tbuckley/cabot-search huggingface dataset:
Comparison of awareness, training and assessment of teaching competence between hospital and community general practice trainers
Authors: Jie Gu, Tianhao Wang, Limin Ren, Zhigang Pan
Journal: BMJ (2018)

Objective
To compare the awareness,  and assessment of teaching competence between hospital and community general practice (GP) trainers.


Methods
A questionnaire survey on teaching competence was conducted among 161 hospital GP trainers and 110 community GP trainers in 2016 April.


Results
There were 96 male and 175 female participants with an average age of (30.4±8.0) years. On the the awareness of teaching competence, the propotion of very important of creating a quality teaching environment for students, knowing how to teach students, ability to teach students medical knowledge and skills, feedback ability, showing the virtue of being a teacher in hospital and community trainers were 47.8% (77/161) and 40.0% (44/110), 66.5% (107/161) and 59.1%(65/110), 71.5% (115/161) and 62.8% (69/110), 54.7%(88/161) and 52.7% (58/110), 65.2% (105/161) and 60.9 (67/110), respectively; there were no significant differences of all importance ratings between the two groups (all P>0.05). Hospital trainers had higher proportions of having received teaching method training [70.2% (113/161) vs. 50.0% (55/110) , χ2=11.302, P=0.001] and having received teaching  before practice teaching for the first time [(45.3% (73/161) vs. 21.8% (24/110) , χ2=15.735, P 0.01).


Conclusion
The awareness of teaching competence is similar between hospital and community GP trainers, but the community trainers are lack of teaching competence training, and their teaching competence evaluation methods need to be improved.


Key words: 
General practice trainer; Teaching competence; Investigation
Prognostic value of piR-39980 in patients with colorectal cancer.
Authors: Wei Peng, Jingfeng Mei, Jianwei Lu, Jun Bao, Guoren Zhou
Journal: Journal of Clinical Oncology (2020)

e16087 Background: Colorectal cancer (CRC) accounts for a common gastrointestinal malignancy all over world. Piwi-interacting RNAs (piRNAs) show a substantial role in the oncogenesis of a variety of tumors. The objective of this work was to uncover the expression profile of piR-39980 and its prognostic value in CRC. Methods: The levels of piR-39980 expression in CRC tissues and paired normal tissues was determined by quantitative real-time polymerase chain reaction (qRT-PCR). Association of piR-39980 with CRC clinical feathers was assessed by Chi-square test. Overall survival curve was built via log-rank test by Kaplan–Meier analysis. The prognostic significance of piR-39980 in CRC was measured by Cox regression model. Results: piR-39980 was upregulated in CRC specimens than the paired normal specimens ( P &lt; 0.001). Importantly, upregulation of piR-39980 was related to tumor size and T stage (all P &lt; 0.05). Survival evaluation suggested that CRC folks with high expression of piR-39980 went through poorer overall survival than folks with low piR-39980 expression (log rank test, P = 0.0429). piR-39980 could be an independent indicator for CRC patients’ prognosis (HR = 3.308, 95% CI = 1.762-6.594, P = 0.043). Conclusions: piR-39980 plays oncogenic roles in CRC tumorigenesis and may be an independent indicator for CRC prognosis.
Survival outcomes of patients with resectable pancreatic cancer treated with upfront surgery versus neoadjuvant chemotherapy: A retrospective tertiary care center experience.
Authors: Fang Liu, Matthew Mirsky, Sulin Wu, Pingfu Fu, Shufen Cao, John Shanahan, Ravi Kumar Kyasaram, Prantesh Jain, Jeffrey Hardacre, John Brian Ammori, Jordan Michael Winter, David Lawrence Bajor
Journal: Journal of Clinical Oncology (2020)

4623 Background: The role of neoadjuvant chemotherapy (NAC) for resectable pancreatic cancer (RPC) remains controversial. We sought to compare the outcomes of NAC with upfront surgery (UFS). Methods: The study retrospectively enrolled patients with RPC who had UFS or received neoadjuvant FOLFIRINOX (FFX) or gemcitabine plus albumin-bound paclitaxel (GA). Between-group differences were assessed with T-test for continuous variables, and Chi-square / Fisher’s exact test for categorical variables. The overall survival (OS) and recurrence-free survival (RFS) were determined by the Kaplan-Meier method with Wilcoxon test for the difference between groups. The effects of NAC vs. UFS on OS and RFS were further estimated using Cox regression controlling the effects of age and CA 19-9. Results: Between 2011 and 2019, 131 patients with RPC underwent UFS followed by adjuvant chemotherapy (gemcitabine, n = 65; gemcitabine/capecitabine, n = 18; FFX, n = 9). Up to 32 patients (24.4%) could not receive adjuvant chemotherapy due to surgical complications or poor recovery. Total 50 patients with RPC received NAC (FFX, n = 32; GA, n = 18). Median of 5.5 cycles of FFX or 3 cycles of GA were given prior to surgery. Resection rate was 72% (FFX 62.5%; GA 88.9%). The rest (28%) were no longer surgical candidates due to disease progression rather than toxicities from NAC. On surgical pathological review, complete resection (R0) was achieved in 83.3% of resected cases after NAC (FFX 90%; GA 75%) and 79.4% with UFS. The tumor size distribution was: pT1 11.1%, pT2 41.7%, pT3 44.4% with NAC; pT1 5.4%, pT2 18.3%, pT3 76.3% with UFS. The nodal status distribution was: pN0 27.8%, pN1 55.5%, pN2 16.7% with NAC; pN0 23.7%, pN1 71.0%, pN2 5.3% with UFS. Median pre-treatment CA 19-9 was 321.95 unit/mL in the NAC group and 79.99 unit/mL in the UFS group (p = 0.009). Median age was 70.5 in the NAC group and 72 in the UFS group (p = 0.374). There was no significant difference in the performance status between the two groups. In Kaplan-Meier analysis, there was a significant difference of OS between UFS and NAC with median OS of 648 days under UFS versus 884 days under NAC (p = 0.029); the median of RFS was 390 days under UFS versus 392 days under NAC (p = 0.953). The hazard ratio (NAC vs UFS) adjusted for CA19-9 and age was 0.7 (p = 0.176) for OS and 0.98 (p = 0.918) for RFS. Conclusions: We observed a signal of tumor downstaging, higher R0 rate, and improved OS with NAC compared with UFS. Further prospective trials are needed to validate these results.
X-连锁无丙种球蛋白血症并幼年特发性关节炎四例
Authors: 崔广梅, 李华南, 刘华林
Journal: BMJ (2011)

X-连锁无丙种球蛋白血症(XLA)是一种遗传性体液免疫缺陷病,其临床表现除反复、严重的细菌感染外,部分患者合并自身免疫性疾病,发生率最高的为幼年特发性关节炎(JIA).经合理治疗,其预后及转归良好,但须强调治疗的个体化和特殊性.现总结我院1999年至2009年收治的4例XLA合并JIA患儿的临床资料如下。
Metabolic syndrome, metabolic comorbid conditions, and risk of early-onset colorectal cancer.
Authors: Hanyu Chen, Zitong Li, Xiaobin Zheng, Jinhee Hur, Xiaoyu Zong, William Chapman, Katelin B. Nickel, Andrew Tipping, Graham A. Colditz, Margaret A. Olsen, Edward L. Giovannucci, Ryan Fields, Yin Cao
Journal: Journal of Clinical Oncology (2020)

1571 Background: The etiology and contributors to the rising incidence of early-onset colorectal cancer (CRC diagnosed under age 50), driven largely by distal and rectal cancer, remain largely unknown. Metabolic syndrome is associated with higher risk of CRC diagnosed at older ages; however, its association with early-onset CRC remains unclear. Methods: We conducted a nested case-control study among participants aged 18-50 years with ≥2 years of enrollment and prescription drug coverage in the IBM MarketScan Commercial Databases (2006-2015). Incident CRC cases were identified using ICD-9-CM diagnosis codes. Controls without any cancer were identified using frequency matching on age, sex, geographical region, and duration of insurance enrollment. Metabolic syndrome was defined using either ICD-9-CM diagnosis codes or the presence of at least 3 of the following: obesity, hypertension, hyperlipidemia, and hyperglycemia/type 2 diabetes. In addition to ICD-9-CM codes, hypertension, hyperlipidemia, and hyperglycemia/type 2 diabetes were also defined based on regular use of medications. Multivariable logistic regressions were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs). Results: A total of 4,673 early-onset CRC and 40,832 controls were included. Metabolic syndrome was associated with increased risk of early-onset CRC (OR: 1.33, 95% CI 1.16-1.52), after adjusting for a range of potential confounders. The number of metabolic comorbid conditions was positively associated with risk of early-onset CRC in a dose-response fashion. Compared to individuals without any conditions, individuals with 1, 2, ≥3 metabolic conditions had a 13% (OR: 1.13, CI 1.04-1.22), 18% (OR: 1.18, CI 1.07-1.31), and 40% (OR: 1.40, CI 1.22-1.61) higher risk of early-onset CRC (P trend &lt;0.001), respectively. These associations were driven by proximal (OR for ≥2 vs 0 metabolic comorbid conditions: 1.40, CI 1.15-1.69) and distal colon cancer, OR ≥2 vs 0: 1.25, CI 1.03-1.53), but not rectal cancer (OR≥2 vs 0: 1.07, CI 0.92-1.24). Conclusions: Metabolic syndrome and metabolic comorbid conditions were associated with increased risk of early-onset CRC, largely driven by proximal and distal colon cancer. Metabolic dysregulations may contribute to the rising incidence of early-onset CRC.
The efficacy and safety of EGFR-TKI combined with chemotherapy in non-small cell lung cancer (NSCLC) patients with EGFR co-mutation with other oncogenic alterations.
Authors: Qitao Yu, Wei Jiang, Aiping Zeng, Hongtu Qiu, Chuang Qi, Xing Zhang
Journal: Journal of Clinical Oncology (2020)

e21666 Background: Previous studies indicated primary resistance to EGFR-TKIs might occur in EGFR co-mutation with other oncogenic alterations, including TP53, KRAS, PIK3CA and so on. However, the optimal therapeutic regimens for EGFR co-mutation other oncogenic alterations were still unknown. This respective observation study aimed to evaluate the efficacy and safety of EGFR-TKIs combined with chemotherapy in this sub-population, in order to offer new treatments in clinical practice. Methods: In this retrospectively study, from March 2017 to November 2019 advanced NSCLC patients with EGFR co-mutation with other oncogenic alterations in Medical Oncology of Respiratory, Affiliated Tumor Hospital of Guangxi Medical University were screened for eligibility. All included patients were administrated with EGFR-TKIs combined with platinum-based chemotherapy or EGFR-TKIs monotherapy. The clinicopathological data of the patients, and the efficacy and safety of treatment were accorded for statistic analysis. The Kaplan-Meier method was used to estimate median PFS and OS. For all analyses, p value &lt; 0.05 was considered statistically significant, and confidence interval use 95% confidence level. The primary outcome was Progression-free survival (PFS), and Overall survival (OS), Disease control rate (DCR) and safety profile were considered to be the secondary endpoints. Results: Total 23 patients were enrolled in this retrospectively study. The median age of the combination and monotherapy group was 58.7± 8.8 and 58.9 ± 13.5years, respectively. The frequency of female patients was 53.8% and 40% in monotherapy and combination group, respectively. The median PFS (mPFS) was 5.03 months (95% CI: 1.16- 8.9) and not reach in combination therapy group (P = 0.004). No significantly different in mOS was observed in two groups (P = 0.244). The DCR was 92.3% and 100% in monotherapy and combination group, respectively. In combination group, the common adverse events of grade 1 or 2 were adverse reactions of the blood system and rash (40%). Treatment-related grade 3 or 4 toxicity appeared in 3 patients and no patients harbored treatment-related above grade 4 side effects. No cases of treatment-related death occurred. Conclusions: EGFR-TKIs combined with chemotherapy was effective in NSLCL patients with EGFR co-mutation with other oncogenic alterations and side-effects were tolerable. The outcomes of this study should be confirmed by prospective clinical trials in future.
糖皮质激素在类风湿关节炎治疗中的应用
Authors: 穆荣, 栗占国
Journal: BMJ (2005)

糖皮质激素(GCs)是类风湿关节炎(RA)治疗中的双刃剑,既可迅速缓解关节肿痛等症状,又可能引起明显的不良反应.由于GCs具有突出的抗炎作用及价廉易得的特点,曾广泛用于RA的治疗.但是,不规范使用GCs所导致的不良反应又使其在RA中的应用价值受到质疑.近年来的研究发现,如果GCs剂量<10 mg/d(按泼尼松剂量计算,下同),则不良反应的发生率明显降低,长期应用还可能有减缓RA病变进展的作用[1,2].如何选择治疗适应证及正确使用GCs仍是临床医师必须注意的问题.为使临床医生对RA治疗中GCs的规范化使用有更明确的认识,本文主要就国内外对GCs在RA中的临床应用及研究进展进行讨论。
IgG-cleaving endopeptidase enables in vivo gene therapy in the presence of anti-AAV neutralizing antibodies
Authors: Christian Leborgne, Elena Barbon, Jeffrey M. Alexander, Hayley Hanby, Sandrine Delignat, Daniel M. Cohen, Fanny Collaud, Saghana Muraleetharan, Dan Lupo, Joseph Silverberg, Karen Huang, Laetitia van Wittengerghe, Béatrice Marolleau, Adeline Miranda, Anna Fabiano, Victoria Daventure, Heena Beck, Xavier M. Anguela, Giuseppe Ronzitti, Sean M. Armour, Sebastien Lacroix-Desmazes, Federico Mingozzi
Journal: Nature Medicine (2020)
Prevention and management of accessory hepatic duct injury during laparoscopic cholecystectomy
Authors: Yuhua Zhang, Zhiming Hu, Chengwu Zhang, Weiding Wu, Liang Tao, Huaping Huang, Jie Liu, Minjie Shang, Zhijie Xie
Journal: BMJ (2014)

To explore the prevention and management of accessory hepatic duct (AHD) injury during laparoscopic cholecystectomy (LC). Four cases of type Ⅰ AHDs were found in our series. In three cases, the injured ADHs were clipped by Hemolock during LC while another case was sutured during laparoscopic re-operation. Four cases of typeⅡ, Ⅲ, Ⅳ AHDs injury were found and treated by different intraoperative methods. Conclusion for preventing AHD injury during LC, anatomic identification is essential for surgeons. A small AHD ( 3 mm) injury requires an effective drainage.


Key words: 
Cholecystectomy, laparoscopic; Injury of accessory bile duct
Prognostic role of beta-2 microglobulin in patients with light chain amyloidosis treated with autologous stem cell transplantation.
Authors: Abdullah S. Al Saleh, Angela Dispenzieri, Eli Muchtar, Robert C. Wolf, David Dingli, Martha Lacy, Rahma M. Warsame, Wilson I. Gonsalves, Taxiarchis Kourelis, William J. Hogan, Suzanne R. Hayman, Prashant Kapoor, Francis Buadi, Shaji Kumar, Morie A. Gertz
Journal: Journal of Clinical Oncology (2020)

e20506 Background: Autologous stem cell transplantation (ASCT) prolongs survival in patients with light chain (AL) amyloidosis. Mayo 2012 stage and increased plasma cell percentage (%PC) are known predictors for survival. Increased beta-2 microglobulin (B2M) predicts survival in patients with multiple myeloma. However, its prognostic effect in patients with AL amyloidosis undergoing ASCT is not known. Methods: We retrospectively reviewed patients who had a diagnosis of AL amyloidosis and were treated with ASCT between July-1996 and September-2017. Patients with creatinine &gt; 1.2 mg/dL were excluded, as that affects B2M levels. The receiver operator curve was used to determine the best cutoff for B2M in predicting survival and was 2.5 mcg/mL. Baseline characteristics were compared between patients with B2M &gt; 2.5 and ≤2.5. Progression-free survival (PFS) was defined as time from ASCT to relapse or death, whichever occurred first. Overall survival (OS) was calculated from ASCT to death of any cause. Univariate and multivariate analysis were done for OS. Results: Five-hundred patients were identified and 222 (44%) had a B2M &gt; 2.5. These patients were more likely to be &gt; 65 years old (32% vs. 17%, P = 0.0001), have Mayo 2012 stage III/IV (33% vs. 8%, P &lt; 0.0001), have ≥3 organs involved (25% vs. 14%, P = 0.001), and have ≥10% PCs (56% vs. 40%, P = 0.0002) compared to patients with B2M ≤2.5. The median PFS and OS were shorter in patients with B2M &gt; 2.5 (median PFS: 64 vs. 80 months, P = 0.03); (median OS: 104.9 vs. 175.5 months, P &lt; 0.0001). On univariate analysis, predictors for OS included age &gt; 65 (HR: 1.6, P = 0.001), Mayo 2012 stage III/IV (HR: 3.3, P &lt; 0.0001), ≥3 organs involved (HR: 1.3, P = 0.06), ≥10% PC (HR: 1.5, P = 0.004), melphalan conditioning 200mg/m 2 (HR: 0.28, P &lt; 0.0001), and B2M &gt; 2.5 (HR: 1.8, P &lt; 0.0001). In a multivariate analysis, only Mayo 2012 stage III/IV (HR: 1.8, P = 0.006), melphalan conditioning 200mg/m 2 (HR: 0.35, P &lt; 0.0001), and B2M &gt; 2.5 (HR: 1.7, P = 0.01) remained independent predictive of OS. Conclusions: Beta-2 microglobulin &gt; 2.5 is an independent predictor for OS in AL amyloidosis patients undergoing ASCT and should be routinely measured.
Should pay high attention to early prevention and treatment for diabetic kidney disease
Authors: 谌贻璞
Journal: BMJ (2010)

中国是世界上三个糖尿病大国(印度、中国及美国)之一,而且患病率还在迅速增加.2002年全国流行病学调查显示,我国大城市、中小城市和农村18岁以上居民的糖尿病患病率分别为6.1%、3.7%和1.8%。
Survey on contraceptive knowledge and service ability among postpartum visitors in Shanghai Minhang district
Authors: Longmei Jin, Wei Cui, Huibin Yang, Xiaohua Zhang, Linan Cheng
Journal: BMJ (2019)

Objective
To survey the contraceptive knowledge and service ability of postpartum visitors in Shanghai Minhang district.


Methods
A questionnaire survey on the contraceptive knowledge and contraceptive services was conducted in May 2018 among postpartum visitors from 13 community health service centers in Shanghai Minhang district.


Results
One hundred and forty-eight valid questionnaires were collected. All the participants were women, among whom 6.8% (10/148) were obstetricians and gynecologists, 8.1% (12/148) were general practitioners and public health doctors, 52.7% (78/148) were nurses and 32.4% (48/148) were village doctors. One hundred and ten participants were married women of childbearing age, among whom 18.2% (20/110) did not take contraceptive measures, 43.6% (48/110) used condom, 10.9% (12/110) used in vitro ejaculation or safe period or combination of two methods, and only 27.3% (30/110) used IUD or tubal ligation. The overall correct rate of contraceptive knowledge was 65.9% (1 755/2 664) . The correct rates of knowledge about postpartum intrauterine device, the placement time of subcutaneous implantation of contraceptives, the correct use of condoms were particularly low. During the visits, postpartum lactating mothers, condom and safe period were recommended for contraception; and condom was recommended most (93.2%, 138/148), however, only 24.3% (36/148) of them carried free contraceptive condom when visiting home.


Conclusions
The general levels of contraception-related knowledge and ability of community postpartum visitors are less satisfactory. It is necessary to strengthen the training and assessment of contraceptive knowledge for them.


Key words: 
Postnatal care; Knowledge, contraception; Postpartum contraceptive guidance; Community health services
Impairment of renal function in patients with hyperuricemia and hypertension
Authors: Haifeng Yu, Meilin Zhao, Yanfang Nie
Journal: BMJ (2014)

Objective
To investigate the effect of hypertension and hyperuricemia (HUA) on renal function.


Method
Total 1 209 subjects undergoing health check up from December 2000 to December 2002 and 45 patients with renal disorders were enrolled in the study. The blood pressure, height, weight, renal function and liver function were measured; and the glomerular filtration rate (GFR) was calculated. The GFR in patients with hypertension, HUA and hypertension with HUA was compared.


Results
The incidence of hypertension in HUA group and non-HUA was 23.9%(58/243) and 13.9%(134/966), respectively (χ2=14.52, P=0.000). GFR in HUA with hypertension, HUA and hypertension groups were (69.1±30.5), (82.8±25.3) and (90.1±21.7)ml·min-1·(1.73 m2)-1, respectively (P<0.01). Logistic regression analysis showed that the risk factors for GFR were UA, systolic pressure and age. After 5 years of follow up, GFR in hypertension group was significantly decreased from (90.7±18.1) to (85.6±17.6)ml·min-1·(1.73 m2)-1m, in HUA group from (86.3±10.9) to (62.1±8.2) and in HUA with hypertension group from (77.9±18.9) to (49.3±9.8) ml·min-1·(1.73 m2)-1, UA and age were the long-term factors that affect GFR (P<0.05).


Conclusions
Both hyperuricemia and hypertension can impair the kidney function, if hypertension is complicated with hyperurecemia the effect is more marked.


Key words: 
Hypertension; Hyperuricemia; Glomerular filtration rate
Abstract 17130: Air Pollution And Carotid Atherosclerosis In Coronary Artery Disease Patients
Authors: Vasiliki Chara Mystakidi, Evangelos Oikonomou, Panagiotis Theofilis, Petros Fountoulakis, Margarita N Asimakopoulou, Nikolaos Barbaresos, Ioannis Giannarakis, Georgia Vogiatzi, Margenti Papakonstantinou, Sotiris Tsalamandris, George Lazaros, Dimitris Tousoulis
Journal: Circulation (2019)

Introduction: The deleterious action of air pollution on cardiovascular health is undeniable, as it has been linked with increased risk of myocardial infarction and cerebrovascular events. However,...
A phase Ib study of nivolumab in patients with autoimmune disorders and advanced malignancies (AIM-NIVO).
Authors: Ecaterina Elena Ileana Dumbrava, Maria E. Suarez-Almazor, Jeane Painter, Tanner Johanns, Michael L. Dougan, Laura Cappelli, Clifton O. Bingham, Yinghong Wang, Sarthak Gupta, Blake M Warner, Osama E. Rahma, Jarushka Naidoo, Patrick Alexander Ott, David A Hafler, Harriet M. Kluger, Arezou Khosroshahi, Tamiko R Katsumoto, Shivaani Kummar, Elad Sharon, Hussein Abdul-Hassan Tawbi
Journal: Journal of Clinical Oncology (2020)

TPS3158 Background: Immune checkpoint inhibitors (ICI) such as anti-PD-1/PD-L1 antibodies have become a pivotal approach to cancer therapy. Nivolumab is an anti-PD1 antibody approved for an increasing number of solid tumors and hematological malignancies. However, patients (pts) with history of autoimmune disorders are excluded from the majority of clinical trials testing ICI. Consequently, the risks of flares and worsening of pre-existing autoimmune disorders in pts with tumor types who otherwise stand to benefit from ICI therapy are largely unknown, posing a challenge for oncologists. We are conducting a phase Ib study to test the hypothesis that nivolumab can be safely administered to pts with varying severity of Dermatomyositis, Systemic Sclerosis, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Inflammatory Bowel Disease, Multiple Sclerosis, Sjögren's Syndrome and Other Autoimmune Disorders (AIM-Nivo). Methods: AIM-Nivo is an open-label, multi-center ongoing phase Ib study with nivolumab 480mg IV every 28 days in pts with autoimmune diseases and advanced malignancies (NCT03816345). The study has autoimmune disease-specific cohorts overseen by a multidisciplinary group of experts. The primary objective is to assess the overall safety and toxicity profile of nivolumab in pts with autoimmune disorders and advanced malignancies. Secondary objectives are to evaluate the antitumor efficacy, the impact of nivolumab on the autoimmune disease severity indices, and to explore potential biomarkers of response, resistance or toxicity. Key overall inclusion criteria include age ≥18 years, histologically confirmed advanced malignancies in which ICI are approved or have shown clinical activity. Key overall exclusion criteria include prior therapy with anti-PD-1/PD-L1 antibodies. Specific eligibility criteria are defined for each disease-specific cohort. For each autoimmune disorder, severity level of the disease as defined by disease-specific severity indices will be assessed, and up to a total of 12 pts will be included in each disease cohort at each severity level. Primary endpoints are dose-limiting toxicities, adverse events (AEs) and serious AEs. Continuous monitoring of toxicity will be conducted. Key secondary endpoints are best objective response, progression free and overall survival and cohort specific tumor tissue, blood and non-tumor tissue-based biomarkers. The AIM-Nivo trial opened in May 2019 and is enrolling pts through the National Cancer Institute Experimental Therapeutics Clinical Trials Network (ETCTN). Clinical trial information: NCT03816345 .