is an autosomal dominant, adult-onset disorder characterized by the deposition of iron and ferritin in the brain and a decreased level of serum ferritin. The disease is caused by mutations of the gene encoding ferritin light chain polypeptide. Seven pathogenic mutations have so far been reported, and two of the mutations were found in Japanese families. The mutations are predicted to affect tertiary structure and stability of the ferritin light chain polypeptide and may cause inappropriate iron release from feritin polymers. The excess iron may cause oxidative stress and lead to cell and tissue damage. The typical clinical features are dystonia and involuntary movement. Some patients may present cerebellar ataxia and cognitive decline. The clinical features appear to be restricted to the nervous system. The variety of MRI findings including T(2) hypointense lesions reflecting iron deposits, cystic degeneration of the basal ganglia, and cortical atrophy are characteristic of neuroferritinopathy. Iron depletion therapy by iron chelation in symptomatic patients has not been shown to be beneficial. Recent study shows the iron deposition in neuroferritinopathy begins in early childhood before symptomatic presentation. This finding suggests the importance of early intervention of therapy. PMID:23196480
Glycemic control and its benefits in preventing microvascular diabetic complications are convincingly proved by various prospective trials. Diabetes control and complications trial (DCCT) had reported variable glycated hemoglobin (HbA1C) as a cause of increased microvascular complications in conventional glycemic control group versus intensive one. However, in spite of several indirect evidences, its link with cardiovascular events or macrovascular complications is still not proved. Glycemic variability (GV) is one more tool to explain relation between hyperglycemia and increased cardiovascular risk in diabetic patients. In fact GV along with fasting blood sugar, postprandial blood sugar, HbA1C, and quality of life has been proposed to form glycemic pentad, which needs to be considered in diabetes management. Postprandial spikes in blood glucose as well as hypoglycemic events, both are blamed for increased cardiovascular events in Type 2 diabetics. GV includes both these events and hence minimizing GV can prevent future cardiovascular events. Modern diabetes management modalities including improved sulfonylureas, glucagon like peptide-1 (GLP-1)-based therapy, newer basal insulins, and modern insulin pumps address the issue of GV effectively. This article highlights mechanism, clinical implications, and measures to control GV in clinical practice.
Satya Krishna, Surabhi Venkata; Kota, Sunil K.; Modi, Kirtikumar D.
|Despite the similarity between single-subject research sessions and clinical sessions, single-subject research designs are not intrinsically more appropriate than group designs for clinical research concerning the communication disordered. (Author/CB)|
Siegel, Gerald M.; Young, Martin A.
Our study entails two aspects of translational research related to the clinical application of digital mammography: technology optimization (Phase 1) and a clinical evaluation (Phase 2). The technology/system optimization work is near completion and has f...
L. L. Fajardo
\\u000a Clinical Study Data Management Systems (CSDMSs) support the process of managing data gathered during clinical research. Clinical\\u000a research involves much more than clinical data management – for example, research-grant tracking and reporting to the sponsor\\u000a and to institutional review boards (IRBs, also called Human Investigations Committees) as well as financial management. I’ll\\u000a focus on the data-capture, reporting and query aspects,
Prakash M. Nadkarni
In 1998, during the Second World Symposium on Pulmonary Hypertension (PH) held in Evian, France, a clinical classification of PH was proposed. The aim of the Evian classification was to individualize different categories sharing similarities in pathophysiological mechanisms, clinical presentation, and therapeutic options. The Evian classification is now well accepted and widely used in clinical practice, especially in specialized centers.
Gerald Simonneau; Nazzareno Galiè; Lewis J Rubin; David Langleben; Werner Seeger; Guido Domenighetti; Simon Gibbs; Didier Lebrec; Rudolf Speich; Maurice Beghetti; Stuart Rich; Alfred Fishman
Reviews the present status of clinical psychology. An analysis is presented of the reasons for the failure of clinical psychologists to provide strong supporting evidence for the utility of their diagnostic and therapeutic techniques, for the declining interest in diagnostic testing, and for the proliferation of new methods of intervention. A new conception of clinical practice, research, and graduate training
Julian B. Rotter
The development of the Behavioral Coding System (BCS) used by the Social Learning Project has encompassed approximately 8 years of clinical and research experience with naturalistic observation as a clinical assessment tool. The BCS, while originally designed to accomplish certain broad purposes, illustrates a solution to an assessment task that should be applicable to other research and clinical settings in
G. R. Patterson
The School of Medicine at The University of Notre Dame Australia (UNDA) has adopted a clinical apprenticeship model for the final two years of its MBBS course. In the context of real clinical settings, students observe experienced clinicians as they consult with real patients. Students are provided with opportunities to practice clinical skills under the watchful eye of these clinicians
Carole Steketee; Adrian Bower
Therapeutic preparations of botulinum toxin (BT) consist of botulinum neurotoxin (BNT), complexing proteins, and excipients. Depending on the target tissue, BNT can block cholinergic neuromuscular innervation of intra- and extrafusal muscle fibres or cholinergic autonomic innervation of sweat, lacrimal, and salival glands and smooth muscles. Indirect CNS effects are numerous; direct ones have not been reported after intramuscular application. Botulinum toxin type A is distributed as Botox, Dysport, Xeomin, Hengli/CBTX-A, and Neuronox and BT type B as NeuroBloc/Myobloc. Differences in potency labelling of therapeutic BT preparations can be corrected by introduction of a conversion factor of 1:3 between Botox and Dysport, of 1:1 between Botox and Xeomin, and of 1:40 between Botox and NeuroBloc/Myobloc. Acute adverse effects of BT can be obligate, local or systemic. Adverse effect profiles of the different preparations are similar. However, BT type B frequently produces additional autonomic systemic adverse effects. Long-term application does not produce additional adverse effects. BNT can be partially or completely blocked by antibodies. Risk factors include the amount of BNT applied at each injection series, the interval between injection series, and the specific biological potency (SBP) of the BT preparation used. The SBP is 5 equivalent mouse units/ng BNT for NeuroBloc, 60 for Botox, 100 for Dysport, and 167 for Xeomin. Xeomin should therefore have a particularly low antigenicity. Clinical confirmation of this predicition, however, is lacking. PMID:16810528
Cannabis has a potential for clinical use often obscured by unreliable and purely anecdotal reports. The most important natural cannabinoid is the psychoactive tetrahydrocannabinol (delta9-THC); others include cannabidiol (CBD) and cannabigerol (CBG). Not all the observed effects can be ascribed to THC, and the other constituents may also modulate its action; for example CBD reduces anxiety induced by THC. A standardised extract of the herb may be therefore be more beneficial in practice and clinical trial protocols have been drawn up to assess this. The mechanism of action is still not fully understood, although cannabinoid receptors have been cloned and natural ligands identified. Cannabis is frequently used by patients with multiple sclerosis (MS) for muscle spasm and pain, and in an experimental model of MS low doses of cannabinoids alleviated tremor. Most of the controlled studies have been carried out with THC rather than cannabis herb and so do not mimic the usual clincal situation. Small clinical studies have confirmed the usefulness of THC as an analgesic; CBD and CBG also have analgesic and antiinflammatory effects, indicating that there is scope for developing drugs which do not have the psychoactive properties of THC. Patients taking the synthetic derivative nabilone for neurogenic pain actually preferred cannabis herb and reported that it relieved not only pain but the associated depression and anxiety. Cannabinoids are effective in chemotherapy-induced emesis and nabilone has been licensed for this use for several years. Currently, the synthetic cannabinoid HU211 is undergoing trials as a protective agent after brain trauma. Anecdotal reports of cannabis use include case studies in migraine and Tourette's syndrome, and as a treatment for asthma and glaucoma. Apart from the smoking aspect, the safety profile of cannabis is fairly good. However, adverse reactions include panic or anxiety attacks, which are worse in the elderly and in women, and less likely in children. Although psychosis has been cited as a consequence of cannabis use, an examination of psychiatric hospital admissions found no evidence of this, however, it may exacerbate existing symptoms. The relatively slow elimination from the body of the cannabinoids has safety implications for cognitive tasks, especially driving and operating machinery; although driving impairment with cannabis is only moderate, there is a significant interaction with alcohol. Natural materials are highly variable and multiple components need to be standardised to ensure reproducible effects. Pure natural and synthetic compounds do not have these disadvantages but may not have the overall therapeutic effect of the herb. PMID:11152013
Williamson, E M; Evans, F J
Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: (-)-Epigallocatechin gallate; ACP-103, Ad.Egr.TNF.11 D, adalimumab, AF-IL 12, AIDSVAX gp120 B/B, alefacept, alemtuzumab, a-Galactosylceramide, ALVAC vCP 1452, alvimopan hydrate, alvocidib hydrochloride, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, anakinra, anidulafungin, antarelix, aprepitant, aripiprazole, arsenic sulfide, asoprisnil, atazanavir sulfate, atomoxetine hydrochloride; Bevacizumab, bimatoprost, BMS-184476, bortezomib, bosentan, botulinum toxin type B, BrachySil, brivudine; Caffeine, calcipotriol/betamethasone dipropionate, cannabidiol, capsaicin for injection, caspofungin acetate, CC-4047, cetuximab, CGP-36742, clofazimine, CpG-7909, Cypher; Darbepoetin alfa, dextromethorphan/quinidine sulfate, dimethylfumarate, dronabinol/cannabidiol, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Ecogramostim, efalizumab, eletriptan, emtricitabine, enfuvirtide, eplerenone, esomeprazole magnesium, estradiol acetate, eszopiclone, etoricoxib, exenatide, ezetimibe, ezetimibe/simvastatin; Fampridine, fondaparinux sodium, fosamprenavir calcium; Gefitinib, GPI-0100; hA 20, HTU-PA, human insulin, HuOKT 3 gamma 1(Ala 234-Ala 235), hyaluronic acid; Icatibant, imatinib mesylate, Indiplon, INKP-100, INKP-102, iodine (I131) tositumomab, istradefylline, IV gamma-globulin, ivabradine hydrochloride, ixabepilone; Lacosamide, landiolol, lanthanum carbonate, lasofoxifene tartrate, LB-80380, lenalidomide, lidocaine/tetracaine, linezolid, liposomal doxorubicin, liposomal vincristine sulfate, lopinavir, lopinavir/ritonavir, lumiracoxib, lurtotecan; Maribavir, morphine glucuronide, MVA-5 T 4; NBI-56418, NCX-4016, nesiritide, nicotine conjugate vaccine, NSC-330507; Oglufanide, omalizumab, oxipurinol; Palifermin, palonosetron hydrochloride, parecoxib sodium, PEG-filgrastim, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, PEGylated interferon alfacon-1, perospirone hydrochloride, pimecrolimus, pixantrone maleate, plerixafor hydrochloride, PowderJect lidocaine, pradefovir mesylate, prasterone, pregabalin, Prostvac VF, PT-141, PTC-124, pyridoxamine; QS-21, quercetin; R-126638, R-411, ralfinamide, rasagiline mesilate, rF-PSA, RG-2077, rhThrombin, rimonabant hydrochloride, rofecoxib, rosuvastatin calcium, rotigotine hydrochloride, rV-PSA; S-18886, S-303, seocalcitol, SGN-40, sitaxsentan sodium, SPP-301, St. John's Wort extract; Tadalafil, taxus, telithromycin, tenatoprazole, tenofovir disoproxil fumarate, testosterone MDTS, testosterone transdermal patch, tgAAC-09, TH-9507, thioacetazone, tipifarnib, TQ-1011, trabectedin, travoprost, trimethoprim; Valdecoxib, valganciclovir hydrochloride, valopicitabine, voriconazole; Xcellerated T cells. PMID:16179960
Bayes, M; Rabasseda, X; Prous, J R
Type 1 diabetes affects over 1 million persons in the United States, with over 30,000 new cases diagnosed annually. Transplantation of new insulin-producing b cells, in the form of the whole pancreas or isolated islets, has been shown to ameliorate the disease by eliminating the need for exogenous insulin and normalizing glycosylated hemoglobin levels. Islet transplants are a particularly attractive form of therapy because they are a minimally invasive procedure and are more likely to be scaled-up to treat the large numbers of people affected by diabetes. Currently, only a handful of programs have been successful in the endeavor. Nevertheless, the early clinical experience strongly demonstrates that islet transplantation is an effective treatment strategy in select patients with type 1 diabetes. To scale up this therapy and use it earlier in the disease and for more people, the shortage of suitable donor tissue must be solved and the requirement of lifelong immunosuppression must be minimized. PMID:12866999
Kaufman, Dixon B; Lowe, William L
New doctors and those studying to practice medicine may need a bit of assistance as they prepare to administer direct care to patients. The Clinical Skills Online website was created to offer some helpful videos for such persons, and was funded by the United Kingdom's Higher Education Academy Subject Centre for Medicine, Dentistry and Veterinary Medicine. The thirteen videos are all available at no cost. They cover topics like History Taking, Thyroid Examination, and Abdominal Examination. The videos contain precise language and are designed to complement existing formal medical training. Needless to say, there is a disclaimer on the website that highlights the terms under which these videos should be used. It's a nice resource for those entering a range of health care professions, and it's worth sharing with others in the field.
?-Thalassemia mutations affect up to 5% of the world's population. The clinical spectrum ranges from an asymptomatic condition to a fatal in utero disease. Hemoglobin H disease results from mutations of three ?-globin genes. Deletional forms result in a relatively mild anemia, whereas nondeletional mutations result in a moderate to severe disease characterized by ineffective erythropoiesis, recurrent transfusions, and growth delay. Hemosiderosis develops secondary to increased iron absorption, as well as transfusion burden. Hemoglobin Bart's hydrops fetalis is usually a fatal in utero disease caused by the absence of ? genes. Population screening to identify at-risk couples is essential. Affected pregnancies result in severe fetal and maternal complications. Doppler ultrasonography with intrauterine transfusion therapy may improve the fetal prognosis but creates ethical challenges for the family and health providers. PMID:23543077
Vichinsky, Elliott P
Heritable hypermutation in bacteria is mainly due to alterations in the methyl-directed mismatch repair (MMR) system. MMR-deficient strains have been described from several bacterial species, and all of the strains exhibit increased mutation frequency and recombination, which are important mechanisms for acquired drug resistance in bacteria. Antibiotics select for drug-resistant strains and refine resistance determinants on plasmids, thus stimulating DNA recombination via the MMR system. Antibiotics can also act as indirect promoters of antibiotic resistance by inducing the SOS system and certain error-prone DNA polymerases. These alterations have clinical consequences in that efficacious treatment of bacterial infections requires high doses of antibiotics and/or a combination of different classes of antimicrobial agents. There are currently few new drugs with low endogenous resistance potential, and the development of such drugs merits further research. PMID:21349992
Jolivet-Gougeon, Anne; Kovacs, Bela; Le Gall-David, Sandrine; Le Bars, Hervé; Bousarghin, Latifa; Bonnaure-Mallet, Martine; Lobel, Bernard; Guillé, François; Soussy, Claude-James; Tenke, Peter
This is a case of a 21-year-old lady who presented with history of episodes where she would display extraordinary strength while becoming aggressive towards her family members, speak in foreign language and display bizarre behaviour. The episode would last for 15-20 min and would resolve spontaneously. She would always claim amnesia for the event. This would remain irritable in the intervening period. The frequency of such episodes is at least three times a week. The family members took her to several faith healers with no improvement in her condition. On the suggestion of a family friend, the patient was brought in for consultation in the psychiatric clinic. The patient remained a diagnostic dilemma though there has been some reduction in intensity of such episodes on psychotropic medication. Unfortunately, there is no remission in episodes. PMID:22701065
This is a case of a 21-year-old lady who presented with history of episodes where she would display extraordinary strength while becoming aggressive towards her family members, speak in foreign language and display bizarre behaviour. The episode would last for 15–20 min and would resolve spontaneously. She would always claim amnesia for the event. This would remain irritable in the intervening period. The frequency of such episodes is at least three times a week. The family members took her to several faith healers with no improvement in her condition. On the suggestion of a family friend, the patient was brought in for consultation in the psychiatric clinic. The patient remained a diagnostic dilemma though there has been some reduction in intensity of such episodes on psychotropic medication. Unfortunately, there is no remission in episodes.
The number of patients who continue to smoke after a major cardiac event is high. More and more often the patients ask the cardiologist to help them quitting smoking. In the last few years the rapid developments in the neuropharmacological field set up the bases for a more effective and evidence based treatment of nicotine dependence. Thus a number of reviews, guidelines and original articles has been published in internal medicine, cardiology and pneumology journals and their main purpose was to increase as much as possible the number of physicians able to set up a "specialistic" nicotine dependence treatment. The aim of this article is instead to review the stages of the smoker clinical evaluation in a "specialistic" environment and to translate them in practical tips ready to be used in the cardiological daily practice. Three issues are specifically reviewed: motivation to quit, degree of nicotine dependence and the role of mood disturbances. PMID:12418433
An analysis of the normal tissue effects of irradiation of the kidney is presented. Various clinical syndromes resulting from treatment are described as well as the potential cellular basis for these findings. Effects of concurrent and/or sequential treatment with irradiation and various chemotherapeutic agents are discussed and the impact of these agents on toxicity presented. Adverse consequences of renal treatment in the child is described and possible radiation effects on so-called compensatory hypertrophy following nephrectomy presented. Renal consequences described to date of bone marrow transplantation programs utilizing irradiation are also presented. The necessity of a dose-volume histogram analysis approach to analyzing renal toxic effects in patients followed for long (>10 year) periods is essential in developing accurate guidelines of renal tolerance. 53 refs., 6 figs., 5 tabs.
Cassady, J.R. [Univ. of Arizona Health Sciences Center, Tucson, AZ (United States)
Progestogens are used in clinical practice in some conditions. Their effects depend on their chemical structure, pharmacokinetics, pharmacodynamics, with important differences among various progestogens. Generally, progestins are classified according to their parent molecule, of which often they keep some features. Derivatives of 19-nor-progesterone are characterized by high selectivity of action on progestin receptor. In particular, nomegestrol acetate (NomAc) shows an important progestational potency, neutral gluco-lipid profile, and antigonadotropic activity. It is used for treating menstrual cycle disorders and for hormone replacement therapy in menopause in association with an estrogen. In future, thanks to its antigonadotropic activity, NomAc will be used in estroprogestin combinations in fertile women, thus taking advantage of its tolerability profile and obtaining numerous non-contraceptive benefits as well. PMID:19749678
Symptoms, physical, laboratory, and x-ray findings in osteoarthrosis are reviewed, special emphasis is drawn to the different clinical forms as compensated, activated, decompensated osteoarthrosis. A sample of 2,494 patients with degenerative joint disease or functional disorders as e.g. myalgia were studied with respect to symptoms and physical findings. As previously described in other studies it turned out, that osteoarthrosis of the knee specially in women is correlated with high body weight; furthermore it could be shown that foot deformities--hallux valgus and pes planus in gonarthrosis, hallux valgus and hammer-toe in polyarthrosis of the finger joints--are significantly more frequent in some degenerative joint diseases. PMID:7597808
Kolarz, G; Adlassnig, K P
Fibromyalgia is a common chronic syndrome defined by core symptoms of widespread pain, fatigue, and sleep disturbance. Other common symptoms include cognitive difficulty, headache, paresthesia, and morning stiffness. Fibromyalgia is increasingly understood as 1 of several disorders that are referred to as central sensitivity syndromes; these disorders share underlying causes and clinical features. Tender points are often detected in patients with fibromyalgia and were formerly required for diagnosis. Newly proposed criteria, however, rely on patients' reports of widespread pain and other somatic symptoms to establish the diagnosis of fibromyalgia. The management of fibromyalgia requires a multidimensional approach including patient education, cognitive behavioral therapy, exercise, and pharmacologic therapy. The present review provides an update on these various aspects of treating a patient with fibromyalgia. PMID:24005088
Hawkins, Robert A
Gateways to clinical trials is a guide to the most recent trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity(R), the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: (+)-Dapoxetine hydrochloride, (S)-Tenatoprazole sodium salt monohydrate 19-28z, Acotiamide hydrochloride hydrate, ADV-TK, AE-37, Aflibercept, Albinterferon alfa-2b, Aliskiren fumarate, Asenapine maleate, Axitinib; Bavituximab, Becatecarin, beta-1,3/1,6-Glucan, Bevacizumab, Bremelanotide; Calcipotriol/betamethasone dipropionate, Casopitant mesylate, Catumaxomab, CDX-110, Cediranib, CMD-193, Cositecan; Darinaparsin, Denosumab, DP-b99, Duloxetine hydrochloride; E75, Ecogramostim, Elacytarabine, EMD-273063, EndoTAG-1, Enzastaurin hydrochloride, Eplerenone, Eribulin mesilate, Esomeprazole magnesium, Etravirine, Everolimus, Ezetimibe; Faropenem daloxate, Febuxostat, Fenretinide; Ghrelin (human); I-131 ch-TNT-1/B, I-131-3F8, Iclaprim, Iguratimod, Iloperidone, Imatinib mesylate, Inalimarev/Falimarev, Indacaterol, Ipilimumab, Iratumumab, Ispinesib mesylate, Ixabepilone; Lapatinib ditosylate, Laquinimod sodium, Larotaxel dehydrate, Linezolid, LOR-2040; Mapatumumab, MKC-1, Motesanib diphosphate, Mycophenolic acid sodium salt; NK-012; Olanzapine pamoate, Oncolytic HSV, Ortataxel; Paclitaxel nanoparticles, Paclitaxel poliglumex, Paliperidone palmitate, Panitumumab, Patupilone, PCV-9, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pertuzumab, Picoplatin, Pimavanserin tartrate, Pimecrolimus, Plerixafor hydrochloride, PM-02734, Poly I:CLC, PR1, Prasugrel, Pregabalin, Progesterone caproate, Prucalopride, Pumosetrag hydrochloride; RAV-12, RB-006, RB-007, Recombinant human erythropoietin alfa, Rimonabant, Romidepsin; SAR-109659, Satraplatin, Sodium butyrate; Tadalafil, Talampanel, Tanespimycin, Tarenflurbil, Tariquidar, Taurine, Tecovirimat, Telatinib, Telavancin hydrochloride, Telcagepant, Terameprocol, Tesofensine, Tetrodotoxin, Tezampanel, Tipifarnib, TPI-287, Tremelimumab; Valspodar, Vatalanib succinate, VCL-CB01, vCP1452, Vorinostat; XL-228; Ziprasidone hydrochloride. PMID:19088949
Tomillero, A; Moral, M A
Cefotetan is a 7-alpha-methoxy beta-lactam. A long serum half-life and resistance to beta-lactamase hydrolysis have made cefotetan an attractive chemotherapeutic agent, and the results of clinical trials worldwide have demonstrated its efficacy in a wide variety of clinical situations. Cefotetan can be administered intravenously (bolus or infusion) or intramuscularly with lidocaine (lignocaine) 0.5%. Mean peak plasma concentrations are almost linearly related to dose. The volume of distribution is between 8 and 13L and is not different from other cephalosporins. No accumulation is seen after repeated doses and no metabolite has been detected in either plasma or urine. Total body clearance is 1.8 to 2.9 L/h. Renal clearance accounts for about 64 to 84% of a dose, and 75% of a dose is excreted in the urine within 24 hours. The plasma elimination half-life is between 3 and 4 hours after intravenous and intramuscular doses. Half-life is considerably prolonged in patients with renal impairment (up to 10 hours). Cefotetan concentrations are likely to be active against susceptible bacteria in most tissues and body fluids. Breast milk and cerebrospinal fluid concentrations are low. The recommended dosage is 1g every 12 hours, increasing to 2g in severe infections and 3g in life-threatening infections. In surgical prophylaxis, a single dose of 2g is given with the induction of anaesthesia; an additional dose of 2g may be administered 12 hours later. In children over 6 months, the recommended dosage is 30 mg/kg given 12-hourly. In patients with a creatinine clearance of 10 to 40 ml/min (0.6 to 2.4 L/h), the dose is halved or the dosage interval is doubled. When creatinine clearance is less than 10 ml/min (0.6 L/h), the dose is quartered or the dosage interval quadrupled. PMID:8013159
Martin, C; Thomachot, L; Albanese, J
Venomous animals occur in numerous phyla and present a great diversity of taxa, toxins, targets, clinical effects and outcomes. Venomous snakes are the most medically significant group globally and may injure >1.25 million humans annually, with up to 100 000 deaths and many more cases with long-term disability. Scorpion sting is the next most important cause of envenoming, but significant morbidity and even deaths occur following envenoming with a wide range of other venomous animals, including spiders, ticks, jellyfish, marine snails, octopuses and fish. Clinical effects vary with species and venom type, including local effects (pain, swelling, sweating, blistering, bleeding, necrosis), general effects (headache, vomiting, abdominal pain, hypertension, hypotension, cardiac arrhythmias and arrest, convulsions, collapse, shock) and specific systemic effects (paralytic neurotoxicity, neuroexcitatory neurotoxicity, myotoxicity, interference with coagulation, haemorrhagic activity, renal toxicity, cardiac toxicity). First aid varies with organism and envenoming type, but few effective first aid methods are recommended, while many inappropriate or frankly dangerous methods are in widespread use. For snakebite, immobilisation of the bitten limb, then the whole patient is the universal method, although pressure immobilisation bandaging is recommended for bites by non-necrotic or haemorrhagic species. Hot water immersion is the most universal method for painful marine stings. Medical treatment includes both general and specific measures, with antivenom being the principal tool in the latter category. However, antivenom is available only for a limited range of species, not for all dangerous species, is in short supply in some areas of highest need, and in many cases, is supported by historical precedent rather than modern controlled trials. PMID:20358686
The imperative to undertake randomised trials in children arises from extraordinary advances in basic biomedical sciences, needing a matching commitment to translational research if child health is to reap the benefits from this new knowledge. Unfortunately, many prescribed treatments for children have not been adequately tested in children, sometimes resulting in harmful treatments being given and beneficial treatments being withheld. Government, industry, funding agencies, and clinicians are responsible for research priorities being adult-focused because of the greater burden of disease in adults, coupled with financial and marketing considerations. This bias has meant that the equal rights of children to participate in trials has not always been recognised. This is changing, however, as the need for clinical trials in children has been increasingly recognised by the scientific community and broader public, leading to new legislation in some countries making trials of interventions mandatory in children as well as adults before drug approval is given. Trials in children are more challenging than those in adults. The pool of eligible children entering trials is often small because many conditions are uncommon in children, and the threshold for gaining consent is often higher and more complex because parents have to make decisions about trial participation on behalf of their child. Uncertain about what is best, despite supporting the notion of trials in principle, parents and paediatricians generally opt for the new intervention or for standard care rather than trial participation. In this review, we explore issues relating to trial participation for children and suggest some strategies for improving the conduct of clinical trials involving children. PMID:15337409
Caldwell, Patrina H Y; Murphy, Sharon B; Butow, Phyllis N; Craig, Jonathan C
Although the clinical and the sexual are commonly treated as antithetical realms of experience, queer commentary teaches that the clinic is a positively sexual space and that clinical intimacy is a creative form of sexual intimacy. Contrary to writers such as Engelhardt, the clinic is a space where queer publics are forged, and the barriers between moral friends and moral strangers potentially dissolve, but only to the extent that one is disposed to allow oneself to enjoy experiences of identification that confound the ideals of human dignity typically invoked in writings about sexual ethics on the one hand and clinical medical ethics on the other hand. PMID:23475403
Clinical researchers and clinical practitioners share a goal of increasing the integration of research and clinical practice, which is reflected in an evidence-based practice (EBP) approach to psychology. The EBP framework involves the integration of research findings with clinical expertise and client characteristics, values, and preferences, and consequently provides an important foundation for conducting clinically relevant research, as well as empirically based and clinically sensitive practice. Given the critical role that early training can play in the integration of science and practice and in promoting the future of the field, the present article addresses predoctoral training programs as a context for adopting an EBP approach to clinical work. We address training in the three components of EBP and provide suggestions for curriculum development and practicum training that we hope will contribute to bridging the gap between research and practice.
Hershenberg, Rachel; Drabick, Deborah A. G.; Vivian, Dina
Normal bone mineral accrual requires adequate dietary intake of calcium, vitamin D and other nutrients; hepatic and renal activation of vitamin D; normal hormone levels (thyroid, parathyroid, reproductive and growth hormones); and neuromuscular functioning with sufficient stress upon the skeleton to induce bone deposition. The presence of genetic or acquired diseases and the therapies that are used to treat them can also impact bone health. Since the introduction of clinical DXA in pediatrics in the early 1990s, there has been considerable investigation into the causes of low bone mineral density (BMD) in children. Pediatricians have also become aware of the role adequate bone mass accrual in childhood has in preventing osteoporotic fractures in late adulthood. Additionally, the availability of medications to improve BMD has increased with the development of bisphosphonates. These factors have led to the increased utilization of DXA in pediatrics. This review summarizes much of the previous research regarding BMD in children and is meant to assist radiologists and clinicians with DXA utilization and interpretation.
Sparke, Paul; Henwood, Maria J.
Water is an essential foundation for life, having both a regulatory and structural function. The former results from active and passive participation in all metabolic reactions, and its role in conserving and maintaining body temperature. Structurally speaking it is the major contributer to tissue mass, accounting for 60% of the basis of blood plasma, intracellular and intersticial fluid. Water is also part of the primary structures of life such as genetic material or proteins. Therefore, it is necessary that the nurse makes an early assessment of patients water needs to detect if there are signs of electrolyte imbalance. Dehydration can be a very serious problem, especially in children and the elderly. Dehydrations treatment with oral rehydration solution decreases the risk of developing hydration disorders, but even so, it is recommended to follow preventive measures to reduce the incidence and severity of dehydration. The key to having a proper hydration is prevention. Artificial nutrition encompasses the need for precise calculation of water needs in enteral nutrition as parenteral, so the nurse should be part of this process and use the tools for calculating the patient's requirements. All this helps to ensure an optimal nutritional status in patients at risk. Ethical dilemmas are becoming increasingly common in clinical practice. On the subject of artificial nutrition and hydration, there isn't yet any unanimous agreement regarding hydration as a basic care. It is necessary to take decisions in consensus with the health team, always thinking of the best interests of the patient. PMID:21428011
Maristany, Cleofé Pérez-Portabella; Segurola Gurruchaga, Hegoi
Adverse drug reactions or side effects are usually expected, dose dependent, and occur at therapeutic doses. Anaphylactic and anaphylactoid reactions are unexpected and dose independent and can occur at the first exposure to drugs used during anesthesia. Perioperative anaphylaxis is a severe and rapid clinical condition that can be lethal even in previously healthy patients. The initial diagnosis of anaphylaxis is presumptive. A precise identification of the drug responsible for the adverse reaction is more difficult to establish in the case of anaphylactoid reaction because the adverse reaction could result from additive side effects of different drugs injected simultaneously. The timing of the reaction in relation to events, e.g. induction, start of surgery, administration of other drugs, i.v. fluids, is essential for the diagnosis. Generally, reactions are predominant in the induction and recovery phases, and manifested mainly as cutaneous symptoms. Reactions to drugs coincide with the phases when they are administered. Reactions to antibiotics are more frequent in the induction phase, to neuromuscular agents in the initiation and maintenance phases and to non-steroidal anti-inflammatory agents in the recovery phase. The differential diagnosis of any adverse reaction during or following anesthesia should include the possibility of anaphylaxis. PMID:22014928
Peroni, D G; Sansotta, N; Bernardini, R; Cardinale, F; Paravati, F; Franceschini, F; Boner, A L
Purpose of review Obtaining precise post-operative target refraction is of utmost importance in today’s modern cataract and refractive surgery. Given the growing number of patients undergoing premium intraocular lens implantations, patient expectation continues to rise. In order to meet heightened patient expectations, it is crucial to pay utmost attention to patient selection, accurate keratometry and biometry readings, as well as to the application of correct intraocular lens power formula with optimized lens constants. This article reviews recent advances in the field of clinical biometry and intraocular lens power calculations. Recent findings Recently developed low-coherence reflectometry optical biometry is comparable to older ultrasonic biometric and keratometric techniques. In addition, the new IOL Master software upgrade has improved reproducibility and enhanced signal acquisition. Further, the modern lens power formulas currently determine the effective lens position and the shape of the intraocular lens power prediction curve more accurately. Summary In order to reach target refraction, precise biometric measurements are imperative. Understanding the strengths and limitations of the currently available biometry devices, allows prevention of high variability and inaccuracy, ultimately determining the refractive outcomes.
Sahin, Afsun; Hamrah, Pedram
Meloxicam (CAS 71125-38-7, UH-AC 62 XX) is a new non-steroidal anti-inflammatory drug (NSAID) which was developed for the treatment of osteoarthritis and rheumatoid arthritis. The basic clinical pharmacokinetics of meloxicam (7.5-30 mg) have been investigated in 78 healthy male volunteers after single and multiple dosing via oral, intravenous and rectal routes. Plasma concentrations of meloxicam were determined by validated high performance liquid chromatography (HPLC) methods. The pharmaco-kinetic profile of meloxicam is characterized by almost complete absorption over a prolonged phase-avoiding high initial drug concentrations- and is bound to plasma proteins by more than 99.5%. Meloxicam is metabolized to four biologically inactive metabolites and excreted in urine and faeces with an elimination half-life (t1/2) of around 20 h. This is reflected in a total plasma clearance of 7 to 8 ml/min. Steady state is achieved within 3 to 5 days. In addition, the pharmacokinetic parameters are linear over the entire dose range, there are no changes with multiple dosing and bioequivalence was shown for a number of different formulations. The results indicate that meloxicam is suitable for once-daily administration and that a switch from one formulation to another is easily possible if necessary or convenient for the patient. PMID:9105543
Türck, D; Busch, U; Heinzel, G; Narjes, H
Due to its oral route of administration and mild toxicity profile, as well as its potent laboratory and clinical effects, hydroxyurea (or hydroxycarbamide) has been the primary focus of fetal hemoglobin (HbF) induction strategies for the treatment of children with sickle cell anemia (SCA). When administered orally once a day, hydroxyurea treatment is very well tolerated with little short-term toxicity. Hydroxyurea has documented laboratory efficacy with increases in Hb and HbF; treatment also significantly reduces the number of painful episodes, acute chest syndrome, transfusions, and hospitalizations. Most young patients reach a maximum tolerated dose of hydroxyurea at 25-30 mg/kg/d, where they will achieve key laboratory thresholds (Hb ? 9 g/dL and HbF ? 20%) without excessive myelosuppression. Potential long-term toxicities continue to be of great concern and should be monitored in all patients with SCA who receive hydroxyurea therapy. To date, however, no increases in stroke, myelodysplasia, or carcinogenicity have been detected in SCA patient cohorts, with drug exposure now reaching 15 years for some treated children. Taken together, available evidence suggests that hydroxyurea represents an inexpensive and effective treatment option that should be offered to most, if not all, patients with SCA. As countries in Africa develop newborn screening programs to identify SCA, the widespread use of hydroxyurea may prove to be a useful treatment to help ameliorate the disease in resource-limited settings. Hydroxyurea is the only currently available disease-modifying therapy for SCA, and is emerging as a safe and effective treatment for all patients with SCA, in both developed and developing countries. PMID:23643402
Ware, Russell E
In patients with stable and unstable coronary disease and those undergoing coronary stenting, the activation of platelets plays a central role in the occurrence of major thrombotic events such as death, myocardial infarction and stent thrombosis. Antiplatelet therapy for primary and secondary prevention of thromboembolic events is a cornerstone for the management of these patients and for many years the cyclooxygenase-1 (COX-1) inhibitor aspirin and the second generation thienopyridine clopidogrel which targets the ADP P2Y12 receptor on platelets served as the main antiplatelet agents for these indications. Clopidogrel in particular is very efficient in reducing ischemic cardiovascular events but exposes patients to an increased risk of bleeding. Therefore the optimal dosage and duration of clopidogrel therapy is of utmost importance. Furthermore, platelet function studies have revealed that responsiveness to clopidogrel is not uniform and that a low response is linked to a higher incidence of thrombotic events. Causes are multifactorial and several genetic and non-genetic factors including patients' co-morbidities and co-medications have been identified. As a result clopidogrel's long lasting monopole as the only antiplatelet agent in patients undergoing coronary stenting is currently challenged by the newer P2Y12 blockers such as prasugrel and ticagrelor, which provide a stronger and more consistent inhibition of platelets. In the setting of acute coronary syndromes, this more potent platelet inhibition led to less thrombotic events with these newer agents, but at the cost of a higher bleeding risk. This review provides an overview of the indication, dosage and duration of clopidogrel therapy and discusses its role in light of the recent introduction of newer P2Y12 receptor antagonists, the combination with newer oral anticoagulants such as dabigatran, apixaban and rivaroxaban as well as the emerging use of platelet function testing in clinical practice. PMID:22724411
Sarafoff, Nikolaus; Byrne, Robert A; Sibbing, Dirk
Of the 400 consecutive completed suicides investigated over a 5-year period, 114 (28.5%) who had consulted a doctor in the week preceding death were specifically reviewed and compared with those who did not. The study comprised an analysis of the medical history, the scene of death and a complete autopsy with histological and toxicological examination and the identification of features which occurred more frequently in this group when compared with other suicides not contacting their doctors. Suicide-associated factors include psychiatric illness (58.8%), deteriorating health (16.7%), and a loss of spouse (7.0%); all these features were manifested by this group of suicides more frequently than by those who made no clinical contact (P < 0.001). A pre-indication of suicidal intention was made by 45% of these patients. This feature, as with previous attempts, occurred more commonly in patients who consulted a doctor (P < 0.001). Drug overdose was the most common suicidal method chosen (50.9%) and anti-depressants predominated (35%); 78% of those who overdosed ingested prescribed drugs. Poisoning was more common in this group (P < 0.001). Half of the victims committed suicide within 24 hours following consultation; of these, 51% overdosed on drugs with 61% of them ingesting their prescribed drugs. Of these 114 cases, the final consultation in 43% was to collect more drugs. All suicidal threats should be taken seriously, and particular care should be taken in prescribing and dispensing medication which may be fatal in overdose.
Obafunwa, J. O.; Busuttil, A.
Abstract Objective: Measure the adoption and utilization of, opinions about, and attitudes toward clinical computing,among,general dentists in the United States. Design: Telephone,survey,of a random,sample,of 256 general dentists in active practice in the United States. Measurements:,A 39-item telephone,interview,measuring,practice characteristics and,information,technology,infra- structure; clinical information,storage; data entry and,access; attitudes toward,and,opinions,about,clinical computing (features of practice management systems, barriers, advantages, disadvantages, and potential improvements); clinical
TITUS K. L. SCHLEYER; THANKAM P. THYVALIKAKATH; HEIKO SPALLEK; MIGUEL H. TORRES-URQUIDY; PEDRO HERNANDEZ; JEANNIE YUHANIAK
Sir Bernard Tomlinson's report focuses on London's health services, but his proposals have major implications for the future of clinical research--not just in London but in the United Kingdom as a whole. They must be seen in the context of a widely perceived decline in British research and development which also threatens clinical research. This article examines the implications of Tomlinson's proposals and related strategies and recommends the construction of a research market for the patient costs of clinical research to complement the NHS market for patient services introduced in 1991. These arrangements would help sustain the clinical research base and guarantee excellence. Images p1084-a
Parkinson's disease (PD) is a common disorder that causes a marked decrease in the quality of life of patients and implies high costs at the social, familiar and economic levels. The diagnosis is essentially achieved on clinical grounds and there is an extensive list of possible differential diagnoses, thus being fundamental to recognize the typical clinical features of PD, and then proceed to effective treatment, thus improving disability and the quality of life of patients. This review article, built on evidence-based knowledge and clinical experience, approaches pathogenesis, clinical features, the diagnostic methodology and current concepts in the treatment of PD in a pragmatic and updated manner. PMID:22863490
Improving the efficiency with which clinical research studies are conducted can lead to faster medication innovation and decreased time to market for new drugs. To increase this efficiency, the parties involved in a regulated clinical research study, namely, the sponsor, the clinical investigator and the regulatory body, each with their own software applications, need to exchange data seamlessly. However, currently, the clinical research and the clinical care domains are quite disconnected because each use different standards and terminology systems. In this article, we describe an initial implementation of the Semantic Framework developed within the scope of SALUS project to achieve interoperability between the clinical research and the clinical care domains. In our Semantic Framework, the core ontology developed for semantic mediation is based on the shared conceptual model of both of these domains provided by the BRIDG initiative. The core ontology is then aligned with the extracted semantic models of the existing clinical care and research standards as well as with the ontological representations of the terminology systems to create a model of meaning for enabling semantic mediation. Although SALUS is a research and development effort rather than a product, the current SALUS knowledge base contains around 4.7 million triples representing BRIDG DAM, HL7 CDA model, CDISC standards and several terminology ontologies. In order to keep the reasoning process within acceptable limits without sacrificing the quality of mediation, we took an engineering approach by developing a number of heuristic mechanisms. The results indicate that it is possible to build a robust and scalable semantic framework with a solid theoretical foundation for achieving interoperability between the clinical research and clinical care domains. PMID:23008263
Laleci, G; Yuksel, M; Dogac, A
The biguanide metformin (dimethylbiguanide) is an oral antihyperglycaemic agent widely used in the management of non-insulin-dependent diabetes mellitus (NIDDM). Considerable renewal of interest in this drug has been observed in recent years. Metformin can be determined in biological fluids by various methods, mainly using high performance liquid chromatography, which allows pharmacokinetic studies in healthy volunteers and diabetic patients. Metformin disposition is apparently unaffected by the presence of diabetes and only slightly affected by the use of different oral formulations. Metformin has an absolute oral bioavailability of 40 to 60%, and gastrointestinal absorption is apparently complete within 6 hours of ingestion. An inverse relationship was observed between the dose ingested and the relative absorption with therapeutic doses ranging from 0.5 to 1.5 g, suggesting the involvement of an active, saturable absorption process. Metformin is rapidly distributed following absorption and does not bind to plasma proteins. No metabolites or conjugates of metformin have been identified. The absence of liver metabolism clearly differentiates the pharmacokinetics of metformin from that of other biguanides, such as phenformin. Metformin undergoes renal excretion and has a mean plasma elimination half-life after oral administration of between 4.0 and 8.7 hours. This elimination is prolonged in patients with renal impairment and correlates with creatinine clearance. There are only scarce data on the relationship between plasma metformin concentrations and metabolic effects. Therapeutic levels may be 0.5 to 1.0 mg/L in the fasting state and 1 to 2 mg/L after a meal, but monitoring has little clinical value except when lactic acidosis is suspected or present. Indeed, when lactic acidosis occurs in metformin-treated patients, early determination of the metformin plasma concentration appears to be the best criterion for assessing the involvement of the drug in this acute condition. After confirmation of the diagnosis, treatment should rapidly involve forced diuresis or haemodialysis, both of which favour rapid elimination of the drug. Although serious, lactic acidosis due to metformin is rare and may be minimised by strict adherence to prescribing guidelines and contraindications, particularly the presence of renal failure. Finally, only very few drug interactions have been described with metformin in healthy volunteers. Plasma levels may be reduced by guar gum and alpha-glucosidase inhibitors and increased by cimetidine, but no data are yet available in the diabetic population. PMID:8743335
Scheen, A J
Different blends of knowledge, decision making, problem solving,professional behaviors, values, and technical skills are necessary in the changing health care environments in which respiratory therapists practice. Frequently, novice students are expected to perform quickly and efficiently,and it may be forgotten that students are still learning and mastering the foundation pieces of practice. Clinical educators take on the responsibility of student development in addition to overseeing patient care. Normally,these volunteer instructors are role models for respiratory therapy students. The characteristic of initiative when demonstrated by a beginning student is attractive to the clinical instructor, promotes sharing of experiences, and may evolve into a mentor-protege relationship. Some clinical instructors may be underprepared to teach and are uncomfortable with student evaluation. Respiratory therapy facilities in conjunction with academic institutions may consider sponsoring ongoing programs for clinical teachers. Teaching and learning in the clinical environment is more than demonstration of skills and knowledge. Furthermore, it can be debated whether the memorization of facts or of the steps of a skill is more valuable than competency in problem solving, clinical reasoning, or information retrieval. New knowledge is built within a context and is further integrated when grounded by experience. Development of "prediction in practice" or the anticipation of the next necessary actions may be worth integrating into the instructional toolbox. Intuition has been defined as an "understanding without a rationale". This definition separates intuition from rational decision making and presents intuition as a type of innate ability. Reflection when guided by clinical instructors can help deepen critical thinking, as will Socratic questioning on a regular basis. Most clinical staff can agree on the performance of an incompetent student, but discrimination of the levels of competence is more challenging. Observations allow the assessor to obtain the data necessary to evaluate performance, followed by assessment, which denotes a judgment made on the basis of an observation of events. Performance assessment should have stability and consistency, measure what is intended to be measured, and truly determine competence. In contrast, reflective analysis has been shown to be successful for clinical evaluation, thus departing from strict competency and product-based assessment. Students yearn to become clinically knowledgeable, and their enthusiasm should be fostered. An interest in clinical practice is the primary reason individuals enroll in respiratory therapy education programs. Educators,managers, and staff should assure that students experience an appropriate, rich, and diverse clinical curriculum that with practice develops clinical judgment, reasoning, and reflection on practice. PMID:16168912
Cullen, Deborah L
Electroencephalography (EEG) remains central to the investigation of epilepsy. This review discusses two clinical problems at the temporal extremes of neurophysiologic recording: evaluation of the clinical significance of individual spike discharges in benign epilepsy of childhood with centrotemporal spikes (BECTS), and prolonged (several days) continuous EEG monitoring in the ICU. BECTS is misdiagnosed often, and probably mis-treated often as well.
Susan T. Herman; Masanori Takeoka; John R. Hughes; Frank W. Drislane
General aspects of avian clinical pathology are reviewed. It is concluded that in a clinical setting a volume of blood equivalent to 1 per cent of body weight can be collected safely from avian species for laboratory examinations. The anticoagulant of choice for most laboratory investigations is lithium heparin. In most bird species the right jugular vein is the preferred
J. T. Lumeij
Professional nursing practice at Mayo Clinic emphasises nursing research as integral to professional practice and development. A commitment to nursing research at the clinic has evolved over the past 20 years with expanded resources, the implementation of a research training scholarship programme and the development of an ambitious strategic plan. Four primary goals are outlined in the strategic plan: advancing
Sharon J. Tucker
The authors summarize the data of 60 patients of the Memory Clinic of the National Institute of Psychiatry and Neurology between 6 January 1992 and 6 June 1994 where the probable Alzheimer's disease (NINCDS-ADRDA) was diagnosed. It was examined whether it was possible to isolate homogenous subtypes based on clinical data. Interesting differences of tendency level could be demonstrated in
Péter Tariska; Kinga Urbanics
Clinical microbiology is probably the slowest of the laboratory-supported disciplines in a hospital. However, in clinical diagnostic microbiology, the speed at which laboratory results become available can mean the difference between life and dead. The sooner the cause of an infection is known, the sooner an optimised therapy can be started. Over the last years, we have been developing a
Kees Maquelin; Gerwin Puppels
The behavior-analytic approach to clinical phenomena is presented. An operationalized framework for conducting behavioral analysis with clinical cases is provided. Idiographic analysis and treatment innovation are conceptualized and conducted within the framework of the experimental method. Differences between technological and behavior-analytic approaches are illustrated.
Victor Meyer; Ira Daniel Turkaff
A distinction is made between the function of ethics in clinical medicine, which is to guide the clinician in his\\/her practice, and the role of the ethicist. It suggests that ethicists can help by clarifying values expressed in various clinical behaviours. The author proposes that certain ethical positions, such as patient advocacy, have compromised the privacy of the doctor-patient relationship
Gregory T. Lyon-Loftus
Deranged phosphorus metabolism is commonly encountered in clinical medicine. Disturbances in phosphate intake, excretion and transcellular shift account for the abnormal serum levels. As a result of the essential role played by phosphate in intracellular metabolism, the clinical manifestations of hypophosphatemia and hyperphosphatemia are extensive. An understanding of the pathophysiology of various phosphate disorders is helpful in guiding therapeutic decisions. Images
Yu, George C.; Lee, David B. N.
Violence against abortion clinics and other activities directed toward patients and staff of abortion facilities have been termed terrorism by the pro?choice movement. However, the Federal Bureau of Investigation denies that these actions are terrorism. Instances of abortion clinic violence for 1982–1987 were examined in order to determine whether there is a correspondence between these incidents and definitions or models
Michele Wilson; John Lynxwiler
Clinical studies have been performed to investigate the pharmacokinetics and pharmacodynamics of alendronate, an inhibitor of bone resorption for the treatment of osteoporosis. Alendronate is one of the most potent bisphosphonates currently undergoing clinical investigation (>100-fold more potent than etidronate in vivo). The pharmacokinetics of alendronate are similar to those of other bisphosphonates. After a 2-h intravenous infusion, plasma concentrations
B. J. Gertz; S. D. Holland; W. F. Kline; B. K. Matuszewski; A. G. Porras
Since its introduction, capillary electrophoresis has diversified, spreading out into different specialized fields covering solutions for almost any analytical questions arising in research laboratories. In the context of clinical chemistry, results must be provided at low costs and in a clinically relevent time frame; however, the attributes which have made capillary electrophoresis such a successful tool in basic research are
Rainer Lehmann; Wolfgang Voelter; Hartmut M. Liebich
Evidence-based decision making is becoming increasingly important in healthcare. Much valuable evidence is in the form of the results from clinical trials that compare the relative merits of treatments. For this, in previous papers, we have proposed a general framework for representing and synthesizing knowledge from clinical trials involving the same outcome indicator. Now, in this paper, we present a
Anthony Hunter; Matthew Williams
Nanotechnology–the creation and utilization of materials, devices, and systems through the control of matter on the nanometer–has been applied to molecular diagnostics. This article reviews nanobiotechnologies that are clinically relevant and have the potential to be incorporated in clinical laboratory diagnosis. Nanotechnologies enable the diagnosis at single cell and molecule level and some of these can be incorporated in the
Kewal K. Jain
A recently established program of clinical psychological service in all general hospitals and in the major station hospitals is analyzed under the following headings: scope of the program, qualifications of clinical psychologists, administration of the hospital program, and training of professional personnel.
M. A. Seidenfeld
Reviews recent experimental evidence on the hypnotic treatment of obesity, cigarette smoking, alcoholism, clinical pain, warts, and asthma. It is concluded that although hypnosis may be effective with addictive behavior, the therapeutic success is attributable to nonhypnotic factors. In contrast, hypnosis appears to be of unique value in the treatment of clinical pain, warts, and asthma. Differential effectiveness may be
Thomas A. Wadden; Charles H. Anderton
A physiological model of nearpoint stress, based on autonomic arousal, was presented in a companion paper. This paper deals with clinical implications of the nearpoint stress model, including clinical manifestations, adaptive responses to nearpoint stress, and management of nearpoint stress-induced vision disorders. PMID:4008858
Birnbaum, M H
|This manual contains information concerning the policies and procedures of the Southern Illinois University-Carbondale Dental Hygiene Clinic. The manual is presented in a question/answer format for the information and convenience of dental hygiene students in the program, and is intended to answer their questions concerning clinical policies and…
|The practice of mindfulness is increasingly being integrated into contemporary clinical psychology. Based in Buddhist philosophy and subsequently integrated into Western health care in the contexts of psychotherapy and stress management, mindfulness meditation is evolving as a systematic clinical intervention. This article describes…
Salmon, Paul; Sephton, Sandra; Weissbecker, Inka; Hoover, Katherine; Ulmer, Christi; Studts, Jamie L.
|This tutorial paper examines the potential of otoacoustic emissions (OAEs) in diagnostic audiology. It discusses classification of OAEs, basic properties of various types of OAEs, and clinical applications. It concludes that both transiently evoked and distortion product OAEs have beneficial clinical application resulting from their objectivity,…
Lonsbury-Martin, Brenda L.; And Others
Medical students have been rating clinical teaching in an obstetrics and gynecology clerkship at the University of Washington using an assessment form designed to reflect six factors of clinical teaching effectiveness. High interrater reliability and the utility of the data for faculty development and advancement are discussed. (Author/JMD)
Irby, David; Rakestraw, Philip
|THE RATIONALE OF A CLINICAL APPROACH TO RESEARCH ON TEACHER BEHAVIOR IS SET FORTH TOGETHER WITH INDICATION OF DIFFICULTIES. IN ONE CLINICAL STUDY, RECORDS OF FOCUSED OBSERVATIONS OF TEACHER BEHAVIOR WERE REVIEWED BY A SPECIALIST IN LEARNING AND A SPECIALIST IN SOCIAL PSYCHOLOGY IN RELATION TO RESEARCH FROM THESE FIELDS. TEACHER DECISIONS PROVED…
WARD, TED W.
Rapid identification of microorganisms in the clinical microbiology laboratory can be of great value for selection of optimal patient management strategies for infections caused by bacteria, viruses, fungi, mycobacteria, and parasites. Rapid identification of microorganisms in clinical samples enables expedient de-escalation from broad-spectrum agents to targeted antimicrobial therapy. The switch to tailored therapy minimizes risks of antibiotics, namely, disruption of normal flora, toxic side effects, and selective pressure. There is a critical need for new technologies in clinical microbiology, particularly for bloodstream infections, in which associated mortality is among the highest of all infections. Just as importantly, there is a need for the clinical laboratory community to embrace the practices of evidence-based interventional laboratory medicine and collaborate in translational research projects to establish the clinical utility, cost benefit, and impact of new technologies.
Wolk, Donna M.; Dunne, W. Michael
Clinical inquiry is the ongoing process of questioning and evaluating practice, providing informed practice based on best-available data, and innovating practice though research. It is about noticing subtle differences at the bedside and asking "what if" questions. Critically ill patients and their families require care that is based on our best-available evidence. In the quantitative research paradigm, the highest level of evidence is derived from randomized controlled clinical trials. Currently, few adequately powered clinical trials support our practice, but this is changing. In critical care, clinical research should be conducted in the same manner as we practice, collaboratively within multidisciplinary teams. Our core value of the primacy of patient and family, our spirit of inquiry, and our passion for innovation centers our practice. During this year's Distinguished Research Lecture, Martha Curley describes how together, we can build stronger, bolder clinical research. PMID:22751365
Curley, Martha A Q
Data generated in all clinical trial are recorded on the data collection instrument Case report Form / Electronic Case Report Form by investigators located at various sites in various countries. In multicentric clinical trials since different investigator or medically qualified experts are from different sites / centers recording the medical term(s) uniformly is a big challenge. Medical coders from clinical data management team process these terms and perform medical coding. Medical coding is performed to categorize the medical terms reported appropriately so that they can be analyzed/reviewed. This article describes process which is used for medical coding in clinical data management and two most commonly used medical dictionaries MedDRA and WHO-DDE in brief. It is expected to help medical coders to understand the process of medical coding in clinical data management. Few common issues which the medical coder faces while performing medical coding, are also highlighted. PMID:21829779
Background: Clinical reasoning has long been a valuable tool for health care practitioners, but it has been under-researched in the field of massage therapy. Case reports have been a useful method for exploring the clinical reasoning process in various fields of manual therapy and can provide a model for similar research in the field of massage therapy. A diagnostically challenging case concerning a client with low back pain serves as a guideline for examining the clinical reasoning process of a massage therapist. Methods: A two-part methodology was employed: Client profileReflective inquiry The inquiry included questions pertaining to beliefs about health problems; beliefs about the mechanisms of pain; medical conditions that could explain the client’s symptoms; knowledge of the client’s anatomy, assessment, and treatment choices; observations made during treatment; extent of experience in treating similar problems; and ability to recognize clinical patterns. Results: The clinical reasoning process of a massage therapist contributed to a differential diagnosis, which provided an explanation for the client’s symptoms and led to a satisfactory treatment resolution. Conclusion: The present report serves as an example of the value of clinical reasoning in the field of massage therapy, and the need for expanded research into its methods and applications. The results of such research could be beneficial in teaching the clinical reasoning process at both the introductory and the advanced levels of massage therapy education.
Background With the volume of medical research currently published, any one practitioner cannot independently review the literature to\\u000a determine best evidence-based medical care. Additionally, non-specialists usually do not have the experience to know best\\u000a practice for all of the frequent clinical circumstances for which there is no good evidence. Clinical practice guidelines\\u000a (CPGs) help clinicians to address these problems because they
J. Stuart Wolf; Heddy Hubbard; Martha M. Faraday; John B. Forrest
Our understanding of the molecular and pathophysiological mechanisms underlying the disease process in patients with ?-thalassemia intermedia has substantially increased over the past decade. Earlier studies observed that patients with ?-thalassemia intermedia experience a clinical-complications profile that is different from that in patients with ?-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.
Musallam, Khaled M.; Taher, Ali T.; Rachmilewitz, Eliezer A.
The United States District Court, D. South Carolina, Greenville Division, 5 February 1999 [date of decision], ruled that a state regulation of abortion clinics was so burdensome as to be unconstitutional and issued an injunction preventing its enforcement. The twenty-seven pages of regulations applied only to abortion clinics performing five or more first trimester abortions per month and not to those performing less. The excessively detailed requirements on clinic licensing were in effect an undue burden on a woman's right to an abortion and thus violated both the Due Process and the Equal Protection clauses of the U. S. Constitution. PMID:12664905
A method is provided for a virtual clinic to establish communications and working relationships among itself, patients, physicians, and insurance companies patient to facilitate the remote diagnosis and treatment of patients. In one embodiment, a patient may contact its insurance carrier via a web page on the Internet. The insurance company then matches the patient to one of its plans and then forwards information to the virtual clinic which then responds to the patient's web request. The patient is then put in operative communication with a physician who is known by the virtual clinic to be licensed to practice medicine in the patient's current location and to have expertise in the patient's condition.
Haq; Mohamed M. (Galveston County, Friendswood, TX)
Text Version... placed on integrating scientific information and using various technical tools (eg ... Drug Interaction Studies-Decision Tree (Refer to Journal of Clinical ... More results from www.fda.gov/downloads/aboutfda/centersoffices
... Information for Clinical Investigators (INDs). ... During these trials, an investigation compound is administered to humans and is evaluated for its safety ... More results from www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved
Skip to Content Search this site Clinical Assay Development Program (CADP) Do you need: Advice on further development of a cancer diagnostics assay? Assay optimization? Design or implementation of assay controls, assay standards or assay calibrators? Determination
Clinical trials employing immunotherapy frequently involve patients with many different types of cancer. Accordingly, this Cancergram focuses on the immunotherapy employed rather than the disease diagnosis. Adoptive, active specific, and active non-specif...
A microbiological and clinical study of the action of piperacillin is presented. The drug showed an excellent in vitro antibacterial action on gram positive and gram negative microorganisms. Its in vitro action on Ps. aeruginosa (70.8% of strains inhibited) was also extremely interesting, making it the second most effective of the antibiotics tested after polymyxin B and colistin, polypeptides unsuitable for clinical use. In vivo, the administration of piperacillin achieved a clinical and bacteriological cure in 35 out of 40 patients and a clinical cure in 2 out of 40. It was only therapeutically unsuccessful in 3 cases. It is concluded that its microbiological, kinetic and tolerance features make piperacillin suitable for a wide range of therapeutic purposes. PMID:6223239
Soranzo, M L; Capra, E; Angela, G C; Salassa, B; Bramato, C; Andreoni, G; Pizzo, L; Musso, E; Spezia, C; Cignolo, G; Di Nola, F
Clinical trials employing immunotherapy frequently involve patients with many different types of cancer. Accordingly, this Cancergram focuses on the immunotherapy employed rather than the disease diagnosis. Adoptive, active specific, and active nonspecifi...
The Clinical Proteomic Tumor Analysis Consortium (CPTAC) is a comprehensive and coordinated effort to accelerate the understanding of the molecular basis of cancer through the application of robust, quantitative, proteomic technologies and workflows.
Text Version... Ultrasound biomicroscopy can be used to perform a darkroom provocative test ... at the University of Wisconsin and one of its satellite clinics between ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess
Biomarkers are the measurable characteristics of an individual that may represent risk factors for a disease or outcome, or that may be indicators of disease progression or of treatment-associated changes. In general, the process by which biomarkers, once identified, might be translated into clinical practice has received scant attention in recent psychiatric literature. A body of work in diagnostic development suggests a framework for evaluating and validating novel biomarkers, but this work may be unfamiliar to clinical and translational researchers in psychiatry. Therefore, this review focuses on the steps that might follow the identification of putative biomarkers. It first addresses standard approaches to characterizing biomarker performance, followed by demonstrations of how a putative biomarker might be shown to have clinical relevance. Finally, it addresses ways in which a biomarker-based test might be validated for clinical application in terms of efficacy and cost-effectiveness.
|This master's thesis presents several instructional methods and techniques developed for each of eleven topics or subject areas in clinical chemistry: carbohydrate metabolism, lipid metabolism, diagnostic enzymology, endocrinology, toxicology, quality control, electrolytes, acid base balance, hepatic function, nonprotein nitrogenous compounds,…
The processing of Case Report Form data collected in clinical trials is a data processing task unlike any other. Conventional systems approaches to clinical data management are not responsive to user demands and require excessive amounts of manpower to support. The Clinical Data Management System implemented at Merck utilizes Infodata 's Inquire database management software, IBM's CICS communications software, IBM's VSAM file management software, and SAS Institute's SAS software. System flexibility was the paramount consideration when the CDMS was designed. Clinical data at Merck is now processed on a system that provides on-line ad hoc retrieval capabilities through a user friendly query language, and allows for drug specific database designs coupled with a common update and retrieval mechanism. PMID:10278245
Schwartz, S; George, R; Owenr, J; Edson, J
Text Version... In general, there is agreement with the investigator's description of the endoscopy videos and what was observed by the FDA clinical review team. ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess
Skip to Content Cancer Control and Population Sciences Home Applied Research Home Ductal Carcinoma in Situ Research Resources Funded DCIS Projects: Awarded NIH Grants Research with Non-NIH Funding Clinical Trials DCIS Resources: About Workshop Funding Funded
The purpose of this article is to motivate the use of effect size (ES) for single-subject research in clinical phonology, with an eye towards meta-analyses of treatment effects for children with phonological disorders. Standard mean difference (SMD) is introduced and illustrated as one ES well suited to the multiple baseline (MBL) design and evaluation of generalization learning, both of which are key to experimental studies in clinical phonology.
Gierut, Judith A.; Morrisette, Michele L.
? Abstract When clinical psychologists make judgments, are they likely to be cor- rect or incorrect? The following topics are reviewed: (a) methodological,advances,in evaluating the validity of descriptions of personality and psychopathology, (b) recent findings on the cognitive processes of clinicians, and (c) the validity of judgments and utility of decisions made,by mental,health professionals. Results from research on clinical judgment,and
Howard N. Garb
American College of Radiology Imaging Network (ACRIN)ACRIN is an international cooperative group sponsored by NCI's Cancer Imaging Program (CIP) as well as philanthropies. Through clinical trials of diagnostic imaging and image-guided therapeutic technologies, ACRIN's goal is to generate information that will lengthen and improve the quality of the lives of cancer patients. ACRIN's clinical trials address both existing and emerging technologies as they apply to cancer screening, diagnosis, staging, imaging as a biomarker, and image-guided treatment.
Purpose To define and discuss unnecessary clinical tests in ophthalmology, review the justifications commonly given by clinicians for obtaining unnecessary clinical tests, and suggest a more rational approach to clinical testing in the future. Methods The author defines an unnecessary clinical test as a test on a human subject that is unlikely to influence that patient’s diagnosis, prognosis, or management or is performed exclusively, primarily, or in large part for research purposes. Results Examples of clinical tests the author categorizes as unnecessary are tests performed to evaluate a new or nonstandard diagnostic instrument or method; tests performed to evaluate sensitivity, specificity, and predictive value of a new instrument or method; tests obtained to provide images or data for future analysis, presentation, or publication; tests obtained routinely in patients of a certain class or category without regard to the individual’s personal characteristics, recent clinical history, or clinical signs; and duplicate tests performed without retrieval and review of recent prior tests of the same types and determination of the quality of and findings revealed by those tests. Several justifications that are commonly given by clinicians for their ordering of unnecessary tests are presented, and each of these justifications is critiqued. The principal problems with unnecessary testing are increased costs of medical care, worsening rather than improvement in patient outcomes, and unethical practice. Conclusion Unnecessary testing is perhaps an unavoidable aspect of current clinical ophthalmic practice in the United States. In spite of this, clinicians (especially academic ophthalmologists) need to be aware of this issue and take appropriate steps to minimize such testing.
Augsburger, James J
This article addresses the essential components of the clinical image evaluation process for mammography examinations. The American College of Radiology Mammography Accreditation Program has specified 8 categories of image evaluation that are addressed in this article. While focused on the 2-view screening examination, the same general principles should apply to diagnostic mammograms. This article specifically focuses on the clinical image evaluation process as it applies to digital mammography. PMID:20868893
Bassett, Lawrence W; Hoyt, Anne C; Oshiro, Thomas
The introduction of recombinant human erythropoietin (RHuEPO) has revolutionised the treatment of patients with anaemia of chronic renal disease. Clinical studies have demonstrated that RHuEPO is also useful in various non-uraemic conditions including haematological and oncological disorders, prematurity, HIV infection, and perioperative therapies. Besides highlighting both the historical and functional aspects of RHuEPO, this review discusses the applications of RHuEPO in clinical practice and the potential problems of RHuEPO treatment.
Ng, T; Marx, G; Littlewood, T; Macdougall, I
\\u000a From its very beginning, modern scientific psychology has dealt with issues regarding mind-body, health-disease relationships;\\u000a in particular, clinical psychology, in its various applications, has tried to provide a structure to psychological concepts\\u000a tied to organic disease. Clinical psychology is described as the “area of psychology whose objectives are the explanation,\\u000a understanding, interpretation and reorganization of dysfunctional or pathological mental processes,
E. Molinari; L. Bellardita; A. Compare
Clinical excellence requires the consideration of many factors--the dentist's own level of expertise and the collaborative effort of the clinical team. The Standard Operating Procedures (SOPs) method of standardization can help a dentist move closer to that objective by allowing the completion of each task according to tested, successful protocols and can mean the difference between occasionally hitting the mark and consistently achieving greatness. PMID:15119564
Background:Clinical performance measurement is an increasingly important way for public and private purchasers alike to compare the value of health services provided by competing health delivery systems. The widespread use of performance measures has increased the demand for development of new measures that cover previously unevaluated aspects of care.Methods:Four steps required to develop a clinical performance measure that is suitable
Elizabeth A. McGlynn; Steven M. Asch
Clinical cardiac electrophysiology is a subspecialty of cardiology dealing with the evaluation and management of patients\\u000a with complex rhythm or conduction abnormalities. In the last four decades, clinical cardiac electrophysiology has evolved\\u000a into an established discipline credited with improving and saving hundreds of thousands of lives. We briefly review the basic\\u000a electrophysiologic principles, anatomy of the electric system of the
Senthil Thenappan; Jaffar Ali Raza; R. Wayne Kreeger; Assad Movahed
The recording of cochlear and auditory nerve potentials in humans via Electrocochleography (ECochG) has emerged as a valuable tool for a variety of clinical applications. This review consolidates current research on the use of cochlear potentials Ménière’s disease\\/ and ECochG in the clinical setting and identifies several areas in need of additional study. Methodological topics discussed include a review of
John A. Ferraro; Geetha Krishnan
This review summarizes current clinical use of the forced oscillation technique (FOT) for analysis of lung function. It presents an intuitive approach to FOT pattern recognition for interpretation of results in human subjects, and the view that FOT is now well established and, clinically, eminently useful in patients with airflow obstruction. The focus of this review is on findings that relate directly to clinical utility, with less emphasis on theoretical mechanisms. The major thrust for clinical application of FOT derives from a number of European clinical research centers. Farre and Navajas and their colleagues in Barcelona, Harf and the Lorinos and their coworkers in Paris, Peslin and Duvivier and their coworkers in Vandoeuvre-les-Nancy, Pride and coworkers in London, and Van de Woestijne, Clement, Demedts, Landser, Van Noord, and their colleagues in Leuven have essentially been responsible for clinical development of FOT over the past 25 years. Publishing space does not permit an exhaustive listing of the many contributions of these investigators, but it is intended that the present review will provide a useful infrastructure from which the reader may progress to other research citations as desired. PMID:11603948
Goldman, M D
Objectives Due to the increasing use of electronic patient records and other health care information technology, we see an increase in requests to utilize these data. A highly level of standardization is required during the gathering of these data in the clinical context in order to use it for analyses. Detailed Clinical Models (DCM) have been created toward this purpose and several initiatives have been implemented in various parts of the world to create standardized models. This paper presents a review of DCM. Methods Two types of analyses are presented; one comparing DCM against health care information architectures and a second bottom up approach from concept analysis to representation. In addition core parts of the draft ISO standard 13972 on DCM are used such as clinician involvement, data element specification, modeling, meta information, and repository and governance. Results Six initiatives were selected: Intermountain Healthcare, 13606/OpenEHR Archetypes, Clinical Templates, Clinical Contents Models, Health Level 7 templates, and Dutch Detailed Clinical Models. Each model selected was reviewed for their overall development, involvement of clinicians, use of data types, code bindings, expressing semantics, modeling, meta information, use of repository and governance. Conclusions Using both a top down and bottom up approach to comparison reveals many commonalties and differences between initiatives. Important differences include the use of or lack of a reference model and expressiveness of models. Applying clinical data element standards facilitates the use of conceptual DCM models in different technical representations.
Goossen-Baremans, Anneke; van der Zel, Michael
Juvenile dermatomyositis (JDM) is a multisystem inflammatory disease of unknown etiology that affects primarily the skin and muscles. Although the prognosis of JDM has improved considerably in the last three decades, a number of patients may develop irreversible damage due to the disease activity or its treatment. This damage may cause permanent disability and affect the quality of life of patients and their families. In the clinical management of patients with JDM, there is, therefore, the need of monitoring the level of disease activity, the accrual of organ damage, and the impact of the illness on patients' daily living. A reliable assessment of these different aspects of disease requires the availability of well-designed and standardized clinical tools. In the recent years, there has been increasing collaborative effort to devise new assessment measures and these measures have been included into disease activity and damage core sets of outcome variables that have been developed through international consensus. In addition, preliminary definitions of clinical improvement for patients with JDM and other idiopathic inflammatory myopathies have been created. In this review, the latest advances in the development of standardized instruments for the clinical assessment of JDM patients are illustrated and the recent international efforts that have led to the development of core sets of outcome measures and to preliminary definitions of improvement for JDM clinical trials are summarized. PMID:16769653
Ravelli, Angelo; Ruperto, Nicolino; Trail, Lucia; Felici, Enrico; Sala, Elena; Martini, Alberto
Heeding the words of their father, one Dr. W.W. Mayo, ÂNo one is big enough to be independent of othersÂ, Dr. William J. Mayo and Dr. Charles H. Mayo helped create one of the worldÂs first private integrated group practices of medicine. Now known as the Mayo Clinic, the story of their work is closely intertwined with the story of American medical history. As an attempt to bring this story to the web-browsing public, staff members at the Clinic recently created this historical timeline that offers some perspective on their institutional history. With their mouse in hand, visitors can move across the interactive timeline, which deploys high-quality photographs and short descriptions in its quest to document the ClinicÂs various achievements, such as the creation of the first heart bypass machine in 1955. Finally, online visitors can get up close and personal to some of the artifacts that are close to the Mayo Clinic traditions, including a 1904 photograph of some of the medical staff at the Clinic.
The oncology nurse may assume many different roles in clinical trials, including direct care provider, educator, advocate, data collector, primary investigator, and member of the IRB. Regardless of the role, the nurse is in a key position to promote the interests of the individual subject as well as helping to assure that the clinical trial is conducted with scientific and ethical integrity. The nurse can help to assure that the subject is adequately informed and facilitate rational decision making. The nurse can also assure that the requirements of the protocol are consistently attended to and that subjects are well monitored and data precisely collected. "In oncology, perhaps more than in any other medical specialty, there is a blurring of the distinction between research, therapeutic innovation, and medical practice. The frontiers of knowledge in cancer are continuously advancing. The final step in the process of procuring usable knowledge is the clinical trial, a meeting place of the practice of medicine and clinical research. Because of this there are many ethical considerations which must be attended to in the justification of and conduct of a clinical trial. PMID:1775780
This series of Clinical Pearls presents four cases presenting with infection. Each of these cases had clinical clues to the correct diagnosis, which could be picked up on meticulous history, clinical examination, or basic laboratory investigations. The authors highlight the important lessons to be learnt from each case. The first is a 7 year old boy with recurrent respiratory tract infections since early life. Clinical examination revealed the presence of dextrocardia and situs inversus and bronchiectasis leading to a diagnosis of Primary Ciliary Dyskinesia. The second case is a 1.5-month-old infant who presented with meningitis and increasing head size since birth. CSF examination and CT scanning led to the correct diagnosis of congenital Toxoplasmosis. The next case is an infant with high grade fever and neck swelling. He had the rare Lemierre's syndrome comprising of oro-pharyngeal infection, suppurative thrompbophlebitis of the internal jugular vein and systemic dissemination of septic emboli. The fourth case is a 2-year-old infant with recurrent respiratory tract infections and discharging neck swellings from early life. Repeated testing for tuberculosis was negative. The diagnosis was Chronic granulomatous disease. The authors describe the clinical approach and investigations in these cases; along with an outline of the management. PMID:21625832
Singhi, Sunit; Mathew, Joseph; Jindal, Atul; Verma, Sanjay
... Statistics Research & Funding News About NCI Learn About Clinical Trials Reviewed: 05/26/2005 Children's Assent Background The ... Clinical Trials States Requiring Coverage Children's Assent to Clinical Trial Participation If you are considering enrolling your child ...
Myeloproliferative/Myelodysplastic Disorders - Featured Clinical Trials The following list shows Featured Clinical Trials for a specific type of cancer. You may also want to view: Multiple Cancer Types - Featured Clinical Trials Supportive Care - Featured
CLINICAL CYTOGENETICS LABORATORY NIH/NCI/CCR LABORATORY OF PATHOLOGY TEST REQUEST FORM DATE AND TIME SPECIMEN OBTAINED WARD/CLINIC SPECIMEN DESCRIPTION PATIENT NAME SEX RACE IDENTIFICATION NO. DOB AGE DIAGNOSIS BRIEF CLINICAL HISTORY/PERTINENT
...DEPARTMENT OF DEFENSE Office of the Secretary Cancer Treatment Clinical Trials AGENCY: Office...expand a current demonstration for breast cancer treatment clinical trials to include all cancer treatment clinical trials under approved...
Imaging clinical trials take place in doctor's offices, cancer centers, other medical centers, community hospitals and clinics, and veterans' and military hospitals in cities and towns across the United States and in other countries. Imaging clinical
The Journal of Clinical Endocrinology & Metabolism (JCE&M) online, featuring original works in clinical practice and applied clinical research, begins January 1997 (Vol 82), abstracts from February 1975 (Vol 40), and tables of contents from September 1965.
Over the years, medical imaging has become very common and data intensive. New technology is needed to help visualize and analyze these large, complex data sets, especially in an acute care situation where time is of the essence. Also it is very important to present the data in an efficient and simple manner to aid the clinical decision making processes. There is a need for a clinical workstation that handles data from different modalities and performs the necessary post- processing operations on the data in order to enhance the image quality and improve the reliability of diagnosis. This paper briefly explains clinical workstation, emphasizing the requirements and challenges in design and architecture for the development of such systems.
Narayanan, Venkatesh; Vedula, Venumadhav [Philips Medical Systems, Bangalore, Karnataka, 560045 (India)
Approximately 20 per 100,000 people in the United States are currently living with myasthenia gravis (MG). MG is a chronic condition that occurs in all genders, ethnicities, and ages. The result of a defect at the neuromuscular junction, MG is characterized by fluctuating muscle weakness and fatigue. The purpose of the first edition of this American Association of Neuroscience Nurses' Clinical Practice Guideline is to summarize what is currently known about MG and to provide the reader with nursing-specific recommendations based on supporting evidence from nursing and other disciplines. Nursing Management of the Patient with Myasthenia Gravis includes information on epidemiology; types and classification of MG; pathophysiology; clinical features; clinical course; diagnostic tests; assessment; pharmacological, immunological, and surgical management; and the nurses' pivotal role in the care of the patient with MG. PMID:24025471
Blissitt, Patricia A
Proteomics has emerged from the labs of technologists to enter widespread application in clinical contexts. This transition, however, has been hindered by overstated early claims of accuracy, concerns about reproducibility, and the challenges of handling batch effects properly. New efforts have produced sets of performance metrics and measurements of variability that establish sound expectations for experiments in clinical proteomics. As researchers begin incorporating these metrics in a quality by design paradigm, the variability of individual steps in experimental pipelines will be reduced, regularizing overall outcomes. This review discusses the evolution of quality assessment in 2D gel electrophoresis, mass spectrometry-based proteomic profiling, tandem mass spectrometry-based protein inventories, and proteomic quantitation. Taken together, the advances in each of these technologies are establishing databases that will be increasingly useful for decision-making in clinical experimentation. PMID:23246537
Tabb, David L
A number of anti-obesity drugs are currently undergoing clinical development. These include: (i) centrally-acting drugs, such as the noradrenergic and dopaminergic reuptake inhibitor radafaxine, the endocannabinoid antagonist rimonabant, the selective serotonin 5-HT2c agonist APD-356, and oleoyl-estrone; (ii) drugs that target peripheral episodic satiety signals, such as glucagon-like peptide-1 (exenatide, exenatide-LAR and liraglutide), peptide YY (intranasal PYY3-36 and AC-162325) and amylin (pramlintide); (iii) drugs that block fat absorption, such as the novel lipase inhibitors cetilistat and GT-389255; and (iv) a human growth hormone fragment (AOD-9604) that increases adipose tissue breakdown. Of these, only rimonabant has got as far as completing phase III clinical trials. This review will provide an overview of the most prominent drugs currently undergoing clinical development as potential anti-obesity therapies. PMID:16625817
Halford, Jason C G
The clinical evaluation of microbicide formulations presents variable and interacting challenges. Specific domains of acceptability, pharmacokinetics, and toxicity interact with each other to potentially inhibit or enhance a microbicide's efficacy. Each of these is further influenced by application and use parameters in the relative presence (or absence) of vaginal and/or seminal fluids, ultimately impacting effectiveness. Historically, acceptability of formulation and use parameters, and their concomitant behavioral influences, have been considered separately from pharmacokinetics and toxicity. While independent evaluation of these elements is necessary in some respects, we must acknowledge that this approach is not sufficient for the successful development of microbicides. Each needs to be considered in an integrated clinical evaluation strategy. This article presents the rationale for such an approach. This article forms part of a special supplement covering two presentations on clinical evaluation of microbicides from the symposium on “Recent Trends in Microbicide Formulations” held on 25 and 26 January 2010, Arlington, VA.
Morrow, Kathleen M.; Hendrix, Craig
As chairman of the Expert Panel on Instrumentation (EPI) of the International Federation of Clinical Chemistry (IFCC), I presided over its closed and open meetings held on June 29, 1987, and July 2, 1987, respectively. As chairman-elect of the Organizing Committee of the 1990 International Congress on Clinical Chemistry, I also attended the meeting of the IFCC Congress Committee to give a progress report. This report was subsequently also presented to the IFCC Executive Board and Council and to its corporate members. These meetings were held prior to, or in conjunction with, the 13th International Congress of Clinical Chemistry. Consequently, I had an opportunity to attend several of the scientific sessions and the Trade Exposition of the Congress.
This paper presents the data examples for clinical application of the authors' original thermographic techniques named developmental thermography (DT); (1) triple aspect thermography (TAT), (2) multiple aspect thermography (MAT) and (3) panoramic thermography (PT). Appropriate examples for the advantageous application for each technique of DT are selected and the specific advantages are discussed. The greatest advantage in the clinical application of DT is the capability of simultaneous display of the thermogram over even the entire aspect of a subject, and so DT has a lot of advantages in clinical application. Error free and wide coverage in DT are especially useful for the diagnosis of cancer. DT is expected to contribute to future advance of medical thermology.
Nagasawa, Akinori; Katoh, Kazuichi
Invasive aspergillosis, chronic pulmonary aspergillosis and allergic bronchopulmonary aspergillosis are the clinical forms of aspergillosis. Although there is a great number of Aspergillus species, Aspergillus fumigatus-complex is the more frequent aetiological agent, regardless of clinical form or baseline condition. The increase in immunosuppressive agents and the higher use of corticosteroids in chronic obstructive pulmonary disease have led to aspergillosis becoming more prominent in recent years. Galactomannan detection and radiological diagnostic images complement the limitations of microbiology cultures in these patients. Voriconazole and liposomal amphotericin B are the gold standard in patients requiring therapy, and posaconazole, itraconazole, caspofungin and other echinocandins are effective alternatives. The prognosis depends of clinical forms and characteristics of the host, but it is particularly poor in the disseminated invasive forms. PMID:22341751
Fortún, Jesús; Meije, Yolanda; Fresco, Gema; Moreno, Santiago
Background: Moebius syndrome (MBS) is an infrequent disease, having an incidence of 1 in 10,000 births, mainly characterized by a congenital bilateral facial paralysis due to an agenesia of the sixth and seventh cranial nerves. In addition, orofacial and limb anomalies are frequently found in these patients. The diagnosis is fundamentally based on different clinical manifestations of the disorder. Clinical case: a female newborn with the clinical picture of Moebius syndrome is presented, and genetic or environmental aspects are discussed. Since the use of misoprostol for abortion and inducing uterine activity in combination with NSAIDs, the number of newborns with MBS associated with this drug has increased. Nowadays, either genetic or environmental factors are associated with MBS. Conclusions: it is necessary that the general and medical community be aware of the risk of teratogenic effects of misoprostol, and the usefulness of genetic counseling whenever there is a newborn with Moebius syndrome. PMID:24144154
Palmer-Morales, Yusvisaret; Zárate-Márquez, Rosario Elena; Prince-Vélez, Roberto; González-Méndez, Roberto; Zamarripa-Sandoval, Thania Ayerim; Verdugo-Salazar, Nahim; Torres-Félix, Victor Gabriel; Salcido-Daniel, Remigio; Valdez-Hernández, Pedro; Morfín-Vela, Andrés
The Arabic Scale of Death Anxiety (ASDA) was administered, individually, to 7 groups (N = 765) of Egyptian normal participants (non-clinical), anxiety disorder patients, and patients suffering from schizophrenia (males and females), and addicts (males only). They were generally matched as groups according to age, occupation, and education. The female and male anxiety disorder patients means were, respectively, significantly higher than the
AHMED M. ABDEL-KHALEK
BACKGROUND: The impact of global and tissue-specific brain atrophy on conversion to multiple sclerosis (MS) after a clinically isolated syndrome (CIS) is not fully gauged. OBJECTIVES: We aimed to determine the magnitude and clinical relevance of brain volume dynamics in the first year after a CIS. METHODS: We assessed 176 patients with CIS within 3 months of onset, clinically and by conventional magnetic resonance imaging (MRI) scans, at baseline and 1 year after clinical onset. We determined the percentage of brain volume change (PBVC) and the brain parenchymal (BPF), grey matter (GMF) and white matter (WMF) fractions. RESULTS: The mean follow-up time was 53 months (SD = 16.8): 76 patients (43%) experienced a second attack, 32 (18%) fulfilled MRI-only 2005 McDonald criteria and 68 (39%) remained as CIS. Statistically significant decreases in the volume measures tested were observed in patients with a second attack, for BPF and PBVC; in both MS groups for GMF; whereas in all groups, the WMF was unchanged. Patients with a second attack had larger PBVC decreases (- 0.65% versus + 0.059%; p < 0.001). PBVC decreases below - 0.817% independently predicted shorter times to a second attack. CONCLUSIONS: Global brain and grey matter volume loss occurred within the first year after a CIS; brain volume loss predicted conversion to MS. PMID:23652215
Pérez-Miralles, F; Sastre-Garriga, J; Tintoré, M; Arrambide, G; Nos, C; Perkal, H; Río, J; Edo, Mc; Horga, A; Castilló, J; Auger, C; Huerga, E; Rovira, A; Montalban, X
The principal investigators and staff scientists of the Center for Cancer Research (CCR) are conducting outstanding, cutting-edge, basic and clinical research on cancer, and translating these discoveries into treatment and prevention that will reduce the burden of cancer in humans.
...Administration [Docket No. FDA-2013-N-0001] Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices...will be open to the public. Name of Committee: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical...
... Return to General Biologics Guidances. 2013 | 2012 | 2011 | 2010 | 2009 | 2007 | 2006 | 2005 | 2004 | 2001 | 2000 | 1999 | 1998 | 1995 |. ... 2012, ... More results from www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances
The shoulder joint is complex in structure and functionality. It is often difficult to assess clinically due to the great variety of associated pathology. This article presents an overview of the anatomy of the shoulder region and associated pathologies, whilst providing a summary of the clinical examination of the shoulder and associated ‘special tests’. A full history is vital when assessing shoulder pathology. No particular test is fully sensitive or specific alone and accuracy varies between both clinicians and patients alike. Assessment of the shoulder should be conducted systematically with a range of tests combined.
Donnelly, Thomas D; Ashwin, Sridhar; MacFarlane, Robert J; Waseem, Mohammed
Cysticercosis is a potentially fatal parasitic disease caused by cysticercus cellulosae, the larval stage of Taenia solium. Oral cysticercosis is a rare entity and represents difficulty in clinical diagnosis. This article reports two cases of oral cysticercosis involving buccal and labial mucosa. Both the cases presented with solitary, nodular swelling that had been clinically diagnosed as a mucocele. Histopathology of excisional biopsy revealed it to be cysticercosis. Single, cystic nodular swelling of oral cavity may be the only evidence of cysticercosis and may present first to dentist. These cases emphasise the role of dentist and thorough histopathological examination in the early diagnosis of disease that can prevent potential systemic complication. PMID:23580668
Wanjari, Sangeeta Panjab; Patidar, Kalpana A; Parwani, Rajkumar N; Tekade, Satyajitraje A
Written in outline format, this reference will help nurses further their understanding of advanced nursing procedures. Information is provided on the physiological, psychological, environmental, and safety considerations of nursing activities associated with diagnostic and therapeutic procedures. Special consideration is given to the areas of pediatric nursing, nursing assessment, and selected radiologic and nuclear medicine procedures for each system. Contents: Clinical Introduction. Clinical Nursing Practice: Focus on Basics. Focus on Cardiovascular Function. Focus on Respiratory Function. Focus on Gastrointestinal Function. Focus on Renal and Genito-Urological Function. Focus on Neuro-Skeletal and Muscular Function. Appendices.
Asheervath, J.; Blevins, D.R.
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.
Wang, You; Xu, Hui; Zhang, Jianming; Li, Guang
Seborrheic dermatitis is a chronic relapsing inflammatory skin condition characterized by scaling and poorly defined erythematous patches in areas rich in sebaceous glands. It is one of the most frequent skin disorders and may be socially embarrassing. Fungi of the genus Malassezia, lipid-dependent, ubiquitous skin residents, play a pathogenic role. Topical antifungal agents (e.g., ketoconazole) are the mainstay of treatment, and if used intermittently they can maintain remission. The vehicle itself may also play a relevant role. Improvements in diagnostic criteria, severity measures and outcome variables are needed to better design clinical trials and inform clinical practice. PMID:21572485
Rovelli, Francesca; Mercuri, Santo Raffaele; Naldi, Luigi
We combined two-photon fluorescence and coherent anti-Stokes Raman scattering (CARS) imaging in a clinical hybrid multiphoton tomograph for in vivo imaging of human skin. The clinically approved TPEF/CARS system provides simultaneous imaging of endogenous fluorophores and non-fluorescent lipids. The Stokes laser for the two-beam configuration of CARS is based on spectral broadening of femtosecond laser pulses in a photonic crystal fiber (PCF). We report on the highly flexible medical TPEF/CARS tomograph MPTflex®-CARS with an articulated arm and first in vivo measurements on human skin.
Weinigel, Martin; Breunig, Hans Georg; Kellner-Höfer, Marcel; Bückle, Rainer; Darvin, Maxim; Lademann, Juergen; König, Karsten
Pramipexol retard is the newest drug for the treatment of Parkinson's disease. The prolonged release of the agent in this preparation allows a more continuous dopaminergic stimulation than previous preparations, without reducing the agent's already known and proven clinical efficiency. In addition, it has a more favourable adverse effect profile than previous preparations, and patient compliance can also be better as it needs to be taken only once daily. These benefits have been proven in recent clinical studies, of which the most important ones are reviewed here. PMID:20648781
Klivényi, Péter; Vécsei, László
Clinical practice guidelines are textual recommendations based on the consensus of medical experts with the aim to solve diagnostic and therapeutic problems. For more advanced use in real medical applications it is necessary to find out mathematical models of physicians' decision-making processes. The acquisition of a formal model from text-based guidelines is a crucial point for development of decision support systems. We introduce a system for formalization and presentation of medical knowledge contained in clinical practice guidelines where knowledge formalization is based on the GLIF model. PMID:18487723
Buchtela, David; Peleska, Jan; Veselý, Arnost; Zvárová, Jana; Zvolský, Miroslav
... Geriatric Use Supplement Clinical Efficacy Trials Category. FDA Data Element Number. ... Geriatric Use Supplement Clinical Efficacy Trials Category. ... More results from www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements
|Discussion of the future of clinical dentistry looks at a variety of influences, including historical development factors; demographic trends; the role of the Human Genome Project in the development of scientific knowledge; a paradigm shift in approaches to oral infection and systemic disease; advancing technology; and reforms resulting from…
Slavkin, Harold C.
Purpose of review Ischemic preconditioning (IPC) is gaining attention as a novel neuroprotective therapy and could provide an improved mechanistic understanding of tolerance to cerebral ischemia. The purpose of this article is to review the recent work in the field of IPC and its applications to clinical scenarios. Recent findings The cellular signaling pathways that are activated following IPC are now better understood and have enabled investigators to identify several IPC mimetics. Most of these studies were performed in rodents, and efficacy of these mimetics remains to be evaluated in human patients. Additionally, remote ischemic preconditioning (RIPC) may have higher translational value than IPC. Repeated cycles of temporary ischemia in a remote organ can activate protective pathways in the target organ, including the heart and brain. Clinical trials are underway to test the efficacy of RIPC in protecting brain against subarachnoid hemorrhage. Summary IPC, RIPC, and IPC mimetics have the potential to be therapeutic in various clinical scenarios. Further understanding of IPC-induced neuroprotection pathways and utilization of clinically relevant animal models are necessary to increase the translational potential of IPC in the near future.
Narayanan, Srinivasan V.; Dave, Kunjan R.; Perez-Pinzon, Miguel A.
AKI is an important public health issue. AKI is a common hospital complication associated with increased in-hospital and long-term mortality, extensive morbidity (including prolonged hospital length of stay), and an estimated annual cost of at least $10 billion in the United States. At present, no specific therapy has been developed to prevent AKI, hasten recovery of kidney function, or abrogate the deleterious systemic effects of AKI. However, recent progress includes establishing a consensus definition of AKI and discovery of novel biomarkers that may allow early detection of AKI. Furthermore, significant insights into the pathophysiology of AKI and its deleterious systemic effects have been gleaned from animal studies. Urgently needed are large, definitive randomized clinical trials testing interventions to prevent and/or treat AKI. This review summarizes and analyzes current ongoing clinical trials registered with clinicaltrials.gov that address prevention or management of AKI. The purpose of this review is to provide a resource for people interested in potential prophylactic and therapeutic approaches to patient care and investigators hoping to plan and execute the next round of randomized clinical trials. Finally, this review discusses research needs that are not addressed by the current clinical trials portfolio and suggests key areas for future research in AKI. PMID:22442183
Faubel, Sarah; Chawla, Lakhmir S; Chertow, Glenn M; Goldstein, Stuart L; Jaber, Bertrand L; Liu, Kathleen D
A report on the meeting organized by The Chromatographic Society and the Separation Science Group, Analytical Division of the Royal Society of Chemistry. Over 60 delegates and commercial exhibitors attended this event, held to celebrate the careers of Robert Flanagan and David Perrett, and acknowledge their extensive contributions in the field of clinical analysis. PMID:23330556
Couchman, Lewis; Mills, Graham A
As the healthcare system undergoes a transformation in scope and funding, there remain many unfinished projects which will be essential for the next generation of automated medical support services. The most demanding and labor intensive tasks for this new frontier deal with the accumulation of knowledge which can be used as a clinical database to support supervisory functions in a
Ralph R. Grams
Background: The diagnosis of Sever's injury (apophysitis calcanei) has previously been partly based on radiographic findings in the calcaneal apophysis. Sclerosis and fragmentation have been supposed to represent signs of inflammation due to tractions from the Achilles tendon. The clinical findings, diagnostic criteria, and studied population are often poorly defined. We sought to define diagnostic criteria by analyzing clinical and radiographic characteristics in a population with Sever's injury and to compare the findings with those of a control group of matched, symptom-free children. Methods: We assessed 30 consecutive children with Sever's injury with high levels of pain but high physical activity levels in sports activities and 15 pain-free matched controls. Results: One-leg heel standing showed 100% sensitivity; the squeeze test, 97%; and the palpation test, 80%. All three tests showed 100% specificity. All of the patients and controls showed increased density of the apophysis. Half of the pain-free controls showed fragmentation versus almost 90% of children with heel pain. Conclusions: The diagnosis of Sever's injury is clinical, not radiologic. Radiologic findings of increased density and fragmentation are found also in pain-free controls with high levels of physical activity and may, therefore, represent normal growth and development. We suggest that the diagnosis of Sever's injury should be based on patient history and the results of two specific clinical tests. PMID:24072363
Perhamre, Stefan; Lazowska, Dagmara; Papageorgiou, Sofia; Lundin, Fredrik; Klässbo, Maria; Norlin, Rolf
The purpose of this important paper by Doctor MacCurdy is to point out why psychiatric clinics in the schools may offer reasonable hope of reducing insanity in the later life of the pupils. And since it is undoubtedly true that the next problem of public health administration will be concerned with mental disorders, where better to begin than with the school child?
MacCurdy, John T.
This master's thesis presents several instructional methods and techniques developed for each of eleven topics or subject areas in clinical chemistry: carbohydrate metabolism, lipid metabolism, diagnostic enzymology, endocrinology, toxicology, quality control, electrolytes, acid base balance, hepatic function, nonprotein nitrogenous compounds, and…
A system for developing and producing clinical endpoints based on patient reported outcome data utilizing algorithms to generate decision rules to evaluate patient reported outcome type questionnaire is provided. The questionnaires can include health-related quality of life questionnaires and can predict the reliability of endpoints in supporting one or more medical labeling claims.
Paty; Jean (Pittsburgh, PA); Shields; Alan (Johnson City, TN); Gwaltney; Chad (Westerly, RI); Tiplady; Brian (Edinburgh, GB)
|The purpose of this article is to motivate the use of effect size (ES) for single-subject research in clinical phonology, with an eye towards meta-analyses of treatment effects for children with phonological disorders. Standard mean difference (SMD) is introduced and illustrated as one ES well suited to the multiple baseline (MBL) design and…
Gierut, Judith A.; Morrisette, Michele L.
The present prospective study aimed to identify risk factors for subsequent clinical burnout. Three hundred eighty-eight working individuals completed a baseline questionnaire regarding work stress, sleep, mood, health, and so forth. During a 2-year period, 15 subjects (7 women and 8 men) of the total sample were identified as \\
Marie Söderström; Kerstin Jeding; Mirjam Ekstedt; Aleksander Perski; Torbjörn Åkerstedt
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. PMID:23343656
The regeneration or restitution of lost supporting tissue has always been considered the ideal objective of periodontal therapy. However, attempts to convert this intention into solid clinical practice can become tremendously complex, the results of which are very different from the original intention. The aim of this article is to offer an up-to-date, general perspective on periodontal regeneration, orienting the
Francisco Manuel Alpiste Illueca; Pedro Buitrago Vera; Pablo de Grado Cabanilles; Vicente Fuenmayor Fernandez; Francisco José Gil Loscos
Clinical research is an important part of an academic surgery practice. To be successful, it is important to understand the multiple regularity committees and organizations that impact research. The author briefly reviews these groups and provides guidance on how to initiate and conduct research.
Fleshman, James W.
Robert Yarchoan, M.D., vividly remembers the day in 1981 when, as a Clinical Fellow in the Metabolism Branch of NCI, he saw a young man who had developed a profound immunodeficiency. That patient, who had almost no T lymphocytes, represented a moment in medical history—the first NIH patient with what would come to be known as acquired immunodeficiency syndrome (AIDS).
Joint impingement is a painful syndrome caused by the friction of joint tissues, which is both the cause and the effect of altered joint biomechanics. From the anatomical and clinical viewpoints, these syndromes are classified as bone impingement, soft tissue impingement and entrapment neuropathy, depending on what joint portion impinges on the others. We considered the most important impingement syndromes
Andrea Billi; Alessia Catalucci; Antonio Barile; Carlo Masciocchi
Clinical gait analysis allows the measurement and assessment of walking biomechanics, which facilitates the identification of abnormal characteristics and the recommendation of treatment alternatives. The predominant methods for this analysis currently include the tracking of external markers placed on the patient, the monitoring of patient\\/ground interaction (e.g. ground reaction forces), and the recording of muscle electromyographic (EMG) activity, all during
Roy B Davis
Discussion of the future of clinical dentistry looks at a variety of influences, including historical development factors; demographic trends; the role of the Human Genome Project in the development of scientific knowledge; a paradigm shift in approaches to oral infection and systemic disease; advancing technology; and reforms resulting from these…
Slavkin, Harold C.
A trained human being is, in many cases, the best diagnostician. This certainly remains true in medicine, but the success of new imaging technologies and clinical applications of molecular biology has meant that doctors are now inundated with diagnostic data. Although rule based systems have had some limited success assisting doctors, much concern remains about the poorly defined factors that
D. I. Lewin
Jellyfish produce clinical diseases in humans. Death from venom toxicity is more common than anaphylaxis. The main venom actions are on the cardiovascular, respiratory and renal systems and these agents may induce systemic symptoms accompanying their cutaneous lesions. Keloids, fat atrophy, gangrene, contractions, arthralgias, neuritis, hyperpigmentation, corneal ulcerations, vasospasm and post-envenomation herpes simplex or granuloma annulare may appear. Recurrent eruptions,
Joseph W. Burnett
Summary Mitochondrial disorders have long been regarded as neuromuscular diseases only. In fact, owing to the ubiquitous nature of the oxidative phosphorylation, a broad spectrum of clinical features should be expected in mitochondrial disorders. Here, we present eight puzzling observations which give support to the view that a disorder of oxidative phosphorylation can give rise to any symptom in any
A. Munnich; P. Rustin; A. Rötig; D. Chretien; J.-P. Bonnefont; C. Nuttin; V. Cormier; A. Vassault; P. Parvy; J. Bardet; C. Charpentier; D. Rabier; J.-M. Saudubray
Laparoscopic proctocolectomy is a safe and feasible but complicated procedure, which is widely used clinically. Fully understanding of surgical plane and vascular anatomy is important for operation. The anastomosis methods, the type of ileal reservoir pouch and whether or not performing protective ilostomy should be considered preoperatively. Many details should be paid attention to. PMID:23072018
Tao, Kai-xiong; Shuai, Xiao-ming
New applications for facility-based clinical practice continue to be the fastest growing area of interest in nursing informatics (Fig. 7.1). Although there are many technological advances discussed here, the areas of greatest interest are conceptual. Source data capture, the development and use of decision support and expert systems, and the development of a nursing minimum data set as they relate
Kathryn Hannah; Marion Ball; Margaret Edwards
Experimental studies have demonstrated that myocardium reperfused after reversible ischemia exhibits prolonged depression of contractile function (“stunning”). Despite the multiplicity of clinical situations in which myocardial stunning would be expected to occur, investigation of this phenomenon in humans has been hindered by several major problems, including the limited accuracy of the methods available to measure regional left ventricular function, the
Roberto Bolli; Craig J. Hartley; Raphael S. Rabinovitz
Research on bias in clinical trials may help identify some of the reasons why investigators sometimes reach the wrong conclusions about intervention effects. Several quality components for the assessment of bias control have been suggested, but although they seem intrinsically valid, empirical evidence is needed to evaluate their effects on the extent and direction of bias. This narrative review summarizes
Lise Lotte Gluud
Comments on the report by the APA Presidential Task Force on Evidence-Based Practice (see record 2006-05893-001) entitled Evidence-based practice in psychology. The Task Force is to be commended for their report valuing evidence from "clinical expertise" on a par with "research data" (p. 272) in guiding psychological practices. The current author…
Hunsberger, Peter Hume
Zusammenfassung Ziel der Studie. Diese Studie beschreibt die Konzipierung und Implementierung einer neuen Prüfungsform in der notfallmedizinischen Studentenausbildung, die die Anforderungen an eine moderne Prüfung erfüllt. Methodik. Am Ende des Kurses „Akute Notfälle und Erste Ärztliche Hilfe“ nahmen 32 Studenten am Probelauf eines Prüfungsparcours im Sinne eines Objective Structured Clinical Examination teil. Der Parcours bestand aus 11 Stationen, davon 7 theoretisch-fallorientierten, die
F. O. Weißer; B. Dirks; M. Georgieff
Information for patients, their families and friends, and the general public about how the rights and safety of people who take part in clinical trials are protected. Learn about informed consent, institutional review boards (IRB's), and how trials are closely monitored for safety.
Breath testing has the potential to benefit the medical field as a cost-effective, non-invasive diagnostic tool for diseases of the lung and beyond. With growing evidence of clinical worth, standardization of methods, and new sensor and detection technologies the stage is set for breath testing to gain considerable attention and wider application in upcoming years.
Paschke, Kelly M; Mashir, Alquam
There is a widespread view that clinical research is failing to advance appropriately, particularly in comparison with other aspects of biomedical science. I argue that this is due in part to an inadequate understanding of how medical advance occurs.The common usage of such terms as basic or fundamental, or the uncritical use of the term model is unhelpful—unhelpful, in that
Surveyed clinical psychology training programs and internships to estimate the impact of federal budget cutbacks. For the 1973–1974 academic year, there were 20 graduate school applicants and 9 internship applicants for each funded position. Funded positions decreased 9–22% compared with the previous year.
Cardiovascular measures are central to clinical psychophysiology. This article briefly describes the range of measures typically recorded in the laboratory and field. Laboratory testing procedures are outlined, and the theoretical bases for the selection of mental stress tests and the reliability of responses are discussed. New developments in the analysis of laboratory and ambulatory cardiovascular measures are described, including autoregressive
Andrew Steptoe; Derek Johnston
|This text examines the characteristics that define autism: impairments in communication; abnormal social development; and clinically significant odd behaviors. Specific chapters include: (1) Neural Mechanisms in Autism (Andrew W. Zimmerman and Barry Gordon); (2) Epidemiology of Autism and Other Pervasive Developmental Disorders: Current…
Accardo, Pasquale J., Ed.; Magnusen, Christy, Ed.; Capute, Arnold J., Ed.
A clinical and pathologic study of 38 hemangiomas of the placenta was carried out, with emphasis on the presence of other complications of pregnancy. One or more complications were found in 22 of the 38 patients; these included premature delivery, hydramn...
L. A. Asadourian H. B. Taylor
Modeling and simulation in general, and specifically clinical trial simulation (CTS), have been recognized by the (larger) pharmaceutical companies and regulatory authorities as being pivotal to improving the efficiency of the drug development process. This includes the use of CTS to learn about drug effectiveness and safety and to optimize trial designs at the various stages of development. By reviewing
N Holford; S C Ma; B A Ploeger
Hepatocellular carcinoma (HCC) is one of the most common cancers in the world. The resistance of HCC to existing treatments and the lack of biomarkers for early detection make it one of most hard-to-treat cancers. Surgical tumor resection, including liver transplantation, remains the only curative modality for HCC. Several clinical prognostic models have been developed for the staging of patients
Volker Meier; Giuliano Ramadori
Clinical disorders of brain plasticity are common in the practice of child neurology. Children have an enhanced capacity for brain plasticity compared to adults as demonstrated by their superior ability to learn a second language or their capacity to recover from brain injuries or radical surgery such as hemispherectomy for epilepsy. Basic mechanisms that support plasticity during development include persistence
Michael V. Johnston
There is much variation in the implementation of the best available evidence into clinical practice. These gaps between evidence and practice are often a result of multiple individual decisions. When making a decision, there is so much potentially relevant information available, it is impossible to know or process it all (so called ‘bounded rationality’). Usually, a limited amount of information is selected to reach a sufficiently satisfactory decision, a process known as satisficing. There are two key processes used in decision making: System 1 and System 2. System 1 involves fast, intuitive decisions; System 2 is a deliberate analytical approach, used to locate information which is not instantly recalled. Human beings unconsciously use System 1 processing whenever possible because it is quicker and requires less effort than System 2. In clinical practice, gaps between evidence and practice can occur when a clinician develops a pattern of knowledge, which is then relied on for decisions using System 1 processing, without the activation of a System 2 check against the best available evidence from high quality research. The processing of information and decision making may be influenced by a number of cognitive biases, of which the decision maker may be unaware. Interventions to encourage appropriate use of System 1 and System 2 processing have been shown to improve clinical decision making. Increased understanding of decision making processes and common sources of error should help clinical decision makers to minimize avoidable mistakes and increase the proportion of decisions that are better.
Bate, Louise; Hutchinson, Andrew; Underhill, Jonathan; Maskrey, Neal
Clinical audit has an increasingly important role in the quality of care being offered to patients. Only good quality data can enable valid conclusions to be drawn, which in turn enable changes to be made for the better. More and more patient data are held on NHS computer systems, and increasingly these data are being used to facilitate the audit
Background: Mutations in the SCN5A gene have been linked to a variety of diseases causing sudden cardiac death, with important variability in expressivity and phenotypic overlap. With the availability of genetic testing family members may now be diagnosed as carriers based solely on the presence of the genetic defect. Clinical decision making in this situation is complex and generates important
Antonio Oliva; Preben Bjerregaard; Kui Hong; Steven Evans; Kevin Vernooy; Jorge McCormack; Josep Brugada; Pedro Brugada; Vincenzo L. Pascali; Ramon Brugada
Usually the clinical diagnostic of tinea is easy for the dermatologist, but occasionally, mostly as a result of an unsuitable treatment, the cutaneous lesions can show up atypical forms. In this article tinea capitis in the elderly, tinea follicularis et granulomatosa of the legs, tinea faciei and tinea incognito are discussed. PMID:18473600
Moreno Giménez, J C
This text examines the characteristics that define autism: impairments in communication; abnormal social development; and clinically significant odd behaviors. Specific chapters include: (1) Neural Mechanisms in Autism (Andrew W. Zimmerman and Barry Gordon); (2) Epidemiology of Autism and Other Pervasive Developmental Disorders: Current…
Accardo, Pasquale J., Ed.; Magnusen, Christy, Ed.; Capute, Arnold J., Ed.
Criticisms of the efficacy of psychotherapy and the failure of criminal rehabilitation call for continued attempts to develop successful intervention modalities. During the past decade, the clinical sociology of the 1930s has been revived and may be effectively applied to correctional counseling. Since theorizing concerning criminal etiology is primarily sociological in nature, treatment paradigms should be grounded in sociological theory.
Daniel B. Kennedy
This clinical audit examines the adherence to guidelines suggested by the Royal College of Nursing (2005); the results uphold previous studies of a preoperative starving period for patients undergoing elective surgical procedures. Patients excessively starved of food or fluids report problems relating to their health. These include hunger, distress and complaints of nausea. PMID:23413526
Probiotic bacteria are applied to balance disturbed intestinal microflora and related dysfunctions of the gastrointestinal tract. Current clinical applications include well-documented areas such as treatment of acute rotavirus diarrhoea, lactose maldigestion, constipation, colonic disorders and side-effects of pelvic radiotherapy, and more recently, food allergy including milk hypersensitivity and changes associated with colon cancer development. Many novel probiotics appear to be
S. Salminen; A. C. Ouwehand; E. Isolauri
Development of a computer program for simulation, diagnosis and informatics in Geographic Medicine and Clinical Microbiology. The GIDEON (Global Infectious Diseases and EpidemiOgy Network) software follows the status of all infectious diseases and pathogens in all countries; in addition to the pharmacology and use of all antiinfective agents and vaccines in the field.
Stephen A. Berger
Reactions of the gastrointestinal tract and the central nervous system are the most often observed adverse effects during therapy with fluoroquinolones. Pathogenesis of the neurotoxiceffects of fluoroquinolones could be related to the activation of the NMDA receptor. Animal experiments as well as clinical experience show that the cardiotoxicpotentials of sparfloxacin and grepafloxacin are higher than those of the other fluoroquinolones:
|This paper presents replies to comments published by M. S. Schulz and R. J. Waldinger, J. M. Wood and M. T. Nezworski, and H. N. Garb and W. M. Grove on the original article by D. Westen and J. Weinberger. Schulz and Waldinger (2005) make the important point that just as researchers can capitalize on the knowledge of experienced clinical…
Westen, Drew; Weinberger, Joel
|Supervisors must become aware of the possible conflicts that could arise during clinical supervision. It is important that supervisors communicate their roles and expectations effectively with their supervisees. This paper supports the notion that supervision is a mutual agreement between the supervisee and the supervisor and the roles of…
Simulations used as an educational strategy can mimic clinical reality bringing real life activity into the learning environment. This paper presents a conceptual approach to simulation development and validation that is applied to develop assessment simulations for both childbirth and triage situations. A process-based method of presenting information to the learner in the assessment phase is incorporated in simulations developed
Severe facial burns cause significant deformities that are technically challenging to treat. Conventional treatments almost always result in poor aesthetic and functional outcomes. This is due to the fact that current treatments cover or replace the delicate anatomical facial tissues with autologus grafts and flaps from remote sites. The recent introduction of clinical composite tissue allotransplantation (CTA) that uses healthy
Sathnur B. Pushpakumar; John H. Barker; Chirag V. Soni; Hazel Joseph; Vera C. van Aalst; Joseph C. Banis; Johannes Frank
Greenfield's excellent appraisal (Amer. Psychologist, 1960, 15, 624-625) of the role of clinical psychology in medical education deserves commendation. Despite its brevity, it offers a great deal. In fact, it reads so well and makes such good sense, I was hopeful, as I neared the end, that Greenfield might have an answer to the question he raises implicitly: \\
Milton J. Horowitz
The aim of this paper is to describe how interventions by clinical pharmacists can provide quality pharmaceutical care to inpatients. Evidence-based pharmacotherapy is necessary for the practice of clinical pharmacy. The use of published data, patient-specific data, and data generated by conducted research are discussed with respect to unit dose computer systems, nutrition teams, and pharmacokinetic services, based on the experience of an European hospital pharmacy. Incorporating evidence into clinical pharmacy activities results in added value to these services. The implementation of evidence-based pharmacotherapy is not an easy task for three reasons: a lack of scientific evidence in many medical areas, a lack of authority of pharmacists in Europe to take an active part in decision-making for drug prescribing, and reluctance of some physicians to accept pharmacists within the health care team. Also, efforts are required to change education programs at the universities in Europe to better prepare clinical pharmacists in pharmacotherapy and pharmaceutical care. PMID:11034053
Bonal, J F
Landmark studies published in the 1980s were the first to reveal the long-term consequences of rheumatoid arthritis (RA). Instead of the benign outcomes previously reported from early population studies, disability, deformity and excess mortality were evident. At this time, the conventional pyramid approach was the standard for therapeutic intervention. Patients were initially treated with non-steroidal anti-inflammatory drug with rest and splinting a approach. Disease-modifying anti-rheumatic drugs and corticosteroids were reserved for patients with joint damage and disability, who had 'earned their treatment' and the perceived risk of toxicity. Thus irreversible damage and disability occurred prior to effective therapy being instituted, with the consequences of poor outcomes. The late 1980s saw the introduction of the concept of early intervention in RA and, shortly after, the introduction of specialist clinics for early assessment of patients with inflammatory arthritis (IA), so-called 'early arthritis clinics' (EACs). Such clinics, initially in large research units, targeted patients with early RA or IA with the potential to evolve to RA, with the aim of early case definition and treatment. After all, the common sense approach to treatment of a chronic inflammatory, destructive condition would be to treat it effectively from its onset, prior to the development of irreversible damage. The detailed documentation undertaken in these clinics subsequently provided much information regarding persistence and prognosis in early IA. Since their initial introduction, EACs have become commonplace, not only in academic units, but also kas part of clinical service provision in many institutions. This review details what an EAC is, who should be referred and when, and the benefits and potential future benefits of their introduction. PMID:15588968
Quinn, Mark A; Emery, Paul
The field of clinical laboratory tests is facing an increase in the number of test items as well as a corresponding diversification due to the demands of medical institutions as well as improvements in analytical techniques. To respond to this situation, medical institutions have been promoting systematization of their testing procedures; information exchange among the institutions has likewise expanded with the use of media such as on-line systems and internet. Standardization of interfaces has been proposed to secure a common framework compatible with different types of information. Some embodiments in this country includes; (1) Interface Standards on Clinical Laboratory Information For information exchange, the format and reporting comments used in the media systems were standardized under the sponsorship of The Medical Information System Development Center, with a publication issued on 1993. (2) Standardization of Laboratory Test Code Standardization of codes for information exchange has been established under the sponsorship of The Japan Society of Clinical Pathology (Laboratory Test Coding Committee), through the systematization of laboratory test code used in media systems. A publication entitled "Classification & Coding for Clinical Laboratory Tests (8th edition in 1992, 9th edition in 1994 and supplement in 1996)" has been issued. The system for "Classification & Coding for Clinical Laboratory Tests" is divided into 5 components; (1) analyte code, (2) identification code, (3) specimen code, (4) methodology code, and (5) data classification code. The Laboratory test codes are precisely classified by "(1) analyte code", and then are identified by combination of additional codes such as specimen and methodology codes. In this year, we are making a new easily-used-codes composed of 5 Arabic figures. PMID:9306714
Headache is a common complaint that affects the majority of the population at some point in their lives. The underlying pathological bases for headache symptoms are many, diverse, and often difficult to distinguish. Classification of headache is principally based on the evaluation of headache symptoms as well as clinical testing. Although manual therapy has been advocated to treat a variety of different forms of headache, the current evidence only supports treatment for cervicogenic headache (CGH). This form of headache can be identified from migraine and other headache forms by a comprehensive musculoskeletal examination. Examination and subsequent diagnosis is essential not only to identify patients with headache where manual therapy is appropriate but also to form a basis for selection of the most appropriate treatment for the identified condition. The purpose of this paper is to outline, in clinical terms, the classification of headache, so that the clinician can readily identify those patients with headache suited to manual therapy.
Hall, Toby; Briffa, Kathy; Hopper, Diana
For the past century, autopsy techniques in clinical pathology have not changed significantly, while autopsy rates are declining. Modern imaging techniques offer interesting prospects of supportive post-mortem diagnostic investigation. In a prospective study of 29 autopsy cases, complimentary virtual autopsy using unenhanced post-mortem computed tomography (pmCT) was performed. We analysed in a prospective cohort study 29 unenhanced pmCT scans, generated prior to autopsy. Clinical information regarding clinical history and circumstances of death were provided. The objective of the study was to find consistency and/or discrepancy between virtual autopsy and conventional autopsy findings regarding cause of death and death-related diagnoses, reconstruction of the pathogenetic mechanisms involved, side diagnoses and CPR (cardiopulmonary resuscitation)- or death-related post-mortem changes. Accuracy of pmCT for cause of death was 68 % and the positive predictive value (PPV) was 75 %. Regarding the pathogenetic mechanisms, accuracy of pmCT was 21 % and PPV was 29 %. The combined diagnostic yield of autopsy and pmCT was 133 % compared to autopsy only. Modern imaging techniques give an opportunity for post-mortem diagnostics to complete but not yet replace traditional autopsy. We could show that in two out of three cases, the cause of death found by pmCT matched the diagnosis from classical autopsy. While both disciplines, pathology and radiology, will profit from the mutual exchange of data, it seems a realistic aim to strive for virtual autopsy possibly further supported by biopsies and contrast-enhanced pmCT as an alternative to the classical clinical autopsy. A combination of both methods enhances diagnostic quality and completeness of the autopsy report. PMID:22729140
Westphal, Saskia E; Apitzsch, Jonas; Penzkofer, Tobias; Mahnken, Andreas H; Knüchel, Ruth
Consider three views:Subjective—Chronic widespread pain with multiple tender points (fibromyalgia syndrome) is a common clinical presentation. Criteria for inclusion of fibromyalgia patients into research studies have led to a medical model which integrates symptoms, signs, epidemiology, pathogenesis, responses to treatment, and prognosis. Controversy regarding fibromyalgia relates mostly to issues of compensation.Theoretical—The diagnosis of fibromyalgia has been challenged as an inappropriate
I. Jon Russell
Pimecrolimus (Elidel) is a novel cell-selective inhibitor of inflammatory cytokines that has specifically been developed for the treatment of inflammatory skin diseases due to its favourable skin selective pharmacological profile. Therapeutic efficacy and safety of pimecrolimus cream 1% has been established in the short-term treatment and the long-term management of atopic eczema in clinical studies in adults, children and infants. It rapidly relieves pruritus, and redness and swelling disappear or are only mild in up to 70% of pimecrolimus treated patients during the first three weeks. When applied at the first signs and symptoms of atopic eczema, pimecrolimus has proven to prevent flare progression and to provide superior long-term disease control compared with a conventional treatment, based on reactive use of corticosteroids. Pimecrolimus cream 1% is well tolerated, even on sensitive areas such as the face and neck. Blood concentrations remain low, even when extensive body areas are treated and no clinically significant systemic effects have been observed during short- or long-term clinical studies with pimecrolimus. PMID:12800465
Graham-Brown, R A; Grassberger, M
Clinical data management is involved in ensuring data quality and integrity from the time a draft of a clinical protocol is issued through the final statistical analysis of the resultant data. This involves careful consideration of the clinical forms and schedule of patient visits; feedback to clinical monitors of systematic errors by investigators; feedback to data processing on data entry
Gene Averkin; Bonnie M. Beaver
Clinical biomarker tests that aid in making treatment decisions will play an important role in achieving personalized medicine for cancer patients. Definitive evaluation of the clinical utility of these biomarkers requires conducting large randomized clinical trials (RCTs). Efficient RCT design is therefore crucial for timely introduction of these medical advances into clinical practice, and a variety of designs have been
Boris Freidlin; Lisa M. McShane; Edward L. Korn
The opinion is expressed that clinical psychology is essential to the best practice of psychiatry. Clinical psychology stems from a background of testing, investigation and experimental approach, while psychiatry originates from a background of humanics, public service, interpersonal relationships with suffering people and an almost entirely clinical approach. Details in the relationship between psychiatry and clinical psychology in four areas
William C. Menninger
A clinical study must address true endpoints that matter for the patients and the doctors. A good clinical study starts with a good clinical question. Formulating a clinical question in the form of PECO can sharpen one's original question. In order to perform a good clinical study one must have a knowledge of study design, measurements and statistical analyses: The first is taught by epidemiology, the second by psychometrics and the third by biostatistics. PMID:22834102
Objective To explore associated clinical factors in children with pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS). Study design Children with tics and/or OCD (n = 109) were examined by personal and family history, diagnostic interview, physical examination, medical record review, and measurement of baseline levels of streptococcal antibodies. Results Significant group differences were found on several variables, such that those diagnosed with PANDAS (versus without PANDAS) were more likely to have had dramatic onset; definite remissions; remission of neuropsychiatric symptoms during antibiotic therapy; a history of tonsillectomies/adenoidectomies; evidence of GAS infection, and clumsiness. Conclusion The identification of clinical features associated with PANDAS should assist in delineating risks for this subtype of OCD/tics.
Murphy, Tanya K.; Storch, Eric A.; Lewin, Adam B.; Edge, Paula J.; Goodman, Wayne K.
Botulinum toxin, the most potent biological toxin, has become a powerful therapeutic tool for a growing number of clinical applications. This review draws attention to new findings about the mechanism of action of botulinum toxin and briefly reviews some of its most frequent uses, focusing on evidence based data. Double blind, placebo controlled studies, as well as open label clinical trials, provide evidence that, when appropriate targets and doses are selected, botulinum toxin temporarily ameliorates disorders associated with excessive muscle contraction or autonomic dysfunction. When injected not more often than every three months, the risk of blocking antibodies is slight. Long term experience with this agent suggests that it is an effective and safe treatment not only for approved indications but also for an increasing number of off-label indications.
Friedreich ataxia, the most common hereditary ataxia, affects about 1:29 000 Caucasians. In about 98% of these individuals it is due to homozygosity for a GAA trinucleotide repeat expansion in intron 1 of FXN; in the other 2% it is due to compound heterozygosity for a GAA expansion and point mutation or deletion. The condition affects multiple sites in the central and peripheral nervous system as well as a number of other organ systems, resulting in multiple signs and symptoms. Onset of this autosomal recessive condition is usually in the first 2 decades of life. Major clinical features include progressive ataxia, absent lower limb reflexes, upgoing plantar responses, and peripheral sensory neuropathy. The main non-neurological sites of morbidity are the heart, resulting in cardiomyopathy, and the pancreas, resulting in diabetes mellitus. In this review, we provide an overview of the clinical features of Friedreich ataxia and discuss differential diagnoses.
Delatycki, Martin B; Corben, Louise A
Sarcoidosis is a multisystem disease of unknown cause. Sarcoidosis can affect all individuals with any race, sex, or age but commonly affects young- and middle-aged adults and usually presents with bilateral hilar lymphadenopathy, pulmonary infiltration, skin and ocular lesions. Other organs can also be affected. Diagnosis is established when clinical and radiological findings are supported by the presence of non-caseating epithelioid cell granulomas, however, local sarcoid reactions and granulomas of known cause should be excluded. The optimal management has not been well defined yet, although corticosteroids remain the mainstay of treatment, there is little evidence on which to base the indications for treatment including dosage and duration of therapy. Certain clinical features are helpful in the prognosis of the condition that can vary from a self-limiting course to progressive life-threatening fibrosis of the vital organs. PMID:22845844
Dastoori, Mahmoud; Fedele, Stefano; Leao, Jair C; Porter, Stephen R
Introduction An expanding understanding of the importance of angiogenesis in oncology and the development of numerous angiogenesis inhibitors are driving the search for biomarkers of angiogenesis. We review currently available candidate biomarkers and surrogate markers of anti-angiogenic agent effect. Discussion A number of invasive, minimally invasive, and non-invasive tools are described with their potential benefits and limitations. Diverse markers can evaluate tumor tissue or biological fluids, or specialized imaging modalities. Conclusions The inclusion of these markers into clinical trials may provide insight into appropriate dosing for desired biological effects, appropriate timing of additional therapy, prediction of individual response to an agent, insight into the interaction of chemotherapy and radiation following exposure to these agents, and perhaps most importantly, a better understanding of the complex nature of angiogenesis in human tumors. While many markers have potential for clinical use, it is not yet clear which marker or combination of markers will prove most useful.
Brown, Aaron P.; Citrin, Deborah E.; Camphausen, Kevin A.
We analysed the perceived stresses associated with the transition from preclinical to clinical teaching among dental students at the Faculty of Dentistry, University of Otago. An anxiety questionnaire was completed by 120 students in their Second and Third Years of study. Because of the institution of a new curriculum, these students were uniquely in the same class. The highest levels of anxiety associated with general clinical situations were felt for getting diagnoses wrong, hurting patients, dealing with medical emergencies, and getting infected. In general, there were no significant gender or academic year differences. When faced with specific situations, students were most stressed by the prospect of surgical procedures, temporomandibular joint problems, and failed local analgesia. Significant differences between the two years centred on giving an inferior alveolar nerve block and in dealing with poor oral hygiene, the Second-year students showing the greater anxiety. PMID:11198550
Kieser, J; Herbison, P
Prevalence of Lyme borreliosis in Europe has been well esablished during the last decade. The highest morbidity in Poland, exceeding 100 cases (100.000) year, was demonstrated in north-estern part of the country. Additional small endemic areas were also described in south-western and central part of the country. Clinical picture of the disease do not differ significantly from observed in other parts of Europe. Lyme borreliosis is characterized with a wide variety of manifestations recognized as typical: erythema migrans, borrelial lymphocytoma, acrodermatitis chronica atrophicans, arthritis, facial palsy, lymphocytic meningitis and cardiac transduction disturbances. However there are also controversial syndroms, that have confirmed etiology of Borrelia burgdorferi but only in some cases, such as: morphea sclerodermatous lesions, cardiomyopathy and some neurologic disorders. Diagnosis of Lyme borreliosis is still based on typical signs of the disease and laboratory techniques can not solve clinical doubts. PMID:16886455
Flisiak, R; Prokopowicz, D
Recent technological advances have fueled the growth in hybrid radionuclide and CT imaging of the heart. Noninvasive imaging studies are reliable means to diagnose coronary artery disease (CAD), stratify risk, and guide clinical management. Myocardial perfusion scintigraphy is a robust, widely available noninvasive modality for the evaluation of ischemia from known or suspected CAD. Cardiac CT (coronary artery calcium score and coronary CT angiography) has emerged as a clinically robust noninvasive anatomic imaging test, capable of rapidly diagnosing or excluding obstructive CAD. Both anatomic and functional modalities have strengths and weaknesses, and can complement each other by offering integrated structural and physiologic information. As we discuss below, in selected patients, hybrid imaging may facilitate more accurate diagnosis, risk stratification, and management in a “one-stop shop” setting.
Hsiao, Edward M.; Ali, Bilal
New biomarkers are urgently needed to accelerate efforts in developing new drugs and treatments of known diseases. New clinical and translational proteomics studies emerge almost every day. However, discovery of new diagnostic biomarkers lags behind because of variability at every step in proteomics studies (e.g., assembly of a cohort of patients, sample preparation and the nature of body fluids, selection of a profiling method and uniform protocols for data analysis). Quite often, the validation step that follows the discovery phase does not reach desired levels of sensitivity and specificity or reproducibility between laboratories. Mass spectrometry and gel-based methods do not provide enough throughput for screening thousands of clinical samples. Further development of protein arrays may address this issue. Despite many obstacles, proteomics delivers vast amounts of information useful for understanding the molecular mechanisms underlying diseases.
Silberring, Jerzy; Ciborowski, Pawel
A paediatric dietitian, occupational therapist and speech and language therapist describe how they jointly run a feeding clinic for infants and children with feeding difficulties. Conditions treated include cerebral palsy, autism, learned aversion following severe gastro-oesophageal reflux, and delayed oral development that affects feeding. The therapists' co-ordinated approach enables parents to receive clear guidance on feeding at one combined appointment, without the inconvenience of having to attend three separate appointments. The article outlines the role of each therapist, with examples of how they assess and alleviate the children's problems. The need for safety, nutrition and hydration is balanced against the desire for developmental progress in a holistic approach involving all three therapy disciplines. The aim of the feeding clinic is to provide advice, support and intervention plans to help make feeding a pleasurable and safe experience for all the children who attend. PMID:16094900
Seabert, Heidi; Eastwood, E Clare; Harris, Alyson
Effective prophylactic and/or therapeutic vaccination is a key strategy for controlling the global TB epidemic. The partial effectiveness of the existing TB vaccine, bacille Calmette–Guérin (BCG), suggests effective vaccination is possible and highlights the need for an improved vaccination strategy. Clinical trials are evaluating both modifications to the existing BCG immunization methods and also novel TB vaccines, designed to replace or boost BCG. Candidate vaccines in clinical development include live mycobacterial vaccines designed to replace BCG, subunit vaccines designed to boost BCG and therapeutic vaccines designed as an adjunct to chemotherapy. There is a great need for validated animal models, identification of immunological biomarkers of protection and field sites with the capacity for large-scale efficacy testing in order to develop and license a novel TB vaccine or regimen.
Rowland, Rosalind; McShane, Helen
Advances in nanotechnology have led to the development of novel fluorescent probes called quantum dots. Quantum dots have revolutionalized the processes of tagging molecules within research settings and are improving sentinel lymph node mapping and identification in vivo studies. As the unique physical and chemical properties of these fluorescent probes are being unraveled, new potential methods of early cancer detection, rapid spread and therapeutic management, that is, photodynamic therapy are being explored. Encouraging results of optical and real time identification of sentinel lymph nodes and lymph flow using quantum dots in vivo models are emerging. Quantum dots have also superseded many of the limitations of organic fluorophores and are a promising alternative as a research tool. In this review, we examine the promising clinical potential of quantum dots, their hindrances for clinical use and the current progress in abrogating their inherent toxicity.
Iga, Arthur M.; Robertson, John H. P.; Winslet, Marc C.; Seifalian, Alexander M.
Regional odontodysplasia (ROD) is a rare, localized developmental anomaly of the dental tissues with distinctive clinical, radiographic, and histologic findings. The purpose of this study was to describe the characteristics and clinical management of 2 patients diagnosed with ROD at the Pediatric Dentistry Service at the Hospital Sant Joan de Déu, Barcelona, Spain. In both cases, temporary and permanent dentition were involved. It was concluded that therapeutic decisions during childhood must be based on the degree of involvement and each case's functional and aesthetic needs. Autotransplantation may be a good partial treatment option during the period of mixed dentition in some cases. Definitive treatment will include prosthetic rehabilitation with implants once the patient reaches adulthood. PMID:15839393
Cahuana, Abel; González, Yndira; Palma, Camila
The changing operational tempo and types of deployment have, since the end of the Cold War, required a change in CBRN training. The threat from weapons of mass destruction has been replaced with the threat from improvised explosive devices and insurgent attempts to develop asymmetric weapons to target military and civilian populations. In addition exposure to hazardous materials as well as environmental hazards and natural toxins requires a greater awareness of the necessary supportive and definitive management. Developing a cadre of specialists with an interest in toxicology and environmental medicine, within either emergency or acute medicine, would be advantageous to deployed units as well as specialised units, including those tasked in support of UK homeland security. An established pathway for sub-specialisation in clinical toxicology does not yet exist. With the establishment of the College of Emergency Medicine, as well as the Acute Medicine Society and Intensive Care Society further development of clinical toxicology is likely. PMID:17310611
Bland, S A
Genetic alterations cause predisposition to malignancy by increased cancer risk related to constitutional mutations in growth-regulating or DNA repair genes. Some pediatric malignancies are associated with dysmorphic features in several body areas. Through physical examination, we recognise characteristic signs of genetic dysmorphic disorders, such as somatic overgrowth, undergrowth, macrocephaly, microcephaly and dysmorphic changes of the face, eyes, mouth and lips, heart, gastrointestinal tract, urinary tract, genitalia and skeleton. Recognition of a cancer-associated dysmorphic syndrome allows intensive cancer screening and genetic counseling. Therefore, it is recommended that every child with cancer should be examined by a clinical geneticist. Molecular diagnostics of germinal mutations may very effectively detect families at high risk of malignancy and help provide primary prevention. This work presents clinical syndromes with genetic background and cancer screening recommendations for 18 syndromes with increased cancer risk. PMID:22920206
Ilen?íková, D; Cižmárová, M; Kraj?iová, A; Požgayová, S; Rybárová, A; Kovács, L
...clinical psychologist or clinical social worker; (4) Furnished...clinical psychologist, clinical social worker or physician; and ...member of the center's health care staff who is an employee of...clinical psychologist or clinical social worker is permitted to...
Reperfusion therapy is the primary treatment of acute myocardial infarction and must be applied as soon as possible to limit\\u000a the ischemic insult. Unfortunately, reperfusion is responsible for additional myocardial damage likely involving opening of\\u000a the mitochondrial permeability transition pore. Ischemic postconditioning is a powerful intervention that dramatically reduces\\u000a lethal reperfusion injury. Several clinical studies using angioplasty postconditioning now support
Fabrice Ivanes; Nathan Mewton; Gilles Rioufol; Christophe Piot; Meyer Elbaz; Didier Revel; Pierre Croisille; Michel Ovize
Neuroplasticity can be defined as the ability of the nervous system to respond to intrinsic or extrinsic stimuli by reorganizing its structure, function and connections. Major advances in the understanding of neuroplasticity have to date yielded few established interventions. To advance the translation of neuroplasticity research towards clinical applications, the National Institutes of Health Blueprint for Neuroscience Research sponsored a workshop in 2009. Basic and clinical researchers in disciplines from central nervous system injury/stroke, mental/addictive disorders, paediatric/developmental disorders and neurodegeneration/ageing identified cardinal examples of neuroplasticity, underlying mechanisms, therapeutic implications and common denominators. Promising therapies that may enhance training-induced cognitive and motor learning, such as brain stimulation and neuropharmacological interventions, were identified, along with questions of how best to use this body of information to reduce human disability. Improved understanding of adaptive mechanisms at every level, from molecules to synapses, to networks, to behaviour, can be gained from iterative collaborations between basic and clinical researchers. Lessons can be gleaned from studying fields related to plasticity, such as development, critical periods, learning and response to disease. Improved means of assessing neuroplasticity in humans, including biomarkers for predicting and monitoring treatment response, are needed. Neuroplasticity occurs with many variations, in many forms, and in many contexts. However, common themes in plasticity that emerge across diverse central nervous system conditions include experience dependence, time sensitivity and the importance of motivation and attention. Integration of information across disciplines should enhance opportunities for the translation of neuroplasticity and circuit retraining research into effective clinical therapies.
Sur, Mriganka; Dobkin, Bruce H.; O'Brien, Charles; Sanger, Terence D.; Trojanowski, John Q.; Rumsey, Judith M.; Hicks, Ramona; Cameron, Judy; Chen, Daofen; Chen, Wen G.; Cohen, Leonardo G.; deCharms, Christopher; Duffy, Charles J.; Eden, Guinevere F.; Fetz, Eberhard E.; Filart, Rosemarie; Freund, Michelle; Grant, Steven J.; Haber, Suzanne; Kalivas, Peter W.; Kolb, Bryan; Kramer, Arthur F.; Lynch, Minda; Mayberg, Helen S.; McQuillen, Patrick S.; Nitkin, Ralph; Pascual-Leone, Alvaro; Reuter-Lorenz, Patricia; Schiff, Nicholas; Sharma, Anu; Shekim, Lana; Stryker, Michael; Sullivan, Edith V.; Vinogradov, Sophia
This article provides a clinical step-by-step approach for assessing a patient with tinnitus as primary complaint. The medical diagnosis of the disease provoking the tinnitus has to be made first in a comprehensive evaluation, including imaging. The psycho-acoustic characteristics and the influence on health-related quality of life is a compulsory complementary assessment to establish a complete picture of the patient. PMID:18225603
Van de Heyning, P; Meeus, O; Blaivie, C; Vermeire, K; Boudewyns, A; De Ridder, D
Capillary electrophoresis (CE) is an extremely sensitive technique, which has been used in the clinical laboratory for almost\\u000a 10 yr. The components of CE instrumentation are described, as are injection modes, buffers, and effects of electroosmotic\\u000a flow. The modes of separation used in CE, namely, capillary zone electrophoresis, capillary isoelectric focusing, capillary\\u000a isotachophoresis, and micellar electrokinetic capillary chromatography, are explained.
M. A. Jenkins
\\u000a Neuropathic pain syndromes, i.e., pain after a lesion or disease of the peripheral or central nervous system, are clinically\\u000a characterized by spontaneous pain (ongoing, paroxysms) and evoked types of pain (hyperalgesia, allodynia). A variety of distinct\\u000a pathophysiological mechanisms in the peripheral and central nervous system operate in concert: In some patients the nerve\\u000a lesion triggers molecular changes in nociceptive neurons
A retrospective survey of all patients with a positive anticentromere antibody (ACA) determination was undertaken over a 3-years period of time in a university hospital. Forty-five patients were positive for anticentromere antibodies. The analysis of the clinical characteristics and diagnoses of the patients with anticentromere antibodies were correlated and showed a diverse array of symptoms. Only 4.4% had CREST syndrome,
M. Zuber; R. Gotzen; I. Filler
The clinical application of botulinum toxin (BoNT) was first proposed by Justinus Kerner in 1822. BoNT was formally accepted as a therapeutic agent in the 1970s, and currently, it is used worldwide for treating diseases as well as for cosmetic conditions. In Japan, Botox® is the only type A formulation that has been officially approved for the treatment of blepharospasm, hemifacial spasm, cervical dystonia, pes equinus of cerebral palsy, adult spasticity of upper and lower limbs, and Botox Vista® is applied for glabellar frown lines. Its effect is symptomatic, but long-lasting remission is noted after treatment in more than 30% of cases with cervical dystonia. Ultrasound guidance is useful and may be even superior to electromyographic monitoring, especially when the obliquus capitis inferior muscle is targeted in rotatocollis, because the vertebral artery or upper cervical nerve root(s) may be injured when the needle penetrates the muscle. BoNT alleviates pain or glandular secretion besides causing a neuromuscular block. After being transported to the axons, BoNT is carried centrally and even to the adjacent neurons via synapses (toxin jump). A direct central action has also been postulated. BoNT is generally safe, but serious adverse reactions may occur very rarely. Individual differences in toxin sensitivity may be considerably greater than assumed, and even the routine clinical dose may be too high in some patients. The future strategy includes clinical application of other types of toxin or chimera toxins, or the use of the toxin as a cargo ("Trojan Horse") carrying some bioactive molecules into the cell. A non-injection procedure for mucosal application or cosmetic use is currently under clinical trials. PMID:21747149
A relatively new occupational disease, beryllium poisoning, is discussed. The history of this respiratory disease among workers after beryllium exposure from extraction and alloy manufacturing is not well documented in the US Attempts by industry to delay investigations into beryllium toxicity are described. The specific incidents occurring at a fluorescent lamp manufacturing plant in Salem, Massachusetts are presented. Clinical observations of chronic beryllium disease are discussed. Symptoms are described. The current status of diagnosis and treatment of beryllium poisoning is presented.
\\u000a Child neuropsychology is the study of brain function and behavior in children and adolescents. Brain functioning has a direct\\u000a impact on the behavioral, cognitive, and psychosocial adjustment of children and adolescents. Thus, disorders must be addressed\\u000a within an integrated model of child clinical neuropsychology. Further, the development of the central nervous system (CNS)\\u000a and the neurodevelopmental course of childhood disorders
Margaret Semrud-Clikeman; Phyllis Anne Teeter Ellison
Since 1992, Human Botulism Immune Globulin has been provided by the California Department of Health Services to infants with probable infant botulism, the intestinal toxemia form of human botulism. Human Botulism Immune Globulin became available in California in 1992-1997 within a randomized, controlled, double-blinded, pivotal clinical trial and subsequently became available nationwide in 1998 -2003 in an open-label study until
Marie O. Francisco; Stephen S. Arnon
A longitudinal study of patients with persistent hyperamylasemia was carried out to evaluate the clinical significance of this condition. Twenty-five outpatients were studied by means of serum amylase, isoamylase (wheat germ-inhibition method), and lipase determination; macroamylase detection; and abdominal ultrasonography over a one-year period. Cellulose acetate electrophoresis was carried out to validate the wheat germ-inhibition tests; the results of the
M. Ventrucci; R. Pezzilli; D. Festi
The technical and political changes that have occurred in diagnostic imaging have created immense changes in the education of radiographers, both pre-registration and post-registration. The variety of courses available has extended, but there has been little or no research to look at the effect those courses have on clinical practice.This paper presents a project that involved 150 radiographers selected at
Penny Haines; Suzanne M. Henwood
ASCO (Atherosclerosis, Small vessel disease, Cardiac source, Other cause) is a new of classification of ischemic cerebrovascular diseases. This classification categorizes the data of the patients according to all underlying diseases and allows the clinician to grade the severity of cause (Each of the four phenotypes can be graded 1, 2, or 3). It is suggested to use ASCO classification in large epidemiologic studies but this classification may be used in daily practice. In this study we aimed to analyze the clinical features of patients with ischemic stroke and to investigate results of ASCO classification of these patients and data of 35 patients with ischemic stroke is analyzed. Use of ASCO classification is discussed with the special example cases. Patients' etiology of stroke was classified according to ASCO as known, unknown, completely unknown and unclassifiable group. Percentile of the patients classified as "known" was 71.4% (n = 25), "unknown" was 17.1% (n = 6), "completely unknown" was 5.7% (n = 2) and "unclassifiable group" was 5.7% (n = 2). We think that the ASCO classification which is thought to be more useful in large epidemiologic studies may be used in clinical follow-up period of the stroke patients. Further studies, from different neurology centers and stroke units, are needed to expand our experiences about use of ASCO classification in clinical practice. PMID:23607231
Degirmenci, Eylem; Erdogan, Cagdas; Oguzhanoglu, Attila; Bir, Levent Sinan
Taking into account the high frequency of adverse drug reactions (ADRs) in the clinic and taking into account the growing knowledge of the genetic mechanisms underlying some of these ADRs, we believe that every clinician should know at least the basic principles of pharmacogenetics. However, our experience is that many clinicians are unaware of the potential contribution of pharmacogenetic testing and have not implemented this new modality in their daily practice. We present a case of Stevens-Johnson syndrome in a patient treated with carbamazepine. Following the pathways of clinical reasoning, we describe the possibilities of pharmacogenetic testing in the clinic (HLA-B*1502 and HLA-A*3101 in our patient). We describe the pharmacological and pharmacogenetic aspects relevant for the clinician's daily practice (the existence of ADR subtypes, cytochrome P450, drug-drug interactions, genetic variations, CYP450 and HLA genotyping). Based on the Dutch top 100 of most prescribed drugs, we provide data on CYP450 and HLA genotypes relevant to those 100 most commonly used drugs. We discuss the availability and costs of pharmacogenetic testing, show a calculation of the 'number needed to genotype' and, based on these data, we propose a decision model for pharmacogenetic testing by clinicians. PMID:23712814
de Graaff, L C G; van Schaik, R H N; van Gelder, T
To optimize patient management in breast cancer a number of factors are considered, including hormone receptor and HER2 status. A feasible approach for women with less aggressive, estrogen receptor/HER2-positive metastatic breast cancer is to consider trastuzumab (Herceptin; F. Hoffmann-La Roche, Basel, Switzerland) combined with endocrine therapy. Randomized clinical trials are ongoing to assess the combination of trastuzumab with aromatase inhibitors. In patients with aggressive HER2-positive metastatic breast cancer, trastuzumab/chemotherapy combination regimens are warranted. When administered first line in combination with a taxane, trastuzumab improves all clinical outcome parameters, including survival, in such patients. Trastuzumab adds little to the toxicity profile of taxanes, and trastuzumab combination therapy is associated with improvements in quality of life when compared with chemotherapy alone. There is encouraging evidence of improved efficacy when trastuzumab is combined with other cytotoxic agents with proven single-agent activity in breast cancer, including capecitabine (Xeloda; F. Hoffmann-La Roche), gemcitabine, and vinorelbine. Trastuzumab is also being investigated as part of triplet drug regimens. Trastuzumab has good single-agent activity in first-line therapy. This is of relevance to women with HER2-positive disease who are not suitable for, or do not wish to receive, cytotoxic chemotherapy. The benefits noted with trastuzumab-containing regimens were documented in clinical trials where trastuzumab was given until disease progression. A further rationale exists to continue trastuzumab beyond progression. Data from retrospective reviews indicate that this strategy is feasible. PMID:15490373
Bell, Richard; Verma, Shail; Untch, Michael; Cameron, David; Smith, Ian
Phase II CLOTBUST randomized clinical trial (Houston, Barcelona, Edmonton, Calgary) evaluated patients with acute ischemic stroke due to intracranial occlusion and treated with intravenous tissue plasminogen activator (TPA) within 3 h of symptom onset. Randomization: monitoring with pulsed wave 2 MHz transcranial Doppler (TCD) (Target) or placebo monitoring (Control). Safety: symptomatic bleeding to the brain (sICH). Primary end-point: complete recanalization on TCD or dramatic clinical recovery by the total NIHSS score <3, or improvement by >10 NIHSS points within 2 hours after TPA bolus. All projected 126 patients were randomized 1:1 to target (median NIHSS 16) or control (NIHSS 17). sICH: 4.8% Target, 4.8% Controls. Primary end-point was achieved by 31 (49%, Target) versus 19 (30%, Control), p<0.03. At 3 months, 22 (42% Target) and 14 (29% Control) patients achieved favorable outcomes. Continuous TCD monitoring of intracranial occlusion safely augments TPA-induced arterial recanalization, and 2 MHz diagnostic ultrasound has a positive biological activity that aids systemic thrombolytic therapy. For the first time in clinical medicine, the CLOTBUST trial provides the evidence that ultrasound enhances thrombolytic activity of a drug in humans thereby confirming intense multi-disciplinary experimental research conducted worldwide for the past 30 years.
Alexandrov, Andrei V.
Clinical narratives, such as radiology and pathology reports, are commonly available in electronic form. However, they are also commonly entered and stored as free text. Knowledge of the structure of clinical narratives is necessary for enhancing the productivity of healthcare departments and facilitating research. This study attempts to automatically segment medical reports into semantic sections. Our goal is to develop a robust and scalable medical report segmentation system requiring minimum user input for efficient retrieval and extraction of information from free-text clinical narratives. Hand-crafted rules were used to automatically identify a high-confidence training set. This automatically created training dataset was later used to develop metrics and an algorithm that determines the semantic structure of the medical reports. A word-vector cosine similarity metric combined with several heuristics was used to classify each report sentence into one of several pre-defined semantic sections. This baseline algorithm achieved 79% accuracy. A Support Vector Machine (SVM) classifier trained on additional formatting and contextual features was able to achieve 90% accuracy. Plans for future work include developing a configurable system that could accommodate various medical report formatting and content standards. PMID:19965054
Apostolova, Emilia; Channin, David S; Demner-Fushman, Dina; Furst, Jacob; Lytinen, Steven; Raicu, Daniela
The calcium sensing receptor (CaSR) is expressed in cells secreting calcium-regulating hormones, in cells involved in calcium transport and in many other tissues, with an as yet not completely defined role. In parathyroid cells, the CaSR stimulation inhibits parathyroid hormone (PTH) secretion, synthesis and parathyroid cell proliferation. Cinacalcet belongs to calcimimetic type II compounds that can interact with CaSR, increasing its affinity for calcium. Clinical studies have proved cinacalcet to be effective in reducing calcium and PTH levels in primary hyperparathyroidism and in reducing PTH, calcium and phosphate in patients with secondary hyperparathyroidism owing to chronic renal failure, with a relatively safe profile, the only reported adverse events being hypocalcaemia and gastrointestinal symptoms. However, though calcimimetics do represent a real advancement in the field of the treatment of PTH secretion disturbances, there is a need for clinical trials, which should aim to demonstrate that a better control of biochemical parameters is also matched with better clinical outcomes. PMID:19040330
Messa, Piergiorgio; Alfieri, Carlo; Brezzi, Brigida
Despite improvements in the treatment of acute coronary syndromes, cardiovascular disease remains the leading cause of death in Europe and the United States. Antiplatelet agents, such as aspirin and clopidogrel, play an important role in the treatment of those patients. Several new alternatives have been tested in clinical trails and some of them have been approved for routine treatment of patients with ACS in Switzerland and the European Union. The latter include Prasugrel (Efient®) and Ticagrelor (Brilique®). Those substances provide more rapid and consistent platelet inhibition but increase the risk of bleeding in some patient subgroups. Thus, the main challenge is to tailor treatment for each patient by taking into consideration patient characteristics, comorbidities, underlying short- and long-term risk factors, ischemic and bleeding risks, and expected individual responses to different medications. This ambitious new approach will be a challenge for in daily clinical work and may ultimately require prioritization among several treatment alternatives. In this article, we review the new antiplatelet agents being developed as well as their pharmacological characteristics, key interactions and side effects and potential clinical indications in subpopulations. PMID:23117664
Gebhard, C; Beer, J
Cough is among the most common complaints for which patients worldwide seek medical attention. Thus, the evaluation and treatment of cough result in tremendous financial expenditure and consumption of health care resources. Yet, despite the clinical significance of cough, research efforts aimed at improving diagnostic capabilities and developing more effective therapeutic agents have been, to date, disappointing in their limited scope and outcomes. Acute cough due to the common cold represents the most common type of cough. Currently, available medications for the symptomatic management of acute cough are inadequate due to lack of proven efficacy and/or their association with undesirable or intolerable side effects at anti-tussive doses. Subacute cough, often representing a prolonged post-viral response, is typically refractory to standard anti-tussive therapy. Few clinical trials have evaluated therapeutic options for subacute cough. Diagnostic challenges facing the clinician in the management of chronic cough include the determination of whether symptoms of upper airway cough syndrome (formerly, postnasal drip syndrome) or gastro-oesophageal reflux disease are indeed the underlying cause of cough. Chronic, refractory unexplained (formerly, idiopathic) cough must be distinguished from cough that has not been fully evaluated and treated according to current guideline recommendations. Eagerly awaited are new safe and effective anti-tussive agents for use when cough suppression is desired, regardless of underlying aetiology of cough, as well as practical, validated ambulatory cough counters to aid clinical assessment and future research in the field of cough. PMID:21198555
Dicpinigaitis, Peter V
Three unusual clinical forms of sporotrichosis described in this paper will be a primer for the clinicians for an early diagnosis and treatment, especially in its unusual presentations. Case 1, a 52-year-old man, developed sporotrichosis over pre-existing facial nodulo-ulcerative basal cell carcinoma of seven-year duration, due to its contamination perhaps from topical herbal pastes and lymphocutaneous sporotrichosis over right hand/forearm from facial lesion/herbal paste. Case 2, a 25-year-old woman, presented with disseminated systemic-cutaneous, osteoarticular and possibly pleural (effusion) sporotrichosis. There was no laboratory evidence of tuberculosis and treatment with anti-tuberculosis drugs (ATT) did not benefit. Both these cases were diagnosed by histopathology/culture of S. schenckii from tissue specimens. Case 3, a 20-year-old girl, had multiple intensely pruritic, nodular lesions over/around left knee of two-year duration. She was diagnosed clinically as a case of prurigo nodularis and histologically as cutaneous tuberculosis, albeit, other laboratory investigations and treatment with ATT did not support the diagnosis. All the three patients responded well to saturated solution of potassium iodide (SSKI) therapy. A high clinical suspicion is important in early diagnosis and treatment to prevent chronicity and morbidity in these patients. SSKI is fairly safe and effective when itraconazole is not affordable/available. PMID:20445301
Mahajan, Vikram K; Sharma, Nand Lal; Shanker, Vinay; Gupta, Poonam; Mardi, Kavita
For this What's new in clinical dermatology?, I have selected some important publications mainly in the field of the infectious dermatosis and drugs allergy. The Chikungunya virus which is responsible of several epidemics since 2005 seems to be a virus with a cutaneous tropism. Sexually transmitted diseases are still a public health problem and we shall review the situation for syphilis, lymphogranuloma venereum and the new dynamic profile of HIV in France. Lyme disease has been the subject of consensus conference in France and in the United States. Original clinical presentations in relation with infectious agent will be also presented. We shall give a large place to what I call the toxidermatology. During the year 2007, the role of gadolinium in the nephrogenic systemic fibrosis has been confirmed, many publications have reported the side effects of biotherapies on the skin and we shall emphasize the paradoxical of some of them. Hypersensitivity syndrome and notably the controversial role of viral reactivations has been reported. The relationship between psoriasis and metabolic syndrome or cardiovascular risks has been discussed since 2006. New clinical features have been described and will be presented during this session. PMID:18675139
Clinical pharmacology assumes that deductions can be made about the concentrations of drugs from a knowledge of the pharmacokinetic parameters in an individual; and that the effects are related to the measured concentration. Post-mortem changes render the assumptions of clinical pharmacology largely invalid, and make the interpretation of concentrations measured in post-mortem samples difficult or impossible. Qualitative tests can show the presence of substances that were not present in life, and can fail to detect substances that led to death. Quantitative analysis is subject to error in itself, and because post-mortem concentrations vary in largely unpredictable ways with the site and time of sampling, as a result of the phenomenon of post-mortem redistribution. Consequently, compilations of ‘lethal concentrations’ are misleading. There is a lack of adequate studies of the true relationship between fatal events and the concentrations that can be measured subsequently, but without such studies, clinical pharmacologists and others should be wary of interpreting post-mortem measurements.
Ferner, R E
We investigated the effectiveness of botulinum toxin A intramuscular injection for the management of masseteric muscle hypertrophy. Five patients with masseteric muscle hypertrophy were treated with botulinum toxin A (Dysport, Beaufour Ipsen, France). Clinical photographs were obtained before and between 3 and 6 months after application. Four patients are pleased with their present facial appearance. However, one patient reported mild discomfort about his appearance. Neither local nor general adverse effects were noted. Botulinum toxin A is a safe, easy-to-use, and effective nonsurgical option in the management of masseteric muscle hypertrophy. Its use is associated with a high degree of patient and physician satisfaction. PMID:16527016
Arikan, Osman Kursat; Tan, Funda Uysal; Kendi, Tuba; Koc, Can
This paper is an inquiry into the nature of clinical facts in psychoanalysis. The attainment of representability of psychic reality being requisite for insight, the author examines inductive processes on the part of both analyst and analysand, which are to be considered proper aspects of the study of clinical facts. It is argued that the analyst chooses his interpretations guided in good measure by nonverbal material, based on how he intuits that he is 'used' by the analysand and the ways the analysand feels 'used' by him; such nonverbal clues on the nature of the unconscious relational 'frames' operating in sessions guide him to select relevant associations from the universe of the analysand's verbal utterances. He thus comes to voice his interpretations, purveying a 'mapping' of psychic reality that typically makes use of a new viewpoint for description. Insight is achieved when the analysand attains ostensive refutation or redefinition of his unconscious 'theories' about the relationship, and this happens only in concrete individual situations, when the effects of his relational unconscious 'theories' come to be contrasted observationally in diverse 'screens', perceptual and mnemic, against the background of the analyst's neutrality: in such a way unconscious 'theories' attain the Pcs.-Cs. domain of the 'no'. PMID:7713672
Ahumada, J L
For many years, placebos have been conceptualised by their inert content and their use as controls in clinical trials and treatments in clinical practice. Recent research demonstrates that placebo effects are genuine psychobiological phenomenon attributable to the overall therapeutic context, and that placebo effects can be robust in both laboratory and clinical settings. Evidence has also emerged that placebo effects can exist in clinical practice, even if no placebo is given. Further promotion and integration of laboratory and clinical research will allow advances in the ethical harnessing of placebo mechanisms that are inherent in routine clinical care and the potential use of treatments to primarily promote placebo effects.
Kaptchuk, Ted J; Miller, Franklin; Benedetti, Fabrizio
Widespread unexplained variations in clinical practices and patient outcomes suggest major opportunities for improving the quality and safety of medical care. However, there is little consensus regarding how to best identify and disseminate healthcare improvements and a dearth of theory to guide the debate. Many consider multicenter randomized controlled trials to be the gold standard of evidence-based medicine, although results are often inconclusive or may not be generally applicable due to differences in the contexts within which care is provided. Increasingly, others advocate the use “quality improvement collaboratives”, in which multi-institutional teams share information to identify potentially better practices that are subsequently evaluated in the local contexts of specific institutions, but there is concern that such collaborative learning approaches lack the statistical rigor of randomized trials. Using an agent-based model, we show how and why a collaborative learning approach almost invariably leads to greater improvements in expected patient outcomes than more traditional approaches in searching simulated clinical fitness landscapes. This is due to a combination of greater statistical power and more context-dependent evaluation of treatments, especially in complex terrains where some combinations of practices may interact in affecting outcomes. The results of our simulations are consistent with observed limitations of randomized controlled trials and provide important insights into probable reasons for effectiveness of quality improvement collaboratives in the complex socio-technical environments of healthcare institutions. Our approach illustrates how modeling the evolution of medical practice as search on a clinical fitness landscape can aid in identifying and understanding strategies for improving the quality and safety of medical care.
Eppstein, Margaret J.; Horbar, Jeffrey D.; Buzas, Jeffrey S.; Kauffman, Stuart A.
Cough is among the most common complaints for which patients worldwide seek medical attention. Thus, the evaluation and treatment of cough result in tremendous financial expenditure and consumption of health care resources. Yet, despite the clinical significance of cough, research efforts aimed at improving diagnostic capabilities and developing more effective therapeutic agents have been, to date, disappointing in their limited scope and outcomes. Acute cough due to the common cold represents the most common type of cough. Currently, available medications for the symptomatic management of acute cough are inadequate due to lack of proven efficacy and/or their association with undesirable or intolerable side effects at anti-tussive doses. Subacute cough, often representing a prolonged post-viral response, is typically refractory to standard anti-tussive therapy. Few clinical trials have evaluated therapeutic options for subacute cough. Diagnostic challenges facing the clinician in the management of chronic cough include the determination of whether symptoms of upper airway cough syndrome (formerly, postnasal drip syndrome) or gastro-oesophageal reflux disease are indeed the underlying cause of cough. Chronic, refractory unexplained (formerly, idiopathic) cough must be distinguished from cough that has not been fully evaluated and treated according to current guideline recommendations. Eagerly awaited are new safe and effective anti-tussive agents for use when cough suppression is desired, regardless of underlying aetiology of cough, as well as practical, validated ambulatory cough counters to aid clinical assessment and future research in the field of cough. LINKED ARTICLES This article is part of a themed issue on Respiratory Pharmacology. To view the other articles in this issue visit http://dx.doi.org/10.1111/bph.2011.163.issue-1
Dicpinigaitis, Peter V
This guideline presents recommendations for the evaluation and management of patients with gastroparesis. Gastroparesis is identified in clinical practice through the recognition of the clinical symptoms and documentation of delayed gastric emptying. Symptoms from gastroparesis include nausea, vomiting, early satiety, postprandial fullness, bloating, and upper abdominal pain. Management of gastroparesis should include assessment and correction of nutritional state, relief of symptoms, improvement of gastric emptying and, in diabetics, glycemic control. Patient nutritional state should be managed by oral dietary modifications. If oral intake is not adequate, then enteral nutrition via jejunostomy tube needs to be considered. Parenteral nutrition is rarely required when hydration and nutritional state cannot be maintained. Medical treatment entails use of prokinetic and antiemetic therapies. Current approved treatment options, including metoclopramide and gastric electrical stimulation (GES, approved on a humanitarian device exemption), do not adequately address clinical need. Antiemetics have not been specifically tested in gastroparesis, but they may relieve nausea and vomiting. Other medications aimed at symptom relief include unapproved medications or off-label indications, and include domperidone, erythromycin (primarily over a short term), and centrally acting antidepressants used as symptom modulators. GES may relieve symptoms, including weekly vomiting frequency, and the need for nutritional supplementation, based on open-label studies. Second-line approaches include venting gastrostomy or feeding jejunostomy; intrapyloric botulinum toxin injection was not effective in randomized controlled trials. Most of these treatments are based on open-label treatment trials and small numbers. Partial gastrectomy and pyloroplasty should be used rarely, only in carefully selected patients. Attention should be given to the development of new effective therapies for symptomatic control.
Camilleri, Michael; Parkman, Henry P.; Shafi, Mehnaz A.; Abell, Thomas L.; Gerson, Lauren
Aim of the study The technological progress that is currently being witnessed in the areas of diagnostic imaging, treatment planning systems and therapeutic equipment has caused radiotherapy to become a high-tech and interdisciplinary domain involving staff of various backgrounds. This allows steady improvement in therapy results, but at the same time makes the diagnostic, imaging and therapeutic processes more complex and complicated, requiring every stage of those processes to be planned, organized, controlled and improved so as to assure high quality of services provided. The aim of this paper is to present clinical quality standards for radiotherapy as developed by the author. Material and methods In order to develop the quality standards, a comparative analysis was performed between European and Polish legal acts adopted in the period of 1980-2006 and the universal industrial ISO 9001:2008 standard, defining requirements for quality management systems, and relevant articles published in 1984-2009 were reviewed, including applicable guidelines and recommendations of American, international, European and Polish bodies, such as the American Association of Physicists in Medicine (AAPM), the European Society for Radiotherapy & Oncology (ESTRO), the International Atomic Energy Agency (IAEA), and the Organisation of European Cancer Institutes (OECI) on quality assurance and management in radiotherapy. Results As a result, 352 quality standards for radiotherapy were developed and categorized into the following three groups: 1 – organizational standards; 2 – physico-technical standards and 3 – clinical standards. Conclusion Proposed clinical quality standards for radiotherapy can be used by any institution using ionizing radiation for medical purposes. However, standards are of value only if they are implemented, reviewed, audited and improved, and if there is a clear mechanism in place to monitor and address failure to meet agreed standards.
This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost.
Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual
False and true hermaphroditism (FH and TH) are often encountered in surgery for hypospadia. A clinically validated classification of various types and variants of hermaphroditism is proposed. FH is divided into male FH and female FH. TH also falls into two categories: TH without anomalies of external genitalia and that with these anomalies. The latter category has three variants: 1) all genitalia of males or females and some genitalia of the other sex; 2) some female and male organs in various combinations; 3) all organs of both sexes. All TH variants are illustrated by 5 case reports. These patients were thoroughly examined and their sex was surgically corrected. PMID:14708246
Derevianko, I M; Derevianko, T I; Ryzhkov, V V
Scientists have been trying to determine whether the main clinical findings in the 4p deletion syndrome are due to a deletion of one small critical segment, or whether deletions of some particular segments of 4p are responsible for different phenotypic manifestations. This is the basic issue for the whole group of autosomal deletion syndromes, as well as for our understanding of mechanisms of the origin of the abnormal phenotype. All circumstances need to be taken into consideration when trying to apply molecular methods for the mapping of phenotypic findings in the 4p deletion or in any other autosomal deletion syndrome. 8 refs.
Lurie, I.W.; Opitz, J.M. [Foundaton for Developmental and Medical Genetics, Helena, MT (United States)
This paper presents a brief introduction to the techniques, methods and tools used to implement clinical systems. It begins with a taxonomy of software systems, describes the classic approach to development, provides some guidelines for the planning and management of software projects, and finishes with a guide to further reading. The conclusions are that there is no single right way to develop software, that most decisions are based upon judgment built from experience, and that there are tools that can automate some of the better understood tasks.
Autism spectrum disorders are neurodevelopmental disorders characterized by deficits in social interactions, communication, and repetitive or restricted interests. There is strong evidence that de novo or inherited genetic alterations play a critical role in causing Autism Spectrum Disorders, but non-genetic causes, such as in utero infections, may also play a role. Magnetic resonance imaging based and autopsy studies indicate that early rapid increase in brain size during infancy could underlie the deficits in a large subset of subjects. Clinical studies show benefits for both behavioral and pharmacological treatment strategies. Genotype-specific treatments have the potential for improving outcome in the future. PMID:24176418
Mehta, Sunil Q; Golshani, Peyman
Ocular bobbing is a distinctive movement disorder occurring in a variety of related forms herein classified as `typical', `monocular', and `atypical'. `Typical' ocular bobbing occurs in patients with paralysis of horizontal conjugate eye movements and consists of abrupt, spontaneous downward jerks of the eyes with a slow return to the mid position. The `monocular' type reflects co-existing unilateral third nerve paresis in addition to the bobbing. The `atypical' type includes either a variation unexplained by associated oculomotor palsy, or bobbing with intact spontaneous or reflex horizontal eye movements. The clinical spectrum of ocular bobbing, its varied causes, and its prognostic significance are exemplified in a report of nine cases.
Susac, John O.; Hoyt, William F.; Daroff, Robert B.; Lawrence, William
RNA is a versatile biological macromolecule that is crucial in mobilizing and interpreting our genetic information. It is not surprising then that researchers have sought to exploit the inherent properties of RNAs so as to interfere with or repair dysfunctional nucleic acids or proteins and to stimulate the production of therapeutic gene products in a variety of pathological situations. The first generation of the resulting RNA therapeutics are now being evaluated in clinical trials, raising significant interest in this emerging area of medical research. PMID:12110902
Sullenger, Bruce A; Gilboa, Eli
Three scenarios are presented, based on real patients, illustrating various clinical dilemmas involving critical illness and extracorporeal membrane oxygenation (ECMO). The scenarios are outlined in the form of questions and answers. In most cases there is no single correct answer to the dilemmas presented. The pros and cons of particular interventions are discussed along with the actual treatment provided. In all cases, the ECMO circuit consisted of a polymethylpentene oxygenator (Quadrox PLS; MAQUET Cardiovascular, Hirlingen, Germany) and a centrifugal pump (Rotaflow; MAQUET Cardiovascular). Case 2 has been previously published as a letter to the editor (1). PMID:23441569
Background A 52-year old lady presented for admission with severe depression characterised by suicidal ideation and delusional belief. Case presentation Her treatment regime was reviewed and modified. The dilemma was whether she suffered from a psychotic depression with delusion or an obsessional disorder. She responded well to change of antipsychotic medication. Conclusions Her depression went in remission and her delusional belief decreased in intensity. She also gained reasonable insight into her problem. She is currently being followed up in the psychiatric outpatient clinic.
Pressure ulcers are chronic and difficult to heal. Pressure-reducing devices are clearly superior to a standard hospital mattress in preventing pressure ulcers, but only limited evidence and clinical intuition supports pressure-reducing devices in improving the healing rate of pressure ulcers. Local wound treatment should aim at maintaining a moist wound environment. The choice of a particular dressing depends on wound characteristics, such as the amount of exudate, dead space, or wound location. Nutritional status should be addressed as a process of good care. Debridement may improve time to a clean wound bed, but no clearly superior approach has been demonstrated. PMID:23571035
Thomas, David R
We have developed a simulator for phacoemulsification cataract extraction. In the current project, modules for clinical evaluation were developed. The system was structured into a processing computer and an administrator interface and a trainee interface. The simulation is defined by administrator adjustable parameters and trainee adjustable parameters. The parameters may be categorized as session characteristic parameters, patient characteristic parameters and trainee characteristic parameters. The simulation is measured in variables. Further an air bubble generator was created. We believe that simulator training in future will be required for becoming cataract surgeons.
Soderberg, Per G.; Laurell, Carl-Gustaf; Nordqvist, Per; Skarman, Eva; Nordh, Leif
Although the field of gene therapy has experienced significant setbacks and limited success, it is one of the most promising and active research fields in medicine. Interest in this therapeutic modality is based on the potential for treatment and cure of some of the most malignant and devastating diseases affecting humans. Over the next decade, the relevance of gene therapy to medical practices will increase and it will become important for physicians to understand the basic principles and strategies that underlie the therapeutic intervention. This report reviews the history, basic strategies, tools, and several current clinical paradigms for application.
Pre-2000, the clinical management of keratoconus centred on rigid contact lens fitting when spectacle corrected acuity was no longer adequate, and transplantation where contact lens wear failed. Over the last decade, outcome data have accumulated for new interventions including corneal collagen crosslinking, intracorneal ring implantation, topographic phototherapeutic keratectomy, and phakic intraocular lens implantation. We review the current evidence base for these interventions and their place in new management pathways for keratoconus under two key headings: corneal shape stabilisation and visual rehabilitation. PMID:23258309
Gore, D M; Shortt, A J; Allan, B D
Leishmaniasis is a global term for cutaneous and visceral anthroponotic and zoonotic diseases caused by the vector-borne parasites of the genus Leishmania. These diseases afflict at least 2 million people each year with more than 350 million at risk in 98 countries worldwide. These are diseases mostly of the impoverished making prevention, diagnosis and treatment difficult. Therapy of leishmaniasis ranges from local treatment of cutaneous lesions to systemic, often toxic, therapy for disseminated cutaneous, mucocutaneous and deadly visceral disease. This review is a summary of the clinical syndromes caused by Leishmania and treatment regimens currently used for various forms of leishmaniasis. PMID:23744570
McGwire, B S; Satoskar, A R
Dupuytren's disease (DD) is a common progressive fibrotic condition affecting the palmar and digital fascia. Although its management is undertaken by hand surgeons, it is commonly seen by other doctors as an incidental finding. In many cases it is believed to be associated with other medical conditions, although the evidence for such associations is not always clear. This review considers the evidence behind these associations and discusses the aetiology of DD. By doing so, it is hoped that this review will permit a better understanding of the relevance of DD as a clinical sign.
Hart, M; Hooper, G
Bronchoalveolar lavage (BAL) is a minimally invasive procedure used to characterize the status of the alveolar space. Standardization of the procedure and the analysis of samples taken is essential for their proper interpretation. In nonresolving or ventilator-associated pneumonia, BAL contributes to the detection of resistant pathogens and noninfectious etiologies. In immunocompromised hosts with radiological infiltrates, BAL should be performed early during work-up since outcome is significantly modified in this population group. In cases of interstitial lung disease, BAL can exclude infectious or neoplastic causes. Associated with a clinical and radiological evaluation, it provides valuables additional diagnostic information. PMID:23240296
Pasche, A; Braunschweig, R; Fitting, J-W; Nicod, L P
Compared with the current focus on the development of clinical practice guidelines the effort devoted to their evaluation is meagre. Yet the ultimate success of guidelines depends on routine evaluation. Three types of evaluation are identified: evaluation of guidelines under development and before dissemination and implementation, evaluation of health care programs in which guidelines play a central role, and scientific evaluation, through studies that provide the scientific knowledge base for further evolution of guidelines. Identification of evaluation and program goals, evaluation design and a framework for evaluation planning are discussed.
Basinski, A S
Veterinary clinical oncology involves a multidisciplinary approach to the recognition and management of spontaneously occurring neoplasms of domestic animals. This requires some knowledge of the causes, incidence, and natural course of malignant disease as it occurs in domestic species. The purpose of this course is to acquaint you with the more common neoplastic problems you will encounter in practice, so that you can offer your clients an informed opinion regarding prognosis and possible therapeutic modalities. A major thrust will be directed toward discussing and encouraging treatment/management of malignant disease. Multimodality therapy will be stressed. 10 refs., 3 tabs.
|A clinical guide is an experienced nurse who supports nursing students throughout the program, particularly in clinical placements. More than a mentor, a guide is fully involved in promoting deep learning in clinical settings. (SK)|
Andrews, Margaret; Roberts, Debbie
Hepatitis D is caused by infection with hepatitis D virus (HDV), a defective RNA virus that requires the obligatory helper function of hepatitis B virus (HBV) for its in vivo transmission. Thus, HDV is acquired only by coinfection with HBV or by superinfection of an HBV carrier. The clinical outcome of hepatitis D differs according to the modality of infection. Whereas coinfection evolves to chronicity in only 2% of the cases, superinfection results in chronic infection in over 90% of the cases. HDV is a highly pathogenic virus that causes acute, often fulminant hepatitis, as well as a rapidly progressive form of chronic viral hepatitis, leading to cirrhosis in 70 to 80% of the cases. The clinical picture of HDV disease is evolving as a consequence of a significant change in the epidemiology of HDV infection, which has led to a significant decline in incidence in Western countries, mainly as a result of universal HBV vaccination programs. However, in the face of a declining prevalence in areas of old endemicity like Europe, immigration poses a threat of HDV resurgence. The interaction of HDV with other hepatitis viruses or human immunodeficiency virus is complex and may lead to different patterns in terms of virologic expression and immunologic responses. Multiple viral infections are associated with rapid progression of liver fibrosis and eventually with the development of hepatocellular carcinoma. Hepatitis D is not a vanishing disease, and continuous efforts should be made to improve its prevention and treatment. PMID:22932971
Farci, Patrizia; Niro, Grazia Anna
Patients who cannot walk, particularly those with orthopaedic deformities, need more than a simple wheelchair; they require a special seating system. Since the early 1970's many different systems have been introduced to the field of orthotics and prescribed through "Seating Clinics" in many centres in North America and around the world. Our experience in the Seating Clinic at the University of Kansas Medical centre is presented. Most patients were children (70%) with 69% male and 31% female. Various seating systems were prescribed, including the Safety Travel Chair, the Moulded Plastic Insert, the Orthopaedic Body Support (foam on plywood), the Spinal Support System, the Moulded Seat Total Contact Shell (sitting support orthosis) and the DESEMO support system. The majority of patients had cerebral palsy (58%) and muscular dystrophy (33%). Other conditions included spinal cord injury, spina bifida and multiple orthopaedic deformities. Sixty five percent of the custom made seating systems prescribed were the Orthopaedic Body Support. Unilateral dislocation of the hip presents a major problem in seating because of pelvic obliquity. PMID:3912340
Medhat, M A; Redford, J B
Discussions on the ethics and regulation of clinical research have a great deal to say about the responsibilities of investigators, sponsors, research institutions and institutional review boards, but very little about the responsibilities of research participants. In this article, we discuss the responsibilities of participants in clinical research. We argue that competent adult participants are responsible for complying with study requirements and fulfilling other obligations they undertake when they make an informed choice to enroll in a study. These responsibilities are based on duties related to promise-keeping, avoiding harm to one's self or others, beneficence and reciprocity. Investigators and research staff should inform participants about their responsibilities during the consent process, and should stress the importance of fulfilling study requirements. They should address any impediments to compliance, and they may provide participants with financial incentives for meeting study requirements. In very rare cases, coercive measures may be justified to prevent immanent harm to others resulting from non-compliance with study requirements. PMID:22822200
Resnik, David B; Ness, Elizabeth
Purpose Even though aural fullness is ubiquitous among patients presenting to otolaryngology clinics, the association between aural fullness and disease development has not yet been clearly determined. Materials and Methods Our study was performed on outpatients from June 2006 to February 2010 whose major complaint was "ear fullness", "aural fullness", or "ear pressure". We assessed their demographic and clinical characteristics, including sex, associated diseases, symptoms, otoscopic findings, audiology test results, and final diagnoses. Results Among 432 patients, 165 (38.2%) were males and 267 (61.8%) were females, with mean ages of 42±19 years and 47±17 years, respectively. Tinnitus, hearing disturbance, autophony (p<0.01) as well as nasal obstruction and sore throat (p<0.05) showed a statistically significant correlation with aural fullness. Among patients who complained of hearing fullness, tests and measures such as impedance audiometry, speech reception threshold, and pure tone audiometry generated statistically significant results (p<0.05). Ear fullness was most frequently diagnosed as Eustachian tube dysfunction (28.9%), followed by otitis media with effusion (13.4%) and chronic otitis media (7.2%). However, 13.4% of patients could not be definitively diagnosed. Conclusion Among patients complaining of ear fullness, Eustachian tube dysfunction, otitis media with effusion, chronic otitis media were most commonly observed. Performance of otoscopy, nasal endoscopy, the Valsalva maneuver, and additional audiological tests is necessary to exclude other diseases.
Park, Moon Suh; Lee, Ho Yun; Kang, Ho Min; Ryu, Eun Woong; Lee, Sun Kyu
Three types of clinical studies were carried out to better understand diaper dermatitis in a general infant population. In 'snapshot' clinical studies, skin condition under the diaper was evaluated at a given point in time across a large base of infants. Correlations were sought between diaper dermatitis incidence and severity and a number of factors, including sex, diet, maturity, type of diaper, history of allergy, contact with fecal matter, presence of Candida albicans, and diaper change frequency. Severe diaper rash correlated strongly with the presence of C. albicans, and the frequency of rash correlated with duration of contact with feces and inversely with diaper change frequency. Diaper rash peaked at ages 9-12 months and was lower for breast-fed than for formula-fed infants. Exclusive use of disposable diapers correlated with lower rash levels than when some or all cloth diapers were used. In a longitudinal study, infants were observed daily for 50 days in order to determine the frequency and duration of rash episodes. In this study, the tendency for some infants to be rash-prone was clearly indicated. In a third type of study, over 10,000 infant visits to physicians' offices were used to record skin condition. Results showed a three-to fourfold increase in diaper rash if the child had diarrhea during the previous 48 h. PMID:3299331
Test results from clinical laboratories must ensure accuracy, as these are crucial in several areas of health care. It is necessary that the laboratory implements quality assurance to achieve this goal. The implementation of quality should be audited by independent bodies,referred to as accreditation bodies. Accreditation is a third-party attestation by an authoritative body, which certifies that the applicant laboratory meets quality requirements of accreditation body and has demonstrated its competence to carry out specific tasks. Although in most of the countries,accreditation is mandatory, in India it is voluntary. The quality requirements are described in standards developed by many accreditation organizations. The internationally acceptable standard for clinical laboratories is ISO15189, which is based on ISO/IEC standard 17025. The accreditation body in India is the National Accreditation Board for Testing and Calibration Laboratories, which has signed Mutual Recognition Agreement with the regional cooperation the Asia Pacific Laboratory Accreditation Cooperation and with the apex cooperation the International Laboratory Accreditation Cooperation. PMID:22727005
Handoo, Anil; Sood, Swaroop Krishan
Currently, several ibuprofen compounds are available on the market, mainly differing in terms of pharmaceutical composition that influence the pharmacokinetic profile and eventually the onset of drug action. This review will mainly deal with the clinical pharmacokinetics of ibuprofen arginine, an alternative formulation specifically designed to improve the absorption of ibuprofen. Indeed, available data from studies in healthy volunteers have consistently shown that the formulation of ibuprofen arginine is characterized by prompt absorption of ibuprofen as compared to the conventional formulation at all tested doses with higher peak plasma concentration and lower Tmax values. This trend has been confirmed also in studies dealing with chiral ibuprofen pharmacokinetics. Most importantly, the shortening in the absorption time observed either with racemic mixture or with the S(+)-enantiomer of ibuprofen arginine did not imply a faster drug elimination eventually leading to inadequate daily drug exposure, as documented by T1/2 and AUC values being comparable to those measured with the free acid form. Taken together, the pharmacokinetic/dynamic characteristics of ibuprofen arginine can be considered particularly favorable for several clinical conditions, such as moderate/severe pain, in which a rapid pharmacologic effect is required. PMID:20925647
Cattaneo, Dario; Clementi, Emilio
Benzoporphyrin derivative monoacid ring A (BPD) is currently in Phase II clinical trials for the treatment of cutaneous malignancies (basal cell carcinoma and cutaneous metastases) and psoriasis. Results to date suggest that this photosensitizer has potential in both of these areas. Recently, a clinical trial with BPD was initiated for the treatment of age related macular degeneration, a neovascular condition in the eye which leads to blindness. BPD is a lipophilic photosensitizer which is rapidly taken up by activated cells and the vascular endothelium of neovasculature. The PDT effects seen with BPD appear to be a combination of vascular occlusion and direct killing of target cells. Since many diseases involve either activated cells and/or neovasculature, PDT with photosensitizer with characteristics like those of BPD, has applications far wider than oncology. A new area of interest involving photosensitizers is that of immune modulation. A number of photosensitizers have been shown to effect immune modulation in animal models of immune dysfunction including autoimmunity (rheumatoid arthritis, lupus), cutaneous hypersensitivity and allografts. BPD and PHOTOFRINR have both been shown to be effective in ameliorating arthritic symptoms in a number of animal models. The mechanisms by which immune modulation is affected in these studies still remains to be resolved.
Levy, Julia G.; Chan, Agnes H.; Strong, H. Andrew
What is the current state of clinical application of inhibition of gonadal activity with LHRH agonists or antagonists? It seems unlikely in the short term that antagonists will be widely applied due to the short-acting nature of the present compounds and their troublesome side-effects. In contrast clinical studies with a number of agonists have demonstrated their efficacy in producing a hypogonadal state safely with rapid recovery following cessation of therapy. Although nasal administration may be suitable for short-term suppression (up to 28 days) it seems likely that long-acting depot preparations will be useful for more prolonged suppression. Perhaps the easiest application to determine will be the profound suppression required to produce medical castration in hormone-dependent tumours. The combination of agonist and receptor blocker is attractive particularly when the receptor blocker like cyproterone acetate also suppresses the release of LH, FSH and adrenocorticotrophic hormone. In cancer of the prostate and breast the side-effects due to inhibition of secretion of testosterone and oestradiol are tolerable although the only benefit over castration is the avoidance of minor surgery. The agonists should improve significantly the existing treatment for precocious puberty, endometriosis, uterine fibroids, polycystic ovary syndrome (PCO) and induction of ovulation although large scale trials comparing different therapies and doses are required. Finally, the concept of combination therapies to block further the influence of steroid hormones suggests challenging possibilities for even more effective therapy. PMID:3109366
Fraser, H M; Baird, D T
Since 1992, Human Botulism Immune Globulin has been provided by the California Department of Health Services to infants with probable infant botulism, the intestinal toxemia form of human botulism. Human Botulism Immune Globulin became available in California in 1992-1997 within a randomized, controlled, double-blinded, pivotal clinical trial and subsequently became available nationwide in 1998-2003 in an open-label study until its licensure in October 2003 as BabyBIG. Thereafter, Human Botulism Immune Globulin remained available nationwide as an approved orphan-drug product. To achieve prompt neutralization of circulating botulinum toxin, the decision to treat with Human Botulism Immune Globulin has been based on clinical criteria that include a consistent history and physical findings of bulbar palsies, hypotonia, and weakness. After licensure, the charts of patients who did not have laboratory-confirmed infant botulism were reviewed to identify their actual diagnoses. The approximately 5% of 681 patients treated with Human Botulism Immune Globulin who did not have infant botulism fell into 5 categories: spinal muscular atrophy, metabolic disorders, other infectious diseases, miscellaneous, and probable infant botulism lacking laboratory confirmation. PMID:17403857
Francisco, Ann Marie O; Arnon, Stephen S
We are beginning to see the potential of robotics in the clinical laboratory through integration with automated analyzers and computer systems. However, there is a need for training programs that will prepare technologists to design and implement robotic systems for clinical laboratories. What will the robot laboratory of the future look like? We will see hospital laboratories begin to be located some distance away from the main facility because the labor component of staffing satellite laboratories will have been greatly reduced. Instrument manufacturers will see the need for analyzers that are robot-friendly and allow for simplified interfacing, both electronic and mechanical. Robots will become more versatile even to the point of performing complete instrument repair. Laboratories will be equipped with many task-oriented robotic stations, including, for example, accessioning and processing robots that prepare samples for transport by robotic carts. Analysis will be performed by a combination of robot and dedicated analyzer. Laboratory results will be reviewed by algorithms in the larger laboratory computer, which will alert the laboratory worker to unusual results. A large variety of analyses will be available to the patient with rapid turnaround. The end result will be more efficient health care delivery at reduced cost. PMID:3061728
Felder, R A; Boyd, J C; Savory, J; Margrey, K; Martinez, A; Vaughn, D
Proton imaging is not yet applied as a clinical routine, although its advantages have been demonstrated. In the context of quality assurance in proton therapy, proton images can be used to verify the correct positioning of the patient and to control the range of protons. Proton computed tomography (pCT) is a 3D imaging method appropriate for planning and verification of proton radiation treatments, because it allows evaluating the distributions of proton stopping power within the tissues and can be directly utilized when the patient is in the actual treatment position. The aim of the PRoton IMAging experiment, supported by INFN, and the PRIN 2006 project, supported by MIUR, is to realize a proton computed radiography (pCR) prototype for reconstruction of proton images from a single projection in order to validate the technique with pre-clinical studies and, eventually, to conceive the configuration of a complete pCT system. A preliminary experiment performed at the 250 MeV proton synchrotron of Loma Linda University Medical Center (LLUMC) allowed acquisition of experimental data before the completion of PRIMA project's prototype. In this paper, the results of the LLUMC experiment are reported and the reconstruction of proton images of two phantoms is discussed.
Talamonti, C.; Reggioli, V.; Bruzzi, M.; Bucciolini, M.; Civinini, C.; Marrazzo, L.; Menichelli, D.; Pallotta, S.; Randazzo, N.; Sipala, V.; Cirrone, G. A. P.; Petterson, M.; Blumenkrantz, N.; Feldt, J.; Heimann, J.; Lucia, D.; Seiden, A.; Williams, D. C.; Sadrozinski, H. F.-W.; Bashkirov, V.; Schulte, R.
The diagnosis chronic fatigue syndrome (CFS) was conceptualized in the mid-1980s. It is a clinically defined condition characterized by severe and disabling new onset fatigue with at least four additional symptoms: impaired memory or concentration, sore throat, tender cervical or axillary lymph nodes, muscle pain, multi-joint pain, new headaches, unrefreshing sleep or post-exertion malaise. Chronic fatigue syndrome in adolescents is a rare condition compared to symptomatic fatigue. The estimated prevalence of adolescent CFS ranges between 0.11 and 1.29 % in Dutch, British, and US populations. Diagnosis of the chronic fatigue syndrome is established through exclusion of other medical and psychiatric causes of chronic fatiguing illness. Taking a full clinical history and a full physical examination are therefore vital. In adolescence, CFS is associated with considerable school absence with long-term detrimental effects on academic and social development. One of the most successful potential treatments for adolescents with CFS is cognitive behavioural therapy, which has been shown to be effective after 6 months in two thirds of the adolescents with CFS. This treatment effect sustains at 2-3-year follow-up. In conclusion, the diagnosis CFS should be considered in any adolescent patient with severe disabling long-lasting fatigue. Cognitive behavioural therapy is effective in 60-70 % of the patients. Prompt diagnosis favours the prognosis. PMID:23756916
Werker, Charlotte L; Nijhof, Sanne L; van de Putte, Elise M
Vascular parkinsonism has not been well defined and the clinical correlation of vascular parkinsonism is still not clear. The aim of the study was to estimate prevalence of occurrence of vascular parkinsonism, analysis of risk factors leading to its development and to identify clinical features that suggest a vascular origin. 214 patients with Parkinson's disease were examined. Their ages ranged from 37 to 88 years (median 66.4 years). Evidence of vascular parkinsonism was assessed using a vascular rating scale previously described by Winikates and Jankovic. Statistical analysis was performed with Mann-Whitney U test, chi 2 Pearson test, chi 2 Yates test, Spearman rank correlation and Student's t test. Out of 214 patients 8 were proved to have developed Parkinson's disease due to vascular disease, what gave 3.74%. Out of risk factors for stroke 5 patients had hypertension, 3 had diabetes mellitus, 2 suffered from heart disease, 2 had infarctus myocardii, 1 had hyperlipidemia, 1 had atrial fibrillation. Additionally, those patients had neuroimaging (CT or MRI) evidence of vascular disease in one or more vascular territories. Patients with vascular parkinsonism were older, had shorter duration of disease, were more likely to present rigidity rather than tremor. Dementia and incontinence were more common in vascular group than in Parkinson's disease group. Patients with vascular parkinsonism were also significantly more likely to have corticospinal findings. Proving that Parkinson's disease had vascular etiology is extremely difficult. The test results are inconclusive. PMID:15098342
Honczarenko, Krystyna; Budzianowska, Anna
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Text Version... 2005 Vice President, Global Clinical Research ... forms, enlisted investigators, ordered clinical supplies ... Canadian Journal of Contact Lens Practice ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials
Text Version... Clinical Trial Design Issues – Development of New Therapies for ... Clinical Trial Design Issues – Development of New Therapies for ... More results from www.fda.gov/downloads/drugs/newsevents
The Clinical Research Unit at Ulm, Germany is an outstanding unit at an extremely progressive university. The present scientific program at the Clinical Research Unit in the Department of Physiology is on experimental hematology, studying cell system phys...
C. R. Valeri
... RSS Feed FDA 101: Clinical Trials and Institutional Review Boards Search the Consumer Updates Section Get Consumer ... parties. Clinical trial procedures are reviewed by institutional review boards (IRBs). These boards are composed of at ...
Depression (major depression) Basics In-Depth Multimedia Expert Answers Resources Reprints A single copy of this article may be reprinted for personal, noncommercial use only. 'Clinical depression': What does that mean? By Mayo Clinic staff ...
|Describes the responsibilities of the clinical medical librarian, an occupation in which the medical librarian operates in a clinical setting, identifying information needs of medical personnel through direct patient-physician-librarian contact. (CWM)|
Lawrence, Gerri G.
... IND Applications for Clinical Investigations: Overview. ... Review Time for initial submission of an ... may proceed with a clinical investigation once the ... More results from www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved
Text VersionPage 1. 1 Capital Reporting Company Endpoints in Clinical Trials of Kidney Transplantation 09-11-2012 ENDPOINTS IN CLINICAL TRIALS ... More results from www.fda.gov/downloads/drugs/newsevents
Alex McMahon and colleagues critique the International Conference on Harmonisation (ICH) guidance on good clinical practice (GCP), arguing that it is having a disastrous effect on noncommerical randomized clinical trials in Europe.
Alex D. McMahon; David I. Conway; Tom M. MacDonald; Gordon T. McInnes
...DEPARTMENT OF DEFENSE Office of the Secretary Cancer Treatment Clinical Trials AGENCY: Office...for eligible beneficiaries who receive cancer treatment under approved National Institutes of Health, National Cancer Institute (NCI) clinical trials....
Two types of male gonad shields, designed for use with support garments, were tested in a number of hospitals and clinics throughout the United States. The clinical evaluation consisted of: (1) Measuring dose reduction with thermoluminescent dosimeters; a...
W. W. Church B. M. Burnett
... Jack A. Cook, Ph.D. Expertise: Clinical Pharmacology Term: 04/04/2012 – 10/31/2015 Clinical Pharmacology Specialty Care Business Unit Pfizer ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs
The traditional clinical examination has been shown to have serious limitations in terms of its validity and reliability. The OSCE provides some answers to these limitations and has become very popular. Many variants on the original OSCE format now exist and much research has been done on various aspects of their use. Issues to be addressed relate to organization matters and to the quality of the assessment. This paper focuses particularly on the latter with respect to ways of ensuring content validity and achieving acceptable levels of reliability. A particular concern has been the demonstrable need for long examinations if high levels of reliability are to be achieved. Strategies for reducing the practical difficulties this raises are discussed. Standard setting methods for use with OSCEs are described. PMID:14871390
This presentation will focus on McNeil Pharmaceutical's method of managing clinical data from the final stages of data entry to the final archiving stage. We use a Decsys-tem-10 timesharing computer which allows us to monitor most information on-line with various systems. The management of clinical data is aided by various computer systems including a Clinical Tracking System, a Clinical Information
Thomas W. Teal; Stephen J. Kopko
We examined differences in perfectionism between burned-out employees (n=77), depressed employees (n=29), anxiety-disordered employees (n=31), employees with comorbid disorders, that is, a combination of clinical burnout, depression, or anxiety disorder (n=28), and individuals without clinical burnout, depression disorder, or anxiety disorder (clinical control group; n=110). The results suggest that setting high personal standards per se is not associated with clinical
Nico W. Van Yperen; Marc Verbraak; Ellen Spoor
Types of Sensitivity or Specificity Analytical Sensitivity is how often the test is positive when the analyte is present (true positivity). Analytical Specificity is how often the test is negative when the analyte is absent (true negativity). Clinical Sensitivity is how often the clinical endpoint is present or reached when the test is positive. Clinical Specificity is how often the clinical endpoint is absent or not reached when the test is negative.
Evaluation of OVERALL Clinical Training program (to be completed semiannually by Fellows) Name___________________________________________ Date _________________ Training Program _______________________________________________________ Educational Experience
This research surveyed the state of computerized clinical data management across 28 companies attending the April 1989 Drug Information Association Clinical Data Management workshop in Philadelphia, Pennsylvania. It studies clinical trial characteristics, computer systems used, and experience with remote data entry (RDE) and electronic submissions (ENDAs). It also compares 1989 results with previous research done in September 1985. Results: (1)
Theresa E. Stokes
This study examines the pharmaceutical industry clinical data management experience as of September 1985. It looks at data turnaround in Phase III clinical studies, data-handling systems used, and remote data entry experiences across 20 companies. Data were gathered through a Drug Information Association (DIA) Workshop Survey Form. Results: (1) It takes an average of 11 weeks to get clinical data
Theresa E. Stokes
This handbook and study guide were developed as a textbook to be used as a review course for preparation for the clinical licensing examination. It presents a summary of a graduate level academic program in clinical mental health counseling. It contains 17 chapters on clinical information; 4 chapters on test taking; 2 types of sample tests; and 3…
Bullard, Bonnie; Lawless, Linda; Williams, Midge; Bergstrom, Deborah
|Three research projects were conducted at the University of Maryland's Reading Clinic (for students in grades one through twelve) to evaluate the efficiency of clinical procedures and to generate research hypotheses and techniques. Using data from randomly selected clinical case studies, the research projects focused on two diagnostic procedures:…
|In this paper, I explore how we might link ideas about clinical facts to current issues in child psychotherapy research. I consider what our understanding of clinical facts might contribute to our research methods and how our research methods might better represent the clinical facts. The paper introduces a selection of psychoanalytic writers'…
Stroke has enormous clinical, social, and economic implications, and demands a significant effort from both basic and clinical science in the search for successful therapies. Atherosclerosis, the pathologic process underlying most coronary artery disease and the majority of ischemic stroke in humans, is an inflammatory process. Complex interactions occur between the classic risk factors for atherosclerosis and its clinical consequences.
Hedley C A Emsley; Pippa J Tyrrell; Hedley CA Emsley
Diabetic control in 88 children attending three general paediatric clinics was compared prospectively over one year with that of 89 children attending a specialist paediatric diabetic clinic. Glycated haemoglobin (HbA1) concentration and days admitted were significantly lower in the group attending the specialist clinic. This has implications for the organisation of paediatric diabetic services.
Bloomfield, S; Farquhar, J W
Summary: Hypersensitivity pneumonitis (HP) is an inflammatory interstitial lung disease caused by recurring exposure to a variety of occupational and environmental antigens. It features widely variable clinical, radiologic, and histopathologic findings. Because the clinical findings of HP mimic multiple other diseases, a high degree of clinical suspicion and a thorough occupational and environmental history are essential for accurate diagnosis. There
Craig S. Glazer; Cecile S. Rose; David A. Lynch
|Aim: To effectively provide clinical placements for students and increase healthcare options for rural communities, an investigation of university clinics was conducted. Method: This project adopted a consultative inquiry strategy and involved two processes: (1) a review of literature; and (2) interviews with existing health sciences clinic…
Allan, Julaine; Pope, Rod; O'Meara, Peter; Higgs, Joy; Kent, Jenny
A preceptorial is a one-on-one reality-based clinical experience in which the staff nurse supervises the learning experience. Many schools of nursing use preceptor clinicals for the last clinical experience, but no studies were found that examined how students viewed that experience. This qualitative study was undertaken to ascertain how undergraduate preceptorial students view their clinical experience. In addition, since the program studied also uses preceptorials for its students' first clinical experience, the study examined differences in perception about the preceptorial between first- and second-level students. The students were asked to complete an anonymous open-ended questionnaire about their clinical experience. Content analysis was performed on the answers using the whole response to the question as the unit of analysis. Indicators of reliability and validity were established. Two themes emerged from the analysis: what students desire from their clinical experience and the factors that influence the preceptorial clinical experience. In addition, differences were found between perceptions of students in the first and last preceptorial clinical experiences. The results were discussed in terms of clinical experiences and possible differences in perception of clinical between those who have preceptorial and traditional faculty-led clini