SU-C-BRA-06: Developing Clinical and Quantitative Guidelines for a 4DCT-Ventilation Functional Avoidance Clinical Trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vinogradskiy, Y; Waxweiler, T; Diot, Q

Purpose: 4DCT-ventilation is an exciting new imaging modality that uses 4DCTs to calculate lung ventilation. Because 4DCTs are acquired as part of routine care, calculating 4DCT-ventilation allows for lung function evaluation without additional cost or inconvenience to the patient. Development of a clinical trial is underway at our institution to use 4DCT-ventilation for thoracic functional avoidance with the idea that preferential sparing of functional lung regions can decrease pulmonary toxicity. The purpose of our work was to develop the practical aspects of a 4DCT-ventilation functional avoidance clinical trial including: 1.assessing patient eligibility 2.developing trial inclusion criteria and 3.developing treatment planningmore » and dose-function evaluation strategies. Methods: 96 stage III lung cancer patients from 2 institutions were retrospectively reviewed. 4DCT-ventilation maps were calculated using the patient’s 4DCTs, deformable image registrations, and a density-change-based algorithm. To assess patient eligibility and develop trial inclusion criteria we used an observer-based binary end point noting the presence or absence of a ventilation defect and developed an algorithm based on the percent ventilation in each lung third. Functional avoidance planning integrating 4DCT-ventilation was performed using rapid-arc and compared to the patient’s clinically used plan. Results: Investigator-determined clinical ventilation defects were present in 69% of patients. Our regional/lung-thirds ventilation algorithm identified that 59% of patients have lung functional profiles suitable for functional avoidance. Compared to the clinical plan, functional avoidance planning was able to reduce the mean dose to functional lung by 2 Gy while delivering comparable target coverage and cord/heart doses. Conclusions: 4DCT-ventilation functional avoidance clinical trials have great potential to reduce toxicity, and our data suggest that 59% of lung cancer patients

Effects of sleep bruxism on functional and occlusal parameters: a prospective controlled investigation

PubMed Central

Alicia Ommerborn, Michelle; Giraki, Maria; Schneider, Christine; Michael Fuck, Lars; Handschel, Jörg; Franz, Matthias; Hans-Michael Raab, Wolfgang; Schäfer, Ralf

2012-01-01

This study was conducted to verify the results of a preceding retrospective pilot study by means of a prospective controlled investigation including a larger sample size. Therefore, the aim of this clinical investigation was to analyze the relationship between sleep bruxism and several functional and occlusal parameters. The null hypothesis of this study was that there would be no differences among sleep bruxism subjects and non-sleep bruxism controls regarding several functional and occlusal parameters. Fifty-eight sleep bruxism subjects and 31 controls participated in this study. The diagnosis sleep bruxism was based on clinical criteria of the American Academy of Sleep Medicine. Sixteen functional and occlusal parameters were recorded clinically or from dental study casts. Similar to the recently published retrospective pilot study, with a mean slide of 0.77 mm (s.d., 0.69 mm) in the sleep bruxism group and a mean slide of 0.4 mm (s.d., 0.57 mm) in the control group, the evaluation of the mean comparison between the two groups demonstrated a larger slide from centric occlusion to maximum intercuspation in sleep bruxism subjects (Mann–Whitney U-test; P=0.008). However, following Bonferroni adjustment, none of the 16 occlusal and functional variables differed significantly between the sleep bruxism subjects and the non-sleep bruxism controls. The present study shows that the occlusal and functional parameters evaluated do not differ between sleep bruxism subjects and non-sleep bruxism subjects. However, as the literature reveals a possible association between bruxism and certain subgroups of temporomandibular disorders, it appears advisable to incorporate the individual adaptive capacity of the stomatognathic system into future investigations. PMID:22935746

Effects of sleep bruxism on functional and occlusal parameters: a prospective controlled investigation.

PubMed

Ommerborn, Michelle Alicia; Giraki, Maria; Schneider, Christine; Fuck, Lars Michael; Handschel, Jörg; Franz, Matthias; Hans-Michael Raab, Wolfgang; Schäfer, Ralf

2012-09-01

This study was conducted to verify the results of a preceding retrospective pilot study by means of a prospective controlled investigation including a larger sample size. Therefore, the aim of this clinical investigation was to analyze the relationship between sleep bruxism and several functional and occlusal parameters. The null hypothesis of this study was that there would be no differences among sleep bruxism subjects and non-sleep bruxism controls regarding several functional and occlusal parameters. Fifty-eight sleep bruxism subjects and 31 controls participated in this study. The diagnosis sleep bruxism was based on clinical criteria of the American Academy of Sleep Medicine. Sixteen functional and occlusal parameters were recorded clinically or from dental study casts. Similar to the recently published retrospective pilot study, with a mean slide of 0.77 mm (s.d., 0.69 mm) in the sleep bruxism group and a mean slide of 0.4 mm (s.d., 0.57 mm) in the control group, the evaluation of the mean comparison between the two groups demonstrated a larger slide from centric occlusion to maximum intercuspation in sleep bruxism subjects (Mann-Whitney U-test; P=0.008). However, following Bonferroni adjustment, none of the 16 occlusal and functional variables differed significantly between the sleep bruxism subjects and the non-sleep bruxism controls. The present study shows that the occlusal and functional parameters evaluated do not differ between sleep bruxism subjects and non-sleep bruxism subjects. However, as the literature reveals a possible association between bruxism and certain subgroups of temporomandibular disorders, it appears advisable to incorporate the individual adaptive capacity of the stomatognathic system into future investigations.

Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project.

PubMed

Perez, Raymond P; Finnigan, Shanda; Patel, Krupa; Whitney, Shanell; Forrest, Annemarie

2016-12-15

Use of electronic clinical trial portals has increased in recent years to assist with sponsor-investigator communication, safety reporting, and clinical trial management. Electronic portals can help reduce time and costs associated with processing paperwork and add security measures; however, there is a lack of information on clinical trial investigative staff's perceived challenges and benefits of using portals. The Clinical Trials Transformation Initiative (CTTI) sought to (1) identify challenges to investigator receipt and management of investigational new drug (IND) safety reports at oncologic investigative sites and coordinating centers and (2) facilitate adoption of best practices for communicating and managing IND safety reports using electronic portals. CTTI, a public-private partnership to improve the conduct of clinical trials, distributed surveys and conducted interviews in an opinion-gathering effort to record investigator and research staff views on electronic portals in the context of the new safety reporting requirements described in the US Food and Drug Administration's final rule (Code of Federal Regulations Title 21 Section 312). The project focused on receipt, management, and review of safety reports as opposed to the reporting of adverse events. The top challenge investigators and staff identified in using individual sponsor portals was remembering several complex individual passwords to access each site. Also, certain tasks are time-consuming (eg, downloading reports) due to slow sites or difficulties associated with particular operating systems or software. To improve user experiences, respondents suggested that portals function independently of browsers and operating systems, have intuitive interfaces with easy navigation, and incorporate additional features that would allow users to filter, search, and batch safety reports. Results indicate that an ideal system for sharing expedited IND safety information is through a central portal used by

Memory functioning in children with reading disabilities and/or attention deficit/hyperactivity disorder: a clinical investigation of their working memory and long-term memory functioning.

PubMed

Kibby, Michelle Y; Cohen, Morris J

2008-11-01

We examined memory functioning in children with reading disabilities (RD), Attention deficit/hyperactivity disorder (ADHD), and RD/ADHD using a clinic sample with a clinical instrument: the Children's Memory Scale, enhancing its generalizability. Participants included 23 children with RD, 30 with ADHD, 30 with RD/ADHD, and 30 controls. Children with RD presented with reduced verbal short-term memory (STM) but intact visual STM, central executive (CE), and long-term memory (LTM) functioning. Their deficit in STM appeared specific to tasks requiring phonetic coding of material. Children with ADHD displayed intact CE and LTM functioning but reduced visual-spatial STM, especially when off stimulant medication. Children with RD/ADHD had deficits consistent with both disorders.

Clinical Investigation Program Annual Progress Report

DTIC Science & Technology

1989-10-01

Investigators: Linda K. Kullama, Ph.D., Dr. Kenneth T. Nakamura,MD; Dr. Venkataraman Balaraman, MD, Wayne M. Ichimura, Biomedical Engineer. Department/Section...Investigators: John R. Claybaugh, Ph.D.; Kenneth T. Nakamura, MD; Dr. Venkataraman Balaraman, M.D. Department/Section: Clinical Investigation/Physiology Key...Pigs and Rats Principal ’Investigator: Linda K. Kullama, Ph.D.; John R. Claybaugh, Ph.D. Associate Investigators: Dr. Venkataraman Balaraman, M.D.; Dr

A preliminary investigation of sleep quality in functional neurological disorders: Poor sleep appears common, and is associated with functional impairment.

PubMed

Graham, Christopher D; Kyle, Simon D

2017-07-15

Functional neurological disorders (FND) are disabling conditions for which there are few empirically-supported treatments. Disturbed sleep appears to be part of the FND context; however, the clinical importance of sleep disturbance (extent, characteristics and impact) remains largely unknown. We described sleep quality in two samples, and investigated the relationship between sleep and FND-related functional impairment. We included a sample recruited online via patient charities (N=205) and a consecutive clinical sample (N=20). Participants completed validated measures of sleep quality and sleep characteristics (e.g. total sleep time, sleep efficiency), mood, and FND-related functional impairment. Poor sleep was common in both samples (89% in the clinical range), which was characterised by low sleep efficiency (M=65.40%) and low total sleep time (M=6.05h). In regression analysis, sleep quality was negatively associated with FND-related functional impairment, accounting for 16% of the variance and remaining significant after the introduction of mood variables. These preliminary analyses suggest that subjective sleep disturbance (low efficiency, short sleep) is common in FND. Sleep quality was negatively associated with the functional impairment attributed to FND, independent of depression. Therefore, sleep disturbance may be a clinically important feature of FND. Copyright © 2017 Elsevier B.V. All rights reserved.

Clinical applications of the functional connectome

PubMed Central

Castellanos, F. Xavier; Di Martino, Adriana; Craddock, R. Cameron; Mehta, Ashesh D.; Milham, Michael P.

2013-01-01

Central to the development of clinical applications of functional connectomics for neurology and psychiatry is the discovery and validation of biomarkers. Resting state fMRI (R-fMRI) is emerging as a mainstream approach for imaging-based biomarker identification, detecting variations in the functional connectome that can be attributed to clinical variables (e.g., diagnostic status). Despite growing enthusiasm, many challenges remain. Here, we assess evidence of the readiness of R-fMRI based functional connectomics to lead to clinically meaningful biomarker identification through the lens of the criteria used to evaluate clinical tests (i.e., validity, reliability, sensitivity, specificity, and applicability). We focus on current R-fMRI-based prediction efforts, and survey R-fMRI used for neurosurgical planning. We identify gaps and needs for R-fMRI-based biomarker identification, highlighting the potential of emerging conceptual, analytical and cultural innovations (e.g., the Research Domain Criteria Project (RDoC), open science initiatives, and Big Data) to address them. Additionally, we note the need to expand future efforts beyond identification of biomarkers for disease status alone to include clinical variables related to risk, expected treatment response and prognosis. PMID:23631991

Clinical Applications of Resting State Functional Connectivity

PubMed Central

Fox, Michael D.; Greicius, Michael

2010-01-01

During resting conditions the brain remains functionally and metabolically active. One manifestation of this activity that has become an important research tool is spontaneous fluctuations in the blood oxygen level-dependent (BOLD) signal of functional magnetic resonance imaging (fMRI). The identification of correlation patterns in these spontaneous fluctuations has been termed resting state functional connectivity (fcMRI) and has the potential to greatly increase the translation of fMRI into clinical care. In this article we review the advantages of the resting state signal for clinical applications including detailed discussion of signal to noise considerations. We include guidelines for performing resting state research on clinical populations, outline the different areas for clinical application, and identify important barriers to be addressed to facilitate the translation of resting state fcMRI into the clinical realm. PMID:20592951

A functional neuroimaging study of the clinical reasoning of medical students.

PubMed

Chang, Hyung-Joo; Kang, June; Ham, Byung-Joo; Lee, Young-Mee

2016-12-01

As clinical reasoning is a fundamental competence of physicians for good clinical practices, medical academics have endeavored to teach reasoning skills to undergraduate students. However, our current understanding of student-level clinical reasoning is limited, mainly because of the lack of evaluation tools for this internal cognitive process. This functional magnetic resonance imaging (fMRI) study aimed to examine the clinical reasoning processes of medical students in response to problem-solving questions. We recruited 24 2nd-year medical students who had completed their preclinical curriculum. They answered 40 clinical vignette-based multiple-choice questions during fMRI scanning. We compared the imaging data for 20 problem-solving questions (reasoning task) and 20 recall questions (recall task). Compared to the recall task, the reasoning task resulted in significantly greater activation in nine brain regions, including the dorsolateral prefrontal cortex and inferior parietal cortex, which are known to be associated with executive function and deductive reasoning. During the recall task, significant activation was observed in the brain regions that are related to memory and emotions, including the amygdala and ventromedial prefrontal cortex. Our results support that medical students mainly solve clinical questions with deductive reasoning involving prior knowledge structures and executive functions. The problem-solving questions induced the students to utilize higher cognitive functions compared with the recall questions. Interestingly, the results suggested that the students experienced some emotional distress while they were solving the recall questions. In addition, these results suggest that fMRI is a promising research tool for investigating students' cognitive processes.

21 CFR 312.40 - General requirements for use of an investigational new drug in a clinical investigation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... new drug in a clinical investigation. 312.40 Section 312.40 Food and Drugs FOOD AND DRUG... clinical investigation. (a) An investigational new drug may be used in a clinical investigation if the... requirements in this part and parts 50 and 56 with respect to the conduct of the clinical investigations; and...

Theory of mind and emotional functioning in fibromyalgia syndrome: an investigation of the relationship between social cognition and executive function.

PubMed

Di Tella, Marialaura; Castelli, Lorys; Colonna, Fabrizio; Fusaro, Enrico; Torta, Riccardo; Ardito, Rita B; Adenzato, Mauro

2015-01-01

Fibromyalgia (FM) is a syndrome primarily characterised by chronic, widespread musculoskeletal pain. In the aetiology of this syndrome a crucial role is played by complex interactions among biological, genetic, psychological, and socio-cultural factors. Recently, researchers have started to explore emotional functioning in FM, with their attention focused on alexithymia, a personality construct that affects the regulation of a person's own emotions. On the other hand, the detection and experience of emotional signals from other people have only been sparsely investigated in FM syndrome and no studies have investigated the ability to represent other people's mental states (i.e. Theory of Mind, ToM) in these patients. Here we present the first study investigating a large set of social-cognitive abilities, and the possible relationships between these abilities and the performance on executive-function tasks, in a homogenous sample of patients with FM. Forty women with FM and forty-one healthy women matched for education and age were involved in the study. Social cognition was assessed with a set of validated experimental tasks. Measures of executive function were used to test the correlations between this dimension and the social-cognitive profile of patients with FM. Relationships between social-cognitive abilities and demographic, clinical and psychological variables were also investigated. Patients with FM have impairments both in the regulation of their own affect and in the recognition of other's emotions, as well as in representing other people's mental states. No significant correlations were found between social cognition tasks and the subcomponents of the executive function that were analysed. The results show the presence of several impairments in social cognition skills in patients with FM, which are largely independent of both executive function deficits and symptoms of psychological distress. The impairments reported highlight the importance of adequately

Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations.

PubMed

Taylor, Ann M; Phillips, Kristine; Patel, Kushang V; Turk, Dennis C; Dworkin, Robert H; Beaton, Dorcas; Clauw, Daniel J; Gignac, Monique A M; Markman, John D; Williams, David A; Bujanover, Shay; Burke, Laurie B; Carr, Daniel B; Choy, Ernest H; Conaghan, Philip G; Cowan, Penney; Farrar, John T; Freeman, Roy; Gewandter, Jennifer; Gilron, Ian; Goli, Veeraindar; Gover, Tony D; Haddox, J David; Kerns, Robert D; Kopecky, Ernest A; Lee, David A; Malamut, Richard; Mease, Philip; Rappaport, Bob A; Simon, Lee S; Singh, Jasvinder A; Smith, Shannon M; Strand, Vibeke; Tugwell, Peter; Vanhove, Gertrude F; Veasley, Christin; Walco, Gary A; Wasan, Ajay D; Witter, James

2016-09-01

Although pain reduction is commonly the primary outcome in chronic pain clinical trials, physical functioning is also important. A challenge in designing chronic pain trials to determine efficacy and effectiveness of therapies is obtaining appropriate information about the impact of an intervention on physical function. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) and Outcome Measures in Rheumatology (OMERACT) convened a meeting to consider assessment of physical functioning and participation in research on chronic pain. The primary purpose of this article is to synthesize evidence on the scope of physical functioning to inform work on refining physical function outcome measurement. We address issues in assessing this broad construct and provide examples of frequently used measures of relevant concepts. Investigators can assess physical functioning using patient-reported outcome (PRO), performance-based, and objective measures of activity. This article aims to provide support for the use of these measures, covering broad aspects of functioning, including work participation, social participation, and caregiver burden, which researchers should consider when designing chronic pain clinical trials. Investigators should consider the inclusion of both PROs and performance-based measures as they provide different but also important complementary information. The development and use of reliable and valid PROs and performance-based measures of physical functioning may expedite development of treatments, and standardization of these measures has the potential to facilitate comparison across studies. We provide recommendations regarding important domains to stimulate research to develop tools that are more robust, address consistency and standardization, and engage patients early in tool development.

21 CFR 312.70 - Disqualification of a clinical investigator.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Disqualification of a clinical investigator. 312.70 Section 312.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... and Investigators § 312.70 Disqualification of a clinical investigator. (a) If FDA has information...

Theory of Mind and Emotional Functioning in Fibromyalgia Syndrome: An Investigation of the Relationship between Social Cognition and Executive Function

PubMed Central

Di Tella, Marialaura; Castelli, Lorys; Colonna, Fabrizio; Fusaro, Enrico; Torta, Riccardo; Ardito, Rita B.; Adenzato, Mauro

2015-01-01

Background Fibromyalgia (FM) is a syndrome primarily characterised by chronic, widespread musculoskeletal pain. In the aetiology of this syndrome a crucial role is played by complex interactions among biological, genetic, psychological, and socio-cultural factors. Recently, researchers have started to explore emotional functioning in FM, with their attention focused on alexithymia, a personality construct that affects the regulation of a person’s own emotions. On the other hand, the detection and experience of emotional signals from other people have only been sparsely investigated in FM syndrome and no studies have investigated the ability to represent other people’s mental states (i.e. Theory of Mind, ToM) in these patients. Here we present the first study investigating a large set of social-cognitive abilities, and the possible relationships between these abilities and the performance on executive-function tasks, in a homogenous sample of patients with FM. Methodology Forty women with FM and forty-one healthy women matched for education and age were involved in the study. Social cognition was assessed with a set of validated experimental tasks. Measures of executive function were used to test the correlations between this dimension and the social-cognitive profile of patients with FM. Relationships between social-cognitive abilities and demographic, clinical and psychological variables were also investigated. Principal Findings Patients with FM have impairments both in the regulation of their own affect and in the recognition of other’s emotions, as well as in representing other people’s mental states. No significant correlations were found between social cognition tasks and the subcomponents of the executive function that were analysed. Conclusions The results show the presence of several impairments in social cognition skills in patients with FM, which are largely independent of both executive function deficits and symptoms of psychological distress

Benchmarking Outpatient Rehabilitation Clinics Using Functional Status Outcomes.

PubMed

Gozalo, Pedro L; Resnik, Linda J; Silver, Benjamin

2016-04-01

To utilize functional status (FS) outcomes to benchmark outpatient therapy clinics. Outpatient therapy data from clinics using Focus on Therapeutic Outcomes (FOTO) assessments. Retrospective analysis of 538 clinics, involving 2,040 therapists and 90,392 patients admitted July 2006-June 2008. FS at discharge was modeled using hierarchical regression methods with patients nested within therapists within clinics. Separate models were estimated for all patients, for those with lumbar, and for those with shoulder impairments. All models risk-adjusted for intake FS, age, gender, onset, surgery count, functional comorbidity index, fear-avoidance level, and payer type. Inverse probability weighting adjusted for censoring. Functional status was captured using computer adaptive testing at intake and at discharge. Clinic and therapist effects explained 11.6 percent of variation in FS. Clinics ranked in the lowest quartile had significantly different outcomes than those in the highest quartile (p < .01). Clinics ranked similarly in lumbar and shoulder impairments (correlation = 0.54), but some clinics ranked in the highest quintile for one condition and in the lowest for the other. Benchmarking models based on validated FS measures clearly separated high-quality from low-quality clinics, and they could be used to inform value-based-payment policies. © Health Research and Educational Trust.

Clinical decision making-a functional medicine perspective.

PubMed

Pizzorno, Joseph E

2012-09-01

As 21st century health care moves from a disease-based approach to a more patient-centric system that can address biochemical individuality to improve health and function, clinical decision making becomes more complex. Accentuating the problem is the lack of a clear standard for this more complex functional medicine approach. While there is relatively broad agreement in Western medicine for what constitutes competent assessment of disease and identification of related treatment approaches, the complex functional medicine model posits multiple and individualized diagnostic and therapeutic approaches, most or many of which have reasonable underlying science and principles, but which have not been rigorously tested in a research or clinical setting. This has led to non-rigorous thinking and sometimes to uncritical acceptance of both poorly documented diagnostic procedures and ineffective therapies, resulting in less than optimal clinical care.

Clinical Decision Making—A Functional Medicine Perspective

PubMed Central

2012-01-01

As 21st century health care moves from a disease-based approach to a more patient-centric system that can address biochemical individuality to improve health and function, clinical decision making becomes more complex. Accentuating the problem is the lack of a clear standard for this more complex functional medicine approach. While there is relatively broad agreement in Western medicine for what constitutes competent assessment of disease and identification of related treatment approaches, the complex functional medicine model posits multiple and individualized diagnostic and therapeutic approaches, most or many of which have reasonable underlying science and principles, but which have not been rigorously tested in a research or clinical setting. This has led to non-rigorous thinking and sometimes to uncritical acceptance of both poorly documented diagnostic procedures and ineffective therapies, resulting in less than optimal clinical care. PMID:24278827

Validation of Procedures for Monitoring Crewmember Immune Function - Short Duration Biological Investigation

NASA Technical Reports Server (NTRS)

Sams, Clarence; Crucian, Brian; Stowe, Raymond; Pierson, Duane; Mehta, Satish; Morukov, Boris; Uchakin, Peter; Nehlsen-Cannarella, Sandra

2008-01-01

Validation of Procedures for Monitoring Crew Member Immune Function - Short Duration Biological Investigation (Integrated Immune-SDBI) will assess the clinical risks resulting from the adverse effects of space flight on the human immune system and will validate a flightcompatible immune monitoring strategy. Immune system changes will be monitored by collecting and analyzing blood, urine and saliva samples from crewmembers before, during and after space flight.

Clinical measurement of gastrointestinal motility and function: who, when and which test?

PubMed

Fox, Mark R; Kahrilas, Peter J; Roman, Sabine; Gyawali, C Prakash; Scott, S Mark; Rao, Satish S; Keller, Jutta; Camilleri, Michael

2018-06-05

Symptoms related to abnormal gastrointestinal motility and function are common. Oropharyngeal and oesophageal dysphagia, heartburn, bloating, abdominal pain and alterations in bowel habits are among the most frequent reasons for seeking medical attention from internists or general practitioners and are also common reasons for referral to gastroenterologists and colorectal surgeons. However, the nonspecific nature of gastrointestinal symptoms, the absence of a definitive diagnosis on routine investigations (such as endoscopy, radiology or blood tests) and the lack of specific treatments make disease management challenging. Advances in technology have driven progress in the understanding of many of these conditions. This Review serves as an introduction to a series of Consensus Statements on the clinical measurements of gastrointestinal motility, function and sensitivity. A structured, evidence-based approach to the initial assessment and empirical treatment of patients presenting with gastrointestinal symptoms is discussed, followed by an outline of the contribution of modern physiological measurement on the management of patients in whom the cause of symptoms has not been identified with other tests. Discussions include the indications for and utility of high-resolution manometry, ambulatory pH-impedance monitoring, gastric emptying studies, breath tests and investigations of anorectal structure and function in day-to-day practice and clinical management.

21 CFR 812.119 - Disqualification of a clinical investigator.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Disqualification of a clinical investigator. 812.119 Section 812.119 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 812.119 Disqualification of a clinical investigator. (a) If FDA has information indicating that an...

The value of formal clinical research training in initiating a career as a clinical investigator.

PubMed

Kapoor, Karan; Wu, Bechien U; Banks, Peter A

2011-12-01

The aim of this study was to determine whether formal clinical research training is of value in the initiation of a successful career as a clinical investigator. We conducted a retrospective review of the career choices of all 25 fellows who entered the Academic Clinical Research Track at Brigham and Women's Hospital since its inception in 1995 and examined the impact of formal clinical research training during their fellowship on their career choice. The primary measure of a successful career as a clinical investigator was the obtainment of external funding for clinical research within 3 years of completion of fellowship. Thirteen of the 25 fellows (52%) received a Master of Public Health (MPH) degree at the Harvard School of Public Health during their fellowship. Ten of these 13 fellows (77%) obtained external funding for clinical research within 3 years of completion of their fellowship. None of the 5 fellows who had already obtained an MPH degree prior to their fellowship and none of the 7 fellows who completed a 7-week summer Program in Clinical Effectiveness but did not complete an MPH degree attempted to receive external funding for clinical research within 3 years of completion of their fellowship. We conclude that formal clinical research training culminating in an MPH degree was extremely valuable in the initiation of a successful career as a clinical investigator.

21 CFR 50.51 - Clinical investigations not involving greater than minimal risk.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Clinical investigations not involving greater than... HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Additional Safeguards for Children in Clinical Investigations § 50.51 Clinical investigations not involving greater than minimal risk. Any clinical...

Multimethod Investigation of Interpersonal Functioning in Borderline Personality Disorder

PubMed Central

Stepp, Stephanie D.; Hallquist, Michael N.; Morse, Jennifer Q.; Pilkonis, Paul A.

2011-01-01

Even though interpersonal functioning is of great clinical importance for patients with borderline personality disorder (BPD), the comparative validity of different assessment methods for interpersonal dysfunction has not yet been tested. This study examined multiple methods of assessing interpersonal functioning, including self- and other-reports, clinical ratings, electronic diaries, and social cognitions in three groups of psychiatric patients (N=138): patients with (1) BPD, (2) another personality disorder, and (3) Axis I psychopathology only. Using dominance analysis, we examined the predictive validity of each method in detecting changes in symptom distress and social functioning six months later. Across multiple methods, the BPD group often reported higher interpersonal dysfunction scores compared to other groups. Predictive validity results demonstrated that self-report and electronic diary ratings were the most important predictors of distress and social functioning. Our findings suggest that self-report scores and electronic diary ratings have high clinical utility, as these methods appear most sensitive to change. PMID:21808661

[Clinical application of functional near-infrared spectroscopy in rehabilitation medicine].

PubMed

Mihara, Masahito; Yagura, Hajime; Hatakenaka, Megumi; Hattori, Noriaki; Miyai, Ichiro

2010-02-01

Functional near-infrared spectroscopy (fNIRS) is an effective tool to non-invasively investigate cerebral oxygenation and hemodynamics. fNIRS as well as other functional neuroimaging techniques including functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) have been used for investigating the neural mechanisms of functional recovery after a stroke or a traumatic brain injury. fNIRS has several advantages over other neuroimaging techniques in terms of clinical application in the field of rehabilitation medicine. In addition to its portability and low equipment cost, fNIRS does not require strict motion restriction during measurement, unlike other functional imaging techniques. Therefore, this technique enables the examination of cortical activation during physically dynamic activities, like gait or balance perturbation. Studies using fNIRS have revealed several implications for gait recovery after stroke. These studies have shown that the medial sensorimotor cortex (SMC) and the supplementary motor area (SMA) are mainly involved in steadying gait and that the prefrontal cortex (PFC) is involved in the adjustment of walking speed. In hemiparetic patients, lateralization of SMC activation during gait is reduced, and additional cortical activations in the premotor cortex and PFC during gait became evident after focused rehabilitation for several months. The cortical activation pattern may be modified after different types of rehabilitative interventions. These results imply that fNIRS data is a potential biomarker for functional recovery and the response to rehabilitative interventions. Although further studies are required, fNIRS might provide useful information for customizing rehabilitation programs in order to enhance functional recovery.

Prevalence, Clinical Characteristics, and Management of Functional Constipation at Pediatric Gastroenterology Clinics

PubMed Central

Chang, Soo Hee; Park, Kie Young; Kang, Sung Kil; Kang, Ki Soo; Na, So Young; Yang, Hye Ran; Uhm, Ji Hyun

2013-01-01

The purpose of this study was to investigate the prevalence, clinical characteristics, and management of functional constipation at pediatric gastroenterology clinics. A prospective survey using the Rome III criteria was distributed to a group of parents of children with a constipation history and its control group in May 2008. The mean prevalence of constipation was 6.4%, which was similar to those in other countries. Statistically significant variables for children without constipation were that more children had a body mass index of below the 10th percentile even though they received more mother's care and ate balanced meals compared to the constipation group. Meanwhile, the constipation group frequently showed a history of constipation in infancy, picky-eating, lack of exercise, and retentive posturing. When analyzed with the Rome III criteria, the children showed greater than 60% rate of hard stools, painful stools, a history of large fecal mass in rectum, and its disappearance of constipation symptoms after passing a large stool. Our study found different approaches amongst pediatric gastroenterologists like rectal examinations, disimpaction, or drug treatment. Several factors addressed in our study can provide better guidelines for clinicians treating constipation and its future research. PMID:24015043

Prevalence, clinical characteristics, and management of functional constipation at pediatric gastroenterology clinics.

PubMed

Chang, Soo Hee; Park, Kie Young; Kang, Sung Kil; Kang, Ki Soo; Na, So Young; Yang, Hye Ran; Uhm, Ji Hyun; Ryoo, Eell

2013-09-01

The purpose of this study was to investigate the prevalence, clinical characteristics, and management of functional constipation at pediatric gastroenterology clinics. A prospective survey using the Rome III criteria was distributed to a group of parents of children with a constipation history and its control group in May 2008. The mean prevalence of constipation was 6.4%, which was similar to those in other countries. Statistically significant variables for children without constipation were that more children had a body mass index of below the 10th percentile even though they received more mother's care and ate balanced meals compared to the constipation group. Meanwhile, the constipation group frequently showed a history of constipation in infancy, picky-eating, lack of exercise, and retentive posturing. When analyzed with the Rome III criteria, the children showed greater than 60% rate of hard stools, painful stools, a history of large fecal mass in rectum, and its disappearance of constipation symptoms after passing a large stool. Our study found different approaches amongst pediatric gastroenterologists like rectal examinations, disimpaction, or drug treatment. Several factors addressed in our study can provide better guidelines for clinicians treating constipation and its future research.

Assessment of positive functioning in clinical psychology: theoretical and practical issues.

PubMed

Joseph, Stephen; Wood, Alex

2010-11-01

Positive psychology has led to an increasing emphasis on the promotion of positive functioning in clinical psychology research and practice, raising issues of how to assess the positive in clinical setting. Three key considerations are presented. First, existing clinical measures may already be assessing positive functioning, if positive and negative functioning exist on a single continuum (such as on bipolar dimensions from happiness to depression, and from anxiety to relaxation). Second, specific measures of positive functioning (e.g., eudemonic well-being) could be used in conjunction with existing clinical scales. Third, completely different measures would be needed depending on whether well-being is defined as emotional or medical functioning, or as humanistically orientated growth (e.g., authenticity). It is important that clinical psychologists introduce positive functioning into their research and practice in order to widen their armoury of therapeutic interventions, but in doing so researchers and practitioners need also to be aware that they are shifting the agenda of clinical psychology. As such, progress in clinical psychology moving toward the adoption of positive functioning requires reflection on epistemological foundations. Copyright © 2010 Elsevier Ltd. All rights reserved.

Development of a decision support tool to facilitate primary care management of patients with abnormal liver function tests without clinically apparent liver disease [HTA03/38/02]. Abnormal Liver Function Investigations Evaluation (ALFIE).

PubMed

Donnan, Peter T; McLernon, David; Steinke, Douglas; Ryder, Stephen; Roderick, Paul; Sullivan, Frank M; Rosenberg, William; Dillon, John F

2007-04-16

Liver function tests (LFTs) are routinely performed in primary care, and are often the gateway to further invasive and/or expensive investigations. Little is known of the consequences in people with an initial abnormal liver function (ALF) test in primary care and with no obvious liver disease. Further investigations may be dangerous for the patient and expensive for Health Services. The aims of this study are to determine the natural history of abnormalities in LFTs before overt liver disease presents in the population and identify those who require minimal further investigations with the potential for reduction in NHS costs. A population-based retrospective cohort study will follow up all those who have had an incident liver function test (LFT) in primary care to subsequent liver disease or mortality over a period of 15 years (approx. 2.3 million tests in 99,000 people). The study is set in Primary Care in the region of Tayside, Scotland (pop approx. 429,000) between 1989 and 2003. The target population consists of patients with no recorded clinical signs or symptoms of liver disease and registered with a GP. The health technologies being assessed are LFTs, viral and auto-antibody tests, ultrasound, CT, MRI and liver biopsy. The study will utilise the Epidemiology of Liver Disease In Tayside (ELDIT) database to determine the outcomes of liver disease. These are based on hospital admission data (Scottish Morbidity Record 1), dispensed medication records, death certificates, and examination of medical records from Tayside hospitals. A sample of patients (n = 150) with recent initial ALF tests or invitation to biopsy will complete questionnaires to obtain quality of life data and anxiety measures. Cost-effectiveness and cost utility Markov model analyses will be performed from health service and patient perspectives using standard NHS costs. The findings will also be used to develop a computerised clinical decision support tool. The results of this study will be

Functional Imaging in Radiotherapy in the Netherlands: Availability and Impact on Clinical Practice.

PubMed

Vogel, W V; Lam, M G E H; Pameijer, F A; van der Heide, U A; van de Kamer, J B; Philippens, M E; van Vulpen, M; Verheij, M

2016-12-01

Functional imaging with positron emission tomography/computed tomography (PET/CT) and multiparametric magnetic resonance (mpMR) is increasingly applied for radiotherapy purposes. However, evidence and experience are still limited, and this may lead to clinically relevant differences in accessibility, interpretation and decision making. We investigated the current patterns of care in functional imaging for radiotherapy in the Netherlands in a care evaluation study. The availability of functional imaging in radiotherapy centres in the Netherlands was evaluated; features available in >80% of academic and >80% of non-academic centres were considered standard of care. The impact of functional imaging on clinical decision making was evaluated using case questionnaires on lung, head/neck, breast and prostate cancer, with multiple-choice questions on primary tumour delineation, nodal involvement, distant metastasis and incidental findings. Radiation oncologists were allowed to discuss cases in a multidisciplinary approach. Ordinal answers were evaluated by median and interquartile range (IQR) to identify the extent and variability of clinical impact; additional patterns were evaluated descriptively. Information was collected from 18 radiotherapy centres in the Netherlands (all except two). PET/CT was available for radiotherapy purposes to 94% of centres; 67% in the treatment position and 61% with integrated planning CT. mpMR was available to all centres; 61% in the treatment position. Technologists collaborated between departments to acquire PET/CT or mpMR for radiotherapy in 89%. All sites could carry out image registration for target definition. Functional imaging generally showed a high clinical impact (average median 4.3, scale 1-6) and good observer agreement (average IQR 1.1, scale 0-6). However, several issues resulted in ignoring functional imaging (e.g. positional discrepancies, central necrosis) or poor observer agreement (atelectasis, diagnostic discrepancies

Investigating Functions with a Ferris Wheel

ERIC Educational Resources Information Center

Johnson, Heather Lynn; Hornbein, Peter; Azeem, Sumbal

2016-01-01

The authors provide a dynamic Ferris wheel computer activity that teachers can use as an instructional tool to help students investigate functions. They use a student's work to illustrate how students can use relationships between quantities to further their thinking about functions.

Executive function impairments in fibromyalgia syndrome: Relevance of clinical variables and body mass index.

PubMed

Muñoz Ladrón de Guevara, Cristina; Fernández-Serrano, María José; Reyes Del Paso, Gustavo A; Duschek, Stefan

2018-01-01

Several investigations suggest the presence of deterioration of executive function in fibromyalgia syndrome (FMS). The study quantified executive functions in patients with FMS. A wide array of functions was assessed, including updating, shifting and inhibition, as well as decision making and mental planning. Moreover, clinical variables were investigated as possible mediators of executive dysfunction, including pain severity, psychiatric comorbidity, medication and body mass index (BMI). Fifty-two FMS patients and 32 healthy controls completed a battery of 14 neuropsychological tests. Clinical interviews were conducted and the McGill Pain Questionnaire, Beck Depression Inventory, State-Trait Anxiety Inventory, Fatigue Severity Scale and Oviedo Quality of Sleep Questionnaire were presented. Patients performed poorer than controls on the Letter Number Sequencing, Arithmetic and Similarities subtests of the Wechsler Adult Intelligence Scale, the Spatial Span subtest of the Wechsler Memory Scale, an N-back task, a verbal fluency task, the Ruff Figural Fluency Test, the Inhibition score of the Stroop Test, the Inhibition and Shifting scores of the Five Digits Test, the Key Search Test and the Zoo Map Task. Moreover, patients exhibited less steep learning curves on the Iowa Gambling Task. Among clinical variables, BMI and pain severity explained the largest proportion of performance variance. This study demonstrated impairments in executive functions of updating, shifting inhibition, decision making and planning in FMS. While the mediating role of pain in cognitive impairments in FMS had been previously established, the influence of BMI is a novel finding. Overweight and obesity should be considered by FMS researchers, and in the treatment of the condition.

Clinical, Functional, and Biological Correlates of Cognitive Dimensions in Major Depressive Disorder - Rationale, Design, and Characteristics of the Cognitive Function and Mood Study (CoFaM-Study).

PubMed

Baune, Bernhard T; Air, Tracy

2016-01-01

Cross-sectional and longitudinal studies exploring clinical, functional, and biological correlates of major depressive disorder are frequent. In this type of research, depression is most commonly defined as a categorical diagnosis based on studies using diagnostic instruments. Given the phenotypic and biological heterogeneity of depression, we chose to focus the phenotypic assessments on three cognitive dimensions of depression including (a) cognitive performance, (b) emotion processing, and (c) social cognitive functioning. Hence, the overall aim of the study is to investigate the long-term clinical course of these cognitive dimensions in depression and its functional (psychosocial) correlates. We also aim to identify biological "genomic" correlates of these three cognitive dimensions of depression. To address the above overall aim, we created the Cognition and Mood Study (CoFaMS) with the key objective to investigate the clinical, functional, and biological correlates of cognitive dimensions of depression by employing a prospective study design and including a healthy control group. The study commenced in April 2015, including patients with a primary diagnosis of a major depressive episode of major depressive disorder or bipolar disorder according to DSM-IV-TR criteria. The assessments cover the three cognitive dimensions of depression (cognitive performance, emotion processing, and social cognition), cognitive function screening instrument, plus functional scales to assess general, work place, and psychosocial function, depression symptom scales, and clinical course of illness. Blood is collected for comprehensive genomic discovery analyses of biological correlates of cognitive dimensions of depression. The CoFaM-Study represents an innovative approach focusing on cognitive dimensions of depression and its functional and biological "genomic" correlates. The CoFaMS team welcomes collaborations with both national and international researchers.

Clinical Investigator Development Program | Center for Cancer Research

Cancer.gov

Clinical Investigator Development Program Application Deadline:  September 30, 2018 Program Starts: July 1, 2019 The NCI Center for Cancer Research (CCR) is pleased to announce our annual call for applications for an exciting training opportunity intended for physicians interested in dedicating their careers to clinical research. Come join a vibrant, multidisciplinary research

Applicable or non-applicable: investigations of clinical heterogeneity in systematic reviews.

PubMed

Chess, Laura E; Gagnier, Joel J

2016-02-17

Clinical heterogeneity can be defined as differences in participant characteristics, types or timing of outcome measurements and intervention characteristics. Clinical heterogeneity in systematic reviews has the possibility to significantly affect statistical heterogeneity leading to inaccurate conclusions and misled decision making. The aim of this study is to identify to what extent investigators are assessing clinical heterogeneity in both Cochrane and non-Cochrane systematic reviews. The most recent 100 systematic reviews from the top five journals in medicine-JAMA, Archives of Internal Medicine, British Medical Journal, The Lancet, and PLOS Medicine-and the 100 most recently published and/or updated systematic reviews from Cochrane were collected. Various defined items of clinical heterogeneity were extracted from the included reviews. Investigators used chi-squared tests, logarithmic modeling and linear regressions to determine if the presence of such items served as a predictor for clinical heterogeneity when comparing Cochrane to non-Cochrane reviews. Extracted variables include number of studies, number of participants, presence of quantitative synthesis, exploration of clinical heterogeneity, heterogeneous characteristics explored, basis and methods used for investigating clinical heterogeneity, plotting/visual aids, author contact, inferences from clinical heterogeneity investigation, reporting assessment, and the presence of a priori or post-hoc analysis. A total of 317 systematic reviews were considered, of which 199 were in the final analysis. A total of 81% of Cochrane reviews and 90% of non-Cochrane reviews explored characteristics that are considered aspects of clinical heterogeneity and also described the methods they planned to use to investigate the influence of those characteristics. Only 1% of non-Cochrane reviews and 8% of Cochrane reviews explored the clinical characteristics they initially chose as potential for clinical heterogeneity. Very

Origin, functional role, and clinical impact of Fanconi anemia FANCA mutations.

PubMed

Castella, Maria; Pujol, Roser; Callén, Elsa; Trujillo, Juan P; Casado, José A; Gille, Hans; Lach, Francis P; Auerbach, Arleen D; Schindler, Detlev; Benítez, Javier; Porto, Beatriz; Ferro, Teresa; Muñoz, Arturo; Sevilla, Julián; Madero, Luis; Cela, Elena; Beléndez, Cristina; de Heredia, Cristina Díaz; Olivé, Teresa; de Toledo, José Sánchez; Badell, Isabel; Torrent, Montserrat; Estella, Jesús; Dasí, Angeles; Rodríguez-Villa, Antonia; Gómez, Pedro; Barbot, José; Tapia, María; Molinés, Antonio; Figuera, Angela; Bueren, Juan A; Surrallés, Jordi

2011-04-07

Fanconi anemia is characterized by congenital abnormalities, bone marrow failure, and cancer predisposition. To investigate the origin, functional role, and clinical impact of FANCA mutations, we determined a FANCA mutational spectrum with 130 pathogenic alleles. Some of these mutations were further characterized for their distribution in populations, mode of emergence, or functional consequences at cellular and clinical level. The world most frequent FANCA mutation is not the result of a mutational "hot-spot" but results from worldwide dissemination of an ancestral Indo-European mutation. We provide molecular evidence that total absence of FANCA in humans does not reduce embryonic viability, as the observed frequency of mutation carriers in the Gypsy population equals the expected by Hardy-Weinberg equilibrium. We also prove that long distance Alu-Alu recombination can cause Fanconi anemia by originating large interstitial deletions involving FANCA and 2 adjacent genes. Finally, we show that all missense mutations studied lead to an altered FANCA protein that is unable to relocate to the nucleus and activate the FA/BRCA pathway. This may explain the observed lack of correlation between type of FANCA mutation and cellular phenotype or clinical severity in terms of age of onset of hematologic disease or number of malformations.

Origin, functional role, and clinical impact of Fanconi anemia FANCA mutations

PubMed Central

Castella, Maria; Pujol, Roser; Callén, Elsa; Trujillo, Juan P.; Casado, José A.; Gille, Hans; Lach, Francis P.; Auerbach, Arleen D.; Schindler, Detlev; Benítez, Javier; Porto, Beatriz; Ferro, Teresa; Muñoz, Arturo; Sevilla, Julián; Madero, Luis; Cela, Elena; Beléndez, Cristina; de Heredia, Cristina Díaz; Olivé, Teresa; de Toledo, José Sánchez; Badell, Isabel; Torrent, Montserrat; Estella, Jesús; Dasí, Ángeles; Rodríguez-Villa, Antonia; Gómez, Pedro; Barbot, José; Tapia, María; Molinés, Antonio; Figuera, Ángela; Bueren, Juan A.

2011-01-01

Fanconi anemia is characterized by congenital abnormalities, bone marrow failure, and cancer predisposition. To investigate the origin, functional role, and clinical impact of FANCA mutations, we determined a FANCA mutational spectrum with 130 pathogenic alleles. Some of these mutations were further characterized for their distribution in populations, mode of emergence, or functional consequences at cellular and clinical level. The world most frequent FANCA mutation is not the result of a mutational “hot-spot” but results from worldwide dissemination of an ancestral Indo-European mutation. We provide molecular evidence that total absence of FANCA in humans does not reduce embryonic viability, as the observed frequency of mutation carriers in the Gypsy population equals the expected by Hardy-Weinberg equilibrium. We also prove that long distance Alu-Alu recombination can cause Fanconi anemia by originating large interstitial deletions involving FANCA and 2 adjacent genes. Finally, we show that all missense mutations studied lead to an altered FANCA protein that is unable to relocate to the nucleus and activate the FA/BRCA pathway. This may explain the observed lack of correlation between type of FANCA mutation and cellular phenotype or clinical severity in terms of age of onset of hematologic disease or number of malformations. PMID:21273304

Executive function impairments in fibromyalgia syndrome: Relevance of clinical variables and body mass index

PubMed Central

2018-01-01

Background Several investigations suggest the presence of deterioration of executive function in fibromyalgia syndrome (FMS). The study quantified executive functions in patients with FMS. A wide array of functions was assessed, including updating, shifting and inhibition, as well as decision making and mental planning. Moreover, clinical variables were investigated as possible mediators of executive dysfunction, including pain severity, psychiatric comorbidity, medication and body mass index (BMI). Methods Fifty-two FMS patients and 32 healthy controls completed a battery of 14 neuropsychological tests. Clinical interviews were conducted and the McGill Pain Questionnaire, Beck Depression Inventory, State-Trait Anxiety Inventory, Fatigue Severity Scale and Oviedo Quality of Sleep Questionnaire were presented. Results Patients performed poorer than controls on the Letter Number Sequencing, Arithmetic and Similarities subtests of the Wechsler Adult Intelligence Scale, the Spatial Span subtest of the Wechsler Memory Scale, an N-back task, a verbal fluency task, the Ruff Figural Fluency Test, the Inhibition score of the Stroop Test, the Inhibition and Shifting scores of the Five Digits Test, the Key Search Test and the Zoo Map Task. Moreover, patients exhibited less steep learning curves on the Iowa Gambling Task. Among clinical variables, BMI and pain severity explained the largest proportion of performance variance. Conclusions This study demonstrated impairments in executive functions of updating, shifting inhibition, decision making and planning in FMS. While the mediating role of pain in cognitive impairments in FMS had been previously established, the influence of BMI is a novel finding. Overweight and obesity should be considered by FMS researchers, and in the treatment of the condition. PMID:29694417

Clinical significance of sleep bruxism on several occlusal and functional parameters.

PubMed

Ommerborn, Michelle A; Giraki, Maria; Schneider, Christine; Fuck, Lars Michael; Zimmer, Stefan; Franz, Matthias; Raab, Wolfgang Hans-michael; Schaefer, Ralf

2010-10-01

The aim of this study was to evaluate the association between various functional and occlusal parameters and sleep bruxism. Thirty-nine (39) sleep bruxism patients and 30 controls participated in this investigation. The assessment of sleep bruxism was performed using the Bruxcore Bruxism-Monitoring Device (BBMD) combined with a new computer-based analyzing method. Sixteen functional and/or occlusal parameters were recorded. With a mean slide of 0.95 mm in the sleep bruxism group and a mean slide of 0.42 mm in the control group (Mann Whitney U test; p<0.003), results solely demonstrated a significant group difference regarding the length of a slide from centric occlusion to maximum intercuspation. The results suggest that the slightly pronounced slide could be of clinical importance in the development of increased wear facets in patients with current sleep bruxism activity. Following further evaluation including polysomnographic recordings, the BBMD combined with this new analyzing technique seems to be a clinically feasible instrument that allows the practitioner to quantify abrasion over a short period.

Factors associated with poor functional outcome in bipolar disorder: sociodemographic, clinical, and neurocognitive variables.

PubMed

Sanchez-Moreno, J; Bonnin, C M; González-Pinto, A; Amann, B L; Solé, B; Balanzá-Martinez, V; Arango, C; Jiménez, E; Tabarés-Seisdedos, R; Garcia-Portilla, M P; Ibáñez, A; Crespo, J M; Ayuso-Mateos, J L; Martinez-Aran, A; Torrent, C; Vieta, E

2018-05-03

The current investigation aimed at studying the sociodemographic, clinical, and neuropsychological variables related to functional outcome in a sample of euthymic patients with bipolar disorder(BD) presenting moderate-severe levels of functional impairment. Two-hundred and thirty-nine participants with BD disorders and with Functioning Assessment Short Test(FAST) scores equal or above 18 were administered a clinical and diagnostic interview, and the administration of mood measure scales and a comprehensive neuropsychological battery. Analyses involved preliminary Pearson bivariate correlations to identify sociodemographic and clinical variables associated with the FAST total score. Regarding neuropsychological variables, a principal component analysis (PCA) was performed to group the variables in orthogonal factors. Finally, a hierarchical multiple regression was run. The best fitting model for the variables associated with functioning was a linear combination of gender, age, estimated IQ, Hamilton Depression Rating Scale (HAM-D), number of previous manic episodes, Factor 1 and Factor 2 extracted from the PCA. The model, including all these previous variables, explained up to 29.4% of the observed variance. Male gender, older age, lower premorbid IQ, subdepressive symptoms, higher number of manic episodes, and lower performance in verbal memory, working memory, verbal fluency, and processing speed were associated with lower functioning in patients with BD. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Functional MRI in the Investigation of Blast-Related Traumatic Brain Injury

PubMed Central

Graner, John; Oakes, Terrence R.; French, Louis M.; Riedy, Gerard

2012-01-01

This review focuses on the application of functional magnetic resonance imaging (fMRI) to the investigation of blast-related traumatic brain injury (bTBI). Relatively little is known about the exact mechanisms of neurophysiological injury and pathological and functional sequelae of bTBI. Furthermore, in mild bTBI, standard anatomical imaging techniques (MRI and computed tomography) generally fail to show focal lesions and most of the symptoms present as subjective clinical functional deficits. Therefore, an objective test of brain functionality has great potential to aid in patient diagnosis and provide a sensitive measurement to monitor disease progression and treatment. The goal of this review is to highlight the relevant body of blast-related TBI literature and present suggestions and considerations in the development of fMRI studies for the investigation of bTBI. The review begins with a summary of recent bTBI publications followed by discussions of various elements of blast-related injury. Brief reviews of some fMRI techniques that focus on mental processes commonly disrupted by bTBI, including working memory, selective attention, and emotional processing, are presented in addition to a short review of resting state fMRI. Potential strengths and weaknesses of these approaches as regards bTBI are discussed. Finally, this review presents considerations that must be made when designing fMRI studies for bTBI populations, given the heterogeneous nature of bTBI and its high rate of comorbidity with other physical and psychological injuries. PMID:23460082

[ISO 9001certification of a quality management system in a clinical investigation center].

PubMed

Chesnais, Jimmy; Fougerou-Leurent, Claire; Laforest, Claire; Renault, Alain; Bellissant, Eric; Laviolle, Bruno

2018-05-03

Beyond the application of legal requirements, clinical trials must have a permanent approach of quality control. The clinical investigation centers (CICs) are academic structures of clinical research certified by the French National institute of health and medical research (Inserm) and whose functioning relies on recommendations of good practice. It is important to accompany this standardization of practices by the implementation of a quality management system. This article presents the process that enabled the CIC of Rennes to become certified ISO 9001 by French standards association (Afnor) certification in May, 2016. The application of the fundamental principles of the standard ISO 9001 in the domain of clinical research is approached. The problem of the perimeter for the certification and the related process mapping are exposed. The activities of methodology, management and analysis of clinical studies were chosen for the initial certification of the CIC of Rennes. The perspectives for the extension of the perimeter of certification are also approached at the end of article. Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

Deliberate self-injury functions and their clinical correlates among adolescent psychiatric inpatients.

PubMed

Radziwiłłowicz, Wioletta; Lewandowska, Magdalena

2017-04-30

The aim of the study was to analyze the relationships between clinical variables (the severity of depression symptoms, feelings towards the body, dissociation, number and type of traumatic events) and deliberate self-injury functions. Moreover, we investigated whether the of group self-mutilating adolescents is internally diverse in terms of how important individual functions of self-mutilation are, and whether the subgroups singled out by these functions differ between each other in terms of clinical variables. The Inventory of Statements about Self-Injury was used. Characterizations of examined individuals and other research tools are included in our previous article (year, issue, pages). Associated with negative feelings towards the body are the functions of self-injuries (anti-dissociation, self-punishment) that can be described as interpersonal. High levels of depression symptoms (self-depreciation included) are mainly associated with the self-injury functions: self-punishment, anti-dissociation, establishing interpersonal boundaries. Affect regulation becomes more important as a function of self-inflicted injuries in cases of biological dysregulation and intense dissociative symptoms. The adolescents psychiatric inpatients are internally diverse in terms of dominant functions of self-injuries, which can be categorized into intra- and interpersonal. Intrapersonal functions dominate when an individual experiences severe depression, dissociative symptoms, and negative feelings towards the body. In cases of moderate intensity of depression, dissociative symptoms and negative feelings towards the body, both intrapersonal and interpersonal functions of self-mutilation are similarly important. Further research is required to explain the lowest severity of depression symptoms, dissociative symptoms and negative feelings towards the body co-occurs with no awareness of self-injuries functions.

An empirical investigation of incompleteness in a large clinical sample of obsessive compulsive disorder.

PubMed

Sibrava, Nicholas J; Boisseau, Christina L; Eisen, Jane L; Mancebo, Maria C; Rasmussen, Steven A

2016-08-01

Obsessive Compulsive Disorder (OCD) is a disorder with heterogeneous clinical presentations. To advance our understanding of this heterogeneity we investigated the prevalence and clinical features associated with incompleteness (INC), a putative underlying core feature of OCD. We predicted INC would be prominent in individuals with OCD and associated with greater severity and impairment. We examined the impact of INC in 307 adults with primary OCD. Participants with clinically significant INC (22.8% of the sample) had significantly greater OCD severity, greater rates of comorbidity, poorer ratings of functioning, lower quality of life, and higher rates of unemployment and disability. Participants with clinically significant INC were also more likely to be diagnosed with OCPD and to endorse symmetry/exactness obsessions and ordering/arranging compulsions than those who reported low INC. Our findings provide evidence that INC is associated with greater severity, comorbidity, and impairment, highlighting the need for improved assessment and treatment of INC in OCD. Copyright © 2016 Elsevier Ltd. All rights reserved.

An Empirical Investigation of Incompleteness in a Large Clinical Sample of Obsessive Compulsive Disorder

PubMed Central

Sibrava, Nicholas J.; Boisseau, Christina L.; Eisen, Jane L.; Mancebo, Maria C.; Rasmussen, Steven A.

2016-01-01

Obsessive Compulsive Disorder (OCD) is a disorder with heterogeneous clinical presentations. To advance our understanding of this heterogeneity we investigated the prevalence and clinical features associated with incompleteness (INC), a putative underlying core feature of OCD. We predicted INC would be prominent in individuals with OCD and associated with greater severity and impairment. We examined the impact of INC in 307 adults with primary OCD. Participants with clinically significant INC (22.8% of the sample) had significantly greater OCD severity, greater rates of comorbidity, poorer ratings of functioning, lower quality of life, and higher rates of unemployment and disability. Participants with clinically significant INC were also more likely to be diagnosed with OCPD and to endorse symmetry/exactness obsessions and ordering/arranging compulsions than those who reported low INC. Our findings provide evidence that INC is associated with greater severity, comorbidity, and impairment, highlighting the need for improved assessment and treatment of INC in OCD. PMID:27268401

A Data Accounting System for Clinical Investigators

PubMed Central

Kashner, T. Michael; Hinson, Robert; Holland, Gloria J.; Mickey, Don D.; Hoffman, Keith; Lind, Lisa; Johnson, Linda D.; Chang, Barbara K.; Golden, Richard M.; Henley, Steven S.

2007-01-01

Clinical investigators often preprocess, process, and analyze their data without benefit of formally organized research centers to oversee data management. This article outlines a practical three-file structure to help guide these investigators track and document their data through processing and analyses. The proposed process can be implemented without additional training or specialized software. Thus, it is particularly well suited for research projects with small budgets or limited access to viable research/data coordinating centers. PMID:17460138

brief report: Burnout Among Early Career Clinical Investigators

PubMed Central

Primack, Brian A.; Dilmore, Terri C.; Switzer, Galen E.; Bryce, Cindy L.; Seltzer, Deborah L.; Li, Jie; Landsittel, Douglas P.; Kapoor, Wishwa N.; Rubio, Doris M.

2010-01-01

Abstract Burnout is a pervasive problem among clinicians. However, little is known about burnout among early career clinical investigators, who must balance clinical responsibilities with challenges related to research. We aimed to determine the prevalence of and demographic associations with burnout in a cohort of early career clinical investigators. A cross‐sectional questionnaire was administered to 179 trainees at the University of Pittsburgh Institute for Clinical Research Education in 2007–2008. We used chi‐square analyses and Fisher’s exact test to determine whether associations between demographic characteristics and burnout were significant. Of the participants, 29 (16%) reported feeling burned out. Burnout was more prevalent among those over 35 years of age relative to their younger counterparts (29% vs. 13%, p= 0.01) and among females relative to males (22% vs. 10%, p= 0.03). With regard to race and ethnicity, burnout was most common among underrepresented minorities (30%) followed by Caucasians (18%) and Asians (3%); these differences were significant (p= 0.02). Considering the early career status of these research trainees, rates of burnout were concerning. Certain demographic subgroups—including older trainees, females, and underrepresented minorities—had particularly high rates of burnout and may benefit from interventions that provide them with skills needed to sustain successful clinical research careers. Clin Trans Sci 2010; Volume 3: 186–188 PMID:20718821

Levels of personality functioning and their association with clinical features and interpersonal functioning in patients with personality disorders.

PubMed

Lowyck, Benedicte; Luyten, Patrick; Verhaest, Yannic; Vandeneede, Bart; Vermote, Rudi

2013-06-01

Recently, the DSM-5 Personality and Personality Disorders Work Group has proposed a multiple level approach toward the classification and diagnosis of personality disorders (PDs), with the first level entailing a rating of impairments in levels of personality functioning. Although a number of measures that assess levels of personality functioning have been validated, given its prominent status in the DSM-5 proposal and contemporary theories of personality pathology, the Work Group has called for more research in this area (e.g., Bender, Morey, & Skodol, 2011). In response to this call, this study investigates the relationship between two major, well-validated dimensional measures of levels of personality functioning, that is, the Differentiation-Relatedness Scale (DR-S; Diamond, Blatt, Stayner, & Kaslow, 1991), as scored on the Object Relations Inventory (ORI; Blatt, Wein, Chevron, & Quinlan, 1979), and the Inventory of Personality Organization (IPO; Lenzenweger, Clarkin, Kernberg, & Foelsch, 2001), a self-report instrument, and their relationship with different measures of clinical and interpersonal functioning in 70 patients with a PD. First, results showed that higher levels of differentiation and relatedness of descriptions of self and significant others, and of the self in particular, were negatively related to indices of personality functioning as assessed by the IPO. Lower levels of personality functioning, as measured with both the DR-S and the IPO, were positively related to severity of depression, symptomatic distress, self-harm, and interpersonal problems. Finally, results showed that the DR-S and the IPO independently predicted clinical features and interpersonal functioning. Hence, this study lends further support for the concurrent and predictive validity of the DR-S and the IPO in assessing levels of personality functioning. However, more research concerning the validity of these measures in assessing levels of personality functioning is needed

77 FR 60440 - Clinical Investigator Training Course

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-03

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Clinical Investigator Training Course AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research/Office of Medical...

INVESTIGATING DIFFERENCES IN BRAIN FUNCTIONAL NETWORKS USING HIERARCHICAL COVARIATE-ADJUSTED INDEPENDENT COMPONENT ANALYSIS.

PubMed

Shi, Ran; Guo, Ying

2016-12-01

Human brains perform tasks via complex functional networks consisting of separated brain regions. A popular approach to characterize brain functional networks in fMRI studies is independent component analysis (ICA), which is a powerful method to reconstruct latent source signals from their linear mixtures. In many fMRI studies, an important goal is to investigate how brain functional networks change according to specific clinical and demographic variabilities. Existing ICA methods, however, cannot directly incorporate covariate effects in ICA decomposition. Heuristic post-ICA analysis to address this need can be inaccurate and inefficient. In this paper, we propose a hierarchical covariate-adjusted ICA (hc-ICA) model that provides a formal statistical framework for estimating covariate effects and testing differences between brain functional networks. Our method provides a more reliable and powerful statistical tool for evaluating group differences in brain functional networks while appropriately controlling for potential confounding factors. We present an analytically tractable EM algorithm to obtain maximum likelihood estimates of our model. We also develop a subspace-based approximate EM that runs significantly faster while retaining high accuracy. To test the differences in functional networks, we introduce a voxel-wise approximate inference procedure which eliminates the need of computationally expensive covariance matrix estimation and inversion. We demonstrate the advantages of our methods over the existing method via simulation studies. We apply our method to an fMRI study to investigate differences in brain functional networks associated with post-traumatic stress disorder (PTSD).

Noninvasive assessment of arterial function in children: clinical applications

PubMed Central

Aggoun, Y; Beghetti, M

2002-01-01

Non invasive methods to assess arterial function are widely used in adults. The development and progression of arterial vascular disease is a multifactorial process that can start early in life, thus even in a pediatric population. Risk factors for cardiovascular disease mediate their effects by altering the structure, properties and function of wall and endothelial components of the arterial blood vessels. The ability to detect and monitor sub-clinical damage, representing the cumulative and integrated influence of risk factors in impairing arterial wall integrity, holds potential to further refine cardiovascular risk stratification and enable early intervention to prevent or attenuate disease progression. Measurements that provide more direct information in relation to changes in arterial wall integrity clearly hold predictive and therapeutic potential. The aim of this current review will be to describe the non-invasive procedure used in children to investigate the mechanical properties of a great elastic artery, the common carotid, and the endothelial function of the brachial artery. The accuracy of recording noninvasively the blood pressure wave contour along the arterial tree has been improved by the technique of applanation tonometry. The results obtained with these methods in previous studies are described. PMID:22368620

Clinical, Functional, and Biological Correlates of Cognitive Dimensions in Major Depressive Disorder – Rationale, Design, and Characteristics of the Cognitive Function and Mood Study (CoFaM-Study)

PubMed Central

Baune, Bernhard T.; Air, Tracy

2016-01-01

Cross-sectional and longitudinal studies exploring clinical, functional, and biological correlates of major depressive disorder are frequent. In this type of research, depression is most commonly defined as a categorical diagnosis based on studies using diagnostic instruments. Given the phenotypic and biological heterogeneity of depression, we chose to focus the phenotypic assessments on three cognitive dimensions of depression including (a) cognitive performance, (b) emotion processing, and (c) social cognitive functioning. Hence, the overall aim of the study is to investigate the long-term clinical course of these cognitive dimensions in depression and its functional (psychosocial) correlates. We also aim to identify biological “genomic” correlates of these three cognitive dimensions of depression. To address the above overall aim, we created the Cognition and Mood Study (CoFaMS) with the key objective to investigate the clinical, functional, and biological correlates of cognitive dimensions of depression by employing a prospective study design and including a healthy control group. The study commenced in April 2015, including patients with a primary diagnosis of a major depressive episode of major depressive disorder or bipolar disorder according to DSM-IV-TR criteria. The assessments cover the three cognitive dimensions of depression (cognitive performance, emotion processing, and social cognition), cognitive function screening instrument, plus functional scales to assess general, work place, and psychosocial function, depression symptom scales, and clinical course of illness. Blood is collected for comprehensive genomic discovery analyses of biological correlates of cognitive dimensions of depression. The CoFaM-Study represents an innovative approach focusing on cognitive dimensions of depression and its functional and biological “genomic” correlates. The CoFaMS team welcomes collaborations with both national and international researchers. PMID

Clinical investigations for SUS, the Brazilian public health system.

PubMed

Paula, Ana Patrícia de; Giozza, Silvana Pereira; Pereira, Michelle Zanon; Boaventura, Patrícia Souza; Santos, Leonor Maria Pacheco; Sachetti, Camile Giaretta; Tamayo, César Omar Carranza; Kowalski, Clarissa Campos Guaragna; Elias, Flavia Tavares Silva; Serruya, Suzanne Jacob; Guimarães, Reinaldo

2012-01-01

Scientific and technological development is crucial for advancing the Brazilian health system and for promoting quality of life. The way in which the Brazilian Ministry of Health has supported clinical research to provide autonomy, self-sufficiency, competitiveness and innovation for the healthcare industrial production complex, in accordance with the National Policy on Science, Technology and Innovation in Healthcare, was analyzed. Descriptive investigation, based on secondary data, conducted at the Department of Science and Technology, Ministry of Health. The Ministry of Health's research management database, PesquisaSaúde, was analyzed from 2002 to 2009, using the key word "clinical research" in the fields "primary sub-agenda" or "secondary sub-agenda". The 368 projects retrieved were sorted into six categories: basic biomedical research, preclinical studies, expanded clinical research, clinical trials, infrastructure support and health technology assessment. From a structured review on "clinical research funding", results from selected countries are presented and discussed. The amount invested was R$ 140 million. The largest number of projects supported "basic biomedical research", while the highest amounts invested were in "clinical trials" and "infrastructure support". The southeastern region had the greatest proportion of projects and financial resources. In some respects, Brazil is ahead of other BRICS countries (Russia, India, China and South Africa), especially with regard to establishing a National Clinical Research Network. The Ministry of Health ensured investments to encourage clinical research in Brazil and contributed towards promoting cohesion between investigators, health policies and the healthcare industrial production complex.

Recommendations from the Investigational New Drug/Investigational Device Exemption Task Force of the clInical and Translational Science Award Consortium: developing and implementing a sponsor-investigators training program.

PubMed

Holbein, M E Blair; Berglund, Jelena Petrovic; O'Reilly, Erin K; Hartman, Karen; Speicher, Lisa A; Adamo, Joan E; O'Riordan, Gerri; Brown, Jennifer Swanton; Schuff, Kathryn G

2014-06-01

The objective of this study was to provide recommendations for provision of training for sponsor and investigators at Academic Health Centers. A subgroup of the Investigational New Drug/Investigational Device Exemption (IND/IDE) Task Force of the Clinical and Translational Science Award (CTSA) program Regulatory Knowledge Key Function Committee was assembled to specifically address how clinical investigators who hold an IND/IDE and thus assume the role of sponsor-investigators are adequately trained to meet the additional regulatory requirements of this role. The participants who developed the recommendations were representatives of institutions with IND/IDE support programs. Through an informal survey, the task force determined that a variety and mix of models are used to provide support for IND/IDE holders within CTSA institutions. In addition, a CTSA consortium-wide resources survey was used. The participants worked from the models and survey results to develop consensus recommendations to address institutional support, training content, and implementation. The CTSA IND/IDE Task Force recommendations are as follows: (1) Institutions should assess the scope of Food and Drug Administration-regulated research, perform a needs analysis, and provide resources to implement a suitable training program; (2) The model of training program should be tailored to each institution; (3) The training should specifically address the unique role of sponsor-investigators, and the effectiveness of training should be evaluated regularly by methods that fit the model adopted by the institution; and (4) Institutional leadership should mandate sponsor-investigator training and effectively communicate the necessity and availability of training.

Explaining ethnic disparities in lung function among young adults: A pilot investigation

PubMed Central

Patel, Jaymini; Minelli, Cosetta; Burney, Peter G. J.

2017-01-01

Background Ethnic disparities in lung function have been linked mainly to anthropometric factors but have not been fully explained. We conducted a cross-sectional pilot study to investigate how best to study ethnic differences in lung function in young adults and evaluate whether these could be explained by birth weight and socio-economic factors. Methods We recruited 112 university students of White and South Asian British ethnicity, measured post-bronchodilator lung function, obtained information on respiratory symptoms and socio-economic factors through questionnaires, and acquired birth weight through data linkage. We regressed lung function against ethnicity and candidate predictors defined a priori using linear regression, and used penalised regression to examine a wider range of factors. We reviewed the implications of our findings for the feasibility of a larger study. Results There was a similar parental socio-economic environment and no difference in birth weight between the two ethnic groups, but the ethnic difference in FVC adjusted for sex, age, height, demi-span, father’s occupation, birth weight, maternal educational attainment and maternal upbringing was 0.81L (95%CI: -1.01 to -0.54L). Difference in body proportions did not explain the ethnic differences although parental immigration was an important predictor of FVC independent of ethnic group. Participants were comfortable with study procedures and we were able to link birth weight data to clinical measurements. Conclusion Studies of ethnic disparities in lung function among young adults are feasible. Future studies should recruit a socially more diverse sample and investigate the role of markers of acculturation in explaining such differences. PMID:28575113

Thiopurine pharmacogenomics: association of SNPs with clinical response and functional validation of candidate genes

PubMed Central

Matimba, Alice; Li, Fang; Livshits, Alina; Cartwright, Cher S; Scully, Stephen; Fridley, Brooke L; Jenkins, Gregory; Batzler, Anthony; Wang, Liewei; Weinshilboum, Richard; Lennard, Lynne

2014-01-01

Aim We investigated candidate genes associated with thiopurine metabolism and clinical response in childhood acute lymphoblastic leukemia. Materials & methods We performed genome-wide SNP association studies of 6-thioguanine and 6-mercaptopurine cytotoxicity using lymphoblastoid cell lines. We then genotyped the top SNPs associated with lymphoblastoid cell line cytotoxicity, together with tagSNPs for genes in the ‘thiopurine pathway’ (686 total SNPs), in DNA from 589 Caucasian UK ALL97 patients. Functional validation studies were performed by siRNA knockdown in cancer cell lines. Results SNPs in the thiopurine pathway genes ABCC4, ABCC5, IMPDH1, ITPA, SLC28A3 and XDH, and SNPs located within or near ATP6AP2, FRMD4B, GNG2, KCNMA1 and NME1, were associated with clinical response and measures of thiopurine metabolism. Functional validation showed shifts in cytotoxicity for these genes. Conclusion The clinical response to thiopurines may be regulated by variation in known thiopurine pathway genes and additional novel genes outside of the thiopurine pathway. PMID:24624911

Is reflective functioning associated with clinical symptoms and long-term course in patients with personality disorders?

PubMed

Antonsen, Bjørnar T; Johansen, Merete S; Rø, Frida G; Kvarstein, Elfrida H; Wilberg, Theresa

2016-01-01

Mentalization is the capacity to understand behavior as the expression of various mental states and is assumed to be important in a range of psychopathologies, especially personality disorders (PDs). The first aim of the present study was to investigate the relationship between mentalization capacity, operationalized as reflective functioning (RF), and clinical manifestations before entering study treatment. The second aim was to investigate the relationship between baseline RF and long-term clinical outcome both independent of treatment (predictor analyses) and dependent on treatment (moderator analyses). Seventy-nine patients from a randomized clinical trial (Ullevål Personality Project) who had borderline and/or avoidant PD were randomly assigned to either a step-down treatment program, comprising short-term day-hospital treatment followed by outpatient combined group and individual psychotherapy, or to outpatient individual psychotherapy. Patients were evaluated on variables including symptomatic distress, psychosocial functioning, personality functioning, and self-esteem at baseline, 8 and 18months, and 3 and 6years. RF was significantly associated with a wide range of variables at baseline. In longitudinal analyses RF was not found to be a predictor of long-term clinical outcome. However, when considering treatment type, there were significant moderator effects of RF. Patients with low RF had better outcomes in outpatient individual therapy compared to the step-down program. In contrast, patients in the medium RF group achieved better results in the step-down program. These findings indicate that RF is associated with core aspects of personality pathology and capture clinically relevant phenomena in adult patients with PDs. Moreover, patients with different capacities for mentalization may need different kinds of therapeutic approaches. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

THE CLINICAL, FUNCTIONAL AND BIOMECHANICAL PRESENTATION OF PATIENTS WITH SYMPTOMATIC HIP ABDUCTOR TENDON TEARS.

PubMed

Ebert, Jay R; Retheesh, Theertha; Mutreja, Rinky; Janes, Gregory C

2016-10-01

Hip abductor tendon (HAT) tearing is commonly implicated in greater trochanteric pain syndrome (GTPS), though limited information exists on the disability associated with this condition and specific presentation of these patients. To describe the clinical, functional and biomechanical presentation of patients with symptomatic HAT tears. Secondary purposes were to investigate the association between these clinical and functional measures, and to compare the pain and disability reported by HAT tear patients to those with end-stage hip osteoarthritis (OA). Prospective case series. One hundred forty-nine consecutive patients with symptomatic HAT tears were evaluated using the Harris (HHS) and Oxford (OHS) Hip Scores, SF-12, an additional series of 10 questions more pertinent to those with lateral hip pain, active hip range of motion (ROM), maximal isometric hip abduction strength, six-minute walk capacity and 30-second single limb stance (SLS) test. The presence of a Trendelenburg sign and pelvis-on-femur (POF) angle were determined via 2D video analysis. An age matched comparative sample of patients with end-stage hip OA was recruited for comparison of all patient-reported outcome scores. Independent t-tests investigated group and limb differences, while analysis of variance evaluated pain changes during the functional tests. Pearson's correlation coefficients investigated the correlation between clinical measures in the HAT tear group. No differences existed in patient demographics and patient-reported outcome scores between HAT tear and hip OA cohorts, apart from significantly worse SF-12 mental subscale scores (p = 0.032) in the HAT tear group. Patients with HAT tears demonstrated significantly lower (p < 0.05) hip abduction strength and active ROM in all planes of motion on their affected limb. Pain significantly increased throughout the 30-second SLS test for the HAT tear group, with 57% of HAT tear patients demonstrating a positive Trendelenburg sign

THE CLINICAL, FUNCTIONAL AND BIOMECHANICAL PRESENTATION OF PATIENTS WITH SYMPTOMATIC HIP ABDUCTOR TENDON TEARS

PubMed Central

Retheesh, Theertha; Mutreja, Rinky; Janes, Gregory C.

2016-01-01

Background Hip abductor tendon (HAT) tearing is commonly implicated in greater trochanteric pain syndrome (GTPS), though limited information exists on the disability associated with this condition and specific presentation of these patients. Purpose To describe the clinical, functional and biomechanical presentation of patients with symptomatic HAT tears. Secondary purposes were to investigate the association between these clinical and functional measures, and to compare the pain and disability reported by HAT tear patients to those with end-stage hip osteoarthritis (OA). Study Design Prospective case series. Methods One hundred forty-nine consecutive patients with symptomatic HAT tears were evaluated using the Harris (HHS) and Oxford (OHS) Hip Scores, SF-12, an additional series of 10 questions more pertinent to those with lateral hip pain, active hip range of motion (ROM), maximal isometric hip abduction strength, six-minute walk capacity and 30-second single limb stance (SLS) test. The presence of a Trendelenburg sign and pelvis-on-femur (POF) angle were determined via 2D video analysis. An age matched comparative sample of patients with end-stage hip OA was recruited for comparison of all patient-reported outcome scores. Independent t-tests investigated group and limb differences, while analysis of variance evaluated pain changes during the functional tests. Pearson's correlation coefficients investigated the correlation between clinical measures in the HAT tear group. Results No differences existed in patient demographics and patient-reported outcome scores between HAT tear and hip OA cohorts, apart from significantly worse SF-12 mental subscale scores (p = 0.032) in the HAT tear group. Patients with HAT tears demonstrated significantly lower (p < 0.05) hip abduction strength and active ROM in all planes of motion on their affected limb. Pain significantly increased throughout the 30-second SLS test for the HAT tear group, with 57% of HAT tear patients

Evaluation of esophageal motor function in clinical practice.

PubMed

Gyawali, C P; Bredenoord, A J; Conklin, J L; Fox, M; Pandolfino, J E; Peters, J H; Roman, S; Staiano, A; Vaezi, M F

2013-02-01

Esophageal motor function is highly coordinated between central and enteric nervous systems and the esophageal musculature, which consists of proximal skeletal and distal smooth muscle in three functional regions, the upper and lower esophageal sphincters, and the esophageal body. While upper endoscopy is useful in evaluating for structural disorders of the esophagus, barium esophagography, radionuclide transit studies, and esophageal intraluminal impedance evaluate esophageal transit and partially assess motor function. However, esophageal manometry is the test of choice for the evaluation of esophageal motor function. In recent years, high-resolution manometry (HRM) has streamlined the process of acquisition and display of esophageal pressure data, while uncovering hitherto unrecognized esophageal physiologic mechanisms and pathophysiologic patterns. New algorithms have been devised for analysis and reporting of esophageal pressure topography from HRM. The clinical value of HRM extends to the pediatric population, and complements preoperative evaluation prior to foregut surgery. Provocative maneuvers during HRM may add to the assessment of esophageal motor function. The addition of impedance to HRM provides bolus transit data, but impact on clinical management remains unclear. Emerging techniques such as 3-D HRM and impedance planimetry show promise in the assessment of esophageal sphincter function and esophageal biomechanics. © 2013 Blackwell Publishing Ltd.

76 FR 1173 - Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-07

...] Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations; Availability... Documentation in Clinical Investigations.'' This document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving...

77 FR 11555 - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-27

... either http://www.regulations.gov or http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinical...] Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Continuing Review After Clinical Investigation Approval; Availability AGENCY: Food and Drug Administration...

Fibrocartilaginous embolic myelopathy: demographics, clinical presentation, and functional outcomes.

PubMed

Moore, Brittany J; Batterson, Anna M; Luetmer, Marianne T; Reeves, Ronald K

2018-05-25

Retrospective cohort study. To describe the demographics, clinical presentation, and functional outcomes of fibrocartilaginous embolic myelopathy (FCEM). Academic inpatient rehabilitation unit in the midwestern United States. We retrospectively searched our database to identify patients admitted between January 1, 1995 and March 31, 2016, with a high probability of FCEM. Demographic, clinical, and functional outcome measures, including Functional Independence Measure (FIM) information was obtained by chart review. We identified 31 patients with findings suggestive of FCEM (52% male), which was 2% of the nontraumatic spinal cord injury population admitted to inpatient rehabilitation. The age distribution was bimodal, with peaks in the second and sixth-to-seventh decades. The most common clinical presentation was acute pain and rapid progression of neurologic deficits consistent with a vascular myelopathy. Only three patients (10%) had FCEM documented as a diagnostic possibility. Most patients had paraplegia and neurologically incomplete injuries and were discharged to home. Nearly half of the patients required no assistive device for bladder management at discharge, but most were discharged with medications for bowel management. Median FIM walking locomotion score for all patients was 5, but most patients were discharged using a wheelchair for primary mobility. Median motor FIM subscale score was 36 at admission and 69 at discharge, with a median motor efficiency of 1.41. FCEM may be underdiagnosed and should be considered in those with the appropriate clinical presentation, because their functional outcomes may be more favorable than those with other causes of spinal cord infarction.

[Standard Cancer Therapy Are Established by the Investigator-Initiated Post-Marketing Clinical Trials, Not by the Indication-Directed Clinical Trials].

PubMed

Shimada, Yasuhiro

2016-04-01

The financial supports for investigator-initiated post-marketing clinical trial in clinical oncology are reduced after scandals related to the other fields of clinical trials in Japan. These clinical trials are the essential final steps of clinical development in newer cancer therapy, which should be conducted in the investigator-initiated clinical trial groups with well-organized infrastructure and continuous financial supports. The present problems are discussed and summarized. Future perspectives with the national viewpoints needed to be included the idea of "health technology assessment".

Relationship between dynapenia and cardiorespiratory functions in healthy postmenopausal women: novel clinical criteria.

PubMed

Barbat-Artigas, Seébastien; Dupontgand, Sophie; Fex, Annie; Karelis, Antony D; Aubertin-Leheudre, Mylène

2011-04-01

Muscle strength seems to be a better indicator of physical limitations than skeletal muscle mass is. The purpose of this study was to investigate, using a new developed clinical tool, the relationship between type I dynapenia and cardiorespiratory functions in postmenopausal women. Forty-six postmenopausal women were recruited and divided into two groups (dynapenic vs nondynapenic). Body composition (bioelectrical impedancemetry), muscle strength (dynamometer), cardiorespiratory functions (maximum oxygen consumption and forced expiratory volume in 1 second), resting energy expenditure (indirect calorimetry), and dietary intake (3-d dietary journal) were measured. Type I dynapenia was defined as less than 1.53 kg per skeletal muscle mass (kg) based on handgrip dynamometer. Significant differences were found between dynapenic (n=23) and nondynapenic (n=23) postmenopausal women for cardiorespiratory functions (maximum oxygen consumption, P=0.003; and forced expiratory volume in 1 second, P=0.046). We observed no differences between groups for age, age at menopause, use of hormone therapy, body mass index, waist circumference, fat mass, resting energy expenditure, and total energy intake, which are known to be potential confounders. No differences were observed for cardiorespiratory functions when our population was divided into sarcopenic and nonsarcopenic groups. Type I dynapenic women have significantly poorer cardiorespiratory functions that do nondynapenic women even if they presented the same skeletal muscle mass index. Thus, based on our results, dynapenia could potentially be used as a marker of cardiorespiratory functions. The clinical method developed to identify dynapenic women could be used by health professionals. © 2011 by The North American Menopause Society

[The Clinical Investigation Centers in France: Whatzat? What for? How does it work?].

PubMed

Montagne, O; Le Corvoisier, P

2008-01-01

For the last 15 years, French university-affiliated hospitals have dramatically modified how biomedical research is conducted in France. Multidisciplinary and technically complex research projects are increasingly difficult to conduct in clinical units. To ensure quality, good clinical practice, and security, platforms dedicated to clinical research with specific staff have been implanted. These units, called Clinical Investigation Centers (CICs), are open to academic and industrial investigators working in the medical fields involving patients and healthy volunteers. The CICs' activities are always closely related to the university hospital research programs and can also serve as a tool for locally implanted clinical and fundamental research teams (INSERM). Nowadays, clinical research requires specific tools and platforms. To enhance French university hospital research efficiency and provide a more open research environment, all investigators, on-site as well as from other institutions, are invited to use these cohesive research facilities and skills to conduct protocols that are fully adapted to their needs in optimal conditions of professional clinical research.

75 FR 1790 - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: IRB...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-13

....gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default...] Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval; Availability AGENCY: Food and Drug Administration, HHS...

Clinical symptoms predict concurrent social and global functioning in an early psychosis sample.

PubMed

Cacciotti-Saija, Cristina; Langdon, Robyn; Ward, Philip B; Hickie, Ian B; Guastella, Adam J

2018-04-01

Although well established in chronic schizophrenia, the key determinants of functioning remain unknown during the early phase of a psychotic disorder. The aim of this study was to comprehensively examine the social cognitive, basic neurocognitive and clinical predictors of concurrent social functioning and global functioning in an early psychosis sample. This study examined the relationship between social cognition, basic neurocognition and clinical symptoms with concurrent functioning in 51 early psychosis individuals. Assessments included a range of self-report, observational and clinician-rated measures of cognitive, symptom severity and functioning domains. Results revealed a significant association between self-reported social function and lower levels of both social interaction anxiety and negative psychotic symptoms. A significant association was also observed between lower levels of negative psychotic symptoms and observed social functioning. Lastly, results demonstrated a significant association between reduced negative psychotic symptoms and clinician-rated global functioning. Clinical domains such as negative symptoms and social interaction anxiety significantly contribute to an optimal model predicting outcome during the early phase of a psychotic disorder. These clinical features may also provide useful markers of an individual's capacity for social participation. Clinical implications include the need for early targeted intervention to address social anxiety and negative psychotic symptoms to facilitate optimum patient outcome. © 2015 Wiley Publishing Asia Pty Ltd.

Functional speech disorders: clinical manifestations, diagnosis, and management.

PubMed

Duffy, J R

2016-01-01

Acquired psychogenic or functional speech disorders are a subtype of functional neurologic disorders. They can mimic organic speech disorders and, although any aspect of speech production can be affected, they manifest most often as dysphonia, stuttering, or prosodic abnormalities. This chapter reviews the prevalence of functional speech disorders, the spectrum of their primary clinical characteristics, and the clues that help distinguish them from organic neurologic diseases affecting the sensorimotor networks involved in speech production. Diagnosis of a speech disorder as functional can be supported by sometimes rapidly achieved positive outcomes of symptomatic speech therapy. The general principles of such therapy are reviewed. © 2016 Elsevier B.V. All rights reserved.

The relationship between subconcussive impacts and concussion history on clinical measures of neurologic function in collegiate football players.

PubMed

Gysland, Sonia M; Mihalik, Jason P; Register-Mihalik, Johna K; Trulock, Scott C; Shields, Edgar W; Guskiewicz, Kevin M

2012-01-01

Concussions sustained during college and professional football careers have been associated with both acute and chronic neurologic impairment. The contribution of subconcussive impacts to this impairment has not been adequately studied. Therefore, we investigated the relationship between subconcussive impacts and concussion history on clinical measures of neurologic function. Forty-six collegiate football players completed five clinical measures of neurologic function commonly employed in the evaluation of concussion before and after a single season. These tests included the Automated Neuropsychological Assessment Metrics, Sensory Organization Test, Standardized Assessment of Concussion, Balance Error Scoring System, and Graded Symptom Checklist. The Head Impact Telemetry (HIT) System recorded head impact data including the frequency, magnitude, and location of impacts. College football players sustain approximately 1,000 subconcussive impacts to the head over the course of a season, but for the most part, do not demonstrate any clinically meaningful changes from preseason to postseason on measures of neurologic function. Changes in performance were mostly independent of prior concussion history, and the total number, magnitude and location of sustained impacts over one season as observed R(2) values ranged between 0.30 and 0.35. Repetitive subconcussive head impacts over a single season do not appear to result in short-term neurologic impairment, but these relationships should be further investigated for a potential dose-response over a player's career.

78 FR 57395 - Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-18

...] Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability AGENCY: Food and... the availability of a guidance for industry entitled ``Electronic Source Data in Clinical Investigations.'' This document provides guidance to sponsors, contract research organizations (CROs), clinical...

Comparing methods to combine functional loss and mortality in clinical trials for amyotrophic lateral sclerosis

PubMed Central

van Eijk, Ruben PA; Eijkemans, Marinus JC; Rizopoulos, Dimitris

2018-01-01

Objective Amyotrophic lateral sclerosis (ALS) clinical trials based on single end points only partially capture the full treatment effect when both function and mortality are affected, and may falsely dismiss efficacious drugs as futile. We aimed to investigate the statistical properties of several strategies for the simultaneous analysis of function and mortality in ALS clinical trials. Methods Based on the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database, we simulated longitudinal patterns of functional decline, defined by the revised amyotrophic lateral sclerosis functional rating scale (ALSFRS-R) and conditional survival time. Different treatment scenarios with varying effect sizes were simulated with follow-up ranging from 12 to 18 months. We considered the following analytical strategies: 1) Cox model; 2) linear mixed effects (LME) model; 3) omnibus test based on Cox and LME models; 4) composite time-to-6-point decrease or death; 5) combined assessment of function and survival (CAFS); and 6) test based on joint modeling framework. For each analytical strategy, we calculated the empirical power and sample size. Results Both Cox and LME models have increased false-negative rates when treatment exclusively affects either function or survival. The joint model has superior power compared to other strategies. The composite end point increases false-negative rates among all treatment scenarios. To detect a 15% reduction in ALSFRS-R decline and 34% decline in hazard with 80% power after 18 months, the Cox model requires 524 patients, the LME model 794 patients, the omnibus test 526 patients, the composite end point 1,274 patients, the CAFS 576 patients and the joint model 464 patients. Conclusion Joint models have superior statistical power to analyze simultaneous effects on survival and function and may circumvent pitfalls encountered by other end points. Optimizing trial end points is essential, as selecting suboptimal outcomes may disguise

Clinical team functioning and IT innovation: a study of the diffusion of a point-of-care online evidence system.

PubMed

Gosling, A Sophie; Westbrook, Johanna I; Braithwaite, Jeffrey

2003-01-01

To investigate the association between clinical team functioning and diffusion (awareness, use, and impact) of a 24-hour online evidence retrieval system. To examine the relationships between clinical team characteristics and the adoption of the online evidence system. 18 clinical teams, consisting of 180 clinicians from three Australian hospitals, were identified and studied. Teams were categorized as small ( 15). Clinical team functioning was assessed using the Team Climate Inventory (TCI). Awareness, use, and impact of an online evidence retrieval system were measured using a self-administered questionnaire. The relationships between TCI scores and awareness, use, and impact were examined using t-tests and one-way ANOVAs. Chi square analyses were used to examine differences between small and large teams. RESULTS were interpreted within a diffusion of innovations framework. Clinical team functioning was not related to awareness or use of the online evidence retrieval system. However, clinical team functioning was significantly associated with the impact of online evidence in terms of reported experience of improved patient care following system use. Clinicians in small teams ( 15) teams. Team functioning had the greatest impact on the fourth stage of innovation diffusion, the effective use of online evidence for clinical care. This supports Rogers' diffusion of innovation theory, to the effect that different types of communication about an innovation are important at different stages in the diffusion process. Members of small teams were more aware of the system than members of large teams. Team functioning is amenable to improvement through interventions. The findings suggest that the role of team climate in the diffusion of information systems is a promising area for future research.

Structural-functional relationships between eye orbital imaging biomarkers and clinical visual assessments

NASA Astrophysics Data System (ADS)

Yao, Xiuya; Chaganti, Shikha; Nabar, Kunal P.; Nelson, Katrina; Plassard, Andrew; Harrigan, Rob L.; Mawn, Louise A.; Landman, Bennett A.

2017-02-01

Eye diseases and visual impairment affect millions of Americans and induce billions of dollars in annual economic burdens. Expounding upon existing knowledge of eye diseases could lead to improved treatment and disease prevention. This research investigated the relationship between structural metrics of the eye orbit and visual function measurements in a cohort of 470 patients from a retrospective study of ophthalmology records for patients (with thyroid eye disease, orbital inflammation, optic nerve edema, glaucoma, intrinsic optic nerve disease), clinical imaging, and visual function assessments. Orbital magnetic resonance imaging (MRI) and computed tomography (CT) images were retrieved and labeled in 3D using multi-atlas label fusion. Based on the 3D structures, both traditional radiology measures (e.g., Barrett index, volumetric crowding index, optic nerve length) and novel volumetric metrics were computed. Using stepwise regression, the associations between structural metrics and visual field scores (visual acuity, functional acuity, visual field, functional field, and functional vision) were assessed. Across all models, the explained variance was reasonable (R2 0.1-0.2) but highly significant (p < 0.001). Instead of analyzing a specific pathology, this study aimed to analyze data across a variety of pathologies. This approach yielded a general model for the connection between orbital structural imaging biomarkers and visual function.

Clinical utility of resting-state functional connectivity magnetic resonance imaging for mood and cognitive disorders.

PubMed

Takamura, T; Hanakawa, T

2017-07-01

Although functional magnetic resonance imaging (fMRI) has long been used to assess task-related brain activity in neuropsychiatric disorders, it has not yet become a widely available clinical tool. Resting-state fMRI (rs-fMRI) has been the subject of recent attention in the fields of basic and clinical neuroimaging research. This method enables investigation of the functional organization of the brain and alterations of resting-state networks (RSNs) in patients with neuropsychiatric disorders. Rs-fMRI does not require participants to perform a demanding task, in contrast to task fMRI, which often requires participants to follow complex instructions. Rs-fMRI has a number of advantages over task fMRI for application with neuropsychiatric patients, for example, although applications of task fMR to participants for healthy are easy. However, it is difficult to apply these applications to patients with psychiatric and neurological disorders, because they may have difficulty in performing demanding cognitive task. Here, we review the basic methodology and analysis techniques relevant to clinical studies, and the clinical applications of the technique for examining neuropsychiatric disorders, focusing on mood disorders (major depressive disorder and bipolar disorder) and dementia (Alzheimer's disease and mild cognitive impairment).

Relationships Between Varus–Valgus Laxity of the Severely Osteoarthritic Knee and Gait, Instability, Clinical Performance, and Function

PubMed Central

Freisinger, Gregory M.; Hutter, Erin E.; Lewis, Jacqueline; Granger, Jeffrey F.; Glassman, Andrew H.; Beal, Matthew D.; Pan, Xueliang; Schmitt, Laura C.; Siston, Robert A.; Chaudhari, Ajit M.W.

2017-01-01

Increased varus–valgus laxity has been reported in individuals with knee osteoarthritis (OA) compared to controls. However, the majority of previous investigations may not report truly passive joint laxity, as their tests have been performed on conscious participants who could be guarding against motion with muscle contraction during laxity evaluation. The purpose of this study was to investigate how a measure of passive knee laxity, recorded when the participant is under anesthesia, is related to varus–valgus excursion during gait, clinical measures of performance, perceived instability, and self-reported function in participants with severe knee OA. We assessed passive varus–valgus knee laxity in 29 participants (30 knees) with severe OA, as they underwent total knee arthroplasty (TKA). Participants also completed gait analysis, clinical assessment of performance (6-min walk (6 MW), stair climbing test (SCT), isometric knee strength), and self-reported measures of function (perceived instability, Knee injury, and Osteoarthritis Outcome Score (KOOS) a median of 18 days before the TKA procedure. We observed that greater passive varus–valgus laxity was associated with greater varus–valgus excursion during gait (R2 =0.34, p =0.002). Significant associations were also observed between greater laxity and greater isometric knee extension strength (p =0.014), farther 6 MW distance (p =0.033) and shorter SCT time (p =0.046). No relationship was observed between passive varus–valgus laxity and isometric knee flexion strength, perceived instability, or any KOOS subscale. The conflicting associations between laxity, frontal excursion during gait, and functional performance suggest a complex relationship between laxity and knee cartilage health, clinical performance, and self-reported function that merits further study. PMID:27664972

DRY CUPPING IN CHILDREN WITH FUNCTIONAL CONSTIPATION: A RANDOMIZED OPEN LABEL CLINICAL TRIAL.

PubMed

Shahamat, Mahmoud; Daneshfard, Babak; Najib, Khadijeh-Sadat; Dehghani, Seyed Mohsen; Tafazoli, Vahid; Kasalaei, Afshineh

2016-01-01

As a common disease in pediatrics, constipation poses a high burden to the community. In this study, we aimed to investigate the efficacy of dry cupping therapy (an Eastern traditional manipulative therapy) in children with functional constipation. One hundred and twenty children (4-18 years old) diagnosed as functional constipation according to ROME III criteria were assigned to receive a traditional dry cupping protocol on the abdominal wall for 8 minutes every other day or standard laxative therapy (Polyethylene glycol (PEG) 40% solution without electrolyte), 0.4 g/kg once daily) for 4 weeks, in an open label randomized controlled clinical trial using a parallel design with a 1:1 allocation ratio. Patients were evaluated prior to and following 2, 4, 8 and 12 weeks of the intervention commencement in terms of the ROME III criteria for functional constipation. There were no significant differences between the two arms regarding demographic and clinical basic characteristics. After two weeks of the intervention, there was a significant better result in most of the items of ROME III criteria of patients in PEG group. In contrast, after four weeks of the intervention, the result was significantly better in the cupping group. There was no significant difference in the number of patients with constipation after 4 and 8 weeks of the follow-up period. This study showed that dry cupping of the abdominal wall, as a traditional manipulative therapy, can be as effective as standard laxative therapy in children with functional constipation.

Social cognition in schizophrenia: factor structure, clinical and functional correlates.

PubMed

Buck, Benjamin E; Healey, Kristin M; Gagen, Emily C; Roberts, David L; Penn, David L

2016-08-01

Social cognition is consistently impaired in people with schizophrenia, separable from general neurocognition, predictive of real-world functioning and amenable to psychosocial treatment. Few studies have empirically examined its underlying factor structure. This study (1) examines the factor structure of social cognition in both a sample of individuals with schizophrenia-spectrum disorders and non-clinical controls and (2) explores relationships of factors to neurocognition, symptoms and functioning. A factor analysis was conducted on social cognition measures in a sample of 65 individuals with schizophrenia or schizoaffective disorder, and 50 control participants. The resulting factors were examined for their relationships to symptoms and functioning. Results suggested a two-factor structure in the schizophrenia sample (social cognition skill and hostile attributional style) and a three-factor structure in the non-clinical sample (hostile attributional style, higher-level inferential processing and lower-level cue detection). In the schizophrenia sample, the social cognition skill factor was significantly related to negative symptoms and social functioning, whereas hostile attributional style predicted positive and general psychopathology symptoms. The factor structure of social cognition in schizophrenia separates hostile attributional style and social cognition skill, and each show differential relationships to relevant clinical variables in schizophrenia.

Mental exercises for cognitive function: clinical evidence.

PubMed

Kawashima, Ryuta

2013-01-01

The purpose of this study was to examine the beneficial effects of a new cognitive intervention program designed for the care and prevention of dementia, namely Learning Therapy. The training program used systematized basic problems in arithmetic and Japanese language as training tasks. In study 1, 16 individuals in the experimental group and 16 in the control group were recruited from a nursing home. In both groups, all individuals were clinically diagnosed with senile dementia of the Alzheimer type. In study 2, we performed a single-blind, randomized controlled trial in our cognitive intervention program of 124 community-dwelling seniors. In both studies, the daily training program using reading and arithmetic tasks was carried out approximately 5 days a week, for 15 to 20 minutes a day in the intervention groups. Neuropsychological measures were determined simultaneously in the groups both prior to and after six months of the intervention. The results of our investigations indicate that our cognitive intervention using reading and arithmetic problems demonstrated a transfer effect and they provide convincing evidence that cognitive training maintains and improves the cognitive functions of dementia patients and healthy seniors.

Investigating neuronal function with optically controllable proteins

PubMed Central

Zhou, Xin X.; Pan, Michael; Lin, Michael Z.

2015-01-01

In the nervous system, protein activities are highly regulated in space and time. This regulation allows for fine modulation of neuronal structure and function during development and adaptive responses. For example, neurite extension and synaptogenesis both involve localized and transient activation of cytoskeletal and signaling proteins, allowing changes in microarchitecture to occur rapidly and in a localized manner. To investigate the role of specific protein regulation events in these processes, methods to optically control the activity of specific proteins have been developed. In this review, we focus on how photosensory domains enable optical control over protein activity and have been used in neuroscience applications. These tools have demonstrated versatility in controlling various proteins and thereby cellular functions, and possess enormous potential for future applications in nervous systems. Just as optogenetic control of neuronal firing using opsins has changed how we investigate the function of cellular circuits in vivo, optical control may yet yield another revolution in how we study the circuitry of intracellular signaling in the brain. PMID:26257603

Clinical Investigator Development Program | Center for Cancer Research

Cancer.gov

The Center for Cancer Research (CCR), a division of the National Cancer Institute (NCI), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), is pleased to announce its annual call for applications for the Clinical Investigator Development Program (CIDP). This is an exciting training opportunity intended for physicians interested in dedicating

Effect of Acupuncture on Functional Connectivity of Anterior Cingulate Cortex for Bell's Palsy Patients with Different Clinical Duration

PubMed Central

Wu, Hongli; Kan, Hongxing; Li, Chuanfu; Park, Kyungmo; Zhu, Yifang; Mohamed, Abdalla Z.; Xu, Chunsheng; Wu, Yuanyuan; Zhang, Wei

2015-01-01

Acupuncture is widely used in the treatment of Bell's palsy (BP) in many countries, but its underlying physiological mechanism remained controversial. In order to explore the potential mechanism, changes of functional connectivity (FC) of anterior cingulate gyrus (ACC) were investigated. We collected 20 healthy (control group) participants and 28 BP patients with different clinical duration accepted resting state functional MRI (rfMRI) scans before and after acupuncture, respectively. The FC of ACC before and after acupuncture was compared with paired t-test and the detailed results are presented in the paper. Our results showed that effects of the acupuncture on FC were closely related to clinical duration in patients with BP, which suggested that brain response to acupuncture was closely connected with the status of brain functional connectivity and implied that acupuncture plays a homeostatic role in the BP treatment. PMID:26161125

Measuring Disability in Population Based Surveys: The Interrelationship between Clinical Impairments and Reported Functional Limitations in Cameroon and India

PubMed Central

2016-01-01

Purpose To investigate the relationship between two distinct measures of disability: self-reported functional limitations and objectively-screened clinical impairments. Methods We undertook an all age population-based survey of disability in two areas: North-West Cameroon (August/October 2013) and Telangana State, India (Feb/April 2014). Participants were selected for inclusion via two-stage cluster randomised sampling (probability proportionate to size cluster selection and compact segment sampling within clusters). Disability was defined as the presence of self-reported functional limitations across eight domains, or presence of moderate or greater clinical impairments. Clinical impairment screening comprised of visual acuity testing for vision impairment, pure tone audiometry for hearing impairment, musculoskeletal functioning assessment for musculoskeletal impairment, reported seizure history for epilepsy and reported symptoms of clinical depression (depression adults only). Information was collected using structured questionnaires, observations and examinations. Results Self-reported disability prevalence was 5.9% (95% CI 4.7–7.4) and 7.5% (5.9–9.4) in Cameroon and India respectively. The prevalence of moderate or greater clinical impairments in the same populations were 8.4% (7.5–9.4) in Cameroon and 10.5% (9.4–11.7) in India. Overall disability prevalence (self-report and/or screened positive to a moderate or greater clinical impairment) was 10.5% in Cameroon and 12.2% in India, with limited overlap between the sub-populations identified using the two types of tools. 33% of participants in Cameroon identified to have a disability, and 45% in India, both reported functional limitations and screened positive to objectively-screened impairments, whilst the remainder were identified via one or other tool only. A large proportion of people with moderate or severe clinical impairments did not self-report functional difficulties despite reporting

Measuring Disability in Population Based Surveys: The Interrelationship between Clinical Impairments and Reported Functional Limitations in Cameroon and India.

PubMed

Mactaggart, Islay; Kuper, Hannah; Murthy, G V S; Oye, Joseph; Polack, Sarah

2016-01-01

To investigate the relationship between two distinct measures of disability: self-reported functional limitations and objectively-screened clinical impairments. We undertook an all age population-based survey of disability in two areas: North-West Cameroon (August/October 2013) and Telangana State, India (Feb/April 2014). Participants were selected for inclusion via two-stage cluster randomised sampling (probability proportionate to size cluster selection and compact segment sampling within clusters). Disability was defined as the presence of self-reported functional limitations across eight domains, or presence of moderate or greater clinical impairments. Clinical impairment screening comprised of visual acuity testing for vision impairment, pure tone audiometry for hearing impairment, musculoskeletal functioning assessment for musculoskeletal impairment, reported seizure history for epilepsy and reported symptoms of clinical depression (depression adults only). Information was collected using structured questionnaires, observations and examinations. Self-reported disability prevalence was 5.9% (95% CI 4.7-7.4) and 7.5% (5.9-9.4) in Cameroon and India respectively. The prevalence of moderate or greater clinical impairments in the same populations were 8.4% (7.5-9.4) in Cameroon and 10.5% (9.4-11.7) in India. Overall disability prevalence (self-report and/or screened positive to a moderate or greater clinical impairment) was 10.5% in Cameroon and 12.2% in India, with limited overlap between the sub-populations identified using the two types of tools. 33% of participants in Cameroon identified to have a disability, and 45% in India, both reported functional limitations and screened positive to objectively-screened impairments, whilst the remainder were identified via one or other tool only. A large proportion of people with moderate or severe clinical impairments did not self-report functional difficulties despite reporting participation restrictions. Tools to

Epidemiology, clinical presentation and diagnosis of non-functioning pituitary adenomas.

PubMed

Ntali, Georgia; Wass, John A

2018-04-01

Non-functioning pituitary adenomas (NFPAs) are benign pituitary neoplasms that do not cause a hormonal hypersecretory syndrome. An improved understanding of their epidemiology, clinical presentation and diagnosis is needed. A literature review was performed using Pubmed to identify research reports and clinical case series on NFPAs. They account for 14-54% of pituitary adenomas and have a prevalence of 7-41.3/100,000 population. Their standardized incidence rate is 0.65-2.34/100,000 and the peak occurence is from the fourth to the eighth decade. The clinical spectrum of NFPAs varies from being completely asymptomatic to causing significant hypothalamic/pituitary dysfunction and visual field compromise due to their large size. Most patients present with symptoms of mass effect, such as headaches, visual field defects, ophthalmoplegias, and hypopituitarism but also hyperprolactinaemia due to pituitary stalk deviation and less frequently pituitary apoplexy. Non-functioning pituitary incidentalomas are found on brain imaging performed for an unrelated reason. Diagnostic approach includes magnetic resonance imaging of the sellar region, laboratory evaluations, screening for hormone hypersecretion and for hypopituitarism, and a visual field examination if the lesion abuts the optic nerves or chiasm. This article reviews the epidemiology, clinical behaviour and diagnostic approach of non-functioning pituitary adenomas.

Experimental protocol of a randomized controlled clinical trial investigating the effects of personalized exercise rehabilitation on kidney transplant recipients' outcomes.

PubMed

Kastelz, Alexandra; Tzvetanov, Ivo G; Fernhall, Bo; Shetty, Aneesha; Gallon, Lorenzo; West-Thielke, Patricia; Hachaj, Greg; Grazman, Mark; Benedetti, Enrico

2015-11-01

This randomized controlled trial (RCT) will investigate the effects of a personalized exercise rehabilitation regimen on return to work and find work rate, vascular health, functional capacity, quality of life, kidney function, and body composition in kidney transplant (KT) recipients. This RCT will recruit 120 men and/or women who have had a KT to participate in a 12 month exercise intervention or control (standard clinical care only) group. The 12 month exercise intervention will consist of one-on-one, progressive exercise rehabilitation sessions twice a week, for 60 min each session. The control group will continue standard clinical care as recommended by their post-transplant medical team without any intervention. The primary outcomes will be assessments of vascular structure and function, walking and strength measures to assess functional capacity, blood markers to assess kidney function, questionnaires to assess quality of life, DXA body scan to assess body composition, and a 1-week free living physical activity assessment. Additionally, employment status will be assessed. These assessments will be performed at baseline, 6 months, and 12 months. This investigation will increase the understanding of the role exercise rehabilitation has on managing the physiological and psychological health of the individual as well as on the individual's personal economic impact (via employment status). This study design has the potential to assist in constructing an effective exercise rehabilitation program that can be incorporated into part of standard post-transplant care. Copyright © 2015 Elsevier Inc. All rights reserved.

Clinical Components of Borderline Personality Disorder and Personality Functioning.

PubMed

Ferrer, Marc; Andión, Óscar; Calvo, Natalia; Hörz, Susanne; Fischer-Kern, Melitta; Kapusta, Nestor D; Schneider, Gudrun; Clarkin, John F; Doering, Stephan

2018-01-01

Impairment in personality functioning (PF) represents a salient criterion of the DSM-5 alternative diagnostic model for personality disorders (AMPD). The main goal of this study is to analyze the relationship of the borderline personality disorder (BPD) clinical components derived from the DSM-5 categorical diagnostic model (affective dysregulation, behavioral dysregulation, and disturbed relatedness) with personality organization (PO), i.e., PF, assessed by the Structured Interview of Personality Organization (STIPO). STIPO and the Structured Clinical Interviews for DSM-IV (SCID-I and -II) were administered to 206 BPD patients. The relationship between PO and BPD components were studied using Spearman correlations and independent linear regression analyses. Significant positive correlations were observed between STIPO scores and several DSM-5 BPD criteria and comorbid psychiatric disorders. STIPO dimensions mainly correlated with disturbed relatedness and, to a lesser extent, affective dysregulation components. Each BPD clinical component was associated with specific STIPO dimensions. Both diagnostic models, DSM-5 BPD criteria and PO, are not only related but complementary concepts. The results of this study particularly recommend STIPO for the assessment of relational functioning, which is a major domain of the Personality Functioning Scale Levels of the DSM-5 AMPD. © 2018 S. Karger AG, Basel.

Imaging of autoimmune encephalitis--Relevance for clinical practice and hippocampal function.

PubMed

Heine, J; Prüss, H; Bartsch, T; Ploner, C J; Paul, F; Finke, C

2015-11-19

The field of autoimmune encephalitides associated with antibodies targeting cell-surface antigens is rapidly expanding and new antibodies are discovered frequently. Typical clinical presentations include cognitive deficits, psychiatric symptoms, movement disorders and seizures and the majority of patients respond well to immunotherapy. Pathophysiological mechanisms and clinical features are increasingly recognized and indicate hippocampal dysfunction in most of these syndromes. Here, we review the neuroimaging characteristics of autoimmune encephalitides, including N-methyl-d-aspartate (NMDA) receptor, leucine-rich glioma inactivated 1 (LGI1), contactin-associated protein-like 2 (CASPR2) encephalitis as well as more recently discovered and less frequent forms such as dipeptidyl-peptidase-like protein 6 (DPPX) or glycine receptor encephalitis. We summarize findings of routine magnetic resonance imaging (MRI) investigations as well as (18)F-fluoro-2-deoxy-d-glucose (FDG)-positron emission tomography (PET) and single photon emission tomography (SPECT) imaging and relate these observations to clinical features and disease outcome. We furthermore review results of advanced imaging analyses such as diffusion tensor imaging, volumetric analyses and resting-state functional MRI. Finally, we discuss contributions of these neuroimaging observations to the understanding of the pathophysiology of autoimmune encephalitides. Copyright © 2015 IBRO. Published by Elsevier Ltd. All rights reserved.

Patient-reported outcomes of pain and physical functioning in neurofibromatosis clinical trials.

PubMed

Wolters, Pamela L; Martin, Staci; Merker, Vanessa L; Tonsgard, James H; Solomon, Sondra E; Baldwin, Andrea; Bergner, Amanda L; Walsh, Karin; Thompson, Heather L; Gardner, Kathy L; Hingtgen, Cynthia M; Schorry, Elizabeth; Dudley, William N; Franklin, Barbara

2016-08-16

Tumors and other disease complications of neurofibromatosis (NF) can cause pain and negatively affect physical functioning. To document the clinical benefit of treatment in NF trials targeting these manifestations, patient-reported outcomes (PROs) assessing pain and physical functioning should be included as study endpoints. Currently, there is no consensus on the selection and use of such measures in the NF population. This article presents the recommendations of the PRO group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) International Collaboration for assessing the domains of pain and physical functioning for NF clinical trials. The REiNS PRO group reviewed and rated existing PRO measures assessing pain intensity, pain interference, and physical functioning using their systematic method. Final recommendations are based primarily on 4 main criteria: patient characteristics, item content, psychometric properties, and feasibility for clinical trials. The REiNS PRO group chose the Numeric Rating Scale-11 (≥8 years) to assess pain intensity, the Pain Interference Index (6-24 years) and the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Scale (≥18 years) to evaluate pain interference, and the PROMIS Physical Functioning Scale to measure upper extremity function and mobility (≥5 years) for NF clinical trials. The REiNS Collaboration currently recommends these PRO measures to assess the domains of pain and physical functioning for NF clinical trials; however, further research is needed to evaluate their use in individuals with NF. A final consensus recommendation for the pain interference measure will be disseminated in a future publication based on findings from additional published research. © 2016 American Academy of Neurology.

Cognitive function in schizoaffective disorder and clinical subtypes of schizophrenia.

PubMed

Goldstein, Gerald; Shemansky, Wendy Jo; Allen, Daniel N

2005-03-01

Cognitive studies of patients with Schizoaffective Disorder typically indicate that the cognitive function of these patients resembles that of patients with Schizophrenic Disorder more than it does patients with nonpsychotic Mood Disorder. In this study patients with Schizoaffective Disorder were compared with patients with Paranoid, Undifferentiated and Residual clinical subtypes on a number of measures of cognitive function. Multivariate analyses of variance indicated that the cognitive function of Schizoaffective and Paranoid patients had more intact cognitive function that did Undifferentiated and Residual patients. Application of cluster analysis indicated that there were relative high percentages of Schizoaffective and Paranoid patients in a "Neuropsychologically Normal" cluster. It was concluded that Schizoaffective Disorder as well as other clinical subtypes of schizophrenia are cognitively heterogeneous, and it was suggested that a subgroup of patients with Schizoaffective Disorder may not differ in cognitive ability from patients with nonpsychotic Mood Disorder.

Epilepsy-related clinical factors and psychosocial functions in pediatric epilepsy.

PubMed

Eom, Soyong; Eun, So-Hee; Kang, Hoon-Chul; Eun, Baik-Lin; Nam, Sang Ook; Kim, Sun Jun; Chung, Hee Jung; Kwon, Soon Hak; Lee, Young-Mock; Lee, Joon Soo; Kim, Dong Wook; Oh, Kyung Ja; Kim, Heung Dong

2014-08-01

The aim of this study was to identify the different influencing patterns of demographic and epilepsy-related variables on various aspects of psychosocial function in pediatric epilepsy. Five hundred ninety-eight patients with pediatric epilepsy between the ages of 4 and 18 years (boys=360, 60% and girls=238, 40%) and their parents participated in the study. Parents completed the Social Maturity Scale (SMS), the Korean version of the Child Behavior Checklist (K-CBCL), and the Korean version of the Quality of Life in Childhood Epilepsy Questionnaire (K-QOLCE) to assess daily living function, behavior, and quality of life. The Children's Global Assessment Scale (CGAS) was completed by clinicians to assess general adaptive function. Demographic variables, such as age and sex of child, and epilepsy-related clinical variables, including seizure type, seizure frequency, duration of epilepsy, and number of medications, were obtained from medical records. Demographic and epilepsy-related clinical variables had a strong influence (22-32%) on the cognition-related domain such as general adaptive function, school/total competence, and quality of life for cognitive function while a comparatively smaller effect (2-16%) on the more psychological domain including behavioral, emotional, and social variables. Younger age, shorter duration of illness, and smaller number of medications showed a strong positive impact on psychosocial function in pediatric epilepsy, particularly for adaptive function, competence, and quality-of-life aspects. Given the wide range of impact of demographic and clinical variables on various facets of psychosocial functions, more specific understanding of the various aspects of factors and their particular pattern of influence may enable more effective therapeutic approaches that address both the medical and psychological needs in pediatric epilepsy. Copyright © 2014 Elsevier Inc. All rights reserved.

Social cognition in schizophrenia: Factor structure, clinical and functional correlates

PubMed Central

Buck, Benjamin E.; Healey, Kristin M.; Gagen, Emily C.; Roberts, David L.; Penn, David L.

2016-01-01

Background Social cognition is consistently impaired in people with schizophrenia, separable from general neurocognition, predictive of real-world functioning, and amenable to psychosocial treatment. Few studies have empirically examined its underlying factor structure. Aims The present study (1) examines the factor structure of social cognition in both a sample of individuals with schizophrenia-spectrum disorders and non-clinical controls, and (2) explores relationships of factors to neurocognition, symptoms and functioning. Method A factor analysis was conducted on social cognition measures in a sample of sixty-five individuals with schizophrenia or schizoaffective disorder, and fifty control participants. The resulting factors were examined for their relationships to symptoms and functioning. Results Results suggested a two-factor structure in the schizophrenia sample (social cognition skill and hostile attributional style) and a three-factor structure in the non-clinical sample (hostile attributional style, higher-level inferential processing, and lower-level cue detection). In the schizophrenia sample, the social cognition skill factor was significantly related to negative symptoms and social functioning, while hostile attributional style predicted positive and general psychopathology symptoms. Conclusions The factor structure of social cognition in schizophrenia separates hostile attributional style and social cognition skill, and each show differential relationships to relevant clinical variables in schizophrenia. PMID:26747063

Post-tuberculous lung function impairment in a tuberculosis reference clinic in Cameroon.

PubMed

Mbatchou Ngahane, Bertrand Hugo; Nouyep, Junior; Nganda Motto, Malea; Mapoure Njankouo, Yacouba; Wandji, Adeline; Endale, Mireille; Afane Ze, Emmanuel

2016-05-01

After completion of treatment, a proportion of pulmonary TB (pTB) patients experience lung function impairment which can influence their quality of life. This study aimed to determine the prevalence of lung function impairment in patients treated for pTB and investigate its associated factors. A cross-sectional study was conducted in TB clinic of the Douala Laquintinie Hospital in Cameroon. Patients aged 15 and above who were treated for pTB between 2008 and 2012 were included in the study. Demographic data, respiratory symptoms prior TB diagnosis, comorbidities and chest radiography findings prior to TB treatment were collected. All participants underwent spirometric measurements. Airflow obstruction was defined as a post-bronchodilation FEV1/FVC <70% with FVC >80%, restrictive defects as an FEV1/FVC ratio of ≥70% with an FVC <80% predicted, and mixed defects as FVC of <80% predicted and an FEV1/FVC ratio of <70%. Lung function impairment was defined by the presence of at least one of these three abnormalities. Logistic regression analysis was employed to investigate risk factors of lung function impairment. Of a total of 269 participants included in the study, 146 (54.3%) were male. The median age of participants was 33 years. The median duration of symptoms before diagnosis of TB was 4 weeks [interquartile range (IQR) 3-8]. The prevalence of lung function impairment was 45.4% (95% CI 39-51). The multivariate analysis identified duration of symptoms [OR 1.08; 95% CI (1.01-1.15)] and fibrotic pattern [OR 3.54; 95% CI (1.40-8.95)] as independent risk factors for lung function impairment. Post-tuberculous pulmonary function impairment is frequent in Douala. Sensitization of patient with symptoms of pulmonary TB for an earlier visit to healthcare facilities could reduce the impact of pTB on lung function of patients. Copyright © 2016 Elsevier Ltd. All rights reserved.

42 CFR 493.2001 - Establishment and function of the Clinical Laboratory Improvement Advisory Committee.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Establishment and function of the Clinical... LABORATORY REQUIREMENTS Consultations § 493.2001 Establishment and function of the Clinical Laboratory Improvement Advisory Committee. (a) HHS will establish a Clinical Laboratory Improvement Advisory Committee to...

Vision therapy in adults with convergence insufficiency: clinical and functional magnetic resonance imaging measures.

PubMed

Alvarez, Tara L; Vicci, Vincent R; Alkan, Yelda; Kim, Eun H; Gohel, Suril; Barrett, Anna M; Chiaravalloti, Nancy; Biswal, Bharat B

2010-12-01

This research quantified clinical measurements and functional neural changes associated with vision therapy in subjects with convergence insufficiency (CI). Convergence and divergence 4° step responses were compared between 13 control adult subjects with normal binocular vision and four CI adult subjects. All CI subjects participated in 18 h of vision therapy. Clinical parameters quantified throughout the therapy included: nearpoint of convergence, recovery point of convergence, positive fusional vergence at near, near dissociated phoria, and eye movements that were quantified using peak velocity. Neural correlates of the CI subjects were quantified with functional magnetic resonance imaging scans comparing random vs. predictable vergence movements using a block design before and after vision therapy. Images were quantified by measuring the spatial extent of activation and the average correlation within five regions of interests (ROI). The ROIs were the dorsolateral prefrontal cortex, a portion of the frontal lobe, part of the parietal lobe, the cerebellum, and the brain stem. All measurements were repeated 4 months to 1 year post-therapy in three of the CI subjects. Convergence average peak velocities to step stimuli were significantly slower (p = 0.016) in CI subjects compared with controls; however, significant differences in average peak velocities were not observed for divergence step responses (p = 0.30). The investigation of CI subjects participating in vision therapy showed that the nearpoint of convergence, recovery point of convergence, and near dissociated phoria significantly decreased. Furthermore, the positive fusional vergence, average peak velocity from 4° convergence steps, and the amount of functional activity within the frontal areas, cerebellum, and brain stem significantly increased. Several clinical and cortical parameters were significantly correlated. Convergence peak velocity was significantly slower in CI subjects compared with controls

Anorexia, functional capacity, and clinical outcome in patients with chronic heart failure: results from the Studies Investigating Co‐morbidities Aggravating Heart Failure (SICA‐HF)

PubMed Central

Saitoh, Masakazu; dos Santos, Marcelo R.; Emami, Amir; Ishida, Junichi; Ebner, Nicole; Valentova, Miroslava; Bekfani, Tarek; Sandek, Anja; Lainscak, Mitja; Doehner, Wolfram; Anker, Stefan D.

2017-01-01

Abstract Aims We aimed to assess determinants of anorexia, that is loss of appetite in patients with heart failure (HF) and aimed to further elucidate the association between anorexia, functional capacity, and outcomes in affected patients. Methods and results We assessed anorexia status among 166 patients with HF (25 female, 66 ± 12 years) who participated in the Studies Investigating Co‐morbidities Aggravating HF. Anorexia was assessed by a 6‐point Likert scale (ranging from 0 to 5), wherein values ≥1 indicate anorexia. Functional capacity was assessed as peak oxygen uptake (peak VO2), 6 min walk test, and short physical performance battery test. A total of 57 patients (34%) reported any anorexia, and these patients showed lower values of peak VO2, 6 min walk distance, and short physical performance battery score (all P < 0.05). Using multivariate analysis adjusting for clinically important factors, only high‐sensitivity C‐reactive protein [odds ratio (OR) 1.24, P = 0.04], use of loop diuretics (OR 5.76, P = 0.03), and the presence of cachexia (OR 2.53, P = 0.04) remained independent predictors of anorexia. A total of 22 patients (13%) died during a mean follow‐up of 22.5 ± 5.1 months. Kaplan‐Meier curves for cumulative survival showed that those patients with anorexia presented higher mortality (Log‐rank test P = 0.03). Conclusions Inflammation, use of loop diuretics, and cachexia are associated with an increased likelihood of anorexia in patients with HF, and patients with anorexia showed impaired functional capacity and poor outcomes. PMID:28960880

DRY CUPPING IN CHILDREN WITH FUNCTIONAL CONSTIPATION: A RANDOMIZED OPEN LABEL CLINICAL TRIAL

PubMed Central

Shahamat, Mahmoud; Daneshfard, Babak; Najib, Khadijeh-Sadat; Dehghani, Seyed Mohsen; Tafazoli, Vahid; Kasalaei, Afshineh

2016-01-01

Background: As a common disease in pediatrics, constipation poses a high burden to the community. In this study, we aimed to investigate the efficacy of dry cupping therapy (an Eastern traditional manipulative therapy) in children with functional constipation. Materials and Methods: One hundred and twenty children (4-18 years old) diagnosed as functional constipation according to ROME III criteria were assigned to receive a traditional dry cupping protocol on the abdominal wall for 8 minutes every other day or standard laxative therapy (Polyethylene glycol (PEG) 40% solution without electrolyte), 0.4 g/kg once daily) for 4 weeks, in an open label randomized controlled clinical trial using a parallel design with a 1:1 allocation ratio. Patients were evaluated prior to and following 2, 4, 8 and 12 weeks of the intervention commencement in terms of the ROME III criteria for functional constipation. Results: There were no significant differences between the two arms regarding demographic and clinical basic characteristics. After two weeks of the intervention, there was a significant better result in most of the items of ROME III criteria of patients in PEG group. In contrast, after four weeks of the intervention, the result was significantly better in the cupping group. There was no significant difference in the number of patients with constipation after 4 and 8 weeks of the follow-up period. Conclusion: This study showed that dry cupping of the abdominal wall, as a traditional manipulative therapy, can be as effective as standard laxative therapy in children with functional constipation. PMID:28852716

Limits of clinical tests to screen autonomic function in diabetes type 1.

PubMed

Ducher, M; Bertram, D; Sagnol, I; Cerutti, C; Thivolet, C; Fauvel, J P

2001-11-01

A precocious detection of cardiac autonomic dysfunction is of major clinical interest that could lead to a more intensive supervision of diabetic patients. However, classical clinical exploration of cardiac autonomic function is not easy to undertake in a reproducible way. Thus, respective interests of autonomic nervous parameters provided by both clinical tests and computerized analysis of resting blood pressure were checked in type 1 diabetic patients without orthostatic hypotension and microalbuminuria. Thirteen diabetic subjects matched for age and gender to thirteen healthy subjects volunteered to participate to the study. From clinical tests (standing up, deep breathing, Valsalva maneuver, handgrip test), autonomic function was scored according to Ewing's methodology. Analysis of resting beat to beat blood pressure provided autonomic indices of the cardiac function (spectral analysis or Z analysis). 5 of the 13 diabetic patients exhibited a pathological score (more than one pathological response) suggesting the presence of cardiovascular autonomic dysfunction. The most discriminative test was the deep breathing test. However, spectral indices of BP recordings and baro-reflex sensitivity (BRS) of these 5 subjects were similar to those of healthy subjects and of remaining diabetic subjects. Alteration in Ewing's score given by clinical tests may not reflect an alteration of cardiac autonomic function in asymptomatic type 1 diabetic patients, because spectral indices of sympathetic and parasympathetic (including BRS) function were within normal range. Our results strongly suggest to confront results provided by both methodologies before concluding to an autonomic cardiac impairment in asymptomatic diabetic patients.

77 FR 69631 - Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-20

...://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances...] Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the... IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of...

Clinical and cognitive factors affecting psychosocial functioning in remitted patients with bipolar disorder.

PubMed

Konstantakopoulos, G; Ioannidi, N; Typaldou, M; Sakkas, D; Oulis, P

2016-01-01

Impaired interpersonal, social, and occupational functioning is very often observed in patients with bipolar disorder, not only at the acute stages of the illness but in remission as well. This finding raises the question of multiple factors that might affect psychosocial functioning in bipolar patients, such as residual subsyndromal symptoms and neuropsychological deficits. Social cognition impairment, especially impaired Theory of Mind (ToM), might also play an important role in bipolar patients' every-day functioning, similarly to what was found in patients with schizophrenia. The present study aimed to investigate the potential effect of clinical and cognitive factors on the psychosocial functioning of patients with bipolar disorder during remission, assessing ToM along with a broad range of basic cognitive functions. Forty-nine patients with bipolar disorder type I in remission and 53 healthy participants were assessed in general intelligence, working memory, attention, speed processing, verbal learning and memory, and executive functions using a comprehensive battery of neuropsychological tests. The Faux Pas Recognition Test was used to assess ToM. The two groups were matched for gender, age and education level. The Hamilton Rating Scale for Depression (HDRS), the Young Mania Rating Scale (YMRS), and the Brief Psychiatric Rating Scale (BPRS) were also administered to the patients. Every-day functioning was assessed with the Global Assessment of Functioning (GAF). In order to examine the contribution of many factors in psychosocial functioning, we used hierarchical multiple regression analysis. Bipolar patients presented significant impairment compared to healthy participants in all the basic cognitive functions tested with the exception of verbal memory. Moreover, patients had significant poorer performance than healthy controls in overall psyand cognitive ToM but not in affective ToM as measured by Faux Pas. Psychosocial functioning in patient group was

Functional Hypothalamic Amenorrhea: An Endocrine Society Clinical Practice Guideline.

PubMed

Gordon, Catherine M; Ackerman, Kathryn E; Berga, Sarah L; Kaplan, Jay R; Mastorakos, George; Misra, Madhusmita; Murad, M Hassan; Santoro, Nanette F; Warren, Michelle P

2017-05-01

The American Society for Reproductive Medicine, the European Society of Endocrinology, and the Pediatric Endocrine Society. This guideline was funded by the Endocrine Society. To formulate clinical practice guidelines for the diagnosis and treatment of functional hypothalamic amenorrhea (FHA). The participants include an Endocrine Society-appointed task force of eight experts, a methodologist, and a medical writer. This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation approach to describe the strength of recommendations and the quality of evidence. The task force commissioned two systematic reviews and used the best available evidence from other published systematic reviews and individual studies. One group meeting, several conference calls, and e-mail communications enabled consensus. Endocrine Society committees and members and cosponsoring organizations reviewed and commented on preliminary drafts of this guideline. FHA is a form of chronic anovulation, not due to identifiable organic causes, but often associated with stress, weight loss, excessive exercise, or a combination thereof. Investigations should include assessment of systemic and endocrinologic etiologies, as FHA is a diagnosis of exclusion. A multidisciplinary treatment approach is necessary, including medical, dietary, and mental health support. Medical complications include, among others, bone loss and infertility, and appropriate therapies are under debate and investigation. Copyright © 2017 Endocrine Society

Clinical, psychological and maternal characteristics in early functional constipation.

PubMed

Kilincaslan, Huseyin; Abali, Osman; Demirkaya, Sevcan Karakoc; Bilici, Mustafa

2014-08-01

This cross-sectional study investigated the clinical features of functional constipation (FC) at preschool age, as well as emotional and behavioral characteristics of the children, psychological symptom level and parental attitudes of the mothers, and compared these with that of non-referred typically developing controls with normal intestinal habits. Participants included 65 children with FC (mean age, 43.6 ± 15.4 months; range, 25-72 months), 59 healthy controls (mean age, 46.9 ± 14.5 months; range, 25-72 months) and the mothers of the children. The Childhood Behavior Checklist, Symptom Checklist 90 and Parental Attitude Research Instrument were filled in by the mothers. Participants with FC had higher problem scores than the comparison children in a variety of emotional and behavioral parameters. Approximately half exhibited internalizing and one-third had externalizing problems in the clinical range. The mothers of the patient group had higher levels of psychological distress, overprotective parenting and strict discipline. On multiple logistic regression analysis child psychopathology, maternal education level and maternal distress were independently associated with FC. Behavior problems are common in children with FC from an early age. Low level of education and high psychological distress of the mothers seem to be important risk factors for constipation and should be assessed carefully in the management of these cases. © 2013 Japan Pediatric Society.

78 FR 13070 - Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-26

... http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsand...] (formerly 1999D-4396) Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial Disclosure by Clinical Investigators; Availability AGENCY: Food and Drug Administration, HHS...

77 FR 69632 - Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-20

...] Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``Electronic Source Data in Clinical... in Clinical Investigations.'' This revised draft document provides guidance to sponsors, contract...

Social support and clinical and functional outcome in people with schizophrenia.

PubMed

Vázquez Morejón, Antonio J; León Rubio, Jose Mª; Vázquez-Morejón, Raquel

2018-05-01

The impact of Social Support (SS) on the clinical and functional evolution of patients diagnosed with schizophrenia was studied from a multidimensional concept of SS in the framework of the vulnerability-stress model. In total, 152 patients diagnosed with schizophrenia according to the International Classification of Diseases, Tenth Edition (ICD-10) treated in a Community Mental Health Unit were assessed using the Mannheim Interview on Social Support (MISS) and the Brief Psychiatric Rating Scale (BPRS). Then they were followed up for 3 years with a final assessment for the period using the Social Functioning Scale. The impact of SS was explored in clinical and functional measurements with a multiple regression analysis in a 3-year longitudinal prospective design. The quality of Global Social Support (GSS) and satisfaction with GSS appeared to be protective factors from frequency and duration of hospital admissions, with explanatory intensity varying from 9% in survival time to relapse to 13% in number of relapses. Concerning functional measurements, GSS quantity, quality and satisfaction showed an explanatory power for several different dimensions of social functioning, varying from 12% in isolation to 20% in communication. The results confirm SS as a protective factor in the evolution of schizophrenia patients and enable the SS variables with the most explanatory power in their clinical and functional evolution to be identified.

The visual and functional impacts of astigmatism and its clinical management.

PubMed

Read, Scott A; Vincent, Stephen J; Collins, Michael J

2014-05-01

To provide a comprehensive overview of research examining the impact of astigmatism on clinical and functional measures of vision, the short and longer term adaptations to astigmatism that occur in the visual system, and the currently available clinical options for the management of patients with astigmatism. The presence of astigmatism can lead to substantial reductions in visual performance in a variety of clinical vision measures and functional visual tasks. Recent evidence demonstrates that astigmatic blur results in short-term adaptations in the visual system that appear to reduce the perceived impact of astigmatism on vision. In the longer term, uncorrected astigmatism in childhood can also significantly impact on visual development, resulting in amblyopia. Astigmatism is also associated with the development of spherical refractive errors. Although the clinical correction of small magnitudes of astigmatism is relatively straightforward, the precise, reliable correction of astigmatism (particularly high astigmatism) can be challenging. A wide variety of refractive corrections are now available for the patient with astigmatism, including spectacle, contact lens and surgical options. Astigmatism is one of the most common refractive errors managed in clinical ophthalmic practice. The significant visual and functional impacts of astigmatism emphasise the importance of its reliable clinical management. With continued improvements in ocular measurement techniques and developments in a range of different refractive correction technologies, the future promises the potential for more precise and comprehensive correction options for astigmatic patients. © 2014 The Authors Ophthalmic & Physiological Optics © 2014 The College of Optometrists.

Clinical characteristics and functional status of children with different subtypes of dyskinetic cerebral palsy.

PubMed

Sun, Dianrong; Wang, Qiang; Hou, Mei; Li, Yutang; Yu, Rong; Zhao, Jianhui; Wang, Ke

2018-05-01

Dyskinetic cerebral palsy (CP) is the second major subtype of CP. Dyskinetic CP can be classified into different subtypes, but the exact clinical characteristics of these subtypes have been poorly studied. To investigate the clinical characteristics and functional classification of dyskinetic CP from the perspective of neurologic subtypes in a hospital-based follow-up study.This was an observational study of consecutive children with dyskinetic CP treated at The Affiliated Women & Children Hospital of Qingdao University (China) from October 2005 to February 2015. The children were stratified according to their neurologic subtype and assessed with the Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), and Communication Function Classification System (CFCS). MRI scanning was conducted at 1 year of age for most children.Twenty-six participants (28.0%) had dystonic CP, 26 (28.0%) had choreoathetotic CP, and 41 (44.1%) had mixed CP. Auditory impairment and basal ganglion lesions occurred more frequently in the dystonia group (n = 8, 31%; and n = 16, 67%), while seizures, microcephaly, white matter lesions, and mixed lesions were more frequent in the mixed type (n = 14, 34%; n = 10, 24%; n = 15, 41%; n = 12, 32%). Functional classification levels were distributed unequally among the 3 subgroups (P < .01). No significant difference between GMFCS and MACS was found among the 3 subgroups (P > .05).Different subtypes of dyskinetic CP have specific comorbidities, radiological characteristics, and functional attributes according to their etiological factors and brain lesions. Children with dystonic CP have more limited functional status than children with choreoathetotic CP.

Clinical research: business opportunities for pharmacy-based investigational drug services.

PubMed

Marnocha, R M

1999-02-01

The application by an academic health center of business principles to the conduct of clinical research is described. Re-engineering of the infrastructure for clinical research at the University of Wisconsin and University of Wisconsin Hospital and Clinics began in 1990 with the creation of the Center for Clinical Trials (CCT) and the restructuring of the investigational drug services (IDS). Strategies to further improve the institution's clinical research activities have been continually assessed and most recently have centered on the adaptation of a business philosophy within the institution's multidisciplinary research infrastructure. Toward that end, the CCT and IDS have introduced basic business principles into operational activities. Four basic business concepts have been implemented: viewing the research protocol as a commodity, seeking payment for services rendered, tracking investments, and assessing performance. It is proposed that incorporation of these basic business concepts is not only compatible with the infrastructure for clinical research but beneficial to that infrastructure. The adaptation of a business mindset is likely to enable an academic health center to reach its clinical research goals.

Clinical and Histopathological Investigation of Seborrheic Keratosis

PubMed Central

Roh, Nam Kyung; Hahn, Hyung Jin; Lee, Yang Won; Choe, Yong Beom

2016-01-01

Background Seborrheic keratosis (SK) is one of the most common epidermal tumors of the skin. However, only a few large-scale clinicohistopathological investigations have been conducted on SK or on the possible correlation between histopathological SK subtype and location. Objective The aim of this study was to analyze the clinical and histopathological features of a relatively large number of cases of diagnosed SK. Methods Two hundred and seventy-one pathology slides of skin tissue from patients with clinically diagnosed SK and 206 cases of biopsy-proven SK were analyzed. The biopsy-proven cases of SK were assessed for histopathological subclassification. The demographic, clinical, and histopathological data of the patients were collected for analysis of associated factors. Results The most frequent histopathological subtype was the acanthotic type, followed by mixed, hyperkeratotic, melanoacanthoma, clonal, irritated, and adenoid types; an unexpectedly high percentage (9.2%) of the melanoacanthoma variant was observed. The adenoid type was more common in sun-exposed sites than in sun-protected sites (p=0.028). Premalignant and malignant entities together represented almost one-quarter (24.2%) of the clinicopathological mismatch cases (i.e., mismatch between the clinical and histopathological diagnoses). Regarding the location of SK development, the frequency of mismatch for the sun-exposed areas was significantly higher than that for sun-protected areas (p=0.043). Conclusion The adenoid type was more common in sun-exposed sites. Biopsy sampling should be performed for lesions situated in sun-exposed areas to exclude other premalignant or malignant diseases. PMID:27081260

A history of the American Society for Clinical Investigation

PubMed Central

Howell, Joel D.

2009-01-01

One hundred years ago, in 1909, the American Society for Clinical Investigation (ASCI) held its first annual meeting. The founding members based this new society on a revolutionary approach to research that emphasized newer physiological methods. In 1924 the ASCI started a new journal, the Journal of Clinical Investigation. The ASCI has also held an annual meeting almost every year. The society has long debated who could be a member, with discussions about whether members must be physicians, what sorts of research they could do, and the role of women within the society. The ASCI has also grappled with what else the society should do, especially whether it ought to take a stand on policy issues. ASCI history has reflected changing social, political, and economic contexts, including several wars, concerns about the ethics of biomedical research, massive increases in federal research funding, and an increasingly large and specialized medical environment. PMID:19348041

Neighborhood graph and learning discriminative distance functions for clinical decision support.

PubMed

Tsymbal, Alexey; Zhou, Shaohua Kevin; Huber, Martin

2009-01-01

There are two essential reasons for the slow progress in the acceptance of clinical case retrieval and similarity search-based decision support systems; the especial complexity of clinical data making it difficult to define a meaningful and effective distance function on them and the lack of transparency and explanation ability in many existing clinical case retrieval decision support systems. In this paper, we try to address these two problems by introducing a novel technique for visualizing inter-patient similarity based on a node-link representation with neighborhood graphs and by considering two techniques for learning discriminative distance function that help to combine the power of strong "black box" learners with the transparency of case retrieval and nearest neighbor classification.

Mental Imagery: Functional Mechanisms and Clinical Applications

PubMed Central

Pearson, Joel; Naselaris, Thomas; Holmes, Emily A.; Kosslyn, Stephen M.

2015-01-01

Mental imagery research has weathered both disbelief of the phenomenon and inherent methodological limitations. Here we review recent behavioral, brain imaging, and clinical research that has reshaped our understanding of mental imagery. Research supports the claim that visual mental imagery is a depictive internal representation that functions like a weak form of perception. Brain imaging work has demonstrated that neural representations of mental and perceptual images resemble one another as early as the primary visual cortex (V1). Activity patterns in V1 encode mental images and perceptual images via a common set of low-level depictive visual features. Recent translational and clinical research reveals the pivotal role that imagery plays in many mental disorders and suggests how clinicians can utilize imagery in treatment. PMID:26412097

Predicting functional remission in patients with schizophrenia: a cross-sectional study of symptomatic remission, psychosocial remission, functioning, and clinical outcome

PubMed Central

Valencia, Marcelo; Fresán, Ana; Barak, Yoram; Juárez, Francisco; Escamilla, Raul; Saracco, Ricardo

2015-01-01

Background New approaches to assess outcome in schizophrenia include multidimensional measures such as remission, cognition, psychosocial functioning, and quality of life. Clinical and psychosocial measures have been recently introduced to assess functional outcome. Objective The study presented here was designed to examine the rates of symptomatic remission, psychosocial remission, global functioning, and clinical global impressions in a sample of schizophrenia outpatients in order to assess functional remission and to identify predictive factors for functional remission. Methods A total of 168 consecutive Mexican outpatients receiving pharmacological treatment at the National Institute of Psychiatry in Mexico City were enrolled in a cross-sectional study. Symptomatic remission was assessed according to the definition and criteria proposed by the Remission in Schizophrenia Working Group using the Positive and Negative Symptom Scale. Psychosocial remission was assessed according to Barak criteria using the Psychosocial Remission in Schizophrenia scale. Functioning was measured with the Global Assessment of Functioning, and clinical outcome with the Clinical Global Impressions (CGI) Scale. Results Findings showed that 45.2% of patients fulfilled the symptomatic remission criteria, 32.1% achieved psychosocial remission, and 53% reported adequate functioning. However, the combination of these three outcome criteria – symptomatic, psychosocial remission, and functioning – indicated that 14.9% of the patients achieved our predefined functional remission outcome. The logistic regression model included five predictive variables for functional remission: (1) being employed, (2) use of atypical antipsychotics, (3) lower number of medications, (4) lower negative symptom severity, and (5) lower excitement symptom severity. Conclusion The study demonstrated that symptomatic remission, psychosocial remission, and functioning could be achievable goals for a considerable

Clinical Supervision and Psychological Functions: A New Direction for Theory and Practice.

ERIC Educational Resources Information Center

Pajak, Edward

2002-01-01

Relates Carl Jung's concept of psychological functions to four families of clinical supervision: the original clinical models, the humanistic/artistic models, the technical/didactic models, and the developmental/reflective models. Differences among clinical supervision models within these families are clarified as representing "communication…

Functional and clinical neuroanatomy of morality.

PubMed

Fumagalli, Manuela; Priori, Alberto

2012-07-01

Morality is among the most sophisticated features of human judgement, behaviour and, ultimately, mind. An individual who behaves immorally may violate ethical rules and civil rights, and may threaten others' individual liberty, sometimes becoming violent and aggressive. In recent years, neuroscience has shown a growing interest in human morality, and has advanced our understanding of the cognitive and emotional processes involved in moral decisions, their anatomical substrates and the neurology of abnormal moral behaviour. In this article, we review research findings that have provided a key insight into the functional and clinical neuroanatomy of the brain areas involved in normal and abnormal moral behaviour. The 'moral brain' consists of a large functional network including both cortical and subcortical anatomical structures. Because morality is a complex process, some of these brain structures share their neural circuits with those controlling other behavioural processes, such as emotions and theory of mind. Among the anatomical structures implicated in morality are the frontal, temporal and cingulate cortices. The prefrontal cortex regulates activity in subcortical emotional centres, planning and supervising moral decisions, and when its functionality is altered may lead to impulsive aggression. The temporal lobe is involved in theory of mind and its dysfunction is often implicated in violent psychopathy. The cingulate cortex mediates the conflict between the emotional and the rational components of moral reasoning. Other important structures contributing to moral behaviour include the subcortical nuclei such as the amygdala, hippocampus and basal ganglia. Brain areas participating in moral processing can be influenced also by genetic, endocrine and environmental factors. Hormones can modulate moral behaviour through their effects on the brain. Finally, genetic polymorphisms can predispose to aggressivity and violence, arguing for a genetic

Predictors of clinical outcome following lumbar disc surgery: the value of historical, physical examination, and muscle function variables.

PubMed

Hebert, Jeffrey J; Fritz, Julie M; Koppenhaver, Shane L; Thackeray, Anne; Kjaer, Per

2016-01-01

Explore the relationships between preoperative findings and clinical outcome following lumbar disc surgery, and investigate the prognostic value of physical examination findings after accounting for information acquired from the clinical history. We recruited 55 adult patients scheduled for first time, single-level lumbar discectomy. Participants underwent a standardized preoperative evaluation including real-time ultrasound imaging assessment of lumbar multifidus function, and an 8-week postoperative rehabilitation programme. Clinical outcome was defined by change in disability, and leg and low back pain (LBP) intensity at 10 weeks. Linear regression models were used to identify univariate and multivariate predictors of outcome. Univariate predictors of better outcome varied depending on the outcome measure. Clinical history predictors included a greater proportion of leg pain to LBP, pain medication use, greater time to surgery, and no history of previous physical or injection therapy. Physical examination predictors were a positive straight or cross straight leg raise test, diminished lower extremity strength, sensation or reflexes, and the presence of postural abnormality or pain peripheralization. Preoperative pain peripheralization remained a significant predictor of improved disability (p = 0.04) and LBP (p = 0.02) after accounting for information from the clinical history. Preoperative lumbar multifidus function was not associated with clinical outcome. Information gleaned from the clinical history and physical examination helps to identify patients more likely to succeed with lumbar disc surgery. While this study helps to inform clinical practice, additional research confirming these results is required prior to confident clinical implementation.

CLINICAL AND MORPHOLOGICAL CHARACTERISTICS OF THE CHRONIC GASTRITIS WITH FUNCTIONAL DYSPEPSIA IN THE REPUBLIC OF SAKHA (YAKUTIA).

PubMed

Avvakumova, N V; Chibyeva, L G; Vasiliev, N N

2015-01-01

Chronic gastritis with syndrome, functional dyspepsia (SFD) is one of the most pressing problems in medicine. Certain scientific and practical interest is the elucidation of the frequency and clinical manifestations of functional dyspepsia in patients hospitalized in the gastroenterology department YAGKB and frequency combinations of chronic gastritis (including H. pylori) with functional dyspepsia. The aim of the study was to investigate the clinical and morphological features of the chronic gastritis with syndrome pattern of functional dyspepsia in native-born and people of the Republic of Sakha (Yakutia), and to assess the effectiveness of treatment, depending on the gastric acid and H. pylori. This study examined 105 patients with functional dyspepsia, including 41 patients with epigastric pain syndrome and 64 patients with postprandial distress syndrome. Considered groups of patients were homogeneous for age, gender, by ethnicity. Of the 105 patients included in the study, I group were 57 indigenous people (80% of them--Yakutia), 11 group--48 people visiting (Caucasians). Clinical presentation and course of chronic gastritis with functional dyspepsia in the Republic of Sakha (Yakutia) have a number of distinctive features: epigastric pain syndrome occurs in 26.8% of patients and 73.2% of the indigenous population of the visitor, the intensity of pain in the root is much lower than that of visitors--12 and 85% respectively. Postprandial distress syndrome was diagnosed in 71.9% of patients and 28.1% of the indigenous newcomers. At endoscopy in all patients with functional dyspepsia diagnosed chronic gastritis. The native inhabitants of the most common mixed gastritis (54.5%), the newcomers--superficial gastritis (66.7%). The found features of a current of functional dyspepsia can be further the basis for the individualized and differentiated approaches to treatment of this disease.

A complete investigation of monocular and binocular functions in clinically treated amblyopia.

PubMed

Zhao, Wuxiao; Jia, Wu-Li; Chen, Ge; Luo, Yan; Lin, Borong; He, Qing; Lu, Zhong-Lin; Li, Min; Huang, Chang-Bing

2017-09-06

The gold standard of a successful amblyopia treatment is full recovery of visual acuity (VA) in the amblyopic eye, but there has been no systematic study on both monocular and binocular visual functions. In this research, we aimed to quantify visual qualities with a variety of perceptual tasks in subjects with treated amblyopia. We found near stereoacuity and pAE dominance in binocular rivalry in "treated" amblyopia were largely comparable to those of normal subjects. CSF of the pAE remained deficient in high spatial frequencies. The binocular contrast summation ratio is significantly lower than normal standard. The interocular balance point is 34%, indicating that contrast in pAE is much less effective as the same contrast in pFE in binocular phase combination. Although VA, stereoacuity and binocular rivalry at low spatial frequency in treated amblyopes were normal or nearly normal, the pAE remained "lazy" in high frequency domain, binocular contrast summation, and interocular phase combination. Our results suggest that structured monocular and binocular training are necessary to fully recover deficient functions in amblyopia.

Results from a prospective acute inpatient rehabilitation database: clinical characteristics and functional outcomes using the Functional Independence Measure.

PubMed

Ng, Yee Sien; Jung, Heeyoune; Tay, San San; Bok, Chek Wai; Chiong, Yi; Lim, Peter A C

2007-01-01

Rehabilitation improves functional outcomes, but there is little data on the profiles and outcomes of patients undergoing inpatient rehabilitation in Singapore. The aims of this paper were to document the clinical characteristics and functional outcomes, using the Functional Independence Measure (FIM), of all patients admitted to an inpatient rehabilitation unit in a tertiary teaching hospital, and to identify and analyse factors significantly associated with better discharge functional scores and higher functional gains. In this prospective cohort study over a 4-year period, clinical and functional data for 1502 patients admitted consecutively to the Singapore General Hospital inpatient rehabilitation unit were charted into a custom-designed rehabilitation database. The primary outcome measures were the discharge total FIM scores, FIM gain and FIM efficiency. Multiple linear regression analysis was used to identify independent variables associated with better discharge FIM scores and FIM gain. The mean age was 61.3 +/- 15.0 years and 57.2% of the patients were male. Stroke (57.9%) followed by spinal cord injury (9.7%) were the most common diagnoses. The average rehabilitation length of stay was 21.5 +/- 19.0 days. The mean admission total FIM score was 70.3 +/- 23.2 and the mean discharge total FIM score was 87.3 +/- 23.0, with this gain being highly significant (P <0.001). The mean FIM gain was 17.0 +/- 13.4 and FIM efficiency was 0.95 +/- 0.90 points/day. Factors associated with better functional outcomes were higher admission motor and cognitive FIM scores, male gender, a longer rehabilitation length of stay and the use of acupuncture. Factors associated with poorer functional outcomes were older age, clinical deconditioning, ischaemic heart disease, depression, pressure sores and the presence of a domestic worker as a caregiver. The FIM is an easy-to-use, standardised and robust general measure of functional disability. Multiple demographic, clinical and socio

Survey of clinical infant lung function testing practices.

PubMed

Peterson-Carmichael, Stacey L; Rosenfeld, Margaret; Ascher, Simon B; Hornik, Christoph P; Arets, H G M; Davis, Stephanie D; Hall, Graham L

2014-02-01

Data supporting the clinical use of infant lung function (ILF) tests are limited making the interpretation of clinical ILF measures difficult. To evaluate current ILF testing practices and to survey users regarding the indications, limitations and perceived clinical benefits of ILF testing. We created a 26-item survey hosted on the European Respiratory Society (ERS) website between January and May 2010. Notifications were sent to members of the ERS, American Thoracic Society and the Asian Pacific Society of Respirology. Responses were sought from ILF laboratory directors and pediatric respirologists. The survey assessed the clinical indications, patient populations, equipment and reference data used, and perceived limitations of ILF testing. We received 148 responses with 98 respondents having ILF equipment and performing testing in a clinical capacity. Centers in North America were less likely to perform ≥50 studies/year than centers in Europe or other continents (13% vs. 41%). Most respondents used ILF data to either "start a new therapy" (78%) or "help decide about initiation of further diagnostic workup such as bronchoscopy, chest CT or serological testing" (69%). Factors reported as limiting clinical ILF testing were need for sedation, uncertainty regarding clinical impact of study results and time intensive nature of the study. Clinical practices associated with ILF testing vary significantly; centers that perform more studies are more likely to use the results for clinical purposes and decision making. The future of ILF testing is uncertain in the face of the limitations perceived by the survey respondents. © 2013 Wiley Periodicals, Inc.

Predicting cognitive function from clinical measures of physical function and health status in older adults.

PubMed

Bolandzadeh, Niousha; Kording, Konrad; Salowitz, Nicole; Davis, Jennifer C; Hsu, Liang; Chan, Alison; Sharma, Devika; Blohm, Gunnar; Liu-Ambrose, Teresa

2015-01-01

Current research suggests that the neuropathology of dementia-including brain changes leading to memory impairment and cognitive decline-is evident years before the onset of this disease. Older adults with cognitive decline have reduced functional independence and quality of life, and are at greater risk for developing dementia. Therefore, identifying biomarkers that can be easily assessed within the clinical setting and predict cognitive decline is important. Early recognition of cognitive decline could promote timely implementation of preventive strategies. We included 89 community-dwelling adults aged 70 years and older in our study, and collected 32 measures of physical function, health status and cognitive function at baseline. We utilized an L1-L2 regularized regression model (elastic net) to identify which of the 32 baseline measures were strongly predictive of cognitive function after one year. We built three linear regression models: 1) based on baseline cognitive function, 2) based on variables consistently selected in every cross-validation loop, and 3) a full model based on all the 32 variables. Each of these models was carefully tested with nested cross-validation. Our model with the six variables consistently selected in every cross-validation loop had a mean squared prediction error of 7.47. This number was smaller than that of the full model (115.33) and the model with baseline cognitive function (7.98). Our model explained 47% of the variance in cognitive function after one year. We built a parsimonious model based on a selected set of six physical function and health status measures strongly predictive of cognitive function after one year. In addition to reducing the complexity of the model without changing the model significantly, our model with the top variables improved the mean prediction error and R-squared. These six physical function and health status measures can be easily implemented in a clinical setting.

Current status of registry of vaccine clinical trials conducted by Korean investigators in ClinicalTrials.gov, database of US National Institutes of Health.

PubMed

Cho, Jahyang; Kim, Bo Bae; Bae, Chong-Woo; Cha, Sung-Ho

2013-01-01

PubMed is not only includes international medical journals but also has a registration site for the ongoing clinical trials, such as ClinicalTrials.gov, under the supervision of US National Institutes of Health. We analyzed current status of vaccine clinical trials conducted by Korean investigators in database of ClinicalTrial.gov. As of October 2012, there are total of 72 trials found on registry of vaccine clinical trials conducted by Korean investigators in database of ClinicalTrial.gov. These trials were analyzed and classified by conditions of vaccine clinical trials, biologicals or drugs used in vaccine clinical trials, status of proceeding research, and list of sponsor and collaborators. Total 72 trials of vaccine clinical trials conducted by Korean investigators are classified by groups of infection (64 trials), cancer (4 trials), and others (4 trials). Infections group shown are as follows: poliomyelitis, pertussis, diphtheria, tetanus, and Haemophilus influenzae type b (10), influenza (9), human papillomavirus infection (8), pneumococcal vaccine (6), herpes zoster (4), smallpox (4), hepatitis B (4), etc. One trial of each in lung cancer, breast cancer, prostate cancer, and colorectal cancer are shown in cancer group. One trial of each in Crohn's disease, ulcerative colitis, renal failure, and rheumatoid arthritis are shown in other group. Vaccine clinical trials conducted by Korean investigators in ClinicalTrial.gov reflects the current status of Korean research on vaccine clinical trials at the international level and can indicate research progress. It is hoped that this aids the development of future vaccine clinical trials in Korea.

Self-care and quality of life of heart failure patients at a multidisciplinary heart function clinic.

PubMed

Seto, Emily; Leonard, Kevin J; Cafazzo, Joseph A; Masino, Caterina; Barnsley, Jan; Ross, Heather J

2011-01-01

Multidisciplinary heart function clinics aim to improve self-care through patient education and to provide clinical management. The objectives of the present study were to investigate the self-care and quality of life of patients attending a multidisciplinary heart function clinic and to explore the relationship between self-care and quality of life. One hundred outpatients attending a multidisciplinary heart function clinic were asked to complete a questionnaire. The questionnaire included the Self-care of Heart Failure Index (SCHFI) and the Minnesota Living With Heart Failure Questionnaire, which were used to assess self-care behavior and quality of life, respectively. Self-care practices and perceived barriers were also assessed through semistructured interviews with each patient. : The returned questionnaires (n = 94) were used to compute the following SCHFI maintenance, management, and confidence scores: 60.8 (SD, 19.3), 62.0 (SD, 20.7), and 55.9 (SD, 19.7), respectively. Higher SCHFI scores indicate better self-care. None of the self-care dimensions reached the self-care adequacy cut point of 70. The average score on the Minnesota Living With Heart Failure Questionnaire was 49.9 (SD, 25.4), indicating a moderate health-related quality of life. Lower ejection fraction, older age, and better quality of life were associated with better self-care. Determinants of better quality of life were older age, better functional capacity, higher self-care confidence, and fewer comorbidities. The patient interviews revealed that better quality of life is associated with higher self-care confidence and barriers to self-care caused anxiety to the patients. The self-care barriers were found to include lack of self-care education, financial constraints, lack of perceived benefit, and low self-efficacy. Patients attending a large multidisciplinary Canadian heart failure clinic do not perform adequate self-care as measured with the SCHFI and report only a moderate quality of life

21 CFR 50.52 - Clinical investigations involving greater than minimal risk but presenting the prospect of direct...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Clinical investigations involving greater than... OF HUMAN SUBJECTS Additional Safeguards for Children in Clinical Investigations § 50.52 Clinical... subjects. Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in...

Clinical and demographic characteristics and functional status of the patients with fibromyalgia syndrome

PubMed Central

Sahin, Nilay; Atik, Aziz; Dogan, Erdal

2014-01-01

OBJECTIVE: To investigate the clinical and demographic characteristics and functional status of the patients with fibromyalgia syndrome (FMS). METHODS: Ninety-four patients with the diagnosis of FMS were included in the study. All patients were evaluated with short form 36 for quality of life (SF-36), pain, depression, benign joint hypermobility syndrome (BJHS), myofacial pain syndrome (MPS), and demogrophic characteristics. End-point measurements were SF-36 for quality of life, visual analogue scale, Beck Depression Index, anamnesis, and physical examination. RESULTS: The majority of the patients were women who were suffering from generalised pain with a median age of 40.4. Mostly depression and sleep disorders were accompanying the syndrome. Physical examination revealed MPS and BJHS in most of the patients. CONCLUSION: BJHS and MPS must also be investigated in patients with the diagnosis of FMS. PMID:28058309

Clinical Manifestations among Children with Chronic Functional Constipation

PubMed Central

Dehghani, Seyed Mohsen; Kulouee, Niloofar; Honar, Naser; Imanieh, Mohammad-Hadi; Haghighat, Mahmood; Javaherizadeh, Hazhir

2015-01-01

BACKGROUND Constipation is one of the most frequent cause of patient visits to pediatric gastroenterology clinics. Early diagnosis and treatment is important. There are few studies about clinical manifestations of constipation in children. We aimed to find the relative frequency of gastrointestinal manifestations of constipation among constipated children. METHODS This cross-sectional study was carried out on children aged < 18 years old with chronic functional constipation referred to Imam Reza Clinic of Shiraz University of Medical Sciences. Children with organic causes of chronic constipation were excluded from study. Rome III criteria were used for defining constipation. The duration of study was 1 year starting from September 2010. Abdominal pain, fecal mass, rectal bleeding, anorexia, fecal soiling, retentive posture, withholding behavior, anal fissure, and peri-anal erythema were recorded for each case based on history and physical examination. Data were analyzed using SPSS software, version 13.0 (Chicago, IL, USA). RESULTS Of 222 children with functional constipation, 124(55.9%) were girls and 98 (44.1%) were boys with a mean ± SD age of 5±3.12 years. The mean ± SD duration of constipation was 2.2±1.9 years. Large and hard stool was present in 93.7% of the patients. Painful defecation and withholding behavior were seen in 92.3% and 91.9% of the patients, respectively. Fecal impaction was more frequent among boys compared with girls (p<0.01). Fecal soiling was present in 40.8% of the boys and 28.2% of the girls (p=0.04). CONCLUSION Large and hard stool, painful defecation and withholding behavior were the most frequent signs or symptoms among children with chronic functional constipation. Fresh rectal bleeding and anal fissure were the least frequent signs and symptoms in this group. PMID:25628851

Clinical Manifestations among Children with Chronic Functional Constipation.

PubMed

Dehghani, Seyed Mohsen; Kulouee, Niloofar; Honar, Naser; Imanieh, Mohammad-Hadi; Haghighat, Mahmood; Javaherizadeh, Hazhir

2015-01-01

BACKGROUND Constipation is one of the most frequent cause of patient visits to pediatric gastroenterology clinics. Early diagnosis and treatment is important. There are few studies about clinical manifestations of constipation in children. We aimed to find the relative frequency of gastrointestinal manifestations of constipation among constipated children. METHODS This cross-sectional study was carried out on children aged < 18 years old with chronic functional constipation referred to Imam Reza Clinic of Shiraz University of Medical Sciences. Children with organic causes of chronic constipation were excluded from study. Rome III criteria were used for defining constipation. The duration of study was 1 year starting from September 2010. Abdominal pain, fecal mass, rectal bleeding, anorexia, fecal soiling, retentive posture, withholding behavior, anal fissure, and peri-anal erythema were recorded for each case based on history and physical examination. Data were analyzed using SPSS software, version 13.0 (Chicago, IL, USA). RESULTS Of 222 children with functional constipation, 124(55.9%) were girls and 98 (44.1%) were boys with a mean ± SD age of 5±3.12 years. The mean ± SD duration of constipation was 2.2±1.9 years. Large and hard stool was present in 93.7% of the patients. Painful defecation and withholding behavior were seen in 92.3% and 91.9% of the patients, respectively. Fecal impaction was more frequent among boys compared with girls (p<0.01). Fecal soiling was present in 40.8% of the boys and 28.2% of the girls (p=0.04). CONCLUSION Large and hard stool, painful defecation and withholding behavior were the most frequent signs or symptoms among children with chronic functional constipation. Fresh rectal bleeding and anal fissure were the least frequent signs and symptoms in this group.

Current status of functional gastrointestinal evaluation in clinical practice

PubMed Central

Ang, Daphne; Fock, Kwong Ming; Law, Ngai Moh; Ang, Tiing Leong

2015-01-01

Neurogastroenterology and motility disorders of the gastrointestinal (GI) tract encompass a broad spectrum of diseases involving the GI tract and central nervous system. They have varied pathophysiology, clinical presentation and management, and make up a substantial proportion of outpatient clinic visits. Typically, patients experience persistent symptoms referable to the GI tract despite normal endoscopic and radiologic findings. An appropriate evaluation is thus important in the patient’s care. Advances in technology and understanding of the disease pathophysiology have provided better insight into the physiological basis of disease and a more rational approach to patient management. While technological advances serve to explain patients’ persistent symptoms, they should be balanced against the costs of diagnostic tests. This review highlights the GI investigative modalities employed to evaluate patients with persistent GI symptoms in the absence of a structural lesion, with particular emphasis on investigative modalities available locally and the clinical impact of such tools. PMID:25715853

The association of calcaneal spur length and clinical and functional parameters in plantar fasciitis.

PubMed

Kuyucu, Ersin; Koçyiğit, Figen; Erdil, Mehmet

2015-09-01

Plantar fasciitis (PF)is the most common cause of plantar heel pain. Despite many treatment alternatives for heel spur, the association of calcaneal spur size with clinical and functional parameters is inconclusive. The objective of this study to investigate the correlation of calcaneal spur length with clinical findings and functional status documented with Foot Function Index in patients with plantar fasciitis. We performed power analysis for the sample size estimation. 87 patients with PF were scrutinized to reach the estimated patient number 75. Computer-aided linear measurements were done for spur length from tip to base in milimeters. Perceived pain intensity was evaluated by visual analog scale (VAS). Patients were asked to rate the pain experienced on a 10-cm VAS. Foot function index was applied to the patients to evaluate pain, disability and activity limitation of the patients. Of the 75 participants, 24 were males (32%) and 51 were females (68%). The mean age was 47 ± 10 years (range 30-65 years). The mean calcaneal spur length was 3.86 ± 3.36 mm (range between 0 and 12.2). Calcaneal spur length was significantly correlated with age (p = 0.003), BMI (p = 0.029), symptom duration, (p = 0.001) VAS (p = 0.003), and FFI total score (p < 0.001). Our study demonstrated that length of the calcaneal spur is significantly correlated with age, BMI, symptom duration, perceived pain, FFI pain and disability subscores, and FFI total scores. The size of the calcaneal spur is an important parameter correlated with pain and functional scores in PF. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

Clinical Validation of 4-Dimensional Computed Tomography Ventilation With Pulmonary Function Test Data

DOE Office of Scientific and Technical Information (OSTI.GOV)

Brennan, Douglas; Schubert, Leah; Diot, Quentin

Purpose: A new form of functional imaging has been proposed in the form of 4-dimensional computed tomography (4DCT) ventilation. Because 4DCTs are acquired as part of routine care for lung cancer patients, calculating ventilation maps from 4DCTs provides spatial lung function information without added dosimetric or monetary cost to the patient. Before 4DCT-ventilation is implemented it needs to be clinically validated. Pulmonary function tests (PFTs) provide a clinically established way of evaluating lung function. The purpose of our work was to perform a clinical validation by comparing 4DCT-ventilation metrics with PFT data. Methods and Materials: Ninety-eight lung cancer patients withmore » pretreatment 4DCT and PFT data were included in the study. Pulmonary function test metrics used to diagnose obstructive lung disease were recorded: forced expiratory volume in 1 second (FEV1) and FEV1/forced vital capacity. Four-dimensional CT data sets and spatial registration were used to compute 4DCT-ventilation images using a density change–based and a Jacobian-based model. The ventilation maps were reduced to single metrics intended to reflect the degree of ventilation obstruction. Specifically, we computed the coefficient of variation (SD/mean), ventilation V20 (volume of lung ≤20% ventilation), and correlated the ventilation metrics with PFT data. Regression analysis was used to determine whether 4DCT ventilation data could predict for normal versus abnormal lung function using PFT thresholds. Results: Correlation coefficients comparing 4DCT-ventilation with PFT data ranged from 0.63 to 0.72, with the best agreement between FEV1 and coefficient of variation. Four-dimensional CT ventilation metrics were able to significantly delineate between clinically normal versus abnormal PFT results. Conclusions: Validation of 4DCT ventilation with clinically relevant metrics is essential. We demonstrate good global agreement between PFTs and 4DCT-ventilation, indicating

[An Investigation of the Role Responsibilities of Clinical Research Nurses in Conducting Clinical Trials].

PubMed

Kao, Chi-Yin; Huang, Guey-Shiun; Dai, Yu-Tzu; Pai, Ya-Ying; Hu, Wen-Yu

2015-06-01

Clinical research nurses (CRNs) play an important role in improving the quality of clinical trials. In Taiwan, the increasing number of clinical trials has increased the number of practicing CRNs. Understanding the role responsibilities of CRNs is necessary to promote professionalism in this nursing category. This study investigates the role responsibilities of CRNs in conducting clinical trials / research. A questionnaire survey was conducted in a medical center in Taipei City, Taiwan. Eighty CRNs that were registered to facilitate and conduct clinical trials at this research site completed the survey. "Subject protection" was the CRN role responsibility most recognized by participants, followed by "research coordination and management", "subject clinical care", and "advanced professional nursing". Higher recognition scores were associated with higher importance scores and lower difficulty scores. Participants with trial training had significantly higher difficulty scores for "subject clinical care" and "research coordination and management" than their peers without this training (p < .05). Participants who had participated in a long-term trial-training course earned higher importance scores for "CRN four-subthemes role responsibilities" (p <.05) and lower difficulty scores for "subject protection", "research coordination and management" (p <.005) than their short-term course peers. "Recognition of overall responsibilities" and "receiving trial training" were the significant predictors of difficulty in performing CRN role responsibilities, explaining 21.9% of the total variance. To further promote CRN as a professional career in Taiwan, the findings of this study recommend identifying the core competences of CRNs and adding CRN-related study materials into the advanced nursing curriculum. Long-term and systematic educational training may help CRNs understand the importance of their role responsibilities, better recognize their professional role, and reflect these

Social Cognition in Psychosis: Multidimensional Structure, Clinical Correlates, and Relationship With Functional Outcome

PubMed Central

Mancuso, Francesco; Horan, William P.; Kern, Robert S.; Green, Michael F.

2010-01-01

Social cognitive impairments are common, detectable across a wide range of tasks, and appear to play a key role in explaining poor outcome in schizophrenia and related psychotic disorders. However, little is known about the underlying factor structure of social cognition in people with psychotic disorders due to a lack of exploratory factor analyses using a relatively comprehensive social cognitive assessment battery. In a sample of 85 outpatients with psychosis, we examined the factor structure and clinical/functional correlates of eight indexes derived from five social cognition tasks that span the domains of emotional processing, social perception, attributional style, and Theory of Mind. Exploratory factor analysis revealed three factors with relatively low inter-correlations that explained a total of 54% of the variance: (1) Hostile attributional style, (2) Lower-level social cue detection, and (3) Higher-level inferential and regulatory processes. None of the factors showed significant correlations with negative symptoms. Factor 1 significantly correlated with clinical symptoms (positive, depression-anxiety, agitation) but not functional outcome, whereas Factors 2 and 3 significantly correlated with functional outcome (functional capacity and real-world social and work functioning) but not clinical symptoms. Furthermore, Factor 2 accounted for unique incremental variance in functional capacity, above and beyond non-social neurocognition (measured with MATRICS Consensus Cognitive Battery) and negative symptoms. Results suggest that multiple separable dimensions of social cognition can be identified in psychosis, and these factors show distinct patterns of correlation with clinical features and functional outcome. PMID:21112743

Experimental Investigation on Minimum Frame Rate Requirements of High-Speed Videoendoscopy for Clinical Voice Assessment

PubMed Central

Deliyski, Dimitar D; Powell, Maria EG; Zacharias, Stephanie RC; Gerlach, Terri Treman; de Alarcon, Alessandro

2015-01-01

This study investigated the impact of high-speed videoendoscopy (HSV) frame rates on the assessment of nine clinically-relevant vocal-fold vibratory features. Fourteen adult patients with voice disorder and 14 adult normal controls were recorded using monochromatic rigid HSV at a rate of 16000 frames per second (fps) and spatial resolution of 639×639 pixels. The 16000-fps data were downsampled to 16 other rate denominations. Using paired comparisons design, nine common clinical vibratory features were visually compared between the downsampled and the original images. Three raters reported the thresholds at which: (1) a detectable difference between the two videos was first noticed, and (2) differences between the two videos would result in a change of clinical rating. Results indicated that glottal edge, mucosal wave magnitude and extent, aperiodicity, contact and loss of contact of the vocal folds were the vibratory features most sensitive to frame rate. Of these vibratory features, the glottal edge was selected for further analysis, due to its higher rating reliability, universal prevalence and consistent definition. Rates of 8000 fps were found to be free from visually-perceivable feature degradation, and for rates of 5333 fps, degradation was minimal. For rates of 4000 fps and higher, clinical assessments of glottal edge were not affected. Rates of 2000 fps changed the clinical ratings in over 16% of the samples, which could lead to inaccurate functional assessment. PMID:28989342

Longitudinal investigation of the relationship between family history of psychosis and affective disorders and Child Behavior Checklist ratings in clinical high-risk adolescents.

PubMed

Simeonova, Diana I; Lee, Frances J; Walker, Elaine F

2015-08-01

This is the first study to investigate whether positive family history (FH) of psychosis and affective disorders moderates the relationship between child diagnostic status and parent-reported social and behavioral problems on the Child Behavior Checklist (CBCL) in clinical high-risk adolescents. This longitudinal investigation assessed 122 participants (mean age=14.25±1.8years) from three groups (at-risk, other personality disorders, non-psychiatric controls) at baseline and one year follow-up. As predicted, there was a main effect of FH for a number of CBCL scales indicating higher scores for adolescents with positive FH. The findings also demonstrate a significant Diagnostic Status×Family History interaction for several behavioral scales providing support for FH as a concurrent and longitudinal moderator of the relationship between diagnostic status and CBCL scales. The moderating effect is present for areas of functioning associated with depression, anxiety, social adjustment, thought problems, attention problems, and aggressive behavior. The findings also indicate that both positive and negative symptoms are related to the genetic vulnerability for developing psychosis in clinical high-risk individuals, particularly those symptoms reflective of emotional, attentional, and interpersonal functioning. The present findings are novel and have significant clinical and research implications. This investigation provides a platform for future studies to clarify further the role of FH in clinical high-risk individuals and contributes to integration of this knowledge in the development of early intervention and prevention approaches in at-risk populations for the emergence of severe mental illness. Copyright © 2015 Elsevier B.V. All rights reserved.

Psychosocial student functioning in comprehensive dental clinic education: A qualitative study.

PubMed

Moore, R

2018-02-17

The aims were to describe first-year clinical dental students' psychosocial experiences in a known well-functioning comprehensive clinic teaching group (F+Grp) and a known dysfunctional group (Dys-Grp) and, thus, discover and describe phenomena related to psychosocial functioning of students. These groups were compared and contrasted regarding negative stress symptoms, perfectionism and coping with stress. Eight female dental students (mean 26 years old), four in each group, were interviewed after the first clinical year about learning and emotional experiences. The students also rated their perceived stress using a 0-10 scale, where 0 is no stress, and 10 is highest stress. Qualitative analyses involved searching for recurring themes and discovery of categories of clinical and social functioning. All 8 students were revisited as dentists after 8 years and filled out a 15-item survey as longitudinal validation of their first-year clinical experiences and to estimate group consensus and informant accuracy. Both groups suffered from negative stress symptoms attributed to lack of time for clinical tasks, worries about work quality with confusion about their own expectations and worries about how others perceived them. Dys-Grp experienced higher negative stress and maladaptive perfectionism and described crying behaviours, withdrawal and unwillingness to cooperate with others. In contrast, students in F+Grp provided rich content about mutual cooperation related to social networking and positive support. The 8 subjects exhibited high internal consistency (α  =  .98) in their responses to the follow-up survey about their first year of clinic. The comprehensive care teaching clinic environment with students working in groups appeared to provide a possibility for students to support each other for improved stress coping. Unfortunately, the opposite also occurred. Positive, supportive teacher supervision of student challenges related to perfectionism and stress is

Vision Therapy in Adults with Convergence Insufficiency: Clinical and Functional Magnetic Resonance Imaging Measures

PubMed Central

Alvarez, Tara L.; Vicci, Vincent R.; Alkan, Yelda; Kim, Eun H.; Gohel, Suril; Barrett, Anna M.; Chiaravalloti, Nancy; Biswal, Bharat B.

2011-01-01

Purpose This research quantified clinical measurements and functional neural changes associated with vision therapy in subjects with convergence insufficiency (CI). Methods Convergence and divergence 4° step responses were compared between 13 control adult subjects with normal binocular vision and four CI adult subjects. All CI subjects participated in 18 h of vision therapy. Clinical parameters quantified throughout the therapy included: nearpoint of convergence, recovery point of convergence, positive fusional vergence at near, near dissociated phoria, and eye movements that were quantified using peak velocity. Neural correlates of the CI subjects were quantified with functional magnetic resonance imaging scans comparing random vs. predictable vergence movements using a block design before and after vision therapy. Images were quantified by measuring the spatial extent of activation and the average correlation within five regions of interests (ROI). The ROIs were the dorsolateral prefrontal cortex, a portion of the frontal lobe, part of the parietal lobe, the cerebellum, and the brain stem. All measurements were repeated 4 months to 1 year post-therapy in three of the CI subjects. Results Convergence average peak velocities to step stimuli were significantly slower (p = 0.016) in CI subjects compared with controls; however, significant differences in average peak velocities were not observed for divergence step responses (p = 0.30). The investigation of CI subjects participating in vision therapy showed that the nearpoint of convergence, recovery point of convergence, and near dissociated phoria significantly decreased. Furthermore, the positive fusional vergence, average peak velocity from 4° convergence steps, and the amount of functional activity within the frontal areas, cerebellum, and brain stem significantly increased. Several clinical and cortical parameters were significantly correlated. Conclusions Convergence peak velocity was significantly slower in

Physiological and biochemical basis of clinical liver function tests: a review.

PubMed

Hoekstra, Lisette T; de Graaf, Wilmar; Nibourg, Geert A A; Heger, Michal; Bennink, Roelof J; Stieger, Bruno; van Gulik, Thomas M

2013-01-01

To review the literature on the most clinically relevant and novel liver function tests used for the assessment of hepatic function before liver surgery. Postoperative liver failure is the major cause of mortality and morbidity after partial liver resection and develops as a result of insufficient remnant liver function. Therefore, accurate preoperative assessment of the future remnant liver function is mandatory in the selection of candidates for safe partial liver resection. A MEDLINE search was performed using the key words "liver function tests," "functional studies in the liver," "compromised liver," "physiological basis," and "mechanistic background," with and without Boolean operators. Passive liver function tests, including biochemical parameters and clinical grading systems, are not accurate enough in predicting outcome after liver surgery. Dynamic quantitative liver function tests, such as the indocyanine green test and galactose elimination capacity, are more accurate as they measure the elimination process of a substance that is cleared and/or metabolized almost exclusively by the liver. However, these tests only measure global liver function. Nuclear imaging techniques ((99m)Tc-galactosyl serum albumin scintigraphy and (99m)Tc-mebrofenin hepatobiliary scintigraphy) can measure both total and future remnant liver function and potentially identify patients at risk for postresectional liver failure. Because of the complexity of liver function, one single test does not represent overall liver function. In addition to computed tomography volumetry, quantitative liver function tests should be used to determine whether a safe resection can be performed. Presently, (99m)Tc-mebrofenin hepatobiliary scintigraphy seems to be the most valuable quantitative liver function test, as it can measure multiple aspects of liver function in, specifically, the future remnant liver.

Analysis of protein function in clinical C. albicans isolates

PubMed Central

Gerami-Nejad, Maryam; Forche, Anja; McClellan, Mark; Berman, Judith

2012-01-01

Clinical isolates are prototrophic and hence are not amenable to genetic manipulation using nutritional markers. Here we describe a new set of plasmids carrying the NAT1 (nourseothricin) drug resistance marker (Shen et al., 2005) that can be used both in clinical isolates and in laboratory strains. We constructed novel plasmids containing HA-NAT1 or MYC-NAT1 cassettes to facilitate PCR-mediated construction of strains with C-terminal epitope-tagged proteins and a NAT1-pMet3-GFP plasmid to enable conditional expression of proteins with or without the green fluorescent protein fused at the N-terminus. Furthermore, for proteins that require both the endogenous N- and C-termini for function, we have constructed a GF-NAT1-FP cassette carrying truncated alleles that facilitate insertion of an intact, single copy of GFP internal to the coding sequence. In addition, GFP-NAT1, RFP-NAT1, and M-Cherry-NAT1 plasmids were constructed expressing two differently labeled gene products for the study of protein co-expression and co-localization in vivo. Together, these vectors provide a useful set of genetic tools for studying diverse aspects of gene function in C. albicans clinical as well as laboratory strains. PMID:22777821

Clinical assessment of social cognitive function in neurological disorders.

PubMed

Henry, Julie D; von Hippel, William; Molenberghs, Pascal; Lee, Teresa; Sachdev, Perminder S

2016-01-01

Social cognition broadly refers to the processing of social information in the brain that underlies abilities such as the detection of others' emotions and responding appropriately to these emotions. Social cognitive skills are critical for successful communication and, consequently, mental health and wellbeing. Disturbances of social cognition are early and salient features of many neuropsychiatric, neurodevelopmental and neurodegenerative disorders, and often occur after acute brain injury. Its assessment in the clinic is, therefore, of paramount importance. Indeed, the most recent edition of the American Psychiatric Association's Diagnostic and Statistical Manual for Mental Disorders (DSM-5) introduced social cognition as one of six core components of neurocognitive function, alongside memory and executive control. Failures of social cognition most often present as poor theory of mind, reduced affective empathy, impaired social perception or abnormal social behaviour. Standard neuropsychological assessments lack the precision and sensitivity needed to adequately inform treatment of these failures. In this Review, we present appropriate methods of assessment for each of the four domains, using an example disorder to illustrate the value of these approaches. We discuss the clinical applications of testing for social cognitive function, and finally suggest a five-step algorithm for the evaluation and treatment of impairments, providing quantitative evidence to guide the selection of social cognitive measures in clinical practice.

76 FR 70151 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption Clinical...

Clinical role and biological function of CDK5 in hepatocellular carcinoma: A study based on immunohistochemistry, RNA-seq and in vitro investigation.

PubMed

Zhang, Rui; Lin, Peng; Yang, Hong; He, Yun; Dang, Yi-Wu; Feng, Zhen-Bo; Chen, Gang

2017-12-12

To investigate the clinical role and biological function of cyclin-dependent kinase 5 (CDK5) in hepatocellular carcinoma (HCC), 412 surgically resected tissue samples (HCC, n=171; non-HCC=241) were obtained and analyzed with immunohistochemistry. The diagnostic and prognostic values of CDK5 expression levels in HCC were clarified. Moreover, RNA-seq data or microarray datasets from The Cancer Genome Atlas (TCGA) (HCC, n=374; normal, n=50) or other public databases (HCC, n=1864; non-tumor=1995) regarding CDK5 in HCC were extracted and examined. Several bioinformatic methods were performed to identify CDK5-regulated pathways. In vitro experiments were adopted to measure proliferation and apoptosis in HCC cells after CDK5 mRNA was inhibited in the HCC cell lines HepG2 and HepB3. Based on immunohistochemistry, CDK5 expression levels were notably increased in HCC tissues (n=171) compared with normal (n=33, P <0.001), cirrhosis (n=37, P <0.001), and adjacent non-cancerous liver (n=171, P <0.001) tissues. The up-regulation of CDK5 was associated with higher differentiation ( P <0.001), metastasis ( P <0.001), advanced clinical TNM stages ( P <0.001), portal vein tumor embolus ( P =0.003) and vascular invasion ( P =0.004). Additionally, TCGA data analysis also revealed significantly increased CDK5 expression in HCC compared with non-cancerous hepatic tissues ( P <0.001). The pooled standard mean deviation (SMD) based on 36 included datasets (HCC, n=2238; non-cancerous, n=2045) indicated that CDK5 was up-regulated in HCC (SMD=1.23, 95% CI: 1.00-1.45, P <0.001). The area under the curve (AUC) of the summary receiver operating characteristic (SROC) curve was 0.88. Furthermore, CDK5 knock-down inhibited proliferation and promoted apoptosis. In conclusion, CDK5 plays an essential role in the initiation and progression of HCC, most likely via accelerating proliferation and suppressing apoptosis in HCC cells by regulating the cell cycle and DNA replication pathways.

Incremental peritoneal dialysis: Clinical outcomes and residual kidney function preservation.

PubMed

Borràs Sans, Mercè; Chacón Camacho, Andrea; Cerdá Vilaplana, Carla; Usón Nuño, Ana; Fernández, Elvira

2016-01-01

Initiation of peritoneal dialysis (PD) with 3 exchanges has become common practice in recent years, despite the lack of published clinical data. To describe experience with incremental peritoneal dialysis (IPD) at a single site. A total of 46 IPD patients undergoing 2-year clinical, laboratory, treatment and progression follow-up. To 25% of patients were trasplanted on IPD. Mean time on IPD before transfer to conventional PD of 24 months, half of the patients because of fluid balance. Good clinical and biochemical results with a peritonitis rate of one episode per 99 months. There was an improvement in the loss of residual kidney function compared to the pre-dialysis period (-7.06 vs. -1.58ml/min/year; P=.0001). IPD with 3 peritoneal exchanges offers good results. Most patients remain stable during the first 2 years and there is an improvement in the loss of residual kidney function compared to the pre-dialysis period. Copyright © 2016 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. All rights reserved.

The effect on physical performance of a functional assessment and immediate rehabilitation of acutely admitted elderly patients with reduced functional performance: the design of a randomised clinical trial

PubMed Central

Bruun, Inge Hansen; Nørgaard, Birgitte; Maribo, Thomas; Schiøttz-Christensen, Berit; Mogensen, Christian Backer

2014-01-01

Introduction Illness and hospitalisation, even of short duration, pose separate risks for permanently reduced functional performance in elderly medical patients. Functional assessment in the acute pathway will ensure early detection of declining performance and form the basis for mobilisation during hospitalisation and subsequent rehabilitation. For optimal results rehabilitation should begin immediately after discharge.The aim of this study is to investigate the effect of a systematic functional assessment in the emergency department (ED) of elderly medical patients with reduced functional performance when combined with immediate postdischarge rehabilitation. Method and analysis The study is a two-way factorial randomised clinical trial. Participants will be recruited among patients admitted to the ED who are above 65 years of age with reduced functional performance. Patients will be randomly assigned to one of four groups: (1) functional assessment and immediate rehabilitation; (2) functional assessment and rehabilitation as usual; (3) assessment as usual and immediate rehabilitation; (4) assessment and rehabilitation as usual. Primary outcome 30 s chair-stand test administered at admission and 3 weeks after discharge. Ethics and dissemination The study has been approved by the Regional Scientific Ethical Committees of Southern Denmark in February 2014. The study findings will be published in peer-reviewed journals and presented at national and international conferences. Trial registration number: ClinicalTrials.gov Identifier: NCT02062541. PMID:24939812

Sporadic Inclusion Body Myositis: MRI Findings and Correlation With Clinical and Functional Parameters.

PubMed

Guimaraes, Julio Brandao; Zanoteli, Edmar; Link, Thomas M; de Camargo, Leonardo V; Facchetti, Luca; Nardo, Lorenzo; Fernandes, Artur da Rocha Correa

2017-12-01

The purpose of this prospective study is to assess MRI findings in patients with sporadic inclusion body myositis (IBM) and correlate them with clinical and functional parameters. This study included 12 patients with biopsy-proven sporadic IBM. All patients underwent MRI of the bilateral upper and lower extremities. The images were scored for muscle atrophy, fatty infiltration, and edema pattern. Clinical data included onset and duration of disease. Muscle strength was measured using the Medical Research Council (MRC) scale, and functional status was assessed using the Modified Rankin Scale. Correlation between MRI and different clinical and functional parameters was calculated using the Spearman rank test and Pearson correlation. All patients showed MRI abnormalities, which were more severe within the lower limbs and the distal segments. The most prevalent MRI finding was fat infiltration. There was a statistically significant correlation between disease duration and number of muscles infiltrated by fat (r = 0.65; p = 0.04). The number of muscles with fat infiltration correlated with the sum of the scores of MRC (r = -0.60; p = 0.04) and with the Modified Rankin Scale (r = 0.48; p = 0.03). Our findings suggest that most patients with biopsy-proven sporadic IBM present with a typical pattern of muscle involvement at MRI, more extensively in the lower extremities. Moreover, MRI findings strongly correlated with clinical and functional parameters, because both the extent and severity of muscle involvement assessed by MRI and clinical and functional parameters are associated with the early onset of the disease and its duration.

Clinical significance of knowledge about the structure, function, and impairments of working memory

PubMed Central

Brodziak, Andrzej; Brewczyński, Adam; Bajor, Grzegorz

2013-01-01

A review of contemporary research on the working memory system (WMS) is important, both due to the need to focus the discussion on further necessary investigations on the structure and function of this key part of the human brain, as well as to share this knowledge with clinicians. In our introduction we try to clarify the actual terminology and provide an intuitively understandable model for 3 basic cognitive operations: perception, recognition, imagery, and manipulation of recalled mental images. We emphasize the importance of knowledge of the structure and function of the WMS for the possibility to demonstrate the links between genetic polymorphisms and the prevalence to some mental disorders. We also review current knowledge of working memory dysfunction in the most common diseases and specific clinical situations such as maturation and aging. Finally, we briefly discuss methods for assessment of WMS capacity. This article establishes a kind of compendium of knowledge for clinicians who are not familiar with the structure and operation of the WMS. PMID:23645218

Development of FuGO: An Ontology for Functional Genomics Investigations

PubMed Central

Whetzel, Patricia L.; Brinkman, Ryan R.; Causton, Helen C.; Fan, Liju; Field, Dawn; Fostel, Jennifer; Fragoso, Gilberto; Gray, Tanya; Heiskanen, Mervi; Hernandez-Boussard, Tina; Morrison, Norman; Parkinson, Helen; Rocca-Serra, Philippe; Sansone, Susanna-Assunta; Schober, Daniel; Smith, Barry; Stevens, Robert; Stoeckert, Christian J.; Taylor, Chris; White, Joe; Wood, Andrew

2009-01-01

The development of the Functional Genomics Investigation Ontology (FuGO) is a collaborative, international effort that will provide a resource for annotating functional genomics investigations, including the study design, protocols and instrumentation used, the data generated and the types of analysis performed on the data. FuGO will contain both terms that are universal to all functional genomics investigations and those that are domain specific. In this way, the ontology will serve as the “semantic glue” to provide a common understanding of data from across these disparate data sources. In addition, FuGO will reference out to existing mature ontologies to avoid the need to duplicate these resources, and will do so in such a way as to enable their ease of use in annotation. This project is in the early stages of development; the paper will describe efforts to initiate the project, the scope and organization of the project, the work accomplished to date, and the challenges encountered, as well as future plans. PMID:16901226

Motor programme activating therapy influences adaptive brain functions in multiple sclerosis: clinical and MRI study.

PubMed

Rasova, Kamila; Prochazkova, Marie; Tintera, Jaroslav; Ibrahim, Ibrahim; Zimova, Denisa; Stetkarova, Ivana

2015-03-01

There is still little scientific evidence for the efficacy of neurofacilitation approaches and their possible influence on brain plasticity and adaptability. In this study, the outcome of a new kind of neurofacilitation approach, motor programme activating therapy (MPAT), was evaluated on the basis of a set of clinical functions and with MRI. Eighteen patients were examined four times with standardized clinical tests and diffusion tensor imaging to monitor changes without therapy, immediately after therapy and 1 month after therapy. Moreover, the strength of effective connectivity was analysed before and after therapy. Patients underwent a 1-h session of MPAT twice a week for 2 months. The data were analysed by nonparametric tests of association and were subsequently statistically evaluated. The therapy led to significant improvement in clinical functions, significant increment of fractional anisotropy and significant decrement of mean diffusivity, and decrement of effective connectivity at supplementary motor areas was observed immediately after the therapy. Changes in clinical functions and diffusion tensor images persisted 1 month after completing the programme. No statistically significant changes in clinical functions and no differences in MRI-diffusion tensor images were observed without physiotherapy. Positive immediate and long-term effects of MPAT on clinical and brain functions, as well as brain microstructure, were confirmed.

Investigations of the functional states of dendritic cells under different conditioned microenvironments by Fourier transformed infrared spectroscopy.

PubMed

Dong, Rong; Long, Jinhua; Xu, Xiaoli; Zhang, Chunlin; Wen, Zongyao; Li, Long; Yao, Weijuan; Zeng, Zhu

2014-01-10

Dendritic cells are potent and specialized antigen presenting cells, which play a crucial role in initiating and amplifying both the innate and adaptive immune responses. The dendritic cell-based vaccination against cancer has been clinically achieved promising successes. But there are still many challenges in its clinical application, especially for how to identify the functional states. The CD14+ monocytes were isolated from human peripheral blood after plastic adherence and purified to approximately 98% with cocktail immunomagnetic beads. The immature dendritic cells and mature dendritic cells were induced by traditional protocols. The resulting dendritic cells were cocultured with normal cells and cancer cells. The functional state of dendritic cells including immature dendritic cells (imDCs) and mature dendritic cells (mDCs) under different conditioned microenvironments were investigated by Fourier transformed infrared spectroscopy (FTIR) and molecular biological methods. The results of Fourier transformed infrared spectroscopy showed that the gene transcription activity and energy states of dendritic cells were specifically suppressed by tumor cells (P < 0.05 or 0.01). The expression levels of NF-kappa B (NF-κB) in dendritic cells were also specifically inhibited by tumor-derived factors (P < 0.05 or 0.01). Moreover, the ratios of absorption intensities of Fourier transformed infrared spectroscopy at given wave numbers were closely correlated with the expression levels of NF-κB (R2:0.69 and R2:0.81, respectively). Our results confirmed that the ratios of absorption intensities of Fourier transformed infrared spectroscopy at given wave numbers were positively correlated with the expression levels of NF-κB, suggesting that Fourier transformed infrared spectroscopy technology could be clinically applied to identify the functional states of dendritic cell when performing dendritic cell-based vaccination. It's significant for the simplification and

Mapping causal functional contributions derived from the clinical assessment of brain damage after stroke.

PubMed

Zavaglia, Melissa; Forkert, Nils D; Cheng, Bastian; Gerloff, Christian; Thomalla, Götz; Hilgetag, Claus C

2015-01-01

Lesion analysis reveals causal contributions of brain regions to mental functions, aiding the understanding of normal brain function as well as rehabilitation of brain-damaged patients. We applied a novel lesion inference technique based on game theory, Multi-perturbation Shapley value Analysis (MSA), to a large clinical lesion dataset. We used MSA to analyze the lesion patterns of 148 acute stroke patients together with their neurological deficits, as assessed by the National Institutes of Health Stroke Scale (NIHSS). The results revealed regional functional contributions to essential behavioral and cognitive functions as reflected in the NIHSS, particularly by subcortical structures. There were also side specific differences of functional contributions between the right and left hemispheric brain regions which may reflect the dominance of the left hemispheric syndrome aphasia in the NIHSS. Comparison of MSA to established lesion inference methods demonstrated the feasibility of the approach for analyzing clinical data and indicated its capability for objectively inferring functional contributions from multiple injured, potentially interacting sites, at the cost of having to predict the outcome of unknown lesion configurations. The analysis of regional functional contributions to neurological symptoms measured by the NIHSS contributes to the interpretation of this widely used standardized stroke scale in clinical practice as well as clinical trials and provides a first approximation of a 'map of stroke'.

Mapping causal functional contributions derived from the clinical assessment of brain damage after stroke

PubMed Central

Zavaglia, Melissa; Forkert, Nils D.; Cheng, Bastian; Gerloff, Christian; Thomalla, Götz; Hilgetag, Claus C.

2015-01-01

Lesion analysis reveals causal contributions of brain regions to mental functions, aiding the understanding of normal brain function as well as rehabilitation of brain-damaged patients. We applied a novel lesion inference technique based on game theory, Multi-perturbation Shapley value Analysis (MSA), to a large clinical lesion dataset. We used MSA to analyze the lesion patterns of 148 acute stroke patients together with their neurological deficits, as assessed by the National Institutes of Health Stroke Scale (NIHSS). The results revealed regional functional contributions to essential behavioral and cognitive functions as reflected in the NIHSS, particularly by subcortical structures. There were also side specific differences of functional contributions between the right and left hemispheric brain regions which may reflect the dominance of the left hemispheric syndrome aphasia in the NIHSS. Comparison of MSA to established lesion inference methods demonstrated the feasibility of the approach for analyzing clinical data and indicated its capability for objectively inferring functional contributions from multiple injured, potentially interacting sites, at the cost of having to predict the outcome of unknown lesion configurations. The analysis of regional functional contributions to neurological symptoms measured by the NIHSS contributes to the interpretation of this widely used standardized stroke scale in clinical practice as well as clinical trials and provides a first approximation of a ‘map of stroke’. PMID:26448908

Physical function impairment in survivors of critical illness in an ICU Recovery Clinic.

PubMed

Bakhru, Rita N; Davidson, James F; Bookstaver, Rebecca E; Kenes, Michael T; Welborn, Kristin G; Morris, Peter E; Clark Files, D

2018-06-01

The aims were to 1) determine feasibility of measuring physical function in our ICU Recovery Clinic (RC), 2) determine if physical function was associated with 6-month re-hospitalization and 1-year mortality and 3) compare ICU survivors' physical function to other comorbid populations. We established the Wake Forest ICU RC. Patients were seen in clinic 1month following hospital discharge. Testing included the Short Form-36 questionnaire and Short Physical Performance Battery (SPPB). We related these measures to 6month re-hospitalizations and 1year mortality, and compared patients' functional performance with other comorbid populations. Thirty-six patients were seen in clinic from July 2014 to June 2015; the median SPPB score was 5 (IQR 5). The median SF-36 physical component summary score was 21.8 (IQR 28.8). Mortality was 14% at 1year. Of those who did not die by 1year, 35% were readmitted to our hospital within 6months of hospital discharge. SPPB scores demonstrated a non-significant trend with both mortality (p=0.06) and readmissions (p=0.09). ICU survivors' SPPB scores were significantly lower than those of other chronically ill populations (p<0.001). Physical function measurement in a recovery clinic is feasible and may inform subsequent morbidity and mortality. Copyright © 2018 Elsevier Inc. All rights reserved.

Evaluation of counseling outcomes at a university counseling center: the impact of clinically significant change on problem resolution and academic functioning.

PubMed

Choi, Keum-Hyeong; Buskey, Wendy; Johnson, Bonita

2010-07-01

The main purpose of this study was to investigate how receiving personal counseling at a university counseling center helps students deal with their personal problems and facilitates academic functioning. To that end, this study used both clinical and academic outcome measures that are relevant to the practice of counseling provided at a counseling center and its unique function in an institution of higher education. In addition, this study used the clinical significance methodology (N. S. Jacobson & P. Truax, 1991) that takes into account clients' differences in making clinically reliable and significant change. Pre-intake and post-termination surveys, including the Outcome Questionnaire (M. J. Lambert, K. Lunnen, V. Umphress, N. Hansen, & G. Burlingame, 1994), were completed by 78 clients, and the responses were analyzed using clinical significance methodology. The results revealed that those who made clinically reliable and significant change (i.e., the recovered group) reported the highest level of improvement in academic commitment to their educational goals and problem resolution, compared with those who did not make clinically significant change. The implications of the findings on practice for counseling at university counseling centers and for administrators in higher education institutions are discussed. (c) 2010 APA, all rights reserved.

An interactive data management and analysis system for clinical investigators.

PubMed

Groner, G F; Hopwood, M D; Palley, N A; Sibley, W L; Baker, W R; Christopher, T G; Thompson, H K

1978-09-01

An interactive minicomputer-based system has been developed that enables the clinical research investigator to personally explore and analyze his research data and, as a consequence of these explorations, to acquire more information. This system, which does not require extensive training or computer programming, enables the investigator to describe his data interactively in his own terms, enter data values while having them checked for validity, store time-oriented patient data in a carefully controlled on-line data base, retrieve data by patient, variable, and time, create subsets of patients with common characteristics, perform statistical analyses, and produce tables and graphs. It also permits data to be transferred to and from other computers. The system is well accepted and is being used by a variety of medical specialists at the three clinical research centers where it is operational. Reported benefits include less elapsed and nonproductive time, more thorough analysis of more data, greater and earlier insight into the meaning of research data, and increased publishable results.

Investigation of Methylene Blue Release from Functional Polymeric Systems Using Dielectric Analysis.

PubMed

Bruschi, Marcos Luciano; Junqueira, Mariana Volpato; Borghi-Pangoni, Fernanda Belincanta; Yu, Tao; Andrews, Gavin Paul; Jones, David Simon

2018-01-01

Methylene blue (MB) is a photosensitizer used in photodynamic therapy (PDT) to treat colorectal cancer tumors and leishmaniasis infection. The clinical efficacy of PDT using MB is dependent on the physicochemical characteristics of the formulation. Bioadhesive thermoresponsive systems containing poloxamer 407 and Carbopol 934P have been proposed as platforms for PDT. However, the effect of MB on the physicochemical properties of these platforms is not fully understood, particularly in light of the MB availability. The aim of this study was to investigate the dielectric characteristics of functional polymeric systems containing MB and their influence on mucoadhesion and drug release. Binary polymeric systems containing different concentrations of poloxamer 407, Carbopol 934P and MB were evaluated as dielectric and mucoadhesive properties, as well as in vitro drug release profile. MB, temperature and polymeric composition influenced the physicochemical properties of the systems. The presence of MB altered the supramolecular structure of the preparations. The mucoadhesive properties of systems were influenced by MB presence and the formulation with the lowest amount of MB displayed faster release. The lower MB concentration in the systems displayed better results in terms of ionic mobility and drug release, and is indicative of a suitable clinical performance. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

An academic writing needs assessment of English-as-a-second-language clinical investigators.

PubMed

Wang, Min-Fen; Bakken, Lori L

2004-01-01

Academic writing for publication is competitive and demanding for researchers. For the novice English-as-a-second-language (ESL) researcher, the pressure to publish compounds the difficulties of mastering the English language. Very few studies have used ESL graduate and post-graduate students as academic writing research subjects. The purpose of this project was to assess the learning needs of ESL clinical investigators regarding academic writing for English scholarly publication. A qualitative evaluation approach was used to examine the gap between the current and desired proficiency level for the academic writing of ESL clinical investigators. We considered the perspectives of seven ESL clinical investigators plus three mentors and three writing instructors. Semi-structured questions were asked. Field notes were organized using a field-work recording system. They were analyzed using the constant comparative method. ESL clinical investigators do not accurately perceive their writing deficiencies. They have little knowledge of criteria for academic writing and they are influenced by their prior English learning experiences in their home culture, which engender passive attitudes toward seeking appropriate writing resources. Adequate time is especially needed to develop successful writing skills. Four basic steps are recommended to guide program planners in developing ESL writing activities for professional learning: (1) recognize discrepancies, (2) establish clear standards and performance criteria for scholarly writing, (3) develop individual plans, and (4) organize long-term writing assistance.

Investigating emotion in moral cognition: a review of evidence from functional neuroimaging and neuropsychology.

PubMed

Young, Liane; Koenigs, Michael

2007-01-01

Human moral decision-making has long been a topic of philosophical debate, and, more recently, a topic for empirical investigation. Central to this investigation is the extent to which emotional processes underlie our decisions about moral right and wrong. Neuroscience offers a unique perspective on this question by addressing whether brain regions associated with emotional processing are involved in moral cognition. We conduct a narrative review of neuroscientific studies focused on the role of emotion in morality. Specifically, we describe evidence implicating the ventromedial prefrontal cortex (VMPC), a brain region known to be important for emotional processing. Functional imaging studies demonstrate VMPC activation during tasks probing moral cognition. Studies of clinical populations, including patients with VMPC damage, reveal an association between impairments in emotional processing and impairments in moral judgement and behaviour. Considered together, these studies indicate that not only are emotions engaged during moral cognition, but that emotions, particularly those mediated by VMPC, are in fact critical for human morality.

78 FR 60291 - Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-01

...] Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY... Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Through the...

Clinical and genetic investigation of pediatric cases of Wolff-Parkinson-White syndrome in Tunisian families.

PubMed

Nouira, Sonia; Ouarda, Fatma; Charfeddine, Cherine; Arfa, Imen; Ouragini, Houyem; Abid, Fekria; Abdelhak, Sonia

2010-01-01

Wolff-Parkinson-White (WPW) syndrome is an autosomal-dominant heart disease characterized by an accessory pathway that arises from an aberrant conduction from the atria to the ventricles. Several mutations within the PRKAG2 gene were shown to be responsible for WPW. This gene encodes the γ2 regulatory subunit of adenosine monophosphate (AMP)-activated protein kinase, which functions as a metabolic sensor in cells, responding to cellular energy demands. This first study of WPW in a North African population comprises the clinical and genetic investigation of 3 Tunisian families, including 11 affected members. The involvement of the PRKAG2 and NKX2-5 genes was investigated. Mutation screening showed that with the exception of two already reported single-nucleotide polymorphisms, no mutations were detected within the coding region of PRKAG2 or in the NKX2-5 gene. This study provides further evidence of the genetic heterogeneity of WPW. Copyright © 2010 Elsevier Inc. All rights reserved.

Effectiveness of functional electrical stimulation on walking speed, functional walking category, and clinically meaningful changes for people with multiple sclerosis.

PubMed

Street, Tamsyn; Taylor, Paul; Swain, Ian

2015-04-01

To determine the effectiveness of functional electrical stimulation (FES) on drop foot in patients with multiple sclerosis (MS), using data from standard clinical practice. Case series with a consecutive sample of FES users collected between 2008 and 2013. Specialist FES center at a district general hospital. Patients with MS who have drop foot (N=187) (117 women, 70 men; mean age, 55y [range, 27-80y]; mean duration since diagnosis, 11.7y [range, 1-56y]). A total of 166 patients were still using FES after 20 weeks, with 153 patients completing the follow-up measures. FES of the common peroneal nerve (178 unilateral, 9 bilateral FES users). Clinically meaningful changes (ie, >.05m/s and >0.1m/s) and functional walking category derived from 10-m walking speed. An increase in walking speed was found to be highly significant (P<.001), both initially where a minimum clinically meaningful change was observed (.07m/s) and after 20 weeks with a substantial clinically meaningful change (.11m/s). After 20 weeks, treatment responders displayed a 27% average improvement in their walking speed. No significant training effect was found. Overall functional walking category was maintained or improved in 95% of treatment responders. FES of the dorsiflexors is a well-accepted intervention that enables clinically meaningful changes in walking speed, leading to a preserved or an increased functional walking category. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Functional heartburn: clinical characteristics and outcome.

PubMed

Surdea Blaga, Teodora; Dumitrascu, Dan; Galmiche, Jean-Paul; Bruley des Varannes, Stanislas

2013-03-01

Patients with heartburn and normal upper gastrointestinal endoscopy, normal oesophageal acid exposure, no symptom-reflux association and who fail to respond to a proton-pump inhibitor are classified as having functional heartburn (FH). This study aimed (i) to characterize the symptoms and functional abnormalities of patients with FH and (ii) to describe their clinical outcome. Among all patients referred for 24 h multichannel intraluminal impedance-pH (MII-pH), patients with FH were identified. The clinical characteristics and high-resolution oesophageal pressure topography recordings of FH patients were analyzed at the time of the 24-h MII-pH test. A symptom-related and health-related quality-of-life questionnaire was then sent to FH patients to assess the long-term outcome. Forty patients fulfilled the criteria for FH, representing 8.5% of the referred population. Twenty-two months after initial testing, 66% of patients still suffered from heartburn. The rate of mixed reflux (liquid/gas) was higher in patients with persisting heartburn at the final evaluation (63 vs. 50%, P=0.04). Sixty-six per cent of patients had one or more manometric abnormalities. Acid clearance time in MII-pH was significantly higher in patients with weak peristalsis than patients with normal peristalsis (60 ± 45 vs. 31 ± 19 s, P=0.03). A high rate of mixed reflux and/or a manometric abnormality were associated with a higher risk of persistent heartburn. FH is a chronic disorder with persisting symptoms in two-thirds of patients. An increased rate of mixed reflux and/or the presence of manometric abnormalities are associated with a higher risk of persisting symptoms and may help to identify the population with unmet therapeutic needs.

Movement-Pattern Training to Improve Function in People With Chronic Hip Joint Pain: A Feasibility Randomized Clinical Trial.

PubMed

Harris-Hayes, Marcie; Czuppon, Sylvia; Van Dillen, Linda R; Steger-May, Karen; Sahrmann, Shirley; Schootman, Mario; Salsich, Gretchen B; Clohisy, John C; Mueller, Michael J

2016-06-01

Study Design Feasibility randomized clinical trial. Background Rehabilitation may be an appropriate treatment strategy for patients with chronic hip joint pain; however, the evidence related to the effectiveness of rehabilitation is limited. Objectives To assess feasibility of performing a randomized clinical trial to investigate the effectiveness of movement-pattern training (MPT) to improve function in people with chronic hip joint pain. Methods Thirty-five patients with chronic hip joint pain were randomized into a treatment (MPT) group or a control (wait-list) group. The MPT program included 6 one-hour supervised sessions and incorporated (1) task-specific training for basic functional tasks and symptom-provoking tasks, and (2) strengthening of hip musculature. The wait-list group received no treatment. Primary outcomes for feasibility were patient retention and adherence. Secondary outcomes to assess treatment effects were patient-reported function (Hip disability and Osteoarthritis Outcome Score), lower extremity kinematics, and hip muscle strength. Results Retention rates did not differ between the MPT (89%) and wait-list groups (94%, P = 1.0). Sixteen of the 18 patients (89%) in the MPT group attended at least 80% of the treatment sessions. For the home exercise program, 89% of patients reported performing their home program at least once per day. Secondary outcomes support the rationale for conduct of a superiority randomized clinical trial. Conclusion Based on retention and adherence rates, a larger randomized clinical trial appears feasible and warranted to assess treatment effects more precisely. Data from this feasibility study will inform our future clinical trial. Level of Evidence Therapy, level 2b-. J Orthop Sports Phys Ther 2016;46(6):452-461. Epub 26 Apr 2016. doi:10.2519/jospt.2016.6279.

Diagnostic and functional structure of a high-resolution thyroid nodule clinic.

PubMed

Fernández-García, José Carlos; Mancha-Doblas, Isabel; Ortega-Jiménez, María Victoria; Ruiz-Escalante, José Francisco; Castells-Fusté, Ignasi; Tofé-Povedano, Santiago; Argüelles-Jiménez, Iñaki; Tinahones, Francisco José

2014-01-01

Appearance of a thyroid nodule has become a daily occurrence in clinical practice. Adequate thyroid nodule assessment requires several diagnostic tests and multiple medical appointments, which results in a substantial delay in diagnosis. Implementation of a high-resolution thyroid nodule clinic largely avoids these drawbacks by condensing in a single appointment all tests required for adequate evaluation of thyroid nodule. This paper reviews the diagnostic and functional structure of a high-resolution thyroid nodule clinic. Copyright © 2013 SEEN. Published by Elsevier Espana. All rights reserved.

The assessment of function: How is it measured? A clinical perspective

PubMed Central

Reiman, Michael P; Manske, Robert C

2011-01-01

Testing for outcome or performance can take many forms; including multiple iterations of self-reported measures of function (an assessment of the individual’s perceived dysfunction) and/or clinical special tests (which are primarily assessments of impairments). Typically absent within these testing mechanisms is whether or not one can perform a specific task associated with function. The paper will operationally define function, discuss the construct of function within the disablement model, will overview the multi-dimensional nature of ‘function’ as a concept, will examine the current evidence for functional testing methods, and will propose a functional testing continuum. Limitations of functional performance testing will be discussed including recommendations for future research. PMID:22547919

Clinical Physiology: A Successful Academic and Clinical Discipline is Threatened in Sweden

ERIC Educational Resources Information Center

Arheden, Hakan

2009-01-01

Clinical physiologists in Sweden are physicians (the majority with a PhD degree) with thorough training in system physiology and pathophysiology. They investigate patients in a functional approach and are engaged in basic and applied physiology teaching and research. In 1954, clinical physiology was founded as an independent academic and clinical…

Investigation of pituitary functions in patients with acute meningitis: a pilot study.

PubMed

Tanriverdi, F; Alp, E; Demiraslan, H; Dokmetas, H S; Unluhizarci, K; Doganay, M; Casanueva, F F; Kelestimur, F

2008-06-01

Although long-term pituitary consequences of tuberculous meningitis are well documented in the literature, there have been few case reports of pituitary dysfunction after acute bacterial or viral meningitis. In this preliminary study, we have assessed the pituitary functions in adult patients who had acute bacterial or viral meningitis. Fourteen patients (8 men, 6 women; mean age 35.3+/-13.3) were included in the study. The diagnosis of bacterial and viral meningitis was proven by clinical findings, cerebrospinal fluid (CSF) examination, gram staining, and blood and CSF cultures. Pituitary functions were evaluated ranging from 6 to 48 months (mean 20 months) after acute meningitis. GH deficiency was investigated by the GHRH+arginine stimulation test. Four of 14 patients (28.6%) had isolated GH deficiency. In GH-deficient patients, the earliest duration was 6 months and the latest duration was 48 months after the diagnosis of acute meningitis. Three of the GH-deficient patients had acute bacterial meningitis and 1 patient had acute viral meningitis. Pituitary magnetic resonance imaging revealed normal pituitary gland in the patients with GH deficiency. This is the first systematic study evaluating the anterior pituitary function long term after the diagnosis of acute meningitis. Based on the present study, it is tempting to speculate that pituitary dysfunction is a more common sequel of acute bacterial or viral meningitis than hitherto reported. Studies with high numbers of patients are warranted to ascertain the prevalence of meningitis-induced hypopituitarism.

Clinical Investigation of the Dopaminergic System with PET and FLUORINE-18-FLUORO-L-DOPA.

NASA Astrophysics Data System (ADS)

Oakes, Terrence Rayford

1995-01-01

Positron Emission Tomography (PET) is a tool that provides quantitative physiological information. It is valuable both in a clinical environment, where information is sought for an individual, and in a research environment, to answer more fundamental questions about physiology and disease states. PET is particularly attractive compared to other nuclear medicine imaging techniques in cases where the anatomical regions of interest are small or when true metabolic rate constants are required. One example with both of these requirements is the investigation of Parkinson's Disease, which is characterized as a presynaptic motor function deficit affecting the striatum. As dopaminergic neurons die, the ability of the striatum to affect motor function decreases. The extent of functional neuronal damage in the small sub-structures may be ascertained by measuring the ability of the caudate and putamen to trap and store dopamine, a neurotransmitter. PET is able to utilize a tracer of dopamine activity, ^ {18}F- scL-DOPA, to quantitate the viability of the striatum. This thesis work deals with implementing and optimizing the many different elements that compose a PET study of the dopaminergic system, including: radioisotope production; conversion of aqueous ^{18}F ^-into [^ {18}F]-F2; synthesis of ^{18}F- scL -DOPA; details of the PET scan itself; measurements to estimate the radiation dosimetry; accurate measurement of a plasma input function; and the quantitation of dopaminergic activity in normal human subjects as well as in Parkinson's Disease patients.

A 5-Year Investigation of Children's Adaptive Functioning Following Conformal Radiation Therapy for Localized Ependymoma

DOE Office of Scientific and Technical Information (OSTI.GOV)

Netson, Kelli L.; Conklin, Heather M.; Wu Shengjie

2012-09-01

Purpose: Conformal and intensity modulated radiation therapies have the potential to preserve cognitive outcomes in children with ependymoma; however, functional behavior remains uninvestigated. This longitudinal investigation prospectively examined intelligence quotient (IQ) and adaptive functioning during the first 5 years after irradiation in children diagnosed with ependymoma. Methods and Materials: The study cohort consisted of 123 children with intracranial ependymoma. Mean age at irradiation was 4.60 years (95% confidence interval [CI], 3.85-5.35). Serial neurocognitive evaluations, including an age-appropriate IQ measure and the Vineland Adaptive Behavior Scales (VABS), were completed before irradiation, 6 months after treatment, and annually for 5 years. Amore » total of 579 neurocognitive evaluations were included in these analyses. Results: Baseline IQ and VABS were below normative means (P<.05), although within the average range. Linear mixed models revealed stable IQ and VABS across the follow-up period, except for the VABS Communication Index, which declined significantly (P=.015). Annual change in IQ (-.04 points) did not correlate with annual change in VABS (-.90 to +.44 points). Clinical factors associated with poorer baseline performance (P<.05) included preirradiation chemotherapy, cerebrospinal fluid shunt placement, number and extent of surgical resections, and younger age at treatment. No clinical factors significantly affected the rate of change in scores. Conclusions: Conformal and intensity modulated radiation therapies provided relative sparing of functional outcomes including IQ and adaptive behaviors, even in very young children. Communication skills remained vulnerable and should be the target of preventive and rehabilitative interventions.« less

Variations of the Functional Brain Network Efficiency in a Young Clinical Sample within the Autism Spectrum: A fNIRS Investigation.

PubMed

Li, Yanwei; Yu, Dongchuan

2018-01-01

Autism is a neurodevelopmental disorder with dimensional behavioral symptoms and various damages in the structural and functional brain. Previous neuroimaging studies focused on exploring the differences of brain development between individuals with and without autism spectrum disorders (ASD). However, few of them have attempted to investigate the individual differences of the brain features among subjects within the Autism spectrum. Our main goal was to explore the individual differences of neurodevelopment in young children with Autism by testing for the association between the functional network efficiency and levels of autistic behaviors, as well as the association between the functional network efficiency and age. Forty-six children with Autism (ages 2.0-8.9 years old) participated in the current study, with levels of autistic behaviors evaluated by their parents. The network efficiency (global and local network efficiency) were obtained from the functional networks based on the oxy-, deoxy-, and total-Hemoglobin series, respectively. Results indicated that the network efficiency decreased with age in young children with Autism in the deoxy- and total-Hemoglobin-based-networks, and children with a relatively higher level of autistic behaviors showed decreased network efficiency in the oxy-hemoglobin-based network. Results suggest individual differences of brain development in young children within the Autism spectrum, providing new insights into the psychopathology of ASD.

78 FR 48173 - Guidance for Industry on Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-07

...] Guidance for Industry on Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring... Administration (FDA) is announcing the availability of a guidance for industry entitled ``Oversight of Clinical... monitoring strategies and plans for clinical investigations of human drugs, biologics, medical devices, and...

Clinical application of optical coherence tomography in combination with functional diagnostics: advantages and limitations for diagnosis and assessment of therapy outcome in central serous chorioretinopathy.

PubMed

Schliesser, Joshua A; Gallimore, Gary; Kunjukunju, Nancy; Sabates, Nelson R; Koulen, Peter; Sabates, Felix N

2014-01-01

While identifying functional and structural parameters of the retina in central serous chorioretinopathy (CSCR) patients, this study investigated how an optical coherence tomography (OCT)-based diagnosis can be significantly supplemented with functional diagnostic tools and to what degree the determination of disease severity and therapy outcome can benefit from diagnostics complementary to OCT. CSCR patients were evaluated prospectively with microperimetry (MP) and spectral domain optical coherence tomography (SD-OCT) to determine retinal sensitivity function and retinal thickness as outcome measures along with measures of visual acuity (VA). Patients received clinical care that involved focal laser photocoagulation or pharmacotherapy targeting inflammation and neovascularization. Correlation of clinical parameters with a focus on functional parameters, VA, and mean retinal sensitivity, as well as on the structural parameter mean retinal thickness, showed that functional measures were similar in diagnostic power. A moderate correlation was found between OCT data and the standard functional assessment of VA; however, a strong correlation between OCT and MP data showed that diagnostic measures cannot always be used interchangeably, but that complementary use is of higher clinical value. The study indicates that integrating SD-OCT with MP provides a more complete diagnosis with high clinical relevance for complex, difficult to quantify diseases such as CSCR.

Longitudinal Investigation of Adaptive Functioning following Conformal Irradiation for Pediatric Craniopharyngioma and Low-Grade Glioma

PubMed Central

Netson, Kelli L.; Conklin, Heather M.; Wu, Shengjie; Xiong, Xiaoping; Merchant, Thomas E.

2013-01-01

Purpose Children treated for brain tumors with conformal radiation therapy experience preserved cognitive outcomes. Early evidence suggests that adaptive functions or independent living skills may be spared. This longitudinal investigation prospectively examined intellectual and adaptive functioning during the first 5 years following irradiation for childhood craniopharyngioma and low-grade glioma (LGG). The effect of visual impairment on adaptive outcomes was investigated. Methods and Materials Children with craniopharyngioma (n=62) and LGG (n=77) were treated using conformal or intensity-modulated radiation therapy. The median age was 8.05 years (3.21 years –17.64 years) and 8.09 years (2.20 years–19.27 years), respectively. Serial cognitive evaluations including measures of intelligence quotient (IQ) and the Vineland Adaptive Behavior Scales (VABS) were conducted at pre-irradiation baseline, 6 months after treatment, and annually through 5 years. A total of 588 evaluations were completed during the follow-up period. Results Baseline assessment revealed no deficits in IQ and VABS indices for children with craniopharyngioma, with significant (p < .05) longitudinal decline in VABS Communication and Socialization indices. Clinical factors associated with more rapid decline included females and pre-irradiation chemotherapy (interferon). The only change in VABS Daily Living Skills correlated with IQ change (r = .34; p = .01) in children with craniopharyngioma. Children with LGG performed below population norms (p < .05) at baseline on VABS Communication, Daily Living Indices, and the Adaptive Behavior Composite, with significant (p < .05) longitudinal decline limited to VABS Communication. Older age at irradiation was a protective factor against longitudinal decline. Severe visual impairment did not independently correlate with poorer adaptive outcomes for either tumor group. Conclusions There was relative sparing of post-irradiation functional outcomes over time

Longitudinal Investigation of Adaptive Functioning Following Conformal Irradiation for Pediatric Craniopharyngioma and Low-Grade Glioma

DOE Office of Scientific and Technical Information (OSTI.GOV)

Netson, Kelli L.; Conklin, Heather M.; Wu, Shengjie

2013-04-01

Purpose: Children treated for brain tumors with conformal radiation therapy experience preserved cognitive outcomes. Early evidence suggests that adaptive functions or independent-living skills may be spared. This longitudinal investigation prospectively examined intellectual and adaptive functioning during the first 5 years following irradiation for childhood craniopharyngioma and low-grade glioma (LGG). The effect of visual impairment on adaptive outcomes was investigated. Methods and Materials: Children with craniopharyngioma (n=62) and LGG (n=77) were treated using conformal or intensity modulated radiation therapy. The median age was 8.05 years (3.21-17.64 years) and 8.09 years (2.20-19.27 years), respectively. Serial cognitive evaluations including measures of intelligence quotientmore » (IQ) and the Vineland Adaptive Behavior Scales (VABS) were conducted at preirradiation baseline, 6 months after treatment, and annually through 5 years. Five hundred eighty-eight evaluations were completed during the follow-up period. Results: Baseline assessment revealed no deficits in IQ and VABS indices for children with craniopharyngioma, with significant (P<.05) longitudinal decline in VABS Communication and Socialization indices. Clinical factors associated with more rapid decline included females and preirradiation chemotherapy (interferon). The only change in VABS Daily Living Skills correlated with IQ change (r=0.34; P=.01) in children with craniopharyngioma. Children with LGG performed below population norms (P<.05) at baseline on VABS Communication, Daily Living Indices, and the Adaptive Behavior Composite, with significant (P<.05) longitudinal decline limited to VABS Communication. Older age at irradiation was a protective factor against longitudinal decline. Severe visual impairment did not independently correlate with poorer adaptive outcomes for either tumor group. Conclusions: There was relative sparing of postirradiation functional outcomes over time in

Emotion Understanding in Clinically Anxious Children: A Preliminary Investigation

PubMed Central

Bender, Patrick K.; Pons, Francisco; Harris, Paul L.; Esbjørn, Barbara H.; Reinholdt-Dunne, Marie L.

2015-01-01

Children’s understanding of the nature, origins and consequences of emotions has been intensively investigated over the last 30–40 years. However, few empirical studies have looked at the relation between emotion understanding and anxiety in children and their results are mixed. The aim of the present study was to perform a preliminary investigation of the relationships between emotion understanding, anxiety, emotion dysregulation, and attachment security in clinically anxious children. A sample of 16 clinically anxious children (age 8–12, eight girls/boys) was assessed for emotion understanding (Test of Emotion Comprehension), anxiety (Screening for Child Anxiety Related Emotional Disorders-Revised and Anxiety Disorder Interview Schedule), emotion dysregulation (Difficulties in Emotion Regulation Scale) and attachment security (Security Scale). Children who reported more overall anxiety also reported greater difficulties in regulating their emotions, and were less securely attached to their parents. The results also showed that more specific symptoms of anxiety (i.e., OCD and PTSD) correlated not only with emotion dysregulation and attachment insecurity but also with emotion understanding. Finally, there were interrelations among emotion understanding, attachment security, and emotion dysregulation. The present results provide the first comprehensive evidence for a socio-emotional framework and its relevance to childhood anxiety. PMID:26733909

Applying novel nutrient drink to clinical trial of functional dyspepsia.

PubMed

Lim, Chul-Hyun; Choi, Myung-Gyu; Baeg, Myong Ki; Moon, Sung Jin; Kim, Jin Su; Cho, Yu Kyung; Park, Jae Myung; Lee, In Seok; Kim, Sang Woo; Choi, Kyu Yong

2014-04-30

The drink test has been regarded as a surrogate marker of gastric accommodation. The aims of this study were to develop a novel nutrient drink test (NDT) protocol and investigate its potential for application to a clinical trial of functional dyspepsia (FD). A novel NDT was designed, involving drinking 125 mL of nutrient 4 times at 5-minute intervals or until maximal tolerability. Healthy volunteers and patients with FD rated their symptoms every 5 minutes for 20 minutes in a developmental study. Patients with FD were enrolled in an open trial of itopride for 4 weeks. NDT was performed before and after treatment. Improvement of integrative symptoms score during NDT after treatment for more than 50% compared with baseline was de-fined as responder. Total aggregate symptom scores, sum of symptom scores measured during NDT, were higher in FD patients (n = 40, 368.1 ± 245.3) than in controls (n = 19, 215.9 ± 171.2) (P = 0.018) in a developmental study. In an open trial of itopride, symp-tom scores measured during NDT decreased significantly at all time points after treatment in responders (n = 49), whereas did not in non-responders (n = 25). Total aggregate symptom score for NDT correlated significantly with integrative dyspeptic symptom score, sum of 8 symptom scores of NDI questionnaire, at baseline (r = 0.374, P = 0.001) and after treatment (r = 0.480, P ＜ 0.001). Our novel NDT can quantify dyspeptic symptoms and reflected therapeutic effects of itopride treatment in a clinical trial of FD patients. This NDT can be used as an effective parameter in clinical trials or drug development programs for assessing effects of novel therapies on postprandial symptoms.

Applying Novel Nutrient Drink to Clinical Trial of Functional Dyspepsia

PubMed Central

Lim, Chul-Hyun; Choi, Myung-Gyu; Baeg, Myong Ki; Moon, Sung Jin; Kim, Jin Su; Cho, Yu Kyung; Park, Jae Myung; Lee, In Seok; Kim, Sang Woo; Choi, Kyu Yong

2014-01-01

Background/Aims The drink test has been regarded as a surrogate marker of gastric accommodation. The aims of this study were to develop a novel nutrient drink test (NDT) protocol and investigate its potential for application to a clinical trial of functional dyspepsia (FD). Methods A novel NDT was designed, involving drinking 125 mL of nutrient 4 times at 5-minute intervals or until maximal tolerability. Healthy volunteers and patients with FD rated their symptoms every 5 minutes for 20 minutes in a developmental study. Patients with FD were enrolled in an open trial of itopride for 4 weeks. NDT was performed before and after treatment. Improvement of integrative symptoms score during NDT after treatment for more than 50% compared with baseline was defined as responder. Results Total aggregate symptom scores, sum of symptom scores measured during NDT, were higher in FD patients (n = 40, 368.1 ± 245.3) than in controls (n = 19, 215.9 ± 171.2) (P = 0.018) in a developmental study. In an open trial of itopride, symptom scores measured during NDT decreased significantly at all time points after treatment in responders (n = 49), whereas did not in non-responders (n = 25). Total aggregate symptom score for NDT correlated significantly with integrative dyspeptic symptom score, sum of 8 symptom scores of NDI questionnaire, at baseline (r = 0.374, P = 0.001) and after treatment (r = 0.480, P < 0.001). Conclusions Our novel NDT can quantify dyspeptic symptoms and reflected therapeutic effects of itopride treatment in a clinical trial of FD patients. This NDT can be used as an effective parameter in clinical trials or drug development programs for assessing effects of novel therapies on postprandial symptoms. PMID:24840374

Impact of Neurocognition on Social and Role Functioning in Individuals at Clinical High Risk for Psychosis

PubMed Central

Carrión, Ricardo E.; Goldberg, Terry E.; McLaughlin, Danielle; Auther, Andrea M.; Correll, Christoph U.; Cornblatt, Barbara A.

2011-01-01

Objective Cognitive deficits have been well documented in schizophrenia and have been shown to impair quality of life and to compromise everyday functioning. Recent studies of adolescents and young adults at high risk for developing psychosis show that neurocognitive impairments are detectable before the onset of psychotic symptoms. However, it remains unclear how cognitive impairments affect functioning before the onset of psychosis. The authors assessed cognitive impairment in adolescents at clinical high risk for psychosis and examined its impact on social and role functioning. Method A sample of 127 treatment-seeking patients at clinical high risk for psychosis and a group of 80 healthy comparison subjects were identified and recruited for research in the Recognition and Prevention Program. At baseline, participants were assessed with a comprehensive neurocognitive battery as well as measures of social and role functioning. Results Relative to healthy comparison subjects, clinical high-risk patients showed significant impairments in the domains of processing speed, verbal memory, executive function, working memory, visuospatial processing, motor speed, sustained attention, and language. Clinical high-risk patients also displayed impaired social and role functioning at baseline. Among patients with attenuated positive symptoms, processing speed was related to social and role functioning at baseline. Conclusions These findings demonstrate that cognitive and functional impairments are detectable in patients at clinical high risk for psychosis before the onset of psychotic illness and that processing speed appears to be an important cognitive predictor of poor functioning. PMID:21536691

Impact of neurocognition on social and role functioning in individuals at clinical high risk for psychosis.

PubMed

Carrión, Ricardo E; Goldberg, Terry E; McLaughlin, Danielle; Auther, Andrea M; Correll, Christoph U; Cornblatt, Barbara A

2011-08-01

Cognitive deficits have been well documented in schizophrenia and have been shown to impair quality of life and to compromise everyday functioning. Recent studies of adolescents and young adults at high risk for developing psychosis show that neurocognitive impairments are detectable before the onset of psychotic symptoms. However, it remains unclear how cognitive impairments affect functioning before the onset of psychosis. The authors assessed cognitive impairment in adolescents at clinical high risk for psychosis and examined its impact on social and role functioning. A sample of 127 treatment-seeking patients at clinical high risk for psychosis and a group of 80 healthy comparison subjects were identified and recruited for research in the Recognition and Prevention Program. At baseline, participants were assessed with a comprehensive neurocognitive battery as well as measures of social and role functioning. Relative to healthy comparison subjects, clinical high-risk patients showed significant impairments in the domains of processing speed, verbal memory, executive function, working memory, visuospatial processing, motor speed, sustained attention, and language. Clinical high-risk patients also displayed impaired social and role functioning at baseline. Among patients with attenuated positive symptoms, processing speed was related to social and role functioning at baseline. These findings demonstrate that cognitive and functional impairments are detectable in patients at clinical high risk for psychosis before the onset of psychotic illness and that processing speed appears to be an important cognitive predictor of poor functioning.

Minocycline in leprosy patients with recent onset clinical nerve function impairment.

PubMed

Narang, Tarun; Arshdeep; Dogra, Sunil

2017-01-01

Nerve function impairment (NFI) in leprosy may occur and progress despite multidrug therapy alone or in combination with corticosteroids. We observed improvement in neuritis when minocycline was administered in patients with type 2 lepra reaction. This prompted us to investigate the role of minocycline in recent onset NFI, especially in corticosteroid unresponsive leprosy patients. Leprosy patients with recent onset clinical NFI (<6 months), as determined by Monofilament Test (MFT) and Voluntary Muscle Test (VMT), were recruited. Minocycline 100mg/day was given for 3 months to these patients. The primary outcome was the proportion of patients with 'restored,' 'improved,' 'stabilized,' or 'deteriorated' NFI. Secondary outcomes included any improvement in nerve tenderness and pain. In this pilot study, 11 patients were recruited. The progression of NFI was halted in all; with 9 out of 11 patients (81.82%) showing ?restored? or ?improved? sensory or motor nerve functions, on assessment with MFT and VMT. No serious adverse effects due to minocycline were observed. Our pilot study demonstrates the efficacy and safety of minocycline in recent onset NFI in leprosy patients. However, larger and long term comparative trials are needed to validate the efficacy of minocycline in leprosy neuropathy. © 2016 Wiley Periodicals, Inc.

NAA TECHNIQUE FOR CLINICAL INVESTIGATION OF MICE IMMUNIZED WITH BOTHROP VENOM

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zamboni, C. B.; Aguiar, R. O.; Kovacs, L.

2009-06-03

In the present study Neutron Activation Analysis (NAA) technique was used to determine sodium concentration in whole blood of mice immunized with Bothrops venom. With this value it was possible to perform clinical investigation in this animal model using whole blood.

Functional Assessment of Genetic Variants with Outcomes Adapted to Clinical Decision-Making

PubMed Central

Thouvenot, Pierre; Ben Yamin, Barbara; Fourrière, Lou; Lescure, Aurianne; Boudier, Thomas; Del Nery, Elaine; Chauchereau, Anne; Goldgar, David E.; Stoppa-Lyonnet, Dominique; Nicolas, Alain; Millot, Gaël A.

2016-01-01

Understanding the medical effect of an ever-growing number of human variants detected is a long term challenge in genetic counseling. Functional assays, based on in vitro or in vivo evaluations of the variant effects, provide essential information, but they require robust statistical validation, as well as adapted outputs, to be implemented in the clinical decision-making process. Here, we assessed 25 pathogenic and 15 neutral missense variants of the BRCA1 breast/ovarian cancer susceptibility gene in four BRCA1 functional assays. Next, we developed a novel approach that refines the variant ranking in these functional assays. Lastly, we developed a computational system that provides a probabilistic classification of variants, adapted to clinical interpretation. Using this system, the best functional assay exhibits a variant classification accuracy estimated at 93%. Additional theoretical simulations highlight the benefit of this ready-to-use system in the classification of variants after functional assessment, which should facilitate the consideration of functional evidences in the decision-making process after genetic testing. Finally, we demonstrate the versatility of the system with the classification of siRNAs tested for human cell growth inhibition in high throughput screening. PMID:27272900

Platelet Function Tests: Preanalytical Variables, Clinical Utility, Advantages, and Disadvantages.

PubMed

Hvas, Anne-Mette; Grove, Erik Lerkevang

2017-01-01

Platelet function tests are mainly used in the diagnostic work-up of platelet disorders. During the last decade, the additional use of platelet function tests to evaluate the effect of antiplatelet therapy has also emerged in an attempt to identify patients with an increased risk of arterial thrombosis. Furthermore, platelet function tests are increasingly used to measure residual effect of antiplatelet therapy prior to surgery with the aim of reducing the risk of bleeding. To a limited extend, platelet function tests are also used to evaluate hyperaggregability as a potential marker of a prothrombotic state outside the setting of antiplatelet therapy. This multifaceted use of platelet function tests and the development of simpler point-of-care tests with narrower application have increased the use of platelet function testing and also facilitated the use of platelet function tests outside the highly specialized laboratories. The present chapter describes the preanalytical variables, which should be taken into account when planning platelet function testing. Also, the most widely used platelet function tests are introduced, and their clinical utility and their relative advantages and disadvantages are discussed.

Exhaustion and endocrine functioning in clinical burnout: an in-depth study using the experience sampling method.

PubMed

Sonnenschein, Mieke; Mommersteeg, Paula M C; Houtveen, Jan H; Sorbi, Marjolijn J; Schaufeli, Wilmar B; van Doornen, Lorenz J P

2007-05-01

The current study investigates the relationship between HPA-axis functioning and burnout symptoms by employing an electronic symptom diary. This diary method circumvents the retrospection bias induced by symptom questionnaires and allows to study relationships within-in addition to between-subjects. Forty two clinically burned-out participants completed the exhaustion subscale of the Maslach burnout inventory and kept an electronic diary for 2 weeks to assess momentary exhaustion and daily recovery through sleep. On 3 consecutive weekdays within the diary period, saliva was sampled to determine the cortisol awakening response (CAR), levels of dehydroepiandrosterone-sulphate (DHEAS) on the first 2 weekdays, and to conduct the dexamethasone suppression test (DST) on the third weekday. We found significant relationships between endocrine values and general momentary symptom severity as assessed with the diary, but not with the retrospective questionnaire-assessed burnout symptoms. Simultaneous assessments of endocrine values and burnout symptoms assessed with the diary after awakening rendered significant associations between persons, and a trend within persons. More severe burnout symptoms were consistently associated with a lower level and smaller increase of CAR, higher DHEAS levels, smaller cortisol/DHEAS ratios and a stronger suppression after DST. Burnout symptoms were significantly related to endocrine functioning in clinical burnout under the best possible conditions of symptom measurement. This adds support to the view that severity of burnout symptoms is associated with HPA-axis functioning.

Preliminary investigation of Brain Network Activation (BNA) and its clinical utility in sport-related concussion.

PubMed

Reches, A; Kutcher, J; Elbin, R J; Or-Ly, H; Sadeh, B; Greer, J; McAllister, D J; Geva, A; Kontos, A P

2017-01-01

The clinical diagnosis and management of patients with sport-related concussion is largely dependent on subjectively reported symptoms, clinical examinations, cognitive, balance, vestibular and oculomotor testing. Consequently, there is an unmet need for objective assessment tools that can identify the injury from a physiological perspective and add an important layer of information to the clinician's decision-making process. The goal of the study was to evaluate the clinical utility of the EEG-based tool named Brain Network Activation (BNA) as a longitudinal assessment method of brain function in the management of young athletes with concussion. Athletes with concussion (n = 86) and age-matched controls (n = 81) were evaluated at four time points with symptom questionnaires and BNA. BNA scores were calculated by comparing functional networks to a previously defined normative reference brain network model to the same cognitive task. Subjects above 16 years of age exhibited a significant decrease in BNA scores immediately following injury, as well as notable changes in functional network activity, relative to the controls. Three representative case studies of the tested population are discussed in detail, to demonstrate the clinical utility of BNA. The data support the utility of BNA to augment clinical examinations, symptoms and additional tests by providing an effective method for evaluating objective electrophysiological changes associated with sport-related concussions.

Preliminary investigation of Brain Network Activation (BNA) and its clinical utility in sport-related concussion

PubMed Central

Reches, A.; Kutcher, J.; Elbin, R. J.; Or-Ly, H.; Sadeh, B.; Greer, J.; McAllister, D. J.; Geva, A.; Kontos, A. P.

2017-01-01

ABSTRACT Background: The clinical diagnosis and management of patients with sport-related concussion is largely dependent on subjectively reported symptoms, clinical examinations, cognitive, balance, vestibular and oculomotor testing. Consequently, there is an unmet need for objective assessment tools that can identify the injury from a physiological perspective and add an important layer of information to the clinician’s decision-making process. Objective: The goal of the study was to evaluate the clinical utility of the EEG-based tool named Brain Network Activation (BNA) as a longitudinal assessment method of brain function in the management of young athletes with concussion. Methods: Athletes with concussion (n = 86) and age-matched controls (n = 81) were evaluated at four time points with symptom questionnaires and BNA. BNA scores were calculated by comparing functional networks to a previously defined normative reference brain network model to the same cognitive task. Results: Subjects above 16 years of age exhibited a significant decrease in BNA scores immediately following injury, as well as notable changes in functional network activity, relative to the controls. Three representative case studies of the tested population are discussed in detail, to demonstrate the clinical utility of BNA. Conclusion: The data support the utility of BNA to augment clinical examinations, symptoms and additional tests by providing an effective method for evaluating objective electrophysiological changes associated with sport-related concussions. PMID:28055228

Effects of youth football on selected clinical measures of neurologic function: a pilot study.

PubMed

Munce, Thayne A; Dorman, Jason C; Odney, Tryg O; Thompson, Paul A; Valentine, Verle D; Bergeron, Michael F

2014-12-01

We assessed 10 youth football players (13.4 ± 0.7 y) immediately before and after their season to explore the effects of football participation on selected clinical measures of neurologic function. Postseason postural stability in a closed-eye condition was improved compared to preseason (P = .017). Neurocognitive testing with the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery revealed that reaction time was significantly faster at postseason (P = .015). There were no significant preseason versus postseason differences in verbal memory (P = .507), visual memory (P = .750), or visual motor speed (P = .087). Oculomotor performance assessed by the King-Devick test was moderately to significantly improved (P = .047-.115). A 12-week season of youth football did not impair the postural stability, neurocognitive function, or oculomotor performance measures of the players evaluated. Though encouraging, continued and more comprehensive investigations of this at-risk population are warranted. © The Author(s) 2013.

78 FR 35937 - Food and Drug Administration Decisions for Investigational Device Exemption Clinical...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug...

[Influence of smoking and industrial air pollutants on respiratory health of nickel industry workers].

PubMed

Shilov, V V; Siurin, S A

2015-01-01

Studies covered respiratory health of 1530 workers of nickel industry, among which were 796 (52.0%) smokers. Findings are that tobacco smoke combined with nickel industry hazards cause potentized negative effects in respiratory organs, with earlier and more frequent chronic bronchitis. For isolated influence of these factors, chronic bronchitis risk is higher from exposure to tobacco smoke vs. occupational hazards (OR = 2.48; DI 1.49-4.13). Chronic obstructive lung disease development in nickel industry workers is caused by smoking. Industrial air pollutants appeared to have no potentizing effect on COLD formation, as well as on toxic pneumosclerosis formation.

Evaluation of drug-metabolizing and functional competence of human hepatocytes incubated under hypothermia in different media for clinical infusion.

PubMed

Gómez-Lechón, María José; Lahoz, Agustín; Jiménez, Nuria; Bonora, Ana; Castell, José V; Donato, María Teresa

2008-01-01

Hepatocyte transplantation has been proposed as a method to support patients with liver insufficiency. Key factors for clinical cell transplantation to progress is to prevent hepatocyte damage, loss of viability and cell functionality, factors that depend on the nature of the tissue used for isolation to a large extent. The main sources of tissue for hepatocyte isolation are marginal livers that are unsuitable for transplantation, and segments from reduced cadaveric grafts. Hepatocellular transplantation requires infusing human hepatocytes in suspension over a period of minutes to hours. The beneficial effect of hypothermic preservation of hepatocytes in infusion medium has been reported, but how critical issues towards the success of cell transplantation, such as the composition of infusion medium and duration of hepatocyte storage will affect hepatocyte quality for clinical cell infusion has not been systematically investigated. Infusion media composition is phosphate-buffered saline containing anticoagulants and human serum albumin. The supplementation of infusion media with glucose or N-acetyl-cystein, or with both components at the same time, has been investigated. After isolation, hepatocytes were suspended in each infusion medium and a sample at the 0 time point was harvested for cell viability and functional assessment. Thereafter, cells were incubated in different infusion media agitated on a rocker platform to simulate the clinical infusion technique. The time course of hepatocyte viability, funtionality (drug-metabolizing enzymes, ureogenic capability, ATP, glycogen, and GSH levels), apoptosis (caspase-3 activation), and attachment and monolayer formation were analyzed. The optimal preservation of cell viability, attaching capacity, and functionality, particularly GSH and glycogen levels, as well as drug-metabolizing cytochrome P450 enzymes, was found in infusion media supplemented with 2 mM N-acetyl-cystein and 15 mM glucose.

Inverse optimization of objective function weights for treatment planning using clinical dose-volume histograms

NASA Astrophysics Data System (ADS)

Babier, Aaron; Boutilier, Justin J.; Sharpe, Michael B.; McNiven, Andrea L.; Chan, Timothy C. Y.

2018-05-01

We developed and evaluated a novel inverse optimization (IO) model to estimate objective function weights from clinical dose-volume histograms (DVHs). These weights were used to solve a treatment planning problem to generate ‘inverse plans’ that had similar DVHs to the original clinical DVHs. Our methodology was applied to 217 clinical head and neck cancer treatment plans that were previously delivered at Princess Margaret Cancer Centre in Canada. Inverse plan DVHs were compared to the clinical DVHs using objective function values, dose-volume differences, and frequency of clinical planning criteria satisfaction. Median differences between the clinical and inverse DVHs were within 1.1 Gy. For most structures, the difference in clinical planning criteria satisfaction between the clinical and inverse plans was at most 1.4%. For structures where the two plans differed by more than 1.4% in planning criteria satisfaction, the difference in average criterion violation was less than 0.5 Gy. Overall, the inverse plans were very similar to the clinical plans. Compared with a previous inverse optimization method from the literature, our new inverse plans typically satisfied the same or more clinical criteria, and had consistently lower fluence heterogeneity. Overall, this paper demonstrates that DVHs, which are essentially summary statistics, provide sufficient information to estimate objective function weights that result in high quality treatment plans. However, as with any summary statistic that compresses three-dimensional dose information, care must be taken to avoid generating plans with undesirable features such as hotspots; our computational results suggest that such undesirable spatial features were uncommon. Our IO-based approach can be integrated into the current clinical planning paradigm to better initialize the planning process and improve planning efficiency. It could also be embedded in a knowledge-based planning or adaptive radiation therapy framework to

Inverse optimization of objective function weights for treatment planning using clinical dose-volume histograms.

PubMed

Babier, Aaron; Boutilier, Justin J; Sharpe, Michael B; McNiven, Andrea L; Chan, Timothy C Y

2018-05-10

We developed and evaluated a novel inverse optimization (IO) model to estimate objective function weights from clinical dose-volume histograms (DVHs). These weights were used to solve a treatment planning problem to generate 'inverse plans' that had similar DVHs to the original clinical DVHs. Our methodology was applied to 217 clinical head and neck cancer treatment plans that were previously delivered at Princess Margaret Cancer Centre in Canada. Inverse plan DVHs were compared to the clinical DVHs using objective function values, dose-volume differences, and frequency of clinical planning criteria satisfaction. Median differences between the clinical and inverse DVHs were within 1.1 Gy. For most structures, the difference in clinical planning criteria satisfaction between the clinical and inverse plans was at most 1.4%. For structures where the two plans differed by more than 1.4% in planning criteria satisfaction, the difference in average criterion violation was less than 0.5 Gy. Overall, the inverse plans were very similar to the clinical plans. Compared with a previous inverse optimization method from the literature, our new inverse plans typically satisfied the same or more clinical criteria, and had consistently lower fluence heterogeneity. Overall, this paper demonstrates that DVHs, which are essentially summary statistics, provide sufficient information to estimate objective function weights that result in high quality treatment plans. However, as with any summary statistic that compresses three-dimensional dose information, care must be taken to avoid generating plans with undesirable features such as hotspots; our computational results suggest that such undesirable spatial features were uncommon. Our IO-based approach can be integrated into the current clinical planning paradigm to better initialize the planning process and improve planning efficiency. It could also be embedded in a knowledge-based planning or adaptive radiation therapy framework to

Functional magnetic resonance imaging in clinical practice: State of the art and science.

PubMed

Barras, Christen D; Asadi, Hamed; Baldeweg, Torsten; Mancini, Laura; Yousry, Tarek A; Bisdas, Sotirios

2016-11-01

Functional magnetic resonance imaging (fMRI) has become a mainstream neuroimaging modality in the assessment of patients being evaluated for brain tumour and epilepsy surgeries. Thus, it is important for doctors in primary care settings to be well acquainted with the present and potential future applications, as well as limitations, of this modality. The objective of this article is to introduce the theoretical principles and state-of-the-art clinical applications of fMRI in brain tumour and epilepsy surgery, with a focus on the implications for clinical primary care. fMRI enables non-invasive functional mapping of specific cortical tasks (eg motor, language, memory-based, visual), revealing information about functional localisation, anatomical variation in cortical function, and disease effects and adaptations, including the fascinating phenomenon of brain plasticity. fMRI is currently ordered by specialist neurologists and neurosurgeons for the purposes of pre-surgical assessment, and within the context of an experienced multidisciplinary team to prepare, conduct and interpret the scan. With an increasing number of patients undergoing fMRI, general practitioners can expect questions about the current and emerging role of fMRI in clinical care from these patients and their families.

Clinical Investigation Program, Reports Control Symbol MED-300(R1), Fiscal Year 1988

DTIC Science & Technology

1988-10-01

Dr. Venkataraman Balaraman, M.D. Department/Section: Clinical Investigation Key Words: arginine vasopressin (AVP); vascular smooth muscle responses...Kullama, Ph.D. Associate Investigators: Dr. Venkataraman Balaraman, M.D.; Dr. Kenneth T. Nakamura, M.D.; John R. Claybaugh, Ph.D. Department/Section...Harrison Hassell, MC Associate Investigators: John R. Claybaugh, Ph.D.; Arnold Siemsen, MD; Jon Streltzer, MD Department/Section: Medicine/ Nephrology

Assessment of personality-related levels of functioning: a pilot study of clinical assessment of the DSM-5 level of personality functioning based on a semi-structured interview.

PubMed

Thylstrup, Birgitte; Simonsen, Sebastian; Nemery, Caroline; Simonsen, Erik; Noll, Jane Fjernestad; Myatt, Mikkel Wanting; Hesse, Morten

2016-08-25

The personality disorder categories in the Diagnostic and Statistical Manual of Mental Disorders IV have been extensively criticized, and there is a growing consensus that personality pathology should be represented dimensionally rather than categorically. The aim of this pilot study was to test the Clinical Assessment of the Level of Personality Functioning Scale, a semi-structured clinical interview, designed to assess the Level of Personality Functioning Scale of the DSM-5 (Section III) by applying strategies similar to what characterizes assessments in clinical practice. The inter-rater reliability of the assessment of the four domains and the total impairment in the Level of Personality Functioning Scale were measured in a patient sample that varied in terms of severity and type of pathology. Ratings were done independently by the interviewer and two experts who watched a videotaped Clinical Assessment of the Level of Personality Functioning Scale interview. Inter-rater reliability coefficients varied between domains and were not sufficient for clinical practice, but may support the use of the interview to assess the dimensions of personality functioning for research purposes. While designed to measure the Level of Personality Functioning Scale with a high degree of similarity to clinical practice, the Clinical Assessment of the Level of Personality Functioning Scale had weak reliabilities and a rating based on a single interview should not be considered a stand-alone assessment of areas of functioning for a given patient.

Clinical interpretation of the Spinal Cord Injury Functional Index (SCI-FI).

PubMed

Fyffe, Denise; Kalpakjian, Claire Z; Slavin, Mary; Kisala, Pamela; Ni, Pengsheng; Kirshblum, Steven C; Tulsky, David S; Jette, Alan M

2016-09-01

To provide validation of functional ability levels for the Spinal Cord Injury - Functional Index (SCI-FI). Cross-sectional. Inpatient rehabilitation hospital and community settings. A sample of 855 individuals with traumatic spinal cord injury enrolled in 6 rehabilitation centers participating in the National Spinal Cord Injury Model Systems Network. Not Applicable. Spinal Cord Injury-Functional Index (SCI-FI). Cluster analyses identified three distinct groups that represent low, mid-range and high SCI-FI functional ability levels. Comparison of clusters on personal and other injury characteristics suggested some significant differences between groups. These results strongly support the use of SCI-FI functional ability levels to document the perceived functional abilities of persons with SCI. Results of the cluster analysis suggest that the SCI-FI functional ability levels capture function by injury characteristics. Clinical implications regarding tracking functional activity trajectories during follow-up visits are discussed.

Building sustainable multi-functional prospective electronic clinical data systems.

PubMed

Randhawa, Gurvaneet S; Slutsky, Jean R

2012-07-01

A better alignment in the goals of the biomedical research enterprise and the health care delivery system can help fill the large gaps in our knowledge of the impact of clinical interventions on patient outcomes in the real world. There are several initiatives underway to align the research priorities of patients, providers, researchers, and policy makers. These include Agency for Healthcare Research and Quality (AHRQ)-supported projects to build flexible prospective clinical electronic data infrastructure that meet the needs of these diverse users. AHRQ has previously supported the creation of 2 distributed research networks as a new approach to conduct comparative effectiveness research (CER) while protecting a patient's confidential information and the proprietary needs of a clinical organization. It has applied its experience in building these networks in directing the American Recovery and Reinvestment Act funds for CER to support new clinical electronic infrastructure projects that can be used for several purposes including CER, quality improvement, clinical decision support, and disease surveillance. In addition, AHRQ has funded a new Electronic Data Methods forum to advance the methods in clinical informatics, research analytics, and governance by actively engaging investigators from the American Recovery and Reinvestment Act-funded projects and external stakeholders.

Performance-based functional assessment in older hospitalized patients: feasibility and clinical correlates.

PubMed

Volpato, Stefano; Cavalieri, Margherita; Guerra, Gianluca; Sioulis, Fotini; Ranzini, Monica; Maraldi, Cinzia; Fellin, Renato; Guralnik, Jack M

2008-12-01

Functional evaluation is a cornerstone of multidimensional geriatric assessment; however, little is known of the clinical value of standardized performance-based assessment in the acute care setting. The aim of this study was to evaluate the clinical correlates and short-term predictive value of the Short Physical Performance Battery (SPPB) in older patients admitted to the hospital for an acute medical event. We enrolled 92 women and men 65 years old or older who were able to walk, who had a Mini-Mental State Examination (MMSE) score > or =18, and who were admitted to the hospital with a clinical diagnosis of congestive heart failure, pneumonia, chronic obstructive pulmonary disease (COPD), or minor stroke. The SPPB was assessed at hospital admission and discharge. Self-report functional assessment included basic activities of daily living (ADL) and instrumental activities of daily living (IADL). Spearman's rank correlation coefficients and multivariable linear regression analyses were used to study the association of SPPB score and functional and clinical characteristics, including length of hospital stay. The mean age was 77.7 years (range 65-94 years), 49% were female, 64.1% had congestive heart failure, 16% COPD, 13.1% pneumonia, and 6.5% minor stroke. At hospital admission the mean SPPB score was 6.0 +/- 2.7. SPPB scores were inversely correlated with age, the severity of the index disease, and IADL and ADL difficulty 2 weeks before hospital admission (p <.01), and were directly correlated with MMSE score (p =.002). On average, SPPB score increased 1 point (+0.97, standard error of the mean = 0.2; p for paired t test <.001) from baseline to hospital discharge assessment. After adjustment for potential confounders, baseline SPPB score was significantly associated with the length of hospital stay (p <.007). In older acute care inpatients, SPPB is a valid indicator of functional and clinical status. SPPB score at hospital admission is an independent predictor of

Study of cognitive functions in newly diagnosed cases of subclinical and clinical hypothyroidism.

PubMed

Sharma, Kirti; Behera, Joshil Kumar; Sood, Sushma; Rajput, Rajesh; Satpal; Praveen, Prashant

2014-01-01

Hypothyroidism is associated with significant neurocognitive deficits because hypothyroidism prevents the brain from adequately sustaining the energy consuming processes needed for neurotransmission, memory, and other higher brain functions. Hence, the study was done to assess the cognitive functions of newly diagnosed subclinical and clinical hypothyroid patients by evoked response potential P300. 75 patients each of newly diagnosed subclinical and clinical hypothyroid patients attending endocrinology clinic and 75 healthy age and sex matched euthyroid controls were considered for the study. P300 was recorded with Record Medicare System Polyrite, Chandigarh using auditory "oddball paradigm". The data was analyzed using ANOVA followed by post Tukey's test. Newly diagnosed clinical hypothyroid patients showed a significant increase in P300 latency compared to control (P < 0.05) and subclinical cases (P < 0.01) while there was no significant difference between the P300 latency of subclinical cases and control group. Also, there was no significant difference in P300 amplitude among the three groups. P300 latency in case of newly diagnosed hypothyroid clinical cases is significantly increased compared to newly diagnosed subclinical cases and control.

Interpretation of Blood Microbiology Results - Function of the Clinical Microbiologist.

PubMed

Kristóf, Katalin; Pongrácz, Júlia

2016-04-01

The proper use and interpretation of blood microbiology results may be one of the most challenging and one of the most important functions of clinical microbiology laboratories. Effective implementation of this function requires careful consideration of specimen collection and processing, pathogen detection techniques, and prompt and precise reporting of identification and susceptibility results. The responsibility of the treating physician is proper formulation of the analytical request and to provide the laboratory with complete and precise patient information, which are inevitable prerequisites of a proper testing and interpretation. The clinical microbiologist can offer advice concerning the differential diagnosis, sampling techniques and detection methods to facilitate diagnosis. Rapid detection methods are essential, since the sooner a pathogen is detected, the better chance the patient has of getting cured. Besides the gold-standard blood culture technique, microbiologic methods that decrease the time in obtaining a relevant result are more and more utilized today. In the case of certain pathogens, the pathogen can be identified directly from the blood culture bottle after propagation with serological or automated/semi-automated systems or molecular methods or with MALDI-TOF MS (matrix-assisted laser desorption-ionization time of flight mass spectrometry). Molecular biology methods are also suitable for the rapid detection and identification of pathogens from aseptically collected blood samples. Another important duty of the microbiology laboratory is to notify the treating physician immediately about all relevant information if a positive sample is detected. The clinical microbiologist may provide important guidance regarding the clinical significance of blood isolates, since one-third to one-half of blood culture isolates are contaminants or isolates of unknown clinical significance. To fully exploit the benefits of blood culture and other (non- culture

[Investigation of the effect of vinpocetine on cerebral blood flow and cognitive functions].

PubMed

Valikovics, Attila

2007-07-30

Vinpocetine has been widely used in the treatment of ischaemic cerebrovascular diseases and dementias of vascular type. Chronic cerebral hypoperfusion plays an important role in the development of certain types of dementia. In consequence of complex mode of action vinpocetine plays a significant role in the improvement of cerebral hypoperfusion. The symptoms of mild cognitive impairment considered as "predementia" are similar to those of dementia, although milder. The authors investigated the characteristics of the blood flow parameters of patients with ischemic stroke and mild cognitive impairment both in resting conditions or following chemical stimulus as well as they investigated the severity of mental deterioration in the two patient groups. In a pilot study the authors examined the influence of 12-week long oral vinpocetine therapy on the blood flow parameters and cognitive functions in the two patient groups. The authors studied the blood flow velocity of a. cerebri media in resting conditions and after 30 sec of breath holding with transcranial Doppler before treatment and after a 12-week long oral vinpocetine treatment. At the same time psychometric tests (MMSE, ADAS-Cog) were used in order to examine cognitive functions, while the general condition of the patients were scored by Clinical Global Impression (CGI) scale. After a 12-week long oral vinpocetine treatment the increase of blood flow velocity in resting conditions compared to the baseline values was significant in the vascular group. The percent increase of mean velocity after the breath holding TCD test showed a significant increase compared to the baseline in both patient groups. The authors found a significant improvement of cognitive functions after a 12-week long oral vinpocetine therapy using psychometric tests. The improvement was identical in both groups. The general condition of patients improved significantly according to both the investigator's and the patients' opinion; patients with

Clinical Predictors of Attention and Executive Functioning Outcomes in Children After Perinatal Arterial Ischemic Stroke.

PubMed

Bosenbark, Danielle D; Krivitzky, Lauren; Ichord, Rebecca; Vossough, Arastoo; Bhatia, Aashim; Jastrzab, Laura E; Billinghurst, Lori

2017-04-01

Children with perinatal arterial ischemic stroke (PAIS) are at risk for later neurocognitive and behavioral deficits, yet the clinical predictors of these outcomes are understudied. We examined the influence of clinical and infarct characteristics on attention and executive functioning in children following PAIS. Forty children born at term (≥37 weeks' gestation) with PAIS (28 with neonatal arterial ischemic stroke and 12 with presumed PAIS) underwent a comprehensive neuropsychological battery at age three to 16 years (median age 7.2 years; 58% male) to assess attention and executive functioning. Parents also completed questionnaires regarding real-world functioning. Clinical variables including perinatal stroke subtype, infarct characteristics (location, laterality, and volume), and the presence of comorbid epilepsy were ascertained from the medical record. Presumed PAIS, larger infarct volume, and comorbid epilepsy negatively influenced the performance on attention and executive functioning measures. These clinical variables were also associated with greater functional problems on parent reports, including a higher frequency of attention-deficit/hyperactivity disorder symptoms and greater difficulties in some subdomains of executive functioning. Infarct location and laterality were not associated with performance measures or parental report of functioning. Although all children with PAIS are at risk for later deficits in attention and executive functioning, those with presumed PAIS, larger infarct size, and comorbid epilepsy appear to be the most vulnerable. As they approach and reach school age, these children should undergo neuropsychological assessment to ensure timely implementation of therapeutic interventions and behavioral strategies. Copyright © 2017 Elsevier Inc. All rights reserved.

[Non-commercial clinical trials--who will be the legal sponsor? Sponsorship of investigator-initiated clinical trials according to the German Drug Law].

PubMed

Benninger-Döring, G; Boos, J

2006-07-01

Non-commercial clinical trials may be of great benefit to the patients concerned. The 12th amendment to the German Drug Law (AMG) changed legal liability of the initiators of investigator-initiated clinical trials with extensive consequences for traditional project leaders. The central point under discussion is the sponsor's responsibility according to the AMG. Presently leading management divisions of university hospitals and universities are developing proceedings to assume sponsor responsibility by institutions (institutional sponsorship), which should enable investigator-initiated clinical trials to be conducted according to legal requirements in the future. Detailed problems and special questions can only be resolved in a single-minded fashion, and if necessary political processes should be catalyzed.

Clinical, functional, and neurophysiologic assessment of dysplastic cortical networks: Implications for cortical functioning and surgical management.

PubMed

Duchowny, Michael

2009-10-01

Cortical malformations are highly epileptogenic lesions associated with complex, unanticipated, and often aberrant electrophysiologic and functional relationships. These relationships are inextricably linked to widespread cortical networks subserving eloquent functions, particularly language and motor ability. Cytomegalic neurons but not balloon cells in Palmini type 2 dysplastic cortex are intrinsically hyperexcitable and contribute to local epileptogenesis and functional responsiveness. However, there is much evidence that focal cortical dysplasia is rarely a localized or even regional process, and is a functionally, electrophysiologically, and ultimately clinically integrated neural network disorder. Not surprisingly, malformed cortex is implicated in cognitive dysfunction, particularly disturbances of linguistic processing. An understanding of these relationships is critical for successful epilepsy surgery. Gains in surgical prognosis rely on multiple diagnostic modalities to delineate complex anatomic, electrophysiologic, and functional relationships in magnetic resonance imaging (MRI)-negative patients with rates of seizure-freedom roughly comparable to lesional patients.

Pilot Study to Evaluate the Effect of Topical Dimethicone on Clinical Signs and Skin Barrier Function in Dogs with Naturally Occurring Atopic Dermatitis

PubMed Central

Pellicoro, C.; Marsella, R.; Ahrens, K.

2013-01-01

This study investigated the effects of a skin protectant solution (dimethicone 2%) on clinical signs and skin barrier function in canine atopic dermatitis (AD). Eighteen dogs with AD were randomly divided into two groups, one received dimethicone and the other received the vehicle (cyclomethicone) on selected areas (pinnae, groin, and axillae) daily for 4 weeks. Owners and investigators were blinded regarding group allocation. Clinical efficacy was evaluated using a scoring system and skin barrier by measuring the transepidermal water loss. Twelve dogs completed the study (50% drop rate in the vehicle and 20% in the dimethicone). For clinical signs, analysis of variance showed an effect of time (P < 0.005; day 0 > day 28) and region (axillae < groin < pinnae) but no effect of group or group × time interaction. For transepidermal water loss, analysis of variance showed only a main effect of region (axillae > pinnae > groin). Pearson found no correlation between transepidermal water loss and clinical scores. In this pilot study dimethicone had no significant effect on clinical signs and transepidermal water loss in canine atopic dermatitis. PMID:23710417

Clinical symptoms and alpha band resting-state functional connectivity imaging in patients with schizophrenia: implications for novel approaches to treatment

PubMed Central

Hinkley, Leighton B.N.; Vinogradov, Sophia; Guggisberg, Adrian G.; Fisher, Melissa; Findlay, Anne M.; Nagarajan, Srikantan S.

2011-01-01

Background Schizophrenia is associated with functional decoupling between cortical regions, but we do not know whether and where this occurs in low-frequency electromagnetic oscillations. The goal of this study was to use magnetoencephalography (MEG) to identify brain regions that exhibit abnormal resting-state connectivity in the alpha frequency range in patients with schizophrenia and investigate associations between functional connectivity and clinical symptoms in stable outpatient participants. Method Thirty patients with schizophrenia and fifteen healthy comparison participants were scanned in resting-state MEG (eyes closed). Functional connectivity MEGI (fcMEGI) data were reconstructed globally in the alpha range, quantified by the mean imaginary coherence between a voxel and the rest of the brain. Results In patients, decreased connectivity was observed in left pre-frontal cortex (PFC) and right superior temporal cortex while increased connectivity was observed in left extrastriate cortex and the right inferior PFC. Functional connectivity of left inferior parietal cortex was negatively related to positive symptoms. Low left PFC connectivity was associated with negative symptoms. Functional connectivity of midline PFC was negatively correlated with depressed symptoms. Functional connectivity of right PFC was associated with other (cognitive) symptoms. Conclusions This study demonstrates direct functional disconnection in schizophrenia between specific cortical fields within low-frequency resting-state oscillations. Impaired alpha coupling in frontal, parietal, and temporal regions is associated with clinical symptoms in these stable outpatients. Our findings indicate that this level of functional disconnection between cortical regions is an important treatment target in schizophrenia. PMID:21861988

Clinical interpretation of the Spinal Cord Injury Functional Index (SCI-FI)

PubMed Central

Fyffe, Denise; Kalpakjian, Claire Z.; Slavin, Mary; Kisala, Pamela; Ni, Pengsheng; Kirshblum, Steven C.; Tulsky, David S.; Jette, Alan M.

2016-01-01

Objective: To provide validation of functional ability levels for the Spinal Cord Injury – Functional Index (SCI-FI). Design: Cross-sectional. Setting: Inpatient rehabilitation hospital and community settings. Participants: A sample of 855 individuals with traumatic spinal cord injury enrolled in 6 rehabilitation centers participating in the National Spinal Cord Injury Model Systems Network. Interventions: Not Applicable. Main Outcome Measures: Spinal Cord Injury-Functional Index (SCI-FI). Results: Cluster analyses identified three distinct groups that represent low, mid-range and high SCI-FI functional ability levels. Comparison of clusters on personal and other injury characteristics suggested some significant differences between groups. Conclusions: These results strongly support the use of SCI-FI functional ability levels to document the perceived functional abilities of persons with SCI. Results of the cluster analysis suggest that the SCI-FI functional ability levels capture function by injury characteristics. Clinical implications regarding tracking functional activity trajectories during follow-up visits are discussed. PMID:26781769

Clinical predictors of interpersonal functioning in patients with bipolar disorder.

PubMed

Rosa, Adriane R; Bonnin, Caterina Mar; Mazzarini, Luis; Amann, Benedikt; Kapczinski, Flavio P; Vieta, Eduard

2009-04-01

Functional impairment has been repeatedly reported in patients with bipolar disorder even during clinical remission. Less is known about specific domains, such as interpersonal relationships. The aim of this study was to identify clinical predictors of poor interpersonal relationships. Using a specific subscale of the Functioning Assessment Short Test (FAST), we assessed the interpersonal relationships of a sample of 71 euthymic bipolar (Hamilton Depression Rating Scale [HAM-D] < 8; Young Mania Rating Scale [YMRS] < 5) patients. The sample was divided into two categories: low vs. high level functioning in interpersonal relationships according to the median of the sample. Multivariate analyses were applied to identify significant predictors of interpersonal functioning. Age (p=0.026), the number of previous depressive and mixed episodes and HAM-D scores differed significantly between the two groups (p<0.05). For manic episodes, only a tendency was detected (p=0.064). After running multivariate analyses, age (p=0.026), depressive symptoms (p=0.055) and the number of previous manic episodes (p=0.033) could be considered predictors of poor interpersonal functioning. The model predicted 83.3% of the variance (R=0.59; gl=1; p<0.001). Our results indicate a link between greater impairment in interpersonal relationships and being older and having more residual symptoms and a higher number of previous manic episodes. Patients with these features should be carefully monitored and specific psychosocial interventions should be implemented to improve their outcome. Copyright © 2009 Sociedad Española de Psiquiatría and Sociedad Española de Psiquiatría Biológica. Published by Elsevier Espana. All rights reserved.

Preserving residual renal function in dialysis patients: an update on evidence to assist clinical decision making

PubMed Central

Jensen, Jens Dam; Peters, Christian Daugaard; Jespersen, Bente

2011-01-01

It has been documented that preservation of residual renal function in dialysis patients improves quality of life as well as survival. Clinical trials on strategies to preserve residual renal function are clearly lacking. While waiting for more results from clinical trials, patients will benefit from clinicians being aware of available knowledge. The aim of this review was to offer an update on current evidence assisting doctors in clinical practice. PMID:25949486

Specification-based software sizing: An empirical investigation of function metrics

NASA Technical Reports Server (NTRS)

Jeffery, Ross; Stathis, John

1993-01-01

For some time the software industry has espoused the need for improved specification-based software size metrics. This paper reports on a study of nineteen recently developed systems in a variety of application domains. The systems were developed by a single software services corporation using a variety of languages. The study investigated several metric characteristics. It shows that: earlier research into inter-item correlation within the overall function count is partially supported; a priori function counts, in themself, do not explain the majority of the effort variation in software development in the organization studied; documentation quality is critical to accurate function identification; and rater error is substantial in manual function counting. The implication of these findings for organizations using function based metrics are explored.

Organizational structure and communication strategies of the bypass angioplasty revascularization investigation: a multicenter clinical trial.

PubMed

Naydeck, B L; Sutton-Tyrrell, K; Burek, K; Sopko, G S

1996-06-01

Efficient communication is a challenge for the many operating components of a multicenter randomized clinical trial. Traditional management theory states that communications generally flow along a path established by a hierarchical organizational structure. A multicenter clinical trial does not fit traditional organizational models well and requires modification of traditional communication techniques. While the scientific community typically views a clinical trial as one large and cohesive enterprise, at each site the trial may actually be conducted as a small project related to the medical specialty of the investigator. Therefore overall trial management must be accomplished through collaboration rather than through direct management. In the Bypass Angioplasty Revascularization Investigation (BARI), the BARI clinical coordinating center has designed and utilized several mechanisms that facilitate effective communication and administrative control of a multicenter clinical trial. These mechanisms provide a framework of communication techniques that accommodate the specific needs of a complex organization.

A multiplexed chip-based assay system for investigating the functional development of human skeletal myotubes in vitro.

PubMed

Smith, A S T; Long, C J; Pirozzi, K; Najjar, S; McAleer, C; Vandenburgh, H H; Hickman, J J

2014-09-20

This report details the development of a non-invasive in vitro assay system for investigating the functional maturation and performance of human skeletal myotubes. Data is presented demonstrating the survival and differentiation of human myotubes on microscale silicon cantilevers in a defined, serum-free system. These cultures can be stimulated electrically and the resulting contraction quantified using modified atomic force microscopy technology. This system provides a higher degree of sensitivity for investigating contractile waveforms than video-based analysis, and represents the first system capable of measuring the contractile activity of individual human muscle myotubes in a reliable, high-throughput and non-invasive manner. The development of such a technique is critical for the advancement of body-on-a-chip platforms toward application in pre-clinical drug development screens. Copyright © 2014 Elsevier B.V. All rights reserved.

Early- versus late-onset obsessive-compulsive disorder: investigating genetic and clinical correlates.

PubMed

Hemmings, Sîan M J; Kinnear, Craig J; Lochner, Christine; Niehaus, Dana J H; Knowles, James A; Moolman-Smook, Johanna C; Corfield, Valerie A; Stein, Dan J

2004-09-30

There is increasing evidence that obsessive-compulsive disorder (OCD) is mediated by genetic factors. Although the precise mechanism of inheritance is unclear, recent evidence has pointed towards the involvement of the serotonergic and dopaminergic systems in the disorder's development. Furthermore, early-onset OCD appears to be a subtype that exhibits distinct clinical features and that is associated with greater familial loading. In the present investigation, South African OCD patients (n=252) were stratified according to age of onset and were clinically assessed. Additionally, selected variants in genes encoding serotonergic and dopaminergic components were investigated in a Caucasian OCD subset (n=180). This subgroup was further stratified to evaluate the role that these candidate genes may play in the genetically homogeneous Afrikaner subset (n=80). Analysis of the clinical data revealed an association between early age of onset and an increased frequency of tics, Tourette's disorder, and trichotillomania (TTM). The genetic studies yielded statistically significant results when the allelic distributions of genetic variants in the dopamine receptor type 4 gene (DRD4) were analysed in the Caucasian OCD cohort. These data support a role for the dopaminergic system, which may be relevant to the development of early-onset OCD.

Chemotherapy-Induced Peripheral Neuropathy in Long-term Survivors of Childhood Cancer: Clinical, Neurophysiological, Functional, and Patient-Reported Outcomes.

PubMed

Kandula, Tejaswi; Farrar, Michelle Anne; Cohn, Richard J; Mizrahi, David; Carey, Kate; Johnston, Karen; Kiernan, Matthew C; Krishnan, Arun V; Park, Susanna B

2018-05-14

In light of the excellent long-term survival of childhood cancer patients, it is imperative to screen for factors affecting health, function, and quality of life in long-term survivors. To comprehensively assess chemotherapy-induced peripheral neuropathy in childhood cancer survivors to define disease burden and functional effect and to inform screening recommendations. In this cross-sectional observational study, cancer survivors who were treated with chemotherapy for extracranial malignancy before age 17 years were recruited consecutively between April 2015 and December 2016 from a single tertiary hospital-based comprehensive cancer survivorship clinic and compared with healthy age-matched controls. Investigators were blinded to the type of chemotherapy. A total of 169 patients met inclusion criteria, of whom 48 (28.4%) were unable to be contacted or declined participation. Chemotherapy agents known to be toxic to peripheral nerves. The clinical peripheral neurological assessment using the Total Neuropathy Score was compared between recipients of different neurotoxic chemotherapy agents and control participants and was correlated with neurophysiological, functional, and patient-reported outcome measures. Of the 121 childhood cancer survivors included in this study, 65 (53.7%) were male, and the cohort underwent neurotoxicity assessments at a median (range) age of 16 (7-47) years, a median (range) 8.5 (1.5-29) years after treatment completion. Vinca alkaloids and platinum compounds were the main neurotoxic agents. Clinical abnormalities consistent with peripheral neuropathy were common, seen in 54 of 107 participants (50.5%) treated with neurotoxic chemotherapy (mean Total Neuropathy Score increase, 2.1; 95% CI, 1.4-2.9; P < .001), and were associated with lower limb predominant sensory axonal neuropathy (mean amplitude reduction, 5.8 μV; 95% CI, 2.8-8.8; P < .001). Functional deficits were seen in manual dexterity, distal sensation, and balance. Patient

Upper Limb Assessment in Tetraplegia: Clinical, Functional and Kinematic Correlations

ERIC Educational Resources Information Center

Cacho, Enio Walker Azevedo; de Oliveira, Roberta; Ortolan, Rodrigo L.; Varoto, Renato; Cliquet, Alberto

2011-01-01

The aim of this study was to correlate clinical and functional evaluations with kinematic variables of upper limp reach-to-grasp movement in patients with tetraplegia. Twenty chronic patients were selected to perform reach-to-grasp kinematic assessment using a target placed at a distance equal to the arm's length. Kinematic variables (hand peak…

Clinical classification and neuro-vestibular evaluation in chronic dizziness.

PubMed

Oh, Sun-Young; Kim, Do-Hyung; Yang, Tae-Ho; Shin, Byoung-Soo; Jeong, Seul-Ki

2015-01-01

This study attempts to clarify the clinical characteristics of chronic dizziness and its relationships with specific vestibular, oculomotor, autonomic and psychiatric dysfunctions. 73 Patients with idiopathic chronic dizziness were recruited and classified based on history taking and clinical examination into the following four clinical subgroups; vestibular migraine (VM), dysautonomia, psychogenic, and unspecified groups. They were also evaluated using oculomotor, otolithic and autonomic function tests, and psychologic investigation. Patients in the VM group showed a high proportion of abnormality on smooth pursuit and otolithic function testing compared to the other groups. The dysautonomia group revealed significant abnormalities in sympathetic and cardiovagal autonomic function, while the psychogenic group had a high frequency of abnormality in sympathetic autonomic testing and in Beck's anxiety inventory scale. The unspecified group showed abnormalities on saccade, smooth pursuit and autonomic function testing. Clinical classification of patients with chronic dizziness was relevant and they showed a correlation with disease-specific abnormal results in oculomotor, otolithic, autonomic function and psychology testing. Appropriate diagnostic investigation based on precise clinical diagnosis of chronic dizziness reduces the need for extensive laboratory testing, neuroimaging, and other low-yield tests. Copyright © 2014 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Reactivating Neural Circuits with Clinically Accessible Stimulation to Restore Hand Function in Persons with Tetraplegia

DTIC Science & Technology

2017-09-01

AWARD NUMBER: W81XWH-16-1-0395 TITLE: Reactivating Neural Circuits with Clinically Accessible Stimulation to Restore Hand Function in...estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data...Clinically Accessible Stimulation to Restore Hand Function in Persons with Tetraplegia 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S

Relations between the Woodcock-Johnson III Clinical Clusters and Measures of Executive Functions from the Delis-Kaplan Executive Function System

ERIC Educational Resources Information Center

Floyd, Randy G.; McCormack, Allison C.; Ingram, Elizabeth L.; Davis, Amy E.; Bergeron, Renee; Hamilton, Gloria

2006-01-01

This study examined the convergent relations between scores from four clinical clusters from the Woodcock-Johnson III Tests of Cognitive Abilities (WJ III) and measures of executive functions using a sample of school-aged children and a sample of adults. The WJ III clinical clusters included the Working Memory, Cognitive Fluency, Broad Attention,…

ASSESSMENT OF UPPER EXTREMITY IMPAIRMENT, FUNCTION, AND ACTIVITY FOLLOWING STROKE: FOUNDATIONS FOR CLINICAL DECISION MAKING

PubMed Central

Lang, Catherine E.; Bland, Marghuretta D.; Bailey, Ryan R.; Schaefer, Sydney Y.; Birkenmeier, Rebecca L.

2012-01-01

The purpose of this review is to provide a comprehensive approach for assessing the upper extremity (UE) after stroke. First, common upper extremity impairments and how to assess them are briefly discussed. While multiple UE impairments are typically present after stroke, the severity of one impairment, paresis, is the primary determinant of UE functional loss. Second, UE function is operationally defined and a number of clinical measures are discussed. It is important to consider how impairment and loss of function affect UE activity outside of the clinical environment. Thus, this review also identifies accelerometry as an objective method for assessing UE activity in daily life. Finally, the role that each of these levels of assessment should play in clinical decision making is discussed in order to optimize the provision of stroke rehabilitation services. PMID:22975740

The biology, function and clinical implications of exosomes in lung cancer.

PubMed

Zhou, Li; Lv, Tangfeng; Zhang, Qun; Zhu, Qingqing; Zhan, Ping; Zhu, Suhua; Zhang, Jianya; Song, Yong

2017-10-28

Exosomes are 30-100 nm small membrane vesicles of endocytic origin that are secreted by all types of cells, and can also be found in various body fluids. Increasing evidence implicates that exosomes confer stability and can deliver their cargos such as proteins and nucleic acids to specific cell types, which subsequently serve as important messengers and carriers in lung carcinogenesis. Here, we describe the biogenesis and components of exosomes mainly in lung cancer, we summarize their function in lung carcinogenesis (epithelial mesenchymal transition, oncogenic cell transformation, angiogenesis, metastasis and immune response in tumor microenvironment), and importantly we focus on the clinical potential of exosomes as biomarkers and therapeutics in lung cancer. In addition, we also discuss current challenges that might impede the clinical use of exosomes. Further studies on the functional roles of exosomes in lung cancer requires thorough research. Copyright © 2017 Elsevier B.V. All rights reserved.

Mining approximate temporal functional dependencies with pure temporal grouping in clinical databases.

PubMed

Combi, Carlo; Mantovani, Matteo; Sabaini, Alberto; Sala, Pietro; Amaddeo, Francesco; Moretti, Ugo; Pozzi, Giuseppe

2015-07-01

Functional dependencies (FDs) typically represent associations over facts stored by a database, such as "patients with the same symptom get the same therapy." In more recent years, some extensions have been introduced to represent both temporal constraints (temporal functional dependencies - TFDs), as "for any given month, patients with the same symptom must have the same therapy, but their therapy may change from one month to the next one," and approximate properties (approximate functional dependencies - AFDs), as "patients with the same symptomgenerallyhave the same therapy." An AFD holds most of the facts stored by the database, enabling some data to deviate from the defined property: the percentage of data which violate the given property is user-defined. According to this scenario, in this paper we introduce approximate temporal functional dependencies (ATFDs) and use them to mine clinical data. Specifically, we considered the need for deriving new knowledge from psychiatric and pharmacovigilance data. ATFDs may be defined and measured either on temporal granules (e.g.grouping data by day, week, month, year) or on sliding windows (e.g.a fixed-length time interval which moves over the time axis): in this regard, we propose and discuss some specific and efficient data mining techniques for ATFDs. We also developed two running prototypes and showed the feasibility of our proposal by mining two real-world clinical data sets. The clinical interest of the dependencies derived considering the psychiatry and pharmacovigilance domains confirms the soundness and the usefulness of the proposed techniques. Copyright © 2014 Elsevier Ltd. All rights reserved.

Medication Use in Early-HD Participants in Track-HD: an Investigation of its Effects on Clinical Performance.

PubMed

Keogh, Ruth; Frost, Chris; Owen, Gail; Daniel, Rhian M; Langbehn, Doug R; Leavitt, Blair; Durr, Alexandra; Roos, Raymund A C; Landwehrmeyer, G Bernhard; Reilmann, Ralf; Borowsky, Beth; Stout, Julie; Craufurd, David; Tabrizi, Sarah J

2016-01-11

 Insufficient evidence exists to guide the long-term pharmacological management of Huntington's disease (HD) although most current interventions rely on symptomatic management. The effect of many frontline treatments on potential endpoints for HD clinical trials remains unknown. Our objective was to investigate how therapies widely used to manage HD affect the symptom for which they are prescribed and other endpoints using data from TRACK-HD. We used longitudinal models to estimate effects of medication use on performance on tests of motor, cognitive and neuropsychiatric function using data from 123 TRACK-HD stage 1/2 participants across four study visits. Adjustment for confounding by prior medication use, prior clinical performance, concomitant use of other medications, and baseline variables (sex, disease group, age, CAG, study site, education) enabled a closer-to-causal interpretation of the associations. Adjusting for baseline variables only, medication use was typically associated with worse clinical performance, reflecting greater medication use in more advanced patients. After additional adjustment for longitudinal confounders such "inverse" associations were generally eliminated and in the expected directions: participants taking neuroleptics tended to have better motor performance, improved affect and poorer cognitive performance, and those taking SSRI/SNRIs had less apathy, less affect and better total behaviour scores. However, we uncovered few statistically significant associations. Limitations include sample size and unmeasured confounding. In conclusion, adjustment for confounding by prior measurements largely eliminated associations between medication use and poorer clinical performance from simple analyses. However, there was little convincing evidence of causal effects of medication on clinical performance and larger cohorts or trials are needed.

A novel functional class 2 integron in clinical Proteus mirabilis isolates.

PubMed

Wei, Quhao; Hu, Qingfeng; Li, Shanshan; Lu, Huoyang; Chen, Guoqiang; Shen, Beiqiong; Zhang, Ping; Zhou, Yonglie

2014-04-01

To describe a novel functional class 2 integron that was found in clinical Proteus mirabilis isolates. Class 1 and 2 integrons were screened by PCR in 153 clinical Proteus isolates. The variable regions of class 1 and 2 integrons were determined by restriction analysis and sequencing. The mutations of internal stop codons in class 2 integrons and their common promoters were also determined by sequencing. Enterobacterial repetitive intergenic consensus (ERIC)-PCR was used to analyse the phylogenetic relations of class 2 integron-positive P. mirabilis isolates. Class 1 integrons were detected in 96 (63%) of 153 Proteus isolates: eight different gene cassette arrays were detected, including dfrA32-ereA1-aadA2, which was detected for the first time in P. mirabilis. Class 2 integrons were detected in 101 (66%) of 153 Proteus isolates: four different gene cassette arrays were detected, including dfrA1-catB2-sat2-aadA1, which was detected for the first time in a class 2 integron. A novel functional class 2 integron was detected in 38 P. mirabilis isolates with a common promoter (-35 TTTAAT|16 bp|-10 TAAAGT). The variable region of this functional class 2 integron contained dfrA14 and three novel open reading frames with unknown functions. Very similar ERIC-PCR fingerprinting patterns were detected in these 38 P. mirabilis isolates and were different from other class 2 integron-positive isolates. A novel functional class 2 integron was found for the first time in P. mirabilis. These functional class 2 integron-harbouring P. mirabilis isolates were likely to be clonally spread in our hospital.

Ankle foot orthosis-footwear combination tuning: an investigation into common clinical practice in the United Kingdom.

PubMed

Eddison, Nicola; Chockalingam, Nachiappan; Osborne, Stephen

2015-04-01

Ankle foot orthoses are used to treat a wide variety of gait pathologies. Ankle foot orthosis-footwear combination tuning should be routine clinical practice when prescribing an ankle foot orthosis. Current research suggests that failure to tune ankle foot orthosis-footwear combinations can lead to immediate detrimental effect on function, and in the longer term, it may actually contribute to deterioration. The purpose of this preliminary study was to identify the current level of knowledge clinicians have in the United Kingdom regarding ankle foot orthosis-footwear combination tuning and to investigate common clinical practice regarding ankle foot orthosis-footwear combination tuning among UK orthotists. Cross-sectional survey. A prospective study employing a multi-item questionnaire was sent out to registered orthotists and uploaded on to the official website of British Association of Prosthetists and Orthotists to be accessed by their members. A total of 41 completed questionnaires were received. The results demonstrate that only 50% of participants use ankle foot orthosis-footwear combination tuning as standard clinical practice. The most prevalent factors preventing participants from carrying out ankle foot orthosis-footwear combination tuning are a lack of access to three-dimensional gait analysis equipment (37%) and a lack of time available in their clinics (27%). Although, ankle foot orthosis-footwear combination tuning has been identified as an essential aspect of the prescription of ankle foot orthoses, the results of this study show a lack of understanding of the key principles behind ankle foot orthosis-footwear combination tuning. © The International Society for Prosthetics and Orthotics 2014.

Effectiveness of the Virtual Reality System Toyra on Upper Limb Function in People with Tetraplegia: A Pilot Randomized Clinical Trial.

PubMed

Dimbwadyo-Terrer, I; Gil-Agudo, A; Segura-Fragoso, A; de los Reyes-Guzmán, A; Trincado-Alonso, F; Piazza, S; Polonio-López, B

2016-01-01

The aim of this study was to investigate the effects of a virtual reality program combined with conventional therapy in upper limb function in people with tetraplegia and to provide data about patients' satisfaction with the virtual reality system. Thirty-one people with subacute complete cervical tetraplegia participated in the study. Experimental group received 15 sessions with Toyra(®) virtual reality system for 5 weeks, 30 minutes/day, 3 days/week in addition to conventional therapy, while control group only received conventional therapy. All patients were assessed at baseline, after intervention, and at three-month follow-up with a battery of clinical, functional, and satisfaction scales. Control group showed significant improvements in the manual muscle test (p = 0,043, partial η (2) = 0,22) in the follow-up evaluation. Both groups demonstrated clinical, but nonsignificant, changes to their arm function in 4 of the 5 scales used. All patients showed a high level of satisfaction with the virtual reality system. This study showed that virtual reality added to conventional therapy produces similar results in upper limb function compared to only conventional therapy. Moreover, the gaming aspects incorporated in conventional rehabilitation appear to produce high motivation during execution of the assigned tasks. This trial is registered with EudraCT number 2015-002157-35.

Effectiveness of the Virtual Reality System Toyra on Upper Limb Function in People with Tetraplegia: A Pilot Randomized Clinical Trial

PubMed Central

Dimbwadyo-Terrer, I.; Gil-Agudo, A.; Segura-Fragoso, A.; de los Reyes-Guzmán, A.; Trincado-Alonso, F.; Piazza, S.; Polonio-López, B.

2016-01-01

The aim of this study was to investigate the effects of a virtual reality program combined with conventional therapy in upper limb function in people with tetraplegia and to provide data about patients' satisfaction with the virtual reality system. Thirty-one people with subacute complete cervical tetraplegia participated in the study. Experimental group received 15 sessions with Toyra® virtual reality system for 5 weeks, 30 minutes/day, 3 days/week in addition to conventional therapy, while control group only received conventional therapy. All patients were assessed at baseline, after intervention, and at three-month follow-up with a battery of clinical, functional, and satisfaction scales. Control group showed significant improvements in the manual muscle test (p = 0,043, partial η 2 = 0,22) in the follow-up evaluation. Both groups demonstrated clinical, but nonsignificant, changes to their arm function in 4 of the 5 scales used. All patients showed a high level of satisfaction with the virtual reality system. This study showed that virtual reality added to conventional therapy produces similar results in upper limb function compared to only conventional therapy. Moreover, the gaming aspects incorporated in conventional rehabilitation appear to produce high motivation during execution of the assigned tasks. This trial is registered with EudraCT number 2015-002157-35. PMID:26885511

An Investigation into the Clinical Reasoning Development of Veterinary Students.

PubMed

Vinten, Claire E K; Cobb, Kate A; Freeman, Sarah L; Mossop, Liz H

Clinical reasoning is a fundamental skill for veterinary clinicians and a competency required of graduates by the Royal College of Veterinary Surgeons. However, it is unknown how veterinary students develop reasoning skills and where strengths and shortcomings of curricula lie. This research aimed to use the University of Nottingham School of Veterinary Medicine and Science (SVMS) as a case study to investigate the development of clinical reasoning among veterinary students. The analysis was framed in consideration of the taught, learned, and declared curricula. Sixteen staff and sixteen students from the SVMS participated separately in a total of four focus groups. In addition, five interviews were conducted with recent SVMS graduates. Audio transcriptions were used to conduct a thematic analysis. A content analysis was performed on all curriculum documentation. It was found that SVMS graduates feel they have a good level of reasoning ability, but they still experience a deficit in their reasoning capabilities when starting their first job. Overarching themes arising from the data suggest that a lack of responsibility for clinical decisions during the program and the embedded nature of the clinical reasoning skill within the curriculum could be restricting development. In addition, SVMS students would benefit from clinical reasoning training where factors influencing "real life" decisions (e.g., finances) are explored in more depth. Integrating these factors into the curriculum could lead to improved decision-making ability among SVMS graduates and better prepare students for the stressful transition to practice. These findings are likely to have implications for other veterinary curricula.

Impact of Eating Attitude and Impairment of Physical Quality of Life Between Tertiary Clinic and Primary Clinic Functional Dyspepsia Outpatients in Japan

PubMed Central

Shimpuku, Mayumi; Futagami, Seiji; Tajima, Natsuki; Yamawaki, Hiroshi; Maruki, Yuuta; Kodaka, Yasuhiro; Nagoya, Hiroyuki; Gudis, Katya; Kawagoe, Tetsuro; Sakamoto, Choitsu

2014-01-01

Background/Aims There is no available data on factors associated with healthcare-seeking behavior for functional dyspepsia (FD) symptoms at either tertiary or primary clinics in Japan. Therefore, we aimed to compare clinical symptoms and life styles such as sleep disorders and eating attitude in FD patients visiting general practitioners at primary clinics with those consulting gastroenterologists at tertiary clinics to clarify healthcare-seeking patterns in Japanese patients. Methods Fifty-one FD outpatients in a tertiary clinic (college hospital), 50 FD outpatients visiting primary clinics and 50 healthy volunteers were enrolled. Clinical symptoms, quality of life, sleep disorders, eating attitude and anxiety were estimated using the Gastrointestinal Symptom Rating Scale (GSRS), Social Functioning-8 (SF-8) test, Pittsburg Sleep Quality Index (PSQI) test and State-Trait Anxiety Inventory (STAI) for FD outpatients and healthy volunteers. Results FD outpatients exhibited higher mean scores of GSRS than healthy volunteers. The SF-8 physical component summary scores in the tertiary clinic group were significantly lower than those in the primary clinic group. GSRS scores were significantly (P < 0.001, P = 0.002) associated with global PSQI scores in FD outpatients as well as with STAI-trait scores (P = 0.006, P = 0.001) compared to healthy volunteers. The frequency of eating between meals in the primary clinic group was significantly (P < 0.05) higher than that in the tertiary clinic group. Conclusions It may be important for clarification of healthcare-seeking behavior to determine the difference in both impairment of physical quality of life and eating attitudes between tertiary clinic and primary clinic FD outpatients in Japan. PMID:25273121

Clinical-Functional Vulnerability Index-20 (IVCF-20): rapid recognition of frail older adults

PubMed Central

de Moraes, Edgar Nunes; do Carmo, Juliana Alves; de Moraes, Flávia Lanna; Azevedo, Raquel Souza; Machado, Carla Jorge; Montilla, Dalia Elena Romero

2016-01-01

ABSTRACT OBJECTIVE To evaluate the adequacy of the Clinical-Functional Vulnerability Index-20, a rapid triage instrument to test vulnerability in Brazilian older adults, for the use in primary health care. METHODS The study included convenience sample of 397 patients aged older than or equal to 60 years attended at Centro de Referência para o Idoso (Reference Center for Older Adults) and of 52 older adults the same age attended at the community. The results of the questionnaire, consisting of 20 questions, were compared with those of the Comprehensive Geriatric Assessment, considered a reference for identifying frail older adults. Spearman’s correlation was evaluated in the Clinical-Functional Vulnerability Index-20 with the Comprehensive Geriatric Assessment; the validity was verified by the area under the ROC curve; reliability was estimated by the percentage of agreement among evaluators and by the kappa coefficient, both with quadratic weighted. The cut-off point was obtained based on the higher accuracy criterion. Cronbach’s alpha, a measure of internal consistency, was estimated. RESULTS The Spearman’s correlation coefficient was high and positive for both groups (0.792 for older adults attended at the Reference Center and 0.305 for older adults from the community [p < 0.001]). The area under the ROC curve for older adults attended at the Reference Center was substantial (0.903). The cut-off point obtained was six, and older adults with scores in Clinical-Functional Vulnerability Index-20 above that value had strong possibility of being frail. For older adults from the community, the quadratic weighted agreement among evaluators was 99.5%, and the global quadratic weighted kappa coefficient was 0.94. Cronbach’s alpha was high for older adults attended at the Reference Center (0.861) and those attended at the community (0.740). CONCLUSIONS The Clinical-Functional Vulnerability Index-20 questionnaire, in the sample examined, turned out to be positively

Doing Pre-operative Investigations in Emergency Department; a Clinical Audit.

PubMed

Rafiq, Muhammad Salman; Rafiq, Maria; Rafiq, Muhammad Imran; Salman, Seema Gul; Hafeez, Sania

2017-01-01

Pre-operative investigations for emergency surgical patients differ between centers. Following established guidelines can reduce unnecessary investigation, cost of treatment and hospital stay. The present audit was carried out to evaluate the condition of doing pre-operative investigations for three common surgical emergencies compared to National Institute for Health and Care Excellence (NICE) guidelines and local criteria. A retrospective clinical audit of acute-appendicitis, abscess and hernia patients admitted to the emergency department was carried out over a one-year period from July 2014 to July 2015. Data of laboratory investigations, their indication, cost and duration of hospital stay was collected and compared with NICE-guidelines. A total of 201 patients were admitted to the emergency department during the audit period. These included 77(38.3%) cases of acute-appendicitis, 112 (55.7%) cases of abscesses, and 12 (6%) cases of hernia. Investigations not indicated by NICE-guidelines included 42 (20.9%) full blood counts, 29 (14.4%) random blood sugars, 26 (12.9%) urea tests, 4 (2%) chest x-rays, 13 (6.5%) electrocardiographs, and 58 (28.9%) urine analyses. These cost 25,675 Rupees (245.46 Dollars) in unnecessary investigation costs and 65.7 days of additional hospital stay. Unnecessary investigations for emergency surgical patients can be reduced by following NICE-guidelines. This will reduce workload on emergency services, treatment costs and the length of hospital stay.

Template protocol for clinical trials investigating vaccines—Focus on safety elements☆

PubMed Central

Bonhoeffer, Jan; Imoukhuede, Egeruan B.; Aldrovandi, Grace; Bachtiar, Novilia S.; Chan, Eng-Soon; Chang, Soju; Chen, Robert T.; Fernandopulle, Rohini; Goldenthal, Karen L.; Heffelfinger, James D.; Hossain, Shah; Jevaji, Indira; Khamesipour, Ali; Kochhar, Sonali; Makhene, Mamodikoe; Malkin, Elissa; Nalin, David; Prevots, Rebecca; Ramasamy, Ranjan; Sellers, Sarah; Vekemans, Johan; Walker, Kenneth B.; Wilson, Pam; Wong, Virginia; Zaman, Khalequz; Heininger, Ulrich

2015-01-01

This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I–IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts. PMID:23499603

Longitudinal left ventricular function for prediction of survival in systemic light-chain amyloidosis: incremental value compared with clinical and biochemical markers.

PubMed

Buss, Sebastian J; Emami, Mostafa; Mereles, Derliz; Korosoglou, Grigorios; Kristen, Arnt V; Voss, Andreas; Schellberg, Dieter; Zugck, Christian; Galuschky, Christian; Giannitsis, Evangelos; Hegenbart, Ute; Ho, Anthony D; Katus, Hugo A; Schonland, Stefan O; Hardt, Stefan E

2012-09-18

The aim of the study was to determine whether longitudinal left ventricular (LV) function provides prognostic information in a large cohort of patients with systemic light-chain (AL) amyloidosis. AL amyloidosis is associated with a high incidence of cardiovascular events. Reduced myocardial longitudinal function is one of the hallmarks of myocardial involvement in this rare disease. Two hundred six consecutive patients with biopsy-proven AL amyloidosis were investigated in this prospective observational study. Echocardiographic imaging parameters, mean tissue Doppler-derived longitudinal strain (LS), and two-dimensional global longitudinal strain (2D-GLS) of the LV, cardiac serological biomarkers, and comprehensive clinical disease characteristics were assessed. The primary endpoint was all-cause mortality or heart transplantation. After a median follow-up of 1207 days, LS and 2D-GLS were significant predictors of survival in AL amyloidosis. The cutoff values discriminating survivors from nonsurvivors were -10.65% for LS and -11.78% for 2D-GLS. In a multivariable echocardiographic Cox model, only diastolic dysfunction and 2D-GLS remained as independent predictors of survival. In comprehensive clinical models, 2D-GLS (p < 0.0001), diastolic dysfunction (p < 0.01), the pathologic free light chains (p < 0.05), cardiac troponin-T (cTnT) (p < 0.01), and the Karnofsky index (p < 0.001) remained as independent predictors. 2D-GLS delineated a superior prognostic value compared with that derived from pathologic free light chains or cTnT in patients evaluated before firstline chemotherapy (n = 113; p < 0.0001), and remained the only independent predictor besides the Karnofsky index in subjects with preserved LV ejection fraction (≥50%; n = 127; p < 0.01). LS and 2D-GLS both offered significant incremental information (p < 0.001) for the assessment of outcome compared with clinical variables (age, Karnofsky index, and New York Heart Association functional class) and

Is Early-onset in Major Depression a Predictor of Specific Clinical Features with More Impaired Social Function?

PubMed Central

Liu, Yan-Hong; Chen, Lin; Su, Yun-Ai; Fang, Yi-Ru; Srisurapanont, Manit; Hong, Jin Pyo; Hatim, Ahmad; Chua, Hong Choon; Bautista, Dianne; Si, Tian-Mei

2015-01-01

Background: Early-onset major depressive disorder (MDD) (EOD) is often particularly malignant due to its special clinical features, accompanying impaired social function, protracted recovery time, and frequent recurrence. This study aimed to observe the effects of age onset on clinical characteristics and social function in MDD patients in Asia. Methods: In total, 547 out-patients aged 18–65 years who were from 13 study sites in five Asian countries were included. These patients had MDD diagnose according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition criteria. Clinical features and social function were assessed using Symptom Checklist-90-revised (SCL-90-R) and Sheehan Disability Scale (SDS). Quality of life was assessed by a 36-item Short-form Health Survey (SF-36). Analyses were performed using a continuous or dichotomous (cut-off: 30 years) age-of-onset indicator. Results: Early-onset MDD (EOD, <30 years) was associated with longer illness (P = 0.003), unmarried status (P < 0.001), higher neuroticism (P ≤ 0.002) based on the SCL-90-R, and more limited social function and mental health (P = 0.006, P = 0.007) based on the SF-36 and SDS. The impairment of social function and clinical severity were more prominent at in-patients with younger onset ages. Special clinical features and more impaired social function and quality of life were associated with EOD, as in western studies. Conclusions: EOD often follows higher levels of neuroticism. Age of onset of MDD may be a predictor of clinical features and impaired social function, allowing earlier diagnosis and treatment. PMID:25758278

Changes in functional connectivity of the brain associated with a history of sport concussion: A preliminary investigation.

PubMed

Churchill, Nathan; Hutchison, Michael G; Leung, General; Graham, Simon; Schweizer, Tom A

2017-01-01

There is evidence of long-term clinical consequences associated with a history of sport concussion. However, there remains limited information about the underlying changes in brain function. The goal of this study was to identify brain regions where abnormal resting-state function is associated with chronic concussion, for athletes without persistent symptoms. Functional Magnetic Resonance Imaging (fMRI) was performed on a group of athletes with prior concussion (n = 22) and a group without documented injury (n = 21). Multivariate predictive modelling was used to localize reliable changes in brain connectivity that are associated with a history of concussion and with clinical factors, including number of prior concussions and recovery time from last injury. No significant differences were found between athletes with and without a history of concussion, but functional connectivity was significantly associated with clinical history. The number of prior concussions was associated with most extensive connectivity changes, particularly for elements of the visual attention network and cerebellum. The findings of this preliminary study indicate that functional brain abnormalities associated with chronic concussion may be significantly dependent on clinical history. In addition, elements of the visual and cerebellar systems may be most sensitive to the long-term effects of sport concussion.

Premorbid functional development and conversion to psychosis in clinical high-risk youths

PubMed Central

Tarbox, Sarah I.; Addington, Jean; Cadenhead, Kristin S.; Cannon, Tyrone D.; Cornblatt, Barbara A.; Perkins, Diana O.; Seidman, Larry J.; Tsuang, Ming T.; Walker, Elaine F.; Heinssen, Robert; Mcglashan, Thomas H.; Woods, Scott W.

2014-01-01

Deterioration in premorbid functioning is a common feature of schizophrenia, but sensitivity to psychosis conversion among clinical high-risk samples has not been examined. This study evaluates premorbid functioning as a predictor of psychosis conversion among a clinical high-risk sample, controlling for effects of prior developmental periods. Participants were 270 clinical high-risk individuals in the North American Prodrome Longitudinal Study—I, 78 of whom converted to psychosis over the next 2.5 years. Social, academic, and total maladjustment in childhood, early adolescence, and late adolescence were rated using the Cannon–Spoor Premorbid Adjustment Scale. Early adolescent social dysfunction significantly predicted conversion to psychosis (hazard ratio = 1.30, p = .014), independently of childhood social maladjustment and independently of severity of most baseline positive and negative prodromal symptoms. Baseline prodromal symptoms of disorganized communication, social anhedonia, suspiciousness, and diminished ideational richness mediated this association. Early adolescent social maladjustment and baseline suspiciousness together demonstrated moderate positive predictive power (59%) and high specificity (92.1%) in predicting conversion. Deterioration of academic and total functioning, although observed, did not predict conversion to psychosis. Results indicate early adolescent social dysfunction to be an important early predictor of conversion. As such, it may be a good candidate for inclusion in prediction algorithms and could represent an advantageous target for early intervention. PMID:24229556

Clinical application of a selenium (75Se)-labelled bile acid for the investigation of terminal ileal function.

PubMed

Nyhlin, H; Brydon, G; Danielsson, A; Westman, S

1984-08-01

With the introduction of a selenium bile acid SeHCAT (tauro-23-75Se-Selena-25 homocholic acid) a new and clinically valuable test for the functioning of the terminal ileum has been made available. Previous studies have shown that the test detects patients with bile acid malabsorption due to ileal disease. In this study SeHCAT retention was evaluated in nine patients with Crohn's disease and in seven healthy controls after intravenous administration of 0.15 MBq (4 muCi). A simple way of expressing the results is proposed. By using the calculated time required to eliminate 50% of the SeHCAT (WBR50), information is obtained as to the degree of terminal ileum malfunction regarding bile acid absorption. Accurate values seem to be achieved within 48 hours. As the SeHCAT is a gamma-ray emitter the dose retained could be measured by external counting. We suggest a practical design for the test using a simple scintillation spectro-photometer with a single detector in a low-background room. In patients and healthy controls the SeHCAT retention as calculated by WBR50 was 63 hrs (15-163) and 120 hrs (range 99-141), respectively. There was no overall relation between SeHCAT elimination and the intestinal transit time, although in the patient group a significant correlation was demonstrated, probably secondary to the impairment of the terminal ileum. A significant correlation was shown between the outcome of the test and the faecal excretion of total bile acids.

Understanding Career Success and Its Contributing Factors for Clinical and Translational Investigators.

PubMed

Robinson, Georgeanna F W B; Schwartz, Lisa S; DiMeglio, Linda A; Ahluwalia, Jasjit S; Gabrilove, Janice L

2016-04-01

To understand the factors that facilitate career success for career development awardees in clinical and translational science and reconceptualize understand ing of career success for this population. In 2013-2014, the authors conducted semistructured interviews with former NIH KL2 or K12 scholars from nine Clinical and Translational Science Award-funded institutions. Participants either had or had not secured independent funding at least two years after the end of their last K award. Questions covered the factors that facilitate or hinder junior investigators' transition to independent funding. Interviews were recorded and transcribed, and the transcripts were analyzed thematically. Forty individuals participated, with equal representation by men and women and by independently and not independently funded investigators. Personal factors that facilitated success included networks, persistence and resilience, initiative, autonomy, and personal and professional balance. Organizational factors included appropriate mentorship, protected research time, and institutional resources and support.Even independently funded participants described challenges regarding career direction. Five participants without independent funding modeled a broad spectrum of successful career paths, having assumed leadership positions not reliant on grant funding. Alternative definitions of career success included improving public health, enjoying work, seeing mentees succeed, and receiving external acknowledgment of successes. Awareness of the factors that facilitate or hinder career success can help junior faculty, mentors, and institutional leaders support career development in clinical and translational science. New definitions of career success are needed, as are career paths for faculty who want to engage in research in roles other than principal investigator.

Sexual Function After Stereotactic Body Radiotherapy for Prostate Cancer: Results of a Prospective Clinical Trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wiegner, Ellen A.; King, Christopher R., E-mail: crking@stanford.ed

Purpose: To study the sexual quality of life for prostate cancer patients after stereotactic body radiotherapy (SBRT). Methods and Materials: Using the Expanded Prostate Cancer Index Composite (EPIC)-validated quality-of-life questionnaire, the sexual function of 32 consecutive patients who received prostate SBRT in a prospective Phase II clinical trial were analyzed at baseline, and at median times of 4, 12, 20, and 50 months after treatment. SBRT consisted of 36.25 Gy in five fractions of 7.25 Gy using the Cyberknife. No androgen deprivation therapy was given. The use of erectile dysfunction (ED) medications was monitored. A comprehensive literature review for radiotherapy-alonemore » modalities based on patient self-reported questionnaires served as historical comparison. Results: Median age at treatment was 67.5 years, and median follow-up was 35.5 months (minimum 12 months). The mean EPIC sexual domain summary score, sexual function score, and sexual bother score decreased by 45%, 49%, and 25% respectively at 50 months follow-up. These differences reached clinical relevance by 20 months after treatment. Baseline ED rate was 38% and increased to 71% after treatment (p = 0.024). Use of ED medications was 3% at baseline and progressed to 25%. For patients aged <70 years at follow-up, 60% maintained satisfactory erectile function after treatment compared with only 12% aged {>=}70 years (p = 0.008). Penile bulb dose was not associated with ED. Conclusions: The rates of ED after treatment appear comparable to those reported for other modalities of radiotherapy. Given the modest size of this study and the uncertainties in the physiology of radiotherapy-related ED, these results merit further investigations.« less

Viscoelastic assessment of anal canal function using acoustic reflectometry: a clinically useful technique.

PubMed

Mitchell, Peter J; Klarskov, Niels; Telford, Karen J; Hosker, Gordon L; Lose, Gunnar; Kiff, Edward S

2012-02-01

Anal acoustic reflectometry is a new reproducible technique that allows a viscoelastic assessment of anal canal function. Five new variables reflecting anal canal function are measured: the opening and closing pressure, opening and closing elastance, and hysteresis. The aim of this study was to assess whether the parameters measured in anal acoustic reflectometry are clinically valid between continent and fecally incontinent subjects. This was an age- and sex-matched study of continent and incontinent women. The study was conducted at a university teaching hospital. One hundred women (50 with fecal incontinence and 50 with normal bowel control) were included in the study. Subjects were age matched to within 5 years. Parameters measured with anal acoustic reflectometry and manometry were compared between incontinent and continent groups using a paired t test. Diagnostic accuracy was assessed by the use of receiver operator characteristic curves. Four of the 5 anal acoustic reflectometry parameters at rest were significantly different between continent and incontinent women (eg, opening pressure in fecally incontinent subjects was 31.6 vs 51.5 cm H2O in continent subjects, p = 0.0001). Both anal acoustic reflectometry parameters of squeeze opening pressure and squeeze opening elastance were significantly reduced in the incontinent women compared with continent women (50 vs 99.1 cm H2O, p = 0.0001 and 1.48 vs 1.83 cm H2O/mm, p = 0.012). In terms of diagnostic accuracy, opening pressure at rest measured by reflectometry was significantly superior in discriminating between continent and incontinent women in comparison with resting pressure measured with manometry (p = 0.009). Anal acoustic reflectometry is a new, clinically valid technique in the assessment of continent and incontinent subjects. This technique, which assesses the response of the anal canal to distension and relaxation, provides a detailed viscoelastic assessment of anal canal function. This technique

The investigation of CD4+T-cell functions in primary HIV infection with antiretroviral therapy

PubMed Central

Sun, Yu; Fu, Yajing; Zhang, Zining; Tang, Tian; Liu, Jing; Ding, Haibo; Han, Xiaoxu; Xu, Junjie; Chu, Zhenxing; Shang, Hong; Jiang, Yongjun

2017-01-01

Abstract Human immunodeficiency virus (HIV) infection leads to reduced CD4+T-cell counts and immune dysfunction. Initiation of antiretroviral therapy (ART) in HIV primary infection has been recommended to achieve an optimal clinical outcome, but a comprehensive study on restoration of CD4+T-cell function in primary HIV-infected individuals with ART still needs to be eluciated. We investigated longitudinal changes in the CD4+T-cell counts, phenotypes, and functions in HIV-infected individuals with early ART (initiated within 6 months after HIV infection) or later ART (initiated more than 12 months after HIV infection). Patients from early ART and later ART groups had received ART for at least 1 year. Individuals with early ART had more CD4+T cells, a faster rate of CD4+T-cell recovery than those receiving later ART; the levels of CD4+T-cell activation and senescence were lower in early ART compared to those with later ART (P = .031; P = .016), but the activation was higher than normal controls (NC) (P = .001); thymic emigrant function was more upregulated in early ART than in later ART (P = .015), but still lower than NC (P = .027); proliferative capacity and interferon-γ secretion of CD4+T cells were significantly decreased in primary infection (P < .001; P = .029), and early ART restored these CD4+T-cell functions, there is no difference with NC, later ART could partially restore the functions of CD4+T cells, but it remained lower than that of NC (P = .005; P = .019). Early ART could better improve CD4+T-cell function. PMID:28700479

Enhanced functionalities for annotating and indexing clinical text with the NCBO Annotator.

PubMed

Tchechmedjiev, Andon; Abdaoui, Amine; Emonet, Vincent; Melzi, Soumia; Jonnagaddala, Jitendra; Jonquet, Clement

2018-06-01

Second use of clinical data commonly involves annotating biomedical text with terminologies and ontologies. The National Center for Biomedical Ontology Annotator is a frequently used annotation service, originally designed for biomedical data, but not very suitable for clinical text annotation. In order to add new functionalities to the NCBO Annotator without hosting or modifying the original Web service, we have designed a proxy architecture that enables seamless extensions by pre-processing of the input text and parameters, and post processing of the annotations. We have then implemented enhanced functionalities for annotating and indexing free text such as: scoring, detection of context (negation, experiencer, temporality), new output formats and coarse-grained concept recognition (with UMLS Semantic Groups). In this paper, we present the NCBO Annotator+, a Web service which incorporates these new functionalities as well as a small set of evaluation results for concept recognition and clinical context detection on two standard evaluation tasks (Clef eHealth 2017, SemEval 2014). The Annotator+ has been successfully integrated into the SIFR BioPortal platform-an implementation of NCBO BioPortal for French biomedical terminologies and ontologies-to annotate English text. A Web user interface is available for testing and ontology selection (http://bioportal.lirmm.fr/ncbo_annotatorplus); however the Annotator+ is meant to be used through the Web service application programming interface (http://services.bioportal.lirmm.fr/ncbo_annotatorplus). The code is openly available, and we also provide a Docker packaging to enable easy local deployment to process sensitive (e.g. clinical) data in-house (https://github.com/sifrproject). andon.tchechmedjiev@lirmm.fr. Supplementary data are available at Bioinformatics online.

Expectations and experiences of investigators and parents involved in a clinical trial for Duchenne/Becker muscular dystrophy.

PubMed

Peay, Holly L; Tibben, Aad; Fisher, Tyler; Brenna, Ethan; Biesecker, Barbara B

2014-02-01

The social context of rare disease research is changing, with increased community engagement around drug development and clinical trials. This engagement may benefit patients and families but may also lead to heightened trial expectations and therapeutic misconception. Clinical investigators are also susceptible to harboring high expectations. Little is known about parental motivations and expectations for clinical trials for rare pediatric disorders. We describe the experience of parents and clinical investigators involved in a phase II clinical trial for Duchenne and Becker muscular dystrophy: their expectations, hopes, motivations, and reactions to the termination of the trial. This qualitative study was based on interviews with clinical investigators and parents of sons with Duchenne and Becker muscular dystrophy (DBMD) who participated in the phase IIa or IIb ataluren clinical trial in the United States. Interviews were transcribed and coded for thematic analysis. Participants were 12 parents of affected boys receiving active drug and 9 clinical investigators. High trial expectations of direct benefit were reported by parents and many clinicians. Investigators described monitoring and managing parents' expectations; several worried about their own involvement in increasing parents' expectations. Most parents were able to differentiate their expectations from their optimistic hopes for a cure. Parents' expectations arose from other parents, advocacy organizations, and the sponsor. All parents reported some degree of clinical benefit to their children. Secondary benefits were hopefulness and powerful feelings associated with active efforts to affect the disease course. Parents and clinical investigators reported strong, close relationships that were mutually important. Parents and clinicians felt valued by the sponsor for the majority of the trial. When the trial abruptly stopped, they described loss of engagement, distress, and feeling unprepared for the

Expectations and experiences of investigators and parents involved in a clinical trial for Duchenne/Becker muscular dystrophy

PubMed Central

Peay, Holly L; Tibben, Aad; Fisher, Tyler; Brenna, Ethan; Biesecker, Barbara B

2014-01-01

Background The social context of rare disease research is changing, with increased community engagement around drug development and clinical trials. This engagement may benefit patients and families, but may also lead to heightened trial expectations and therapeutic misconception. Clinical investigators are also susceptible to harboring high expectations. Little is known about parental motivations and expectations for clinical trials for rare pediatric disorders. Purpose We describe the experience of parents and clinical investigators involved in a phase II clinical trial for Duchenne and Becker muscular dystrophy: their expectations, hopes, motivations, and reactions to the termination of the trial. Methods This qualitative study was based on interviews with clinical investigators and parents of sons with DBMD who participated in the phase IIa or IIb ataluren clinical trial in the United States. Interviews were transcribed and coded for thematic analysis. Results Participants were twelve parents of affected boys receiving active drug and nine clinical investigators. High trial expectations of direct benefit were reported by parents and many clinicians. Investigators described monitoring and managing parents’ expectations; several worried about their own involvement in increasing parents’ expectations. Most parents were able to differentiate their expectations from their optimistic hopes for a cure. Parents’ expectations arose from other parents, advocacy organizations, and the sponsor. All parents reported some degree of clinical benefit to their children. Secondary benefits were hopefulness and powerful feelings associated with active efforts to affect the disease course. Parents and clinical investigators reported strong, close relationships that were mutually important. Parents and clinicians felt valued by the sponsor for the majority of the trial. When the trial abruptly stopped, they described loss of engagement, distress, and feeling unprepared for

Clinical Aspects of Type-1 Long-QT Syndrome by Location, Coding Type, and Biophysical Function of Mutations Involving the KCNQ1 Gene

PubMed Central

Moss, Arthur J.; Shimizu, Wataru; Wilde, Arthur A.M.; Towbin, Jeffrey A.; Zareba, Wojciech; Robinson, Jennifer L.; Qi, Ming; Vincent, G. Michael; Ackerman, Michael J.; Kaufman, Elizabeth S.; Hofman, Nynke; Seth, Rahul; Kamakura, Shiro; Miyamoto, Yoshihiro; Goldenberg, Ilan; Andrews, Mark L.; McNitt, Scott

2012-01-01

Background Type-1 long-QT syndrome (LQTS) is caused by loss-of-function mutations in the KCNQ1-encoded IKs cardiac potassium channel. We evaluated the effect of location, coding type, and biophysical function of KCNQ1 mutations on the clinical phenotype of this disorder. Methods and Results We investigated the clinical course in 600 patients with 77 different KCNQ1 mutations in 101 proband-identified families derived from the US portion of the International LQTS Registry (n=425), the Netherlands’ LQTS Registry (n=93), and the Japanese LQTS Registry (n=82). The Cox proportional hazards survivorship model was used to evaluate the independent contribution of clinical and genetic factors to the first occurrence of time-dependent cardiac events from birth through age 40 years. The clinical characteristics, distribution of mutations, and overall outcome event rates were similar in patients enrolled from the 3 geographic regions. Biophysical function of the mutations was categorized according to dominant-negative (>50%) or haploinsufficiency (≤50%) reduction in cardiac repolarizing IKs potassium channel current. Patients with transmembrane versus C-terminus mutations (hazard ratio, 2.06; P<0.001) and those with mutations having dominant-negative versus haploinsufficiency ion channel effects (hazard ratio, 2.26; P<0.001) were at increased risk for cardiac events, and these genetic risks were independent of traditional clinical risk factors. Conclusions This genotype–phenotype study indicates that in type-1 LQTS, mutations located in the transmembrane portion of the ion channel protein and the degree of ion channel dysfunction caused by the mutations are important independent risk factors influencing the clinical course of this disorder. PMID:17470695

hCG: Biological Functions and Clinical Applications

PubMed Central

Nwabuobi, Chinedu; Arlier, Sefa; Schatz, Frederick; Guzeloglu-Kayisli, Ozlem; Lockwood, Charles Joseph; Kayisli, Umit Ali

2017-01-01

Human chorionic gonadotropin (hCG) is produced primarily by differentiated syncytiotrophoblasts, and represents a key embryonic signal that is essential for the maintenance of pregnancy. hCG can activate various signaling cascades including mothers against decapentaplegic homolog 2 (Smad2), protein kinase C (PKC), and/or protein kinase A (PKA) in several cells types by binding to luteinizing hormone/chorionic gonadotropin receptor (LHCGR) or potentially by direct/indirect interaction with transforming growth factor beta receptor (TGFβR). The molecule displays specialized roles in promoting angiogenesis in the uterine endothelium, maintaining myometrial quiescence, as well as fostering immunomodulation at the maternal-fetal interface. It is a member of the glycoprotein hormone family that includes luteinizing hormone (LH), thyroid-stimulating hormone (TSH), and follicle-stimulating hormone (FSH). The α-subunit of hCG displays homologies with TSH, LH, and FSH, whereas the β subunit is 80–85% homologous to LH. The hCG molecule is produced by a variety of organs, exists in various forms, exerts vital biological functions, and has various clinical roles ranging from diagnosis and monitoring of pregnancy and pregnancy-related disorders to cancer surveillance. This review presents a detailed examination of hCG and its various clinical applications. PMID:28937611

hCG: Biological Functions and Clinical Applications.

PubMed

Nwabuobi, Chinedu; Arlier, Sefa; Schatz, Frederick; Guzeloglu-Kayisli, Ozlem; Lockwood, Charles Joseph; Kayisli, Umit Ali

2017-09-22

Human chorionic gonadotropin (hCG) is produced primarily by differentiated syncytiotrophoblasts, and represents a key embryonic signal that is essential for the maintenance of pregnancy. hCG can activate various signaling cascades including mothers against decapentaplegic homolog 2 (Smad2), protein kinase C (PKC), and/or protein kinase A (PKA) in several cells types by binding to luteinizing hormone/chorionic gonadotropin receptor (LHCGR) or potentially by direct/indirect interaction with transforming growth factor beta receptor (TGFβR). The molecule displays specialized roles in promoting angiogenesis in the uterine endothelium, maintaining myometrial quiescence, as well as fostering immunomodulation at the maternal-fetal interface. It is a member of the glycoprotein hormone family that includes luteinizing hormone (LH), thyroid-stimulating hormone (TSH), and follicle-stimulating hormone (FSH). The α-subunit of hCG displays homologies with TSH, LH, and FSH, whereas the β subunit is 80-85% homologous to LH. The hCG molecule is produced by a variety of organs, exists in various forms, exerts vital biological functions, and has various clinical roles ranging from diagnosis and monitoring of pregnancy and pregnancy-related disorders to cancer surveillance. This review presents a detailed examination of hCG and its various clinical applications.

Assessing cognitive function in clinical trials: latest developments and future directions.

PubMed

Wesnes, Keith

2002-01-01

Properly developed automated test systems are of value for assessing changes in cognitive function in clinical trials. Besides the other advantages that automation brings to trials, such as increased reliability and utility, it is shown that such systems are also more sensitive to change in cognitive function than traditional nonautomated procedures. Data from a variety of topical areas in drug development are presented to illustrate the added value such techniques have brought. The latest developments in automation include remote testing via the Internet and telephone.

A clinically meaningful training effect in walking speed using functional electrical stimulation for motor-incomplete spinal cord injury.

PubMed

Street, Tamsyn; Singleton, Christine

2018-05-01

The study aimed to investigate the presence of a training effect for rehabilitation of walking function in motor-incomplete spinal cord injury (SCI) through daily use of functional electrical stimulation (FES). A specialist FES outpatient centre. Thirty-five participants (mean age 53, SD 15, range 18-80; mean years since diagnosis 9, range 5 months - 39 years) with drop foot and motor-incomplete SCI (T12 or higher, ASIA Impairment Scale C and D) able to ambulate 10 metres with the use of a walking stick or frame. FES of the peroneal nerve, glutei and hamstrings as clinically indicated over six months in the community. The data was analysed for a training effect (difference between unassisted ten metre walking speed at baseline and after six months) and orthotic effects (difference between walking speed with and without FES) initially on day one and after six months. The data was further analysed for a minimum clinically important difference (MCID) (>0.06 m/s). A clinically meaningful, significant change was observed for initial orthotic effect (0.13m/s, CI: 0.04-0.17, P = 0.013), total orthotic effect (0.11m/s, CI: 0.04-0.18, P = 0.017) and training effect (0.09m/s, CI: 0.02-0.16, P = 0.025). The results suggest that daily independent use of FES may produce clinically meaningful changes in walking speed which are significant for motor-incomplete SCI. Further research exploring the mechanism for the presence of a training effect may be beneficial in targeting therapies for future rehabilitation.

Multicenter pathophysiologic investigation of erectile dysfunction in clinic outpatients in China.

PubMed

Li, Dongjie; Jiang, Xianzhen; Zhang, Xiaobo; Yi, Lu; Zhu, Xiangsheng; Zeng, Xiangyang; Guo, Xiaoliang; Tang, Yuxin

2012-03-01

To assess the pathophysiologic composition and age structure of erectile dysfunction (ED) in men visiting outpatient clinics in China. We studied 3327 consecutive ED outpatients (median age 39 years) from 2006 to 2010 in the 5 training hospitals in China. Every patient was independently evaluated by an experienced urologist/andrologist using comprehensive diagnostic procedures. The simplified International Index of Erectile Function was used to assess the severity of ED. Most patients (95.0%) were <60 years old, and none were >70 years old. The psychogenic patients were younger and had greater percentage than any other patients. Vasculogenic factors were a major etiology of organic ED. A significant difference was found in the age distribution between the patients with psychogenic ED and those with organic ED (P = .000). Diabetes, hypertension, coronary artery disease, and hyperlipidemia played significant roles in affecting the severity of ED in a statistical model, including age. The International Index of Erectile Function scores decreased with age (rs = -0.199, P = .000). Moreover, the percentage of severe and moderate cases increased with age (P = .003 and P = .002, respectively). However, the constituent ratio of patients sharply declined from 30.3% to 4.5% with age. The number of men visiting outpatient clinics with psychological ED is greater than the number with organic causes in China. The age of the Chinese patients with ED who seek medical help is young and this is mainly because of inadequate sex education to young men and because most older patients are reluctant to visit the hospital just for the loss of erectile function. Copyright © 2012 Elsevier Inc. All rights reserved.

Evaluation of gastric emptying function in clinical practice.

PubMed

Poitras, P; Picard, M; Déry, R; Giguère, A; Picard, D; Morais, J; Plourde, V; Boivin, M

1997-11-01

In this retrospective analysis, we compared different methods to evaluate gastric emptying function, aiming to improve the sensitivity and the clinical availability of our diagnostic testing. In the first study, we compared, in 72 patients clinically suspected of gastroparesis, the emptying of a meal containing two solid nutrients with different disintegration rates: 111In-labeled scrambled eggs and 99Tc-labeled liver cubes. Gastric emptying of 111In-labeled egg was delayed in 12 of our patients and the evacuation of the 99Tc-labeled liver was prolonged in 19 patients. The choice of the nutrient was not important for the identification of diabetic gastroparesis (43% vs 57%; NS), but it was determinant in the case of patients suspected of idiopathic gastroparesis (12% were positive with the egg and 25% with the liver; P < 0.05). In the second study, we compared two different diagnostic methods in 46 patients: a simple radiological detection of the gastric emptying of radiopaque pellets, and the scintigraphic emptying of a solid meal containing 99Tc-labeled liver cubes. Both tests correlated perfectly in 78% of our patients. In 15% of the population (six of these seven patients were diabetics suspected of gastroparesis) the scintigraphic method was normal, while the evacuation of radiopaque pellets was delayed. For clinical purposes, we therefore propose: (1) the scintigraphic method should use liver rather than egg as a radiolabeled tracer in order to improve the sensitivity of the test for detection of gastroparesis; and (2) the radiological detection of radiopaque markers is a reliable and convenient method for the detection of gastroparesis in clinical practice. It is possibly more sensitive than scintigraphy.

Balance Function Disorders

NASA Technical Reports Server (NTRS)

1991-01-01

Researchers at the Balance Function Laboratory and Clinic at the Minneapolis (MN) Neuroscience Institute on the Abbot Northwestern Hospital Campus are using a rotational chair (technically a "sinusoidal harmonic acceleration system") originally developed by NASA to investigate vestibular (inner ear) function in weightlessness to diagnose and treat patients with balance function disorders. Manufactured by ICS Medical Corporation, Schaumberg, IL, the chair system turns a patient and monitors his or her responses to rotational stimulation.

An investigation of nurse educator's perceptions and experiences of undertaking clinical practice.

PubMed

Williams, Angela; Taylor, Cathy

2008-11-01

Educational policy (DOH, 1999. Making a difference: strengthening the nursing, midwifery and health visiting contribution to health and healthcare. Department of Health, London; UKCC, 1999. Fitness for Practice. United Kingdom Central Council for Nursing, Midwifery and Health Visiting, London; Nursing and Midwifery Council, 2006. Standards to support learning and assessment in practice. Nursing and Midwifery Council, London) and current nursing literature (Griscti, O., Jacono, B., Jacono, J., 2005. The nurse educator's clinical role. Journal of Advanced Nursing 50 (1), 84-92; Owen, S., Ferguson, K., Baguley, I., 2005. The clinical activity of mental health nurse lecturers. Journal of Psychiatric and Mental Health Nursing 12, 310-316), place increasing emphasis on nurse educators undertaking clinical practice to facilitate their clinical confidence and competence. This study investigated nurse educators' perceptions and experiences of undertaking clinical practice. A qualitative design and descriptive, exploratory approach were used. A purposive sample of 11 nurse educators in one nursing department, took part in two focus group interviews, one with 5 and the other with 6 respondents, to identify and discuss their perceptions and experiences of undertaking clinical practice. A process of thematic content analysis revealed three broad themes relating to the meaning and importance of clinical practice, perceived benefits and barriers which are examined and discussed. The paper concludes that despite policy recommendations, barriers highlighted in this study such as insufficient time, heavy workload and a lack of valuing of the clinical role have been raised over the past few decades. The effect of undertaking clinical practice, particularly on the quality of teaching is argued to be valuable armoury in the battle to secure sufficient resources to support engagement in clinical practice. Financial and organisational commitment; valuing of clinical practice and research

Clinical Case Reporting in the Peer-Reviewed Physical Therapy Literature: Time to Move Toward Functioning.

PubMed

Davenport, Todd E

2015-12-01

Physical therapists increasingly are contributing clinical case reports to the health literature, which form the basis for higher quality evidence that has been incorporated into clinical practice guidelines. Yet, few resources exist to assist physical therapists with the basic mechanics and quality standards of producing a clinical case report. This situation is further complicated by the absence of uniform standards for quality in case reporting. The importance of including a concise yet comprehensive description of patient functioning in all physical therapy case reports suggest the potential appropriateness of basing quality guidelines on the World Health Organization's International Classification of Functioning Disability and Health (ICF) model. The purpose of this paper is to assist physical therapists in creating high-quality clinical case reports for the peer-reviewed literature using the ICF model as a guiding framework. Along these lines, current recommendations related to the basic mechanics of writing a successful clinical case report are reviewed, as well and a proposal for uniform clinical case reporting requirements is introduced with the aim to improve the quality and feasibility of clinical case reporting in physical therapy that are informed by the ICF model. Copyright © 2013 John Wiley & Sons, Ltd.

Do evoked potentials contribute to the functional follow-up and clinical prognosis of multiple sclerosis?

PubMed

Giffroy, Xavier; Maes, Nathalie; Albert, Adelin; Maquet, Pierre; Crielaard, Jean-Michel; Dive, Dominique

2017-03-01

The clinical variability and complexity of multiple sclerosis (MS) challenges the individual clinical course prognostication. This study aimed to find out whether multimodal evoked potentials (EP) correlate with the motor components of multiple sclerosis functional composite (MSFCm) and predict clinically relevant motor functional deterioration. One hundred MS patients were assessed at baseline (T 0 ) and about 7.5 years later (T 1 ), with visual, somatosensory and motor EP and rated on the Expanded Disability Status Scale (EDSS) and the MSFCm, including the 9 Hole Peg Test and the Timed 25 Foot Walk (T25FW). The Spearman correlation coefficient (r S ) was used to evaluate the cross-sectional and longitudinal relationship between EP Z scores and clinical findings. The predictive value of baseline electrophysiological data for clinical worsening (EDSS, 9-HPT, T25FW, MSFCm) during follow-up was assessed by logistic regression analysis. Unlike longitudinal correlations, cross-sectional correlations between EP Z scores and clinical outcomes were all significant and ranged between 0.22 and 0.67 (p < 0.05). The global EP Z score was systematically predictive of EDSS and MSFCm worsening over time (all p < 0.05). EP latency was a better predictor than amplitude, although weaker than latency and amplitude aggregation in the global EP Z score. The study demonstrates that EP numerical scores can be used for motor function monitoring and outcome prediction in patients with MS.

Template protocol for clinical trials investigating vaccines--focus on safety elements.

PubMed

Bonhoeffer, Jan; Imoukhuede, Egeruan B; Aldrovandi, Grace; Bachtiar, Novilia S; Chan, Eng-Soon; Chang, Soju; Chen, Robert T; Fernandopulle, Rohini; Goldenthal, Karen L; Heffelfinger, James D; Hossain, Shah; Jevaji, Indira; Khamesipour, Ali; Kochhar, Sonali; Makhene, Mamodikoe; Malkin, Elissa; Nalin, David; Prevots, Rebecca; Ramasamy, Ranjan; Sellers, Sarah; Vekemans, Johan; Walker, Kenneth B; Wilson, Pam; Wong, Virginia; Zaman, Khalequz; Heininger, Ulrich

2013-11-12

This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I-IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts. Copyright © 2013 Elsevier Ltd. All rights reserved.

[Clinical electro-ophthalmology at the Max Planck Institute of the Frankfurt University Ophthalmology Clinic 1970-1991].

PubMed

Lorenz, R; Baier, M; Eckl, G; Raile, A

1996-07-01

The survey shows the frequency and distribution of diseases evaluated by electroophthalmological methods. Patients with retinal diseases (51.2%) and those with diseases of the optic nerve (21.8%) were examined most frequently. In a high percentage these investigations lead to a clinically useful assessment: described as confirmation or exclusion of a clinical diagnosis, as establishing a possible differential diagnosis or clearing up formerly unknown aspects of a disease. In cases of hereditary retinal disorders only 11% remained unclear, with presumed optic neuritis only 6%. The importance of electroophthalmological investigations is there ability to assess functional deficits in the visual system especially in somehow more rare retinal and centrally located disorders, functional deficits of unknown origins or in general diseases including the visual system.

Implementation of workflow engine technology to deliver basic clinical decision support functionality

PubMed Central

2011-01-01

Background Workflow engine technology represents a new class of software with the ability to graphically model step-based knowledge. We present application of this novel technology to the domain of clinical decision support. Successful implementation of decision support within an electronic health record (EHR) remains an unsolved research challenge. Previous research efforts were mostly based on healthcare-specific representation standards and execution engines and did not reach wide adoption. We focus on two challenges in decision support systems: the ability to test decision logic on retrospective data prior prospective deployment and the challenge of user-friendly representation of clinical logic. Results We present our implementation of a workflow engine technology that addresses the two above-described challenges in delivering clinical decision support. Our system is based on a cross-industry standard of XML (extensible markup language) process definition language (XPDL). The core components of the system are a workflow editor for modeling clinical scenarios and a workflow engine for execution of those scenarios. We demonstrate, with an open-source and publicly available workflow suite, that clinical decision support logic can be executed on retrospective data. The same flowchart-based representation can also function in a prospective mode where the system can be integrated with an EHR system and respond to real-time clinical events. We limit the scope of our implementation to decision support content generation (which can be EHR system vendor independent). We do not focus on supporting complex decision support content delivery mechanisms due to lack of standardization of EHR systems in this area. We present results of our evaluation of the flowchart-based graphical notation as well as architectural evaluation of our implementation using an established evaluation framework for clinical decision support architecture. Conclusions We describe an implementation of

Implementation of workflow engine technology to deliver basic clinical decision support functionality.

PubMed

Huser, Vojtech; Rasmussen, Luke V; Oberg, Ryan; Starren, Justin B

2011-04-10

Workflow engine technology represents a new class of software with the ability to graphically model step-based knowledge. We present application of this novel technology to the domain of clinical decision support. Successful implementation of decision support within an electronic health record (EHR) remains an unsolved research challenge. Previous research efforts were mostly based on healthcare-specific representation standards and execution engines and did not reach wide adoption. We focus on two challenges in decision support systems: the ability to test decision logic on retrospective data prior prospective deployment and the challenge of user-friendly representation of clinical logic. We present our implementation of a workflow engine technology that addresses the two above-described challenges in delivering clinical decision support. Our system is based on a cross-industry standard of XML (extensible markup language) process definition language (XPDL). The core components of the system are a workflow editor for modeling clinical scenarios and a workflow engine for execution of those scenarios. We demonstrate, with an open-source and publicly available workflow suite, that clinical decision support logic can be executed on retrospective data. The same flowchart-based representation can also function in a prospective mode where the system can be integrated with an EHR system and respond to real-time clinical events. We limit the scope of our implementation to decision support content generation (which can be EHR system vendor independent). We do not focus on supporting complex decision support content delivery mechanisms due to lack of standardization of EHR systems in this area. We present results of our evaluation of the flowchart-based graphical notation as well as architectural evaluation of our implementation using an established evaluation framework for clinical decision support architecture. We describe an implementation of a free workflow technology

A short version of the revised 'experience of close relationships questionnaire': investigating non-clinical and clinical samples.

PubMed

Wongpakaran, Tinakon; Wongpakaran, Nahathai

2012-01-01

This study seeks to investigate the psychometric properties of the short version of the revised 'Experience of Close Relationships' questionnaire, comparing non-clinical and clinical samples. In total 702 subjects participated in this study, of whom 531 were non-clinical participants and 171 were psychiatric patients. They completed the short version of the revised 'Experience of Close Relationships' questionnaire (ECR-R-18), the Perceived Stress Scale-10(PSS-10), the Rosenberg Self-Esteem Scale (RSES) and the UCLA Loneliness scale. A retest of the ECR-R-18 was then performed at four-week intervals. Then, confirmatory factor analyses were performed to test the validity of the new scale. The ECR-R-18 showed a fair to good internal consistency (α 0.77 to 0.87) for both samples, and the test-retest reliability was found to be satisfactory (ICC = 0.75). The anxiety sub-scale demonstrated concurrent validity with PSS-10 and RSES, while the avoidance sub-scale showed concurrent validity with the UCLA Loneliness Scale. Confirmatory factor analysis using method factors yielded two factors with an acceptable model fit for both groups. An invariance test revealed that the ECR-R-18 when used on the clinical group differed from when used with the non-clinical group. The ECR-R-18 questionnaire revealed an overall better level of fit than the original 36 item questionnaire, indicating its suitability for use with a broader group of samples, including clinical samples. The reliability of the ECR-R- 18 might be increased if a modified scoring system is used and if our suggestions with regard to future studies are followed up.

Enhancing physical function in HIV-infected older adults: A randomized controlled clinical trial.

PubMed

Shah, Krupa N; Majeed, Zahraa; Yoruk, Yilmaz B; Yang, Hongmei; Hilton, Tiffany N; McMahon, James M; Hall, William J; Walck, Donna; Luque, Amneris E; Ryan, Richard M

2016-06-01

HIV-infected older adults (HOA) are at risk of functional decline. Interventions promoting physical activity that can attenuate functional decline and are easily translated into the HOA community are of high priority. We conducted a randomized, controlled clinical trial to evaluate whether a physical activity counseling intervention based on self-determination theory (SDT) improves physical function, autonomous motivation, depression and the quality of life (QOL) in HOA. In total, 67 community-dwelling HOA with mild-to-moderate functional limitations were randomized to 1 of 2 groups: a physical activity counseling group or the usual care control group. We used SDT to guide the development of the experimental intervention. Outcome measures that were collected at baseline and final study visits included a battery of physical function tests, levels of physical activity, autonomous motivation, depression, and QOL. The study participants were similar in their demographic and clinical characteristics in both the treatment and control groups. Overall physical performance, gait speed, measures of endurance and strength, and levels of physical activity improved in the treatment group compared to the control group (p < .05). Measures of autonomous regulation such as identified regulation, and measures of depression and QOL improved significantly in the treatment group compared with the control group (p < .05). Across the groups, improvement in intrinsic regulation and QOL correlated with an improvement in physical function (p < .05). Our findings suggest that a physical activity counseling program grounded in SDT can improve physical function, autonomous motivation, depression, and QOL in HOA with functional limitations. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Neurologic Functional and Quality of Life Outcomes after TBI: Clinic Attendees versus Non-Attendees.

PubMed

Patel, Mayur B; Wilson, Laura D; Bregman, Jana A; Leath, Taylor C; Humble, Stephen S; Davidson, Mario A; de Riesthal, Michael R; Guillamondegui, Oscar D

2015-07-01

This investigation describes the relationship between TBI patient demographics, quality of life outcome, and functional status outcome among clinic attendees and non-attendees. Of adult TBI survivors with intracranial hemorrhage, 63 attended our TBI clinic and 167 did not attend. All were telephone surveyed using the Extended-Glasgow Outcome Scale (GOSE), the Quality of Life after Brain Injury (QOLIBRI) scale, and a post-discharge therapy questionnaire. To determine risk factors for GOSE and QOLIBRI outcomes, we created multivariable regression models employing covariates of age, injury characteristics, clinic attendance, insurance status, post-discharge rehabilitation, and time from injury. Compared with those with severe TBI, higher GOSE scores were identified in individuals with both mild (odds ratio [OR]=2.0; 95% confidence interval [CI]: 1.1-3.6) and moderate (OR=4.7; 95% CI: 1.6-14.1) TBIs. In addition, survivors with private insurance had higher GOSE scores, compared with those with public insurance (OR=2.0; 95% CI: 1.1-3.6), workers' compensation (OR=8.4; 95% CI: 2.6-26.9), and no insurance (OR=3.1; 95% CI: 1.6-6.2). Compared with those with severe TBI, QOLIBRI scores were 11.7 points (95% CI: 3.7-19.7) higher in survivors with mild TBI and 17.3 points (95% CI: 3.2-31.5) higher in survivors with moderate TBI. In addition, survivors who received post-discharge rehabilitation had higher QOLIBRI scores by 11.4 points (95% CI: 3.7-19.1) than those who did not. Survivors with private insurance had QOLIBRI scores that were 25.5 points higher (95% CI: 11.3-39.7) than those with workers' compensation and 16.8 points higher (95% CI: 7.4-26.2) than those without insurance. Because neurologic injury severity, insurance status, and receipt of rehabilitation or therapy are independent risk factors for functional and quality of life outcomes, future directions will include improving earlier access to post-TBI rehabilitation, social work services, affordable insurance

Clinical Investigation Program Report.

DTIC Science & Technology

1983-10-01

metastatic to liver. (0) H-83-63. Double-blind, randomized parallel comparison of two different dosage regimens of naproxen sodium in patients with...different dosage regimens of naproxen sodium in patients with bone pain due to m etastatic cancer. Start Date: May 83 Est Comp Date: Indefinite Principal...Investigator: Facility: LTC D Gandara, MD LAMC CPT R Mansour, MD D ept/Svc: Associate Investigators: Hematology-Oncology Key Words: naproxen sodium

25 CFR 900.196 - Do covered services include the conduct of clinical studies and investigations and the provision...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 25 Indians 2 2010-04-01 2010-04-01 false Do covered services include the conduct of clinical studies and investigations and the provision of emergency services, including the operation of emergency... Claims § 900.196 Do covered services include the conduct of clinical studies and investigations and the...

IMAGe syndrome: clinical and genetic implications based on investigations in three Japanese patients.

PubMed

Kato, Fumiko; Hamajima, Takashi; Hasegawa, Tomonobu; Amano, Naoko; Horikawa, Reiko; Nishimura, Gen; Nakashima, Shinichi; Fuke, Tomoko; Sano, Shinichirou; Fukami, Maki; Ogata, Tsutomu

2014-05-01

Arboleda et al. have recently shown that IMAGe (intra-uterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita and genital abnormalities) syndrome is caused by gain-of-function mutations of maternally expressed gene CDKN1C on chromosome 11p15.5. However, there is no other report describing clinical findings in patients with molecularly studied IMAGe syndrome. Here, we report clinical and molecular findings in Japanese patients. We studied a 46,XX patient aged 8·5 years (case 1) and two 46,XY patients aged 16·5 and 15·0 years (cases 2 and 3). Clinical studies revealed not only IMAGe syndrome-compatible phenotypes in cases 1-3, but also hitherto undescribed findings including relative macrocephaly and apparently normal pituitary-gonadal endocrine function in cases 1-3, familial glucocorticoid deficiency (FGD)-like adrenal phenotype and the history of oligohydramnios in case 2, and arachnodactyly in case 3. Sequence analysis of CDKN1C, pyrosequencing-based methylation analysis of KvDMR1 and high-density oligonucleotide array comparative genome hybridization analysis for chromosome 11p15.5 were performed, showing an identical de novo and maternally inherited CDKN1C gain-of-function mutation (p.Asp274Asn) in cases 1 and 2, respectively, and no demonstrable abnormality in case 3. The results of cases 1 and 2 with CDKN1C mutation would argue the following: [1] relative macrocephaly is consistent with maternal expression of CDKN1C in most tissues and biparental expression of CDKN1C in the foetal brain; [2] FGD-like phenotype can result from CDKN1C mutation; and [3] genital abnormalities may primarily be ascribed to placental dysfunction. Furthermore, lack of CDKN1C mutation in case 3 implies genetic heterogeneity in IMAGe syndrome. © 2013 John Wiley & Sons Ltd.

Whole-brain functional connectivity identification of functional dyspepsia.

PubMed

Nan, Jiaofen; Liu, Jixin; Li, Guoying; Xiong, Shiwei; Yan, Xuemei; Yin, Qing; Zeng, Fang; von Deneen, Karen M; Liang, Fanrong; Gong, Qiyong; Qin, Wei; Tian, Jie

2013-01-01

Recent neuroimaging studies have shown local brain aberrations in functional dyspepsia (FD) patients, yet little attention has been paid to the whole-brain resting-state functional network abnormalities. The purpose of this study was to investigate whether FD disrupts the patterns of whole-brain networks and the abnormal functional connectivity could reflect the severity of the disease. The dysfunctional interactions between brain regions at rest were investigated in FD patients as compared with 40 age- and gender- matched healthy controls. Multivariate pattern analysis was used to evaluate the discriminative power of our results for classifying patients from controls. In our findings, the abnormal brain functional connections were mainly situated within or across the limbic/paralimbic system, the prefrontal cortex, the tempo-parietal areas and the visual cortex. About 96% of the subjects among the original dataset were correctly classified by a leave one-out cross-validation approach, and 88% accuracy was also validated in a replication dataset. The classification features were significantly associated with the patients' dyspepsia symptoms, the self-rating depression scale and self-rating anxiety scale, but it was not correlated with duration of FD patients (p>0.05). Our results may indicate the effectiveness of the altered brain functional connections reflecting the disease pathophysiology underling FD. These dysfunctional connections may be the epiphenomena or causative agents of FD, which may be affected by clinical severity and its related emotional dimension of the disease rather than the clinical course.

Upper Limb Evaluation in Duchenne Muscular Dystrophy: Fat-Water Quantification by MRI, Muscle Force and Function Define Endpoints for Clinical Trials.

PubMed

Ricotti, Valeria; Evans, Matthew R B; Sinclair, Christopher D J; Butler, Jordan W; Ridout, Deborah A; Hogrel, Jean-Yves; Emira, Ahmed; Morrow, Jasper M; Reilly, Mary M; Hanna, Michael G; Janiczek, Robert L; Matthews, Paul M; Yousry, Tarek A; Muntoni, Francesco; Thornton, John S

2016-01-01

A number of promising experimental therapies for Duchenne muscular dystrophy (DMD) are emerging. Clinical trials currently rely on invasive biopsies or motivation-dependent functional tests to assess outcome. Quantitative muscle magnetic resonance imaging (MRI) could offer a valuable alternative and permit inclusion of non-ambulant DMD subjects. The aims of our study were to explore the responsiveness of upper-limb MRI muscle-fat measurement as a non-invasive objective endpoint for clinical trials in non-ambulant DMD, and to investigate the relationship of these MRI measures to those of muscle force and function. 15 non-ambulant DMD boys (mean age 13.3 y) and 10 age-gender matched healthy controls (mean age 14.6 y) were recruited. 3-Tesla MRI fat-water quantification was used to measure forearm muscle fat transformation in non-ambulant DMD boys compared with healthy controls. DMD boys were assessed at 4 time-points over 12 months, using 3-point Dixon MRI to measure muscle fat-fraction (f.f.). Images from ten forearm muscles were segmented and mean f.f. and cross-sectional area recorded. DMD subjects also underwent comprehensive upper limb function and force evaluation. Overall mean baseline forearm f.f. was higher in DMD than in healthy controls (p<0.001). A progressive f.f. increase was observed in DMD over 12 months, reaching significance from 6 months (p<0.001, n = 7), accompanied by a significant loss in pinch strength at 6 months (p<0.001, n = 9) and a loss of upper limb function and grip force observed over 12 months (p<0.001, n = 8). These results support the use of MRI muscle f.f. as a biomarker to monitor disease progression in the upper limb in non-ambulant DMD, with sensitivity adequate to detect group-level change over time intervals practical for use in clinical trials. Clinical validity is supported by the association of the progressive fat transformation of muscle with loss of muscle force and function.

An initial investigation of abnormal bodily phenomena in subjects at ultra high risk for psychosis: Their prevalence and clinical implications.

PubMed

Madeira, Luis; Bonoldi, Ilaria; Rocchetti, Matteo; Samson, Carly; Azis, Matilda; Queen, Beverly; Bossong, Matthijs; Perez, Jesus; Stone, James; Allen, Paul; Howes, Oliver D; McGuire, Philip; Raballo, Andrea; Fusar-Poli, Paolo; Ballerini, Massimo; Stanghellini, Giovanni

2016-04-01

Contemporary phenomenological research has considered abnormal bodily phenomena (ABP) to be a phenotypic trait of subjects with schizophrenia in their first psychotic episode. Yet the prevalence of ABP and their clinical significance in subjects at Ultra High Risk (UHR) of psychosis remain unidentified. This study is an exploratory investigation of ABP in UHR subjects and matched healthy controls (HCs) examining their relation to clinical features and basic self-disturbances. A sample of 26 UHR and 14 HC subjects from three prodromal and early intervention clinics in South London, West London and Cambridge was assessed with the Abnormal Bodily Phenomena questionnaire (ABPq), Comprehensive Assessment of At-Risk Mental States (CAARMS), the Positive and Negative Syndrome Scale (PANSS), the Social and Occupational Functioning Assessment Scale (SOFAS) and the Examination of Anomalous Self Experiences (EASE) checklist. In our sample ABP occurred in 73.1% of UHR subjects and prominent ABP (proABP) were referred in 53.8% of them. No HC subject reported ABP. The UHR group with proABP had lower CAARMS total score (t=-9.265, p=0.006). There were no differences in PANSS total score (t=-1.235, p=0.277), SOFAS score (H(2) 22.27, p=0.666) and EASE total scores (z=8.565, adjusted p=0.185) in the UHR subjects with prominent ABP versus those that did not. This initial investigation suggests that ABP could be a prevalent phenotypic feature of UHR subjects. Copyright © 2015 Elsevier Inc. All rights reserved.

Ischaemic memory imaging using metabolic radiopharmaceuticals: overview of clinical settings and ongoing investigations.

PubMed

Yoshinaga, Keiichiro; Naya, Masanao; Shiga, Tohru; Suzuki, Eriko; Tamaki, Nagara

2014-02-01

"Ischaemic memory" is defined as a prolonged functional and/or biochemical alteration remaining after a particular episode of severe myocardial ischaemia. The biochemical alteration has been reported as metabolic stunning. Metabolic imaging has been used to detect the footprint left by previous ischaemic episodes evident due to delayed recovery of myocardial metabolism (persistent dominant glucose utilization with suppression of fatty acid oxidation). β-Methyl-p-[(123)I]iodophenylpentadecanoic acid (BMIPP) is a single-photon emission computed tomography (SPECT) radiotracer widely used for metabolic imaging in clinical settings in Japan. In patients with suspected coronary artery disease but no previous myocardial infarction, BMIPP has shown acceptable diagnostic accuracy. In particular, BMIPP plays an important role in the identification of prior ischaemic insult in patients arriving at emergency departments with acute chest pain syndrome. Recent data also show the usefulness of (123)I-BMIPP SPECT for predicting cardiovascular events in patients undergoing haemodialysis. Similarly, SPECT or PET imaging with (18)F-FDG injected during peak exercise or after exercise under fasting conditions shows an increase in FDG uptake in postischaemic areas. This article will overview the roles of ischaemic memory imaging both under established indications and in ongoing investigations.

Functional Recovery Measures for Spinal Cord Injury: An Evidence-Based Review for Clinical Practice and Research

PubMed Central

Anderson, Kim; Aito, Sergio; Atkins, Michal; Biering-Sørensen, Fin; Charlifue, Susan; Curt, Armin; Ditunno, John; Glass, Clive; Marino, Ralph; Marshall, Ruth; Mulcahey, Mary Jane; Post, Marcel; Savic, Gordana; Scivoletto, Giorgio; Catz, Amiram

2008-01-01

Background/Objective: The end goal of clinical care and clinical research involving spinal cord injury (SCI) is to improve the overall ability of persons living with SCI to function on a daily basis. Neurologic recovery does not always translate into functional recovery. Thus, sensitive outcome measures designed to assess functional status relevant to SCI are important to develop. Method: Evaluation of currently available SCI functional outcome measures by a multinational work group. Results: The 4 measures that fit the prespecified inclusion criteria were the Modified Barthel Index (MBI), the Functional Independence Measure (FIM), the Quadriplegia Index of Function (QIF), and the Spinal Cord Independence Measure (SCIM). The MBI and the QIF were found to have minimal evidence for validity, whereas the FIM and the SCIM were found to be reliable and valid. The MBI has little clinical utility for use in the SCI population. Likewise, the FIM applies mainly when measuring burden of care, which is not necessarily a reflection of functional recovery. The QIF is useful for measuring functional recovery but only in a subpopulation of people with SCI, and substantial validity data are still required. The SCIM is the only functional recovery outcome measure designed specifically for SCI. Conclusions: The multinational work group recommends that the latest version of the SCIM (SCIM III) continue to be refined and validated and subsequently implemented worldwide as the primary functional recovery outcome measure for SCI. The QIF may continue to be developed and validated for use as a supplemental tool for the nonambulatory tetraplegic population. PMID:18581660

Variation in lung function is associated with worse clinical outcomes in cystic fibrosis

PubMed Central

Heinzmann-Filho, João Paulo; Pinto, Leonardo Araujo; Marostica, Paulo José Cauduro; Donadio, Márcio Vinícius Fagundes

2015-01-01

ABSTRACT OBJECTIVE: To determine whether the variation in lung function over one year is associated with worse clinical outcomes, as well as with a decline in lung function in the following years, in patients with cystic fibrosis (CF). METHODS: This was a retrospective study involving CF patients (4-19 years of age), evaluated over a three-year period. We evaluated demographic characteristics, chronic Pseudomonas aeruginosa infection, antibiotic use, hospitalization, six-minute walk distance (6MWD), and lung function. The inclusion criterion was having undergone pulmonary function testing at least three times in the first year and at least once in each of the next two years. RESULTS: We evaluated 35 CF patients. The variation in FEV1 in the first year (ΔFEV1) was greater among those who, in the third year, showed reduced FEV1, had a below-average 6MWD, or were hospitalized than among those with normal FEV1, normal 6MWD, or no hospital admissions, in that same year (p < 0.05), although no such difference was found for antibiotic use in the third year. Subjects showing a ΔFEV1 ≥ 10% also showed a greater decline in FEV1 over the two subsequent years (p = 0.04). The ΔFEV1 also showed an inverse correlation with absolute FEV1 in the third year (r = −0.340, p = 0.04) and with the rate of FEV1 decline (r = −0.52, p = 0.001). Linear regression identified ΔFEV1 as a predictor of FEV1 decline (coefficient of determination, 0.27). CONCLUSIONS: Significant variation in lung function over one year seems to be associated with a higher subsequent rate of FEV1 decline and worse clinical outcomes in CF patients. Short-term ΔFEV1 might prove useful as a predictor of CF progression in clinical practice. PMID:26785959

Clinical trial shows lasting function of a new moisturizing cream against vaginal dryness.

PubMed

Henneicke-von Zepelin, Hans-Heinrich; Williams, Ragna; Havemeister, Wiebke; Wigger-Alberti, Walter; Nolte, Klaus-Ulrich

2017-05-01

Vaginal dryness and associated symptoms may occur in women of any age and are a frequent burden after menopause. The North American Menopause Society recommends long-acting non-hormonal vaginal creams as first-line therapy. A new type of such creams was developed (Remifemin® FeuchtCreme in Austria and Germany). This hormone-free cream contains hamamelis virginiana distillate and well-established vaginal cream ingredients. We explored its physical function and tolerability in an open interventional clinical trial. 20 postmenopausal women (54 to 76 years, median 60) treated their vaginal dryness using this cream once daily for 7 days and reported about their symptoms before, 4 to 8 h after first and 14 to 22 h after last application. A physician assessed tolerability and local physical function. All patients completed the study. Local physical function significantly improved from dryness at baseline (mean 4.0 ± SD 1.8) to a normal moisture level, on average (6.3 ± 2.1 after first, 6.7 ± 2.1 after last application, p = 0.0001). Subjective assessment of a feeling vaginal dryness showed a significant improvement at both times (p = 0.0001). Onset and duration of feeling moisturized were reported to be 0 to 2 min and 11.3 ± 6.9 h after application. All women reported vaginal dryness at baseline. 55 and 80% of patients reported no dryness after first application and at the end of the investigation. The cream was seen at the application site for up to 21 h. Tolerability assessments did not reveal any relevant change over time. There were four adverse events in 4 patients, all not serious and of mild intensity: urinary urgency (2), diarrhoea (1) and mild spotting after first application (1). The latter was caused by the dry surface of the applicator and was avoided by moisturizing the surface of the applicator at subsequent applications. In conclusion, these study results indicate a well-tolerated and long-acting function of this new

Assessment of the Clinical Relevance of BRCA2 Missense Variants by Functional and Computational Approaches.

PubMed

Guidugli, Lucia; Shimelis, Hermela; Masica, David L; Pankratz, Vernon S; Lipton, Gary B; Singh, Namit; Hu, Chunling; Monteiro, Alvaro N A; Lindor, Noralane M; Goldgar, David E; Karchin, Rachel; Iversen, Edwin S; Couch, Fergus J

2018-01-17

Many variants of uncertain significance (VUS) have been identified in BRCA2 through clinical genetic testing. VUS pose a significant clinical challenge because the contribution of these variants to cancer risk has not been determined. We conducted a comprehensive assessment of VUS in the BRCA2 C-terminal DNA binding domain (DBD) by using a validated functional assay of BRCA2 homologous recombination (HR) DNA-repair activity and defined a classifier of variant pathogenicity. Among 139 variants evaluated, 54 had ≥99% probability of pathogenicity, and 73 had ≥95% probability of neutrality. Functional assay results were compared with predictions of variant pathogenicity from the Align-GVGD protein-sequence-based prediction algorithm, which has been used for variant classification. Relative to the HR assay, Align-GVGD significantly (p < 0.05) over-predicted pathogenic variants. We subsequently combined functional and Align-GVGD prediction results in a Bayesian hierarchical model (VarCall) to estimate the overall probability of pathogenicity for each VUS. In addition, to predict the effects of all other BRCA2 DBD variants and to prioritize variants for functional studies, we used the endoPhenotype-Optimized Sequence Ensemble (ePOSE) algorithm to train classifiers for BRCA2 variants by using data from the HR functional assay. Together, the results show that systematic functional assays in combination with in silico predictors of pathogenicity provide robust tools for clinical annotation of BRCA2 VUS. Copyright © 2017 American Society of Human Genetics. Published by Elsevier Inc. All rights reserved.

Clinical investigations of the therapeutic potential of ayahuasca: rationale and regulatory challenges.

PubMed

McKenna, Dennis J

2004-05-01

Ayahuasca is a hallucinogenic beverage that is prominent in the ethnomedicine and shamanism of indigenous Amazonian tribes. Its unique pharmacology depends on the oral activity of the hallucinogen, N,N-dimethyltryptamine (DMT), which results from inhibition of monoamine oxidase (MAO) by beta-carboline alkaloids. MAO is the enzyme that normally degrades DMT in the liver and gut. Ayahuasca has long been integrated into mestizo folk medicine in the northwest Amazon. In Brazil, it is used as a sacrament by several syncretic churches. Some of these organizations have incorporated in the United States. The recreational and religious use of ayahuasca in the United States, as well as "ayahuasca tourism" in the Amazon, is increasing. The current legal status of ayahuasca or its source plants in the United States is unclear, although DMT is a Schedule I controlled substance. One ayahuasca church has received favorable rulings in 2 federal courts in response to its petition to the Department of Justice for the right to use ayahuasca under the Religious Freedom Restoration Act. A biomedical study of one of the churches, the Uñiao do Vegetal (UDV), indicated that ayahuasca may have therapeutic applications for the treatment of alcoholism, substance abuse, and possibly other disorders. Clinical studies conducted in Spain have demonstrated that ayahuasca can be used safely in normal healthy adults, but have done little to clarify its potential therapeutic uses. Because of ayahuasca's ill-defined legal status and variable botanical and chemical composition, clinical investigations in the United States, ideally under an approved Investigational New Drug (IND) protocol, are complicated by both regulatory and methodological issues. This article provides an overview of ayahuasca and discusses some of the challenges that must be overcome before it can be clinically investigated in the United States.

[The role of gonadal peptides in clinical investigation].

PubMed

Lahlou, N; Bouvattier, C; Linglart, A; Rodrigue, D; Teinturier, C

2009-01-01

Inhibins, activins, and anti-Mullerian hormone (AMH) are gonadal dimeric peptides produced in ovaries and testes by homologous cells, granulosa cells and Sertoli cells, respectively. The production of inhibins is driven by FSH, that of AMH may indirectly depends on FSH, while it is down regulated, at least in the male, by testosterone. In the past decade, measurements of serum inhibin and AMH have provided useful tools for clinical investigation in gonadal disorders: pseudohermaphroditism, androgen insensitivity, anorchidism, gonadal dysgenesis, disorders of pubertal developpement. Inhibins, activins, and AMH are also reliable markers of gonadal tumors. They are extensively used as indexes of fertility: in the male the production of inhibin B reflects the spermatogenetic activity, in women both inhibin B and AMH levels are correlated with the number of preantral and early antral follicles and reflect the ovarian reserve of follicles available for recruitment.

Optical transfer function in corneal topography for clinical contrast sensitivity analysis

NASA Astrophysics Data System (ADS)

Bende, Thomas; Jean, Benedikt J.; Oltrup, Theo

2000-06-01

Customized ablation aiming to optimize visual acuity in refractive surgery requires objective data on corneal surface, like the contrast sensitivity. Fast ray tracing, using the high resolution 3-D elevation data in conjunction with Snell's law describe the diffraction of the incident rays and the resulting image on a 'virtual retina.' A retroprojection leads to a 'surface quality map.' For objective contrast sensitivity measurement a sinus (or cos) wave of different frequencies is used for a calculated projection in analogy to the clinical contrast sensitivity charts. The projection on the individual cornea surface is analyzed for the Modular Transfer Function (MTF) and the Phase Shift Function (PSF) as a function of frequencies. PSF, not yet clinically used, is a parameter to determine even minimal corneal tilt. The resulting corneal aberration map (CAM) as described here and applied to a 4.5 D PRK (OZD equals 6.5 mm) reveals that the area of minimal aberration measures only 4.2 mm. The CAM can likewise be used to describe the 'quality' of a laser system's ablation pattern based upon the area of minimal optical aberrations. The CAM only describes surface aberration with high resolution, an advantage over wave front sensing which measures all accumulated optical aberrations including the changing ones of the lens during accommodation and the transient ones due to lens aging and early cataract formation.

Multi-task functional MRI in multiple sclerosis patients without clinical disability.

PubMed

Colorado, René A; Shukla, Karan; Zhou, Yuxiang; Wolinsky, Jerry S; Narayana, Ponnada A

2012-01-02

While the majority of individuals with multiple sclerosis (MS) develop significant clinical disability, a subset experiences a disease course with minimal impairment even in the presence of significant apparent tissue damage on magnetic resonance imaging (MRI). Functional magnetic resonance imaging (fMRI) in MS patients with low disability suggests that increased use of the cognitive control system may limit the clinical manifestation of the disease. The current fMRI studies tested the hypothesis that nondisabled MS patients show increased recruitment of cognitive control regions while performing sensory, motor and cognitive tasks. Twenty two patients with relapsing-remitting MS and an Expanded Disability Status Scale (EDSS) score of ≤1.5 and 23 matched healthy controls were recruited. Subjects underwent fMRI while observing flashing checkerboards, performing right or left hand movements, or executing the 2-back working memory task. Compared to control subjects, patients demonstrated increased activation of the right dorsolateral prefrontal cortex and anterior cingulate cortex during the performance of the working memory task. This pattern of functional recruitment also was observed during the performance of non-dominant hand movements. These results support the mounting evidence of increased functional recruitment of cognitive control regions in the working memory system of MS patients with low disability and provide new evidence for the role of increased cognitive control recruitment in the motor system. Copyright © 2011 Elsevier Inc. All rights reserved.

Maternal Drug Abuse History, Maltreatment, and Functioning in a Clinical Sample of Urban Children

ERIC Educational Resources Information Center

Onigu-Otite, Edore C.; Belcher, Harolyn M. E.

2012-01-01

Objective: This study examined the association between maternal drug abuse history, maltreatment exposure, and functioning, in a clinical sample of young children seeking therapy for maltreatment. Methods: Data were collected on 91 children, mean age 5.3 years (SD 1.0). The Preschool and Early Childhood Functional Assessment Scales (PECFAS) was…

Conversational assessment in memory clinic encounters: interactional profiling for differentiating dementia from functional memory disorders.

PubMed

Jones, Danielle; Drew, Paul; Elsey, Christopher; Blackburn, Daniel; Wakefield, Sarah; Harkness, Kirsty; Reuber, Markus

2016-01-01

In the UK dementia is under-diagnosed, there is limited access to specialist memory clinics, and many of the patients referred to such clinics are ultimately found to have functional (non-progressive) memory disorders (FMD), rather than a neurodegenerative disorder. Government initiatives on 'timely diagnosis' aim to improve the rate and quality of diagnosis for those with dementia. This study seeks to improve the screening and diagnostic process by analysing communication between clinicians and patients during initial specialist clinic visits. Establishing differential conversational profiles could help the timely differential diagnosis of memory complaints. This study is based on video- and audio recordings of 25 initial consultations between neurologists and patients referred to a UK memory clinic. Conversation analysis was used to explore recurrent communicative practices associated with each diagnostic group. Two discrete conversational profiles began to emerge, to help differentiate between patients with dementia and functional memory complaints, based on (1) whether the patient is able to answer questions about personal information; (2) whether they can display working memory in interaction; (3) whether they are able to respond to compound questions; (4) the time taken to respond to questions; and (5) the level of detail they offer when providing an account of their memory failure experiences. The distinctive conversational profiles observed in patients with functional memory complaints on the one hand and neurodegenerative memory conditions on the other suggest that conversational profiling can support the differential diagnosis of functional and neurodegenerative memory disorders.

Validated Measures of Insomnia, Function, Sleepiness, and Nasal Obstruction in a CPAP Alternatives Clinic Population.

PubMed

Lam, Austin S; Collop, Nancy A; Bliwise, Donald L; Dedhia, Raj C

2017-08-15

Although efficacious in the treatment of obstructive sleep apnea (OSA), continuous positive airway pressure (CPAP) can be difficult to tolerate, with long-term adherence rates approaching 50%. CPAP alternatives clinics specialize in the evaluation and treatment of CPAP-intolerant patients; yet this population has not been studied in the literature. To better understand these patients, we sought to assess insomnia, sleep-related functional status, sleepiness, and nasal obstruction, utilizing data from validated instruments. After approval from the Emory University Institutional Review Board, a retrospective chart review was performed from September 2015 to September 2016 of new patient visits at the Emory CPAP alternatives clinic. Patient demographics and responses were recorded from the Insomnia Severity Index, Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10), Epworth Sleepiness Scale, and Nasal Obstruction Symptom Evaluation questionnaires. A total of 172 patients were included, with 81% having moderate-severe OSA. Most of the patients demonstrated moderate-severe clinical insomnia and at least moderate nasal obstruction. FOSQ-10 scores indicated sleep-related functional impairment in 88%. However, most patients did not demonstrate excessive daytime sleepiness. This patient population demonstrates significant symptomatology and functional impairment. Because of the severity of their OSA, they are at increased risk of complications. In order to mitigate the detrimental effects of OSA, these significantly impacted patients should be identified and encouraged to seek CPAP alternatives clinics that specialize in the treatment of this population. © 2017 American Academy of Sleep Medicine

Measurement properties of existing clinical assessment methods evaluating scapular positioning and function. A systematic review.

PubMed

Larsen, Camilla Marie; Juul-Kristensen, Birgit; Lund, Hans; Søgaard, Karen

2014-10-01

The aims were to compile a schematic overview of clinical scapular assessment methods and critically appraise the methodological quality of the involved studies. A systematic, computer-assisted literature search using Medline, CINAHL, SportDiscus and EMBASE was performed from inception to October 2013. Reference lists in articles were also screened for publications. From 50 articles, 54 method names were identified and categorized into three groups: (1) Static positioning assessment (n = 19); (2) Semi-dynamic (n = 13); and (3) Dynamic functional assessment (n = 22). Fifteen studies were excluded for evaluation due to no/few clinimetric results, leaving 35 studies for evaluation. Graded according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN checklist), the methodological quality in the reliability and validity domains was "fair" (57%) to "poor" (43%), with only one study rated as "good". The reliability domain was most often investigated. Few of the assessment methods in the included studies that had "fair" or "good" measurement property ratings demonstrated acceptable results for both reliability and validity. We found a substantially larger number of clinical scapular assessment methods than previously reported. Using the COSMIN checklist the methodological quality of the included measurement properties in the reliability and validity domains were in general "fair" to "poor". None were examined for all three domains: (1) reliability; (2) validity; and (3) responsiveness. Observational evaluation systems and assessment of scapular upward rotation seem suitably evidence-based for clinical use. Future studies should test and improve the clinimetric properties, and especially diagnostic accuracy and responsiveness, to increase utility for clinical practice.

Sub-xyphoid pleural drain as a determinant of functional capacity and clinical results after off-pump coronary artery bypass surgery: a randomized clinical trial.

PubMed

Guizilini, Solange; Alves, Daniel F; Bolzan, Douglas W; Cancio, Andreia S A; Regenga, Marisa M; Moreira, Rita S L; Trimer, Renata; Gomes, Walter J

2014-09-01

The aim of this trial was to compare functional capacity, pulmonary shunt fraction and clinical outcomes between patients undergoing pleurotomy with a pleural drain inserted in the sub-xyphoid position and patients with a pleural drain placed in the intercostal position after off-pump coronary artery bypass surgery. Patients were randomized into two groups according to the pleural drain site: Group II (n = 33 intercostal pleural drain); and Group SI (n = 35 sub-xyphoid pleural drain). Functional capacity was assessed by the distance covered on the 6-min walking test performed preoperatively and on postoperative day (POD) 5; in addition, pulmonary function test was determined preoperatively and on POD 1 and 5. Pulmonary shunt fraction was evaluated preoperatively and on POD 1, and clinical outcomes were recorded throughout the study. Group SI had better preservation of lung volumes and capacities in POD compared with Group II (P <0.05). Pulmonary shunt fraction increased in both groups postoperatively; however, Group SI showed a smaller pulmonary shunt fraction (0.26 ± 0.04 vs 0.21 ± 0.04%; P = 0.0014). Functional capacity was significantly reduced in both groups on POD 5; however, Group SI showed better preservation of functional capacity (P = 0.0001). Group SI had better postoperative clinical results, with lower incidence of atelectasis and pleural effusion (P <0.05), lower pain scores (P <0.0001), and shorter orotracheal intubation and hospitalization lengths (P <0.001). Sub-xyphoid pleural drain determined better functional capacity and exercise tolerance with a smaller pulmonary shunt fraction and improved clinical outcomes compared with intercostal pleural drainage after off-pump coronary artery bypass surgery. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Simple and effective exercise design for assessing in vivo mitochondrial function in clinical applications using (31)P magnetic resonance spectroscopy.

PubMed

Sleigh, Alison; Lupson, Victoria; Thankamony, Ajay; Dunger, David B; Savage, David B; Carpenter, T Adrian; Kemp, Graham J

2016-01-11

The growing recognition of diseases associated with dysfunction of mitochondria poses an urgent need for simple measures of mitochondrial function. Assessment of the kinetics of replenishment of the phosphocreatine pool after exercise using (31)P magnetic resonance spectroscopy can provide an in vivo measure of mitochondrial function; however, the wider application of this technique appears limited by complex or expensive MR-compatible exercise equipment and protocols not easily tolerated by frail participants or those with reduced mental capacity. Here we describe a novel in-scanner exercise method which is patient-focused, inexpensive, remarkably simple and highly portable. The device exploits an MR-compatible high-density material (BaSO4) to form a weight which is attached directly to the ankle, and a one-minute dynamic knee extension protocol produced highly reproducible measurements of post-exercise PCr recovery kinetics in both healthy subjects and patients. As sophisticated exercise equipment is unnecessary for this measurement, our extremely simple design provides an effective and easy-to-implement apparatus that is readily translatable across sites. Its design, being tailored to the needs of the patient, makes it particularly well suited to clinical applications, and we argue the potential of this method for investigating in vivo mitochondrial function in new cohorts of growing clinical interest.

Clinical outcome of patients with heart failure and preserved left ventricular function.

PubMed

Gotsman, Israel; Zwas, Donna; Planer, David; Azaz-Livshits, Tanya; Admon, Dan; Lotan, Chaim; Keren, Andre

2008-11-01

Patients with heart failure have a poor prognosis. However, it has been presumed that patients with heart failure and preserved left ventricular function (LVF) may have a more benign prognosis. We evaluated the clinical outcome of patients with heart failure and preserved LVF compared with patients with reduced function and the factors affecting prognosis. We prospectively evaluated 289 consecutive patients hospitalized with a definite clinical diagnosis of heart failure based on typical symptoms and signs. They were divided into 2 subsets based on echocardiographic LVF. Patients were followed clinically for a period of 1 year. Echocardiography showed that more than one third (36%) of the patients had preserved systolic LVF. These patients were more likely to be older and female and have less ischemic heart disease. The survival at 1 year in this group was poor and not significantly different from patients with reduced LVF (75% vs 71%, respectively). The adjusted survival by Cox regression analysis was not significantly different (P=.25). However, patients with preserved LVF had fewer rehospitalizations for heart failure (25% vs 35%, P<.05). Predictors of mortality in the whole group by multivariate analysis were age, diabetes, chronic renal failure, atrial fibrillation, residence in a nursing home, and serum sodium < or = 135 mEq/L. The prognosis of patients with clinical heart failure with or without preserved LVF is poor. Better treatment modalities are needed in both subsets.

Using Hermeneutic Phenomenology to Investigate How Experienced Practitioners Learn to Communicate Clinical Reasoning

ERIC Educational Resources Information Center

Ajjawi, Rola; Higgs, Joy

2007-01-01

This paper is primarily targeted at doctoral students and other researchers considering using hermeneutic phenomenology as a research strategy. We present interpretive paradigm research designed to investigate how experienced practitioners learn to communicate their clinical reasoning in professional practice. Twelve experienced physiotherapy…

Electronic properties of graphene nanoribbons: A density functional investigation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kumar, Sandeep, E-mail: skumar198712@gmail.com; Sharma, Hitesh, E-mail: dr.hitesh.phys@gmail.com

2015-05-15

Density functional theory calculations have been performed on graphene nano ribbons (GNRs) to investigate the electronic properties as a function of chirality, size and hydrogenation on the edges. The calculations were performed on GNRs with armchair and zigzag configurations with 28, 34, 36, 40, 50, 56, 62, 66 carbon atoms. The structural stability of AGNR and ZGNR increases with the size of nanoribbon where as hydrogenation of GNR tends to lowers their structural stability. All GNRs considered have shown semiconducting behavior with HOMO-LUMO gap decreasing with the increase in the GNR size. The hydrogenation of GNR decreases its HOMO-LUMO gapmore » significantly. The results are in agreement with the available experimental and theoretical results.« less

Brief Report: Biochemical correlates of clinical impairment in high functioning autism and Asperger’s disorder

PubMed Central

Kleinhans, Natalia M.; Richards, Todd; Weaver, Kurt E.; Liang, Olivia; Dawson, Geraldine; Aylward, Elizabeth

2014-01-01

Amygdala dysfunction has been proposed as a critical contributor to social impairment in autism spectrum disorders (ASD). The current study investigated biochemical abnormalities in the amygdala in 20 high functioning adults with autistic disorder or Asperger’s disorder and 19 typically developing adults matched on age and IQ. Magnetic resonance spectroscopy was used to measure n-acetyl aspartate (NAA), creatine/phosphocreatine (Cre), choline/choline containing compounds (Cho), and Myoinositol (mI) in the right and left amygdala. There were no significant between-group differences in any of the metabolites. However, NAA and Cre levels were significantly correlated to clinical ratings on the Autism Diagnostic Interview-Revised. This suggests that altered metabolite levels in the amygdala may be associated with a more severe early developmental course in ASD. PMID:19234776

Microneurography as a tool in clinical neurophysiology to investigate peripheral neural traffic in humans.

PubMed

Mano, Tadaaki; Iwase, Satoshi; Toma, Shinobu

2006-11-01

Microneurography is a method using metal microelectrodes to investigate directly identified neural traffic in myelinated as well as unmyelinated efferent and afferent nerves leading to and coming from muscle and skin in human peripheral nerves in situ. The present paper reviews how this technique has been used in clinical neurophysiology to elucidate the neural mechanisms of autonomic regulation, motor control and sensory functions in humans under physiological and pathological conditions. Microneurography is particularly important to investigate efferent and afferent neural traffic in unmyelinated C fibers. The recording of efferent discharges in postganglionic sympathetic C efferent fibers innervating muscle and skin (muscle sympathetic nerve activity; MSNA and skin sympathetic nerve activity; SSNA) provides direct information about neural control of autonomic effector organs including blood vessels and sweat glands. Sympathetic microneurography has become a potent tool to reveal neural functions and dysfunctions concerning blood pressure control and thermoregulation. This recording has been used not only in wake conditions but also in sleep to investigate changes in sympathetic neural traffic during sleep and sleep-related events such as sleep apnea. The same recording was also successfully carried out by astronauts during spaceflight. Recordings of afferent discharges from muscle mechanoreceptors have been used to understand the mechanisms of motor control. Muscle spindle afferent information is particularly important for the control of fine precise movements. It may also play important roles to predict behavior outcomes during learning of a motor task. Recordings of discharges in myelinated afferent fibers from skin mechanoreceptors have provided not only objective information about mechanoreceptive cutaneous sensation but also the roles of these signals in fine motor control. Unmyelinated mechanoreceptive afferent discharges from hairy skin seem to be

Liver function tests abnormality and clinical severity of dengue infection in adult patients.

PubMed

Kittitrakul, Chatporn; Silachamroon, Udomsak; Phumratanaprapin, Weerapong; Krudsood, Srivicha; Wilairatana, Polrat; Treeprasertsuk, Sombat

2015-01-01

The clinical manifestations of dengue infection in the adult are different from those in children, i.e. having less prevalence to bleeding, and more commonly, abnormal liver function tests. The primary objective is to describe the clinical manifestations of dengue infection in adult patients. The secondary objective is to compare the clinical manifestations of dengue infection between the groups of normal and abnormal liver function tests in adult patients. Retrospective study was done in adults (age 15 years) dengue patients admitted at the Hospital for Tropical Diseases from 2000-2002. Dengue infection diagnosed by WHO clinical criteria 1997 with serological tests confirmed by ELISA test or Rapid Immunochromatographic test. Liver function test was recorded by day of fever. There were 127 adult dengue patients with mean age 26.4 ± 11.5 years. Classifications of dengue infection by WHO criteria were DF 4.7%, DHF grade 126.0%, DHF grade 2 63.0% and DHF grade 3 6.3%. Mean duration of fever clearance time was 6.0 ± 1.9 days but the fever lasted longer in cases of high-level transaminases (> 10 folds). The common presenting symptoms and signs were myalgia (95.9%), nausea/vomiting (87.7%), positive tourniquet test (77.2%), abdominal pain (42.7%), hepatomegaly (34.6%), and bleeding (20.5%). The ratio of AST and ALTwas 1.8:1. Abnormal AST and ALT were found in 88.2% and 69.3% of the patients, respectively. Patients with nausea/vomiting, petechiae or duration of fever > 7 days more frequently had abnormal transaminases. Abnormal AST during the febrile stage was associated with bleeding. High-level AST and ALT occurred in 11.0% and 7.0%, respectively. Shock was associated with high-level ALT during the febrile stage. Adult dengue patients commonly showed abnormal liver function tests and accounted for at least two-thirds of them. High-level ALT during the febrile stage showed association with shock.

Exercise Improves Clinical Symptoms, Quality of Life, Global Functioning, and Depression in Schizophrenia: A Systematic Review and Meta-analysis

PubMed Central

Dauwan, Meenakshi; Begemann, Marieke J. H.; Heringa, Sophie M.; Sommer, Iris E.

2016-01-01

Background: Physical exercise may be valuable for patients with schizophrenia spectrum disorders as it may have beneficial effect on clinical symptoms, quality of life and cognition. Methods: A systematic search was performed using PubMed (Medline), Embase, PsychInfo, and Cochrane Database of Systematic Reviews. Controlled and uncontrolled studies investigating the effect of any type of physical exercise interventions in schizophrenia spectrum disorders were included. Outcome measures were clinical symptoms, quality of life, global functioning, depression or cognition. Meta-analyses were performed using Comprehensive Meta-Analysis software. A random effects model was used to compute overall weighted effect sizes in Hedges’ g. Results: Twenty-nine studies were included, examining 1109 patients. Exercise was superior to control conditions in improving total symptom severity (k = 14, n = 719: Hedges’ g = .39, P < .001), positive (k = 15, n = 715: Hedges’ g = .32, P < .01), negative (k = 18, n = 854: Hedges’ g = .49, P < .001), and general (k = 10, n = 475: Hedges’ g = .27, P < .05) symptoms, quality of life (k = 11, n = 770: Hedges’ g = .55, P < .001), global functioning (k = 5, n = 342: Hedges’ g = .32, P < .01), and depressive symptoms (k = 7, n = 337: Hedges’ g = .71, P < .001). Yoga, specifically, improved the cognitive subdomain long-term memory (k = 2, n = 184: Hedges’ g = .32, P < .05), while exercise in general or in any other form had no effect on cognition. Conclusion: Physical exercise is a robust add-on treatment for improving clinical symptoms, quality of life, global functioning, and depressive symptoms in patients with schizophrenia. The effect on cognition is not demonstrated, but may be present for yoga. PMID:26547223

Sex-specific issues in eating disorders: a clinical and psychopathological investigation.

PubMed

Valente, Stefano; Di Girolamo, Giulia; Forlani, Martina; Biondini, Anna; Scudellari, Paolo; De Ronchi, Diana; Atti, Anna Rita

2017-12-01

To highlight the characteristics of eating disorders (ED) in males, with particular attention to sex-related clinical features and psychiatric co-morbidities. Out of 280 persons, referred to our outpatients ED clinic between January 2011 and June 2014, 267 with complete information were included in this retrospective observational study. The men/women ratio was one to five (male 16.5% vs female 83.5%) with an increasing proportion of male patients over the years. The most frequent ED in males was binge eating disorder, whereas in females anorexia nervosa and bulimia nervosa prevailed. Excessive exercising and fasting were the most common compensation behaviours in males; while self-induced vomiting and laxative-diuretic abuse were more typical in females. Among women, the most represented psychiatric co-morbidities were mood and somatoform disorders, whereas among men, anxiety and psychosis spectrum disorders were the most frequent ones. Borderline and histrionic personality disorders were prevalent in female ED, while narcissistic and antisocial personality disorders prevailed in males. ED in men is a growing phenomenon. Male ED, compared to female ED, show differences in clinical presentation, symptoms and co-morbidities. Despite the use of clinical and psychometric evaluating tools targeting female patients, sex differences do exist and additional studies are required to investigate male specific issues in ED. Level of Evidence Level V, cross-sectional descriptive study.

Functional Relationships for Investigating Cognitive Processes

PubMed Central

Wright, Anthony A.

2013-01-01

Functional relationships (from systematic manipulation of critical variables) are advocated for revealing fundamental processes of (comparative) cognition—through examples from my work in psychophysics, learning, and memory. Functional relationships for pigeon wavelength (hue) discrimination revealed best discrimination at the spectral points of hue transition for pigeons—a correspondence (i.e., functional relationship) similar to that for humans. Functional relationships for learning revealed: Item-specific or relational learning in matching to sample as a function of the pigeons’ sample-response requirement, and same/different abstract-concept learning as a function of the training set size for rhesus monkeys, capuchin monkeys, and pigeons. Functional relationships for visual memory revealed serial position functions (a 1st order functional relationship) that changed systematically with retention delay (a 2nd order relationship) for pigeons, capuchin monkeys, rhesus monkeys, and humans. Functional relationships for rhesus-monkey auditory memory also revealed systematic changes in serial position functions with delay, but these changes were opposite to those for visual memory. Functional relationships for proactive interference revealed interference that varied as a function of a ratio of delay times. Functional relationships for change detection memory revealed (qualitative) similarities and (quantitative) differences in human and monkey visual short term memory as a function of the number of memory items. It is concluded that these findings were made possible by varying critical variables over a substantial portion of the manipulable range to generate functions and derive relationships. PMID:23174335

Use of Statins to Augment Progenitor Cell Function in Preclinical and Clinical Studies of Regenerative Therapy: a Systematic Review.

PubMed

Park, Angela; Barrera-Ramirez, Juliana; Ranasinghe, Indee; Pilon, Sophie; Sy, Richmond; Fergusson, Dean; Allan, David S

2016-06-01

Mesenchymal stromal cells (MSCs) and endothelial progenitor cells (EPCs) are used in cell-based regenerative therapy. HMG CoA reductase inhibitors (statins) appear promising in blocking apoptosis, prolonging progenitor cell survival and improving their capacity to repair organ function. We performed a systematic review of preclinical and clinical studies to clarify whether statins can improve cell-based repair of organ injury. MEDLINE, EMBASE, and PUBMED databases were searched (1947 to June 25, 2013). Controlled clinical and pre-clinical studies were included that evaluated statin therapy used alone or in combination with MSCs or EPCs in patients or animals with organ injury. After screening 771 citations, 100 records underwent full eligibility screening of which 38 studies met eligibility and were included in the review: Studies were grouped into pre-clinical studies that involved statin treatment in combination with cell therapy (18 studies), preclinical studies of statin therapy alone (13 studies) and clinical studies of statin therapy (7 studies). Studies addressed cardiac injury (14 studies), vascular disorders (15 studies), neurologic conditions (8 studies) and bone fractures (1 study). Pre-clinical studies of statins in combination with MSC infusion (15 studies) or EPC therapy (3 studies) were described and despite marked heterogeneity in reporting outcomes of cellular analysis and organ function, all of these cell-based pre-clinical studies reported improved organ recovery with the addition of statin therapy. Moreover, 13 pre-clinical studies involved the administration of a statin drug alone to animals. An increase in EPC number and/or function (no studies of MSCs) was reported in 11 of these studies (85 %) and improved organ function in 12 studies (92 %). We also identified 7 clinical studies and none involved the administration of cells but described an increased number and/or function of EPCs (no studies of MSCs) and improved organ function with

Molar Functional Relations and Clinical Behavior Analysis: Implications for Assessment and Treatment

ERIC Educational Resources Information Center

Waltz, Thomas J.; Follette, William C.

2009-01-01

The experimental analysis of behavior has identified several molar functional relations that are highly relevant to clinical behavior analysis. These include matching, discounting, momentum, and variability. Matching provides a broader analysis of how multiple sources of reinforcement influence how individuals choose to allocate their time and…

Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia

PubMed Central

Franzen, Samuel R P; Chandler, Clare; Enquselassie, Fikre; Siribaddana, Sisira; Atashili, Julius; Angus, Brian; Lang, Trudie

2013-01-01

Objectives Clinical trials provide ‘gold standard’ evidence for policy, but insufficient locally relevant trials are conducted in low-income and middle-income countries. Local investigator-initiated trials could generate highly relevant data for national governments, but information is lacking on how to facilitate them. We aimed to identify barriers and enablers to investigator-initiated trials in Ethiopia to inform and direct capacity strengthening initiatives. Design Exploratory, qualitative study comprising of in-depth interviews (n=7) and focus group discussions (n=3). Setting Fieldwork took place in Ethiopia during March 2011. Participants Local health researchers with previous experiences of clinical trials or stakeholders with an interest in trials were recruited through snowball sampling (n=20). Outcome measures Detailed discussion notes were analysed using thematic coding analysis and key themes were identified. Results All participants perceived investigator-initiated trials as important for generating local evidence. System and organisational barriers included: limited funding allocation, weak regulatory and administrative systems, few learning opportunities, limited human and material capacity and poor incentives for conducting research. Operational hurdles were symptomatic of these barriers. Lack of awareness, confidence and motivation to undertake trials were important individual barriers. Training, knowledge sharing and experience exchange were key enablers to trial conduct and collaboration was unanimously regarded as important for improving capacity. Conclusions Barriers to trial conduct were found at individual, operational, organisational and system levels. These findings indicate that to increase locally led trial conduct in Ethiopia, system wide changes are needed to create a more receptive and enabling research environment. Crucially, the creation of research networks between potential trial groups could provide much needed practical

Using thermographic cameras to investigate eye temperature and clinical severity in depression

NASA Astrophysics Data System (ADS)

Maller, Jerome J.; George, Shefin Sam; Viswanathan, Rekha Puzhavakkathumadom; Fitzgerald, Paul B.; Junor, Paul

2016-02-01

Previous studies suggest that altered corneal temperature may be a feature of schizophrenia, but the association between major depressive disorder (MDD) and corneal temperature has yet to be assessed. The aim of this study is to investigate whether eye temperature is different among MDD patients than among healthy individuals. We used a thermographic camera to measure and compare the temperature profile across the corneas of 16 patients with MDD and 16 age- and sex-matched healthy subjects. We found that the average corneal temperature between the two groups did not differ statistically, although clinical severity correlated positively with right corneal temperature. Corneal temperature may be an indicator of clinical severity in psychiatric disorders, including depression.

Children with ADHD and Depression: A Multisource, Multimethod Assessment of Clinical, Social, and Academic Functioning

ERIC Educational Resources Information Center

Blackman, Gabrielle L.; Ostrander, Rick; Herman, Keith C.

2005-01-01

Although ADHD and depression are common comorbidities in youth, few studies have examined this particular clinical presentation. To address method bias limitations of previous research, this study uses multiple informants to compare the academic, social, and clinical functioning of children with ADHD, children with ADHD and depression, and…

[CLINICAL INVESTIGATION OF AN EXCESSIVE SLEEPINESS COMPLAINT].

PubMed

Evangelista, Elisa; Barateau, Lucie; Dauvilliers, Yves

2016-06-01

Excessive sleepiness is a common problem, defined by a complaint of excessive daytime sleepiness almost daily with an inability to stay awake and alert dosing periods at sleep, with episodes of irresistible sleep need or drowsiness or non-intentional sleep, or by a night's sleep time overly extended often associated with sleep inertia. This sleepiness is variable in terms of phenotype and severity to be specified by the out-patient clinic. It is considered to be chronic beyond three months and often responsible for significant functional impairment of school and professional performance, of the accidents and cardiovascular risk. We need to decipher the causes of excessive sleepiness: sleep deprivation, toxic and iatrogenic, psychiatric disorders (including depression), non-psychiatric medical problems (obesity, neurological pathologies...), sleep disorders (as for example the sleep apnea syndrome), and finally the central hypersomnias namely narcolepsy type 1 and 2, idiopathic hypersomnia, and Kleine-Levin syndrome. If careful questioning often towards one of these etiologies, need most of the time a paraclinical balance with a sleep recording to confirm the diagnosis. Patients affected with potential central hypersomnia must be referred to the Sleep Study Centers that have the skills and the appropriate means to achieve this balance sheet.

Using Ecological Momentary Assessment to Investigate Short-Term Variations in Sexual Functioning in a Sample of Peri-Menopausal Women from Iran

PubMed Central

Pakpour, Amir H.; Yekaninejad, Mir Saeed; Pallich, Gianandrea; Burri, Andrea

2015-01-01

The investigation of short-term changes in female sexual functioning has received little attention so far. The aims of the study were to gain empirical knowledge on within-subject and within- and across-variable fluctuations in women’s sexual functioning over time. More specifically, to investigate the stability of women´s self-reported sexual functioning and the moderating effects of contextual and interpersonal factors. A convenience sample of 206 women, recruited across eight Health care Clinics in Rasht, Iran. Ecological momentary assessment was used to examine fluctuations of sexual functioning over a six week period. A shortened version of the Female Sexual Function Index (FSFI) was applied to assess sexual functioning. Self-constructed questions were included to assess relationship satisfaction, partner’s sexual performance and stress levels. Mixed linear two-level model analyses revealed a link between orgasm and relationship satisfaction (Beta = 0.125, P = 0.074) with this link varying significantly between women. Analyses further revealed a significant negative association between stress and all six domains of women’s sexual functioning. Women not only reported differing levels of stress over the course of the assessment period, but further differed from each other in how much stress they experienced and how much this influenced their sexual response. Orgasm and sexual satisfaction were both significantly associated with all other domains of sexual function (P<0.001). And finally, a link between partner performance and all domains of women`s sexual functioning (P<0.001) could be detected. Except for lubrication (P = 0.717), relationship satisfaction had a significant effect on all domains of the sexual response (P<0.001). Overall, our findings support the new group of criteria introduced in the DSM-5, called “associated features” such as partner factors and relationship factors. Consideration of these criteria is important and necessary for

The association between substantiated childhood maltreatment, asthma and lung function: A prospective investigation.

PubMed

Abajobir, Amanuel Alemu; Kisely, Steve; Williams, Gail; Strathearn, Lane; Suresh, Sadasivam; Najman, Jake Moses

2017-10-01

Asthma reflects multiple and likely complex causal pathways. We investigate the possibility that childhood maltreatment is one such causal pathway. Childhood maltreatment can be interpreted as a form of early life adversity and like other life adversities may predict a range of negative health outcomes, including asthma. A total of 3762 young adults (52.63% female) from the Mater Hospital-University of Queensland Study of Pregnancy (MUSP) participated in this study. MUSP is a prospective Australian birth cohort study of mothers consecutively recruited during their first antenatal clinic visit at Brisbane's Mater Hospital from 1981 to 1983. The study followed both mother-child dyads to the age of 21years after birth. Participants reported whether they had been diagnosed by a physician with asthma by the 21-year follow-up. Trained research assistants also performed gender- and height-standardized lung function tests using a Spirobank G spirometer system attached to a laptop computer. We linked this dataset with data obtained from the child protection services and which comprised all substantiated cases of childhood maltreatment in the MUSP cohort. Substantiations of childhood maltreatment included children in an age range of 0-14years. The experience of any childhood maltreatment, particularly emotional abuse, was independently associated with self-reported physician-diagnosed asthma by the 21-year follow-up. The association was no longer significant after adjustment for a range of confounders and covariates in neglected children. Childhood maltreatment, including multiple events, was not associated with lung function in adjusted models. Childhood maltreatment, including emotional abuse, was associated with lifetime ever asthma. This was in contrast to the absence of an association with objective measures of lung function. More research is indicated on the effect of childhood maltreatment on lung function using objective measures. In the meantime, there should be a

Evaluation of a BED-SIDE platelet function assay: performance and clinical utility.

PubMed

Lau, Wei C; Walker, C Ty; Obilby, David; Wash, Mark M; Carville, David G M; Guyer, Kirk E; Bates, Eric R

2002-01-01

Platelets have a pivotal role in the initial defense against insult to the vasculature and are also recognized of critical importance in the acute care settings of percutaneous coronary intervention and cardiopulmonary bypass. In these environments both platelet count and function may be markedly compromised. Unfortunately, current assays to evaluate the parameters of platelet count and function are of limited utility for bed-side testing. Moreover, it is suggested that there may be significant inter patient variation in response to antiplatelet therapy that may be exacerbated by other agents (e.g. heparin) that are routinely administered during cardiac intervention. Here we describe a practical, rapid and user-friendly whole blood platelet function assay that has been developed for use in bed-side settings. Platelet agonists were formulated with an anticoagulant and lyophilized in blood collection tubes standardised to receive a l mL fresh whole blood sample. In the presence of an agonist, platelets are activated and interact (aggregate). Using traditional cell counting principles, non-aggregated platelets are counted whereas aggregated platelets are not. The percentage (%) of functional platelets in reference to a baseline tube may then be determined. Results are available within four minutes. Platelet aggregation in whole blood demonstrated good correlation with turbidometric aggregometry for both ADP (r=0.91) and collagen (r=0.88). Moreover, in clinical settings where antiplatelet agents were administered, this rapid, bed-side, platelet function assay demonstrated utility in monitoring patient response to these therapies. This novel bed-side assay of platelet function is extremely suitable for the clinical environment with a rapid turn-around time. In addition, it provides a full haematology profile, including platelet count, and should permit enhancement of transfusion and interventional decisions.

Neurocognitive function in clinically stable individuals with long-term bipolar I disorder: Comparisons with schizophrenia patients and controls.

PubMed

Lin, Pei-Yun; Wang, Peng-Wei; Chen, Cheng-Sheng; Yen, Cheng-Fang

2017-05-01

This study compared the levels of the five domains of neurocognitive function-executive function, attention, memory, verbal comprehension, and perceptual organization-among clinically stable individuals with long-term bipolar I disorder, individuals with long-term schizophrenia, and a group of controls. We recruited a total of 93 clinically stable individuals with bipolar I disorder, 94 individuals with schizophrenia, and 106 controls in this study. Their neurocognitive function was measured using a series of neurocognitive function tests: the Wechsler Adult Intelligence Scale-Third Edition (WAIS-III), Line Cancellation Test, Visual Form Discrimination, Controlled Oral Word Association Test, Wisconsin Card Sorting Test, Continuous Performance Task, and Wechsler Memory Scale-Third Edition. Neurocognitive function was compared among the three groups through a multivariate analysis of variance. The results indicated that when the effect of age was controlled, clinically stable individuals with bipolar I disorder and those with schizophrenia demonstrated poor neurocognitive function on all tests except for the WAIS-III Similarity and Information and the Line Cancellation Test. The individuals with bipolar I disorder had similar levels of neurocognitive function compared with the schizophrenia group, but higher levels of neurocognitive function on the WAIS-III Comprehension, Controlled Oral Word Association Test, and Wechsler Memory Scale-Third Edition Auditory Immediate and Delayed Index and Visual Immediate and Delayed Index. The conclusions of this study suggest that compared with controls, individuals with long-term bipolar I disorder and those with long-term schizophrenia have poorer neurocognitive function, even when clinically stable. Individuals with long-term bipolar I disorder and those with long-term schizophrenia have similar levels of deficits in several domains of neurocognitive function. Copyright © 2017. Published by Elsevier Taiwan.

Clinical Investigation Program

DTIC Science & Technology

1990-09-30

with Subretinal Hemorrhage: A Case Report. Ann Ophthalmol, 22:259-262, 1990. Walton WT, Enzenauer RW: " Nutritional Disease" in Levin AV, Enzenauer RW...adequate means of maintaining nutritional status. Publications and Presentations: None. 1 135 FAMC A.P.R. (RCS MED 300) Detail Summary Sheet (HSCR 40-23 as...4) Title: The Effect of Liposucticn on Myocutaneous Flaps in the Yucatan Micro Pig (5) Start Date: (6) Est Compl Date: (7) Principal Investigator: (8

Can computer assistance improve the clinical and functional scores in total knee arthroplasty?

PubMed

Hernández-Vaquero, Daniel; Suarez-Vazquez, Abelardo; Iglesias-Fernandez, Susana

2011-12-01

Surgical navigation in TKA facilitates better alignment; however, it is unclear whether improved alignment alters clinical evolution and midterm and long-term complication rates. We determined the alignment differences between patients with standard, manual, jig-based TKAs and patients with navigation-based TKAs, and whether any differences would modify function, implant survival, and/or complications. We retrospectively reviewed 97 patients (100 TKAs) undergoing TKAs for minimal preoperative deformities. Fifty TKAs were performed with an image-free surgical navigation system and the other 50 with a standard technique. We compared femoral angle (FA), tibial angle (TA), and femorotibial angle (FTA) and determined whether any differences altered clinical or functional scores, as measured by the Knee Society Score (KSS), or complications. Seventy-three patients (75 TKAs) had a minimum followup of 8 years (mean, 8.3 years; range, 8-9.1 years). All patients included in the surgical navigation group had a FTA between 177° and 182º. We found no differences in the KSS or implant survival between the two groups and no differences in complication rates, although more complications occurred in the standard technique group (seven compared with two in the surgical navigation group). In the midterm, we found no difference in functional and clinical scores or implant survival between TKAs performed with and without the assistance of a navigation system. Level II, therapeutic study. See the Guidelines online for a complete description of levels of evidence.

Estrogen biology: new insights into GPER function and clinical opportunities.

PubMed

Prossnitz, Eric R; Barton, Matthias

2014-05-25

Estrogens play an important role in the regulation of normal physiology, aging and many disease states. Although the nuclear estrogen receptors have classically been described to function as ligand-activated transcription factors mediating genomic effects in hormonally regulated tissues, more recent studies reveal that estrogens also mediate rapid signaling events traditionally associated with G protein-coupled receptors. The G protein-coupled estrogen receptor GPER (formerly GPR30) has now become recognized as a major mediator of estrogen's rapid cellular effects throughout the body. With the discovery of selective synthetic ligands for GPER, both agonists and antagonists, as well as the use of GPER knockout mice, significant advances have been made in our understanding of GPER function at the cellular, tissue and organismal levels. In many instances, the protective/beneficial effects of estrogen are mimicked by selective GPER agonism and are absent or reduced in GPER knockout mice, suggesting an essential or at least parallel role for GPER in the actions of estrogen. In this review, we will discuss recent advances and our current understanding of the role of GPER and the activity of clinically used drugs, such as SERMs and SERDs, in physiology and disease. We will also highlight novel opportunities for clinical development towards GPER-targeted therapeutics, for molecular imaging, as well as for theranostic approaches and personalized medicine. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

No benefit of patient-specific instrumentation in TKA on functional and gait outcomes: a randomized clinical trial.

PubMed

Abdel, Matthew P; Parratte, Sébastien; Blanc, Guillaume; Ollivier, Matthieu; Pomero, Vincent; Viehweger, Elke; Argenson, Jean-Noël A

2014-08-01

Although some clinical reports suggest patient-specific instrumentation in TKA may improve alignment, reduce surgical time, and lower hospital costs, it is unknown whether it improves pain- and function-related outcomes and gait. We hypothesized that TKA performed with patient-specific instrumentation would improve patient-reported outcomes measured by validated scoring tools and level gait as ascertained with three-dimensional (3-D) analysis compared with conventional instrumentation 3 months after surgery. We randomized 40 patients into two groups using either patient-specific instrumentation or conventional instrumentation. Patients were evaluated preoperatively and 3 months after surgery. Assessment tools included subjective functional outcome and quality-of-life (QOL) scores using validated questionnaires (New Knee Society Score(©) [KSS], Knee Injury and Osteoarthritis Outcome Score [KOOS], and SF-12). In addition, gait analysis was evaluated with a 3-D system during level walking. The study was powered a priori at 90% to detect a difference in walking speed of 0.1 m/second, which was considered a clinically important difference, and in a post hoc analysis at 80% to detect a difference of 10 points in KSS. There were improvements from preoperatively to 3 months postoperatively in functional scores, QOL, and knee kinematic and kinetic gait parameters during level walking. However, there was no difference between the patient-specific instrumentation and conventional instrumentation groups in KSS, KOOS, SF-12, or 3-D gait parameters. Our observations suggest that patient-specific instrumentation does not confer a substantial advantage in early functional or gait outcomes after TKA. It is possible that differences may emerge, and this study does not allow one to predict any additional variances in the intermediate followup period from 6 months to 1 year postoperatively. However, the goals of the study were to investigate the recovery period as early pain and

Challenging the foundations of the clinical model of foot function: further evidence that the root model assessments fail to appropriately classify foot function.

PubMed

Jarvis, Hannah L; Nester, Christopher J; Bowden, Peter D; Jones, Richard K

2017-01-01

The Root model of normal and abnormal foot function remains the basis for clinical foot orthotic practice globally. Our aim was to investigate the relationship between foot deformities and kinematic compensations that are the foundations of the model. A convenience sample of 140 were screened and 100 symptom free participants aged 18-45 years were invited to participate. The static biomechanical assessment described by the Root model was used to identify five foot deformities. A 6 segment foot model was used to measure foot kinematics during gait. Statistical tests compared foot kinematics between feet with and without foot deformities and correlated the degree of deformity with any compensatory motions. None of the deformities proposed by the Root model were associated with distinct differences in foot kinematics during gait when compared to those without deformities or each other. Static and dynamic parameters were not correlated. Taken as part of a wider body of evidence, the results of this study have profound implications for clinical foot health practice. We believe that the assessment protocol advocated by the Root model is no longer a suitable basis for professional practice. We recommend that clinicians stop using sub-talar neutral position during clinical assessments and stop assessing the non-weight bearing range of ankle dorsiflexion, first ray position and forefoot alignments and movement as a means of defining the associated foot deformities. The results question the relevance of the Root assessments in the prescription of foot orthoses.

Subtyping Schizophrenia by Social Functioning - a Pragmatic Proposal for Clinics and Research.

PubMed

Suzuki, Takefumi

2018-01-03

Schizophrenia has been claimed to be a "heterogeneous" disorder despite the fact that a diagnosis is made without reliable biomarkers but sorely with a constellation of "common" observable symptoms that however may be overlooked. Alternatively functional impairments are the prerequisite to make a diagnosis and may be simpler and more pragmatic to express objectively. It would then be reasonable to categorize patients according to the magnitude of psychosocial impairments, as has been done in terms of the severity of "classical" symptoms. In this context the author proposes a new paradigm in which patients with schizophrenia are classified into three functional subtypes using the anchors for the Clinical Global Impression Functioning subscale (CGI-F, adopted from the CGI) and the Functional Assessment for Comprehensive Treatment of Schizophrenia (FACT-Sz): Class 1 patients are those with no to mild functional impairments (a score of 1-3 in the CGI-F and a score of 60-100 in the FACT-Sz), Class 2 patients are those with moderate to marked impairments (4 or 5 in the CGI-F and 40-59 in the FACT-Sz), and Class 3 patients are those with severe to most severe impairments (6 or 7 in the CGI-F 6,7 and 0-39 in the FACT-Sz). The author has no intention to ignore the importance of other domains of the illness but instead provides a simple framework as what the patient is actually doing is considered to represent the proximal "hard outcome" and certainly has the relevance in the management of schizophrenia. Implications of this pragmatic classification system for clinics and research are discussed.

[On the issues of functioning of the clinic of research institute of balneology].

PubMed

2012-01-01

The article presents the results of analysis of effectiveness of application of main resources in organizing and quality supporting of medical diagnostic care to patients in the clinic of research institute of balneology profile. The result data points out the insufficient effectiveness of application of these resources; the defects in organization and quality of curative diagnostic and rehabilitation care. They determine the priority directions of enhancement of functioning of the institution being a clinical base of research institute of balneology.

Family functioning in bipolar disorder: Characteristics, congruity between patients and relatives, and clinical correlates.

PubMed

Reinares, María; Bonnín, C Mar; Hidalgo-Mazzei, Diego; Colom, Francesc; Solé, Brisa; Jiménez, Esther; Torrent, Carla; Comes, Mercè; Martínez-Arán, Anabel; Sánchez-Moreno, José; Vieta, Eduard

2016-11-30

Functional improvement has become one of the aims of the treatment of bipolar disorder. However, scant attention has been given to family functioning, even though it has a role in the illness outcome and is affected by the disorder. The aims of this study were to compare family functioning reported by euthymic patients with bipolar disorder and healthy controls; explore the level of congruence in the perception of family environment between patients with bipolar disorder and their relatives; and analyse the relationship between clinical variables and family functioning. The sample comprised 82 adult euthymic subjects with bipolar disorder, 82 family caregivers of these patients and 47 healthy controls. Participants completed the Family Environment Scale. Results showed moderate correlations and a mean pattern almost identical between relatives' and patients' reported scores in family functioning subscales. There were significant differences between patients and controls, favourable for the latter, in the subscales cohesion (p<0.005), expressiveness (p=0.002), conflict (p=0.038), intellectual-cultural orientation (p=0.001), active-recreational orientation (p<0.005), and a non-significant trend in organization (p=0.064). Significant associations were found between family environment and clinical variables of severity. These findings contribute to increasing the understanding of family functioning in bipolar disorder and highlight the importance of family work. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The relationship of self-rated function and self-rated health to concurrent functional ability, functional decline, and mortality: findings from the Nun Study.

PubMed

Greiner, P A; Snowdon, D A; Greiner, L H

1996-09-01

We investigated the relationship of self-rated function (i.e., the ability to take care of oneself) and self-rated health to concurrent functional ability, functional decline, and mortality in participants in the Nun Study, a longitudinal study of aging and Alzheimer's disease. A total of 629 of the 678 study participants self-rated their function and health and completed an initial functional assessment in 1991-93. Survivors completed a second assessment in 1993-94. Overall, self-rated function had a stronger relationship to functional ability at the first assessment and to functional decline between the first and second assessments than did self-rated health. Self-rated function also had a stronger relationship to mortality than did self-rated health. Self-rated function may be a better marker of global function than is self-rated health and may be a useful addition to clinical assessment and scientific investigation of the relationships among function, health, and disease.

Informed consent in clinical research at a general hospital in Mexico: opinions of the investigators.

PubMed

Vargas-Parada, Laura; Kawa, Simon; Salazar, Alberto; Mazön, Juan José; Flisser, Ana

2006-03-01

In Mexico informed consent is a legal requirement that ensures that patients who are invited to participate in clinical trials are provided with all the information needed to decide whether to participate, or not, in a research protocol. To improve our understanding of the problems physicians in developing countries encounter, when obtaining informed consent (IC), we examined their opinion on the importance of IC in clinical research, the quantity and quality of the information provided to the participant, and the conditions in which the IC is obtained. Investigators considered that IC was useful to the patients, providing information that helped the patient to make a decision about his/her participation. Nevertheless, they felt that for some aspects of the research, like drug development in general, the use of placebos, and the randomization process, many of the patients were not capable of fully understanding the information provided, referring to the complexity of the information and illiteracy as the main reasons. Many investigators were not acquainted with some of the guidelines established in the Mexican General Law of Health,(1) 36% of them admitting to not having completed their IC letters. Most investigators gave only minutes to the patient to make a decision and 20% of ICs were obtained while the patient was hospitalized. Except for one investigator, all of them considered that specific training in medical ethics would be useful for the daily clinical work.

Understanding Career Success and Its Contributing Factors for Clinical and Translational Investigators

PubMed Central

Robinson, Georgeanna F.W.B.; Schwartz, Lisa S.; DiMeglio, Linda A.; Ahluwalia, Jasjit S.; Gabrilove, Janice L.

2015-01-01

Purpose To understand the factors that facilitate career success for career development awardees in clinical and translational science and to reconceptualize understanding of career success for this population. Method In 2013–2014, the authors conducted semi-structured interviews with former NIH KL2 or K12 scholars from nine Clinical and Translational Science Award-funded institutions. Participants either had or had not secured independent funding at least two years after the end of their last K award. Questions covered the factors that facilitate or hinder junior investigators’ transition to independent funding. Interviews were recorded and transcribed and the transcripts analyzed thematically. Results Forty individuals participated, with equal representation by men and women and by independently and not independently funded investigators. Personal factors that facilitated success included: networks, persistence and resilience, initiative, autonomy, and personal and professional balance. Organizational factors included: appropriate mentorship, protected research time, and institutional resources and support. Even independently funded participants described challenges regarding career direction. Five participants without independent funding modeled a broad spectrum of successful career paths, having assumed leadership positions not reliant on grant funding. Alternative definitions of career success included: improving public health, enjoying work, seeing mentees succeed, and receiving external acknowledgement of successes. Conclusions Awareness of the factors that facilitate or hinder career success can help junior faculty, mentors, and institutional leaders support career development in clinical and translational science. New definitions of career success are needed, as are career paths for faculty who want to engage in research in roles other than principal investigator. PMID:26509600

Comparing Parent-Child Interactions in the Clinic and at Home: An Exploration of the Validity of Clinical Behavior Observations Using Sequential Analysis

ERIC Educational Resources Information Center

Shriver, Mark D.; Frerichs, Lynae J.; Williams, Melissa; Lancaster, Blake M.

2013-01-01

Direct observation is often considered the "gold standard" for assessing the function, frequency, and intensity of problem behavior. Currently, the literature investigating the construct validity of direct observation conducted in the clinic setting reveals conflicting results. Previous studies on the construct validity of clinic-based…

Neuropsychological and socio-occupational functioning in young psychiatric outpatients: a longitudinal investigation.

PubMed

Lee, Rico S C; Hermens, Daniel F; Redoblado-Hodge, M Antoinette; Naismith, Sharon L; Porter, Melanie A; Kaur, Manreena; White, Django; Scott, Elizabeth M; Hickie, Ian B

2013-01-01

Clinical symptoms and neuropsychological deficits are longitudinally associated with functional outcome in chronic psychiatric cohorts. The current study extended these findings to young and early-course psychiatric outpatients, with the aim of identifying cognitive markers that predict later socio-occupational functioning. At baseline, 183 young psychiatric outpatients were assessed. Ninety-three returned for follow-up (M = 21.6 years old; SD = 4.5) with an average re-assessment interval of 21.6 months (SD = 7.0), and primary diagnoses of major depressive disorder (n = 34), bipolar disorder (n = 29), or psychosis (n = 30). The primary outcome measure was cross-validated with various other functional measures and structural equation modelling was used to map out the interrelationships between predictors and later functional outcome. Good socio-occupational functioning at follow-up was associated with better quality of life, less disability, current employment and being in a romantic relationship. The final structural equation model explained 47.5% of the variability in functional outcome at follow-up, with baseline neuropsychological functioning (a composite of memory, working memory and attentional switching) the best independent predictor of later functional outcome. Notably, depressive and negative symptoms were only associated with functioning cross-sectionally. Diagnosis at follow-up was not associated with functional outcome. Neuropsychological functioning was the single best predictor of later socio-occupational outcome among young psychiatric outpatients. Therefore, framing psychiatric disorders along a neuropsychological continuum is likely to be more useful in predicting functional trajectory than traditional symptom-based classification systems. The current findings also have implications for early intervention utilising cognitive remediation approaches.

Infant lung function tests as endpoints in the ISIS multicenter clinical trial in cystic fibrosis.

PubMed

Davis, Stephanie D; Ratjen, Felix; Brumback, Lyndia C; Johnson, Robin C; Filbrun, Amy G; Kerby, Gwendolyn S; Panitch, Howard B; Donaldson, Scott H; Rosenfeld, Margaret

2016-05-01

The Infant Study of Inhaled Saline (ISIS) in CF was the first multicenter clinical trial to utilize infant pulmonary function tests (iPFTs) as an endpoint. Secondary analysis of ISIS data was conducted in order to assess feasibility of iPFT measures and their associations with respiratory symptoms. Standard deviations were calculated to aid in power calculations for future clinical trials. Seventy-three participants enrolled, 70 returned for the final visit; 62 (89%) and 45 (64%) had acceptable paired functional residual capacity (FRC) and raised volume measurements, respectively. Mean baseline FEV0.5, FEF75 and FRC z-scores were 0.3 (SD: 1.2), -0.2 (SD: 2.0), and 1.8 (SD: 2.0). iPFTs are not appropriate primary endpoints for multicenter clinical trials due to challenges of obtaining acceptable data and near-normal average raised volume measurements. Raised volume measures have potential to serve as secondary endpoints in future clinical CF trials. Copyright © 2015 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

[Functional neuroimaging in the diagnosis of patients with Parkinsonism: Update and recommendations for clinical use].

PubMed

Arbizu, J; Luquin, M R; Abella, J; de la Fuente-Fernández, R; Fernandez-Torrón, R; García-Solís, D; Garrastachu, P; Jiménez-Hoyuela, J M; Llaneza, M; Lomeña, F; Lorenzo-Bosquet, C; Martí, M J; Martinez-Castrillo, J C; Mir, P; Mitjavila, M; Ruiz-Martínez, J; Vela, L

2014-01-01

Functional Neuroimaging has been traditionally used in research for patients with different Parkinsonian syndromes. However, the emergence of commercial radiotracers together with the availability of single photon emission computed tomography (SPECT) and, more recently, positron emission tomography (PET) have made them available for clinical practice. Particularly, the development of clinical evidence achieved by functional neuroimaging techniques over the past two decades have motivated a progressive inclusion of several biomarkers in the clinical diagnostic criteria for neurodegenerative diseases that occur with Parkinsonism. However, the wide range of radiotracers designed to assess the involvement of different pathways in the neurodegenerative process underlying Parkinsonian syndromes (dopaminergic nigrostriatal pathway integrity, basal ganglia and cortical neuronal activity, myocardial sympathetic innervation), and the different neuroimaging techniques currently available (scintigraphy, SPECT and PET), have generated some controversy concerning the best neuroimaging test that should be indicated for the differential diagnosis of Parkinsonism. In this article, a panel of nuclear medicine and neurology experts has evaluated the functional neuroimaging techniques emphazising practical considerations related to the diagnosis of patients with uncertain origin parkinsonism and the assessment Parkinson's disease progression. Copyright © 2014 Elsevier España, S.L. and SEMNIM. All rights reserved.

[Correlation of medial compartmental joint line elevation with femorotibial angle correction and clinical function after unicompartmental arthroplasty].

PubMed

Zhang, Zhan-Feng; Wang, Dan; Min, Ji-Kang

2017-04-25

To study the correlation of postoperative femorotibial angle with medial compartmental joint line elevation after unicompartmental arthroplasty(UKA), as well as the correlation of joint line elevation with the clinical function by measuring radiological joint line. A retrospective study of 56 patients from July 2012 to August 2015 was performed. The mean body mass index (BMI) was 23.5 (ranged, 18.3 to 30.1). The standing anteroposterior radiographs of these patients were assessed both pre-and post-operatively, and the knee function was evaluated according to HSS grading. The correlation between postoperative femorotibial angle(FTA) and joint line elevation was analyzed as well as the correlation between joint line elevation and the clinical function. The mean medial joint line elevation was (2.2±2.0) mm(ranged, -3.3 to 7.0 mm), and the mean FTA correction was (2.3±3.0)°(ranged, -4.5° to 9.6°). The mean follow-up period was 12.2 months. There was a significant correlation between in joint line elevation and FTA correction( P <0.05), while there was no significant correlation between joint line elevation and the clinical function( P >0.05). There was a significant correlation between medial compartmental joint line elevation and FTA correction after UKA, and the proximal tibial osteotomy was critical during the procedure. There was no significant correlation between joint line elevation and the clinical function, which may be related to the design of UKA prosthesis.

Infantile Autism. A Clinical and Phenomenological-Anthropological Investigation Taking Language as the Guide.

ERIC Educational Resources Information Center

Bosch, Gerhard

A clinical and phenomenological-anthropological investigation taking language as the guide, the study of infantile autism concentrates upon an analysis of the idiosyncratic language of autistic children and of what is revealed by the way they use it. Following the presentation of very detailed case histories of five of the autistic children…

Neurologic Functional and Quality of Life Outcomes after TBI: Clinic Attendees versus Non-Attendees

PubMed Central

Wilson, Laura D.; Bregman, Jana A.; Leath, Taylor C.; Humble, Stephen S.; Davidson, Mario A.; de Riesthal, Michael R.; Guillamondegui, Oscar D.

2015-01-01

Abstract This investigation describes the relationship between TBI patient demographics, quality of life outcome, and functional status outcome among clinic attendees and non-attendees. Of adult TBI survivors with intracranial hemorrhage, 63 attended our TBI clinic and 167 did not attend. All were telephone surveyed using the Extended-Glasgow Outcome Scale (GOSE), the Quality of Life after Brain Injury (QOLIBRI) scale, and a post-discharge therapy questionnaire. To determine risk factors for GOSE and QOLIBRI outcomes, we created multivariable regression models employing covariates of age, injury characteristics, clinic attendance, insurance status, post-discharge rehabilitation, and time from injury. Compared with those with severe TBI, higher GOSE scores were identified in individuals with both mild (odds ratio [OR]=2.0; 95% confidence interval [CI]: 1.1–3.6) and moderate (OR=4.7; 95% CI: 1.6–14.1) TBIs. In addition, survivors with private insurance had higher GOSE scores, compared with those with public insurance (OR=2.0; 95% CI: 1.1–3.6), workers' compensation (OR=8.4; 95% CI: 2.6–26.9), and no insurance (OR=3.1; 95% CI: 1.6–6.2). Compared with those with severe TBI, QOLIBRI scores were 11.7 points (95% CI: 3.7–19.7) higher in survivors with mild TBI and 17.3 points (95% CI: 3.2–31.5) higher in survivors with moderate TBI. In addition, survivors who received post-discharge rehabilitation had higher QOLIBRI scores by 11.4 points (95% CI: 3.7–19.1) than those who did not. Survivors with private insurance had QOLIBRI scores that were 25.5 points higher (95% CI: 11.3–39.7) than those with workers' compensation and 16.8 points higher (95% CI: 7.4–26.2) than those without insurance. Because neurologic injury severity, insurance status, and receipt of rehabilitation or therapy are independent risk factors for functional and quality of life outcomes, future directions will include improving earlier access to post-TBI rehabilitation, social work

Variations in clinical nurse leaders' confidence with performing the core role functions.

PubMed

Gilmartin, Mattia J

2014-01-01

Clinical nurse leader (CNL) practice, by definition, requires individuals to make career transitions. CNLs must adjust to their new work role and responsibilities and doing so also entails individual adjustment. Prior work has not examined the role of individual-level factors in effective CNL role transition. This study contributes to CNL implementation efforts by developing understanding of personal and contextual factors that explain variation in individuals' levels of self-confidence with performing the key functions of the CNL role. Data were gathered using a cross-sectional survey from a national sample of registered nurses (RNs) certified as CNLs. Respondents' perceptions of their confidence in performing CNL role competencies were measured with the Clinical Nurse Leader Self-Efficacy Scale (CNLSES; Gilmartin MJ, Nokes, K. (in press). The Clinical Nurse Leader Self Efficacy Scale: Results of a pilot study. Nursing Economic$). The CNLSES is a 35-item state-specific self-efficacy scale with established measurement properties that assesses nurses' perceptions of their ability to function effectively as a CNL. Demographic data were also collected. Data were analyzed using a general linear regression model. One hundred forty-seven certified CNLs participated in the survey. Results indicate that respondents vary in their confidence with performing the nine role competencies associated with CNL practice. Results from regression analyses also show that respondents' confidence in their abilities to carry out the core functions associated with the CNL role varied significantly across geographic region, organizational type, and by CNL graduate program model. The results of this study show important differences in CNLs' levels of self-confidence with the core competencies of their role. As a result, it may be important to develop targeted career transition interventions to gain the full benefit of CNL practice. Copyright © 2014 Elsevier Inc. All rights reserved.

Long noncoding RNAs in gastric cancer: functions and clinical applications

PubMed Central

Wang, Jiajun; Sun, Jingxu; Wang, Jun; Song, Yongxi; Gao, Peng; Shi, Jinxin; Chen, Ping; Wang, Zhenning

2016-01-01

Over the last two decades, genome-wide studies have revealed that only a small fraction of the human genome encodes proteins; long noncoding RNAs (lncRNAs) account for 98% of the total genome. These RNA molecules, which are >200 nt in length, play important roles in diverse biological processes, including the immune response, stem cell pluripotency, cell proliferation, apoptosis, differentiation, invasion, and metastasis by regulating gene expression at the epigenetic, transcriptional, and posttranscriptional levels. However, the detailed molecular mechanisms underlying lncRNA function are only partially understood. Recent studies showed that many lncRNAs are aberrantly expressed in gastric cancer (GC) tissues, gastric juice, plasma, and cells, and these alterations are linked to the occurrence, progression, and outcome of GC. Here, we review the current knowledge of the biological functions and clinical aspects of lncRNAs in GC. PMID:26929639

A cross-cultural convergent parallel mixed methods study of what makes a cancer-related symptom or functional health problem clinically important.

PubMed

Giesinger, Johannes M; Aaronson, Neil K; Arraras, Juan I; Efficace, Fabio; Groenvold, Mogens; Kieffer, Jacobien M; Loth, Fanny L; Petersen, Morten Aa; Ramage, John; Tomaszewski, Krzysztof A; Young, Teresa; Holzner, Bernhard

2018-02-01

In this study, we investigated what makes a symptom or functional impairment clinically important, that is, relevant for a patient to discuss with a health care professional (HCP). This is the first part of a European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group project focusing on the development of thresholds for clinical importance for the EORTC QLQ-C30 questionnaire and its corresponding computer-adaptive version. We conducted interviews with cancer patients and HCPs in 6 European countries. Participants were asked to name aspects of a symptom or problem that make it clinically important and to provide importance ratings for a predefined set of aspects (eg, need for help and limitations of daily functioning). We conducted interviews with 83 cancer patients (mean age, 60.3 y; 50.6% men) and 67 HCPs. Participants related clinical importance to limitations of everyday life (patients, 65.1%; HCPs, 77.6%), the emotional impact of a symptom/problem (patients, 53.0%; HCPs, 64.2%), and duration/frequency (patients, 51.8%; HCPs, 49.3%). In the patient sample, importance ratings were highest for worries by partner or family, limitations in everyday life, and need for help from the medical staff. Health care professionals rated limitations in everyday life and need for help from the medical staff to be most important. Limitations in everyday life, need for (medical) help, and emotional impact on the patient or family/partner were found to be relevant aspects of clinical importance. Based on these findings, we will define anchor items for the development of thresholds for clinical importance for the EORTC measures in a Europe-wide field study. Copyright © 2017 John Wiley & Sons, Ltd.

[Clinical investigation on administration method of gatifloxacin based on PK/PD theory].

PubMed

Mikamo, Hiroshige; Tanaka, Kaori; Watanabe, Kunitomo; Tamaya, Teruhiko; Izumi, Koji

2006-10-01

There have not been sufficient clinical studies based on pharmacokinetics/pharmacodynamics (PK/PD) theory, on which many clinical doctors have recently focused. To consider the optimized administration method based on PK/PD theory for gatifloxacin (GFLX), which was one of the oral fluoroquinolone antibacterial, we influenzae investigated clinical efficacies and adverse events for pelvic inflammatory disease (PID) in giving GFLX daily 400 mg divided twice a day or four times a day. The number of leukocyte and the value of CRP were significantly reduced by chemotherapy in twice a day group, compared with four times a day group. We were able to measure the blood level in 4 cases. The AUC/MIC values for presumption causative bacteria (causative bacteria in both cases: Escherichia coli) in cured patients were 142.28 and 280.16, however, in therapy-failed patients, the AUC/MIC value to presumption causative bacterium were 4.10 (causative bacteria: Prevotella bivia) and 4.35 (causative bacteria: Pseudomonas aeruginosa). These results suggested the importance of the therapeutic method based on PK/PD theory.

Clinical Assessment of Cognitive Function in Patients with Head and Neck Cancer: Prevalence and Correlates.

PubMed

Williams, Amy M; Lindholm, Jamie; Siddiqui, Farzan; Ghanem, Tamer A; Chang, Steven S

2017-11-01

Objective Identify the prevalence and clinical correlates of cognitive impairment in patients presenting for treatment of head and neck cancer (HNC) using brief screening within a multidisciplinary care team. Study Design A case series with planned data collection of cognitive function, quality of life (QoL), and psychosocial variables. Setting Urban Midwest academic medical center. Subjects and Methods In total, 209 consecutive patients with a diagnosis of HNC between August 2015 and September 2016 who had a pretreatment assessment with a clinical health psychologist. At pretreatment assessment, the Montreal Cognitive Assessment (MoCA), a brief screening tool for cognitive function, was administered along with a semistructured interview to gather information on psychiatric symptoms, social support, and substance use. Patient information, including demographics, clinical variables, and psychosocial variables, was extracted via chart review. A subset of patients with HNC completed the Functional Assessment of Cancer Therapy-Head and Neck Cancer at pretreatment assessment and was included in the QoL analyses. Results Cognitive impairment was associated with current alcohol use, past tobacco use and number of pack years, time in radiotherapy, and adherence to treatment recommendations. Social, emotional, and functional QoL scales were associated with cognitive impairment, including executive function, language, and memory. Conclusion Cognitive impairment is common in patients with HNC, and there are important associations between cognitive impairment and psychosocial, QoL, and treatment adherence variables. The results argue for the incorporation of cognitive screening as part of pretreatment assessment for patients, as well as further research into more direct, causal relationships via longitudinal, prospective studies.

[Clinical Advantages and Acupoint Selection of Treatment of Chronic Functional Constipation with Acupuncture Therapy].

PubMed

Yu, Zhi; Xu, Bin

2016-08-25

Abundant clinical practice has showed that acupuncture therapy has some distinct advantages in the treatment of chronic functional constipation (CFC), such as faster positive effect, shorter course of treatment, long-term post-effect, etc. In the present paper, the authors reviewed progresses of researches in clinical treatment of CFC with acupuncture therapy in recent years. Results of clinical trials indicated that among the 3 types (slow transit, outlet obstruction and mixed type) of constipation, acupuncture therapy showed a better effect for slow transit constipation by improving severity, increasing defecation frequency, reducing abdominal distension, easing patients' psychological discomfort and raising daily life activity, probably by ameliorating colonic motility, enteric nervous system function and neurotransmitter secretion (vasoactive intestinal peptide, acetylcholine, substance P, nitrix oxide,etc.). Most of the chosen acupoints (ST 25, SP 15, SP 14, CV 6, BL 25, BL 23, etc.) are located in the projection region of colon. For outlet obstruction defecation, the effect of acupuncture is relatively better for chalasia type, in spite of generally being poorer in the efficacy. Majority of the selected acupoints (GV 1, BL 32, BL 33, BL 30, etc.)are located near the pelvic floor region. In addition, the clinical therapeutic effects of acupuncture need being confirmed by more large sample, multiple centers randomized controlled trials.

Investigating the connections between health lean management and clinical risk management.

PubMed

Crema, Maria; Verbano, Chiara

2015-01-01

The purpose of this paper is to investigate connections and overlaps between health lean management (HLM) and clinical risk management (CRM) understanding whether and how these two approaches can be combined together to pursue efficiency and patient safety improvements simultaneously. A systematic literature review has been carried out. Searching in academic databases, papers that focus not only on HLM, but also on clinical errors and risk reduction, were included. The general characteristics of the selected papers were analysed and a content analysis was conducted. In most of the papers, pursing objectives of HLM and CRM and adopting tools and practices of both approaches, results of quality and, particularly, of safety improvements were obtained. A two-way arrow between HLM and CRM emerged but so far, none of the studies has been focused on the relationship between HLM and CRM. Results highlight an emerging research stream, with many useful theoretical and practical implications and opportunities for further research.

Re-evaluating concepts of biological function in clinical medicine: towards a new naturalistic theory of disease.

PubMed

Chin-Yee, Benjamin; Upshur, Ross E G

2017-08-01

Naturalistic theories of disease appeal to concepts of biological function, and use the notion of dysfunction as the basis of their definitions. Debates in the philosophy of biology demonstrate how attributing functions in organisms and establishing the function-dysfunction distinction is by no means straightforward. This problematization of functional ascription has undermined naturalistic theories and led some authors to abandon the concept of dysfunction, favoring instead definitions based in normative criteria or phenomenological approaches. Although this work has enhanced our understanding of disease and illness, we need not necessarily abandon naturalistic concepts of function and dysfunction in the disease debate. This article attempts to move towards a new naturalistic theory of disease that overcomes the limitations of previous definitions and offers advantages in the clinical setting. Our approach involves a re-evaluation of concepts of biological function employed by naturalistic theories. Drawing on recent insights from the philosophy of biology, we develop a contextual and evaluative account of function that is better suited to clinical medicine and remains consistent with contemporary naturalism. We also show how an updated naturalistic view shares important affinities with normativist and phenomenological positions, suggesting a possibility for consilience in the disease debate.

Functional response to cardiac resynchronization therapy is associated with improved clinical outcome and absence of appropriate shocks.

PubMed

Van Boven, Nick; Bogaard, Kjell; Ruiter, Jaap; Kimman, Geert; Theuns, Dominic; Kardys, Isabella; Umans, Victor

2013-03-01

We evaluated clinical outcome and incidence of (in)appropriate shocks in consecutive chronic heart failure (CHF) patients treated with CRT with a defibrillator (CRT-D) according to functional response status. Furthermore, we investigated which factors predict such functional response. In a large teaching hospital, 179 consecutive CHF patients received CRT-D in 2005-2010. Patients were considered functional responders if left ventricular ejection fraction (LVEF) increased to ≥ 35% postimplantation. Analysis was performed on 142 patients, who had CRT-D as primary prevention, complete data and a baseline LVEF <35%. Endpoints consisted of all-cause mortality, heart failure (HF) hospitalizations, appropriate shocks and inappropriate shocks. Median follow-up was 3.0 years (interquartile range [IQR] 1.6-4.4) and median baseline LVEF was 20% (IQR 18-25%). The functional response-group consisted of 42 patients. In this group no patients died, none were hospitalized for HF, none received appropriate shocks and 3 patients (7.1%) received ≥ 1 inappropriate shocks. In comparison, the functional nonresponse group consisted of 100 patients, of whom 22 (22%) died (P = 0.003), 17 (17%) were hospitalized for HF (P = 0.007), 17 (17%) had ≥ 1 appropriate shocks (P = 0.003) and 8 (8.1%) received ≥ 1 inappropriate shocks (P = 0.78). Multivariable analysis showed that left bundle branch block (LBBB), QRS duration ≥ 150 milliseconds and no need for diuretics at baseline are independent predictors of functional response. Functional responders to CRT have a good prognosis and rarely need ICD therapy. LBBB, QRS duration ≥ 150 milliseconds and lack of chronic diuretic use predict functional response. © 2012 Wiley Periodicals, Inc.

HRV biofeedback for pediatric irritable bowel syndrome and functional abdominal pain: a clinical replication series.

PubMed

Stern, Mark J; Guiles, Robert A F; Gevirtz, Richard

2014-12-01

Irritable bowel syndrome (IBS) and Functional Abdominal Pain (FAP) are among the most commonly reported Functional Gastrointestinal Disorders. Both have been associated with varying autonomic dysregulation. Heart Rate Variability Biofeedback (HRVB) has recently begun to show efficacy in the treatment of both IBS and FAP. The purpose of this multiple clinical replication series was to analyze the clinical outcomes of utilizing HRVB in a clinical setting. Archival data of twenty-seven consecutive pediatric outpatients diagnosed with IBS or FAP who received HRVB were analyzed. Clinical outcomes were self-report and categorized as full or remission with patient satisfaction, or no improvement. Qualitative reports of patient experiences were also noted. Full remission was achieved by 69.2 % and partial remission was achieved by 30.8 % of IBS patients. Full remission was achieved by 63.6 % and partial remission was achieved by 36.4 % of FAP patients. No patients in either group did not improve to a level of patient satisfaction or >50 %. Patient's commonly reported feeling validated in their discomfort as a result of psychophysiological education. Results suggest that HRVB is a promising intervention for pediatric outpatients with IBS or FAP. Randomized controlled trials are necessary to accurately determine clinical efficacy of HRVB in the treatment of IBS and FAP.

Dysphagia in Lewy body dementia - a clinical observational study of swallowing function by videofluoroscopic examination.

PubMed

Londos, Elisabet; Hanxsson, Oskar; Alm Hirsch, Ingrid; Janneskog, Anna; Bülow, Margareta; Palmqvist, Sebastian

2013-10-07

Dysphagia, which can result in aspiration pneumonia and death, is a well-known problem in patients with dementia and Parkinson's disease. There are few studies on dysphagia in patients with dementia with Lewy bodies (DLB) and Parkinson's disease dementia (PDD), especially studies objectively documenting the type of swallowing dysfunction. The aim of this study was therefore to investigate the prevalence, and define the actual swallowing dysfunction according to a videofluoroscopic swallowing examination (VFSE) in patients with DLB and PDD. Eighty-two consecutive patients with DLB or PDD in a clinical follow-up program were asked about symptoms of dysphagia. Those experiencing dysphagia were examined with VFSE. Prevalence and type of swallowing dysfunction was recorded. Twenty-six patients (32%) reported symptoms of dysphagia such as swallowing difficulties or coughing. Twenty-four (92%) of these had a documented swallowing dysfunction on VFSE. Eighty-eight percent suffered from pharyngeal dysfunction. Almost all DLB or PDD patients with subjective signs of dysphagia had pathologic results on VFSE, the majority of pharyngeal type. This type of dysphagia has not been reported in DLB before. The results have clinical implications and highlight the importance of asking for and examining swallowing function to prevent complications such as aspiration.

Investigation of Clinically Significant Change by Severity Level in College Counseling Center Clients

ERIC Educational Resources Information Center

Wolgast, Brad M.; Rader, Jill; Roche, Deborah; Thompson, C. Patricia; von Zuben, F. Christian; Goldberg, Allan

2005-01-01

The authors investigated the number of sessions necessary for college counseling center clients of different levels of severity of distress at intake to achieve clinically significant change (CS) in therapy. The Outcome Questionnaire-45 (M. J. Lambert, N. B. Hansen, et al., 1996) was used to categorize 914 clients by severity of distress. Analyses…

Plasma Neutrophil Gelatinase-Associated Lipocalin and Predicting Clinically Relevant Worsening Renal Function in Acute Heart Failure

PubMed Central

Damman, Kevin; A.E. Valente, Mattia; J. van Veldhuisen, Dirk; G.F. Cleland, John; M. O’Connor, Christopher; Metra, Marco; Ponikowski, Piotr; Cotter, Gad; Davison, Beth; M. Givertz, Michael; M. Bloomfield, Daniel; L. Hillege, Hans; A. Voors, Adriaan

2017-01-01

The aim of this study was to evaluate the ability of Neutrophil Gelatinase-Associated Lipocalin (NGAL) to predict clinically relevant worsening renal function (WRF) in acute heart failure (AHF). Plasma NGAL and serum creatinine changes during the first 4 days of admission were investigated in 1447 patients hospitalized for AHF and enrolled in the Placebo-Controlled Randomized Study of the Selective A1Adenosine Receptor Antagonist Rolofylline for Patients Hospitalized with Acute Decompensated Heart Failure and Volume Overload to Assess Treatment Effect on Congestion and Renal Function (PROTECT) study. WRF was defined as serum creatinine rise ≥ 0.3 mg/dL through day 4. Biomarker patterns were described using linear mixed models. WRF developed in 325 patients (22%). Plasma NGAL did not rise earlier than creatinine in patients with WRF. After multivariable adjustment, baseline plasma NGAL, but not creatinine, predicted WRF. AUCs for WRF prediction were modest (<0.60) for all models. NGAL did not independently predict death or rehospitalization (p = n.s.). Patients with WRF and high baseline plasma NGAL had a greater risk of death, and renal or cardiovascular rehospitalization by 60 days than patients with WRF and a low baseline plasma NGAL (p for interaction = 0.024). A rise in plasma NGAL after baseline was associated with a worse outcome in patients with WRF, but not in patients without WRF (p = 0.007). On the basis of these results, plasma NGAL does not provide additional, clinically relevant information about the occurrence of WRF in patients with AHF. PMID:28698481

Plasma Neutrophil Gelatinase-Associated Lipocalin and Predicting Clinically Relevant Worsening Renal Function in Acute Heart Failure.

PubMed

Damman, Kevin; Valente, Mattia A E; van Veldhuisen, Dirk J; Cleland, John G F; O'Connor, Christopher M; Metra, Marco; Ponikowski, Piotr; Cotter, Gad; Davison, Beth; Givertz, Michael M; Bloomfield, Daniel M; Hillege, Hans L; Voors, Adriaan A

2017-07-08

The aim of this study was to evaluate the ability of Neutrophil Gelatinase-Associated Lipocalin (NGAL) to predict clinically relevant worsening renal function (WRF) in acute heart failure (AHF). Plasma NGAL and serum creatinine changes during the first 4 days of admission were investigated in 1447 patients hospitalized for AHF and enrolled in the Placebo-Controlled Randomized Study of the Selective A₁Adenosine Receptor Antagonist Rolofylline for Patients Hospitalized with Acute Decompensated Heart Failure and Volume Overload to Assess Treatment Effect on Congestion and Renal Function (PROTECT) study. WRF was defined as serum creatinine rise ≥ 0.3 mg/dL through day 4. Biomarker patterns were described using linear mixed models. WRF developed in 325 patients (22%). Plasma NGAL did not rise earlier than creatinine in patients with WRF. After multivariable adjustment, baseline plasma NGAL, but not creatinine, predicted WRF. AUCs for WRF prediction were modest (<0.60) for all models. NGAL did not independently predict death or rehospitalization ( p = n.s.). Patients with WRF and high baseline plasma NGAL had a greater risk of death, and renal or cardiovascular rehospitalization by 60 days than patients with WRF and a low baseline plasma NGAL (p for interaction = 0.024). A rise in plasma NGAL after baseline was associated with a worse outcome in patients with WRF, but not in patients without WRF ( p = 0.007). On the basis of these results, plasma NGAL does not provide additional, clinically relevant information about the occurrence of WRF in patients with AHF.

Clinical and electrophysiologic attributes as predictors of results of autonomic function tests

NASA Technical Reports Server (NTRS)

Wu, C. L.; Denq, J. C.; Harper, C. M.; O'Brien, P. C.; Low, P. A.

1998-01-01

Autonomic dysfunction is a feature of some neuropathies and not others. It has been suggested that some clinical and electrophysiologic attributes are predictable of autonomic impairment detected using laboratory testing; however, dear guidelines are unavailable. We evaluated 138 relatively unselected patients with peripheral neuropathy who underwent neurologic evaluation, electromyography (EMG), nerve conduction studies, and autonomic function tests to determine which variables were predictive of laboratory findings of autonomic failure. The variables evaluated were 1) clinical somatic neuropathic findings, 2) clinical autonomic symptoms, and 3) electrophysiologic findings. Autonomic symptoms were strongly predictive (Rs = 0.40, p < 0.001) of autonomic failure. Among the non-autonomic indices, absent ankle reflexes were mildly predictive (Rs = 0.19, p = 0.022) of autonomic impairment, but all others were not (duration, clinical pattern, severity, weakness, sensory loss). Electrophysiologic changes of an axonal neuropathy predicted autonomic impairment while demyelinating neuropathy did not. We conclude that autonomic studies will most likely be abnormal in patients who have symptoms of autonomic involvement and those who have an axonal neuropathy.

Prediction of vocational participation and global role functioning in help-seeking young adults, from neurocognitive, demographic and clinical variables.

PubMed

Cairns, Alice J; Kavanagh, David J; Dark, Frances; McPhail, Steven M

2017-10-15

The purpose of this study was to investigate neurocognitive, demographic and clinical correlates of vocational participation among a sample of young help-seeking adults. Young people (18-25 years) accessing an early intervention youth health service participated. The Global Functioning: Role scale and level of vocational participation, participant characteristics (age, gender, socioeconomic background and family history of serious mental illness), distress, psychotic-like experiences, substance use, and mental health diagnoses were recorded. The Cambridge Neuropsychological Testing Automated Battery was used to assess sustained attention, visual memory and executive function. Of the 107 participants, 33 (31%) were not working or studying and 52 (49%) had a diagnosis of affective disorder. Impairments in neurocognitive tests were evidenced in attention shift, sustained attention target sensitivity, impulsivity and spatial working memory errors. Univariate analyses indicated that information processing and target impulsivity were associated with both vocational participation and global functioning, and that spatial working memory strategy was also associated with vocational participation. After controlling for significant demographic and clinical predictors, strategy formation remained a significant correlate of vocational participation (coefficient (95%CI) = -0.08 (-0.17, -0.01)), but no neurocognitive measures remained significant in the multivariate prediction of global functioning. Neurocognitive outcomes were assessed at a single time point, factors such as fluctuations in motivation could impact on test results. Interventions targeting work and education participation should consider the capacity of vulnerable young people to develop appropriate plans for role success and provide support accordingly. The study also emphasised the importance of high school completion and avoidance of cannabis use, especially in males. Copyright © 2017 Elsevier B.V. All rights

Identification and validation of loss of function variants in clinical contexts.

PubMed

Lescai, Francesco; Marasco, Elena; Bacchelli, Chiara; Stanier, Philip; Mantovani, Vilma; Beales, Philip

2014-01-01

The choice of an appropriate variant calling pipeline for exome sequencing data is becoming increasingly more important in translational medicine projects and clinical contexts. Within GOSgene, which facilitates genetic analysis as part of a joint effort of the University College London and the Great Ormond Street Hospital, we aimed to optimize a variant calling pipeline suitable for our clinical context. We implemented the GATK/Queue framework and evaluated the performance of its two callers: the classical UnifiedGenotyper and the new variant discovery tool HaplotypeCaller. We performed an experimental validation of the loss-of-function (LoF) variants called by the two methods using Sequenom technology. UnifiedGenotyper showed a total validation rate of 97.6% for LoF single-nucleotide polymorphisms (SNPs) and 92.0% for insertions or deletions (INDELs), whereas HaplotypeCaller was 91.7% for SNPs and 55.9% for INDELs. We confirm that GATK/Queue is a reliable pipeline in translational medicine and clinical context. We conclude that in our working environment, UnifiedGenotyper is the caller of choice, being an accurate method, with a high validation rate of error-prone calls like LoF variants. We finally highlight the importance of experimental validation, especially for INDELs, as part of a standard pipeline in clinical environments.

Fundamentals of functional imaging I: current clinical techniques.

PubMed

Luna, A; Martín Noguerol, T; Mata, L Alcalá

2018-05-01

Imaging techniques can establish a structural, physiological, and molecular phenotype for cancer, which helps enable accurate diagnosis and personalized treatment. In recent years, various imaging techniques that make it possible to study the functional characteristics of tumors quantitatively and reproducibly have been introduced and have become established in routine clinical practice. Perfusion studies enable us to estimate the microcirculation as well as tumor angiogenesis and permeability using ultrafast dynamic acquisitions with ultrasound, computed tomography, or magnetic resonance (MR) imaging. Diffusion-weighted sequences now form part of state-of-the-art MR imaging protocols to evaluate oncologic lesions in any anatomic location. Diffusion-weighted imaging provides information about the occupation of the extracellular and extravascular space and indirectly estimates the cellularity and apoptosis of tumors, having demonstrated its relation with biologic aggressiveness in various tumor lines and its usefulness in the evaluation of the early response to systemic and local targeted therapies. Another tool is hydrogen proton MR spectroscopy, which is used mainly in the study of the metabolic characteristics of brain tumors. However, the complexity of the technique and its lack of reproducibility have limited its clinical use in other anatomic areas, although much experience with the use of this technique in the assessment of prostate and breast cancers as well as liver lesions has also accumulated. This review analyzes the imaging techniques that make it possible to evaluate the physiological and molecular characteristics of cancer that have already been introduced into clinical practice, such as techniques that evaluate angiogenesis through dynamic acquisitions after the administration of contrast material, diffusion-weighted imaging, or hydrogen proton MR spectroscopy, as well as their principal applications in oncology. Copyright © 2018 SERAM. Publicado

Functional (Psychogenic) Cognitive Disorders: A Perspective from the Neurology Clinic.

PubMed

Stone, Jon; Pal, Suvankar; Blackburn, Daniel; Reuber, Markus; Thekkumpurath, Parvez; Carson, Alan

2015-09-24

Cognitive symptoms such as poor memory and concentration represent a common cause of morbidity among patients presenting to general practitioners and may result in referral for a neurological opinion. In many cases, these symptoms do not relate to an underlying neurological disease or dementia. In this article we present a personal perspective on the differential diagnosis of cognitive symptoms in the neurology clinic, especially as this applies to patients who seek advice about memory problems but have no neurological disease process. These overlapping categories include the following 'functional' categories: 1) cognitive symptoms as part of anxiety or depression; 2) "normal" cognitive symptoms that become the focus of attention; 3) isolated functional cognitive disorder in which symptoms are outwith 'normal' but not explained by anxiety; 4) health anxiety about dementia; 5) cognitive symptoms as part of another functional disorder; and 6) retrograde dissociative (psychogenic) amnesia. Other 'non-dementia' diagnoses to consider in addition are 1) cognitive symptoms secondary to prescribed medication or substance misuse; 2) diseases other than dementia causing cognitive disorders; 3) patients who appear to have functional cognitive symptoms but then go on to develop dementia/another neurological disease; and finally 4) exaggeration/malingering. We discuss previous attempts to classify the problem of functional cognitive symptoms, the importance of making a positive diagnosis for the patient, and the need for large cohort studies to better define and manage this large group of patients.

Clinical efficacy and safety of polyethylene glycol 3350 versus liquid paraffin in the treatment of pediatric functional constipation.

PubMed

Rafati, Mr; Karami, H; Salehifar, E; Karimzadeh, A

2011-01-01

Functional constipation is prevalent in children. Recently polyethylene glycol has been introduced as an effective and safe drug to treat chronic constipation. There are only a few clinical trials on comparison of PEG and liquid paraffin in childhood constipation. The purpose of this study was to evaluate clinical efficacy and safety of PEG 3350 solution and liquid paraffin in the treatment of children with functional constipation in Sari Toba clinic during the period of 2008-2009. Children with a history of functional constipation were subjects of this study. One hundred and sixty children of 2-12 years old with functional constipation were randomized in two PEG and paraffin treatment groups. Patients received either 1.0-1.5 g/kg/day PEG 3350 or 1.0-1.5 ml/kg/day liquid paraffin for 4 months. Clinical efficacy was evaluated by stool and encopresis frequency/week and overall treatment success rate was compared in two groups. Compared with the baseline, defecation frequency/ week increased significantly and encopresis frequency meaningfully decreased in two groups during the period of the study. Patients using PEG 3350 had more success rate (mean: 95.3%±3.7) compared with the patients in paraffin group (mean: 87.2%±7.1) (p=0.087). Administration of PEG 3350 were associated with less adverse events than liquid paraffin. In conclusion in treatment of pediatric functional constipation, regarding clinical efficacy and safety, PEG 3350 were at least as effective as liquid paraffin and but less adverse drug events.

Designing group sequential randomized clinical trials with time to event end points using a R function.

PubMed

Filleron, Thomas; Gal, Jocelyn; Kramar, Andrew

2012-10-01

A major and difficult task is the design of clinical trials with a time to event endpoint. In fact, it is necessary to compute the number of events and in a second step the required number of patients. Several commercial software packages are available for computing sample size in clinical trials with sequential designs and time to event endpoints, but there are a few R functions implemented. The purpose of this paper is to describe features and use of the R function. plansurvct.func, which is an add-on function to the package gsDesign which permits in one run of the program to calculate the number of events, and required sample size but also boundaries and corresponding p-values for a group sequential design. The use of the function plansurvct.func is illustrated by several examples and validated using East software. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Investigation on the electrochemical interfacial properties of 2-aminothiophenol functionalized graphene oxide modified electrode

NASA Astrophysics Data System (ADS)

Immanuel, Susan; Aparna T., K.; Sivasubramanian, R.

2018-04-01

In this paper the interfacial behavior of graphene oxide and 2-aminothiophenol functionalized graphene oxide was investigated by electrochemical method. The GO was prepared by modified Hummers method and the 2-aminothiophenol was covalently attached on the surface of GO sheets. The electrochemical properties were investigated using a redox couple and the electrokinetic parameter was inferred. It was found that the ATP-GO exhibited slow kinetics compared to GO due to the increased deformation of GO sheets after ATP functionalization.

Anxiety and depression in rheumatoid arthritis: an epidemiologic survey and investigation of clinical correlates in Iranian population.

PubMed

Jamshidi, Ahmad-Reza; Banihashemi, Arash Tehrani; Paragomi, Pedram; Hasanzadeh, Maryam; Barghamdi, Mozhgan; Ghoroghi, Shima

2016-08-01

Psychiatric disorders occur in a considerable proportion of patients with rheumatoid arthritis (RA). This study was conducted in order to evaluate the prevalence of anxiety and depression in Iranian RA patients. In the cross sectional study, 414 RA patients were enrolled prospectively during a period of 6 months from RA clinic of Rheumatology Research Center. Beck's and Cattell's inventories were applied to investigate depression and anxiety in RA patients. RA activity was measured by Disease Activity Score and patients' disability was assessed by Health Assessment Questionnaire. Levels of pain perception were stratified based on Visual Analog Scale. The prevalence of depression was 63.6 % and anxiety was in 84.1 % among RA patients. Mixed anxiety and depression was detected in 60.2 % of the study population. Functional disability was significantly associated with severity of depressive and anxiety symptoms (p < 0.001); however there was no association between disease activity and depression or anxiety (p = 0.420). There was weak correlation between disease activity score and functional disability (Spearman's rho = 0.33; p < 0.01). Severe levels of depression and anxiety were associated with higher levels of pain perception (p < 0.001). Our study stressed the impact of depressive and anxiety symptoms in functional disability and pain perception of RA patients. Our results point out the multidisciplinary management of RA.

Pharmacogenomics of CYP2C9: Functional and Clinical Considerations†

PubMed Central

Rettie, Allan E.; Fowler, Douglas M.; Miners, John O.

2017-01-01

CYP2C9 is the most abundant CYP2C subfamily enzyme in human liver and the most important contributor from this subfamily to drug metabolism. Polymorphisms resulting in decreased enzyme activity are common in the CYP2C9 gene and this, combined with narrow therapeutic indices for several key drug substrates, results in some important issues relating to drug safety and efficacy. CYP2C9 substrate selectivity is detailed and, based on crystal structures for the enzyme, we describe how CYP2C9 catalyzes these reactions. Factors relevant to clinical response to CYP2C9 substrates including inhibition, induction and genetic polymorphism are discussed in detail. In particular, we consider the issue of ethnic variation in pattern and frequency of genetic polymorphisms and clinical implications. Warfarin is the most well studied CYP2C9 substrate; recent work on use of dosing algorithms that include CYP2C9 genotype to improve patient safety during initiation of warfarin dosing are reviewed and prospects for their clinical implementation considered. Finally, we discuss a novel approach to cataloging the functional capabilities of rare ‘variants of uncertain significance’, which are increasingly detected as more exome and genome sequencing of diverse populations is conducted. PMID:29283396

A retrospective investigation of the clinical management of patients attending an out of hours dental clinic in Merseyside under the new NHS dental contract.

PubMed

Tulip, D E; Palmer, N O A

2008-12-20

To investigate the clinical management of patients attending for emergency dental treatment. A retrospective analysis of clinical record cards. Information was collected from patient record cards concerning the patient's reason for attendance and their management at an emergency dental clinic in South Sefton, Liverpool. Over a nine month period, 1,718 patients attended the clinic; 1,472 record cards were analysed. Over 80% of the patients attending the out of hours (OOH) clinic had pain associated with a localised dental infection or dental abscess. Where a diagnosis was recorded, only 67% of patients received appropriate treatment. Over 50% of patients received antibiotics alone with no other definitive treatment provided. The principal antibiotic prescribed for both adult and child patients was amoxicillin. The current study has highlighted that GDPs working within the OOH services are not adhering to current clinical and best practice guidelines with respect to patient examination, diagnosis, management, in particular the correct prescribing of antibiotics for dental infections, and clinical record keeping.

Towards a standardized nutrition and dietetics terminology for clinical practice: An Austrian multicenter clinical documentation analysis based on the International Classification of Functioning, Disability and Health (ICF)-Dietetics.

PubMed

Gäbler, Gabriele; Coenen, Michaela; Lycett, Deborah; Stamm, Tanja

2018-03-03

High quality, continuity and safe interdisciplinary healthcare is essential. Nutrition and dietetics plays an important part within the interdisciplinary team in many health conditions. In order to work more effectively as an interdisciplinary team, a common terminology is needed. This study investigates which categories of the ICF-Dietetics are used in clinical dietetic care records in Austria and which are most relevant to shared language in different medical areas. A national multicenter retrospective study was conducted to collect clinical dietetic care documentation reports. The analysis included the "best fit" framework synthesis, and a mapping exercise using the ICF Linking Rules. Medical diagnosis and intervention concepts were excluded from the mapping, since they are not supposed to be classified by the ICF. From 100 dietetic records, 307 concepts from 1807 quotations were extracted. Of these, 241 assessment, dietetics diagnosis, goal setting and evaluation concepts were linked to 153 ICF-Dietetics categories. The majority (91.3%) could be mapped to a precise ICF-Dietetics category. The highest number of ICF-Dietetics categories was found in the medical area of diabetes and metabolism and belonged to the ICF component Body Function, while very few categories were used from the component Participation and Environmental Factors. The integration of the ICF-Dietetics in nutrition and dietetic care process is possible. Moreover, it could be considered as a conceptual framework for interdisciplinary nutrition and dietetics care. However, a successful implementation of the ICF-Dietetics in clinical practice requires a paradigm shift from medical diagnosis-focused health care to a holistic perspective of functioning with more attention on Participation and Environmental Factors. Copyright © 2018 The Author(s). Published by Elsevier Ltd.. All rights reserved.

[Clinical values of triptorelin stimulating test in assessing hypothalamus-pituitary-gonad axis function in male patients with hypothalamus-pituitary-gonad axis disorders].

PubMed

Wu, Xue-yan; Nie, Min; Lu, Shuang-yu; Mao, Jiang-feng

2011-03-15

To investigate the clinical values of luteinizing hormone-releasing hormone (LHRH) α (triptorelin) stimulating test in the differential diagnoses of hypothalamus-pituitary-gonad axis (HPGA) disorders. A total of 229 male patients with various HPGA disorders were recruited for triptorelin stimulating test. And all patients were followed up for 12 - 48 months until a definite diagnosis was made. The values of triptorelin stimulating test in the differential diagnoses of HPGA disorders were assessed by examining the close relationship between LHmax and the final clinical diagnosis. (1) LH levels rose steady after an intramuscular injection of triptorelin 100 µg and the time of LHmax appeared at 45 - 60 min. (2) LHmax < 4 U/L indicated the function of HPGA was not activated. LHmax in the range of 4 - 12 U/L indicated the patients might have constitutional delayed puberty development. LHmax > 12 U/L indicated the fulfilled puberty development. Triptorelin stimulating test can precisely evaluate the functions of HPGA in various HPGA disorders and provide valuable information for the differential diagnoses in constitutional delayed puberty development, hypogonadotropic hypogonadism, central and peripheral precocious puberty disorders.

Clinical investigation of an outbreak of alveolitis and asthma in a car engine manufacturing plant.

PubMed

Robertson, W; Robertson, A S; Burge, C B S G; Moore, V C; Jaakkola, M S; Dawkins, P A; Burd, M; Rawbone, R; Gardner, I; Kinoulty, M; Crook, B; Evans, G S; Harris-Roberts, J; Rice, S; Burge, P S

2007-11-01

Exposure to metal working fluid (MWF) has been associated with outbreaks of extrinsic allergic alveolitis (EAA) in the USA, with bacterial contamination of MWF being a possible cause, but is uncommon in the UK. Twelve workers developed EAA in a car engine manufacturing plant in the UK, presenting clinically between December 2003 and May 2004. This paper reports the subsequent epidemiological investigation of the whole workforce. The study had three aims: (1) to measure the extent of the outbreak by identifying other workers who may have developed EAA or other work-related respiratory diseases; (2) to provide case detection so that those affected could be treated; and (3) to provide epidemiological data to identify the cause of the outbreak. The outbreak was investigated in a three-phase cross-sectional survey of the workforce. In phase I a respiratory screening questionnaire was completed by 808/836 workers (96.7%) in May 2004. In phase II 481 employees with at least one respiratory symptom on screening and 50 asymptomatic controls were invited for investigation at the factory in June 2004. This included a questionnaire, spirometry and clinical opinion. 454/481 (94.4%) responded and 48/50 (96%) controls. Workers were identified who needed further investigation and serial measurements of peak expiratory flow (PEF). In phase III 162 employees were seen at the Birmingham Occupational Lung Disease clinic. 198 employees returned PEF records, including 141 of the 162 who attended for clinical investigation. Case definitions for diagnoses were agreed. 87 workers (10.4% of the workforce) met case definitions for occupational lung disease, comprising EAA (n = 19), occupational asthma (n = 74) and humidifier fever (n = 7). 12 workers had more than one diagnosis. The peak onset of work-related breathlessness was Spring 2003. The proportion of workers affected was higher for those using MWF from a large sump (27.3%) than for those working all over the manufacturing area (7

New ergonomic and functional design of digital conferencing rooms in a clinical environment

NASA Astrophysics Data System (ADS)

Ratib, Osman M.; Amato, Carlos L.; McGill, D. Ric; Liu, Brent J.; Balbona, Joseph A.; McCoy, J. Michael

2003-05-01

Clinical conferences and multidisciplinary medical rounds play a major role in patient management and decision-making relying on presentation of variety of documents: films, charts, videotapes, graphs etc. These conferences and clinical rounds are often carried out in conferencing rooms or department libraries that are usually not suitable for presentation of the data in electronic format. In most instances digital projection equipment is added to existing rooms without proper consideration to functional, ergonomic, acoustical, spatial and environmental requirements. Also, in large academic institutions, the conference rooms serve multiple purposes including as classrooms for teaching and education of students and for administrative meetings among managers and staff. In the migration toward a fully digital hospital we elected to analyze the functional requirements and optimize the ergonomic design of conferencing rooms that can accommodate clinical rounds, multidisciplinary reviews, seminars, formal lectures and department meetings. 3D computer simulation was used for better evaluation and analysis of spatial and ergonomic parameters and for gathering opinions and input from users on different design options. A critical component of the design is the understanding of the different workflow and requirements of different types of conferences and presentations that can be carried out in these conference rooms.

Clinical trial will investigate targeted radionuclide therapy for inoperable rare tumors | Center for Cancer Research

Cancer.gov

In an upcoming phase II clinical trial, Center for Cancer Research investigators will explore the ability of a targeted radioactive drug to treat inoperable pheochromocytoma and paraganglioma, both rare tumors.  Learn more...

Clinical and cognitive insight in patients with acute-phase psychosis: Association with treatment and neuropsychological functioning.

PubMed

Poyraz, Burç Çağri; Arikan, Mehmet Kemal; Poyraz, Cana Aksoy; Turan, Şenol; Kani, Ayşe Sakalli; Aydin, Eser; İnce, Ezgi

2016-10-01

The severity of psychopathology cannot fully explain deficits in the multi-dimensional construct of insight. The aim of this study was to evaluate the correlates and associations of clinical and cognitive insight in patients in an acute phase of psychosis and to analyse the impact of acute treatment on these variables. This study examined 47 inpatients who were recently hospitalized with acute exacerbation of schizophrenia. All subjects were assessed at both admission and discharge with the Positive and Negative Syndrome Scale (PANSS), Schedule for the Assessment of Insight-Expanded Version (SAI-E), Beck Cognitive Insight Scale (BCIS), and a neurocognition battery. Patients with schizophrenia gained clinical insight after treatment. Cognitive insight did not change significantly after treatment. Insight showed significant negative correlations with positive symptoms and general psychopathology, but not with negative symptoms. Clinical insight was not associated with neuropsychological functioning in this cohort. Gaining clinical insight in the acute phase of illness was associated with the remission of positive symptoms, but not with neuropsychological functioning. Some significant correlations between clinical and cognitive insights were detected, which suggests that cognitive insight contributes to clinical insight but is not treatment-dependent. Long-term treatment may be required to understand the contribution of insight to the outcome of patients with schizophrenia.

Structural and functional alterations in the brain during working memory in medication-naïve patients at clinical high-risk for psychosis.

PubMed

Gisselgård, Jens; Lebedev, Alexander V; Dæhli Kurz, Kathinka; Joa, Inge; Johannessen, Jan Olav; Brønnick, Kolbjørn

2018-01-01

Several previous studies suggest that clinical high risk for psychosis (CHR) is associated with prefrontal functional abnormalities and more widespread reduced grey matter in prefrontal, temporal and parietal areas. We investigated neural correlates to CHR in medication-naïve patients. 41 CHR patients and 37 healthy controls were examined with 1.5 Tesla MRI, yielding functional scans while performing an N-back task and structural T1-weighted brain images. Functional and structural data underwent automated preprocessing steps in SPM and Freesurfer, correspondingly. The groups were compared employing mass-univariate strategy within the generalized linear modelling framework. CHR demonstrated reduced suppression of the medial temporal lobe (MTL) regions during n-back task. We also found that, consistent with previous findings, CHR subjects demonstrated thinning in prefrontal, cingulate, insular and inferior temporal areas, as well as reduced hippocampal volumes. The present findings add to the growing evidence of specific structural and functional abnormalities in the brain as potential neuroimaging markers of psychosis vulnerability.

An Investigation of Upper Limb Motor Function in High Functioning Autism and Asperger's Disorder Using a Repetitive Fitts' Aiming Task

ERIC Educational Resources Information Center

Papadopoulos, Nicole; McGinley, Jennifer; Tonge, Bruce J.; Bradshaw, John L.; Saunders, Kerryn; Rinehart, Nicole J.

2012-01-01

There is now a growing body of research examining movement difficulties in children diagnosed with high functioning autism (HFA) and Asperger's disorder (AD). Despite this, few studies have investigated the kinematic components of movement that may be disrupted in children diagnosed with these disorders. The current study investigated rapid aiming…

Functional assessment of the elderly. A comparison of standard instruments with clinical judgment.

PubMed

Pinholt, E M; Kroenke, K; Hanley, J F; Kussman, M J; Twyman, P L; Carpenter, J L

1987-03-01

Using specific instruments and scales to measure mental status, nutritional state, visual acuity, gait, and activities of daily living, we studied 79 medical inpatients aged 70 years or older. We then interviewed the patients' primary physicians and nurses and asked them to rate their patients. The prevalence of functional impairment was high: 25 (32%) of the 79 patients were mentally impaired, 31 (39%) were malnourished, 18 (23%) were visually impaired, 31 (39%) had impaired gait, and 23 (29%) had problems with continence. Although clinicians recognized severe impairments, the sensitivity of their clinical judgment was poor in detecting moderate impairment in four categories: mental status sensitivity was 28% (5/18); nutrition, 54% (14/26); vision, 27% (4/15); and continence, 42% (5/12). With clinical judgment alone, physicians and nurses correctly identify severe impairment, but the more prevalent moderate impairments in mental status, nutrition, vision, and continence are poorly recognized. Comprehensive functional assessment instruments can detect these moderate impairments, which may be remediable through early intervention.

[What role for paraclinical investigations within clinical trials conducted in psychiatric patients?

PubMed

Kaladjian, A; Adida, M; Simon, N; Belzeaux, R; Blin, O; Fakra, E; Azorin, J-M

2016-12-01

As in the usual care of patients, paraclinical investigations have today only a very modest role in clinical trials in psychiatry, mainly to complete the pre-therapeutical assessments prior to inclusion of subjects or to monitor treatment tolerance. Yet, the accumulation of data in neurosciences suggests the next emergence of biomarkers, whose interest is that they are closely associated to the biological disturbances underlying psychiatric illnesses, and that they are accessible by means of technological tools such as imaging devices. These tools allow to explore the effects on brain of psychotropic medications, such as antidepressants, antipsychotics, or mood stabilizers, in relation to their therapeutic action. The obtained results allow to consider the use of such biomarkers in clinical trials in addition to more conventional approaches. In particular, they could be used as targets to measure brain response to treatment in association with clinical response, to predict a therapeutic response from the neurofunctional characteristics of patients, or to establish the safety profile of drugs on the nervous system. The use of such biomarkers in clinical trials would help to better define the explored populations and their characteristics, as well as the variables to assess, and to better measure the impact of the treatments and their potential harmful effects on the nervous system. © L’Encéphale, Paris, 2016.

21 CFR 50.54 - Clinical investigations not otherwise approvable that present an opportunity to understand...

Code of Federal Regulations, 2014 CFR

2014-04-01

..., after consultation with a panel of experts in pertinent disciplines (for example: science, medicine... the clinical investigation in fact satisfies the conditions of § 50.51, § 50.52, or § 50.53, as...

21 CFR 50.54 - Clinical investigations not otherwise approvable that present an opportunity to understand...

Code of Federal Regulations, 2013 CFR

2013-04-01

..., after consultation with a panel of experts in pertinent disciplines (for example: science, medicine... the clinical investigation in fact satisfies the conditions of § 50.51, § 50.52, or § 50.53, as...

Olfactory Function and Associated Clinical Correlates in Former National Football League Players.

PubMed

Alosco, Michael L; Jarnagin, Johnny; Tripodis, Yorghos; Platt, Michael; Martin, Brett; Chaisson, Christine E; Baugh, Christine M; Fritts, Nathan G; Cantu, Robert C; Stern, Robert A

2017-02-15

Professional American football players incur thousands of repetitive head impacts (RHIs) throughout their lifetime. The long-term consequences of RHI are not well characterized, but may include olfactory dysfunction. RHI has been associated with changes to brain regions involved in olfaction, and olfactory impairment is common after traumatic brain injury. Olfactory dysfunction is a frequent early sequelae of neurodegenerative diseases (e.g., Alzheimer's disease), and RHI is associated with the neurodegenerative disease, chronic traumatic encephalopathy (CTE). We examined olfaction, and its association with clinical measures, in former National Football League (NFL) players. Ninety-five former NFL players (ages 40-69) and 28 same-age controls completed a neuropsychological and neuropsychiatric evaluation as part of a National Institutes of Health-funded study. The Brief Smell Identification Test (B-SIT) assessed olfaction. Principal component analysis generated a four-factor structure of the clinical measures: behavioral/mood, psychomotor speed/executive function, and verbal and visual memory. Former NFL players had worse B-SIT scores relative to controls (p = 0.0096). A B-SIT cutoff of 11 had the greatest accuracy (c-statistic = 0.61) and specificity (79%) for discriminating former NFL players from controls. In the former NFL players, lower B-SIT scores correlated with greater behavioral/mood impairment (p = 0.0254) and worse psychomotor speed/executive functioning (p = 0.0464) after controlling for age and education. Former NFL players exhibited lower olfactory test scores relative to controls, and poorer olfactory test performance was associated with worse neuropsychological and neuropsychiatric functioning. Future work that uses more-comprehensive tests of olfaction and structural and functioning neuroimaging may improve understanding on the association between RHI and olfaction.

Low Left Atrial Compliance Contributes to the Clinical Recurrence of Atrial Fibrillation after Catheter Ablation in Patients with Structurally and Functionally Normal Heart.

PubMed

Park, Junbeom; Yang, Pil-sung; Kim, Tae-Hoon; Uhm, Jae-Sun; Kim, Joung-Youn; Joung, Boyoung; Lee, Moon-Hyoung; Hwang, Chun; Pak, Hui-Nam

2015-01-01

Stiff left atrial (LA) syndrome was initially reported in post-cardiac surgery patients and known to be associated with low LA compliance. We investigated the physiological and clinical implications of LA compliance by estimating LA pulse pressure (LApp) among patients with atrial fibrillation (AF) and structurally and functionally normal heart. Among 1038 consecutive patients with LA pressure measurements before AF ablation, we included 334 patients with structurally and functionally normal heart (81.7% male, 54.1±10.6 years, 77.0% paroxysmal AF) after excluding those with hypertension, diabetes, and previous ablation or cardiac surgery. We measured LApp (peak-nadir LA pressure) at the beginning of the ablation procedure and compared the values with clinical parameters and the AF recurrence rate. AF patients with normal heart were younger and more frequently male and had paroxysmal AF, a lower body mass index, and a lower LApp compared to others (all p<0.05). Based on the median value, the low LA compliance group (LApp≥13 mmHg) had a smaller LA volume index and lower LA voltage (all p<0.05) compared to the high LA compliance group. During a mean follow-up of 16.7±11.8 months, low LA compliance was independently associated with two fold-higher risk of clinical AF recurrence (HR:2.202; 95%CI:1.077-4.503; p = 0.031). Low LA compliance, as determined by an elevated LApp, was associated with a smaller LA volume index and lower LA voltage and independently associated with higher clinical recurrence after catheter ablation in AF patients with structurally and functionally normal heart.

The evaluation of family functioning by the family assessment device: a systematic review of studies in adult clinical populations.

PubMed

Staccini, Laura; Tomba, Elena; Grandi, Silvana; Keitner, Gabor I

2015-03-01

A large body of research, documenting the impact of a family's functioning on health outcomes, highlights the importance of introducing the evaluation of patients' family dynamics into clinical judgment. The Family Assessment Device (FAD) is a self-report questionnaire designed to assess specific dimensions of family functioning. This qualitative systematic review, which follows PRISMA guidelines, aimed to identify the FAD's clinimetric properties and to report the incremental utility of its inclusion in clinical settings. A thorough literature search was performed, using both computerized and manual searches, yielding a total of 148 studies that were included in this review. The FAD has been extensively used in a variety of research contexts. In the majority of studies it was able to discriminate between clinical populations and controls and among groups of patients with different illnesses. The FAD also showed good test-retest and concurrent reliability, and modest sensitivity to change after treatment. FAD-dysfunctional family functioning was related to several patient clinical outcomes, including lower recovery rates and adherence to treatment, longer recovery time, poorer quality of life, and increased risk of relapse and drop-out. The present review demonstrates that the FAD is a suitable instrument for the evaluation of family functioning both in clinical and research settings. © 2014 Family Process Institute.

[Hospital clinical engineer orientation and function in the maintenance system of hospital medical equipment].

PubMed

Li, Bin; Zheng, Yunxin; He, Dehua; Jiang, Ruiyao; Chen, Ying; Jing, Wei

2012-03-01

The quantity of medical equipment in hospital rise quickly recent year. It provides the comprehensive support to the clinical service. The maintenance of medical equipment becomes more important than before. It is necessary to study on the orientation and function of clinical engineer in medical equipment maintenance system. Refer to three grade health care system, the community doctors which is called General practitioner, play an important role as the gatekeeper of health care system to triage and cost control. The paper suggests that hospital clinical engineer should play similar role as the gatekeeper of medical equipment maintenance system which composed by hospital clinical engineer, manufacture engineer and third party engineer. The hospital clinical engineer should be responsible of guard a pass of medical equipment maintenance quality and cost control. As the gatekeeper, hospital clinical engineer should take the responsibility of "General engineer" and pay more attention to safety and health of medical equipment. The responsibility description and future transition? development of clinical engineer as "General Engineer" is discussed. More attention should be recommended to the team building of hospital clinical engineer as "General Engineer".

Clinical examination results in individuals with functional ankle instability and ankle-sprain copers.

PubMed

Wright, Cynthia J; Arnold, Brent L; Ross, Scott E; Ketchum, Jessica; Ericksen, Jeffrey; Pidcoe, Peter

2013-01-01

Why some individuals with ankle sprains develop functional ankle instability and others do not (ie, copers) is unknown. Current understanding of the clinical profile of copers is limited. To contrast individuals with functional ankle instability (FAI), copers, and uninjured individuals on both self-reported variables and clinical examination findings. Cross-sectional study. Sports medicine research laboratory. Participants consisted of 23 individuals with a history of 1 or more ankle sprains and at least 2 episodes of giving way in the past year (FAI: Cumberland Ankle Instability Tool [CAIT] score = 20.52 ± 2.94, episodes of giving way = 5.8 ± 8.4 per month), 23 individuals with a history of a single ankle sprain and no subsequent episodes of instability (copers: CAIT score = 27.74 ± 1.69), and 23 individuals with no history of ankle sprain and no instability (uninjured: CAIT score = 28.78 ± 1.78). Self-reported disability was recorded using the CAIT and Foot and Ankle Ability Measure for Activities of Daily Living and for Sports. On clinical examination, ligamentous laxity and tenderness, range of motion (ROM), and pain at end ROM were recorded. Questionnaire scores for the CAIT, Foot and Ankle Ability Measure for Activities of Daily Living and for Sports, ankle inversion and anterior drawer laxity scores, pain with palpation of the lateral ligaments, ankle ROM, and pain at end ROM. Individuals with FAI had greater self-reported disability for all measures (P < .05). On clinical examination, individuals with FAI were more likely to have greater talar tilt laxity, pain with inversion, and limited sagittal-plane ROM than copers (P < .05). Differences in both self-reported disability and clinical examination variables distinguished individuals with FAI from copers at least 1 year after injury. Whether the deficits could be detected immediately postinjury to prospectively identify potential copers is unknown.

[THE RESULTS OF CLINICAL AND PSYCHOPATHOLOGICAL AND PSYCHOLOGICAL DIAGNOSTIC INVESTIGATIONS EMPLOYEES OF FINANCIAL INSTITUTIONS WHICH WERE IDENTIFIED NEUROTIC DISORDERS].

PubMed

Solovyova, M

2014-12-01

The article presents the results of the clinical and psychopathological and psychological diagnostic, investigations mental health employees of financial institutions, description and analysis of clinical forms identified disorders.

Investigational Clinical Trial of a Prototype Optoelectronic Computer-Aided Navigation Device for Dental Implant Surgery.

PubMed

Jokstad, Asbjørn; Winnett, Brenton; Fava, Joseph; Powell, David; Somogyi-Ganss, Eszter

New digital technologies enable real-time computer-aided (CA) three-dimensional (3D) guidance during dental implant surgery. The aim of this investigational clinical trial was to demonstrate the safety and effectiveness of a prototype optoelectronic CA-navigation device in comparison with the conventional approach for planning and effecting dental implant surgery. Study participants with up to four missing teeth were recruited from the pool of patients referred to the University of Toronto Graduate Prosthodontics clinic. The first 10 participants were allocated to either a conventional or a prototype device study arm in a randomized trial. The next 10 participants received implants using the prototype device. All study participants were restored with fixed dental prostheses after 3 (mandible) or 6 (maxilla) months healing, and monitored over 12 months. The primary outcome was the incidence of any surgical, biologic, or prosthetic adverse events or device-related complications. Secondary outcomes were the incidence of positioning of implants not considered suitable for straightforward prosthetic restoration (yes/no); the perception of the ease of use of the prototype device by the two oral surgeons, recorded by use of a Likert-type questionnaire; and the clinical performance of the implant and superstructure after 1 year in function. Positioning of the implants was appraised on periapical radiographs and clinical photographs by four independent blinded examiners. Peri-implant bone loss was measured on periapical radiographs by a blinded examiner. No adverse events occurred related to placing any implants. Four device-related complications led to a switch from using the prototype device to the conventional method. All implants placed by use of the prototype device were in a position considered suitable for straightforward prosthetic restoration (n = 21). The qualitative evaluation by the surgeons was generally positive, although ergonomic challenges were identified

Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols.

PubMed

Ebile, Akoh Walter; Ateudjieu, Jerome; Yakum, Martin Ndinakie; Djuidje, Marceline Ngounoue; Watcho, Pierre

2015-09-29

International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned. It was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National Ethics Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety. In total, 106 (4.9 %) clinical trial protocols were identified from 2173 protocols seen in the archive and 104 (4.8 %) included for review. Seventy six (73.1 %) trials did not include the surveillance of adverse events as part of their objective. A total of 91 (87.5 %) protocols did not budget for adverse event surveillance, 76 (73.1 %) did not have a data safety management board (DSMB), 11(10.6 %) included insurance for participants, 47 (45.2 %) did not include a case definition for serious adverse events, 33 (31.7 %) described procedures to detect adverse events, 33 (31.7 %) described procedure for reporting and 22 (21.2 %) described procedure for investigating adverse events. Most clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols. Clinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan

[Clinical and genetic investigation of families with Waardenburg syndrome type 2].

PubMed

Chen, H S; Liao, X B; Liu, Y L; He, C F; Zhang, H; Jiang, L; Feng, Y; Mei, L Y

2016-12-01

Objective: To investigate the clinical chacteration and molecular pathology of Waardenburg syndrome type 2 in seven families, and provide genetic diagnosis and hereditary counseling for family members. Method: Clinical data of seven families with WS2（14 patients）were collected. Peripheral blood samples of the probands and related family members were collected and genomic DNA was extracted. The coding sequences of microphthalmia associated transcription factor (MITF), sex-determining region Y-box 10(SOX10), snail family zinc finger 2 (SNAI2) and endothelin receptor type B（EDNRB）were analyzed by polymerase chain reaction and DNA sequencing. Then the raw data was analyzed. Result: The most common manifestations of WS2 are sensorineural hearing loss(10/14,71.4%), freckle(7/14, 50.0%)，heterochromia iridis(6/14, 42.9%) and premature greying(5/14,35.7%). All the deafness phenotype is congenital, bilateral profound sensorineural hearing loss. Freckles phenotype is different from cutaneous pigment abnormalities of WS in Westerners. The heterozygous mutation, c.328C>T in exon 3 of the MITF gene was detected in the proband and all patients of pedigree 2. However, no pathological mutation of the relevant genes (SOX10,SNAI2 and EDNRB) was detected in other pedigrees. Conclusion: There are obvious variations in clinical features of WS, while freckles may be a special subtype of cutaneous pigment disturbances. The MITF gene mutation, R110X,is therefore considered the disease causing mutation in pedigree WS02.However, there are novel disease causing genes or copy number variations in Waardenburg syndrome type 2, which require further research. Copyright© by the Editorial Department of Journal of Clinical Otorhinolaryngology Head and Neck Surgery.

Clinical efficacy and safety of polyethylene glycol 3350 versus liquid paraffin in the treatment of pediatric functional constipation

PubMed Central

Rafati, MR.; Karami, H.; Salehifar, E.; Karimzadeh, A.

2011-01-01

Background and the purpose of the study Functional constipation is prevalent in children. Recently polyethylene glycol has been introduced as an effective and safe drug to treat chronic constipation. There are only a few clinical trials on comparison of PEG and liquid paraffin in childhood constipation. The purpose of this study was to evaluate clinical efficacy and safety of PEG 3350 solution and liquid paraffin in the treatment of children with functional constipation in Sari Toba clinic during the period of 2008–2009. Methods Children with a history of functional constipation were subjects of this study. One hundred and sixty children of 2–12 years old with functional constipation were randomized in two PEG and paraffin treatment groups. Patients received either 1.0–1.5 g/kg/day PEG 3350 or 1.0–1.5 ml/kg/day liquid paraffin for 4 months. Clinical efficacy was evaluated by stool and encopresis frequency/week and overall treatment success rate was compared in two groups. Results and major conclusion Compared with the baseline, defecation frequency/ week increased significantly and encopresis frequency meaningfully decreased in two groups during the period of the study. Patients using PEG 3350 had more success rate (mean: 95.3%±3.7) compared with the patients in paraffin group (mean: 87.2%±7.1) (p=0.087). Administration of PEG 3350 were associated with less adverse events than liquid paraffin. In conclusion in treatment of pediatric functional constipation, regarding clinical efficacy and safety, PEG 3350 were at least as effective as liquid paraffin and but less adverse drug events. PMID:22615652

Sustaining the Clinical Translational Research Workforce: Training and Empowering the Next Generation of Investigators

PubMed Central

Yin, Helen L.; Gabrilove, Janice; Jackson, Rebecca; Sweeney, Carol; Fair, Alecia M.; Toto, Robert

2015-01-01

There is mounting concern that clinician scientists are a vanishing species, and that the pipeline for clinical translational research (CTR) investigators is in jeopardy. For the majority of current junior CTR investigators, the career path involves first obtaining a National Institutes of Health (NIH) funded K-type career development award, particularly K08 and K23, and subsequently an NIH R01. This transition, popularly referred to as K2R, is a major hurdle with a low success rate and gaps in funding. In this Perspective, the authors identify factors that facilitate K2R transition and important aspects of increasing and sustaining the pipeline of CTR investigators. They also highlight significant differences in success rates of women and those underrepresented in biomedical research. Early career exposure to research methodology, protected time, multidisciplinary mentoring, and institutional “culture shift” are important for fostering and rewarding team science. Mentoring is the single most important contributor to K2R success, and emerging evidence suggests that formal mentor training and team mentoring are effective. Leadership training can empower junior investigators to thrive as independent CTR investigators. Future research should focus on delineating the difference between essential and supplemental factors to achieve this transition, and mentoring methods that foster success, including those that promote K2R transition of women and those underrepresented in biomedical research. The Clinical Translational Science Awards National Consortium is well positioned to test existing models aimed at shortening the timeframe, increasing the rate of K2R transition, and identifying strategies that improve success. PMID:26414054

[Clinical significance of detection of internal anal sphincter in children with functional constipation].

PubMed

Hou, Xiang-yu; Wang, Ling-yun; Wang, Wei-lin; Li, Yong; Bai, Yu-zuo

2011-10-01

To investigate the structural and functional changes of internal anal sphincter (IAS) in children with functional constipation (FC), and to evaluate the association between the thickness of IAS and the severity of clinical symptoms. A total of 35 children with FC(constipation group,17 with incontinence) between June 2008 and December 2008 at the Shengjing Hospital of China Medical University were evaluated using anal manometry and endosonography. These patients were compared to 23 hospitalized children who were excluded for digestive and endocrinal diseases(control group). A validated symptom score(SS) was used to assess the severity of symptoms. The sum of SS ranged between 0 and 65. Anorectal manometry showed reflex relaxation of IAS in response to distension of rectal balloon in all patients. Rectal perceptional threshold in FC group was significantly higher than that in the controls[(42.4 ± 19.5) ml vs.(29.1 ± 15.6) ml, P<0.05]. The lowest volume for inducing reflex relaxation of IAS was significantly higher than that in the controls [(55.6 ± 31.6) ml vs.(30.5 ±13.8) ml, P<0.05]. The thickening of IAS was noted in all the patients[(3.8 ± 1.7) mm vs.(2.5 ± 1.0) mm, P<0.05]. However, there was no significant difference between FC and control in median resting anal sphincter pressure[(170.8 ± 62.3) mm Hg vs. (161.3 ± 51.1) mm Hg, P>0.05]. The median symptom score was 9.3 ± 4.3 in the FC group. The thickness of IAS correlated significantly with total symptom severity score(r=0.407, P<0.05). There was no correlation between thickness of IAS and age, sex, or duration of disease(P>0.05). Structural and functional changes of internal anal sphincter exist in children with functional constipation. The thickness of internal anal sphincter correlates significantly with symptom severity.

The effect of active video games on cognitive functioning in clinical and non-clinical populations: A meta-analysis of randomized controlled trials.

PubMed

Stanmore, Emma; Stubbs, Brendon; Vancampfort, Davy; de Bruin, Eling D; Firth, Joseph

2017-07-01

Physically-active video games ('exergames') have recently gained popularity for leisure and entertainment purposes. Using exergames to combine physical activity and cognitively-demanding tasks may offer a novel strategy to improve cognitive functioning. Therefore, this systematic review and meta-analysis was performed to establish effects of exergames on overall cognition and specific cognitive domains in clinical and non-clinical populations. We identified 17 eligible RCTs with cognitive outcome data for 926 participants. Random-effects meta-analyses found exergames significantly improved global cognition (g=0.436, 95% CI=0.18-0.69, p=0.001). Significant effects still existed when excluding waitlist-only controlled studies, and when comparing to physical activity interventions. Furthermore, benefits of exergames where observed for both healthy older adults and clinical populations with conditions associated with neurocognitive impairments (all p<0.05). Domain-specific analyses found exergames improved executive functions, attentional processing and visuospatial skills. The findings present the first meta-analytic evidence for effects of exergames on cognition. Future research must establish which patient/treatment factors influence efficacy of exergames, and explore neurobiological mechanisms of action. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

21 CFR 50.54 - Clinical investigations not otherwise approvable that present an opportunity to understand...

Code of Federal Regulations, 2012 CFR

2012-04-01

... and Drugs, after consultation with a panel of experts in pertinent disciplines (for example: science... either: (1) That the clinical investigation in fact satisfies the conditions of § 50.51, § 50.52, or § 50...

21 CFR 50.54 - Clinical investigations not otherwise approvable that present an opportunity to understand...

Code of Federal Regulations, 2010 CFR

2010-04-01

... and Drugs, after consultation with a panel of experts in pertinent disciplines (for example: science... either: (1) That the clinical investigation in fact satisfies the conditions of § 50.51, § 50.52, or § 50...

21 CFR 50.54 - Clinical investigations not otherwise approvable that present an opportunity to understand...

Code of Federal Regulations, 2011 CFR

2011-04-01

... and Drugs, after consultation with a panel of experts in pertinent disciplines (for example: science... either: (1) That the clinical investigation in fact satisfies the conditions of § 50.51, § 50.52, or § 50...

Performance of the Tinnitus Functional Index as a diagnostic instrument in a UK clinical population.

PubMed

Fackrell, Kathryn; Hall, Deborah A; Barry, Johanna G; Hoare, Derek J

2017-11-09

The Tinnitus Functional Index (TFI) has been optimised as a diagnostic tool for quantifying the functional impact of tinnitus in US veteran and civilian groups. However, the TFI has not been fully evaluated for use in other English-speaking clinical populations despite its increasingly popular uptake. Here, a prospective multi-site longitudinal validation study was conducted to evaluate psychometric properties relevant to the UK clinical population. Guided by quality criteria for the measurement properties of health-related questionnaires, we specifically evaluated three diagnostic properties relating to the degree to which the TFI (i) covers the eight dimensions proposed to be important for diagnosis, (ii) reliably distinguishes individual differences in severity of tinnitus, and (iii) reliably measures the functional impact of tinnitus. We also examine whether clinically meaningful interpretations of the scores can be produced for the UK population. Twelve National Health Service audiology clinics across the UK recruited 255 tinnitus patients to complete questionnaires at four time-intervals, from initial clinical assessment and then over a nine-month period. Patients completed the TFI, the Tinnitus Handicap Inventory (THI), tinnitus case history questions, a Global rating of Perceived Problem with tinnitus and a Clinical Global Impression of perceived change in tinnitus. Baseline TFI data were used to examine the factor structure, construct validity and interpretability of the TFI. Follow-up TFI data were used to examine reliability. Confirmatory factor analysis suggested that of the eight subscales (factors) initially established for the TFI, the 'Auditory' subscale did not contribute to the overall construct 'functional impact of tinnitus', and a modified seven-factor model (TFI-22) better fit the variance in the patient scores. Both the global 25-item TFI and the global TFI-22 scores showed exceptionally high internal consistency (α ≥ 0.95), high

Mining functionally relevant gene sets for analyzing physiologically novel clinical expression data.

PubMed

Turcan, Sevin; Vetter, Douglas E; Maron, Jill L; Wei, Xintao; Slonim, Donna K

2011-01-01

Gene set analyses have become a standard approach for increasing the sensitivity of transcriptomic studies. However, analytical methods incorporating gene sets require the availability of pre-defined gene sets relevant to the underlying physiology being studied. For novel physiological problems, relevant gene sets may be unavailable or existing gene set databases may bias the results towards only the best-studied of the relevant biological processes. We describe a successful attempt to mine novel functional gene sets for translational projects where the underlying physiology is not necessarily well characterized in existing annotation databases. We choose targeted training data from public expression data repositories and define new criteria for selecting biclusters to serve as candidate gene sets. Many of the discovered gene sets show little or no enrichment for informative Gene Ontology terms or other functional annotation. However, we observe that such gene sets show coherent differential expression in new clinical test data sets, even if derived from different species, tissues, and disease states. We demonstrate the efficacy of this method on a human metabolic data set, where we discover novel, uncharacterized gene sets that are diagnostic of diabetes, and on additional data sets related to neuronal processes and human development. Our results suggest that our approach may be an efficient way to generate a collection of gene sets relevant to the analysis of data for novel clinical applications where existing functional annotation is relatively incomplete.

[Clinical effect of functional repair of bilateral cleft lip in 66 patients].

PubMed

Li, Ming; Jiang, Hong-bing; Yuan, Hua; DU, Yi-fei; Wu, Yu-nong; Wan, Lin-zhong

2014-10-01

To explore the clinical effect of functional repair for bilateral cleft lip using modified Mulliken method. Sixty-six patients with bilateral cleft lip were selected and assigned to receive modified Mulliken method. During the operation, the prolabium was kept as narrow "tie" shape, the orbicularis oris was anatomically repositioned, and the orbicularis oris ring was re-built. Vermilion tubercle was reconstructed with the lateral red vermillion. The nasal deformity was preliminarily repaired. and the nasal columella was elongated at the same time. All the patients were followed-up for 0.5-2 years, there was no "trisection upper lip". The symmetry and natural shape of Cupid's bow were obtained in more than 80% patients. The width of philtrum was similar to normal children. Full vermilion of the lips, moderate-size vermilion tubercles and good dynamic and static shape were obtained without whistle deformities. Normal width of nasal base and nostril symmetry were gained. The columella was elongated. Satisfactory contour of the nasal tip was achieved. Modified Mulliken method could functionally repair bilateral cleft lip and effectively correct nasolabial deformities. It is worthy of wide clinical application.

Electrochemical impedance spectroscopy investigation on the clinical lifetime of ProTaper rotary file system.

PubMed

Penta, Virgil; Pirvu, Cristian; Demetrescu, Ioana

2014-01-01

The main objective of the current paper is to show that electrochemical impedance spectroscopy (EIS) could be a method for evaluating and predicting of ProTaper rotary file system clinical lifespan. This particular aspect of everyday use of the endodontic files is of great importance in each dental practice and has profound clinical implications. The method used for quantification resides in the electrochemical impedance spectroscopy theory and has in its main focus the characteristics of the surface titanium oxide layer. This electrochemical technique has been adapted successfully to identify the quality of the Ni-Ti files oxide layer. The modification of this protective layer induces changes in corrosion behavior of the alloy modifying the impedance value of the file. In order to assess the method, 14 ProTaper sets utilized on different patients in a dental clinic have been submitted for testing using EIS. The information obtained in regard to the surface oxide layer has offered an indication of use and proves that the said layer evolves with each clinical application. The novelty of this research is related to an electrochemical technique successfully adapted for Ni-Ti file investigation and correlation with surface and clinical aspects.