scholarly journals SUN-356 Burosumab Resulted in Greater Clinical Improvements Compared with Higher-dose Conventional Therapy in Children with X-linked Hypophosphatemia (XLH)

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Erik A Imel ◽  
Angel Chen ◽  
Ting Chang ◽  
Mary Scott Roberts ◽  
Leanne Marie Ward
Keyword(s):  
Lower Limb ◽  
Conventional Therapy ◽  
Human Monoclonal Antibody ◽  
Least Square ◽  
Eligibility Criteria ◽  
Limb Deformity ◽  
The Mean ◽  
D 12 ◽  
Global Impression Of Change ◽  
Post Hoc

Abstract In XLH, excess circulating FGF23 causes hypophosphatemia, rickets, lower limb deformity, and impaired growth and mobility. An active-controlled, phase 3 trial (CL301; NCT02915705) showed treatment with burosumab, a fully human monoclonal antibody against FGF23, resulted in significantly greater improvements in all of these outcomes in children with XLH, compared with continuing oral phosphate and active vitamin D as conventional therapy (Pi/D) per established guidelines. In a post-hoc analysis, we compared children who received burosumab vs those who received an average 64-week oral phosphate daily dose >40 mg/kg (higher-dose Pi) vs ≤40 mg/kg (lower-dose Pi). Sixty-one children with XLH (1–12 years-old) were randomized 1:1 after a 7-day Pi/D washout to receive burosumab (n=29) starting at 0.8 mg/kg subcutaneously Q2W or to resume Pi/D (n=32) titrated by their investigator, for 64 weeks. Eligibility criteria included Rickets Severity Score (RSS) ≥2.0 despite prior Pi/D treatment. Of the 32 subjects randomized to Pi/D, 12 received average higher-dose Pi and 20 received average lower-dose Pi (as specified above). The primary endpoint was rickets healing, using the Radiographic Global Impression of Change (RGI-C) Scale. At week 64, the improvement in the least square (LS) mean (LS mean [±SE; 95%CI]) RGI-C Global Score for rickets was greater on burosumab (+2.06 [0.072; 1.92, 2.20]) compared with either higher-dose (+1.02 [0.241; 0.55, 1.50]) or lower-dose (+1.04 [0.162; 0.73, 1.36]) Pi. The mean decrease in the total RSS from baseline was also greater on burosumab (-2.23 [0.117; -2.46, -2.00]) compared with higher-dose (-0.87 [0.264; -1.39, -0.35] or lower-dose (-1.09 [0.180; -1.45, -0.74]) Pi. Similarly, the mean RGI-C Lower Limb Deformity Score was greater on burosumab (+1.25 [0.170; 0.92, 1.59]) compared with either higher-dose (+0.32 [0.188; -0.05, 0.69]) or lower-dose (+0.26 [0.146; -0.02, 0.55]) Pi. Adverse events including hypersensitivity and injection site reactions, were more frequent with burosumab, and were mild to moderate in severity overall. No discontinuations occurred. In conclusion, children with XLH treated with burosumab had greater improvements in rickets and lower limb deformity compared with subjects receiving higher or lower doses of Pi.

scholarly journals Burosumab Provides Sustained Improvement in Phosphorus Homeostasis and Heals Rickets in Children Aged 1 to 4 Years With X-Linked Hypophosphatemia (XLH)

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A251-A251
Author(s):  
Gary Gottesman ◽  
Erik Allen Imel ◽  
Thomas O Carpenter ◽  
Angel Chen ◽  
Alison Skrinar ◽  
...  
Keyword(s):  
Lower Limb ◽  
Human Monoclonal Antibody ◽  
Study Drug ◽  
Fasting Serum ◽  
Open Label ◽  
Limb Deformity ◽  
Safety Concerns ◽  
Open Label Phase ◽  
Grade 3 ◽  
Global Impression Of Change

Abstract XLH is the most common heritable rickets. Affected children have high levels of circulating FGF23 that cause hypophosphatemia with consequent rickets and lower limb deformity. Burosumab, a fully human monoclonal antibody that binds FGF23, is FDA-approved for the treatment of XLH in children ≥6 months old and adults. Herein, we report final, 3-year safety and efficacy data from an open-label, phase 2 study of burosumab in children 1 to <5 years old at baseline (NCT02750618). Eligibility required hypophosphatemia and radiographic evidence of rickets. The primary efficacy endpoint was change from baseline in fasting serum phosphorus (Pi). Secondary endpoints included Rickets Severity Score (RSS) and Radiographic Global Impression of Change (RGI-C). Patients received burosumab subcutaneous Q2W starting at 0.8 mg/kg for 160 weeks (64-week treatment + 96-week treatment extension periods). All 13 enrolled patients completed the 64-week treatment period; 1 left the study to transition to commercially available burosumab, and 12 completed all 160 weeks. Baseline mean (SD) age was 2.9 (1.1) years; 69% were boys; all had previously received oral phosphate salts and active vitamin D. Burosumab rapidly corrected fasting serum Pi with mean (SD) levels of 2.5 (0.3) mg/dL at Baseline, 3.7 (0.5) mg/dL at Week 1 (W1), 3.4 (0.5) mg/dL at W64, and 3.4 (0.5) mg/dL at W160 (normal range: 3.2–6.1 mg/dL). Lower RSS indicated improved rickets. Total RSS decreased from 2.9 (1.4) at Baseline to 1.2 (0.5) at W40 and to 0.9 (0.5) at W64 and was maintained through W160 [1.0 (0.6)]. Positive RGI-C scores indicate healing rickets relative to Baseline. Global RGI-C scores indicating substantial healing (≥+2) at W40 [+2.2 (0.3)] and W64 [+2.2 (0.4)] were maintained through W160 [+2.2 (0.4)]. Similarly, lower limb deformity RGI-C scores were +1.2 (0.6) at W40 and +1.5 (0.5) at W64, and sustained healing was evident at W160 [+2.0 (0.3)]. Wrist and knee RSSs and RGI-C scores similarly improved. The upper limit of normal for serum ALP ranged from 297 to 345 U/L depending on the child’s age and sex. Mean ALP was 549 (194) U/L at Baseline, normalized by W40 [335 (88) U/L], and was sustained through W160 [302 (71) U/L]. The burosumab safety profile over 160 weeks resembled previous pediatric studies; no new safety concerns emerged. All patients had ≥1 treatment-emergent adverse event (TEAE). All TEAEs were mild (Grade 1) or moderate (Grade 2) except for one patient with a grade 3 TEAE (food allergy) and one with a grade 3 TEAE (increased serum amylase, 92% salivary/8% pancreatic). One patient had a serious TEAE (dental abscess leading to hospitalization). These grade 3 and serious TEAEs were considered unrelated to study drug. Burosumab rapidly restored Pi homeostasis, improved rickets, and normalized serum ALP in children with XLH aged 1 to <5 years with no new safety concerns. Improvements were maintained during the 3 years of treatment.

Lower limb deformity correction with a simple non-surgical technique

2019 ◽  
Vol 70 (4) ◽  
Author(s):  
Marianna Faggiani ◽  
Selena Desayeux ◽  
Giovanni Martino ◽  
Eraclite Petruccelli ◽  
Alessandro Aprato ◽  
...  
Keyword(s):  
Surgical Technique ◽  
Lower Limb ◽  
Deformity Correction ◽  
Limb Deformity

Deep brain stimulation of the posterior limb of the internal capsule in the treatment of central poststroke neuropathic pain of the lower limb: case series with long-term follow-up and literature review

2020 ◽  
Vol 133 (3) ◽  
pp. 830-838 ◽  
Author(s):  
Andrea Franzini ◽  
Giuseppe Messina ◽  
Vincenzo Levi ◽  
Antonio D’Ammando ◽  
Roberto Cordella ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Lower Limb ◽  
Internal Capsule ◽  
Posterior Limb ◽  
Vas Score ◽  
The Mean ◽  
Deep Brain ◽  
Stimulation Of

OBJECTIVECentral poststroke neuropathic pain is a debilitating syndrome that is often resistant to medical therapies. Surgical measures include motor cortex stimulation and deep brain stimulation (DBS), which have been used to relieve pain. The aim of this study was to retrospectively assess the safety and long-term efficacy of DBS of the posterior limb of the internal capsule for relieving central poststroke neuropathic pain and associated spasticity affecting the lower limb.METHODSClinical and surgical data were retrospectively collected and analyzed in all patients who had undergone DBS of the posterior limb of the internal capsule to address central poststroke neuropathic pain refractory to conservative measures. In addition, long-term pain intensity and level of satisfaction gained from stimulation were assessed. Pain was evaluated using the visual analog scale (VAS). Information on gait improvement was obtained from medical records, neurological examination, and interview.RESULTSFour patients have undergone the procedure since 2001. No mortality or morbidity related to the surgery was recorded. In three patients, stimulation of the posterior limb of the internal capsule resulted in long-term pain relief; in a fourth patient, the procedure failed to produce any long-lasting positive effect. Two patients obtained a reduction in spasticity and improved motor capability. Before surgery, the mean VAS score was 9 (range 8–10). In the immediate postoperative period and within 1 week after the DBS system had been turned on, the mean VAS score was significantly lower at a mean of 3 (range 0–6). After a mean follow-up of 5.88 years, the mean VAS score was still reduced at 5.5 (range 3–8). The mean percentage of long-term pain reduction was 38.13%.CONCLUSIONSThis series suggests that stimulation of the posterior limb of the internal capsule is safe and effective in treating patients with chronic neuropathic pain affecting the lower limb. The procedure may be a more targeted treatment method than motor cortex stimulation or other neuromodulation techniques in the subset of patients whose pain and spasticity are referred to the lower limbs.

Digital volumetric measurements based on 3D scans of the lower limb: A valid and reproducible method for evaluation in lymphedema therapy. (Preprint)

2019 ◽  
Author(s):  
Daniel Schiltz ◽  
Natalie Kiermeier ◽  
Dominik Eibl ◽  
Christoph Koch ◽  
Karolina Müller ◽  
...  
Keyword(s):  
Lower Limb ◽  
Lower Leg ◽  
T Test ◽  
Volume Changes ◽  
Quick Method ◽  
Reproducible Method ◽  
The Mean ◽  
3D Scans ◽  
Paired T Test ◽  
Volumetric Measurements

BACKGROUND Exact quantification of volumetric changes of the extremities is difficult. There are several direct and indirect methods to assess extremity volume. As water displacement volumetry is rarely viable in a clinical setting and circumference measurements are prone to errors due to poor reproducibility and high inter- and intra-observer variability, an objective and easily reproducible method is indispensable. OBJECTIVE The aim of this study was to establish a standardized method based on 3D scans with defined caudal and cranial landmarks of the lower leg which allows for measurements of exactly the same body area. Furthermore, this study tests the method in terms of reproducibility and evaluates volume changes after surgical therapy in patients suffering from lymphedema. METHODS 3D-scans of the lower limb were performed with a mobile 3D-scanner. Volumetric calculation was done digitally. “Repeatability“ and “Inter-observer reliability” of digital volumetry were tested. Furthermore, the method was applied on 31 patients suffering from chronic lymphedema. ANOVA (analyses of variance) was conducted to compare the digital volumetric measurements. To assess the sensitivity to changes in digital volumetry, the mean volume of 31 patients before and 3 months after therapy were compared by a paired t-Test. RESULTS Calculations of repeatability of the volume based on 20 3D-scans of the same lower leg showed a mean volume of 2,488 ± 0,011 liters (range: 2,470 – 2,510). The mean volume of the 7 measurements of the 3 examiners did not differ significantly (F(2,18) = 1,579, p = .233). The paired t-Test showed a significant mean volume decrease of 375ml (95% CI = 245/505ml) between pre and post treatment (t (30) =5,892, p < .001). CONCLUSIONS 3D-Volumetry is a noninvasive, easy and quick method to assess volume changes of the lower leg. Other than the costs, it is reproducible and precise and therefore ideal for evolution of therapy in lymphedema.

scholarly journals Digit Variability in Carotenoid Scores Obtained with the Veggie Meter: A Pilot Study (P02-001-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Velarie Ansu ◽  
Stephanie Dickinson ◽  
Alyce Fly
Keyword(s):  
Indiana University ◽  
Left Hand ◽  
Funding Sources ◽  
Right Hand ◽  
Period Data ◽  
The Mean ◽  
The Right ◽  
Post Hoc ◽  
Main Effects ◽  
Mean Square Errors

Abstract Objectives To determine which digit and hand have the highest and lowest skin carotenoid scores, to compare inter-and-intra-hand variability of digits, and to determine if results are consistent with another subject. Methods Two subjects’ first(F1), second(F2), third(F3) and fifth(F5) digits on both hands were measured for skin carotenoids with a Veggie Meter, for 3 times on each of 18 days over a 37-day period. Data were subjected to ANOVA in a factorial treatment design to determine main effects for hand (2 levels), digits (4), and days (18) along with interactions. Differences between digits were determined by Tukey's post hoc test. Results There were significant hand x digit, hand x day, digit x day, and hand x digit x day interactions and significant simple main effects for hand, digit, and day (all P < 0.001). Mean square errors were 143.67 and 195.62 for subject A and B, respectively, which were smaller than mean squares for all main effects and interactions. The mean scores ± SD for F1, F2, F3, and F5 digits for the right vs left hands for subject A were F1:357.13 ± 45.97 vs 363.74 ± 46.94, F2:403.17 ± 44.77 vs. 353.20 ± 44.13, F3:406.76 ± 43.10 vs. 357.11 ± 45.13, and F5:374.95 ± 53.00 vs. 377.90 ± 47.38. For subject B, the mean scores ± SD for digits for the right vs left hands were F1:294.72 ± 61.63 vs 280.71 ± 52.48, F2:285.85 ± 66.92 vs 252.67 ± 67.56, F3:268.56 ± 57.03 vs 283.22 ± 45.87, and F5:288.18 ± 34.46 vs 307.54 ± 40.04. The digits on the right hand of both subjects had higher carotenoid scores than those on the left hands, even though subjects had different dominant hands. Subject A had higher skin carotenoid scores on the F3 and F2 digits for the right hand and F5 on the left hand. Subject B had higher skin carotenoid scores on F5 (right) and F1 (left) digits. Conclusions The variability due to hand, digit, and day were all greater than that of the 3 replicates within the digit-day for both volunteers. This indicates that data were not completely random across the readings when remeasuring the same finger. Different fingers displayed higher carotenoid scores for each volunteer. There is a need to conduct a larger study with more subjects and a range of skin tones to determine whether the reliability of measurements among digits of both hands is similar across the population. Funding Sources Indiana University.

scholarly journals Drain fluid cryo-explant technique for treatment of superior bullous rhegmatogenous retinal detachment in young adults

2021 ◽  
Vol 13 ◽  
pp. 251584142098821
Author(s):  
Kamal A.M. Solaiman ◽  
Ashraf Mahrous ◽  
Hesham A. Enany ◽  
Ashraf Bor’i
Keyword(s):  
Young Adults ◽  
Retinal Detachment ◽  
Rhegmatogenous Retinal Detachment ◽  
Subretinal Fluid ◽  
Secondary Outcome ◽  
Eligibility Criteria ◽  
Retinal Breaks ◽  
Complicated Cataract ◽  
Drain Fluid ◽  
The Mean

Purpose: To evaluate the efficacy of the drain fluid cryo-explant (DFCE) technique for the management of uncomplicated superior bullous rhegmatogenous retinal detachment (RRD) in young adults. Patients and methods: A retrospective study that included eyes with uncomplicated superior bullous RRD in patients ⩽40 years old. DFCE technique consists of sequential drainage of subretinal fluid, intravitreal fluid injection, cryotherapy, and placement of a scleral explant(s). The primary outcome measure was anatomical reposition of the retina after a single surgery. Secondary outcome measures included improvement in best corrected visual acuity (BCVA) and any reported complication related to the procedure. Results: The study included 51 eyes which met the study eligibility criteria. The mean duration of detachment was 19.7 ± 6.4 days. A single retinal break was found in 31 eyes (60.8%), and more than one break were found in 20 eyes (39.2%). The mean number of breaks per eye was 1.72 ± 1.04. The mean detached area per eye was 7.21 ± 3.19 clock hours, and the macula was detached in 22 eyes (43.1%). Flattening of the retina and closure of all retinal breaks was achieved in all eyes after a single surgery. Late recurrence of retinal detachment occurred in two eyes (3.9%) due to proliferative vitreoretinopathy (PVR). No complicated cataract or iatrogenic retinal breaks were detected in all eyes. Conclusion: DFCE technique could be effectively used for treatment of uncomplicated superior bullous RRD in adults ⩽40 years. It is safe and provides good visualization during surgery with no iatrogenic retinal breaks or complicated cataract.

Evaluation of Changes in Depression Levels of Bruxism Patients Treated With Botulinum Toxin-A

2021 ◽  
pp. 232020682110065
Author(s):  
Deniz Erdil ◽  
Nilsun Bagis ◽  
Hakan Eren ◽  
Melike Camgoz ◽  
Kaan Orhan
Keyword(s):  
Botulinum Toxin ◽  
Botulinum Toxin A ◽  
Age Groups ◽  
Treatment Method ◽  
Definitive Treatment ◽  
Toxin A ◽  
Physiological Factors ◽  
Before And After ◽  
The Mean ◽  
Post Hoc

Aim: Bruxism is defined as the involuntary recurrent masticatory muscle activity characterized by gnashing, grinding, clenching of teeth, and/or pushing the mandible. Factors creating its etiology are peripheral (morphological) or central (physiopathological and physiological), and exogenous. Recently, among physiological factors, depression and bruxism were considered to be related. A definitive treatment method does not exist for bruxism; however, botulinum toxin-A (BT-A) application is an up-to-date and effective way of treatment. The present study is aimed to evaluate the levels of depression in bruxism patients treated with BT-A application. Materials and Methods: A total of 25 individuals (23 females and 2 males) who were diagnosed as bruxism patients were included in the study. 25 U of BT-A for each masseter muscle was injected into the patients. Patients were prospectively observed for a possible change in depression levels by using Beck’s Depression Inventory. The inventory was implemented before and six months after the BT-A application. Depression levels before and six months after the injection were compared. A paired t-test was used to compare “before” and “after” treatment values. One-way analysis of variance and post-hoc Tukey tests were used to evaluate the change in Beck’s Depression Inventory scores according to age groups. Results: The mean total score was 7.80 ± 8.10 before the treatment and 7.16 ± 6.52 six months after the treatment. The decrease in the mean score was not statistically significant ( P > .05). Conclusion: In conclusion, despite the decrease in the mean Beck’s Depression Inventory scores, a statistically significant decrease in the depression levels of patients was not observed.

scholarly journals Happiness, quality of working life, and job satisfaction among nurses working in emergency departments in Iran

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Somayeh Javanmardnejad ◽  
Razieh Bandari ◽  
Majideh Heravi-Karimooi ◽  
Nahid Rejeh ◽  
Hamid Sharif Nia ◽  
...  
Keyword(s):  
Job Satisfaction ◽  
Emergency Departments ◽  
Economic Status ◽  
Linear Regression Analysis ◽  
Working Life ◽  
Least Square ◽  
Life Questionnaire ◽  
Quality Of Working Life ◽  
The Mean

Abstract Background Nurses have a vital role in the healthcare system. One of the basic steps to increase their happiness is to recognize factors such as job satisfaction and quality of working life. Therefore, the goal of the present study was to examine the relationship between happiness and quality of working life and job satisfaction among nursing personnel. Methods This descriptive study was carried out on 270 hospital nurses who worked in emergency departments in Iran. Nurses were recruited through the census method. Data collection instruments included the Oxford Happiness Inventory (OHI), the Quality of Work Life Questionnaire (QWL), and the Job Satisfaction Questionnaire (JSQ). Data were explored using descriptive statistics, and stepwise multiple linear regression analysis. Results The mean age of participants was 30.1 ± 6.26 years. The mean happiness score was 38.5 ± 16.22, the mean Quality of Working Life (QWL) score was 84.3 ± 17.62, and the mean job satisfaction score was found to be 45.5 ± 13.57); corresponding to moderate levels of attributes. The results obtained from the ordinary least-square (OLS) regression indicated that happiness significantly was associated with economic status and satisfaction with closure (R2: 0.38). Conclusion Overall the current study found that nurses who work in emergency departments did not feel happy. Additionally, the findings suggest that their happiness were associated with their economic status, and closure over their duties.

scholarly journals Rapid review of available evidence on the serial interval and generation time of COVID-19

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040263
Author(s):  
John Griffin ◽  
Miriam Casey ◽  
Áine Collins ◽  
Kevin Hunt ◽  
David McEvoy ◽  
...  
Keyword(s):  
Generation Time ◽  
Social Contact ◽  
Careful Consideration ◽  
Rapid Review ◽  
Eligibility Criteria ◽  
Reproduction Numbers ◽  
Serial Interval ◽  
Scientific Papers ◽  
The Mean ◽  
Parameter Values

The serial interval is the time between symptom onsets in an infector–infectee pair. The generation time, also known as the generation interval, is the time between infection events in an infector–infectee pair. The serial interval and the generation time are key parameters for assessing the dynamics of a disease. A number of scientific papers reported information pertaining to the serial interval and/or generation time for COVID-19. Objective Conduct a review of available evidence to advise on appropriate parameter values for serial interval and generation time in national COVID-19 transmission models for Ireland and on methodological issues relating to those parameters. Methods We conducted a rapid review of the literature covering the period 1 January 2020 and 21 August 2020, following predefined eligibility criteria. Forty scientific papers met our inclusion criteria and were included in the review. Results The mean of the serial interval ranged from 3.03 to 7.6 days, based on 38 estimates, and the median from 1.0 to 6.0 days (based on 15 estimates). Only three estimates were provided for the mean of the generation time. These ranged from 3.95 to 5.20 days. One estimate of 5.0 days was provided for the median of the generation time. Discussion Estimates of the serial interval and the generation time are very dependent on the specific factors that apply at the time that the data are collected, including the level of social contact. Consequently, the estimates may not be entirely relevant to other environments. Therefore, local estimates should be obtained as soon as possible. Careful consideration should be given to the methodology that is used. Real-time estimations of the serial interval/generation time, allowing for variations over time, may provide more accurate estimates of reproduction numbers than using conventionally fixed serial interval/generation time distributions.

scholarly journals Partial pulpotomy without age restriction: a retrospective assessment of permanent teeth with carious pulp exposure

2021 ◽  
Author(s):  
Florin Eggmann ◽  
Thomas J. W. Gasser ◽  
Hanjo Hecker ◽  
Mauro Amato ◽  
Roland Weiger ◽  
...  
Keyword(s):  
Survival Rates ◽  
Age Groups ◽  
Permanent Teeth ◽  
Eligibility Criteria ◽  
Presumptive Diagnosis ◽  
Tooth Discoloration ◽  
Significant Difference ◽  
Pulp Exposure ◽  
The Mean

Abstract Objectives This study aimed to retrospectively evaluate clinical and radiographic outcomes of partial pulpotomy performed in permanent teeth with carious pulp exposure. Materials and methods Records of patients undergoing treatment at an undergraduate dental clinic between 2010 and 2019 were screened for partial pulpotomies in teeth with a presumptive diagnosis of normal pulp or reversible pulpitis. The follow-up had to be ≥ 1 year. Patient data were retrieved and analyzed using Mantel-Cox chi square tests and Kaplan–Meier statistics. The level of significance was set at α = 0.05. Results Partial pulpotomy was performed in 111 cases, of which 64 (58%) fulfilled the eligibility criteria. At the time of partial pulpotomy, the mean age was 37.3 (± 13.5) years (age range 18–85). The mean observation period was 3.1 (± 2.0) years. Two early failures (3.1%) and five late failures (7.7%) were recorded. The overall success rate of maintaining pulp vitality was 89.1%, with 98.4% tooth survival. The cumulative pulp survival rates of partial pulpotomy in patients aged < 30 years, between 30 and 40 years, and > 40 years were 100%, 75.5%, and 90.5%, respectively, with no significant difference between the age groups (p = 0.225). At follow-up, narrowing of the pulp canal space and tooth discoloration were observed in 10.9% and 3.1% of cases, respectively. Conclusions Across age groups, partial pulpotomy achieved favorable short and medium-term outcomes in teeth with carious pulp exposure. Clinical relevance Adequate case selection provided, partial pulpotomy is a viable operative approach to treat permanent teeth with deep carious lesions irrespective of patients’ age.

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