tbuckley/cabot-search huggingface dataset:
Single-shot live-attenuated chikungunya vaccine in healthy adults: a phase 1, randomised controlled trial
Authors: Nina Wressnigg, Romana Hochreiter, Oliver Zoihsl, Andrea Fritzer, Nicole Bézay, Anton Klingler, Karen Lingnau, Martina Schneider, Urban Lundberg, Andreas Meinke, Julian Larcher-Senn, Irena Čorbic-Ramljak, Susanne Eder-Lingelbach, Katrin Dubischar, Wolfgang Bender
Journal: The Lancet Infectious Diseases (2020)
Monitoring of <i>PIK3CA</i> and <i>ESR1</i> mutations in circulating tumor DNA as predictive and prognostic biomarkers in patients with endocrine-resistant ER+/HER2- advanced breast cancer.
Authors: Jesús Fuentes Antrás, Vanesa García-Barberán, Irene Gonzalo, Fernando Moreno, Igor López-Cade, Carmen Ramírez-Ruda, Oskia Bueno, Ana Ascaso del Rio, Alejandro Pascual, Alberto Ocana, Trinidad Caldes, Jose Angel Garcia-Saenz
Journal: Journal of Clinical Oncology (2020)

e13045 Background: Combination therapeutic strategies including CDK4/6 inhibitors and an endocrine backbone are the standard of care of treatment for patients with estrogen receptor positive (ER+)/HER2- advanced breast cancer (ABC). Endocrine agents mainly include aromatase inhibitors, which target ER-driven transcription, and fulvestrant, which functions as ER antagonist. PI3K-AKT-mTOR is a key point of resistance to endocrine therapy, activated in 40% of these patients by mutations concentrated in critical regions of PIK3CA, coding for the p110 catalytic subunit α of PI3K. Additionally, 30% of patients previously exposed to non-steroidal aromatase inhibitors develop mutations in the ligand binding domain of ESR1, causing endocrine resistance by constitutive activation of the ER. Furthermore, metastasis and primary tumors may show a highly heterogenous mutational landscape. Monitoring the dynamic changes of these mutations in ctDNA may provide a non-invasive, real-time and accessible tool to convey predictive/prognostic information and guide decisions on sequential endocrine therapies. Methods: Pre-planned interim analysis results of an observational, prospective cohort pilot study to assess the predictive and prognostic value of monitoring PIK3CA and ESR1 mutations in ctDNA of patients with endocrine-resistant ER+/HER2- ABC. We have studied longitudinal liquid biopsies from 30 patients using digital PCR to interrogate PIK3CA mutations (H1047R / E545K) and ESR1 mutations (D538G / Y537S). Blood samples were drawn at the time of progression to endocrine therapy, at 8 weeks of subsequent endocrine line and at new progression. This exploratory analysis will provide preliminary data on clinical homogeneity, treatment regimens, median follow-up and progression-free survival, mutation incidence and intraindividual variation of mutant allele frequency and copy number. The percentage of progressors at 24 weeks of follow-up according to the mutational status will be evaluated by using the Fisher’s exact test. The predictive potential of ctDNA biomarkers will be characterized by ROC curve analysis. Tracking ctDNA mutations to predict endocrine resistance in a real-world setting represents a critical step towards precision medicine in oncology.
Efficacy of afatinib in the clinical practice: Final results of the GIDEON study in EGFR mutated non-small cell lung cancer (NSCLC) in Germany.
Authors: Wolfgang M. Brueckl, Martin Reck, Harald Schäfer, Cornelius Kortsik, Tobias Gaska, Justyna Rawluk, Stefan Krüger, Konrad Kokowski, Stephan Budweiser, Christopher Hoffmann, Andrea Schueler, Eckardt Laack
Journal: Journal of Clinical Oncology (2020)

e21636 Background: Afatinib is an irreversible ErbB family blocker, which is approved for the treatment of advanced non-small cell lung cancer (NSCLC) patients with activating EGFR mutations. Here we report the final results of the prospective non-interventional study (NIS) GIDEON, which was initiated to investigate the efficacy and tolerability of afatinib in the daily clinical routine in Germany. Methods: EGFR-mutated NSCLC patients were treated with afatinib according to label until progression, death or discontinuation. Efficacy (progression-free survival (PFS) rate at 12 months, objective response rate, ORR; disease control rate, DCR; progression-free survival, PFS and overall survival, OS) was prospectively assessed by investigators. Data about tolerability were collected during routine treatment. Results: In total, 161 patients were enrolled at 41 sites in Germany, 152 patients received at least one dose of afatinib (treated set; TS) and 146 patients were treated according to the protocol (PPS). The majority of patients for the entire TS had exon 19 deletions (64.5%), followed by L858R point mut. (22.4%) and uncommon mut. (exon 18-21 point mut.; 13.1%). The primary objective was PFS-rate at 12 months, which was 50.2% in the PPS. Median PFS amounted to 12.2 months. ORR and DCR were 74.6% and 91.5% in the PPS, respectively. Median OS was 30.4 months with 1- and 2-year survival rates of 79.1% and 57.7%, respectively. Among pat. with uncommon EGFR-mut., the 12-months PFS rate was 40.2% with a mPFS of 10.7 months. ORR and DCR were 83.3% and 91.7%, respectively. The most frequent documented adverse drug reactions (ADRs) were diarrhea and rash/acne with 13.8% and 7.2% of grade 3 but no grade 4 or higher. Conclusions: Afatinib is a standard therapy for patients with activating EGFR mut. in Germany. The final results of this prospective NIS confirm the robust clinical data for afatinib in the clinical routine setting, including patients with uncommon exon 18-21 point mutations. Clinical trial information: NCT02047903.
A prevalence survey on chronic pharyngitis in residents of Dongfeng town, Zhongshan city,Guangdong
Authors: 卢春如, 魏伟泉, 马金香
Journal: BMJ (2010)

Personal health records were collected and analyzed for 1804 residents at Dongfeng town,Zhongshan city, Guangdong. One hundred and forty-one of 1804 residents suffered from chronic pharyngitis with a prevalence of 7.8 percent, 11.9 percent in males and 6. 6 percent in females with statistically significant difference (x2 = 12. 076, P ＜ 0. 05 ). Age, body mass index, physical exercise, eating habit,dental caries, oral illness (gingivitis, periondontitis, ondontolith), ear-nose-throat diseases, allergic constitution all were associated with their chronic pharyngitis, which was more prevalent in those of males,with ear-nose-throat diseases, lack of physical exercise, aged less than 24 years and over-intake of sugar.

Key words: 
Pharyngitis ;  Prevalence ;
Effect of cumulative dexamethasone dose during concomitant chemoradiation on lymphopenia in patients with newly diagnosed glioblastoma.
Authors: Stephen Ahn, Jae-Sung Park, Jin Ho Song, Sin-Soo Jeun, Yong-Kil Hong
Journal: Journal of Clinical Oncology (2020)

e14533 Background: Lymphopenia frequently occurs after concomitant chemoradiation (CCRT) in patients with glioblastoma (GBM) and is associated with worse overall survival (OS). A few studies have tried to identify risk factors for lymphopenia; however, the results were not clear. We aimed to identify potential risk factors for lymphopenia, focusing on the use of dexamethasone to control cerebral edema in patients with GBM. Methods: The electronic medical records of 180 patients with newly diagnosed GBM treated at our institution between 2009 and 2017 were retrospectively examined. Acute lymphopenia was defined as TLC (total lymphocyte count) less than 1,000 cells/mm3 at 4 weeks after completion of CCRT. Multivariate logistic regression analysis was used to identify independent risk factors for lymphopenia, and Cox regression analysis was used to identify independent risk factors for OS. Results: Of the 125 eligible patients, 40 patients (32.0%) developed acute lymphopenia. Female sex and median daily dexamethasone dose &gt; 2mg after initiation of CCRT were independent risk factors for acute lymphopenia on multivariate analysis. Acute lymphopenia, extent of surgical resection, and performance status were associated with OS; however, dexamethasone use itself was not an independent risk factor for poor OS. Conclusions: Female sex, median daily dexamethasone dose &gt; 2 mg after initiation of CCRT until four weeks after completion of CCRT may be associated with acute lymphopenia. However, dexamethasone use itself did not affect OS in patients newly diagnosed with GBM. These results should be validated by further prospective studies controlling for other confounding factors.
Leptomeningeal metastasis from non-small cell lung cancer- outcomes from a tertiary care center.
Authors: Dilip Harindran Vallathol, Vijay Maruti Patil, Vanita Noronha, Amit Joshi, Nandini Sharrel Menon, Kumar Prabhash
Journal: Journal of Clinical Oncology (2020)

e14508 Background: Leptomeningeal metastasis from Non-Small Cell Lung Cancer is often an underdiagnosed entity. Despite advances in treatment, the outcomes of Leptomeningeal Metastasis continues to be dismal. The data on outcomes of leptomeningeal metastasis from a tertiary care centre is limited. Methods: Data collected from the 4 prospective randomised controlled trials conducted on Non Small cell Lung cancer patients at our centre in the last decade was used in the analysis. These included 1. Patients who had EGFR sensitizing mutations enrolled in the Pemetrexed versus Gefitinib maintenance trial and Gefitinib versus Gefitinib plus chemotherapy trial. 2. Patients who were diagnosed as Squamous Cell Carcinoma of lung enrolled in the Low Dose Gemcitabine versus Standard-Dose Gemcitabine trial. 3. Patients with adenocarcinoma who were enrolled in the Pemetrexed versus Erlotinib maintenance trial. We separated the patients who developed Leptomeningeal Metastasis from these trials and studied its incidence, presenting features and outcomes. Statistical analysis was done using cox regression analysis and kaplan meier plots. Results: Out of 1148 patients, 36 patients (0.031%; 95%CI 0.022-0.043) developed leptomeningeal metastasis. In these patients, the median time to development of LM was 14.92 months (IQR 7.7-21.84). The median overall survival after development of LM was 61 days (95%CI 38.95-83.05). None of the tested factors- Age (Hazard ratio-0.886; 95% CI 0.424-1.851, P-value = 0.747), ECOG PS (Hazard ratio-0.719; 95%CI 0.299-1.729) or driver mutation status ( Hazard ratio-2.080, 95%CI 0.739-5.855) had an impact on OS. The median OS in driver mutated patients was 66 days (95% CI 14.74-117.26) versus 51 days (95% CI 14.5-87.5) (P-value = 0.201). Conclusions: In our study, there was no single factor which impacted survival in patients who developed Leptomeningeal Metastasis. The median survival was in the range of 2 months. This reiterates the overall poor prognosis of development of Leptomeningeal Metastasis in Non small Cell Lung Cancer even with the development of newer therapeutic modalities. Keywords- Leptomeningeal metastasis, Non small cell lung cancer, Incidence, Survival.
BRCA1/2 and CHEK2 mutation prevalence in patients with breast and/or ovarian cancer in the South of Russia.
Authors: Natalia A. Petrusenko, Natalya N. Timoshkina, Larisa N. Vashchenko, Darya Yakubova, Ekaterina V. Verenikina, Anna P. Menshenina, Galina V. Zhukova, Oleg I. Kit
Journal: Journal of Clinical Oncology (2020)

e13088 Background: The development of breast cancer (BC) and ovarian cancer (OC), as well as their chemoresistance may be due to the presence of mutations in many genes, but most often in BRCA1/2 and CHEK2. Early diagnosis and subsequent preventive interventions improve the survival of patients with mutations in the BRCA1/2 genes. Genotyping of the gene inactivation events predicts a high sensitivity of BC and OC to platinum-containing cytostatics. Our purpose was to study the spectrum of germline mutations in the BRCA1/2 and CHEK2 genes in BC and/or OC patients in the South of Russia. Methods: The study included 622 patients of 10 nationalities with BC and/or OC from the South of Russia. Genomic DNA was isolated from peripheral blood leukocytes; mutations were detected by Real-Time PCR in the BRCA1 (185delAG, 300T &gt; C, 2080delA, 4154delA, 5382insC, 3819delGTAAA, 3875delGTCT), BRCA2 (6174delT), CHEK2 (1100delC, IVS2+1G &gt; A, 470T &gt; C) genes. Results: Mutations in the BRCA1/2 gene were found in 13.5% of cases, in CHEK2 – 6.2%. In the BRCA1/2 gene, the frequency of 5382insC mutation was 76.2%; 4153 delA – 9.5%; 300T &gt; G – 7.1%; 2080delA – 3.6%; 185delAG, 3875delGTCT, 6174delT - 1.2% each. In the CHEK2 gene: 470Т &gt; C – 73.1%; IVS2+1G &gt; A – 23.1%; 1100delC – 3.8%. Two patients showed a combination of 5382insC mutation in the BRCA1 gene and 470T &gt; C mutation in the CHEK2 gene. The observed prevalence of mutations in BRCA1 was generally consistent with that for European countries (p = 0.062). Identification of 470T &gt; C mutation in CHEK2 in two cases confirmed the final diagnosis of Li-Fraumeni syndrome (OMIM: 609265); however, we failed to establish a family history of cancer in one patient. A high-risk cancer group was formed for prophylactic purposes based on the data of genotyping for major mutations in the BRCA1/2 and CHEK2 genes in patients with BC/OC and their healthy relatives. Conclusions: The frequency of BRCA1/2 and CHEK2 mutations in the studied multinational population of Caucasian patients with BC and/or OC was 17.2%. The 5382insC BRCA1/2 (76.2%) and 470Т &gt; C CHEK2 (73.1%) mutations were the most frequent which corresponded to the occurrence of these SNPs in populations of European countries.
An Unusual Electrocardiogram Following Pacemaker Implantation
Authors: Jacob J. Mayfield, Nora Goldschlager
Journal: JAMA Cardiology (2020)

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA Cardiology HomeNew OnlineCurrent IssueFor Authors Podcast Publications JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2023 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA Cardiology journal
肺曲菌球误诊一例
Authors: 柴文戍, 齐风杰
Journal: BMJ (2004)

患者男,41岁,间断咯血15年,加重1 d于2002年9月7日入院.患者15年前无诱因咯血,对症治疗好转,以后反复发作,以往胸片检查均诊断为右下肺支气管扩张,20岁开始做制酒工作,接触曲菌,27岁因咯血改行.在右肺下野闻及湿啰音,肺CT示右肺下叶内基底段及背段多个大小不等囊状透光区,其中在大囊内见球形密度增高阴影,并可见新月形透光区.痰培养示曲菌生长.诊断:右下叶支气管扩张、肺曲菌球.入院后给予抗炎及止血治疗,咯血停止.10月18日行右肺下叶切除术,术中见右肺下叶内基底段有球形肿块,基底段及背段有较多囊泡状物.术后病理检查见大量真菌菌丝和孢子,病理诊断与临床相符.术后追踪观察,情况良好。
哌拉西林-他唑巴坦相关性药物热一例
Authors: 郑旭婷, 陈佰义
Journal: BMJ (2010)

患者男,20岁,以发热3 d、咳嗽和咳痰2 d于2008年10月10日入院.3 d前劳累后感觉发热、鼻塞、头晕,体温未测,口服感康后上述症状好转.2 d前开始轻微咳嗽,咳黄白痰,无咯血及呼吸困难.1 d前症状加重,伴胸痛,体温最高达39.6℃,伴发冷,无寒战.人院前1 d血白细胞15.96×109/L,分类粒细胞0.92,血红蛋白153 g/t,,肺CT平扫左肺上叶可见片状实变影。
Hemoglobin level is a risk factor of non-alcoholic fatty liver disease
Authors: Annan Liu, Jie Pan, Leilei Wang, Shuwen Yang, Yan Zhang, Jing Fu, Suyan Cao
Journal: BMJ (2018)

Total 732 subjects aged 30-60 years undergoing health check-up at Beijing Hospital Medical Examination Center in 2009, who had no history of non-alcoholic fatty liver disease (NAFLD) were recruited in the study.According to the quartile of hemoglobin (HGB) level, the subjects were divided into 4 groups: Q1: HGB≤131 g/L (n=192), Q2: HGB>131 g/L and ≤140 g/L (n=178), Q3: HGB>140 g/L and ≤152 g/L (n=184), Q4: HGB>152 g/L (n=178). All participants were followed up for 4 years, the prevalence rates of NAFLD in groups Q1, Q2, Q3 and Q4 were 8.3% (16/192), 17.4% (31/178), 23.4% (43/184) and 25.3% (45/178), respectively (P<0.05). Logistic regression showed that the rates of NAFLD in groups Q2, Q3 and Q4 were 2.32 (1.22-4.41), 3.36 (1.81-6.21) and 3.72(2.02-6.87) times higher as group Q1(P<0.05). Multiple logistic regression analysis showed that the hemoglobin level, TG and BMI were the independent risk factors of NAFLD.


Key words: 
Fatty liver; Hemoglobins; Cohort studies
先天性左主支气管发育不良一例
Authors: 刘俊举
Journal: BMJ (2011)

患儿男,1岁,以咳嗽伴喘息11d为主诉入院.否认异物吸入史,外院用药情况不详.入院时体检:体温36.8℃,脉搏116次/min,呼吸46次/min,体重11.5kg.发育正常,营养中等,呼吸稍促,无发绀、吸气三凹征,咽充血,扁桃体不大,颈软,心音有力,节律齐,左肺呼吸音较低,双肺闻及哮鸣音、痰鸣音及细湿啰音,腹软,肝脾未触及,肠鸣音正常,脊柱及四肢未见异常,神经反射正常。
Abstract 13375: Can the Rope Score be Used as a Triaging Tool in Assessing the Need for Saline Contrast Study in Stroke Workup to Identify Patent Foramen Ovale ?
Authors: Aditya Singh, Fortune Ojeanor, Guneet Ahluwalia, Karthikeyan Ananthasubramaniam
Journal: Circulation (2019)

Introduction: Patent foramen ovale (PFO) has been found more frequently in patients with cryptogenic stroke in both the younger and older subgroups. Risk of Paradoxical Embolism (RoPE) Score is use...
Progress on management of primary immune thrombocytopenia in pregnancy
Authors: Shuting Chang
Journal: BMJ (2018)

Primary immune thrombocytopenia (ITP) in pregnancy is a special type of ITP, its impact on the mother and fetus cannot be ignored. The correct diagnosis and effective treatment of ITP in pregnancy are the focus of the clinical practice and medical research. This article reviews the progress on the management of the primary immune thrombocytopenia in pregnancy.


Key words: 
Pregnancy; ITP; Diagnosis; Treatment
The diagnostic value of high-frequency ultrasound in metastatic cervical lymph node
Authors: 李超, 李伦, 张兵, 王朝晖, 陈建超, 伍海翔, 杨素琼
Journal: BMJ (2008)

高频超声(high-frequency ultrasound,HFU)对表浅组织显示好,是一种敏感、简便、无创伤、价格低廉、不受特殊条件限制并易于推广的检查方法.可为临床肿瘤N分期尤其是cN0.期判定、肿瘤治疗方案的选择和治疗后疗效评价及监测提供简便实用的方法[1]。
Application of AH Plus root canal filling paste in root canal therapy
Authors: Hai-feng Wang, Mei-zhi Ning, Dan Xing
Journal: BMJ (2011)

To compare the postobturation pain and therapeutic effects in root canal therapy between two root canal filling materials: AH Plus and zinc oxide eugonol. Four hundred and twenty four teeth requiring root canal therapy were randomly divided into 2 groups: AH Plus ( trial group ) or zinc oxide eugonol ( control group) were used in treatment respectively. The pain intensity after treatment was evaluated by visual analogue scale. The therapeutic effects were evaluated by follow-up for 6 and 12 months. The pain intensity of trial group was significantly lower than that of the control group in 3rd and 7th day[8. 5% ( 18/212) vs. 15.6% (33/212),5.2% (11/212) vs. 14.6% (31/212),both P ＜0.05]. There were no significant differences in effictive rate between two groups after follow-up for 6 and 12 months[92. 5% ( 196/212) vs. 89. 6% ( 190/212 ) ,91.5% ( 194/212 ) vs. 88.7% ( 188/212 ), both P ＞ 0. 05]. AH Plus root canal filling paste used in root canal therapy can significantly decrease postoperative pain.

Key words: 
Root canal filling materials;  Root canal therapy
急性肠套叠患儿延误诊断因素分析
Authors: 谢扬, 蒋学武, 陈中献
Journal: BMJ (2005)

将328例急性肠套叠患儿根据诊断时间分为≤24 h组72例和>24 h组256例.应用多因素logistic回归分析等方法研究年龄、性别、体型、发病季节、消化道病史、阵发性哭闹、呕吐、便血、腹腔包块等相关外科体征以及居住地、父母文化水平和初次就诊情况等因素对延误诊断的影响.结果表明消化道疾病诱因、有关症状体征不典型、未接受外科体检、父母文化水平低以及初诊医生水平低等是肠套叠患儿延误诊断的独立相关因素。
专科与全科联网互动全面全程防治心脑血管病
Authors: 顼志敏
Journal: BMJ (2009)

根据卫生部心血管病防治研究中心2008年发布的 ,估计我国心血管病现患人数至少2.3亿,每年心血管病死亡300万人,每年用于心血管病的医疗费用达1100亿元人民币,为社会带来巨大经济负担[1-2].因此,需要采取有效措施,尽快遏制心脑血管疾病发病和死亡率增长的趋势.预防的关键是下放、前移:即下放至全科防治网络;前移到控制导致心血管病发生的危险因素。
DREAMM-2: Single-agent belantamab mafodotin (GSK2857916) in patients with relapsed/refractory multiple myeloma (RRMM) and high-risk (HR) cytogenetics.
Authors: Adam D. Cohen, Suzanne Trudel, Sagar Lonial, Edward N. Libby, Hans Chulhee Lee, Britta Besemer, Thierry Facon, Ajay K. Nooka, Natalie Scott Callander, Ajai Chari, Ira Gupta, Sofia Paul, Joanna Opalinska, Paul G. Richardson
Journal: Journal of Clinical Oncology (2020)

8541 Background: Patients with RRMM and HR cytogenetics have a poor prognosis and need effective therapies. In DREAMM-2 (NCT03525678), single-agent belantamab mafodotin (an immunoconjugate targeting B-cell maturation antigen) demonstrated clinically meaningful activity and a manageable safety profile in patients with heavily pretreated RRMM ( Lancet Oncol.2020). We present outcomes in patients with HR-cytogenetics (9-month follow-up). Methods: Patients with RRMM received single-agent belantamab mafodotin (2.5 or 3.4 mg/kg). For this post hoc analysis, HR-cytogenetics included t(4;14), t(14;16), 17p13del, or 1q21+ (tested locally). Results: The median number of cycles was 3 (2.5: range: 1–15) and 4 (3.4: range: 1–14). Overall response rate (ORR; ≥partial response [PR] per independent review committee) was 27% in the 2.5 mg/kg group (22% with ≥very good partial response [VGPR]) and 40% in the 3.4 mg/kg group (27% with ≥VGPR). The median duration of response (DoR) was not reached in the 2.5 mg/kg group and was 6.2 months in the 3.4 mg/kg group. The most common adverse events ( &gt; 30% in either group) were consistent with the overall population ( Lancet Oncol.2020): keratopathy (2.5: 59%;3.4: 79%), thrombocytopenia (2.5: 44%; 3.4: 65%), nausea (2.5: 27%; 3.4: 33%), anemia (2.5: 24%; 3.4: 42%), and blurred vision (2.5: 20%; 3.4: 42%). Conclusions: Patients with HR-cytogenetics maintain deep and durable clinical responses with single-agent belantamab mafodotin, comparable to that reported in the overall population. The safety profile remained consistent with previous reports. Funding: GlaxoSmithKline (205678). Drug linker technology licensed from Seattle Genetics; monoclonal antibody produced using POTELLIGENT Technology licensed from BioWa. Clinical trial information: NCT03525678 . [Table: see text]