scholarly journals The Effect of Antibiotics on Post-adenotonsillectomy Morbidity in Tanzanian Children: Study Protocol for a Randomized Double-blind Placebo-controlled Trial

2019 ◽  
Author(s):  
Denis Robert Katundu ◽  
Peter Stephen Shija ◽  
Baltazari Nyombi ◽  
Hadija Semvua ◽  
Fieke K Oussoren ◽  
...  
Keyword(s):  
Antibiotic Prescription ◽  
Current Knowledge ◽  
Controlled Trial ◽  
Cochrane Review ◽  
Developed Countries ◽  
Medical Centre ◽  
Cross Resistance ◽  
Paediatric Surgery ◽  
Standard Regimen ◽  
Double Blind

Abstract Background Adenotonsillectomy is the most frequently performed operation in children worldwide. For decades prophylactic antibiotics have been prescribed to limit postoperative complications. In a Cochrane review the effect of this antibiotic use has been refuted. However, all reviewed studied were done in developed countries. In Tanzania, like many other developing countries with limited resources and a high burden of infectious diseases, postoperative antibiotic prescription is still very common to decrease the supposed higher postoperative morbidity. However, as a consequence of this widespread use of postoperative antibiotics cross-resistance and risk of allergic side effects rise. Well designed randomised controlled trials are needed to limit unnecessary antibiotic prescription and secondary antibiotic resistance. Aim The aim of this study is to analyse the prophylactic role of postoperative antibiotic on the morbidity following adenotonsillectomy in children in Tanzania. Design A double blinded randomised placebo controlled trial set in northern Tanzania. Participating centres are the department of otolaryngology at Kilimanjaro Christian Medical Centre (KCMC) in Moshi and the department of paediatric surgery at the Arusha Lutheran Medical Centre (ALMC) in Arusha. Methods Around 270 children aged 2 to 14 years, all scheduled for elective (adeno)tonsillectomy, will be included and assigned to receive either a standard regimen of 5 days antibiotic prophylaxis or placebo after surgery. The primary outcomes are postoperative haemorrhage, raised temperature, pain and consequent need for analgesics. Secondary outcomes are the time until normal diet is resumed, the time until normal activities are resumed and the occurrence of adverse events. Finally, microbial recolonization of the tonsillar beds is analyzed. Discussion This study will enhance increase of proper antimicrobial prescription in Tanzanian institutions as well as other resource-limited countries where prescription of antibiotics is still very common. In addition, it might augment current knowledge about surface and core tonsillar micro-organisms and sensitivity patterns.

scholarly journals The effect of antibiotics on post-adenotonsillectomy morbidity in tanzanian children: study protocol for a randomized double-blind placebo-controlled trial.

2019 ◽  
Author(s):  
Denis Robert Katundu ◽  
Peter Stephen Shija ◽  
Baltazari Nyombi ◽  
Hadija Semvua ◽  
Fieke K Oussoren ◽  
...  
Keyword(s):  
Antibiotic Prescription ◽  
Current Knowledge ◽  
Controlled Trial ◽  
Cochrane Review ◽  
Developed Countries ◽  
Medical Centre ◽  
Cross Resistance ◽  
Paediatric Surgery ◽  
Standard Regimen ◽  
Double Blind

Abstract Background: Adenotonsillectomy is the most frequently performed operation in children worldwide. For decades prophylactic antibiotics have been prescribed to limit postoperative complications. In a Cochrane review the effect of this antibiotic use has been refuted. However, all reviewed studied were done in developed countries. In Tanzania, like many other developing countries with limited resources and a high burden of infectious diseases, postoperative antibiotic prescription is still very common to decrease the supposed higher postoperative morbidity. However, as a consequence of this widespread use of postoperative antibiotics cross-resistance and risk of allergic side effects rise. Well designed randomised controlled trials are needed to limit unnecessary antibiotic prescription and secondary antibiotic resistance. Aim: The aim of this study is to analyse the prophylactic role of postoperative antibiotic on the morbidity following adenotonsillectomy in children in Tanzania. Design: A double blinded randomised placebo controlled trial set in northern Tanzania. Participating centres are the department of otolaryngology at Kilimanjaro Christian Medical Centre (KCMC) in Moshi and the department of paediatric surgery at the Arusha Lutheran Medical Centre (ALMC) in Arusha. Methods: Around 270 children aged 2 to 14 years, all scheduled for elective (adeno)tonsillectomy, will be included and assigned to receive either a standard regimen of 5 days antibiotic prophylaxis or placebo after surgery. The primary outcomes are postoperative haemorrhage, fever and pain. Secondary outcomes are the time until normal diet is resumed, the time until normal activities are resumed, occurrence of adverse events and microbial recolonization of the tonsillar beds. Discussion: This study will enhance increase of proper antimicrobial prescription in Tanzanian institutions as well as other resource-limited countries where prescription of antibiotics is still very common. In addition, it might augment current knowledge about surface and core tonsillar micro-organisms and sensitivity patterns.

scholarly journals The effect of antibiotics on post-adenotonsillectomy morbidity in Tanzanian children: study protocol for a randomized, double-blind, placebo-controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Denis R. Katundu ◽  
Peter S. Shija ◽  
Baltazari Nyombi ◽  
Hadija Semvua ◽  
Fieke K. Oussoren ◽  
...  
Keyword(s):  
Antibiotic Prescription ◽  
Current Knowledge ◽  
Controlled Trial ◽  
Cochrane Review ◽  
Developed Countries ◽  
Medical Centre ◽  
Cross Resistance ◽  
Paediatric Surgery ◽  
Standard Regimen ◽  
Double Blind

Abstract Background Adenotonsillectomy is the most frequently performed operation in children worldwide. For decades, prophylactic antibiotics have been prescribed to limit postoperative complications. The effect of this antibiotic use has been refuted in a Cochrane Review. However, all reviewed studies were carried out in developed countries. In Tanzania, like many other developing countries with limited resources and a high burden of infectious diseases, postoperative antibiotic prescription is still very common to decrease the supposed higher postoperative morbidity. However, as a consequence of this widespread use of postoperative antibiotics, cross-resistance and risk of allergic side effects rise. Well-designed randomized controlled trials are needed to limit unnecessary antibiotic prescription and secondary antibiotic resistance. Aim The aim of this study is to analyse the prophylactic role of postoperative antibiotics on morbidity following adenotonsillectomy in children in Tanzania. Design The double-blinded, randomized, placebo-controlled trial was set in northern Tanzania. Participating centres are the Department of Otolaryngology at Kilimanjaro Christian Medical Centre in Moshi and the Department of Paediatric Surgery at the Arusha Lutheran Medical Centre in Arusha. Methods Around 270 children aged 2–14 years, all scheduled for elective (adeno)tonsillectomy, will be included and assigned to receive either a standard regimen of 5 days of antibiotic prophylaxis or placebo after surgery. The primary outcomes are postoperative haemorrhage, fever and pain. Secondary outcomes are the time until normal diet is resumed, the time until normal activities are resumed and the occurrence of adverse events and microbial recolonization of the tonsillar beds. Discussion This study will enhance an increase of proper antimicrobial prescription in Tanzanian institutions as well as other resource-limited countries where prescription of antibiotics is still very common. In addition, it might augment current knowledge about surface and core tonsillar micro-organisms and sensitivity patterns. Trial registration Pan African Clinical Trials Registry, PACTR201905466349317. Retrospectively registered on 15 May 2019. https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=8119

scholarly journals Early combination therapy with etanercept and methotrexate in JIA patients shortens the time to reach an inactive disease state and remission: results of a double-blind placebo-controlled trial

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Ekaterina Alexeeva ◽  
Gerd Horneff ◽  
Tatyana Dvoryakovskaya ◽  
Rina Denisova ◽  
Irina Nikishina ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Controlled Trial ◽  
Randomized Study ◽  
Primary Objective ◽  
Disease State ◽  
Inactive Disease ◽  
Open Label ◽  
Standard Regimen ◽  
Double Blind ◽  
Early Combination Therapy

Abstract Background Remission is the primary objective of treating juvenile idiopathic arthritis (JIA). It is still debatable whether early intensive treatment is superior in terms of earlier achievement of remission. The aim of this study was to evaluate the effectiveness of early etanercept+methotrexate (ETA+MTX) combination therapy versus step-up MTX monotherapy with ETA added in refractory disease. Methods A multi-centre, double-blind, randomized study in active polyarticular JIA patients treated with either ETA+MTX (n = 35) or placebo+MTX (n = 33) for up to 24 weeks, followed by a 24-week open-label phase. The efficacy endpoints included pedACR30 criteria improvement at week 12, inactive disease at week 24, and remission at week 48. Patients who failed to achieve the endpoints at week 12 or at week 24 escaped to open-label ETA+MTX. Safety was assessed at each visit. Results By intention-to-treat analysis, more patients in the ETA+MTX group reached the pedACR30 response at week 12 (33 (94.3%)) than in the placebo+MTX group (20 (60.6%); p = 0.001). At week 24, comparable percentages of patients reached inactive disease (11 (31.4%) vs 11 (33.3%)). At week 48, 11 (31.4%) and eight (24.2%) patients achieved remission. The median (+/−IQR) times to achieve an inactive disease state in the ETA+MTX and placebo+MTX groups were 24 (14–32) and 32 (24–40) weeks, respectively. Forty-four (74/100 patient-years) adverse events (AEs) were reported, leading to treatment discontinuation in 6 patients. Conclusions Early combination therapy with ETA+MTX proved to be highly effective compared to the standard step-up regimen. Compared to those treated with the standard regimen, more patients treated with a combination of ETA+MTX reached the pedACR30 response and achieved inactive disease and remission more rapidly.

scholarly journals A Randomised Controlled Trial on the Efficacy and Safety of Oral Ketamine in Neonatal Circumcision

2021 ◽  
Author(s):  
Victor Ifeanyichukwu Modekwe ◽  
Jideofor Okechukwu Ugwu ◽  
Okechukwu Hyginus Ekwunife ◽  
Andrew Nwankwo Osuigwe ◽  
Jideofor Chukwuma Orakwe ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Controlled Study ◽  
Categorical Variables ◽  
Paediatric Surgery ◽  
Peripheral Oxygen Saturation ◽  
Double Blind ◽  
Oral Ketamine ◽  
The Mean ◽  
Neonatal Circumcision

Introduction: Procedural analgesia use in neonatal circumcision is not widespread in the developing world. An easy-to-administer, adequate and safe analgesia will encourage usage in neonatal circumcision. Orally administered ketamine may prove effective and safe, and may encourage procedural analgesia use in neonatal circumcision. Aim: To determine the analgesic efficacy of oral ketamine in Plastibell® neonatal circumcision. Materials and Methods: A hospital based randomised double blind controlled study was conducted at the paediatric surgery unit of the hospital, from March 2015 to December 2015. Total 121 neonates were sequentially recruited, and randomised into two groups. Group A received oral ketamine, and Group B received plain syrup (placebo) as procedural analgesia. Continuous pulse oximeter monitoring was done before, during and immediately after the procedure. The pre-procedural and intra-procedural peripheral oxygen saturation (SpO2) and Pulse Rate (PR) were determined at the various stages. Also, the Neonatal Infant Pain Scale (NIPS) scores were assessed during the stages of the procedure. Differences in mean scores were analysed. Mann-Whitney U test and Independent t-test were used to compare means of continuous variable, while Fisher’s exact test was used to compare categorical variables. Significance was set at p<0.05. Results: Sixty-one neonates received oral ketamine, while 60 received placebo. The intraoperative mean SpO2 were lower in the placebo group and significant at the tying stage with p=0.022. The mean intraoperative PR was higher in the placebo group and significant at dorsal-slit, tying and excision stages (p<0.05). The mean intraoperative NIPS scores were significantly higher in the placebo group. Conclusion: Oral ketamine provides effective and safe analgesia for neonatal Plastibell® circumcision in comparison to placebo.

scholarly journals A Feasibility Study of the Mistletoe and Breast Cancer (MAB) Trial: A Protocol for a Randomised Double-blind Controlled Trial

2020 ◽  
Author(s):  
Susan Bryant ◽  
Lorna Duncan ◽  
Gene Feder ◽  
Alyson Huntley
Keyword(s):  
Breast Cancer ◽  
Randomised Controlled Trial ◽  
Feasibility Study ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Cochrane Review ◽  
Double Blind ◽  
Randomised Controlled ◽  
The Uk ◽  
Mistletoe Therapy

Abstract Background: A Cochrane review of mistletoe therapy concludes that there is some evidence that mistletoe extracts may offer benefits on measures of quality of life during chemotherapy for breast cancer, but these results need replication. Our aim was to test the feasibility of a placebo controlled, double blind randomised controlled trial of mistletoe therapy in patients with breast cancer undergoing chemotherapy with or without radiotherapy. Methods/design: A placebo controlled, double blind randomised controlled trial of mistletoe therapy in patients with breast cancer. There will be three arms (groups) in the trial: Iscador M, Iscador P, with physiological saline as the placebo. The aim is to recruit 45 adult patients with a new diagnosis of early or locally advanced breast cancer, up to 12 weeks following definitive breast surgery whose standard treatment plan includes chemotherapy with or without radiotherapy. They will be taught to administer the MAB therapies subcutaneously and will titrate up to their optimal dose. MAB therapy will continue throughout their standard chemotherapy and radiotherapy and one month beyond. The main outcome of the MAB study is the feasibility of conducting such a trial within the NHS in order to inform a future fully powered investigative trial. Feasibility will be measured through recruitment, retention and patient experience using clinical research forms, patient diaries, cancer-related questionnaires and qualitative interviews conducted with both patients and oncology staff.Discussion: This trial is the first of its kind in the UK. Currently mistletoe therapy is mostly available through private practice in the UK. Completion of this feasibility study will support applications for further funding for a fully powered randomised controlled trial which will measure effectiveness and cost-effectiveness of this herbal therapy.

scholarly journals Delavirdine in Combination with Zidovudine in Treatment of Human Immunodeficiency Virus Type 1-Infected Patients: Evaluation of Efficacy and Emergence of Viral Resistance in a Randomized, Comparative Phase III Trial

2000 ◽  
Vol 44 (11) ◽  
pp. 3155-3157 ◽  
Author(s):  
Véronique Joly ◽  
Mauro Moroni ◽  
Ercole Concia ◽  
Adriano Lazzarin ◽  
Bernard Hirschel ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Human Immunodeficiency Virus Type ◽  
Virus Type ◽  
Controlled Trial ◽  
Antiviral Effect ◽  
Phase Iii ◽  
Cross Resistance ◽  
Double Blind ◽  
Immunodeficiency Virus

ABSTRACT We compared the activity of delavirdine (DLV) plus zidovudine (AZT) (n = 300) with that of AZT (n = 297) against human immunodeficiency virus type 1 in a randomized, double-blind, placebo-controlled trial. DLV exerted a transient antiviral effect, and mutations for resistance to DLV were found in more than 90% of subjects at week 12. The K103N mutation, which confers nonnucleoside reverse transcriptase inhibitor cross-resistance, was found in 85% of the patients.

When, If Ever, Is It Ethical to Do Research in Developing Countries That Could Not Be Done Ethically in Developed Countries?

2018 ◽  
pp. 122-144
Author(s):  
Lainie Friedman Ross
Keyword(s):  
United States ◽  
Developing Countries ◽  
Controlled Trial ◽  
Perinatal Transmission ◽  
Developed Countries ◽  
The United States ◽  
Haemophilus Influenzae Type ◽  
Haemophilus Influenzae Type B ◽  
Double Blind ◽  
Double Blind Placebo

In this chapter, three studies performed in the 1990s in three developing countries focused on three neonatal infectious diseases are discussed. The studies were (a) a randomized, double-blind, placebo-controlled trial to reduce perinatal transmission of HIV in Thailand; (b) a randomized, double-blind, placebo-controlled trial to prevent Haemophilus influenzae type b pneumonia in infants in The Gambia; and (c) a nonrandomized cluster trial to reduce neonatal mortality rate from sepsis in infants born at home in India. The chapter examines the ethical controversies raised by these studies and concludes that location and intention matter. Although these studies could not have been performed in the United States or United Kingdom, they were designed to answer a question relevant to the community in which the research was being conducted. Finally, the chapter explores the different ethical scrutiny these studies received and what lessons can be learned.

scholarly journals Treatment effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) combined With immunosuppression therapies in patients of IgA Nephropathy with high-risk of ESRD (TCM-WINE): study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Shen Li ◽  
Jin-pu Li
Keyword(s):  
Randomized Controlled Trial ◽  
High Risk ◽  
Iga Nephropathy ◽  
Controlled Trial ◽  
Combined Therapy ◽  
Eligible Patient ◽  
Developed Countries ◽  
Study Phase ◽  
Double Blind ◽  
Randomized Controlled

Abstract Background: IgA nephropathy (IgAN) is the most common glomerular disease worldwide. It has a high incidence in Asians and is more likely to progress to end-stage renal disease (ESRD). However, for high-risk IgAN clinically characterized by massive proteinuria and renal dysfunction, there has been no international consensus on treatment options. Compared with other developed countries, Chinese IgAN patients are often found to have severe kidney function loss at the initial diagnosis. Yi-Qi-Qing-Jie Formula Granule (a compound recipe of Chinese medicinal herbs, YQF) has shown potential renal protection in our previous clinical studies. To further confirm the efficacy and safety of YQF in the treatment of high-risk IgAN, we design a prospective double-blind randomized placebo-controlled trial. Methods/Design: The TCM-WINE study is a single-center, prospective, double-blind placebo-randomized controlled trial. We plan to randomize 60 participants with biopsy-proven IgAN to YQF combined group (YQF compound, combined with prednisolone, and cyclophosphamide if necessary) and immunosuppression group (placebo-YQF, combined with prednisolone, and cyclophosphamide if necessary). The two groups will enter 48-week in-trial treatment phase and receive post-trial follow-up till study completion (3-year). All patients will receive optimal supportive care. The primary composite outcome is defined as the first occurrence of a 40% decrease in estimated glomerular filtration rate (eGFR) from the baseline lasting for 3 months, initiating continuous renal replacement treatment or death due to chronic kidney disease (CKD), during the 3-year study phase. Secondary endpoint events are defined as the mean annual eGFR decline rate (eGFR-Slope, ml/min per 1.73 m 2 per year) which is calculated by the eGFR regression curve for each eligible patient, and proteinuria remission (prescribed as proteinuria<0.5g/day) at week 24, 36, 48 during the in-trial phase. Safety monitoring and assessment will be undertaken during the study . Discussion: TCM-WINE study will evaluate effects and safety of YQF combined therapy compared with immunosuppression monotherapy on basis of optimal supportive treatment in high-risk IgAN. The evidence from this study will provide a novel, effective and safe Chinese characteristics therapy for high-risk IgAN patients. Trial registration: Clinicaltrials.gov, identifier: NCT03418779. Registered on 18 June 2018. https://clinicaltrials.gov/show/NCT03418779

scholarly journals Early combination therapy with etanercept and methotrexate in JIA patients shortens the time to reach an inactive disease state and remission: Results of a double-blind placebo-controlled trial

2020 ◽  
Author(s):  
Ekaterina Alexeeva ◽  
Gerd Horneff ◽  
Tatyana Dvoryakovskaya ◽  
Rina Denisova ◽  
Irina Nikishina ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Controlled Trial ◽  
Randomized Study ◽  
Primary Objective ◽  
Disease State ◽  
Inactive Disease ◽  
Open Label ◽  
Standard Regimen ◽  
Double Blind ◽  
Early Combination Therapy

Abstract Background Remission is the primary objective of treating juvenile idiopathic arthritis (JIA). It is still debatable whether early intensive treatment is superior in terms of earlier achievement of remission. The aim of this study was to evaluate the effectiveness of early etanercept+methotrexate (ETA+MTX) combination therapy versus step-up MTX monotherapy with ETA added in refractory disease. Methods A multi-centre, double-blind, randomized study in active polyarticular JIA patients treated with either ETA+MTX (n=35) or placebo+MTX (n=33) for up to 24 weeks, followed by a 24-week open-label phase. The efficacy endpoints included pedACR30 criteria improvement at week 12, inactive disease at week 24, and remission at week 48. Patients who failed to achieve the endpoints at week 12 or at week 24 escaped to open-label ETA+MTX. Safety was assessed at each visit. Results By intention-to-treat analysis, more patients in the ETA+MTX group reached the pedACR30 response at week 12 (33 (94.3%)) than in the placebo+MTX group (20 (60.6%); p=0.001). At week 24, comparable percentages of patients reached inactive disease (11 (31.4%) vs 11 (33.3%)). At week 48, 11 (31.4%) and eight (24.2%) patients achieved remission. The median (+/-IQR) times to achieve an inactive disease state in the ETA+MTX and placebo+MTX groups were 24 (14–32) and 32 (24–40) weeks, respectively. Forty-four (74/100 patient-years) adverse events (AEs) were reported, leading to treatment discontinuation in 6 patients.Conclusions Early combination therapy with ETA+MTX proved to be highly effective compared to the standard step-up regimen. Compared to those treated with the standard regimen, more patients treated with a combination of ETA+MTX reached the pedACR30 response and achieved inactive disease and remission more rapidly.Trial registrationThe study was registered by the European Clinical Trials Database (EudraCT) as 2015-003384-11 on 07-21-2014.

scholarly journals Treatment effects of Chinese medicine (Yi-Qi-Qing-Jie herbal compound) combined with immunosuppression therapies in patients of IgA nephropathy with high-risk of ESRD (TCM-WINE): study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Jin-pu Li ◽  
Shen Li
Keyword(s):  
High Risk ◽  
Iga Nephropathy ◽  
Remission Rate ◽  
Controlled Trial ◽  
Combined Therapy ◽  
Eligible Patient ◽  
Developed Countries ◽  
Study Phase ◽  
International Consensus ◽  
Double Blind

Abstract Background: IgA nephropathy (IgAN) is the most common glomerular disease worldwide. It has a high incidence in Asians and is more likely to progress to end-stage renal disease (ESRD). For high-risk IgAN, which is clinically characterized by massive proteinuria and renal dysfunction, however, there has been no international consensus on treatment options. Compared with other developed countries, IgAN patients in China are often found to have severe kidney function loss at initial diagnosis. Yi-Qi-Qing-Jie Formula Granule (a compound recipe of Chinese medicinal herbs, YQF) has shown potential renal protection in our previous clinical studies. To further confirm the efficacy and safety of YQF in the treatment of high-risk IgAN, we design a prospective double-blind randomized placebo-controlled trial. Methods/Design: The TCM-WINE study is a single-center, prospective, double-blind randomized placebo-controlled trial. We plan to randomize 60 participants with biopsy-proven IgAN to YQF combined group (YQF compound, combined with prednisolone, and cyclophosphamide if necessary) and immunosuppression group (placebo-YQF, combined with prednisolone, and cyclophosphamide if necessary). The two groups will enter 48-week in-trial treatment phase and receive post-trial follow-up till study completion (3-year). All patients will receive optimal supportive care. The primary composite outcome is defined as the first occurrence of 40% decrease in estimated glomerular filtration rate (eGFR) from the baseline lasting for 3 months, initiating continuous renal replacement treatment or death due to chronic kidney disease (CKD), during the 3-year study phase. The secondary endpoint events are defined as the mean annual eGFR decline rate (eGFR-Slope, ml/min per 1.73 m2 per year) which is calculated by the eGFR regression curve for each eligible patient, and proteinuria remission (prescribed as proteinuria<0.5g/day) at week 24, 36, 48 during the in-trial phase. The remission rate of symptoms and inflammation status will be evaluated respectively at week 48. Safety monitoring and assessment will be undertaken during the study. Discussion: TCM-WINE study will evaluate effects and safety of YQF combined therapy compared with immunosuppression monotherapy on basis of optimal supportive treatment in high-risk IgAN. The evidence from this study will provide a novel, effective and safe Chinese characteristic therapy for high-risk IgAN patients. Trial registration: Clinicaltrials.gov, identifier: NCT03418779. Registered on 18 June 2018. https://clinicaltrials.gov/show/NCT03418779

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