scholarly journals Effectiveness and Safety of Acupuncture for Poststroke Dysphagia: Study Protocol for a Pragmatic Multicenter Nonrandomized Controlled Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Yu Tat Chan ◽  
Hong Wei Zhang ◽  
Yuan Qi Guo ◽  
Zhi-Xiu Lin
Keyword(s):  
Outcome Measures ◽  
Outcome Measure ◽  
Acupuncture Treatment ◽  
Controlled Trial ◽  
Intervention Group ◽  
Oral Intake ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Life Questionnaire

Background. Dysphagia is one of the most common complications of stroke. Acupuncture is widely employed to treat poststroke dysphagia in East Asia. No evidence is established to support such treatment approach. This proposed study aims to evaluate the effectiveness and safety of acupuncture for the treatment of poststroke dysphagia. Methods and Design. This is a multicenter, pragmatic, single-blinded, nonrandomized controlled clinical trial. A total of 140 eligible patients will be enrolled in the study. Subjects who are eligible in study but refuse to have acupuncture treatment will be put on the no-acupuncture control arm. Both groups of patients will receive standard routine care, while the patients of intervention group will receive add-on standardized acupuncture treatment. Each participant in intervention group will receive a total of 24 sessions of acupuncture treatment (three times per week). The primary outcome measure is the Royal Brisbane Hospital Outcome Measure for Swallowing (RBHOMS). Secondary outcome measures include functional oral intake scale, swallow quality-of-life questionnaire in Chinese version, BMI of the participant, and adverse events. All outcome measures will be assessed at baseline, at the end of acupuncture treatment (month 2), and at two months after treatment (month 4). Ethics and Dissemination. The ethics approval of clinical research study was granted by the Research Ethics Committee of both New Territories East and West Cluster of Hong Kong. Written informed consent will be obtained from all participants and the study will be undertaken according to the ICH-GCP Guidelines. Trial Registration. This trial is registered with chictr.org (registration number: ChiCTR-TRC-12002621 and registration date: 2012-10-26).

scholarly journals Arthroscopic debridement does not enhance surgical treatment of intra-articular distal radius fractures: a randomized controlled trial

2019 ◽  
Vol 45 (4) ◽  
pp. 327-332 ◽  
Author(s):  
Caroline A. Selles ◽  
Marjolein A. M. Mulders ◽  
Joost W. Colaris ◽  
Mark van Heijl ◽  
Berry I. Cleffken ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Distal Radius ◽  
Controlled Trial ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Distal Radius Fractures ◽  
Secondary Outcome ◽  
Arthroscopic Debridement ◽  
Radius Fractures ◽  
Level Of Evidence

The aim of this study was to determine the difference in functional outcomes after open reduction and internal fixation (ORIF) with and without arthroscopic debridement in adults with displaced intra-articular distal radius fractures. In this multicentre trial, 50 patients were randomized between ORIF with or without arthroscopic debridement. The primary outcome measure was the Patient-Rated Wrist Evaluation (PRWE) score. Secondary outcome measures were Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, pain scores, range of wrist motion, grip strength, and complications. Median PRWE was worse for the intervention group at 3 months and was equal for both groups at 12 months. The secondary outcome measures did not show consistent patterns of differences at different time-points of follow-up. We conclude that patients treated with additional arthroscopy to remove intra-articular hematoma and debris did not have better outcomes than those treated with ORIF alone. We therefore do not recommend arthroscopy for removal of hematoma and debris when surgically fixing distal radius fractures. Level of evidence: I

scholarly journals Dignity Impact as a Primary Outcome Measure for Dignity Therapy

2018 ◽  
Vol 35 (11) ◽  
pp. 1417-1420 ◽  
Author(s):  
Lisa Scarton ◽  
Sungho Oh ◽  
Ashley Sylvera ◽  
Ralph Lamonge ◽  
Yingwei Yao ◽  
...  
Keyword(s):  
Palliative Care ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Meaning Making ◽  
Controlled Trial ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Care Group ◽  
Dignity Therapy ◽  
Feedback Questionnaire

Background: Feasibility of dignity therapy (DT) is well established in palliative care. Evidence of its efficacy, however, has been inconsistent and may stem from DT’s primary effects differing from the outcomes measured in previous studies. We proposed that DT effects were in the spiritual domain and created a new outcome measure, Dignity Impact Scale (DIS), from items previously used in a large randomized controlled trial (RCT). Objective: The purpose of this secondary analysis study was to examine properties of a new measure of dignity impact. Design: Using the DIS, we conducted reanalysis of posttest data from a large 3-arm, multi-site RCT study. Setting/Participants: Participants were receiving hospice/palliative care (n = 326, 50.6% female, mean age = 65.1 years, 89.3% white, all with a terminal illness with 6 months or less life expectancy). They had been randomized to standard palliative care (n = 111), client-centered care (n = 107), or DT (n = 108). Measurement: The 7-item DIS was derived from selected items in a posttest DT Patient Feedback Questionnaire. The DIS had strong internal consistency (α = 0.85). Results: The DT group mean DIS score (21.4 ± 5.0) was significantly higher than the usual care group mean score (17.7 ± 5.5; t = 5.2, df = 216, P < .001) and a client-centered intervention group mean score (17.9 ± 4.9; t = 5.2, df = 213, P < .001). Conclusion: We found that, compared to both other groups, patients who received DT reported significantly higher DIS ratings, which is consistent with the DT focus on meaning-making, preparation for death, and life completion tasks. We propose that the DIS be used as the primary outcome measure in evaluating the effects of DT.

The Efficacy of Hypertonic Saline Nasal Irrigation for Chronic Sinonasal Symptoms

2005 ◽  
Vol 133 (1) ◽  
pp. 3-8 ◽  
Author(s):  
David Rabago ◽  
Thomas Pasic ◽  
Aleksandra Zgierska ◽  
Marlon Mundt ◽  
Bruce Barrett ◽  
...  
Keyword(s):  
Side Effects ◽  
Hypertonic Saline ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Intervention Group ◽  
Community Setting ◽  
Adjunctive Treatment ◽  
Secondary Outcome ◽  
Nasal Irrigation ◽  
Sinonasal Symptoms

OBJECTIVE: To assess quality of life (QOL) in patients with sinonasal symptoms in response to hypertonic saline nasal irrigation (HSNI), and to assess HSNI use patterns. STUDY DESIGN AND SETTING: The study was an uncontrolled 12-month follow-up to a randomized controlled trial (RCT) and used HSNI in a community setting. We included 54 participants with recurrent or chronic sinonasal symptoms. Forty participants had been in the intervention group of a previous study; 14 had been control participants. Primary outcome measures were the Rhinosinusitis Disability Index (RSDI), a sinus-symptom severity assessment (SIA), and the Sino-Nasal Outcomes Test (SNOT-20). Secondary outcome measures were frequency and pattern of HSNI use, side effects and satisfaction. RESULTS: Among participants using HSNI in the prior RCT, RSDI scores continued to improve, from 73.2 ± 2.6 points to 80.6 ± 2.4 points ( P < 0.001). SIA and SNOT-20 scores remained stable. Former control participants reported QOL improvement similar to that of HSNI users in the prior RCT. RSDI scores improved from 62.0 ± 3.9 points to 79.7 ± 3.7 points ( P < 0.05), SNOT-20 scores improved from 43.5 ± 5.7 points to 28.4 ± 4.8 points, and SIA scores improved from 4.2 ± 0.3 points to 2.6 ± 0.3 points ( P < 0.01). Mean HSNI use for all participants was 2.4 irrigations per week; 33% of participants used HSNI regularly, 55% when symptomatic. Side effects were minor; satisfaction was high. CONCLUSIONS: Participants with chronic sinonasal symptoms reported improved QOL and frequent, satisfying use of HSNI. SIGNIFICANCE: HSNI is an effective adjunctive treatment of chronic sinonasal symptoms.

scholarly journals Combining Lovastatin and Minocycline for the Treatment of Fragile X Syndrome: Results From the LovaMiX Clinical Trial

2022 ◽  
Vol 12 ◽  
Author(s):  
Camille Champigny ◽  
Florence Morin-Parent ◽  
Laurence Bellehumeur-Lefebvre ◽  
Artuela Çaku ◽  
Jean-François Lepage ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Fragile X Syndrome ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Fragile X ◽  
Combined Therapy ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Global Score

Background: Limited success of previous clinical trials for Fragile X syndrome (FXS) has led researchers to consider combining different drugs to correct the pleiotropic consequences caused by the absence of the Fragile X mental retardation protein (FMRP). Here, we report the results of the LovaMiX clinical trial, the first trial for FXS combining two disease-modifying drugs, lovastatin, and minocycline, which have both shown positive effects when used independently.Aim: The main goals of the study were to assess the safety and efficacy of a treatment combining lovastatin and minocycline for patients with FXS.Design: Pilot Phase II open-label clinical trial. Patients with a molecular diagnostic of FXS were first randomized to receive, in two-step titration either lovastatin or minocycline for 8 weeks, followed by dual treatment with lovastatin 40 mg and minocycline 100 mg for 2 weeks. Clinical assessments were performed at the beginning, after 8 weeks of monotherapy, and at week 20 (12 weeks of combined therapy).Outcome Measures: The primary outcome measure was the Aberrant Behavior Checklist-Community (ABC-C) global score. Secondary outcome measures included subscales of the FXS specific ABC-C (ABC-CFX), the Anxiety, Depression, and Mood Scale (ADAMS), the Social Responsiveness Scale (SRS), the Behavior Rating Inventory of Executive Functions (BRIEF), and the Vineland Adaptive Behavior Scale second edition (VABS-II).Results: Twenty-one individuals out of 22 completed the trial. There were no serious adverse events related to the use of either drugs alone or in combination, suggesting good tolerability and safety profile of the combined therapy. Significant improvement was noted on the primary outcome measure with a 40% decrease on ABC-C global score with the combined therapy. Several outcome measures also showed significance.Conclusion: The combination of lovastatin and minocycline is safe in patients for FXS individuals and appears to improve several elements of the behavior. These results set the stage for a larger, placebo-controlled double-blind clinical trial to confirm the beneficial effects of the combined therapy.

scholarly journals Allogeneic Skin Substitutes Versus Human Placental Membrane Products in the Management of Diabetic Foot Ulcers: A Narrative Comparative Evaluation of the Literature

2019 ◽  
Vol 18 (1) ◽  
pp. 10-22 ◽  
Author(s):  
Joshua Luck ◽  
Timo Rodi ◽  
Alexander Geierlehner ◽  
Afshin Mosahebi
Keyword(s):  
Diabetic Foot ◽  
Wound Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Foot Ulcers ◽  
Skin Substitute ◽  
Diabetic Foot Ulcers ◽  
Skin Substitutes

Outcomes following standard wound care (SWC) for diabetic foot ulcers (DFUs) remain suboptimal. Supplementing SWC with tissue engineered allogeneic cellular wound therapies represents an emerging treatment strategy. This review aimed to evaluate the efficacy and safety of allogeneic skin substitutes and human placental membrane allografts in the management of DFUs. Ovid MEDLINE and Embase databases were searched from inception to October 2017. Any randomized controlled trial (RCT) with an allogeneic skin substitute or placental membrane allograft intervention group was included. Our primary outcome measure was the proportion of completely healed ulcers. Secondary outcome measures included time to complete wound healing and local adverse event rates. Each study was assessed for risk of bias and the quality of evidence was appraised using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach. Moderate quality evidence from 11 included RCTs demonstrated that both allogeneic cellular approaches improve the proportion of completely healed ulcers at 6 and 12 weeks. One RCT showed that a placental membrane allograft was superior to an allogeneic skin substitute, although this has yet to be repeated in other studies. The addition of allogeneic cellular wound products to SWC improves DFU outcomes. Further studies are required to conclusively establish if placental membrane allografts are superior to allogeneic skin substitutes.

Tinnitus Management: Randomized Controlled Trial Comparing Extended-Wear Hearing Aids, Conventional Hearing Aids, and Combination Instruments

2017 ◽  
Vol 28 (06) ◽  
pp. 546-561 ◽  
Author(s):  
James A. Henry ◽  
Garnett McMillan ◽  
Serena Dann ◽  
Keri Bennett ◽  
Susan Griest ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Outcome Measures ◽  
Hearing Aids ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Treatment Groups ◽  
Randomized Controlled ◽  
Point Reduction ◽  
Clinically Significant

Background: Whereas hearing aids have long been considered effective for providing relief from tinnitus, controlled clinical studies evaluating this premise have been very limited. Purpose: The purpose of this study was to systematically determine the relative efficacy of conventional receiver-in-the-canal hearing aids (HA), the same hearing aids with a sound generator (HA+SG), and extended-wear, deep fit hearing aids (EWHA), to provide relief from tinnitus through a randomized controlled trial. Each of these ear-level devices was a product of Phonak, LLC. Research Design: Participants were randomized to HA, HA+SG, or EWHA and wore bilaterally fit devices for about 4 months. Fittings, adjustments, and follow-up appointments were conducted to comply with company guidelines and to ensure that all participants attended appointments on the same schedule. At 4–5 months, participants returned to complete final outcome measures, which concluded their study participation. Study Sample: Participants were 55 individuals (mean age: 63.1 years) with mild to moderately-severe hearing loss who: (a) did not currently use hearing aids; (b) reported tinnitus that was sufficiently bothersome to warrant intervention; and (c) were suitable candidates for each of the study devices. Data Collection and Analysis: The primary outcome measure was the Tinnitus Functional Index (TFI). Secondary outcome measures included hearing-specific questionnaires and the Quick Speech in Noise test (QuickSIN). The goal of the analysis was to evaluate efficacy of the EWHA and HA+SG devices versus the HA standard device. Results: There were 18 participants in each of the HA and EWHA groups and 19 in the HA+SG group. Gender, age, and baseline TFI severity were balanced across treatment groups. Nearly all participants had a reduction in tinnitus symptoms during the study. The average TFI change (improvement) from baseline was 21 points in the HA group, 31 points in the EWHA group, and 33 points in the HA+SG group. A “clinically significant” improvement in reaction to tinnitus (at least 13-point reduction in TFI score) was seen by 67% of HA, 82% of EWHA, and 79% of HA+SG participants. There were no statistically significant differences in the extent to which the devices reduced TFI scores. Likewise, the hearing-specific questionnaires and QuickSIN showed improvements following use of the hearing aids but these improvements did not differ across device groups. Conclusions: There is insufficient evidence to conclude that any of these devices offers greater relief from tinnitus than any other one tested. However, all devices appear to offer some improvement in the functional effects of tinnitus.

Effects of greens+® A Randomized, Controlled Trial

2004 ◽  
Vol 65 (2) ◽  
pp. 66-71 ◽  
Author(s):  
Heather Boon ◽  
Joyce Clitheroe ◽  
Tonia Forte
Keyword(s):  
Outcome Measures ◽  
Repeated Measures ◽  
Outcome Measure ◽  
Statistical Significance ◽  
Treatment Protocol ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Secondary Outcome Measure ◽  
Female Population ◽  
Study Objective

Greens+® is a popular natural health product marketed as energy-enhancing; however, no objective data substantiate this claim. The study objective was to determine if ingestion of greens+® 1. increases vitality, energy, and perception of wellbeing; 2. increases overall mental health and general health, and 3. decreases the incidence of colds and flus in an otherwise healthy female population. A total of 105 women were enrolled in this 12-week, randomized, double-blind, placebo-controlled clinical trial; 63 (60%) completed the treatment protocol. Both treatment and placebo groups showed a significant time trend effect, scoring better on all outcome measures as the trial progressed. Compared with the placebo group, the greens+® group scored marginally higher on vitality, the primary outcome measure (p=0.055), and significantly higher on energy (a secondary outcome measure, p=0.018). Findings were based on repeated measures analysis of variance; baseline scores were used as covariates. Although a trend toward greater improvement in the greens+® group was noted in the other secondary outcome measures, this trend did not reach statistical significance. Overall, our findings were positive but not conclusive that greens+® increases vitality and energy. These results provide justification for further study of the effects of greens+®.

scholarly journals 188 The Use of a Group Based Upper Limb Programme in Improving Outcome in Acute Stroke Rehabilitation

2019 ◽  
Vol 48 (Supplement_3) ◽  
pp. iii17-iii65
Author(s):  
Kerri Donnelly ◽  
Enya Mulcahy ◽  
Catherine Merrick ◽  
Orla Fitzgerald
Keyword(s):  
Acute Stroke ◽  
Grip Strength ◽  
Outcome Measures ◽  
Upper Limb ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Dominant Hand ◽  
Nine Hole Peg Test

Abstract Background After a stroke 85% of patients experience altered arm function. Current research demonstrates that increasing upper limb rehabilitation results in improved outcomes (Ward et al., 2019). The Graded Repetitive Arm Supplementary Programme (GRASP) group is an established adjunctive therapy in the stroke service. The group provides additional therapy for suitable patients with upper extremity deficits. The group is run jointly by a physiotherapist and an occupational therapist. Patients attend twice weekly for a one hour period in addition to their regular therapy. The GRASP group consists of 3 levels of varying abilities and patients are categorised by their Fugl-Meyer score. Methods A prospective audit was completed in 2019 and data was collected using a word document and excel spread sheet. Standardised outcome measures were completed on admission and discharge to establish upper limb ability. The primary outcome measure was the Fugl-Meyer and the secondary outcome measures were the nine hole peg test and grip strength using the Dynamometer. Results 12 patients attended the GRASP group over this period. 75% were males. The average age was 76 years with the age range from 48-95 years. 58% of patients experienced upper limb weakness in their non-dominant hand. Post intervention data was not obtained for 5 patients due to unforeseeable discharge from the acute setting. Preliminary data to date shows that our primary outcome measure improved in 86% of patients with increases ranging from 2-11 points on the Fugl-Meyer score (Minimally Clinical Important Difference =5points). Our secondary outcome measures demonstrated patients had no change (28%) or an improvement (72%) in grip strength and 100% of patients improved on the time taken to complete the nine hole peg test. Conclusion The GRASP group was found to be effective in improving upper limb outcome measures in an acute stroke inpatient hospital setting.

scholarly journals An eHealth Program for Patients Undergoing a Total Hip Arthroplasty: Protocol for a Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Rosemary Saunders ◽  
Karla Seaman ◽  
Catherine Ashford ◽  
Trudy Sullivan ◽  
Judith McDowall ◽  
...  
Keyword(s):  
Total Hip Arthroplasty ◽  
Patient Outcomes ◽  
Hip Arthroplasty ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Care Group ◽  
Total Hip

BACKGROUND Total hip arthroplasty is an effective surgical procedure commonly used worldwide for patients suffering the disabling effects of osteoarthritis when medical therapy is unsuccessful. Traditionally pre- and postoperative information for patients undergoing a hip arthroplasty has been provided by paper-based methods. Electronic health (eHealth) programs to support individualized patient education on preoperative preparation, in-patient care, and home rehabilitation have the potential to increase patient engagement, enhance patient recovery, and reduce potential postoperative complications. OBJECTIVE The aim of this study is to compare the addition of an eHealth program versus standard care for pre- and postoperative education on patient outcomes for primary total hip arthroplasty. METHODS One hundred patients undergoing a primary elective total hip arthroplasty will be recruited from a metropolitan hospital in Western Australia to participate in a 6-month parallel randomized control trial. Participants will be randomized to either the standard care group (n=50) and will be given the education booklet and enrolled to attend a 1-hour education session, or the intervention group (n=50), and will receive the same as the standard care plus access to an eHealth program titled “My Hip Journey.” The eHealth program encourages the patient to log in daily, from 2 weeks prior to surgery to 30 days postsurgery. The information on the platform will be aligned with the patient's individual surgical journey and will include exercises to be completed each day for the duration of the program. The primary outcome measure is the Hip Dysfunction and Osteoarthritis Outcome Score, version LK 2.0. Secondary outcome measures include the EuroQoL EQ-5D-5L, a 5-level 5-dimension quality of life measure, and the Self-Efficacy for Managing Chronic Disease Scale. Data will be collected at pre-admission (presurgery) and at 6 weeks, 3 months, and 6 months postsurgery. A patient satisfaction survey will be completed 6 weeks postsurgery and Web-based analytics will be collected 6 months postsurgery. A cost-effectiveness analysis, using the intention-to-treat principle, will be conducted from the hospital’s perspective. RESULTS Enrollment in the study commenced in January 2018 with recruitment due for completion towards the end of the year. The first results are expected to be submitted for publication in 2019. CONCLUSIONS The outcomes and cost of using an eHealth program to support a patient’s recovery from a hip arthroplasty will be compared with standard care in this study. If the eHealth program is found to be effective, further implementation across clinical practice could lead to improvement in patient outcomes and other surgical areas could be incorporated. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12617001433392; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373657&isReview=true (Archived by WebCite at http://www.webcitation.org/6yzoTuggx). REGISTERED REPORT IDENTIFIER RR1-10.2196/9654

Does Additional Extracorporeal Shock Wave Therapy Improve the Effect of Isolated Percutaneous Radiofreqency Coblation in Patients with Insertional Achilles Tendinopathy? Study Protocol for A Randomized Controlled Clinical Trial

2020 ◽  
Author(s):  
Yu-Jie Song ◽  
Wen-Kai Xuan ◽  
Ying-Hui Hua
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Achilles Tendinopathy ◽  
Conclusive Evidence ◽  
Secondary Outcome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Extracorporeal Shock Wave ◽  
Insertional Achilles Tendinopathy

Abstract Background: No conclusive evidence recommends a prior treatment for insertional Achilles tendinopathy (IAT). It is theorized that both percutaneous radiofreqency coblation and extracorporeal shockwave therapy (ESWT) relieve pain within the insertion. However, no clinical evidence shows that either treatment promote the regeneration of the tendon or if the combination of these 2 interventions offer better function and less pain than one therapy. Methods: The study is a randomized, controlled trial with patients allocated in a 1:1 ratio to one of two parallel groups. Patients with insertional Achilles tendinopathy who are not satisfied with the effect of conservative treatment will be screened. A minimum of 38 patients will be enrolled after deciding to participate in the trial on an informed basis. Then the intervention group and the control group perform radial ESWT and sham-ESWT respectively at 6 months after percutaneous radiofreqency coblation. The primary outcome will be the Victorian Institute of Sports Assessment Achilles (VISA-A) Score. Secondary outcome measures will be Foot and Ankle Outcome Score (FAOS) scale, Visual Analogue Scale (VAS), Tegner Score, and MRI ultra-short echo time (UTE) T2* value. The assessments will occur in 6 months, 1 year, and 2 years post-operatively. The differences between 2 groups will be conducted as intention-to-treat basis. Discussion: We aim to investigate if radiofreqency coblation associated with ESWT can provide more encouraging imaging findings as well as functional and clinical outcomes regarding the treatment of the IAT comparing to the single radiofreqency coblation treatment.Trial registration: ChiCTR1800017898; Pre-results. Registered on 20 August 2018.

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