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Article ; Online: Treatment of cancer-associated venous thromboembolism: 12-month outcomes of the placebo versus rivaroxaban randomization of the SELECT-D Trial (SELECT-D: 12m).

Marshall, Andrea / Levine, Mark / Hill, Catherine / Hale, Danielle / Thirlwall, Jenny / Wilkie, Veronica / French, Karen / Kakkar, Ajay / Lokare, Anand / Maraveyas, Anthony / Chapman, Oliver / Arif, Azra / Petrou, Stavros / Maredza, Mandy / Hobbs, Richard / Dunn, Janet A / Young, Annie M

Journal of thrombosis and haemostasis : JTH

2020 Volume 18, Issue 4, Page(s) 905–915

Abstract: ... of Venous Thromboembolism (SELECT-D) trial demonstrated reduction in recurrent venous thromboembolism (VTE) but increased ... recurrence and bleeding, with anticoagulation or not, beyond 6 months.: Patients/methods: In SELECT-D ... cohort (P = .03).: Conclusion: The SELECT-D trial was underpowered to detect a statistically ...

Abstract	Background: The Anticoagulation Therapy in Selected Cancer Patients at Risk of Recurrence of Venous Thromboembolism (SELECT-D) trial demonstrated reduction in recurrent venous thromboembolism (VTE) but increased bleeding with rivaroxaban compared with dalteparin for treatment of acute VTE in cancer patients, at 6 months. Uncertainty remains around optimal duration of anticoagulation. Objectives: To assess VTE recurrence and bleeding, with anticoagulation or not, beyond 6 months. Patients/methods: In SELECT-D, after 6 months of trial treatment for VTE, patients with active cancer and residual deep vein thrombosis (RDVT) or index pulmonary embolism (PE) were eligible for randomization to a further 6 months of rivaroxaban or placebo. Patients with no RDVT stopped anticoagulation. Primary outcome was VTE recurrence at 12 months. The second randomization closed prematurely because of low recruitment when 92 of the planned 300 patients were recruited. Results: Ninety-two of 136 eligible patients were randomized to rivaroxaban or placebo. The cumulative VTE recurrence after 6 months from the second randomization was 14% with placebo and 4% with rivaroxaban (hazard ratio, 0.32; 95% confidence interval [CI], 0.06-1.58). The major and clinically relevant non-major bleeding rates were 0% and 0% with placebo; and 5% (95% CI, 1-18) and 4% (95% CI, 1-17) with rivaroxaban. In an exploratory analysis, 7 (15%) of 46 placebo patients with RDVT or an index PE experienced recurrent VTE compared to none in the 35 patients in the RDVT-negative cohort (P = .03). Conclusion: The SELECT-D trial was underpowered to detect a statistically significant reduction in recurrent VTE with extended anticoagulation. The absence of RDVT and/or index PE, defined a population at low risk of recurrence.
MeSH term(s)	Anticoagulants/adverse effects ; Humans ; Neoplasms/complications ; Random Allocation ; Rivaroxaban/adverse effects ; Treatment Outcome ; Venous Thromboembolism/diagnosis ; Venous Thromboembolism/drug therapy
Chemical Substances	Anticoagulants ; Rivaroxaban (9NDF7JZ4M3)
Language	English
Publishing date	2020-02-26
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2112661-6
ISSN	1538-7836 ; 1538-7933
ISSN (online)	1538-7836
ISSN	1538-7933
DOI	10.1111/jth.14752
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Zs.A 5805: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article: Hepatitis D Infection in Asia: A Perspective From an Endemic Region.

Gokcan, Hale / Idilman, Ramazan

Clinical liver disease

2021 Volume 18, Issue 1, Page(s) 26–29

Language	English
Publishing date	2021-08-30
Publishing country	United States
Document type	Journal Article
ZDB-ID	2657644-2
ISSN	2046-2484
ISSN	2046-2484
DOI	10.1002/cld.1106
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Article ; Online: Preoperative prophylactic active vitamin D to streamline total thyroidectomy.

Annebäck, Matilda / McHale Sjödin, Edward / Hellman, Per / Stålberg, Peter / Norlén, Olov

BJS open

2022 Volume 6, Issue 3

Abstract: ... consists of calcium and active vitamin D supplementation. Low levels of vitamin D before surgery have been ... vitamin D supplementation have shown conflicting results. This retrospective cohort study aims ... to investigate the potential benefit of preoperative active vitamin D supplementation on hypocalcaemia and ...

Abstract	Background: Hypocalcaemia is a common complication after total thyroidectomy (TT). Treatment consists of calcium and active vitamin D supplementation. Low levels of vitamin D before surgery have been shown to be a risk factor for postoperative hypocalcaemia, yet studies examining routine preoperative vitamin D supplementation have shown conflicting results. This retrospective cohort study aims to investigate the potential benefit of preoperative active vitamin D supplementation on hypocalcaemia and its symptoms after TT. Methods: This study included patients undergoing TT at Uppsala University Hospital from January 2013 to December 2020, resulting in a total of 401 patients after exclusion. Routine preoperative alfacalcidol treatment was initiated for all TT patients in January 2017 resulting in two groups for comparison: one group (pre-January 2017) that was prescribed preoperative alfacalcidol and one that was not. Propensity score matching was used to reduce bias. The primary outcome was early postoperative hypocalcaemia (serum calcium, S-Ca less than 2.10 mmol/l); secondary outcomes were symptoms of hypocalcaemia and length of stay. Results: After propensity score matching, there were 108 patients in each group. There were 2 cases with postoperative day one S-Ca less than 2.10 in the treated group and 10 cases in the non-treated group (P < 0.001). No patients in the treated group had a S-Ca below 2.00 mmol/l. Preoperative alfacalcidol was associated with higher mean serum calcium level day one (2.33 versus 2.27, P = 0.022), and reduced duration of hospital stay (P < 0.001). There was also a trend toward fewer symptoms of hypocalcaemia (18.9 per cent versus 30.5 per cent, P = 0.099). Conclusions: Prophylactic preoperative alfacalcidol was associated with reduced biochemical hypocalcaemia and duration of hospital stay following TT. Also, with this protocol, it is suggested that routine day 1 postoperative S-Ca measurement is not required.
MeSH term(s)	Calcium ; Humans ; Hypocalcemia/etiology ; Hypocalcemia/prevention & control ; Retrospective Studies ; Thyroidectomy/adverse effects ; Vitamin D/therapeutic use
Chemical Substances	Vitamin D (1406-16-2) ; Calcium (SY7Q814VUP)
Language	English
Publishing date	2022-05-30
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2474-9842
ISSN (online)	2474-9842
DOI	10.1093/bjsopen/zrac060
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Article ; Online: D-lactic acidosis presenting as metabolic encephalopathy in a patient with short bowel syndrome.

McHale, Ciarán / Keating, Eoin / O'Donovan, Helen / Slattery, Eoin

BMJ case reports

2021 Volume 14, Issue 5

Abstract: We present a case of D-lactic acidosis presenting as a metabolic encephalopathy secondary ...

Abstract	We present a case of D-lactic acidosis presenting as a metabolic encephalopathy secondary to small intestinal bacterial overgrowth. This patient had a known history of short bowel syndrome. Of note, this case required the alteration of treatment to promote a sustained clinical and biochemical improvement. We discuss the pathophysiological mechanisms thought to be involved. We also review the current therapies as well as potential future strategies. This case highlights the importance of the prompt clinical recognition of signs and symptoms as well as the rapid initiation of management strategies to ameliorate this condition.
MeSH term(s)	Acidosis, Lactic/diagnosis ; Acidosis, Lactic/etiology ; Brain Diseases, Metabolic/diagnosis ; Brain Diseases, Metabolic/etiology ; Humans ; Short Bowel Syndrome/complications ; Short Bowel Syndrome/therapy
Language	English
Publishing date	2021-05-13
Publishing country	England
Document type	Case Reports ; Journal Article
ISSN	1757-790X
ISSN (online)	1757-790X
DOI	10.1136/bcr-2020-241102
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Article ; Online: Vitamin D supplementation and body composition changes in collegiate basketball players: a 12-week randomized control trial.

Hew-Butler, Tamara / Aprik, Carrie / Byrd, Brigid / Sabourin, Jordan / VanSumeren, Matthew / Smith-Hale, Valerie / Blow, Andrew

Journal of the International Society of Sports Nutrition

2022 Volume 19, Issue 1, Page(s) 34–48

Abstract: Background: Vitamin D promotes bone and muscle growth in non-athletes, suggesting supplementation ... may be ergogenic in athletes. Our primary aim was to determine if modest Vitamin D supplementation ... either a weekly 4000 IU Vitamin D: Results: Eighteen of the 23 players completed the trial (8 females/10 males ...

Abstract	Background: Vitamin D promotes bone and muscle growth in non-athletes, suggesting supplementation may be ergogenic in athletes. Our primary aim was to determine if modest Vitamin D supplementation augments favorable body composition changes (increased bone and lean mass and decreased fat mass) and performance in collegiate basketball players following 12 weeks of standardized training. Methods: Members of a men's and women's NCAA D1 Basketball team were recruited. Volunteers were randomized to receive either a weekly 4000 IU Vitamin D Results: Eighteen of the 23 players completed the trial (8 females/10 males). Eight received the placebo (20 ± 1 years; 3 females) while ten received Vitamin D Conclusions: Modest (~517 IU/day) Vitamin D
MeSH term(s)	Basketball/physiology ; Body Composition ; Cholecalciferol ; Dietary Supplements ; Double-Blind Method ; Female ; Humans ; Male ; Vitamin D ; Vitamins/pharmacology
Chemical Substances	Vitamins ; Vitamin D (1406-16-2) ; Cholecalciferol (1C6V77QF41)
Language	English
Publishing date	2022-03-22
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	2162810-5
ISSN	1550-2783 ; 1550-2783
ISSN (online)	1550-2783
ISSN	1550-2783
DOI	10.1080/15502783.2022.2046444
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Article ; Online: Pharmacokinetics of ß-d-N4-Hydroxycytidine, the Parent Nucleoside of Prodrug Molnupiravir, in Nonplasma Compartments of Patients With Severe Acute Respiratory Syndrome Coronavirus 2 Infection.

FitzGerald, Richard / Dickinson, Laura / Else, Laura / Fletcher, Thomas / Hale, Colin / Amara, Alieu / Walker, Lauren / Penchala, Sujan Dilly / Lyon, Rebecca / Shaw, Victoria / Greenhalf, William / Bullock, Katie / Lavelle-Langham, Lara / Reynolds, Helen / Painter, Wendy / Holman, Wayne / Ewings, Sean / Griffiths, Gareth / Khoo, Saye

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2022 Volume 75, Issue 1, Page(s) e525–e528

Abstract: ß-d-N4-hydroxycytidine (NHC), the parent nucleoside of molnupiravir, a COVID-19 antiviral, was ...

Abstract	ß-d-N4-hydroxycytidine (NHC), the parent nucleoside of molnupiravir, a COVID-19 antiviral, was quantified at SARS-CoV-2 transmission sites in 12 patients enrolled in AGILE Candidate-Specific Trial-2. Saliva, nasal, and tear NHC concentrations were 3%, 21%, and 22% that of plasma. Saliva and nasal NHC were significantly correlated with plasma (P < .0001). Clinical Trials Registration. NCT04746183.
MeSH term(s)	Antiviral Agents/therapeutic use ; Cytidine/analogs & derivatives ; Humans ; Hydroxylamines ; Nucleosides ; Parents ; Prodrugs/therapeutic use ; SARS-CoV-2 ; COVID-19 Drug Treatment
Chemical Substances	Antiviral Agents ; Hydroxylamines ; Nucleosides ; Prodrugs ; Cytidine (5CSZ8459RP) ; N(4)-hydroxycytidine (C3D11PV2O4) ; molnupiravir (YA84KI1VEW)
Language	English
Publishing date	2022-03-10
Publishing country	United States
Document type	Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciac199
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Zs.A 1505: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Comparison of an Oral Factor Xa Inhibitor With Low Molecular Weight Heparin in Patients With Cancer With Venous Thromboembolism: Results of a Randomized Trial (SELECT-D).

Young, Annie M / Marshall, Andrea / Thirlwall, Jenny / Chapman, Oliver / Lokare, Anand / Hill, Catherine / Hale, Danielle / Dunn, Janet A / Lyman, Gary H / Hutchinson, Charles / MacCallum, Peter / Kakkar, Ajay / Hobbs, F D Richard / Petrou, Stavros / Dale, Jeremy / Poole, Christopher J / Maraveyas, Anthony / Levine, Mark

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

2018 Volume 36, Issue 20, Page(s) 2017–2023

Abstract: Purpose Venous thromboembolism (VTE) is common in patients with cancer. Long-term daily subcutaneous low molecular weight heparin has been standard treatment for such patients. The purpose of this study was to assess if an oral factor Xa inhibitor, ... ...

Abstract	Purpose Venous thromboembolism (VTE) is common in patients with cancer. Long-term daily subcutaneous low molecular weight heparin has been standard treatment for such patients. The purpose of this study was to assess if an oral factor Xa inhibitor, rivaroxaban, would offer an alternative treatment for VTE in patients with cancer. Patient and Methods In this multicenter, randomized, open-label, pilot trial in the United Kingdom, patients with active cancer who had symptomatic pulmonary embolism (PE), incidental PE, or symptomatic lower-extremity proximal deep vein thrombosis (DVT) were recruited. Allocation was to dalteparin (200 IU/kg daily during month 1, then 150 IU/kg daily for months 2-6) or rivaroxaban (15 mg twice daily for 3 weeks, then 20 mg once daily for a total of 6 months). The primary outcome was VTE recurrence over 6 months. Safety was assessed by major bleeding and clinically relevant nonmajor bleeding (CRNMB). A sample size of 400 patients would provide estimates of VTE recurrence to within ± 4.5%, assuming a VTE recurrence rate at 6 months of 10%. Results A total of 203 patients were randomly assigned to each group, 58% of whom had metastases. Twenty-six patients experienced recurrent VTE (dalteparin, n = 18; rivaroxaban, n = 8). The 6-month cumulative VTE recurrence rate was 11% (95% CI, 7% to 16%) with dalteparin and 4% (95% CI, 2% to 9%) with rivaroxaban (hazard ratio [HR], 0.43; 95% CI, 0.19 to 0.99). The 6-month cumulative rate of major bleeding was 4% (95% CI, 2% to 8%) for dalteparin and 6% (95% CI, 3% to 11%) for rivaroxaban (HR, 1.83; 95% CI, 0.68 to 4.96). Corresponding rates of CRNMB were 4% (95% CI, 2% to 9%) and 13% (95% CI, 9% to 19%), respectively (HR, 3.76; 95% CI, 1.63 to 8.69). Conclusion Rivaroxaban was associated with relatively low VTE recurrence but higher CRNMB compared with dalteparin.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Anticoagulants ; Dalteparin/therapeutic use ; Factor Xa Inhibitors/therapeutic use ; Female ; Fibrinolytic Agents ; Heparin, Low-Molecular-Weight/therapeutic use ; Humans ; Male ; Middle Aged ; Neoplasms/blood ; Neoplasms/pathology ; Pilot Projects ; Rivaroxaban/therapeutic use ; Survival Rate ; Treatment Outcome ; Venous Thromboembolism/drug therapy
Chemical Substances	Anticoagulants ; Factor Xa Inhibitors ; Fibrinolytic Agents ; Heparin, Low-Molecular-Weight ; Rivaroxaban (9NDF7JZ4M3) ; Dalteparin (S79O08V79F)
Language	English
Publishing date	2018-05-10
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	604914-x
ISSN	1527-7755 ; 0732-183X
ISSN (online)	1527-7755
ISSN	0732-183X
DOI	10.1200/JCO.2018.78.8034
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Article ; Online: Stereoretentive Deuteration of α-Chiral Amines with D

Hale, Lillian V A / Szymczak, Nathaniel K

Journal of the American Chemical Society

2016 Volume 138, Issue 41, Page(s) 13489–13492

Abstract: ... 6'-methyl-2'-pyridylimino)isoindolate) complexes and D ...

Abstract	We present the direct and stereoretentive deuteration of primary amines using Ru-bMepi (bMepi = 1,3-(6'-methyl-2'-pyridylimino)isoindolate) complexes and D
Language	English
Publishing date	2016-10-06
Publishing country	United States
Document type	Journal Article
ZDB-ID	3155-0
ISSN	1520-5126 ; 0002-7863
ISSN (online)	1520-5126
ISSN	0002-7863
DOI	10.1021/jacs.6b07879
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Article ; Online: Vitamin D levels in children with familial Mediterranean fever.

Onur, Hatice / Aral, Hale / Arica, Vefik / Bercem, Gamze Atalay / Kasapcopur, Ozgur

Pediatric rheumatology online journal

2016 Volume 14, Issue 1, Page(s) 28

Abstract: Background: This study aimed to determine whether vitamin D deficiency is more common in children ... diagnosed with FMF and 50 healthy children. Serum baseline 25-hydroxyvitamin D levels and other related ... parameters were evaluated.: Results: The mean (standard deviation [SD]) vitamin D levels in patients ...

Abstract	Background: This study aimed to determine whether vitamin D deficiency is more common in children with familial Mediterranean fever (FMF) than in healthy individuals. Methods: The study group consisted of 100 patients diagnosed with FMF and 50 healthy children. Serum baseline 25-hydroxyvitamin D levels and other related parameters were evaluated. Results: The mean (standard deviation [SD]) vitamin D levels in patients with FMF and healthy controls were 24.78 (8.35) and 28.70 (11.70) ng/mL, respectively. Patients with FMF had significantly decreased vitamin D levels compared with those in healthy controls (P = 0.039). Vitamin D levels were similar in patients with FMF with different MEFV mutations (P = 0.633). Age was significantly correlated with vitamin D levels (r = -0.235, P = 0.019). In addition, a negative correlation between parathyroid hormone and vitamin D levels was detected (rs = -0.382, P < 0.0001). Conclusion: This study demonstrated that vitamin D levels are lower in children with FMF than in healthy controls. We speculate that vitamin D levels should be carefully examined, and nutritional supplementation may be required in patients with FMF. Further studies with larger patient populations are needed to confirm the frequency of vitamin D deficiency in patients with FMF.
MeSH term(s)	Adolescent ; Age Factors ; Child ; Familial Mediterranean Fever/blood ; Familial Mediterranean Fever/complications ; Familial Mediterranean Fever/epidemiology ; Familial Mediterranean Fever/genetics ; Female ; Humans ; Male ; Mutation ; Parathyroid Hormone/blood ; Pyrin/genetics ; Statistics as Topic ; Turkey/epidemiology ; Vitamin D/analogs & derivatives ; Vitamin D/blood ; Vitamin D Deficiency/blood ; Vitamin D Deficiency/complications ; Vitamin D Deficiency/diagnosis
Chemical Substances	MEFV protein, human ; Parathyroid Hormone ; Pyrin ; Vitamin D (1406-16-2) ; 25-hydroxyvitamin D (A288AR3C9H)
Language	English
Publishing date	2016-04-27
Publishing country	England
Document type	Journal Article
ZDB-ID	2279468-2
ISSN	1546-0096 ; 1546-0096
ISSN (online)	1546-0096
ISSN	1546-0096
DOI	10.1186/s12969-016-0089-1
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Article ; Online: The development and validation of a novel LC-MS/MS method for the simultaneous quantification of Molnupiravir and its metabolite ß-d-N4-hydroxycytidine in human plasma and saliva.

Amara, Alieu / Penchala, Sujan Dilly / Else, Laura / Hale, Colin / FitzGerald, Richard / Walker, Lauren / Lyons, Rebecca / Fletcher, Tom / Khoo, Saye

Journal of pharmaceutical and biomedical analysis

2021 Volume 206, Page(s) 114356

Abstract: ... and validated for the simultaneous quantification of MPV and its metabolite ß-d-N4-hydroxycytidine ...

Abstract	In light of the recent global pandemic, Molnupiravir (MPV) or EIDD-2801, developed for the treatment of patients with uncomplicated influenza, is now being trialled for the treatment of infections caused by highly pathogenic coronaviruses, including COVID-19. A sensitive LC-MS/MS method was developed and validated for the simultaneous quantification of MPV and its metabolite ß-d-N4-hydroxycytidine (NHC) in human plasma and saliva. The analytes were extracted from the matrices by protein precipitation using acetonitrile. This was followed by drying and subsequently injecting the reconstituted solutions onto the column. Chromatographic separation was achieved using a polar Atlantis C
MeSH term(s)	COVID-19 ; Chromatography, Liquid ; Cytidine/analogs & derivatives ; Humans ; Hydroxylamines ; Reproducibility of Results ; SARS-CoV-2 ; Saliva ; Tandem Mass Spectrometry
Chemical Substances	Hydroxylamines ; Cytidine (5CSZ8459RP) ; molnupiravir (YA84KI1VEW)
Language	English
Publishing date	2021-09-02
Publishing country	England
Document type	Journal Article
ZDB-ID	604917-5
ISSN	1873-264X ; 0731-7085
ISSN (online)	1873-264X
ISSN	0731-7085
DOI	10.1016/j.jpba.2021.114356
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