The Efficacy and Safety of Methylnaltrexone for the Treatment of Postoperative Ileus

2021 ◽  
pp. 000313482110488
Author(s):  
Jennifer Beavers ◽  
Lindsay Orton ◽  
Leanne Atchison ◽  
Andrew Medvecz ◽  
Bradley Dennis ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Postoperative Ileus ◽  
Primary Outcome ◽  
Surgical Complication ◽  
Opioid Antagonist ◽  
Control Group ◽  
Efficacy And Safety ◽  
Gastrointestinal Malignancy ◽  
Gastric Decompression ◽  
Bowel Rest

Background Postoperative ileus (POI) is a surgical complication resulting in increased morbidity and length of stay (LOS). Usual care for POI includes bowel rest and gastric decompression. It has been questioned if methylnaltrexone (MNTX), a peripheral opioid antagonist, could be used as treatment for POI. The purpose of this study was to determine if MNTX is effective and safe for POI treatment. Methods This single-center, retrospective cohort study included patients ⩾ 18 years with a POI. Patients with acute colonic pseudo-obstruction, small bowel obstruction, and gastrointestinal malignancy were excluded. The intervention was MNTX administration. The primary outcome was time to ileus resolution. Secondary outcomes included LOS, duration of nasogastric tube, total parenteral nutrition requirement, and incidence of gastrointestinal perforations. Results 110 patients were included in the analysis; 28 received MNTX. Time to ileus resolution was 9.9 days for the MNTX group and 11.4 days for the control group ( P = .38). Duration of gastric decompression was 4.6 days for the MNTX group and 4.2 days for the control group ( P = .71). Length of stay was 19.9 days for the MNTX group and 19.7 days for the control group ( P = .96). The percentage of TPN requirement was 17.9% in the MNTX group and 22.0% in the control group ( P = .65). No gastrointestinal perforations were observed in either group. Conclusion For the treatment of POI, MNTX did not significantly reduce time to resolution of ileus, LOS, duration of gastric decompression, or TPN requirements. However, no gastrointestinal perforations were seen, indicating that MNTX may be safely used in these patients.

scholarly journals A Randomized Clinical Trial of the Efficacy and Safety of Interferon β-1a in Treatment of Severe COVID-19

2020 ◽  
Vol 64 (9) ◽  
Author(s):  
Effat Davoudi-Monfared ◽  
Hamid Rahmani ◽  
Hossein Khalili ◽  
Mahboubeh Hajiabdolbaghi ◽  
Mohamadreza Salehi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Response ◽  
Randomized Clinical Trial ◽  
Primary Outcome ◽  
Discharge Rate ◽  
Control Group ◽  
Efficacy And Safety ◽  
Interferon Β ◽  
Mortality Effect ◽  
Overall Mortality

ABSTRACT To the best of our knowledge, there is no published study on the use of interferon β-1a (IFN β-1a) in the treatment of severe COVID-19. In this randomized clinical trial, the efficacy and safety of IFN β-1a were evaluated in patients with severe COVID-19. Forty-two patients in the interferon group received IFN β-1a in addition to the national protocol medications (hydroxychloroquine plus lopinavir-ritonavir or atazanavir-ritonavir). Each 44-μg/ml (12 million IU/ml) dose of interferon β-1a was subcutaneously injected three times weekly for two consecutive weeks. The control group consisted of 39 patients who received only the national protocol medications. The primary outcome of the study was time to reach clinical response. Secondary outcomes were duration of hospital stay, length of intensive care unit stay, 28-day mortality, effect of early or late administration of IFN on mortality, adverse effects, and complications during the hospitalization. Between 29 February and 3 April 2020, 92 patients were recruited, and a total of 42 patients in the IFN group and 39 patients in the control group completed the study. As the primary outcome, time to the clinical response was not significantly different between the IFN and the control groups (9.7 ± 5.8 versus 8.3 ± 4.9 days, respectively, P = 0.95). On day 14, 66.7% versus 43.6% of patients in the IFN group and the control group, respectively, were discharged (odds ratio [OR], 2.5; 95% confidence interval [CI], 1.05 to 6.37). The 28-day overall mortality was significantly lower in the IFN than the control group (19% versus 43.6%, respectively, P = 0.015). Early administration significantly reduced mortality (OR, 13.5; 95% CI, 1.5 to 118). Although IFN did not change the time to reach the clinical response, adding it to the national protocol significantly increased discharge rate on day 14 and decreased 28-day mortality. (This study is in the Iranian Registry of Clinical Trials under identifier IRCT20100228003449N28.)

scholarly journals Efficacy and Safety of Interferon Beta-1b in the Management of Patients with COVID-19: A Prospective, Open-Label, Non-Randomized Trial

2021 ◽  
Author(s):  
Nima Rouhani ◽  
Elahe Karimpour-razkenari ◽  
Mostafa Alizadeh Forutan ◽  
Monireh Ghazaeian ◽  
Ebrahim Salehifar ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Interferon Beta ◽  
Clinical Symptoms ◽  
Therapeutic Option ◽  
Control Group ◽  
Efficacy And Safety ◽  
Invasive Ventilation ◽  
Open Label ◽  
Open Label Study ◽  
Duration Of Hospital Stay

Backgrounds: There is no proven therapy for coronavirus disease 2019 (COVID-19) so far. The aim of this study was to evaluate the effect of interferon beta-1b combined with lopinavir/ritonavir and hydroxychloroquine in managing COVID-19. Methods: This is a non-randomized, open-label study on adult patients with moderate to severe COVID-19. The patients (≥ 18 years) received hydroxychloroquine 400 mg single dose, and lopinavir 400 mg/ritonavir 100 mg every 12 h (for 7-10 days) with or without subcutaneous interferon (IFN) beta-1b 250 mcg every other day for e primary outcome was clinical improvement in NEWS2 changes. Duration of hospital stay, mortality rate, and safety profile of therapeutic regimens were secondary outcomes. Results: Between March 20 and April 3, 2020, a total of 114 patients were recruited and 59 patients completed the study. The IFN group had a significant improvement in clinical symptoms due to a significant reduction in NEWS2 (83.3% (25) vs 48.3% (14), P= 0.004). The time to clinical response in the IFN group was shorter than the control group (7 (5-12) days vs 9.5 (7-18), P=0.037). The IFN group also showed a significantly lower rate of 28-day mortality (6.8% (2) vs 34.5% (10), P= 0.01) and a lower need for invasive ventilation (6.8% (2) vs 34.5 (10), P= 0.008). Although the duration of ICU stay was marginally shorter in the IFN group, the results were not significantly different between the two groups (P=0.06). Conclusion: IFN beta-1b could be a potential therapeutic option for patients with moderate to severe COVID-19. 

scholarly journals Efficacy and safety of interferon beta-1a in treatment of severe COVID-19: A randomized clinical trial

2020 ◽  
Author(s):  
Effat Davoudi-Monfared ◽  
Hamid Rahmani ◽  
Hossein Khalili ◽  
Mahboubeh Hajiabdolbaghi ◽  
Mohamadreza Salehi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Response ◽  
Randomized Clinical Trial ◽  
Primary Outcome ◽  
Interferon Beta ◽  
Discharge Rate ◽  
Standard Of Care ◽  
Control Group ◽  
Efficacy And Safety ◽  
Mortality Effect

Objectives: To the best of our knowledge, there is no published study regarding use of IFN beta-1a in the treatment of severe COVID-19. In this randomized clinical trial efficacy and safety of IFN β-1a has been evaluated in patients with severe COVID-19. Methods: Forty-two patients in the interferon group received IFN beta-1a in addition to the standard of care. Each 44 micrograms/ml (12 million IU/ml) of interferon beta-1a was subcutaneously injected three times weekly for two consecutive weeks. The control group received only the standard of care. Primary outcome of study was time to reach clinical response. Secondary outcomes duration of hospital stay, length of ICU stay, 28-day mortality, effect of early or late administration of IFN on mortality, adverse effects and complications during the hospitalization. Results: As primary outcome, time to the clinical response was not significantly different between the IFN and the control groups (9.7 +/- 5.8 vs. 8.3 +/- 4.9 days respectively, P=0.95). On day 14, 66.7% vs. 43.6% of patients in the IFN group and the control group were discharged, respectively (OR= 2.5; 95% CI: 1.05- 6.37). The 28-day overall mortality was significantly lower in the IFN then the control group (19% vs. 43.6% respectively, p= 0.015). Early administration significantly reduced mortality (OR=13.5; 95% CI: 1.5-118). Conclusion: Although did not change time to reach the clinical response, adding to the standard of care significantly increased discharge rate on day 14 and decreased 28-day mortality. Clinical Trial Registration ID #IRCT20100228003449N28.

Abstract 14373: Efficacy and Safety of Antihypertensive Drug Classes: The Systolic Blood Pressure Intervention Trial (SPRINT)

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Christina Byrne ◽  
Anubodh Varshney ◽  
Zaid Almarzooq ◽  
Kristian H Kragholm ◽  
Maria L Krogager ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Adverse Events ◽  
Systolic Blood Pressure ◽  
Antihypertensive Drug ◽  
Primary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Drug Classes ◽  
Safety Outcomes

Purpose: To assess the efficacy and safety of antihypertensive drug classes, including angiotensin converting enzyme inhibitors/angiotensin II receptor blockers (ACEi/ARB), beta blockers (BB), calcium channel blockers (CCB), and thiazide diuretics (TD), in subjects at high cardiovascular (CV) risk. Methods: SPRINT was a randomized, controlled, open-label trial in which individuals without diabetes aged ≥50 years, at high CV risk, and with a systolic blood pressure (SBP) 130-180 mmHg were randomized to intensive (SBP target <120mmHg) or standard BP control (SBP target 135-139 mmHg). The primary outcome was the composite of acute coronary syndromes, stroke, heart failure, or CV death. Safety outcomes included serious adverse events, i.e., hypotension, syncope, electrolyte abnormalities, acute kidney injury or failure, and falls. Associations between baseline antihypertensive drug classes, efficacy, and safety outcomes, stratified by level of SBP control, were examined using Cox proportional-hazards regression. Results: Of 9361 participants, baseline use of antihypertensive agents was as follows: ACEi/ARB in 1317 (14%), BB in 911 (10%), CCB in 796 (9%), and TD in 979 (10%). A total of 1366 (15%) subjects did not have a record of being on an antihypertensive drug at baseline. In the intensive BP control group, use of a BB-based regimen at baseline was associated with a significantly higher risk of the primary outcome when compared with no medications ( Figure ). Similar patterns were observed for secondary efficacy endpoints. The risk of serious adverse events tended to be lower in patients receiving a treatment regimen containing either an ACEi/ARB or a TD compared with those receiving a regimen containing a BB or a CCB ( Figure ). Conclusions: In SPRINT, the risk of adverse events was lowest in patients who were not on an antihypertensive drug at baseline. ACEi/ARB-based and TD-based regimens appeared to have the best balance between efficacy and safety.

scholarly journals Efficacy and Safety of Electro-Acupuncture (EA) on Insomnia in Patients with Lung Cancer: Study Protocol of a Randomized Controlled Trial

2020 ◽  
Author(s):  
Hongyu Yue ◽  
Shuang Zhou ◽  
Huangan Wu ◽  
Xuan Yin ◽  
Shanshan Li ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Cancer Survivors ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Control Group ◽  
Life Questionnaire ◽  
Efficacy And Safety ◽  
Secondary Outcomes

Abstract Background : Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients’ quality of life. As a popular non-pharmacological alternative treatment, acupuncture provides a good clinical curative effect on insomnia. The aim of this trial is to evaluate efficacy and safety of electro-acupuncture on insomnia in patients with lung cancer. Method : This is a protocol for a multicenter randomized single-blinded sham-controlled trial. We will randomly assign 252 eligible patients with lung cancer-related insomnia into two groups at a ratio of 1:1, the treatment group (EA) and the control group (sham EA). All treatment will be given 3 times per week for 8 weeks, and a 12-week follow-up will be conducted. The primary outcome will be measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will include sleep parameters recorded from the actigraphy, scores from Quality of Life Questionnaire Core-30 (QLQ-C30), and Patient Health Questionnaire-9 (PHQ-9). All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS). The primary outcome will be assessed at baseline, week 4, week 8, week 12 and week 20. The secondary outcomes will only be assessed at baseline and week 8. Discussion : This large-sample trial protocol will evaluate the efficacy of electro-acupuncture on insomnia in patients with lung cancer. This protocol, if proven to be effective, will contribute to filling the gap in treatment options in the CRI field and provide a promising intervention for insomnia in lung cancer survivors. Trial registration: ChiCTR, ChiCTR1900026395, Registered 8 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=44068

OBTAIN E: outcome benefits of tranexamic acid in hip arthroplasty with enoxaparin: a randomised double-blinded controlled trial

2018 ◽  
Vol 29 (3) ◽  
pp. 239-244 ◽  
Author(s):  
Andrew Fraval ◽  
Sam Duncan ◽  
Theresa Murray ◽  
Jeremy Duggan ◽  
Oren Tirosh ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Hip Arthroplasty ◽  
Anterior Approach ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Control Group ◽  
Thigh Swelling ◽  
Double Blinded

Background: We examined the blood conserving effect of tranexamic acid in total hip arthroplasty using the direct anterior approach with enoxaparin as deep vein thrombosis (DVT) chemoprophylaxis, and whether this translates to an effect on functional outcomes in the perioperative period. We also compare the effect of aspirin and enoxaparin as DVT chemoprophylactic agents. Methods: We conducted a single-centre randomised, double-blinded, placebo-controlled trial. 105 patients were randomised to receive either tranexamic acid or an equivalent volume of normal saline with enoxaparin used as DVT chemoprophylaxis. The primary outcome measure was thigh swelling. Blood loss and the incidence of blood transfusions was also recorded. Secondary outcome measures including postoperative functional scores and mobility, pain scores and length of stay. We also compared and pooled the results of a previous study with the same study intervention methodology which used aspirin as DVT chemoprophylaxis instead of enoxaparin. Results: There were no statistically significant differences between the primary outcome of thigh swelling. There was significantly less intraoperative blood loss observed in the tranexamic acid (TXA) group (0.510 L, SD 0.210) compared with the control group (0.698, SD 0.301) ( p < 0.001). The estimated blood loss was also significantly less in the TXA group (1.130 L, SD 0.311) compared with the control group (1.48 L, SD 0.510) ( p < 0.001). Pooled data of both consecutive trials showed there was a statistically significant reduction in length of stay for those that received TXA (3.72 days, SD 0.83 versus 4.24 days, SD 0.97, p < 0.001). There was also a statistically significant increased risk of a transfusion in the control group as compared those that received TXA (OR 5.5, 1.188 to 25.449, p = 0.029). There was no difference in blood loss between DVT chemoprophylactic agents. Interpretation: TXA is an effective agent in reducing blood loss in THR using the anterior approach and was not affected by choice of DVT chemoprophylaxis. Patients who received TXA had fewer transfusions and a reduction in their length of stay. The blood conserving effect of TXA was not associated with improved postoperative recovery across the measures of pain and mobility. Clinical trials registration: ANZCTR number: ACTRN12616000606482.

scholarly journals Outcomes of Alvimopan Use in Laparoscopic Intra-abdominal Surgery: A Retrospective Review

2021 ◽  
Vol 12 (4) ◽  
pp. 12
Author(s):  
Aamir A. Kokan ◽  
Sahil Sheth ◽  
Katherine Rogers
Keyword(s):  
Length Of Stay ◽  
Abdominal Surgery ◽  
Postoperative Ileus ◽  
Primary Outcome ◽  
Bowel Resection ◽  
Retrospective Chart Review ◽  
Abdominal Distension ◽  
Secondary Outcomes ◽  
The Impact ◽  
Oral Diet

Background: Postoperative ileus is a transient cessation of bowel motility, occurring after bowel resection, characterized by abdominal distension and pain, nausea, vomiting, and an accumulation of gas/fluids in the bowel. It is associated with a greater incidence of postoperative morbidity and increased length of stay or readmission. Alvimopan, a novel peripheral mu receptor antagonist, is indicated for preventing postoperative ileus in patients undergoing intra-abdominal surgery or bowel resection. The objective of this study was to assess the impact of alvimopan use in laparoscopic abdominal surgeries. Objective: To assess alvimopan use’s impact in laparoscopic abdominal surgeries. Methods: A retrospective chart review was conducted of 84 patients who underwent laparoscopic procedures that received alvimopan (September 1, 2018 to October 31, 2018) and compared to patients that did not receive alvimopan (May 1, 2018 to June 30, 2018, due to a national shortage of the medication). The primary outcome was the rate of postoperative ileus. Secondary outcomes included rate of 30-day readmission, length of stay (LOS), postoperative opioid and laxative use, time to initiation of oral diet, and return of bowel function (ROBF) as demonstrated by recorded bowel movement. Results: There was no statistical difference observed in primary outcome of postoperative ileus between alvimopan and no alvimopan groups (2.7% vs 4.3%, p=1). Secondary outcomes such as length of stay (5.4 days vs 5.4 days, p=0.49), length of postoperative stay (5 vs 4.9, p=0.44), days to oral diet (0.9 vs 0.4, p=0.16), time to BM (1.8 vs 2.2, p=0.32), and 30-day readmission were also similar between the two groups. Conclusion: The similar outcome profiles in all primary and secondary outcomes do not support the use of alvimopan in the setting of laparoscopic intra-abdominal surgery.

scholarly journals The efficacy and safety of fast track surgery (FTS) in patients after hip fracture surgery: a meta-analysis

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Mingyang Jiang ◽  
Siyi Liu ◽  
Huachu Deng ◽  
Xuzhi Liang ◽  
Zhandong Bo
Keyword(s):  
Length Of Stay ◽  
Fast Track ◽  
Meta Analysis ◽  
Pressure Sore ◽  
Research Literature ◽  
Control Group ◽  
Efficacy And Safety ◽  
Fast Track Surgery ◽  
Standard Mean Difference ◽  
Hospitalization Costs

Abstract Background Fast track surgery (FTS) has been gradually applied in perioperative management of orthopedic surgery, but there still some research suspected that the prognosis of patients is not as expected and the cost is high, the effect of the FTS still urgently needed for support by evidence-based medicine. Methods We retrieved RCTs from medical research literature databases. Risk ratios (RR), standard mean difference (SMD), and 95% confidence intervals (CI) were calculated to compare the primary and safety endpoints. Results Overall, a total of 8886 patients were retrieved from 57 articles, of which 4448 patients (50.06%) were randomized to experimental group whereas 4438 patients (49.94%) were randomized to control group. The result showed that FTS could significantly shorten the length of stay (LOS), decrease the visual analog scale (VAS), reduce the leaving bed time and the hospitalization costs, and improve Harris hip joint function score. The incidence of complications such as respiratory system infection, urinary system infection, venous thrombus embolism (VTE), pressure sore, incision infection, constipation, and prosthesis dislocation also has been decreased significantly. Meanwhile, FTS improved patients’ satisfaction apparently. Conclusions This meta-analysis reveals that FTS could significantly shorten the length of stay, alleviate the pain, reduce the leaving bed time and the hospitalization costs, and improve hip function. The incidence of complications also has been decreased significantly. Meanwhile, FTS has been spoken highly in patients in terms of nursing satisfaction. Its efficacy and safety were proved to be reliable.

Thromboembolic complications prevention in the obstetric practice

2017 ◽  
pp. 19-24
Author(s):  
O.V. Grishchenko ◽  
◽  
V.V. Bobrytska ◽  
Keyword(s):  
Pulmonary Embolism ◽  
Comparison Group ◽  
Main Group ◽  
Control Group ◽  
Efficacy And Safety ◽  
Thromboembolic Complications ◽  
Moderate Risk ◽  
Obstetric Practice ◽  
Thrombotic Complications ◽  
And Control

The objective: To evaluate the clinical efficacy and safety of Enoxaparin-Pharmex for the prevention of thrombotic complications (pulmonary embolism) in the postoperative period in patients with moderate risk of these complications. Patients and methods. The study included 50 women after a caesarean section had an average degree of risk of pulmonary embolism. Patients were divided into the main group (n=25) and control group (n=25) in accordance with the treatment: patients of the main group received postoperative Еnoxaparin- Pharmex, group comparisons enoxaparin sodium (brand foreign manufacturer’s). Patients in both groups received the drug at a dose of 20 mg for 5 days, 1 time per day subcutaneously. Results. The research data analysis showed identity results of hemostasiogram of patients in the main group and the comparison group, no side effects after treatment in both groups. Conclusion. The clinical studies suggest the drug Enoxaparin-Pharmex is effective, safe LMWH, which can be used to prevent troboembolic complications, including post-operative treatment in obstetric practice. Spectrum of Enoxaparin-Pharmex can be extended to the prevention and treatment of thromboembolic conditions of varying severity with appropriate doses of the drug. Key words: Enoxaparin-Pharmex, prevention of pulmonary embolism.

Efficacy and Safety of Non-Steroidal Anti-Androgens in Patients with Metastatic Prostate Cancer: Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 15 (1) ◽  
pp. 34-47 ◽  
Author(s):  
Muhammed Rashid ◽  
Madhan Ramesh ◽  
K. Shamshavali ◽  
Amit Dang ◽  
Himanshu Patel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Quality Assessment ◽  
Cochrane Library ◽  
Control Group ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.

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