Displaying publications 101 - 120 of 10711 in total

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  1. Loh, Li Loong, Wong, Kai Ann, Zamzuri Zakaria@Mohamad
    MyJurnal
    Synovial osteochondromatosis is an unusual, rare and benign tumour. This disease is characteristically monoarticular, most commonly found in knee joint, however it is rarely found in the elbow. A 49-year-old Indian man presented to hospital with a 6-month history of pain, swelling, intermittent locking, loss of range of motion of right elbow and a considerable size of elbow with no recollection of associated trauma. Plain radiographs of right elbow showed numerous radiopaque round and oval loose bodies within the right elbow joints. Computer Tomographic (CT) scan showed multiple bony mass within the right elbow joint. Arthroscopic synovectomy, debridement, excisional biopsy and loose body removal combined with miniarthrotomy of the right elbow was performed due to limited exposure for removal of larger loose bodies. Histopathological examination of the tissue sample is consistent with the diagnosis of synovial osteochondromatosis. The clinical and radiological evaluation at 6th month postoperatively showed marked reduction in the volume of the elbow, further improvement of elbow range of motion of this patient and the Mayo elbow performance score before surgery and at 6 months postoperative, with an increase from 50 to 80 points. Synovial osteochondromatosis of the joints is a rare condition. The signs and symptoms are not specific and may be suggestive of other pathology conditions. Arthroscopic synovectomy and removal of loose body is the standard operative procedure till today. However, combination of arthroscopy and miniarthrotomy in cases of large loose bodies may provide a good clinical and functional outcome.
    Matched MeSH terms: Middle Aged
  2. Lau KF, Tan KS, Goh KJ, Ramli N, Tai SM
    Ann Acad Med Singap, 2019 Mar;48(3):109-111.
    PMID: 30997481
    Matched MeSH terms: Middle Aged
  3. Kongpakwattana K, Dejthevaporn C, Krairit O, Dilokthornsakul P, Mohan D, Chaiyakunapruk N
    Value Health, 2019 10;22(10):1137-1145.
    PMID: 31563256 DOI: 10.1016/j.jval.2019.04.1937
    BACKGROUND: Although an increase in the burden of Alzheimer's disease (AD) is evident worldwide, knowledge of costs and health-related quality of life (HRQOL) associated with AD in low- and middle-income countries is still lacking.

    OBJECTIVES: This study aimed to collect real-world cost and HRQOL data, and investigate their associations with multiple disease-severity indicators among AD patients in Thailand.

    METHODS: We recruited AD patients aged ≥60 years accompanied by their caregivers at a university-affiliated tertiary hospital. A one-time structured interview was conducted to collect disease-severity indicators, HRQOL, and caregiving information using standardized tools. The hospital's database was used to retrieve healthcare resource utilization occurred over 6 months preceding the interview date. Costs were annualized and stratified based on cognitive status. Generalized linear models were employed to evaluate determinants of costs and HRQOL.

    RESULTS: Among 148 community-dwelling patients, average annual total societal costs of AD care were $8014 (95% confidence interval [CI]: $7295-$8844) per patient. Total costs of patients with severe stage ($9860; 95% CI: $8785-$11 328) were almost twice as high as those of mild stage ($5524; 95% CI: $4649-$6593). The major cost driver was direct medical costs, particularly those incurred by AD prescriptions. Functional status was the strongest determinant for both total costs and patient's HRQOL (P value

    Matched MeSH terms: Middle Aged
  4. Yew YW, Lai YC, Chan R
    Ann Acad Med Singap, 2016 Nov;45(11):516-519.
    PMID: 27922146
    Matched MeSH terms: Middle Aged
  5. Mohamed M, Mohd Nafi SN, Jaafar H, Paiman NM
    Asian Pac J Cancer Prev, 2021 Jul 01;22(7):2043-2047.
    PMID: 34319025 DOI: 10.31557/APJCP.2021.22.7.2043
    OBJECTIVE: The role of HMG-CoA reductase (HMGCR) in relation to prognostic and treatment predictive information of HER2 positive breast cancer has been newly explored. In this study, we aimed to determine the expression of HMGCR in HER2 immunohistochemistry (IHC) scores of 2+ and 3+ breast cancer and to correlate with the patients' outcomes.

    METHODOLOGY: Using a cross-sectional design, invasive breast carcinoma of no special type (NST) and HER2 IHC scores of 2+ and 3+ cases were selected over a 50-month period in Hospital Sultanah Bahiyah (HSB), Alor Setar. IHC staining for HMGCR was performed on paraffin-embedded tissues at the Pathology Laboratory, Hospital Universiti Sains Malaysia (HUSM), Kubang Kerian using the standard staining procedure. The results were correlated with the patient's demographic and clinicopathological data.

    RESULTS: A total of 59 cases of HER2 IHC 2+ and 3+ invasive breast carcinoma were identified. The cases were predominant in young Malay women with tumours smaller than 50mm, higher grade and positive for lymphovascular invasion, axillary lymph nodes involvement and ER/PR expressions. HMGCR was positively expressed in HER2 IHC 2+ and 3+ breast cancer cases, which the staining intensities varied from weak, moderate to strong. Majority of the cases were scored 1+ for HMGCR expression. A low-positive HMGCR was more likely to be associated with less favourable outcomes of patients with HER2 IHC 2+ and 3+. However, the associations were statistically not significant.

    CONCLUSION: A study in a larger cohort of tumour samples is needed to further validate HMGCR expression as a potential prognostic biomarker for HER2 positive breast cancer. It is also suggested that all the HER2 IHC 2+ and 3+ cases need to be gene amplified using FISH analysis.  
    .

    Matched MeSH terms: Middle Aged
  6. Chin KY, Tay SS
    Nutrients, 2018 Jul 09;10(7).
    PMID: 29987193 DOI: 10.3390/nu10070881
    Alzheimer’s disease (AD) is plaguing the aging population worldwide due to its tremendous health care and socioeconomic burden. Current treatment of AD only offers symptomatic relief to patients. Development of agents targeting specific pathologies of AD is very slow. Tocotrienol, a member of the vitamin E family, can tackle many aspects of AD, such as oxidative stress, mitochondrial dysfunction and abnormal cholesterol synthesis. This review summarizes the current evidence on the role of tocotrienol as a neuroprotective agent. Preclinical studies showed that tocotrienol could reduce oxidative stress by acting as a free-radical scavenger and promoter of mitochondrial function and cellular repair. It also prevented glutamate-induced neurotoxicity in the cells. Human epidemiological studies showed a significant inverse relationship between tocotrienol levels and the occurrence of AD. However, there is no clinical trial to support the claim that tocotrienol can delay or prevent the onset of AD. As a conclusion, tocotrienol has the potential to be developed as an AD-preventing agent but further studies are required to validate its efficacy in humans.
    Matched MeSH terms: Middle Aged
  7. Lee YY, Wahab N, Mustaffa N, Daud N, Mohd Noor N, Shaaban J, et al.
    BMC Gastroenterol, 2013;13:84.
    PMID: 23672671 DOI: 10.1186/1471-230X-13-84
    Backgrounds: The study aimed to survey for FD in a primary care setting in a population known to have an extremely low prevalence of Helicobacter pylori (H. pylori) infection, with the hypothesis that in such a population, dyspepsia should have been relatively less common.
    Methods: The Rome III FD Diagnostic Questionnaire was translated into the Malay language and later tested for reliability. A prospective cross-sectional survey was then performed involving 160 Malay patients attending primary care clinic after informed consent. Patients positive for symptoms of FD were subjected to upper endoscopy and exclusion of H. pylori infection. Univariable and multivariable analyses were used to test for associated risk factors.
    Results: The back-translated questionnaire was similar to the original English version and was reliable (Cronbach Alpha-coefficient 0.85). Of the 160 surveyed subjects, 19 of them (11.9%) had symptoms of FD. With exclusion of erosive diseases (3/160 or 1.9%) from endoscopy, 16 subjects or 10% had FD. None of the 19 subjects were positive for H. pylori infection. Epigastric pain syndrome was present in 11/16 (68.8%) and the rest, overlap with postprandial distress syndrome. With multivariable analysis, a married status (OR = 8.1; 95% CI 1.0-36.5) and positive psychosocial alarm symptoms (OR = 3.8; 95% CI 1.0-14.0) were associated with FD. Of those married subjects, females were more likely to have FD and psychosocial symptoms than men (6.3% vs. 1.9%), P = 0.04.
    Conclusions: FD was more common than one had expected among Malays attending primary care clinic in an area with low prevalence of H. pylori.
    Keywords: Functional dyspepsia, Malays, Rome III, Females, Marriage, Psychosocial alarm
    Questionnaire: Rome III Functional Dyspepsia Diagnostic questionnaire; Red Flag Questionnaire; Psychosocial Alarm Questionnaire; Hospital Anxiety Depression Scale; HADS

    Study site: primary care clinic within the university hospital of Universiti Sains Malaysia (USM)
    Matched MeSH terms: Middle Aged
  8. Ong TL, Goh KJ, Shahrizaila N, Wong KT, Tan CY
    Neurol India, 2019 12 21;67(6):1532-1535.
    PMID: 31857554 DOI: 10.4103/0028-3886.273621
    Distal acquired demyelinating symmetric neuropathy (DADS) is a variant of chronic inflammatory demyelinating polyneuropathy (CIDP) characterized by symmetrical, distal, sensory or sensorimotor involvement. DADS with M-protein (DADS-M) is less responsive to immunotherapy compared to those without M-protein (DADS-I). We report a case of DADS-I with severe clinical presentation viz. early hand involvement with marked wasting, inexcitable peripheral nerves on neurophysiology and poor response to immunotherapy. Despite the unusual presentation, ancillary tests including cerebrospinal fluid analysis, nerve biopsy and nerve ultrasound were supportive of an inflammatory demyelinating polyneuropathy. This case demonstrated the heterogeneity of the disorder and expands the clinical spectrum of DADS neuropathy.
    Matched MeSH terms: Middle Aged
  9. Tah PC, Lee ZY, Poh BK, Abdul Majid H, Hakumat-Rai VR, Mat Nor MB, et al.
    Crit Care Med, 2020 05;48(5):e380-e390.
    PMID: 32168031 DOI: 10.1097/CCM.0000000000004282
    OBJECTIVES: Several predictive equations have been developed for estimation of resting energy expenditure, but no study has been done to compare predictive equations against indirect calorimetry among critically ill patients at different phases of critical illness. This study aimed to determine the degree of agreement and accuracy of predictive equations among ICU patients during acute phase (≤ 5 d), late phase (6-10 d), and chronic phase (≥ 11 d).

    DESIGN: This was a single-center prospective observational study that compared resting energy expenditure estimated by 15 commonly used predictive equations against resting energy expenditure measured by indirect calorimetry at different phases. Degree of agreement between resting energy expenditure calculated by predictive equations and resting energy expenditure measured by indirect calorimetry was analyzed using intraclass correlation coefficient and Bland-Altman analyses. Resting energy expenditure values calculated from predictive equations differing by ± 10% from resting energy expenditure measured by indirect calorimetry was used to assess accuracy. A score ranking method was developed to determine the best predictive equations.

    SETTING: General Intensive Care Unit, University of Malaya Medical Centre.

    PATIENTS: Mechanically ventilated critically ill patients.

    INTERVENTIONS: None.

    MEASUREMENTS AND MAIN RESULTS: Indirect calorimetry was measured thrice during acute, late, and chronic phases among 305, 180, and 91 ICU patients, respectively. There were significant differences (F= 3.447; p = 0.034) in mean resting energy expenditure measured by indirect calorimetry among the three phases. Pairwise comparison showed mean resting energy expenditure measured by indirect calorimetry in late phase (1,878 ± 517 kcal) was significantly higher than during acute phase (1,765 ± 456 kcal) (p = 0.037). The predictive equations with the best agreement and accuracy for acute phase was Swinamer (1990), for late phase was Brandi (1999) and Swinamer (1990), and for chronic phase was Swinamer (1990). None of the resting energy expenditure calculated from predictive equations showed very good agreement or accuracy.

    CONCLUSIONS: Predictive equations tend to either over- or underestimate resting energy expenditure at different phases. Predictive equations with "dynamic" variables and respiratory data had better agreement with resting energy expenditure measured by indirect calorimetry compared with predictive equations developed for healthy adults or predictive equations based on "static" variables. Although none of the resting energy expenditure calculated from predictive equations had very good agreement, Swinamer (1990) appears to provide relatively good agreement across three phases and could be used to predict resting energy expenditure when indirect calorimetry is not available.

    Matched MeSH terms: Middle Aged
  10. Satheesha NB, Soumya KV
    Kathmandu Univ Med J (KUMJ), 2021 6 25;18(72):340-343.
    PMID: 34165088
    Background Gallstone disease (GSD) is one among the most prevalent diseases that affects approximately 10-15% of the population. It is associated with many other diseases like gallbladder cancer, renal stones, atherosclerosis, coronary heart disease and stroke. Objective Objective of this study is to document the prevalence of gallstones among south Indian cadavers. Method One hundred and twenty three South Indian cadaveric livers/gallbladders were observed for the presence of gallstones. The age range was 40 to 70 years. The gallbladders were palpated to know the presence of stones. They were then dissected and the stones were classified based on appearance. Gall bladder walls were also observed to know the associated fibrosis. Result Among the cadavers studied, 0.81% possessed cholesterol stones and 4.06% had pigment stones. Among the stones, 83.33% were pigment stones and 16.66% were cholesterol stones. Conclusion Compared to the western countries and north Indian studies, the prevalence of gallstone diseaseis low in the south Indian population (4.87%). The low prevalence was probably due to the low socioeconomic status and the diet and lifestyle.
    Matched MeSH terms: Middle Aged
  11. Tan HK, Ahmad Tajuddin LS, Lee MY, Ismail S, Wan-Hitam WH
    PMID: 26065503 DOI: 10.1097/APO.0000000000000058
    PURPOSE: To determine the mean central corneal thickness (CCT) and the relationship between the CCT and visual field progression in primary angle closure (PAC) and primary angle closure glaucoma (PACG).

    DESIGN: A combined cross-sectional and prospective study on PAC and PACG.

    METHODS: A total of 35 eyes were included in the study for each group of normal control, PAC, and PACG patients from eye clinics in Kota Bharu, state of Kelantan, Malaysia, from January 2007 to November 2009. The PAC and PACG patients were divided into thin and thick CCT groups. They were followed up for 12 to 18 months for visual field progression assessment with their mean Advanced Glaucoma Intervention Study (AGIS) score.

    RESULTS: The CCT was 516.8 ± 26.0 µm for PAC and 509.7 ± 27.4 µm for PACG. Both were significantly thinner compared with the control group with CCT of 540 ± 27.8 µm (P < 0.001). There was a statistically significant increase in the mean AGIS score after 12.9 ± 1.7 months of follow-up in the thin CCT group for PACG (P = 0.002). However, no significant increase in the mean AGIS score was found for the thick CCT group in PACG and for both thin and thick CCT in PAC.

    CONCLUSIONS: The PAC and PACG had statistically significant thinner CCT compared with the controls. Thin CCT was associated with visual field progression based on the mean AGIS score in PACG.

    Matched MeSH terms: Middle Aged
  12. Perumal K, Mun KS, Yap NY, Razack AHA, Gobe GC, Ong TA, et al.
    Biomed Res Int, 2020;2020:3682086.
    PMID: 32802842 DOI: 10.1155/2020/3682086
    Background: The mechanisms that link obesity and cancer development are not well-defined. Investigation of leptin and leptin receptor expressions may help define some of the mechanisms. These proteins are known for associating with the immune response, angiogenesis and, signalling pathways such as JAK2/STAT3, PI3K, and AKT pathways. Tissue proteins can be easily detected with immunohistochemistry (IHC), a technique widely used both in diagnostic and research laboratories. The identification of altered levels of leptin and leptin receptor proteins in tumour tissues may lead to targeted treatment for cancer.

    Objective: The objective of this study was to use IHC to compare leptin and leptin receptor expressions in clear cell renal cell carcinomas (ccRCC) in non-obese and obese patients to determine the association between these proteins with the clinicopathological features and prognosis of ccRCC. Patients and Methods. The study involved 60 patients who underwent nephrectomy of which 34 were obese, as assessed using body mass index (BMI). Nephrectomy samples provided tissues of ccRCC and adjacent non-cancerous kidney. The intensity and localization of leptin and leptin receptor protein expressions were evaluated using IHC and correlated with clinicopathological features and clinical outcomes. Aperio ImageScope morphometry and digital pathology were applied to assess the IHC results. The chi-square test was used to determine if there was any significant association between the proteins and the clinicopathological features. The Kaplan-Meier test was used to determine the overall survival, disease-free survival, and recurrence-free survival. A value of p < 0.05 was considered significant.

    Results: There was neither significant difference in the overall cellular and nuclear expressions of leptin and leptin receptor between non-cancerous kidney and ccRCC tissues nor in non-obese and obese individuals with ccRCC.

    Conclusion: In this present study, it was revealed that leptin and leptin receptor were not associated with tumour characteristics and progression of ccRCC patients. Interestingly, nuclear expression of leptin was significantly associated with overall survival. However, the significance of these proteins as biomarkers in other RCC histotypes is still unclear.

    Matched MeSH terms: Middle Aged
  13. Tahir AM, Chowdhury MEH, Khandakar A, Al-Hamouz S, Abdalla M, Awadallah S, et al.
    Sensors (Basel), 2020 Feb 11;20(4).
    PMID: 32053914 DOI: 10.3390/s20040957
    Gait analysis is a systematic study of human locomotion, which can be utilized in variousapplications, such as rehabilitation, clinical diagnostics and sports activities. The various limitationssuch as cost, non-portability, long setup time, post-processing time etc., of the current gait analysistechniques have made them unfeasible for individual use. This led to an increase in research interestin developing smart insoles where wearable sensors can be employed to detect vertical groundreaction forces (vGRF) and other gait variables. Smart insoles are flexible, portable and comfortablefor gait analysis, and can monitor plantar pressure frequently through embedded sensors thatconvert the applied pressure to an electrical signal that can be displayed and analyzed further.Several research teams are still working to improve the insoles' features such as size, sensitivity ofinsoles sensors, durability, and the intelligence of insoles to monitor and control subjects' gait bydetecting various complications providing recommendation to enhance walking performance. Eventhough systematic sensor calibration approaches have been followed by different teams to calibrateinsoles' sensor, expensive calibration devices were used for calibration such as universal testingmachines or infrared motion capture cameras equipped in motion analysis labs. This paper providesa systematic design and characterization procedure for three different pressure sensors: forcesensitiveresistors (FSRs), ceramic piezoelectric sensors, and flexible piezoelectric sensors that canbe used for detecting vGRF using a smart insole. A simple calibration method based on a load cellis presented as an alternative to the expensive calibration techniques. In addition, to evaluate theperformance of the different sensors as a component for the smart insole, the acquired vGRF fromdifferent insoles were used to compare them. The results showed that the FSR is the most effectivesensor among the three sensors for smart insole applications, whereas the piezoelectric sensors canbe utilized in detecting the start and end of the gait cycle. This study will be useful for any researchgroup in replicating the design of a customized smart insole for gait analysis.
    Matched MeSH terms: Middle Aged
  14. Faudzi FNM, Armitage CJ, Bryant C, Brown LJE
    Res Aging, 2019 07;41(6):549-574.
    PMID: 30700233 DOI: 10.1177/0164027518825117
    The aim of this study was to describe and systematically evaluate the psychometric properties of attitudes to aging measures that have been validated in adults younger than 60 years. Studies were assessed for methodological quality using the COnsensus-based Standards for the selection of health Measurement INstruments. Best evidence synthesis was performed to summarize the levels of evidence. Systematic searching yielded 21 articles, relating to 10 different measures. Some instruments were validated only in middle-aged and older people, while others were validated in a wider age range. Measures differed in whether their items related to participants' own experiences of aging, their anticipated future aging, and/or aging in general. None of the measures had had all of its psychometric properties assessed. The Expectations Regarding Ageing-12 and the Anxiety About Ageing Scale received positive ratings for the greatest number of psychometric properties, but capture different constructs, and may be differentially suited to different age groups of younger adults.
    Matched MeSH terms: Middle Aged
  15. Loch A, Teoh VWY, Hilmi IN
    Tex Heart Inst J, 2023 Dec 07;50(6).
    PMID: 38087478 DOI: 10.14503/THIJ-23-8230
    Endoscopic ultrasonography-guided transesophageal pericardiocentesis was performed for a posteriorly located effusion not amenable to transthoracic drainage in a 58-year-old woman with a history of recurrent breast adenocarcinoma who presented with dyspnea. The patient had a pericardial effusion that resulted in cardiac tamponade. Transthoracic pericardiocentesis was unsuitable because of the posterior location of the effusion. Pericardiocentesis via the transesophageal route was performed. The pericardial sac was punctured with a 19-gauge needle, and 245 mL of pericardial fluid were aspirated, resulting in the resolution of the tamponade physiology. Endoscopic ultrasonography-guided transesophageal drainage is a novel and promising therapeutic option for posteriorly located pericardial effusions.
    Matched MeSH terms: Middle Aged
  16. Raghavendra U, Gudigar A, Bhandary SV, Rao TN, Ciaccio EJ, Acharya UR
    J Med Syst, 2019 Jul 30;43(9):299.
    PMID: 31359230 DOI: 10.1007/s10916-019-1427-x
    Glaucoma is a type of eye condition which may result in partial or consummate vision loss. Higher intraocular pressure is the leading cause for this condition. Screening for glaucoma and early detection can avert vision loss. Computer aided diagnosis (CAD) is an automated process with the potential to identify glaucoma early through quantitative analysis of digital fundus images. Preparing an effective model for CAD requires a large database. This study presents a CAD tool for the precise detection of glaucoma using a machine learning approach. An autoencoder is trained to determine effective and important features from fundus images. These features are used to develop classes of glaucoma for testing. The method achieved an F - measure value of 0.95 utilizing 1426 digital fundus images (589 control and 837 glaucoma). The efficacy of the system is evident, and is suggestive of its possible utility as an additional tool for verification of clinical decisions.
    Matched MeSH terms: Middle Aged
  17. Langhorne P, Wu O, Rodgers H, Ashburn A, Bernhardt J
    Health Technol Assess, 2017 09;21(54):1-120.
    PMID: 28967376 DOI: 10.3310/hta21540
    BACKGROUND: Mobilising patients early after stroke [early mobilisation (EM)] is thought to contribute to the beneficial effects of stroke unit care but it is poorly defined and lacks direct evidence of benefit.

    OBJECTIVES: We assessed the effectiveness of frequent higher dose very early mobilisation (VEM) after stroke.

    DESIGN: We conducted a parallel-group, single-blind, prospective randomised controlled trial with blinded end-point assessment using a web-based computer-generated stratified randomisation.

    SETTING: The trial took place in 56 acute stroke units in five countries.

    PARTICIPANTS: We included adult patients with a first or recurrent stroke who met physiological inclusion criteria.

    INTERVENTIONS: Patients received either usual stroke unit care (UC) or UC plus VEM commencing within 24 hours of stroke.

    MAIN OUTCOME MEASURES: The primary outcome was good recovery [modified Rankin scale (mRS) score of 0-2] 3 months after stroke. Secondary outcomes at 3 months were the mRS, time to achieve walking 50 m, serious adverse events, quality of life (QoL) and costs at 12 months. Tertiary outcomes included a dose-response analysis.

    DATA SOURCES: Patients, outcome assessors and investigators involved in the trial were blinded to treatment allocation.

    RESULTS: We recruited 2104 (UK, n = 610; Australasia, n = 1494) patients: 1054 allocated to VEM and 1050 to UC. Intervention protocol targets were achieved. Compared with UC, VEM patients mobilised 4.8 hours [95% confidence interval (CI) 4.1 to 5.7 hours; p 

    Matched MeSH terms: Middle Aged
  18. Svane JK, Chiou ST, Groene O, Kalvachova M, Brkić MZ, Fukuba I, et al.
    Implement Sci, 2018 12 22;13(1):153.
    PMID: 30577871 DOI: 10.1186/s13012-018-0848-0
    BACKGROUND: Implementation of clinical health promotion (CHP) aiming at better health gain is slow despite its effect. CHP focuses on potentially modifiable lifestyle risks such as smoking, alcohol, diet, and physical inactivity. An operational program was created to improve implementation. It included patients, staff, and the organization, and it combined existing standards, indicators, documentation models, a performance recognition process, and a fast-track implementation model. The aim of this study was to evaluate if the operational program improved implementation of CHP in clinical hospital departments, as measured by health status of patients and staff, frequency of CHP service delivery, and standards compliance.

    METHODS: Forty-eight hospital departments were recruited via open call and stratified by country. Departments were assigned to the operational program (intervention) or usual routine (control group). Data for analyses included 36 of these departments and their 5285 patients (median 147 per department; range 29-201), 2529 staff members (70; 10-393), 1750 medical records (50; 50-50), and standards compliance assessments. Follow-up was measured after 1 year. The outcomes were health status, service delivery, and standards compliance.

    RESULTS: No health differences between groups were found, but the intervention group had higher identification of lifestyle risk (81% versus 60%, p 

    Matched MeSH terms: Middle Aged
  19. Hall DA, Ray J, Watson J, Sharman A, Hutchison J, Harris P, et al.
    Hear Res, 2019 06;377:153-166.
    PMID: 30939361 DOI: 10.1016/j.heares.2019.03.018
    AUT00063 is an experimental new medicine that has been demonstrated to suppress spontaneous hyperactivity by modulating the action of voltage-gated potassium-channels in central auditory cortical neurons of a rodent model. This neurobiological property makes it a good candidate for treating the central component of subjective tinnitus but this has not yet been tested in humans. The main purpose of the QUIET-1 (QUest In Eliminating Tinnitus) trial was to examine the effect of AUT00063 on the severity of tinnitus symptoms in people with subjective tinnitus. The trial was a randomised, placebo-controlled, observer, physician and participant blinded multi-centre superiority trial with two parallel groups and a primary endpoint of functional impact on tinnitus 28 days after the first drug dosing day. The trial design overcame the scale and logistical challenges of delivering a scientifically robust, statistically powered multi-centre study for subjective tinnitus within the National Health Service in England. The trial was terminated early for futility. Overall, 212 participants consented across 18 sites with 91 participants randomised to groups using age, gender, tinnitus symptom severity and hearing status as minimisation factors. While the pharmacokinetic markers confirm the uptake of AUT00063 in the body, within the expected therapeutic range, with respect to clinical benefit findings indicated that AUT00063 was not effective in alleviating tinnitus symptoms (1.56 point change in Tinnitus Functional Index). In terms of clinical harms, results indicated that a daily dose of 800 mg capsules of AUT00063 taken for 28 days was safe and well tolerated. These findings provide significant advances in the drug development field for hearing sciences, but raise questions about the predictive validity of certain rodent models of noise-induced hearing loss and tinnitus, as least for the mechanism evaluated in the present study. Trial Registration: (EudraCT) 2014-002179-27; NCT02315508.
    Matched MeSH terms: Middle Aged
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