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  1. Article ; Online: Extended follow-up of a short total diet replacement programme: results of the Doctor Referral of Overweight People to Low Energy total diet replacement Treatment (DROPLET) randomised controlled trial at 3 years.

    Astbury, Nerys M / Edwards, Rhiannon M / Ghebretinsea, Fitsum / Shanyinde, Milensu / Mollison, Jill / Aveyard, Paul / Jebb, Susan A

    International journal of obesity (2005)

    2021  Volume 45, Issue 11, Page(s) 2432–2438

    Abstract: Objectives: To test the long-term effectiveness of a total diet replacement programme (TDR) for routine treatment of obesity in a primary care setting.: Methods: This study was a pragmatic, two-arm, parallel-group, open-label, individually randomised ...

    Abstract Objectives: To test the long-term effectiveness of a total diet replacement programme (TDR) for routine treatment of obesity in a primary care setting.
    Methods: This study was a pragmatic, two-arm, parallel-group, open-label, individually randomised controlled trial in adults with obesity. The outcomes were change in weight and biomarkers of diabetes and cardiovascular disease risk from baseline to 3 years, analysed as intention-to-treat with mixed effects models.
    Interventions: The intervention was TDR for 8 weeks, followed by food-reintroduction over 4 weeks. Behavioural support was provided weekly for 8 weeks, bi-weekly for the next 4 weeks, then monthly for 3 months after which no further support was provided. The usual care (UC) group received dietary advice and behavioural support from a practice nurse for up to 3 months.
    Results: Outcome measures were collected from 179 (66%) participants. Compared with baseline, at 3 years the TDR group lost -6.2 kg (SD 9.1) and usual care -2.7 kg (SD 7.7); adjusted mean difference -3.3 kg (95% CI: -5.2, -1.5), p < 0.0001. Regain from programme end (6 months) to 3 years was greater in TDR group +8.9 kg (SD 9.4) than UC + 1.2, (SD 9.1); adjusted mean difference +6.9 kg (95% CI 4.2, 9.5) P < 0.001. At 3 years TDR led to greater reductions than UC in diastolic blood pressure (mean difference -3.3 mmHg (95% CI:-6.2; -0.4) P = 0.024), and systolic blood pressure (mean differences -3.7 mmHg (95% CI: -7.4; 0.1) P = 0.057). There was no evidence of differences between groups in the change from baseline to 3 years HbA
    Conclusions: Treatment of people with obesity with a TDR programme compared with support from a practice nurse leads to greater weight loss which persists to at least 3 years, but there was only evidence of sustained improvements in BP and not in other aspects of cardiometabolic risk.
    MeSH term(s) Adult ; Aftercare/methods ; Aftercare/statistics & numerical data ; Diet Therapy/methods ; Diet Therapy/standards ; Diet Therapy/statistics & numerical data ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Overweight/diet therapy ; Overweight/epidemiology ; Referral and Consultation/standards ; Referral and Consultation/statistics & numerical data ; United Kingdom/epidemiology ; Weight Reduction Programs/methods ; Weight Reduction Programs/standards ; Weight Reduction Programs/statistics & numerical data
    Language English
    Publishing date 2021-07-23
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 752409-2
    ISSN 1476-5497 ; 0307-0565
    ISSN (online) 1476-5497
    ISSN 0307-0565
    DOI 10.1038/s41366-021-00915-1
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Clinical diagnosis of SARS-CoV-2 infection: An observational study of respiratory tract infection in primary care in the early phase of the pandemic.

    van der Velden, Alike W / Shanyinde, Milensu / Bongard, Emily / Böhmer, Femke / Chlabicz, Slawomir / Colliers, Annelies / García-Sangenís, Ana / Malania, Lile / Pauer, Jozsef / Tomacinschii, Angela / Yu, Ly-Mee / Loens, Katherine / Ieven, Margareta / Verheij, Theo J / Goossens, Herman / Vellinga, Akke / Butler, Christopher C

    The European journal of general practice

    2023  Volume 29, Issue 1, Page(s) 2270707

    Abstract: Background: Early in the COVID-19 pandemic, GPs had to distinguish SARS-CoV-2 from other aetiologies in patients presenting with respiratory tract infection (RTI) symptoms on clinical grounds and adapt management accordingly.: Objectives: To test the ...

    Abstract Background: Early in the COVID-19 pandemic, GPs had to distinguish SARS-CoV-2 from other aetiologies in patients presenting with respiratory tract infection (RTI) symptoms on clinical grounds and adapt management accordingly.
    Objectives: To test the diagnostic accuracy of GPs' clinical diagnosis of a SARS-CoV-2 infection in a period when COVID-19 was a new disease. To describe GPs' management of patients presenting with RTI for whom no confirmed diagnosis was available. To investigate associations between patient and clinical features with a SARS-CoV-2 infection.
    Methods: In April 2020-March 2021, 876 patients (9 countries) were recruited when they contacted their GP with symptoms of an RTI of unknown aetiology. A swab was taken at baseline for later analysis. Aetiology (PCR), diagnostic accuracy of GPs' clinical SARS-CoV-2 diagnosis, and patient management were explored. Factors related to SARS-CoV-2 infection were determined by logistic regression modelling.
    Results: GPs suspected SARS-CoV-2 in 53% of patients whereas 27% of patients tested positive for SARS-CoV-2. True-positive patients (23%) were more intensively managed for follow-up, antiviral prescribing and advice than true-negatives (42%). False negatives (5%) were under-advised, particularly for social distancing and isolation. Older age (OR: 1.02 (1.01-1.03)), male sex (OR: 1.68 (1.16-2.41)), loss of taste/smell (OR: 5.8 (3.7-9)), fever (OR: 1.9 (1.3-2.8)), muscle aches (OR: 2.1 (1.5-3)), and a known risk factor for COVID-19 (travel, health care worker, contact with proven case; OR: 2.7 (1.8-4)) were predictive of SARS-CoV-2 infection. Absence of loss of taste/smell, fever, muscle aches and a known risk factor for COVID-19 correctly excluded SARS-CoV-2 in 92.3% of patients, whereas presence of 3, or 4 of these variables correctly classified SARS-CoV-2 in 57.7% and 87.1%.
    Conclusion: Correct clinical diagnosis of SARS-CoV-2 infection, without POC-testing available, appeared to be complicated.
    MeSH term(s) Humans ; Male ; COVID-19/diagnosis ; SARS-CoV-2 ; Pandemics ; COVID-19 Testing ; Ageusia ; Primary Health Care ; Pain
    Language English
    Publishing date 2023-10-23
    Publishing country England
    Document type Observational Study ; Journal Article
    ZDB-ID 1281338-2
    ISSN 1751-1402 ; 1381-4788
    ISSN (online) 1751-1402
    ISSN 1381-4788
    DOI 10.1080/13814788.2023.2270707
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Hepatitis delta coinfection in persons with HIV: misdiagnosis and disease burden in Italy.

    Brancaccio, Giuseppina / Shanyinde, Milensu / Puoti, Massimo / Gaeta, Giovanni B / Monforte, Antonella D'Arminio / Vergori, Alessandra / Rusconi, Stefano / Mazzarelli, Antonio / Castagna, Antonella / Antinori, Andrea / Cozzi-Lepri, Alessandro

    Pathogens and global health

    2022  Volume 117, Issue 2, Page(s) 181–189

    Abstract: Hepatitis Delta virus (HDV) causes severe liver disease. Due to similarities in transmission routes, persons living with HIV (PLWH) are at risk of HDV infection. This analysis investigates the prevalence and the long-term clinical outcome of people with ... ...

    Abstract Hepatitis Delta virus (HDV) causes severe liver disease. Due to similarities in transmission routes, persons living with HIV (PLWH) are at risk of HDV infection. This analysis investigates the prevalence and the long-term clinical outcome of people with HDV in a large cohort of PLWH. We retrieved HBsAg ± anti-HDV positive PLWH enrolled from 1997 to 2015 in the multicentre, prospective ICONA study. The primary endpoint was a composite clinical outcome (CCO = having experienced ≥1 of the following: Fib4 score >3.25; diagnosis of cirrhosis; decompensation; hepatocellular carcinoma or liver-related death). Kaplan-Meier curves and unweighted and weighted Cox regression models were used for data analysis. Less than half of HBsAg positive patients had been tested for anti-HDV in clinical practice. After testing stored sera, among 617 HBV/HIV cases, 115 (19%) were anti-HDV positive; 405 (65%) HBV monoinfected; 99 (16%) undeterminate. The prevalence declined over the observation period. HDV patients were more often males, intravenous drug users, HCV coinfected. After a median of 26 months, 55/115 (48%) developed CCO among HDV+; 98/403 (24%) among HBV monoinfected; 18/99 (18%) in HDV unknown (p < 0.001). After controlling for geographical region, alcohol consumption, CD4 count, anti-HCV status and IFN-based therapies, the association with HDV retained statistical significance [HR = 1.67 (1.15, 2.95; p = 0.025)]. HDV infection among PLWH is underdiagnosed, although HDV entails an high risk of liver disease progression. Because effective drugs to treat HDV are now available, it is even more crucial to identify PLWH at an early stage of liver disease.
    MeSH term(s) Male ; Humans ; Hepatitis Delta Virus ; Hepatitis B Surface Antigens ; Prospective Studies ; Coinfection/epidemiology ; Italy ; HIV Infections/complications ; Diagnostic Errors ; Cost of Illness ; Hepatitis B virus ; Prevalence
    Chemical Substances Hepatitis B Surface Antigens
    Language English
    Publishing date 2022-03-07
    Publishing country England
    Document type Journal Article
    ZDB-ID 2625162-0
    ISSN 2047-7732 ; 2047-7724
    ISSN (online) 2047-7732
    ISSN 2047-7724
    DOI 10.1080/20477724.2022.2047551
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Clinical diagnosis of SARS-CoV-2 infection

    Alike W. van der Velden / Milensu Shanyinde / Emily Bongard / Femke Böhmer / Slawomir Chlabicz / Annelies Colliers / Ana García-Sangenís / Lile Malania / Jozsef Pauer / Angela Tomacinschii / Ly-Mee Yu / Katherine Loens / Margareta Ieven / Theo J. Verheij / Herman Goossens / Akke Vellinga / Christopher C. Butler

    European Journal of General Practice, Vol 29, Iss

    An observational study of respiratory tract infection in primary care in the early phase of the pandemic

    2023  Volume 1

    Abstract: AbstractBackground Early in the COVID-19 pandemic, GPs had to distinguish SARS-CoV-2 from other aetiologies in patients presenting with respiratory tract infection (RTI) symptoms on clinical grounds and adapt management accordingly.Objectives To test the ...

    Abstract AbstractBackground Early in the COVID-19 pandemic, GPs had to distinguish SARS-CoV-2 from other aetiologies in patients presenting with respiratory tract infection (RTI) symptoms on clinical grounds and adapt management accordingly.Objectives To test the diagnostic accuracy of GPs’ clinical diagnosis of a SARS-CoV-2 infection in a period when COVID-19 was a new disease. To describe GPs’ management of patients presenting with RTI for whom no confirmed diagnosis was available. To investigate associations between patient and clinical features with a SARS-CoV-2 infection.Methods In April 2020–March 2021, 876 patients (9 countries) were recruited when they contacted their GP with symptoms of an RTI of unknown aetiology. A swab was taken at baseline for later analysis. Aetiology (PCR), diagnostic accuracy of GPs’ clinical SARS-CoV-2 diagnosis, and patient management were explored. Factors related to SARS-CoV-2 infection were determined by logistic regression modelling.Results GPs suspected SARS-CoV-2 in 53% of patients whereas 27% of patients tested positive for SARS-CoV-2. True-positive patients (23%) were more intensively managed for follow-up, antiviral prescribing and advice than true-negatives (42%). False negatives (5%) were under-advised, particularly for social distancing and isolation. Older age (OR: 1.02 (1.01–1.03)), male sex (OR: 1.68 (1.16–2.41)), loss of taste/smell (OR: 5.8 (3.7–9)), fever (OR: 1.9 (1.3–2.8)), muscle aches (OR: 2.1 (1.5–3)), and a known risk factor for COVID-19 (travel, health care worker, contact with proven case; OR: 2.7 (1.8–4)) were predictive of SARS-CoV-2 infection. Absence of loss of taste/smell, fever, muscle aches and a known risk factor for COVID-19 correctly excluded SARS-CoV-2 in 92.3% of patients, whereas presence of 3, or 4 of these variables correctly classified SARS-CoV-2 in 57.7% and 87.1%.Conclusion Correct clinical diagnosis of SARS-CoV-2 infection, without POC-testing available, appeared to be complicated.
    Keywords SARS-CoV-2 ; COVID-19 ; respiratory tract infection ; prediction ; diagnostic accuracy ; Medicine (General) ; R5-920
    Subject code 610 ; 616
    Language English
    Publishing date 2023-12-01T00:00:00Z
    Publisher Taylor & Francis Group
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: A phase 2a randomised, double-blind, placebo-controlled, parallel-group, add-on clinical trial of ebselen (SPI-1005) as a novel treatment for mania or hypomania.

    Sharpley, Ann L / Williams, Clare / Holder, Adele A / Godlewska, Beata R / Singh, Nisha / Shanyinde, Milensu / MacDonald, Orla / Cowen, Philip J

    Psychopharmacology

    2020  Volume 237, Issue 12, Page(s) 3773–3782

    Abstract: Rationale: Lithium is an effective prophylactic and anti-manic treatment in bipolar disorder; however, its use is declining through perceived poor tolerance and toxicity. Lithium inhibits inositol monophosphatase (IMPase), a probable key therapeutic ... ...

    Abstract Rationale: Lithium is an effective prophylactic and anti-manic treatment in bipolar disorder; however, its use is declining through perceived poor tolerance and toxicity. Lithium inhibits inositol monophosphatase (IMPase), a probable key therapeutic mechanism. The anti-inflammatory drug, ebselen, also inhibits IMPase and appears well-tolerated and safe.
    Objectives: To assess the efficacy of adjunctive ebselen in mania using the Young Mania Rating Scale (YMRS) (primary outcome) and the Altman Self-Rating Mania (ASRM) Scale and Clinical Global Impression-Severity Scale (CGI-S) among the secondary outcomes.
    Methods: Randomised, double-blind, placebo-controlled, parallel-group trial conducted between October 2017 and June 2019, at Oxford Health NHS Foundation Trust. Pharmacy-controlled randomisation was computer-generated, with full allocation concealment. In/outpatients (n = 68) aged 18-70, experiencing mania or hypomania, were assigned to 3 weeks ebselen (600 mg bd) (n = 33) or placebo (n = 35). Participants received usual clinical care and psychotropic medication.
    Results: Ebselen was numerically, but not statistically, superior to placebo in lowering scores on the YMRS (adjusted mean difference and 95% confidence interval, - 1.71 (- 5.34 to 1.91), p = 0.35) and ASRM (- 1.36 (- 3.75 to 1.17), p = 0.29). However, scores on the CGI-S were significantly lower at week 3 in ebselen-treated participants (adjusted mean difference, - 0.58 (- 1.14 to - 0.03), p = 0.04). A post hoc analysis excluding patients taking concomitant valproate treatment magnified the difference between ebselen and placebo on the YMRS. Adverse events were comparable between groups, and mild.
    Conclusions: Ebselen merits further investigation where concomitant psychotropic medication is better controlled and participants taking valproate are excluded. If effective, ebselen's superior tolerance and safety could make it a useful alternative to lithium.
    Trial registration: Trial Registry: www.clinicaltrials.gov , Identifier: NCT03013400.
    MeSH term(s) Adult ; Aged ; Antimanic Agents/administration & dosage ; Azoles/administration & dosage ; Bipolar Disorder/diagnosis ; Bipolar Disorder/drug therapy ; Bipolar Disorder/psychology ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Humans ; Isoindoles ; Male ; Mania/diagnosis ; Mania/drug therapy ; Mania/psychology ; Middle Aged ; Neuroprotective Agents/administration & dosage ; Organoselenium Compounds/administration & dosage ; Treatment Outcome ; Valproic Acid/administration & dosage ; Young Adult
    Chemical Substances Antimanic Agents ; Azoles ; Isoindoles ; Neuroprotective Agents ; Organoselenium Compounds ; ebselen (40X2P7DPGH) ; Valproic Acid (614OI1Z5WI)
    Language English
    Publishing date 2020-09-09
    Publishing country Germany
    Document type Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial
    ZDB-ID 130601-7
    ISSN 1432-2072 ; 0033-3158
    ISSN (online) 1432-2072
    ISSN 0033-3158
    DOI 10.1007/s00213-020-05654-1
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Ivermectin for COVID-19 in adults in the community (PRINCIPLE): An open, randomised, controlled, adaptive platform trial of short- and longer-term outcomes.

    Hayward, Gail / Yu, Ly-Mee / Little, Paul / Gbinigie, Oghenekome / Shanyinde, Milensu / Harris, Victoria / Dorward, Jienchi / Saville, Benjamin R / Berry, Nicholas / Evans, Philip H / Thomas, Nicholas P B / Patel, Mahendra G / Richards, Duncan / Hecke, Oliver V / Detry, Michelle A / Saunders, Christina / Fitzgerald, Mark / Robinson, Jared / Latimer-Bell, Charlotte /
    Allen, Julie / Ogburn, Emma / Grabey, Jenna / de Lusignan, Simon / Hobbs, Fd Richard / Butler, Christopher C

    The Journal of infection

    2024  Volume 88, Issue 4, Page(s) 106130

    Abstract: Background: The evidence for whether ivermectin impacts recovery, hospital admissions, and longer-term outcomes in COVID-19 is contested. The WHO recommends its use only in the context of clinical trials.: Methods: In this multicentre, open-label, ... ...

    Abstract Background: The evidence for whether ivermectin impacts recovery, hospital admissions, and longer-term outcomes in COVID-19 is contested. The WHO recommends its use only in the context of clinical trials.
    Methods: In this multicentre, open-label, multi-arm, adaptive platform randomised controlled trial, we included participants aged ≥18 years in the community, with a positive SARS-CoV-2 test, and symptoms lasting ≤14 days. Participants were randomised to usual care, usual care plus ivermectin tablets (target 300-400 μg/kg per dose, once daily for 3 days), or usual care plus other interventions. Co-primary endpoints were time to first self-reported recovery, and COVID-19 related hospitalisation/death within 28 days, analysed using Bayesian models. Recovery at 6 months was the primary, longer term outcome.
    Trial registration: ISRCTN86534580.
    Findings: The primary analysis included 8811 SARS-CoV-2 positive participants (median symptom duration 5 days), randomised to ivermectin (n = 2157), usual care (n = 3256), and other treatments (n = 3398) from June 23, 2021 to July 1, 2022. Time to self-reported recovery was shorter in the ivermectin group compared with usual care (hazard ratio 1·15 [95% Bayesian credible interval, 1·07 to 1·23], median decrease 2.06 days [1·00 to 3·06]), probability of meaningful effect (pre-specified hazard ratio ≥1.2) 0·192). COVID-19-related hospitalisations/deaths (odds ratio 1·02 [0·63 to 1·62]; estimated percentage difference 0% [-1% to 0·6%]), serious adverse events (three and five respectively), and the proportion feeling fully recovered were similar in both groups at 6 months (74·3% and 71·2% respectively (RR = 1·05, [1·02 to 1·08]) and also at 3 and 12 months.
    Interpretation: Ivermectin for COVID-19 is unlikely to provide clinically meaningful improvement in recovery, hospital admissions, or longer-term outcomes. Further trials of ivermectin for SARS-Cov-2 infection in vaccinated community populations appear unwarranted.
    Funding: UKRI/National Institute of Health Research (MC_PC_19079).
    MeSH term(s) Adult ; Humans ; Adolescent ; COVID-19 ; SARS-CoV-2 ; Ivermectin/therapeutic use ; Bayes Theorem ; Treatment Outcome
    Chemical Substances Ivermectin (70288-86-7)
    Language English
    Publishing date 2024-02-29
    Publishing country England
    Document type Randomized Controlled Trial ; Multicenter Study ; Journal Article
    ZDB-ID 424417-5
    ISSN 1532-2742 ; 0163-4453
    ISSN (online) 1532-2742
    ISSN 0163-4453
    DOI 10.1016/j.jinf.2024.106130
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Long-Term Blood Pressure Control After Hypertensive Pregnancy Following Physician-Optimized Self-Management: The POP-HT Randomized Clinical Trial.

    Kitt, Jamie / Fox, Rachael / Frost, Annabelle / Shanyinde, Milensu / Tucker, Katherine / Bateman, Paul A / Suriano, Katie / Kenworthy, Yvonne / McCourt, Annabelle / Woodward, William / Lapidaire, Winok / Lacharie, Miriam / Santos, Mauro / Roman, Cristian / Mackillop, Lucy / Delles, Christian / Thilaganathan, Basky / Chappell, Lucy C / Lewandowski, Adam J /
    McManus, Richard J / Leeson, Paul

    JAMA

    2023  Volume 330, Issue 20, Page(s) 1991–1999

    Abstract: Importance: Pregnancy hypertension results in adverse cardiac remodeling and higher incidence of hypertension and cardiovascular diseases in later life.: Objective: To evaluate whether an intervention designed to achieve better blood pressure control ...

    Abstract Importance: Pregnancy hypertension results in adverse cardiac remodeling and higher incidence of hypertension and cardiovascular diseases in later life.
    Objective: To evaluate whether an intervention designed to achieve better blood pressure control in the postnatal period is associated with lower blood pressure than usual outpatient care during the first 9 months postpartum.
    Design, setting, and participants: Randomized, open-label, blinded, end point trial set in a single hospital in the UK. Eligible participants were aged 18 years or older, following pregnancy complicated by preeclampsia or gestational hypertension, requiring antihypertensive medication postnatally when discharged. The first enrollment occurred on February 21, 2020, and the last follow-up, November 2, 2021. The follow-up period was approximately 9 months.
    Interventions: Participants were randomly assigned 1:1 to self-monitoring along with physician-optimized antihypertensive titration or usual postnatal care.
    Main outcomes and measures: The primary outcome was 24-hour mean diastolic blood pressure at 9 months postpartum, adjusted for baseline postnatal blood pressure.
    Results: Two hundred twenty participants were randomly assigned to either the intervention group (n = 112) or the control group (n = 108). The mean (SD) age of participants was 32.6 (5.0) years, 40% had gestational hypertension, and 60% had preeclampsia. Two hundred participants (91%) were included in the primary analysis. The 24-hour mean (SD) diastolic blood pressure, measured at 249 (16) days postpartum, was 5.8 mm Hg lower in the intervention group (71.2 [5.6] mm Hg) than in the control group (76.6 [5.7] mm Hg). The between-group difference was -5.80 mm Hg (95% CI, -7.40 to -4.20; P < .001). Similarly, the 24-hour mean (SD) systolic blood pressure was 6.5 mm Hg lower in the intervention group (114.0 [7.7] mm Hg) than in the control group (120.3 [9.1] mm Hg). The between-group difference was -6.51 mm Hg (95% CI, -8.80 to -4.22; P < .001).
    Conclusions and relevance: In this single-center trial, self-monitoring and physician-guided titration of antihypertensive medications was associated with lower blood pressure during the first 9 months postpartum than usual postnatal outpatient care in the UK.
    Trial registration: ClinicalTrials.gov Identifier: NCT04273854.
    MeSH term(s) Female ; Humans ; Antihypertensive Agents/administration & dosage ; Antihypertensive Agents/pharmacology ; Antihypertensive Agents/therapeutic use ; Blood Pressure/drug effects ; Cardiovascular Diseases/complications ; Hypertension/drug therapy ; Hypertension/complications ; Hypertension, Pregnancy-Induced/drug therapy ; Pre-Eclampsia/prevention & control ; Self-Management ; Adult ; Postnatal Care/methods
    Chemical Substances Antihypertensive Agents
    Language English
    Publishing date 2023-11-10
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2023.21523
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Colchicine for COVID-19 in the community (PRINCIPLE): a randomised, controlled, adaptive platform trial.

    Dorward, Jienchi / Yu, Ly-Mee / Hayward, Gail / Saville, Benjamin R / Gbinigie, Oghenekome / Van Hecke, Oliver / Ogburn, Emma / Evans, Philip H / Thomas, Nicholas Pb / Patel, Mahendra G / Richards, Duncan / Berry, Nicholas / Detry, Michelle A / Saunders, Christina / Fitzgerald, Mark / Harris, Victoria / Shanyinde, Milensu / de Lusignan, Simon / Andersson, Monique I /
    Butler, Christopher C / Hobbs, Fd Richard

    The British journal of general practice : the journal of the Royal College of General Practitioners

    2022  Volume 72, Issue 720, Page(s) e446–e455

    Abstract: Background: Colchicine has been proposed as a COVID-19 treatment.: Aim: To determine whether colchicine reduces time to recovery and COVID-19-related admissions to hospital and/or deaths among people in the community.: Design and setting: ... ...

    Abstract Background: Colchicine has been proposed as a COVID-19 treatment.
    Aim: To determine whether colchicine reduces time to recovery and COVID-19-related admissions to hospital and/or deaths among people in the community.
    Design and setting: Prospective, multicentre, open-label, multi-arm, randomised, controlled, adaptive platform trial (PRINCIPLE).
    Method: Adults aged ≥65 years or ≥18 years with comorbidities or shortness of breath, and unwell for ≤14 days with suspected COVID-19 in the community, were randomised to usual care, usual care plus colchicine (500 µg daily for 14 days), or usual care plus other interventions. The co-primary endpoints were time to first self-reported recovery and admission to hospital/death related to COVID-19, within 28 days, analysed using Bayesian models.
    Results: The trial opened on 2 April 2020. Randomisation to colchicine started on 4 March 2021 and stopped on 26 May 2021 because the prespecified time to recovery futility criterion was met. The primary analysis model included 2755 participants who were SARS-CoV-2 positive, randomised to colchicine (
    Conclusion: Colchicine did not improve time to recovery in people at higher risk of complications with COVID-19 in the community.
    MeSH term(s) Adult ; Bayes Theorem ; Colchicine/therapeutic use ; Humans ; Prospective Studies ; SARS-CoV-2 ; Treatment Outcome ; COVID-19 Drug Treatment
    Chemical Substances Colchicine (SML2Y3J35T)
    Language English
    Publishing date 2022-06-30
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 1043148-2
    ISSN 1478-5242 ; 0035-8797 ; 0960-1643
    ISSN (online) 1478-5242
    ISSN 0035-8797 ; 0960-1643
    DOI 10.3399/BJGP.2022.0083
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article: Efficacy and Safety of a Modified Vaccinia Ankara-NP+M1 Vaccine Combined with QIV in People Aged 65 and Older: A Randomised Controlled Clinical Trial (INVICTUS).

    Butler, Chris / Ellis, Chris / Folegatti, Pedro M / Swayze, Hannah / Allen, Julie / Bussey, Louise / Bellamy, Duncan / Lawrie, Alison / Eagling-Vose, Elizabeth / Yu, Ly-Mee / Shanyinde, Milensu / Mair, Catherine / Flaxman, Amy / Ewer, Katie / Gilbert, Sarah / Evans, Thomas G / On Behalf Of The Invictus Investigators

    Vaccines

    2021  Volume 9, Issue 8

    Abstract: Background: Pre-existing T cell responses to influenza have been correlated with improved clinical outcomes in natural history and human challenge studies. We aimed to determine the efficacy, safety and immunogenicity of a T-cell directed vaccine in ... ...

    Abstract Background: Pre-existing T cell responses to influenza have been correlated with improved clinical outcomes in natural history and human challenge studies. We aimed to determine the efficacy, safety and immunogenicity of a T-cell directed vaccine in older people.
    Methods: This was a multicentre, participant- and safety assessor-blinded, randomised, placebo-controlled trial of the co-administration of Modified Vaccinia Ankara encoding nucleoprotein and matrix protein 1 (MVA-NP+M1) and annual influenza vaccine in participants ≥ 65. The primary outcome was the number of days with moderate or severe influenza-like symptoms (ILS) during the influenza season.
    Results: 846 of a planned 2030 participants were recruited in the UK prior to, and throughout, the 2017/18 flu season. There was no evidence of a difference in the reported rates of days of moderate or severe ILS during influenza-like illness episodes (unadjusted OR = 0.95, 95% CI: 0.54-1.69; adjusted OR = 0.91, 95% CI: 0.51-1.65). The trial was stopped after one season due to a change in the recommended annual flu vaccine, for which safety of the new combination had not been established. More participants in the MVA-NP+M1 group had transient moderate or severe pain, redness, and systemic responses in the first seven days.
    Conclusion: The MVA-NP+M1 vaccine is well tolerated in those aged 65 years and over. Larger trials would be needed to determine potential efficacy.
    Language English
    Publishing date 2021-08-03
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2703319-3
    ISSN 2076-393X
    ISSN 2076-393X
    DOI 10.3390/vaccines9080851
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  10. Article ; Online: Effectiveness and Cost-Effectiveness of a Self-Guided Internet Intervention for Social Anxiety Symptoms in a General Population Sample: Randomized Controlled Trial.

    Powell, John / Williams, Veronika / Atherton, Helen / Bennett, Kylie / Yang, Yaling / Davoudianfar, Mina / Hellsing, Annika / Martin, Angela / Mollison, Jill / Shanyinde, Milensu / Yu, Ly-Mee / Griffiths, Kathleen M

    Journal of medical Internet research

    2020  Volume 22, Issue 1, Page(s) e16804

    Abstract: Background: Many people are accessing digital self-help for mental health problems, often with little evidence of effectiveness. Social anxiety is one of the most common sources of mental distress in the population, and many people with symptoms do not ... ...

    Abstract Background: Many people are accessing digital self-help for mental health problems, often with little evidence of effectiveness. Social anxiety is one of the most common sources of mental distress in the population, and many people with symptoms do not seek help for what represents a significant public health problem.
    Objective: This study aimed to evaluate the effectiveness of a self-guided cognitive behavioral internet intervention for people with social anxiety symptoms in the general population.
    Methods: We conducted a two-group randomized controlled trial in England between May 11, 2016, and June 27, 2018. Adults with social anxiety symptoms who were not receiving treatment for social anxiety were recruited using online advertisements. All participants had unrestricted access to usual care and were randomized in a 1:1 ratio to either a Web-based unguided self-help intervention based on cognitive behavioral principles or a waiting list control group. All outcomes were collected through self-report online questionnaires. The primary outcome was the change in 17-item Social Phobia Inventory (SPIN-17) score from baseline to 6 weeks using a linear mixed-effect model that used data from all time points (6 weeks, 3 months, 6 months, and 12 months).
    Results: A total of 2122 participants were randomized, and 6 were excluded from analyses because they were ineligible. Of the 2116 eligible randomized participants (mean age 37 years; 80.24%, 1698/2116 women), 70.13% (1484/2116) had follow-up data available for analysis, and 56.95% (1205/2116) had data on the primary outcome, although attrition was higher in the intervention arm. At 6 weeks, the mean (95% CI) adjusted difference in change in SPIN-17 score in the intervention group compared with control was -1.94 (-3.13 to -0.75; P=.001), a standardized mean difference effect size of 0.2. The improvement was maintained at 12 months. Given the high dropout rate, sensitivity analyses explored missing data assumptions, with results that were consistent with those of the primary analysis. The economic evaluation demonstrated cost-effectiveness with a small health status benefit and a reduction in health service utilization.
    Conclusions: For people with social anxiety symptoms who are not receiving other forms of help, this study suggests that the use of an online self-help tool based on cognitive behavioral principles can provide a small improvement in social anxiety symptoms compared with no intervention, although dropout rates were high.
    Trial registration: ClinicalTrials.gov NCT02451878; https://clinicaltrials.gov/ct2/show/NCT02451878.
    MeSH term(s) Adult ; Anxiety/therapy ; Cost-Benefit Analysis/methods ; Female ; Humans ; Internet ; Internet-Based Intervention/trends ; Male
    Language English
    Publishing date 2020-01-10
    Publishing country Canada
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2028830-X
    ISSN 1438-8871 ; 1439-4456
    ISSN (online) 1438-8871
    ISSN 1439-4456
    DOI 10.2196/16804
    Database MEDical Literature Analysis and Retrieval System OnLINE

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