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  1. Article ; Online: More failure with solanezumab - this time in preclinical Alzheimer's disease.

    Doggrell, Sheila A

    Expert opinion on biological therapy

    2024  Volume 24, Issue 3, Page(s) 119–123

    Abstract: Introduction: There is no cure for Alzheimer's disease, which is the sixth leading cause of death in the USA. Lecanemab is anti-Aβ monoclonal antibody approved for the treatment of early Alzheimer's disease but is only marginally effective. Other ... ...

    Abstract Introduction: There is no cure for Alzheimer's disease, which is the sixth leading cause of death in the USA. Lecanemab is anti-Aβ monoclonal antibody approved for the treatment of early Alzheimer's disease but is only marginally effective. Other antibodies are being developed including solanezumab.
    Areas covered: A phase 3 clinical trial of solanezumab in preclinical Alzheimer's disease. In the A4 study, solanezumab did not reduce the decline in cognition or function and had no effect on brain amyloid burden.
    Expert opinion: After the poor results in the EXPEDITION series of trials, the development of solanezumab should have been terminated. The rationale for undertaking the A4 trial was questionable, and the lack of benefit was probable. The controversial approval of two anti-Aβ monoclonal antibodies (aducanumab and lecanemab) for the treatment of Alzheimer's disease by the US Food and Drug Administration (FDA), despite a high incidence of amyloid-related imagining abnormalities (ARIA), may be fueling this continuation of clinical development of agents such as solanezumab. The lesson from the A4 trial is that more careful/realistic consideration needs to be given before embarking on further phase 3 trials with anti-Aβ monoclonal antibodies.
    MeSH term(s) Humans ; Alzheimer Disease/drug therapy ; Amyloid beta-Peptides ; Brain ; Immunotherapy ; Antibodies, Monoclonal, Humanized
    Chemical Substances solanezumab (5D6PWO0333) ; Amyloid beta-Peptides ; Antibodies, Monoclonal, Humanized
    Language English
    Publishing date 2024-03-03
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2052501-1
    ISSN 1744-7682 ; 1471-2598
    ISSN (online) 1744-7682
    ISSN 1471-2598
    DOI 10.1080/14712598.2024.2325551
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Sibeprenlimab, which neutralizes A PRoliferation Inducing Ligand (APRIL), as a new approach to treating IgA nephropathy.

    Doggrell, Sheila A

    Expert opinion on biological therapy

    2024  , Page(s) 1–4

    Abstract: Introduction: Immunoglobulin A (IgA) nephropathy is a common immune-mediated kidney disease leading to high blood pressure and may progress to kidney failure. None of the present treatments are disease-modifying or prolong life. The levels of A ... ...

    Abstract Introduction: Immunoglobulin A (IgA) nephropathy is a common immune-mediated kidney disease leading to high blood pressure and may progress to kidney failure. None of the present treatments are disease-modifying or prolong life. The levels of A PRoliferation Inducing Ligand (APRIL) are raised in subjects with IgA nephropathy. Sibeprenlimab is a humanized IgG2 monoclonal antibody that binds to, and neutralizes, APRIL.
    Areas covered: A phase 2 clinical trial of intravenous sibeprenlimab (VIS649) in IgA nephropathy: NCT04287985. The primary efficacy endpoint was the change from baseline in 24-h protein-to-creatinine ratio at 12 months, and this was reduced by sibeprenlimab. Sibeprenlimab also caused clinical remission in some subjects, stabilized estimated glomerular filtration rate (eGFR), and reduced galactose deficient IgA1, IgA, IgM, and IgG levels without causing any infections or other adverse events.
    Expert opinion: Sibeprenlimab is a promising new approach to treating IgA nephropathy. The pharmaceutical company behind sibeprenlimab is also developing it for subcutaneous use, which would have advantages over intravenous use. As IgA nephropathy is a long-term progressive disease, key questions that need to be answered, over a long-time course, with sibeprenlimab are (i) whether its safety is maintained, and (ii) whether it improves clinical outcomes.
    Language English
    Publishing date 2024-04-25
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2052501-1
    ISSN 1744-7682 ; 1471-2598
    ISSN (online) 1744-7682
    ISSN 1471-2598
    DOI 10.1080/14712598.2024.2346111
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Continuous subcutaneous levodopa-carbidopa for the treatment of advanced Parkinson's disease: is it an improvement on other delivery?

    Doggrell, Sheila A

    Expert opinion on drug delivery

    2023  Volume 20, Issue 9, Page(s) 1189–1199

    Abstract: Introduction: Parkinson's disease (PD) is the second most common neurodegenerative disease and is growing in prevalence and disability. The standard treatment for PD is oral levo-dopa (LD) with carbidopa (CD). As PD progresses, despite higher doses of ... ...

    Abstract Introduction: Parkinson's disease (PD) is the second most common neurodegenerative disease and is growing in prevalence and disability. The standard treatment for PD is oral levo-dopa (LD) with carbidopa (CD). As PD progresses, despite higher doses of LD/CD, plasma levels of LD fluctuate, and may be associated with motor fluctuations and dyskinesia.
    Areas covered: The development of two new subcutaneous preparations of LD/CD (ND0612 and ABBV-951) for the treatment of motor fluctuations in PD is described in detail. Both reduce motor fluctuations and dyskinesia with minor infusion site adverse events. A third subcutaneous preparation, DIZ102, is in early-stage development.
    Expert opinion: The premise for using continuous release LD in advanced PD is that steady state levels of LD will prevent motor fluctuations/dyskinesia, but this is not the whole story, and will limit the benefits of subcutaneous continuous release LD. With its present pump system ND0612 cannot be used as monotherapy, whereas ABBV-951 can be. Having to combine with oral LD/CD will complicate the use of ND0612. Both ND0612 and ABBV-951 only cause modest reductions in OFF time. It is not clear whether these subcutaneous preparations will have more benefits than the intestinal gel, which also reduces OFF time and dyskinesia.
    MeSH term(s) Humans ; Carbidopa/therapeutic use ; Carbidopa/adverse effects ; Levodopa/therapeutic use ; Levodopa/adverse effects ; Parkinson Disease/drug therapy ; Neurodegenerative Diseases/drug therapy ; Drug Combinations ; Dyskinesias/drug therapy ; Antiparkinson Agents/therapeutic use
    Chemical Substances Carbidopa (MNX7R8C5VO) ; Levodopa (46627O600J) ; Drug Combinations ; Antiparkinson Agents
    Language English
    Publishing date 2023-09-10
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2167286-6
    ISSN 1744-7593 ; 1742-5247
    ISSN (online) 1744-7593
    ISSN 1742-5247
    DOI 10.1080/17425247.2023.2253146
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Retatrutide showing promise in obesity (and type 2 diabetes).

    Doggrell, Sheila A

    Expert opinion on investigational drugs

    2023  Volume 32, Issue 11, Page(s) 997–1001

    Abstract: Introduction: Obesity is a major risk factor for cardiovascular disease, diabetes, osteoarthritis, and some cancers. Retatrutide stimulates Glucagon-like peptide 1 (GLP-1), Glucose-dependent insulinotropic polypeptide (GIP) receptors, and glucagon ... ...

    Abstract Introduction: Obesity is a major risk factor for cardiovascular disease, diabetes, osteoarthritis, and some cancers. Retatrutide stimulates Glucagon-like peptide 1 (GLP-1), Glucose-dependent insulinotropic polypeptide (GIP) receptors, and glucagon receptors, and is being developed for the treatment of obesity and type 2 diabetes.
    Areas covered: A phase 2 clinical trial of retatrutide (LY3437943) in the treatment of obesity. The primary end point was percentage change in weight from baseline to 24 weeks, which ranged from -7.2% to -~18% as the dose of retatrutide increased from 1 mg to 12 mg. The most frequent adverse events were gastrointestinal (nausea, diarrhea, vomiting).
    Expert opinion: The results for retatrutide in phase 2 for obesity (and diabetes) are mostly encouraging. Consistent with being a GLP-1 receptor agonist, heart rate was increased by up to 6.7 beats/min by retatrutide, which may be detrimental and offset some of the benefits of weight loss. Presumably, retatrutide is being developed as a challenger to the recently developed weight loss medicines; semaglutide and/or tirzepatide. Thus, comparator studies are needed between retatrutide and these drugs, but none are ongoing and, in my opinion, this lack is a major omission in the development of retatrutide.
    MeSH term(s) Humans ; Diabetes Mellitus, Type 2/drug therapy ; Obesity/complications ; Obesity/drug therapy ; Risk Factors ; Glucagon-Like Peptide 1 ; Weight Loss ; Glucagon-Like Peptide-1 Receptor ; Hypoglycemic Agents/adverse effects
    Chemical Substances Glucagon-Like Peptide 1 (89750-14-1) ; Glucagon-Like Peptide-1 Receptor ; Hypoglycemic Agents
    Language English
    Publishing date 2023-11-24
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 1182884-5
    ISSN 1744-7658 ; 0967-8298 ; 1354-3784
    ISSN (online) 1744-7658
    ISSN 0967-8298 ; 1354-3784
    DOI 10.1080/13543784.2023.2283020
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Is sotatercept, which traps activins and growth differentiation factors, a new dawn in treating pulmonary arterial hypertension (PAH)?

    Doggrell, Sheila A

    Expert opinion on biological therapy

    2023  Volume 23, Issue 7, Page(s) 589–593

    Abstract: Introduction: Although the prevalence of pulmonary arterial hypertension (PAH) is low, mortality is high. In PAH, there is a down-regulation of the bone morphogenetic protein receptor type 2 pathway, leading to a prominence of the upregulation pathway ... ...

    Abstract Introduction: Although the prevalence of pulmonary arterial hypertension (PAH) is low, mortality is high. In PAH, there is a down-regulation of the bone morphogenetic protein receptor type 2 pathway, leading to a prominence of the upregulation pathway that is mediated by activins and growth differentiation factors acting at the receptor type IIA (ActRIIA). Sotatercept is an ActRIIA fusion protein. STELLAR was a phase 3 study of sotatercept for the treatment of PAH.
    Areas covered: STELLAR. The primary endpoint of STELLAR was change from baseline at 24 weeks in the 6-minute walking distance, which was increased by 34.4 m by sotatercept compared to 1 m in the placebo group. Epistaxis/nosebleed, telangiectasia, and dizziness were more common with sotatercept than placebo.
    Expert opinion: By targeting the remodeling in PAH, sotatercept is providing a new approach to the treatment of PAH and has the potential to slow or reverse cardiovascular remodeling in other conditions, e.g. left heart failure. However, the development of sotatercept for the treatment of PAH still requires a consideration of the appropriate dose and a longer-term assessment of the benefits and safety. If sotatercept becomes available for self-administration, it will be of interest to assess whether this affects adherence and benefits.
    MeSH term(s) Humans ; Pulmonary Arterial Hypertension ; Activins ; Growth Differentiation Factors
    Chemical Substances ACE-011 ; Activins (104625-48-1) ; Growth Differentiation Factors
    Language English
    Publishing date 2023-06-07
    Publishing country England
    Document type Journal Article
    ZDB-ID 2052501-1
    ISSN 1744-7682 ; 1471-2598
    ISSN (online) 1744-7682
    ISSN 1471-2598
    DOI 10.1080/14712598.2023.2221784
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Bempedoic acid as treatment for subjects at cardiovascular risk who are statin-intolerant.

    Doggrell, Sheila A

    Expert opinion on pharmacotherapy

    2023  Volume 24, Issue 15, Page(s) 1673–1677

    Abstract: Introduction: Atherosclerotic cardiovascular disease is the leading cause of death globally. LDL cholesterol is a key risk factor for cardiovascular disease.  The most common group of medicines for lowering LDL cholesterol are the statins, as they ... ...

    Abstract Introduction: Atherosclerotic cardiovascular disease is the leading cause of death globally. LDL cholesterol is a key risk factor for cardiovascular disease.  The most common group of medicines for lowering LDL cholesterol are the statins, as they reduce the risk of cardiovascular events.  However, some subjects are statin-intolerant and remain at high risk.
    Areas covered: CLEAR Outcomes; a phase 3 clinical trial of bempedoic acid, an ATP citrate lyase (ACL) inhibitor, in subjects who do not tolerate statins or are unable to take the recommended dose. It enrolled subjects with prior cardiovascular events (secondary prevention) and at high risk (primary prevention). The primary endpoint was a composite of major adverse cardiovascular events, and this occurred in less subjects in the bempedoic acid than the placebo group.
    Expert opinion: Bempedoic acid is suitable for use as monotherapy in the prevention of cardiovascular events in statin intolerant subjects, and it has a good safety profile in most subjects.However, the effects of bempedoic acid in lowering LDL cholesterol and cardiovascular events are modest.  This suggests that more benefits may ensue ifbempedoic acid was used in combination with other lipid lowering agents to cause larger decreases in LDL cholesterol.
    MeSH term(s) Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects ; Cholesterol, LDL ; Cardiovascular Diseases/prevention & control ; Cardiovascular Diseases/drug therapy ; Risk Factors ; Heart Disease Risk Factors ; Anticholesteremic Agents/therapeutic use
    Chemical Substances Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Cholesterol, LDL ; 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid (1EJ6Z6Q368) ; Anticholesteremic Agents
    Language English
    Publishing date 2023-07-31
    Publishing country England
    Document type Journal Article
    ZDB-ID 2001535-5
    ISSN 1744-7666 ; 1465-6566
    ISSN (online) 1744-7666
    ISSN 1465-6566
    DOI 10.1080/14656566.2023.2242259
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Is retatrutide (LY3437943), a GLP-1, GIP, and glucagon receptor agonist a step forward in the treatment of diabetes and obesity?

    Doggrell, Sheila A

    Expert opinion on investigational drugs

    2023  Volume 32, Issue 5, Page(s) 355–359

    Abstract: Introduction: Despite there being a wide range of medicines available for the treatment of type 2 diabetes, the high rate of mortality suggests treatment needs to be improved. Only a few medicines have shown long-term effectiveness in obesity, and new ... ...

    Abstract Introduction: Despite there being a wide range of medicines available for the treatment of type 2 diabetes, the high rate of mortality suggests treatment needs to be improved. Only a few medicines have shown long-term effectiveness in obesity, and new medicines are urgently needed.
    Areas covered: A multiple-ascending dose phase 1b clinical trial of a new drug retatrutide (LY3437943), which in addition to stimulating Glucagon-like peptide 1 (GLP-1) and Glucose-dependent insulinotropic polypeptide (GIP) receptors, stimulates glucagon receptors, in subjects with type 2 diabetes. Retatrutide was relatively safe and pharmacokinetics support once-weekly dosing.
    Expert opinion: The role of stimulating glucagon receptors in the treatment of type 2 diabetes and/or obesity is poorly defined and needs to be clarified. Although retatrutide may be superior to the GLP-1 receptor agonist dulaglutide in reducing plasma glucose and body weight, this is not a meaningful comparison, as another GLP-1 receptor agonist (semaglutide) is more potent than dulaglutide at this and may have similar efficacy to retatrutide. Retatrutide also needs to be compared to another Eli Lilly and Company drug, the combined GLP-1 and GIP receptor agonist, tirzepatide. The safety of retatrutide needs to be determined in larger and longer trials.
    MeSH term(s) Humans ; Glucagon-Like Peptide 1 ; Glucagon ; Diabetes Mellitus, Type 2/drug therapy ; Receptors, Glucagon ; Hypoglycemic Agents/therapeutic use ; Glucagon-Like Peptide-1 Receptor/agonists ; Obesity/drug therapy
    Chemical Substances Glucagon-Like Peptide 1 (89750-14-1) ; Glucagon (9007-92-5) ; Receptors, Glucagon ; Hypoglycemic Agents ; Glucagon-Like Peptide-1 Receptor
    Language English
    Publishing date 2023-04-24
    Publishing country England
    Document type Journal Article
    ZDB-ID 1182884-5
    ISSN 1744-7658 ; 0967-8298 ; 1354-3784
    ISSN (online) 1744-7658
    ISSN 0967-8298 ; 1354-3784
    DOI 10.1080/13543784.2023.2206560
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article: Follow-up descriptive study of how proportioning marks between coursework and examination affects the performance of students in nursing.

    Doggrell, Sheila A

    BMC nursing

    2023  Volume 22, Issue 1, Page(s) 135

    Abstract: Background: There has been little attention to how the allocation of marks affects the academic performance of students in courses. Our previous study showed that students in nursing had much lower marks in exams than coursework (tutorials and case ... ...

    Abstract Background: There has been little attention to how the allocation of marks affects the academic performance of students in courses. Our previous study showed that students in nursing had much lower marks in exams than coursework (tutorials and case study) in a pharmacology course. It is not known whether this applies to nursing students in other courses and/or with different types of coursework. The purpose of this study was to analyse how the allocation of marks to examination and different coursework affected the performance of students in nursing in a bioscience course.
    Methods: For the 379 completing students in a nursing degree undertaking a first-year first semester bioscience course, a descriptive study was undertaken of (i) the marks for the exam and two coursework components (individually undertaken laboratory skills, and a team/group project on health communication), with the marks being compared by Students t-test, (ii) any association between these marks was determined by regression line analysis, and (iii) modelling was undertaken to determine the effects of changing the allocation of marks on passing and failing rates.
    Results: Students in nursing who completed a bioscience course had much lower marks in the exam than the coursework. Regression line analysis of the marks in the exam versus combined coursework showed (a) a poor line fit and (b) the correlation coefficient was moderate (r = 0.51), for the individual laboratory skills vs. exam was moderate (r = 0.49), but only weak for the group project on health communication vs. exam (r = 0.25). A high percentage of students passed the course (97%). Modelling showed that increasing the marks for the exam decreased the number of students passing the course to as few as 57%.
    Conclusions: The allocation of marks determines the percentage of students in nursing who pass courses, regardless of the type of coursework. The students in nursing in the bioscience course, who pass the course based on marks from coursework, but not the examination component, may not have the necessary knowledge to continue their program of study. Thus, requiring students in nursing to pass exams should be given further consideration.
    Language English
    Publishing date 2023-04-25
    Publishing country England
    Document type Journal Article
    ZDB-ID 2091496-9
    ISSN 1472-6955
    ISSN 1472-6955
    DOI 10.1186/s12912-023-01286-w
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: A new role for an old drug: acetazolamide in decompensated heart failure.

    Doggrell, Sheila A

    Expert opinion on pharmacotherapy

    2022  Volume 24, Issue 3, Page(s) 309–313

    Abstract: Introduction: Mortality from heart failure remains high. Many subjects who have been hospitalized with acute decompensated heart failure leave hospital with residual congestion, despite treatment with loop diuretics. In an attempt to improve this, the ... ...

    Abstract Introduction: Mortality from heart failure remains high. Many subjects who have been hospitalized with acute decompensated heart failure leave hospital with residual congestion, despite treatment with loop diuretics. In an attempt to improve this, the Acetazolamide in Decompensated heart failure with Volume OveRload (ADVOR) trial was undertaken, where acetazolamide was added to the loop diuretic bumetanide.
    Areas covered: This article discusses ADVOR. The primary endpoint of ADVOR was the reversal of congestion, which was increased by adding acetazolamide to bumetanide. However, acetazolamide did not shorten hospital stay or the composite of rehospitalisation and death after three months.
    Expert opinion: The limitations of ADVOR include that acetazolamide did not improve quality of life and that the testing was in white subjects only. During the hospital stay for decompensation, medicines that inhibit the angiotensin and mineralocorticoid systems were increased, which suggests that the treatment for heart failure was not ideal on hospitalization. As the death rates in ADVOR were lower than in previous studies, this suggests that the overall treatment of decompensated/heart failure is improving. However, in the author's opinion, although the addition of acetazolamide is a small improvement in the treatment of acute decompensated heart failure with volume overload, more options need to be considered.
    MeSH term(s) Humans ; Acetazolamide/therapeutic use ; Bumetanide ; Diuretics/therapeutic use ; Quality of Life ; Treatment Outcome ; Heart Failure/drug therapy
    Chemical Substances Acetazolamide (O3FX965V0I) ; Bumetanide (0Y2S3XUQ5H) ; Diuretics
    Language English
    Publishing date 2022-12-28
    Publishing country England
    Document type Journal Article
    ZDB-ID 2001535-5
    ISSN 1744-7666 ; 1465-6566
    ISSN (online) 1744-7666
    ISSN 1465-6566
    DOI 10.1080/14656566.2022.2161886
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: The ULTIMATE trials: are there advantages of ublituximab over teriflunomide in relapsing multiple sclerosis?

    Doggrell, Sheila A

    Expert opinion on biological therapy

    2022  Volume 22, Issue 11, Page(s) 1339–1343

    Abstract: Introduction: The involvement of B-cells in multiple sclerosis has only recently emerged. Ublituximab is a monoclonal antibody that binds to the B-cell antigen CD20 with enhanced B-cell targeting.: Areas covered: This evaluation is of the identical ... ...

    Abstract Introduction: The involvement of B-cells in multiple sclerosis has only recently emerged. Ublituximab is a monoclonal antibody that binds to the B-cell antigen CD20 with enhanced B-cell targeting.
    Areas covered: This evaluation is of the identical ULTIMATE (UbLiTuximab In Multiple Sclerosis Treatment Effects) I and II trials comparing ublituximab (TG-1101) and teriflunomide in relapsing multiple sclerosis. The primary efficacy end point was the annualized relapse rate and was lower in the ublituximab than the teriflunomide group.
    Expert opinion: The continuation rates to oral teriflunomide in ULTIMATE were higher than in other trials, possibly because of the supervised double-dummy protocol used with intravenous ublituximab. This may have contributed to the higher efficacy with teriflunomide in this trial than previously reported. Nevertheless, ublituximab was more effective than teriflunomide at reducing the annualized relapse rates and MRI endpoints, but not for no evidence of disease activity (NEDA). Subsequently, a meta-analysis of the ULTIMATE trials did show that ublituximab was superior to teriflunomide in NEDA. Long-term studies of the adverse effects of ublituximab are required. Despite the positive results from ULTIMATE for ublituximab, it is still under the scrutiny of the Food and Drug Administration (FDA), and conclusions should await their findings.
    MeSH term(s) Humans ; Multiple Sclerosis ; Multiple Sclerosis, Relapsing-Remitting/drug therapy ; Antibodies, Monoclonal/therapeutic use ; Recurrence
    Chemical Substances teriflunomide (1C058IKG3B) ; ublituximab (U59UGK3IPC) ; Antibodies, Monoclonal
    Language English
    Publishing date 2022-11-03
    Publishing country England
    Document type Meta-Analysis ; Journal Article
    ZDB-ID 2052501-1
    ISSN 1744-7682 ; 1471-2598
    ISSN (online) 1744-7682
    ISSN 1471-2598
    DOI 10.1080/14712598.2022.2143262
    Database MEDical Literature Analysis and Retrieval System OnLINE

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