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  • Cambridge University Press (CUP)  (6)
  • 1
    Online Resource
    Online Resource
    4276 Validation of Ototoxicity Prediction Model for Patients with Head and Neck Cancer
    Cambridge University Press (CUP) ; 2020
    In:  Journal of Clinical and Translational Science Vol. 4, No. s1 ( 2020-06), p. 152-152
    Details
    In: Journal of Clinical and Translational Science, Cambridge University Press (CUP), Vol. 4, No. s1 ( 2020-06), p. 152-152
    Abstract: OBJECTIVES/GOALS: To validate the previously developed ototoxicity prediction model for objective (i.e., audiometric-defined) hearing loss from cisplatin-based and radiation treatments in a new cohort of head and neck cancer patients treated from 2018 to 2019. METHODS/STUDY POPULATION: This study will use a cohort of 106 patients undergoing treatment for head and neck cancers at a single institution to temporally validate a model for post-treatment ototoxicity. We are interested in understanding if this model will be able to predict ototoxic risk (calibration) and if this model can differentiate high- and low-risk patients (discrimination). Observed and predicted values for audiometric hearing loss will be calculated and then compared using a calibration curve available in SAS v9.4, while the c-index (area under the receiver-operator curve) will be used to assess discrimination. The implementation of this model will be assessed in a clinical setting. RESULTS/ANTICIPATED RESULTS: The validation cohort is generally similar in age (61 years) and sex-mix (23% female) to the original cohort. However, there seems to be a different case-mix the types of treatments with more patients receiving cisplatin overall (59% vs. 43%), but fewer getting induction and high-dose cisplatin (1% vs. 13%). The original model showed good calibration and fair discrimination in the validation cohort with and area under the curve of 0.700. This concordance statistic suggests possibly-useful discrimination and the calibration curve suggests the model is well-calibrated. DISCUSSION/SIGNIFICANCE OF IMPACT: This project can improve clinical treatment paradigms, enhance patient education, and reduce healthcare costs. Our model allows oncologists to weigh the risks of hearing loss with the benefits of treatment on an individualized level before treatment, facilitating informed treatment decision-making.
    Type of Medium: Online Resource
    ISSN: 2059-8661
    URL: Article
    DOI: 10.1017/cts.2020.446
    Language: English
    Publisher: Cambridge University Press (CUP)
    Publication Date: 2020
    detail.hit.zdb_id: 2898186-8
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  • 2
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    51152 Efficacy of Bimodal Visual-Olfactory Training in Patients with COVID-19 resultant Hyposmia or Anosmia Using Patient-Preferred Scents (VOLT Trial - Visual-OLfactory Training)
    Cambridge University Press (CUP) ; 2021
    In:  Journal of Clinical and Translational Science Vol. 5, No. s1 ( 2021-03), p. 122-122
    Details
    In: Journal of Clinical and Translational Science, Cambridge University Press (CUP), Vol. 5, No. s1 ( 2021-03), p. 122-122
    Abstract: ABSTRACT IMPACT: Olfactory dysfunction is a defining symptom of COVID-19 infection. As the number of total, confirmed COVID-19 cases approaches 7 million in the United States, it is estimated that there will be up to 500,000 new cases of chronically diminished smell. We offer a promising treatment. OBJECTIVES/GOALS: The primary aim is to explore the main effects and interaction of bimodal visual-olfactory training and patient-preferred scents on olfactory training in patients with post-COVID-19 hyposmia or anosmia. METHODS/STUDY POPULATION: The study will utilize a 2x2 factorial design. The two effects we will explore are unimodal versus bimodal training and conventional versus patient-preferred odors. All 4 arms will undergo 12 weeks of olfactory training. Participants will be assessed pre and post-intervention. Measurements of olfactory function include the objective smell identification test and subjective measures including the Clinical Global Impression Scale and Olfactory Dysfunction Outcomes Rating. Individuals eligible for the study include men and women between 18 and 70 years of age with olfactory dysfunction of at least 3 months duration initially diagnosed within 2 weeks of a COVID-19 infection. Of note, we will enroll nationally. RESULTS/ANTICIPATED RESULTS: We anticipate that the bimodal, patient-preferred scents training group will have the greatest improvement in smell scores, number of responders, and patient-reported sense of smell and health-related quality of life due to an additive interaction between the bimodal visual-olfactory and patient-preferred interventions. DISCUSSION/SIGNIFICANCE OF FINDINGS: The pathophysiology of COVID-19 olfactory dysfunction is mediated through damage to the peripheral and central olfactory pathways. This suggests that interventions most likely to be efficacious target both pathways, as olfactory training does.
    Type of Medium: Online Resource
    ISSN: 2059-8661
    URL: Article
    DOI: 10.1017/cts.2021.711
    Language: English
    Publisher: Cambridge University Press (CUP)
    Publication Date: 2021
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  • 3
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    26 Mandibular Advancement vs Home Treatment for Primary Snoring: A Randomized Trial
    Cambridge University Press (CUP) ; 2023
    In:  Journal of Clinical and Translational Science Vol. 7, No. s1 ( 2023-04), p. 7-7
    Details
    In: Journal of Clinical and Translational Science, Cambridge University Press (CUP), Vol. 7, No. s1 ( 2023-04), p. 7-7
    Abstract: OBJECTIVES/GOALS: The primary aim is to evaluate the efficacy of a Mandibular Advancement Device (MAD) vs conservative treatment for adults with non-apneic snoring, as measured by the sleeping partner. The secondary aim is to evaluate the effectiveness of treatment of snoring on the sleeping partner’s sleep quality. METHODS/STUDY POPULATION: We plan to enroll 60 pairs of primary snorers and their sleeping partners in our randomized clinical trial. Snorers will be randomized to either 4 weeks of conservative therapy, consisting of nightly Mometasone nasal rinse, breathe-rite strips, mouth taping, and lateral positional therapy, or 4 weeks of Mandibular Advancement Device therapy (MAD). 30 pairs of snorers and their partners will be in each arm. At follow up the primary outcome measure, the Clinical Global Impression of Improvement Scale (CGI-I), will be assessed by the sleeping partner to evaluate the response to snoring treatment. RESULTS/ANTICIPATED RESULTS: To date, there is no study reporting the rate of response in participants using MAD in Primary Snoring. Due to lack of preliminary data and effect size, we hypothesize that the rate of the responders in the MAD group will be 20% higher than the rate of responders in the active control group based on literature studies and preliminary results. A responder will be classified as someone whose sleeping partner rates on the CGI-I scale that the snoring was much improved or very much improved. MAD has been shown previously to be an effective therapy at treating sleep apnea and reducing snoring, and we anticipate it will continue to be so for patients who do not have sleep apnea. DISCUSSION/SIGNIFICANCE: Snoring is a nearly ubiquitous problem that prevents restful sleep for spouses of snorers, which is known to have detrimental health effects. Yet it does not have scientifically proven treatments. Our study will evaluate these treatments in an effort to improve the health of the sleeping partners.
    Type of Medium: Online Resource
    ISSN: 2059-8661
    URL: Article
    DOI: 10.1017/cts.2023.123
    Language: English
    Publisher: Cambridge University Press (CUP)
    Publication Date: 2023
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  • 4
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    67702 At-Home Screening Tool for Anosmia
    Cambridge University Press (CUP) ; 2021
    In:  Journal of Clinical and Translational Science Vol. 5, No. s1 ( 2021-03), p. 142-143
    Details
    In: Journal of Clinical and Translational Science, Cambridge University Press (CUP), Vol. 5, No. s1 ( 2021-03), p. 142-143
    Abstract: ABSTRACT IMPACT: By developing and validating a simple and cost-effective at-home screening tool for loss of smell, we can efficiently detect infection with COVID-19, neuropsychiatric disease such as Alzheimer’s, and post-operative smell loss. OBJECTIVES/GOALS: To develop and validate a feasible and cost-effective screening tool for olfactory dysfunction (OD) using common household items. METHODS/STUDY POPULATION: The study has two phases. In the Development phase, 120 participants with self-reported smell changes will complete a survey with a list of 45 household items to smell. Item reduction to develop the NASAL Short Smell Test will occur by measuring content validity, factor analysis, and internal consistency. In the Validation phase, 200 participants with self-reported smell changes will take the NASAL Short Smell Test at baseline and again at three weeks. In both phases, the validated University of Pennsylvania Smell Identification Test (UPSIT) will be used as the gold standard. Measures of performance as well as test-retest reliability and sensitivity to change will be measured. RESULTS/ANTICIPATED RESULTS: We anticipate that the majority of participants will have at least half of the items in their household and will report ability to smell for each. Measures of sensitivity, specificity, likelihood ratios, and UPSIT score correlations will allow us to evaluate performance of each item. Item reduction will allow us to create the NASAL Short Smell Test, in which a handful of common items will be used to create a screening tool for smell loss. The Validation phase will allow us to measure discriminative performance of this tool as well as test-retest reliability and sensitivity to change, which we expect to be at least comparable to the validated UPSIT. DISCUSSION/SIGNIFICANCE OF FINDINGS: Current tools for diagnosis of OD are costly, time-consuming, and often require a clinician to evaluate. The validation of the simple at-home NASAL Short Smell Test to screen for OD will allow us to detect infection with COVID-19, neuropsychiatric disease, or post-operative smell loss quickly and efficiently.
    Type of Medium: Online Resource
    ISSN: 2059-8661
    URL: Article
    DOI: 10.1017/cts.2021.764
    Language: English
    Publisher: Cambridge University Press (CUP)
    Publication Date: 2021
    detail.hit.zdb_id: 2898186-8
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  • 5
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    2192 The association of preoperative functional capacity and outcomes for head and neck cancer patients undergoing definitive surgical treatment
    Cambridge University Press (CUP) ; 2018
    In:  Journal of Clinical and Translational Science Vol. 2, No. S1 ( 2018-06), p. 88-88
    Details
    In: Journal of Clinical and Translational Science, Cambridge University Press (CUP), Vol. 2, No. S1 ( 2018-06), p. 88-88
    Abstract: OBJECTIVES/SPECIFIC AIMS: To study the role functional capacity plays in surgical outcomes for head and neck cancers. METHODS/STUDY POPULATION: In this single-institution cohort study, we combined preoperative anesthesia assessment information with oncology registry data for newly-diagnosed patients with squamous cell carcinoma of the oral cavity, pharynx, and larynx (HNSCC) treated with definitive surgery at Siteman Cancer Center from 2012 to 2016. Patient-reported exercise capacity was assessed as metabolic equivalents. Metabolic equivalents 〈 4 was defined as poor functional capacity. The primary outcome measure was overall survival (OS). Kaplan-Meir survival analysis was used to compare the survival of patients with poor functional capacity (PFC) and patients with normal functional capacity (NFC). Cox proportional hazard regression was used to explore the independent prognostic role of functional capacity on overall survival after controlling for other factors. RESULTS/ANTICIPATED RESULTS: A total of 671 patients underwent surgical treatment for HNSCC. The average age was 62 years (range: 19–94 years). Majority of the patients were male (n=481; 72%), White race (n=589; 88%), and smokers (n=528; 79%). Of 671 patients, 22% (n=146) had PFC. Two-year OS rate in PFC patients was 70% compared with 85% in NFC patients (15% difference; 95% CI: 7%–23%). Unadjusted Cox proportional hazard analysis showed that PFC patients had 2.2 times higher risk of death (95% CI: 1.5–3.2) than NFC patients. After adjustment for age at surgery, BMI, preoperative weight loss, comorbidity score, tumor site, and TNM stage the magnitude of the association between functional capacity and OS decreased (aHR=1.3; 95% CI: 0.88–1.98). DISCUSSION/SIGNIFICANCE OF IMPACT: Poor functional capacity is associated with decreased overall survival, but the magnitude of the association, while clinically meaningful, decreases after controlling for other important patient and tumor factors. Nevertheless, we believe preoperative functional capacity status is an important patient factor to consider when discussing prognosis and attempting risk stratification. We also believe that functional capacity may be associated with 30-day unplanned readmissions and 90-day complications and are currently performing chart review to ascertain this information.
    Type of Medium: Online Resource
    ISSN: 2059-8661
    URL: Article
    DOI: 10.1017/cts.2018.306
    Language: English
    Publisher: Cambridge University Press (CUP)
    Publication Date: 2018
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  • 6
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    4347 Bimodal Visual-Olfactory Training for Post-Surgical or Post-Traumatic Olfactory Dysfunction (VOLT Trial)
    Cambridge University Press (CUP) ; 2020
    In:  Journal of Clinical and Translational Science Vol. 4, No. s1 ( 2020-06), p. 23-24
    Details
    In: Journal of Clinical and Translational Science, Cambridge University Press (CUP), Vol. 4, No. s1 ( 2020-06), p. 23-24
    Abstract: OBJECTIVES/GOALS: 1) Assess the patient-reported, perceived change in olfactory function after bimodal visual-olfactory training (OT) 2) Assess change in olfactory function after bimodal visual-olfactory training with a smell identification test 3) Assess which scents are most important to people with olfactory dysfunction (OD) METHODS/STUDY POPULATION: The participants are adults with subjective or clinically diagnosed OD with post-surgical or traumatic etiologies within the last 5 years. At the first of two study visits, participants complete the University of Pennsylvania Smell Identification Test (UPSIT) and complete general health (SF-36) and olfactory-related quality-of-life questionnaires. From a list of 34 scents, participants chose the 4 scents most important to them and smelled the scents twice daily for 3 months. Olfactory testing and the quality-of-life questionnaires were repeated at the final visit. RESULTS/ANTICIPATED RESULTS: 10 participants have enrolled in the study. There was one screen fail and one withdrawal. Six participants are currently undergoing OT and two have completed the study. Seven participants have post-surgical etiology and three have post-traumatic etiology of their OD. Of the two participants who have completed the study, one had an UPSIT score improvement from 25 to 33 out of the 40 questions correct. The minimally clinically important difference on the UPSIT is 4. She reports improvement subjectively. The second participant had a UPSIT score change from 25 to 24 and reports ability to smell is neither better nor worse. DISCUSSION/SIGNIFICANCE OF IMPACT: Traumatic and post-surgical, particularly post-transphenoidal hypophysectomy, are common etiologies of OD and no effective treatments exist. The results from our pilot study will help better inform the best way to undergo OT, how effective it is, and the planning of future studies.
    Type of Medium: Online Resource
    ISSN: 2059-8661
    URL: Article
    DOI: 10.1017/cts.2020.110
    Language: English
    Publisher: Cambridge University Press (CUP)
    Publication Date: 2020
    detail.hit.zdb_id: 2898186-8
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