A prospective, observational clinical trial on the impact of COVID-19-related national lockdown on thyroid hormone in young males

AbstractTrying to manage the dramatic coronavirus disease 2019 (COVID-19) infection spread, many countries imposed national lockdown, radically changing the routinely life of humans worldwide. We hypothesized that both the pandemic per se and the consequent socio-psychological sequelae could constitute stressors for Italian population, potentially affecting the endocrine system. This study was designed to describe the effect of lockdown-related stress on the hypothalamic-pituitary-thyroid (HPT) axis in a cohort of young men. A prospective, observational clinical trial was carried out, including patients attending the male infertility outpatient clinic before and after the national lockdown for COVID-19 pandemic. The study provided a baseline visit performed before and a follow-up visit after the lockdown in 2020. During the follow-up visit, hormonal measurements, lifestyle habits and work management were recorded. Thirty-one male subjects were enrolled (mean age: 31.6 ± 6.0 years). TSH significantly decreased after lockdown (p = 0.015), whereas no significant changes were observed in the testosterone, luteinising hormone, follicle-stimulating hormone, estradiol and prolactin serum levels. No patient showed TSH serum levels above or below reference ranges, neither before nor after lockdown. Interestingly, TSH variation after lockdown was dependent on the working habit change during lockdown (p = 0.042). We described for the first time a TSH reduction after a stressful event in a prospective way, evaluating the HPT axis in the same population, before and after the national lockdown. This result reinforces the possible interconnection between psychological consequences of a stressful event and the endocrine regulation.

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Interleukin-31 Serum And Pruritus Dimension After Acupuncture Treatment In Hemodialysis Patients: A Randomized Clinical Trial

Open Access Macedonian Journal of Medical Sciences ◽

10.3889/oamjms.2021.5599 ◽

2021 ◽

Vol 9 (B) ◽

pp. 196-201

Author(s):

Dedi Ardinata ◽

Rozaimah Zain-Hamid ◽

Irma. D. Roesyanto-Mahadi ◽

Hasan Mihardja

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Intervention Group ◽

Serum Levels ◽

Hemodialysis Patients ◽

Control Group ◽

Placebo Control ◽

Limited Information ◽

Before And After ◽

The Impact

BACKGROUND: Interleukin (IL)-31 serum levels were significantly higher in hemodialysis patients with pruritus, whereas acupuncture in LI11 was shown to improve symptoms of pruritus. However, there is limited information that IL-31 serum levels that correlate with decreased dimensions of the pruritus after acupuncture in LI11 in a hemodialysis patient. AIM: The aim of the study was to demonstrate the impact of acupuncture in LI11 and IL-31 serum level and its correlation with dimensions of the pruritus in hemodialysis patients. METHODS: A randomized clinical trial has been carried out from August 2019 to December 2019 at H. Adam Malik General Hospital, Medan, Indonesia. Sixty patients underwent hemodialysis who were randomly allocated to two groups, one group got acupuncture in Quchi LI11 (intervention group), and the other group got a placebo (control group). IL-31 serum levels and pruritus were measured before and after 6 weeks of acupuncture in both groups. RESULTS: Acupuncture did not significantly reduce IL-31 (p = 0.931) and decreased dimensions: Degree, duration, disability, and distribution of the pruritus between the intervention group and the control group after 6 weeks of acupuncture in LI11. It can be shown that there is no significant correlation between IL-31 serum levels and dimensions of the pruritus. CONCLUSION: This study demonstrates the effect of acupuncture on reducing dimensions of the pruritus not related to IL-31 serum levels. Identifying the action mechanism of acupuncture to minimize pruritus considerably enhances knowledge of the impacts of acupuncture on reducing pruritus in hemodialysis patients.

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FRI0612-HPR EFFECT OF THERMOFORMABLE ORTHOSES ON FOOT FUNCTION IN RHEUMATOID ARTHRITIS PATIENTS: PRELIMINARY RESULTS FROM AN OPEN CLINICAL TRIAL.

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.6308 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 911.2-912

Author(s):

I. Aachari ◽

H. Rkain ◽

F. Safaa ◽

L. Benzakour ◽

T. Latifa ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Clinical Trial ◽

Small Sample ◽

Activity Limitation ◽

Foot Orthoses ◽

Functional Impact ◽

Pain Disability ◽

Before And After ◽

Foot Function ◽

The Impact

Background:Orthoses and footwear can play an important role in managing foot pathology in patients whose systemic disease is controlled. Foot orthoses are frequently prescribed in clinical practice as an intervention for people with rheumatoid arthritis (RA).Objectives:The aim of our study is to evaluate the impact of thermoformable orthoses on the functional index of the foot (FFI) in patients with rheumatoid arthritis.Methods:We conducted an open clinical trial, having consecutively included 14 patients (85.7% female, average age 54.8 ± 10 years) suffering from rheumatoid arthritis (median progression time of 9 years [5 - 12]). The average DAS28 was 2.7 ± 1.2 and the functional impact objectified by the Health Assessment Questionnaire (HAQ) was on average 0.9 ± 0.7.The median deadline from the start of RA and the onset of the foot problem was 3 years [0 – 7,75]. The foot problem was bilateral in 100% of the cases and inaugural in 85.7% of the cases.We evaluated the functional impact of foot injury for all our patients at baseline and 8 weeks after the use of thermoformable orthoses, based on the FFI (Foot function Index) measuring the impact of foot pathology on function in terms of pain, disability and activity limitation.The comparison of the FFI domains before and after the use of orthoses was carried out using parametric or nonparametric paired tests using The SPSS statistical software.Results:With the use of foot orthoses, FFI values decreased in all subscales (p=0,024) (pain, disability and activity limitation). This reduction was significant for disability (0,011) but not for pain and activity limitation.There were no significant correlations between the global FFI and the progression of RA, the duration of foot damage and the functional impact measured by the HAQ.Table 1. The comparison of the FFI domains before and after the use of orthoses.psignificatif if< 0,05; Test used: Non-parametric test for two linked samples.Conclusion:Foot orthoses were effective as an adjuvant in the management of rheumatoid foot. They significantly reduced disability as measured by the FFI. The absence of factors associated with pain and limitation of activity could possibly be related to the small sample size.Disclosure of Interests:None declared

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Aortic endograft and bridging stent-graft remodeling after branched endovascular aortic repair

Vascular ◽

10.1177/1708538120983698 ◽

2020 ◽

pp. 170853812098369

Author(s):

Stefano Fazzini ◽

Giovanni Torsello ◽

Martin Austermann ◽

Efthymios Beropoulis ◽

Roberta Munaò ◽

...

Keyword(s):

Stent Graft ◽

Endovascular Repair ◽

Main Body ◽

Thoracoabdominal Aneurysm ◽

Before And After ◽

Long Term Follow Up ◽

Instability Rate ◽

One Year ◽

The Impact

Objectives The results of branched endovascular repair of thoracoabdominal aneurysms are mainly dependent on durability of the graft used. The purpose of this study was to evaluate postoperative aortic main body and bridging stent-graft remodeling, and their impact on bridging stent-graft instability at one year. Methods Computed tomoangiographies of 43 patients (43 aortic main body mated with 171 bridging stent-grafts) were analyzed before and after branched endovascular repair as well as after a follow-up of 12 months. Primary endpoint was aortic main body remodeling (migration >5 mm, shortening >5 mm, scoliosis >5° or lordosis >5°). Shortening was defined as a reduced length in the long axis, scoliosis as left-right curvature, and lordosis as antero-posterior curvature. Aortic main body remodeling, aneurysm sac changes, and bridging stent-graft tortuosity were evaluated to study their correlations and the impact on the bridging stent-graft instability. Results At 12 months, aortic main body remodeling was observed in 72% of the cases, migration in 39.5% (mean 5.21 mm), shortening in 41.9% (mean 5.79 mm), scoliosis in 58.1%, (mean 10.10°), lordosis in 44.2% (mean 5.78°). Migration, shortening, and scoliosis were more frequent in patients with larger aneurysms ( p = .005), while scoliosis was significantly more frequent in type II thoracoabdominal aneurysm ( p = .019). Aortic main body remodeling was significantly associated to bridging stent-graft remodeling (r: 0.3–0.48). The bridging stent-graft instability rate was 9.3%. Despite a trend toward significance ( p = .07), none of the evaluated aortic main body and bridging stent-graft changes were associated with bridging stent-graft instability at 12 months. Conclusions Aortic main body remodeling is frequent especially in large and extended thoracoabdominal aneurysm aneurysms. Aortic main body and bridging stent-graft remodeling was significantly correlated. While these geometric changes had no significant impact on bridging stent-graft instability at one year, a close long-term follow-up after branched endovascular repair could predict bridging stent-graft failures.

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SP9.1.1 The Impact of Anaesthetic Use on Healing in Sub-cutaneous Abscess Management: A Retrospective Before and After Cohort Study

British Journal of Surgery ◽

10.1093/bjs/znab361.165 ◽

2021 ◽

Vol 108 (Supplement_7) ◽

Author(s):

Hannah Elkadi ◽

Eleanor Dodd ◽

Theodore Poulton ◽

William Bolton ◽

Joshua Burke ◽

...

Keyword(s):

Wound Healing ◽

Local Anaesthetic ◽

Surrogate Endpoints ◽

Incision And Drainage ◽

Number Of Patients ◽

Significant Difference ◽

Patient Reported ◽

Before And After ◽

The Impact

Abstract Aims Despite being the most common surgical procedure, there is wide variation that exists in the management of simple subcutaneous abscesses with no national guideline describing best practice. During the COVID-19 Pandemic national guidelines promoted the use of regional or local anaesthetic (LA) instead of general anaesthesia (GA) to avoid aerosol generating intubation associated with GA. This study aimed to assess the impact of anaesthetic choice in outcomes following incision and drainage of subcutaneous abscesses. Methods Two cohorts of patients undergoing abscess incision and drainage at St. James’ University Hospital Leeds were retrospectively identified over a 14-week period before and after the introduction of the new COVID-19 anaesthetic guidelines. Wound healing surrogate endpoints were used: i) total number of follow up appointments and ii) attendance to healthcare services after 30 days from I&D. Result 133 patients were included. Significantly more procedures were performed under LA after the intervention (84.1% vs 5.7%; p < 0.0001) with a significant reduction in wound packing (68.3% vs 87.1%. p=0.00473). Follow up data found no significant difference in the average number of follow-up appointments (7.46 vs 5.11; p = 0.0731) and the number of patients who required ongoing treatment after 30 days (n = 14 vs n = 14, p = 0.921). Conclusion Drainage of simple subcutaneous abscess under 5 cm is safe under local anaesthetic with no significant difference in surrogate endpoints of wound healing observed in this patient cohort. Recurrent packing may not be required. Future work should explore patient reported measures such as pain management and the health economics of this intervention.

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Impact of an Online Sleep and Circadian Education Program on University Students’ Sleep Knowledge, Attitudes, and Behaviours

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph181910180 ◽

2021 ◽

Vol 18 (19) ◽

pp. 10180

Author(s):

Caitlin R. Semsarian ◽

Gabrielle Rigney ◽

Peter A. Cistulli ◽

Yu Sun Bin

Keyword(s):

University Students ◽

Undergraduate Students ◽

Stages Of Change ◽

Behavioural Change ◽

Poor Sleep ◽

Course Grades ◽

Before And After ◽

Students Attitudes ◽

The Impact

University students consistently report poor sleep. We conducted a before-and-after study to evaluate the impact of an online 10-week course on undergraduate students’ sleep knowledge, attitudes, and behaviours at 6-month follow-up. Data were collected via baseline course surveys (August–September 2020) and follow-up surveys distributed via email (February–March 2021). n = 212 students completed baseline surveys and n = 75 (35%) completed follow-up. Students retained to follow-up possessed higher baseline sleep knowledge and received higher course grades. At the 6-month follow-up, sleep knowledge had increased (mean score out of 5: 3.0 vs. 4.2, p < 0.001). At baseline, 85% of students aimed to increase their sleep knowledge and 83% aimed to improve their sleep. At follow-up, 91% reported being more knowledgeable and 37% reported improved sleep. A novel Stages of Change item revealed that 53% of students’ attitudes towards their sleep behaviours had changed from baseline. There was a reduction in sleep latency at follow-up (mean 33.3 vs. 25.6 min, p = 0.015), but no change in the total Pittsburgh Sleep Quality Index score. In summary, completion of an online course led to increased sleep and circadian knowledge and changed sleep attitudes, with no meaningful change in sleep behaviours. Future interventions should consider components of behavioural change that go beyond the knowledge–attitudes–behaviour continuum.

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Evaluation of a national lung cancer symptom awareness campaign in Wales

British Journal of Cancer ◽

10.1038/s41416-019-0676-2 ◽

2019 ◽

Vol 122 (4) ◽

pp. 491-497 ◽

Cited By ~ 2

Author(s):

Grace McCutchan ◽

Stephanie Smits ◽

Lucy Ironmonger ◽

Ciarán Slyne ◽

Amanda Boughey ◽

...

Keyword(s):

Lung Cancer ◽

Early Stage ◽

Routine Data ◽

X Rays ◽

Before And After ◽

Symptom Awareness ◽

Gp Visits ◽

Symptom Recall ◽

The Impact

Abstract Background Lung cancer is the leading cause of cancer mortality in Wales. We conducted a before- and after- study to evaluate the impact of a four-week mass-media campaign on awareness, presentation behaviour and lung cancer outcomes. Methods Population-representative samples were surveyed for cough symptom recall/recognition and worry about wasting doctors’ time pre-campaign (June 2016; n = 1001) and post-campaign (September 2016; n = 1013). GP cough symptom visits, urgent suspected cancer (USC) referrals, GP-ordered radiology, new lung cancer diagnoses and stage at diagnosis were compared using routine data during the campaign (July–August 2016) and corresponding control (July–August 2015) periods. Results Increased cough symptom recall (p < 0.001), recognition (p < 0.001) and decreased worry (p < 0.001) were observed. GP visits for cough increased by 29% in the target 50+ age-group during the campaign (p < 0.001) and GP-ordered chest X-rays increased by 23% (p < 0.001). There was no statistically significant change in USC referrals (p = 0.82), new (p = 0.70) or early stage (p = 0.27) diagnoses, or in routes to diagnosis. Conclusions Symptom awareness, presentation and GP-ordered chest X-rays increased during the campaign but did not translate into increased USC referrals or clinical outcomes changes. Short campaign duration and follow-up, and the small number of new lung cancer cases observed may have hampered detection effects.

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The impact of changes in serum levels of metalloproteinase-2 and metalloproteinase-9 on pain perception in patients with disc herniation before and after surgery

Journal of Pain Research ◽

10.2147/jpr.s201199 ◽

2019 ◽

Vol Volume 12 ◽

pp. 1457-1464

Author(s):

Piotr Kamieniak ◽

Joanna Bielewicz ◽

Jacek Kurzepa ◽

Beata Daniluk ◽

Joanna Kocot ◽

...

Keyword(s):

Disc Herniation ◽

Pain Perception ◽

Serum Levels ◽

Before And After ◽

The Impact ◽

Metalloproteinase 9

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Skeletal related events (SREs) in metastatic androgen independent prostate cancer (AIPC) treated with docetaxel-based chemotherapy: Results from ASCENT

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.4614 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 4614-4614 ◽

Cited By ~ 1

Author(s):

J. S. Chan ◽

C. W. Ryan ◽

P. M. Venner ◽

D. P. Petrylak ◽

G. S. Chatta ◽

...

Keyword(s):

Prostate Cancer ◽

Clinical Trial ◽

Cord Compression ◽

Entire Group ◽

Large Prospective Study ◽

Free Survival ◽

Skeletal Related Events ◽

The Impact ◽

Androgen Independent

4614 Background: Docetaxel prolongs survival in AIPC patients and zoledronic acid (ZA) reduces the incidence of SREs. The SRE incidence of patients treated with docetaxel-based chemotherapy has not previously been reported. Methods: ASCENT was a randomized clinical trial that compared weekly DN-101 (calcitriol, 45 μg p.o. on day 1) plus docetaxel (36 mg/m2 iv on day 2 for 3 weeks of a 4-week cycle) to placebo plus docetaxel in patients with chemotherapy-naïve metastatic AIPC. ZA use was not restricted. SRE-free survival was described for the entire group and then compared for patients randomly assigned to DN-101 or placebo and stratified by ZA use. Statistical comparisons were conducted using Cochran-Mantel-Haenszel for incidence and log-rank for SRE-free survival. Results: With a median follow-up of 18.3 months, 33% of subjects experienced at least one SRE and the overall median SRE-free survival was 13 (95% CI 10.5–14.3) months. The incidence of SRE by type was: radiation to bone (18.8%), fracture (10%), spinal cord compression (4%), surgery to bone (0.4%). Eighty-five (34%) patients received ZA. The study was not adequately powered to measure the impact of DN-101 or ZA on SRE endpoints. Exploratory analyses showed a trend for an increase in SRE-free survival (HR 0.78, p = 0.13) of DN-101-treated patients. SRE-free survival and incidence for subgroups were examined ( Table ). Conclusions: This is the first report of SRE incidence in a large, prospective study of docetaxel-based therapy. Improved therapies for reducing SREs in AIPC are needed because the risk of SREs remains high despite the use of modern chemotherapy and ZA. [Table: see text] [Table: see text]

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Evaluating the impact of a trial in breast cancer tumor markers: A value of research analysis.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e16524 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e16524-e16524

Author(s):

Rahber Thariani ◽

David K Blough ◽

William Barlow ◽

Norah Lynn Henry ◽

Julie Gralow ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Clinical Trial ◽

Tumor Marker ◽

Tumor Markers ◽

Societal Value ◽

Cancer Tumor ◽

The Impact

e16524 Background: Despite not being recommended by clinical guidelines, the tumor markers carcinoembryonic antigen (CEA), cancer antigen (CA)15-3, and CA 27.29 are used by some clinicians to screen for increased risk of breast cancer recurrence. Although additional research may be warranted to evaluate the benefits and risks of breast cancer tumor marker tests, clinical trials would likely need to involve thousands of women and would take many years to complete. We conducted an analysis to assess the societal value of a prospective randomized clinical trial (RCT) for breast tumor marker testing in routine follow-up of high-risk, stage II-III breast cancer survivors Methods: We used value of information techniques to assess the benefits of reducing uncertainty of using breast cancer tumor markers. We developed a decision-analytic model of biomarker testing in addition to standard surveillance at follow-up appointments every 3-6 months for five years. Expected value of sample information (EVSI) was assessed over a range of trial sizes and assumptions. Results: The overall value of research for an RCT involving 9,000 women was $166 million (EVSI). The value of improved information characterizing the survival impact of tumor markers was $81 million, quality-of-life $38 million, and test performance $95 million. Conclusions: Our analysis indicates that substantial societal value may be gained by conducting a clinical trial evaluating the use of breast cancer tumor markers. The most important aspects of the trial in our analysis were information gained on survival improvements as well as quality-of-life parameters associated with testing and test sensitivity and specificity. Our analysis indicates that smaller randomized trials, as well as adding quality of life instruments to existing trials, retrospective, and observational trials can also generate valuable and relevant information.

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Impact of parenteral opioid shortage on opioid prescriptions among patients seen by the palliative care team of a comprehensive cancer center.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.34_suppl.201 ◽

2018 ◽

Vol 36 (34_suppl) ◽

pp. 201-201

Author(s):

Ali Haider ◽

Yu Qian ◽

Zhanni Lu ◽

Syed Mussadiq Ali Akbar Naqvi ◽

Amy Zhuang ◽

...

Keyword(s):

Palliative Care ◽

Pain Management ◽

Cancer Pain ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Cancer Type ◽

Cancer Pain Management ◽

Before And After ◽

The Impact

201 Background: Recent parenteral opioid shortage (POS) has the potential to impact cancer pain management in hospitalized patients. This study aims to compare changes in the opioid prescriptions by the inpatient palliative care (PC) team before and after the institution first reported the POS. Methods: We reviewed and compared the electronic health records of 386 consecutive eligible consultations seen by the inpatient PC team equally in one month before and after the announcement of POS on February 8, 2018. The eligibility criteria include (1) cancer diagnosis, (2) ≥18 years of age, (3) taking opioid medication at the time of consultation, and (4) having at least two consecutive visits with the PC team. Patient demographics, cancer type, opioid type, route, and dose defined as the morphine equivalent daily dose were assessed. Results: POS was associated with less use of parenteral opioids (patient controlled analgesia, and intravenous breakthrough) and more use of non-parenteral opioids (extended release, transdermal, and oral breakthrough) by the referring oncology teams, and PC team (P≤.001) (Table 1). At first PC follow-up, significantly less proportion of patients achieved better pain control after POS [119/193 (62%) versus 144/193 (75%) (P=.006)] However, at second PC follow-up, the proportion of pain improvement was similar in both cohorts. Conclusions: There is a significant change in opioid routes associated with POS. POS was associated with worse analgesia. More research is needed to better understand the impact of POS on cancer pain management.[Table: see text]

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