tbuckley/cabot-search huggingface dataset:
Epidemiological and clinical characteristics of 199 cases of HIV/AIDS patients
Authors: Hong-jie Ou, Juan-juan Wang
Journal: BMJ (2013)

During the period of January 2006 to December 2012 at our department, retrospective analyses of epidemiological and clinical data were performed for 199 newly diagnosed HIV/AIDS inpatients and outpatients. The male-to-female ratio was 3.78:1. Their age range was 20-40 years. Migrant workers accounted for a large proportion of infection. Sexual contact was a major route of transmission and it accounted for 88.4%. Most of them had non-marital sexual contact. And all infected marital sexual contacts were women. Asymptomatic patients accounted for 55.8%. Pulmonary infection was the most common clinical manifestation. There were more males than females locally. Most of them were young and middle-aged. Sexual contact was a major route of transmission. Out-of-town migrant population was important for transmission.


Key words: 
Acquired immune deficiency syndrome; Epidemiology
A case of systemic lupus erythematosus complicated by lupus nephritis with Graves' disease as the first manifestation
Authors: Wenbin Wen, Yanmei Ma, Wei Zhang, Shuaishuai Shi, Ruijun Zhou, Yu Wang
Journal: BMJ (2019)

报道1例有14年毒性弥漫性甲状腺肿（Graves病）病史的23岁女性患者，近3年规律口服丙硫氧嘧啶治疗，入院前1周在急性上呼吸道感染后出现甲状腺功能亢进加重合并急性肾损伤，完善检查后提示系统性红斑狼疮合并狼疮性肾炎，经使用糖皮质激素联合细胞毒药物、适当增加丙硫氧嘧啶剂量治疗后急性肾损伤及甲状腺功能亢进完全好转。
Serum level changes of leptin and 5-hydroxytrytamine in patients with premature ejaculation before and after hydrochloride sertraline treatment
Authors: Yong Zhou, Kun-long Tang, Bao-long Wang, Lin Yang, Li-ming Li, Chang-hai Yang
Journal: BMJ (2013)

A total of 71 patients with premature ejaculation (PE) received hydrochloride sertraline treatment for 8 weeks and their serum levels of leptin and 5-hydroxytrytamine (5-HT) were determined. Their ejaculation functions were assessed with intravaginal ejaculation latency time (IELT) and Chinese index of premature ejaculation (CIPE-5) value. The study was compared with 64 normal males as control. The baseline level of leptin in the trial group was obviously higher than the controls (P<0.05) while the level of 5-HT in the trial group far lower than the controls (P<0.05). At 8 weeks, the level of leptin dropped while the level of 5-HT rose in the trial group after treatment. Therefore a high serum level of leptin and a low serum level of 5-HT may become biological indicators for PE.


Key words: 
Premature ejaculation; Intravaginal ejaculation latency time; Leptin; 5-hydroxy trytamine
Feasibility and safety of vaginal delivery with scarred uterus after cesarean section
Authors: Haifan Qiu, Lianyun Wang, Yuanyuan Pan
Journal: BMJ (2019)

Objective
To explore the feasibility and safety of vaginal delivery with scarred uterus after cesarean section.


Methods
Sixty two parturients after cesarean section undergoing trial vaginal delivery in our department from October 2016 to October 2017 were enrolled in study (study group); 60 primiparous women admitted at the same period were taken as the control group. The successful rate of vaginal delivery, the duration of labor and the incidence of postpartum complications were analyzed. The postpartum depression was assessed with Edinburgh Postpartum Depression Scale 6 weeks after delivery and compared between two groups.


Results
The vaginal delivery was successful in 49 parturients of each group with a successful rate of 79.0% (49/62) and 81.7% (49/60) respectively (χ2=0.13, P=0.71).The first and the second stages of labor in the study group were (364±105) min and (54±31) min, respectively, which were shorter than those of the control group [(388±93)min and (63±18)min, t=2.325, P=0.03; t=2.145, P=0.04]. The incidence rates of postpartum hemorrhage, infection and urinary retention were 3.2% (2/62) and 1.7% (1/60), 1.6% (1/62) and 1.7% (1/60), 4.8% (3/62) and 3.3% (2/60) in study group and control group, respectively (χ2=0.309, 0.001 and 0.176, P>0.05). The Apgar scores of the newborns in two groups were 8.7±2.1 and 8.5±1.8 (t=1.415, P=0.14) and the postpartum depression scores of the mothers were 13.7±4.3 and 12.4±3.2 (t=1.203, P=0.33), respectively.


Conclusion
Vaginal delivery can be chosen in parturients with scarred uterus after cesarean section, if preparations are adequate, indications of vaginal delivery are sufficient and the course of labor is closely monitored.


Key words: 
Vaginal birth after cesarean; Cicatrix, uterus; Safety
Sharing Health Data and Biospecimens with Industry — A Principle-Driven, Practical Approach
Authors: Kayte Spector-Bagdady, Raymond Hutchinson, Erin O’Brien Kaleba, Sachin Kheterpal
Journal: New England Journal of Medicine (2020)

Regulations give substantial discretion to individual organizations when it comes to sharing deidentified data and specimens with outside entities. Academic medical centers are practically and ethically compelled to establish best practices for such sharing.
Interest in cessation treatment and survival among smokers in a community-based multidisciplinary thoracic oncology program.
Authors: Meghan Meadows, Kenneth Daniel Ward, Nicholas Ryan Faris, Matthew Smeltzer, Carrie Fehnel, Folabi Ariganjoye, Jessica Smith, Laura McHugh, Angela Fulford, Raymond U. Osarogiagbon
Journal: Journal of Clinical Oncology (2020)

2028 Background: Tobacco cessation is essential to high quality oncology care. Many patients smoke when diagnosed and continue to smoke during treatment, which adversely affects treatment response and survival. Although most patients are motivated to quit, few receive effective cessation therapy. The multidisciplinary clinic (MDC), where patients, their caregivers, and key specialists coordinate care, is an ideal setting to integrate a cessation program. To assess the need for cessation services within a MDC setting, we surveyed incoming patients about their smoking status, interest in quitting, and willingness to participate in a clinic-based cessation program. Methods: The study was conducted in the Multidisciplinary Thoracic Oncology Program at Baptist Cancer Center, Memphis TN. We evaluated sociodemographic/clinical characteristics, smoking status, and tobacco dependence of consecutive new patients diagnosed with lung cancer from 2014-2019, who completed a social history questionnaire. Current smokers reported their interest in quitting and their willingness to participate in a cessation program. Chi square tests and logistic regression models were used to compare characteristics of those who would participate vs. those who would not/were unsure. Kaplan-Meier curves and multivariable Cox regression were used to evaluate the association between willingness to participate in a cessation program and overall survival, adjusted for age, sex, race, and total pack-years of smoking. Results: Of 641 patients, the average age was 69 years (range: 32-95), 47% were men, 64% white/34% black, and 17% college graduates; 90% had ever smoked, 34% currently smoked, and 24% quit smoking within the past year. Among current smokers, 60% were very interested in quitting and 37% would participate in a clinic-based cessation program. Willingness to participate was associated with greater interest in quitting (p = 0.0010) and greater overall survival (log rank p = 0.01;HR: 0.48, 95% CI: 0.24-0.95) but was not associated with any sociodemographic, clinical, or smoking-related characteristics. Conclusions: Over half (58%) of patients in a community-based MDC program were current smokers/recent quitters. Willingness to participate in a cessation program was associated with improved survival, suggesting patients with favorable prognoses are especially interested in receiving cessation support. There is considerable need for cessation services and relapse-prevention support within a coordinated, MDC lung cancer care setting.
Effectiveness of distance electrocardiographic consultation network for regional primary medical institutions
Authors: Jiefeng Xu, Zilong Li, Guofeng Chen, Lizheng Fang, Zhengquan Wang, Ya Fang, Haixia Tu, Yanyan Zhang
Journal: BMJ (2016)

Objective
To evaluate the effectiveness of regional electrocardiographic consultation network for primary medical institutions.


Methods
A distance electrocardiographic (ECG) consultation center was established in Yuyao People's Hospital in September 2012, which was connected to 56 regional primary medical through internet. The online consultation was provided by ECG specialists in the center for general practitioners in regional primary health care institutions. Additionally, the ECG training course was also conducted monthly for general practitioners. The 2-year data of ECG consultation were retrospectively reviewed and the effectiveness of the consultation network was evaluated.


Results
During the past two years, 86 593 electrocardiograms were uploaded by primary medical institutions, in which 3 976 were required for consultation. The monthly number of electrocardiograms sent by general practitioners was increased from 3 269±290 in the first year to 3 947±376 in the second year (P<0.01). However, the requirements of ECG consultation were not significantly different between two years. Compared to the first year, the rates of consultation requirements, misdiagnosis and missed diagnosis for ECGs of atrial and ventricular premature beats, atrial fibrillation, supraventricular tachycardia, left and right bundle branch blocks, Ⅰ and Ⅱ degree atrioventricular blocks and myocardial infarction were significantly decreased(all P<0.05)in the second year; meanwhile there was a tendency towards the reduction for ECGs of atrial flutter and Ⅲ degree atrioventricular block in the second year.


Conclusion
The regional electrocardiographic consultation network is effective to improve the capability of primary medical institutions in electrocardiographic diagnosis.


Key words: 
Electrocardiography; Remote consultation; General practitioners
Long-term benefit of adjuvant dabrafenib + trametinib (D+T) in patients (pts) with resected stage III <i>BRAF</i> V600–mutant melanoma: Five-year analysis of COMBI-AD.
Authors: Axel Hauschild, Reinhard Dummer, Mario Santinami, Victoria Atkinson, Mario Mandalà, John M. Kirkwood, Vanna Chiarion Sileni, James M. G. Larkin, Marta Nyakas, Caroline Dutriaux, Andrew Mark Haydon, Caroline Robert, Laurent Mortier, Jacob Schachter, Kohinoor Dasgupta, Eduard Gasal, Monique Tan, Georgina V. Long, Dirk Schadendorf
Journal: Journal of Clinical Oncology (2020)

10001 Background: Previous results of the COMBI-AD trial (NCT01682083) showed a significant relapse-free survival (RFS) benefit with 12 mo of adjuvant D+T vs placebo (PBO) in pts with high-risk resected stage III BRAF V600E/K–mutant melanoma. In the primary analysis, 3-year RFS rates with D+T vs PBO were 58% vs 39% (hazard ratio [HR], 0.47 [95% CI, 0.39-0.58]; P &lt; .001). An interim analysis of overall survival (OS) yielded 3-year OS rates of 86% with D+T vs 77% with PBO (HR, 0.57 [95% CI, 0.42-0.79]). Here we report data from 5-year analyses including long-term RFS and an updated cure rate model. Methods: COMBI-AD is a randomized, Phase III trial evaluating 12 mo of adjuvant D 150 mg twice daily + T 2 mg once daily vs 2 matched PBOs in pts with resected stage III BRAF V600E/K–mutant melanoma. Pts were stratified by BRAF status and disease stage (per AJCC 7 criteria). The primary endpoint is RFS; secondary endpoints include OS and distant metastasis–free survival (DMFS). A Weibull mixture cure rate model was applied to estimate the fraction of pts who will remain relapse free in the long term. As all patients had completed treatment by the time of the primary analysis, updated safety analyses were not performed. Results: This analysis represents a median follow-up of 60 mo for the D+T arm and 59 mo for the PBO arm. As of the data cutoff (Nov 8, 2019), 190 of 438 pts in the D+T arm and 262 of 432 pts in the PBO arm had an RFS event. Median RFS was not reached (NR; 95% CI, 47.9 mo-NR) with D+T vs 16.6 mo (95% CI, 12.7-22.1 mo) with PBO (HR, 0.51 [95% CI, 0.42-0.61]). The 4- and 5-year RFS rates were 55% (95% CI, 50%-60%) and 52% (95% CI, 48%-58%) with D+T vs 38% (95% CI, 34%-43%) and 36% (95% CI, 32%-41%) with PBO. These findings match those estimated by the cure rate model. The RFS benefit with D+T was evident across all AJCC 7 substages (HR [95% CI]: IIIA, 0.61 [0.35-1.07]; IIIB, 0.50 [0.37-0.67]; IIIC, 0.48 [0.36-0.64]). Median DMFS was NR in either arm but favored D+T (HR, 0.55 [95% CI, 0.44-0.70]). OS was not updated at this data cutoff as the prespecified number of events for the final OS analysis had not yet occurred. Conclusions: This 5-year analysis confirms the long-term benefit of adjuvant D+T in pts with resected stage III BRAF V600E/K–mutant melanoma. Clinical trial information: NCT01682083.
A randomized phase II study of second-line treatment with liposomal irinotecan, and S-1 versus liposomal irinotecan and 5-fluorouracil in gemcitabine-refractory metastatic pancreatic cancer patients.
Authors: Esther Pijnappel, Judith de Vos-Geelen, Teresa Macarulla Mercade, Davide Melisi, Per Pfeiffer, Gerald W. Prager, Hanneke W.M. Van Laarhoven, Johanna Wilmink
Journal: Journal of Clinical Oncology (2020)

TPS4664 Background: Pancreatic ductal adenocarcinoma (PDAC) is the deadliest form of cancer with a 5-year survival of less than 5% for patients with metastatic disease. Despite improvements over the past years, with the introduction of FOLFIRINOX and gemcitabine plus nab-paclitaxel, the majority has disease progression within 6 months after start of first line treatment. The NAPOLI trial was the first phase III study showing that patients with metastatic pancreatic cancer that progressed after treatment with gemcitabine-based chemotherapy benefitted from second line treatment. Patients received liposomal irinotecan (nal-IRI) either as a single agent or in combination with 5-fluorouracil/leucovorin (5-FU/LV), or 5-FU/LV alone. Patients treated with both nal-IRI and 5-FU/LV experienced a median overall survival (mOS) of 6.1 months versus 4.2 months for the 5-FU/LV group. Recently, two Japanese studies (GEST and JASPAC 01) reported on the use of S-1 in patients with PDAC. In patients with locally advanced or metastatic PDAC, S-1 was non-inferior compared to gemcitabine in terms of mOS (8.8 months for gemcitabine versus 9.7 months for S-1). In the adjuvant setting, S-1 showed superior mOS compared to gemcitabine, 46.5 and 25.5 months respectively, HR for mortality of S-1 compared with gemcitabine was 0.57 (95% CI 0.44–0.72). In view of these results, the objective of this NAPAN study is to compare the progression free survival (PFS) of nal-IRI plus S-1, with nal-IRI plus 5-FU/LV in a Western study population for second line treatment of PDAC. Methods: This is a multi-center, open label, randomized phase II trial. Patients ≥ 18 years of age with histologically or cytologically confirmed PDAC, previously treated with gemcitabine (-based) therapy, or progression within 6 months of adjuvant gemcitabine-based treatment are eligible. After a safety run-in of the nal-IRI plus S-1 regimen, patients will be randomized between nal-IRI plus S-1 and nal-IRI plus 5-FU/LV. Primary endpoint of the run-in phase is to determine dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of nal-IRI when co-administered with fixed dose S-1. The primary endpoint of the phase II part is to determine the efficacy of the treatment arms in terms of PFS. Secondary endpoints include OS, response rate according to RECIST 1.1, adverse events according to CTC version 5.0 and Quality of life. Until now 2 of the planned 120 patients have been enrolled. Clinical trial information: NCT03986294 .
A phase I study of CX-4945 administered orally twice daily to patients with advanced basal cell carcinoma.
Authors: Zeynep Eroglu, Charles Lance Cowey, John Soong, Daniel McCormick, Phoebe Fan, Jimmy Chen, Mohamed Elgendy, Sekwon Jang, Anne Lynn S. Chang
Journal: Journal of Clinical Oncology (2020)

TPS10080 Background: Smoothened inhibitors (SMOi) targeting the Hedgehog (Hh) pathway have been approved for the treatment of patients with locally advanced Basal Cell Carcinoma (laBCC) or metastatic BCC (mBCC). Unfortunately, resistance against SMO inhibitors (SMOi) can develop. Targeting the signaling cascade downstream of SMO, in this case via a novel small molecule inhibitor, could obviate this issue. Casein Kinase 2 (CK2) affects the terminal component of the Hh signaling pathway by promoting Gli2 stability and Gli2’s interaction with target genes. Given the interplay between CK2 and GLI-2 and the importance of Hh signaling activation, CX-4945, a potent CK2 inhibitor, may provide benefits for the BCC patients with resistance or intolerance to SMOi. Methods: A phase I trial (NCT03897036) to explore various treatment durations of CX-4945 was designed for patients with laBCC or mBCC; with endpoints include safety (CTCAE v5) and objective response rate by RECIST 1.0 for mBCC and composite response for laBCC. Major eligibility criteria include progression or intolerability to SMO inhibitors; laBCC patients must not be surgical candidates and must have received prior radiation unless contraindicated, and basosquamous histology is excluded. The first phase of the trial uses a 3+3 design to test the tolerance of a CX-4945 dose of 1000 mg bid for a duration of 28 days continuously. If 2 out of 3, or 2 out of 6 patients experience a DLT, the regimen of 1000 mg bid for 21 days followed by 7 days off (already tested in prior CX-4945 Phase I trials in other tumor types) will be selected as the recommend phase 2 dose (RP2D). Upon determining the RP2D, a dose-expansion phase will further evaluateCX-4945 in two cohorts (laBCC &amp; mBCC), with 10 patients enrolled in each. Currently, we are enrolling patients and collecting sufficient data for the determination of RP2D in this patient population; thus, further assessments are required to determine the safety, tolerability, and efficacy of CX-4945 in advanced BCC. Clinical trial information: NCT03897036.
First-line FOLFOX plus panitumumab versus 5FU plus panitumumab in RAS-BRAF wild-type metastatic colorectal cancer elderly patients: The PANDA study.
Authors: Sara Lonardi, Marta Schirripa, Federica Buggin, Lorenzo Antonuzzo, Barbara Merelli, Giorgia Boscolo, Saverio Cinieri, Samantha Di Donato, Riccardo Lobefaro, Roberto Moretto, Vincenzo Formica, Alessandro Passardi, Vincenzo Ricci, Nicoletta Pella, Mario Scartozzi, Fable Zustovich, Vittorina Zagonel, Matteo Fassan, Luca Boni, Fotios Loupakis
Journal: Journal of Clinical Oncology (2020)

4002 Background: Data on first-line treatment efficacy in elderly patients are limited. Many analyses adopt a questionable cut-off of 65 years and specific evidence with anti-EGFRs is low. FOLFOX-panitumumab (pan) is an option for RAS wild-type (wt) untreated mCRC patients. Guidelines recommend considering fluoropyrimidine monotherapy as an option for elderly patients, but no randomized studies have ever explored the role of the combination with an anti-EGFR. Methods: This is a prospective, open-label, multicenter phase II randomized trial. Unresectable and previously untreated RAS- BRAF wt mCRC patients aged ≥70 were randomized to receive FOLFOX-pan (arm A), or 5FU/LV-pan (arm B) for up to 12 cycles followed by pan maintenance until PD. The primary EP was PFS in both arms. Stratification criteria were age (≤75 vs &gt; 75 years), ECOG PS (0–1 vs 2) and geriatric assessment with G8 Score (≤14 vs &gt; 14). In each treatment arm, the null hypothesis for median PFS was set at ≤6 months. Assuming an expected median PFS time ≥9.5 months with both experimental regimens, a sample size of 90 patients in each arm granted to the study a power of 90%, with a type I error rate equal to 5% (1-sided Brookmeyer-Crowley test) for rejecting the null hypothesis. No formal comparison between the two arms was planned. Results: From Jul 2016 to Apr 2019 a total of 394 patients were screened, 211 were deemed eligible for inclusion and 185 were randomized (92 arm A and 93 arm B). Main pts’ characteristics were (arm A/B): males 66%/61%; median age 77/77y; PS≥1 49%/55%; right colon 23%/21%; G8 &gt; 14 31%/30%. At a median follow up of 20.5 mos, 135 (arm A/B: 64/71) PD events were collected. Median PFS was 9.6 (95% CI 8.8-10.9) in arm A with FOLFOX-pan and 9.1 (95% CI 7.7-9.9) in arm B with 5FU/LV-pan. Response rates were (arm A/B): 65%/57%. Grade 3-4 toxicities were (arm A/B): neutropenia 9.8%/1.1%; diarrhea 16.3%/1.1%; stomatitis 9.8%/4.4%; neurotoxicity 3.3%/0%; fatigue 6.5%/4.4%; skin rash 25%/24.2%, hypomagnesemia 3.3%/7.7%. Conclusions: Large prospective randomized studies in molecularly selected elderly mCRC are feasible with multicenter collaborative efforts. Primary EP was met in both treatment arms. 5FU/LV plus panitumumab for up to 12 cycles followed by panitumumab maintenance until PD might be a reasonable option in elderly mCRC patients with RAS/BRAF wt tumors deserving further investigations in phase III trials. Clinical trial information: NCT02904031 .
Dissecting outcomes of patients (pts) with &lt;ypT2N0 disease after neoadjuvant chemotherapy (NAC) for muscle invasive bladder cancer (MIBC): Results from a large, international, multicenter collaboration.
Authors: Praful Ravi, Gregory Russell Pond, Leonidas Nikolaos Diamantopoulos, Rohit K. Jain, William Paul Skelton, Sumati Gupta, Jonathan David Tward, Kathleen Olson, Parminder Singh, Camilla Marisa Grunewald, Guenter Niegisch, Jae-Lyun Lee, Andrea Gallina, Marco Bandini, Andrea Necchi, Matthew Mossanen, Bradley Alexander McGregor, Catherine Curran, Petros Grivas, Guru Sonpavde
Journal: Journal of Clinical Oncology (2020)

5043 Background: Pathologic complete response (pCR) after NAC for MIBC is strongly correlated with long-term overall survival. However, there are sparse data on the risk of recurrence based on depth of pathologic response (pT0, pTa, pTis, pT1), and the differential impact of clinicopathologic factors and NAC regimen on recurrence. Methods: Baseline data on all pts with cT2-4N0-1 MIBC receiving NAC and who achieved &lt; ypT2N0 disease at radical cystectomy (RC) from 9 international centers were obtained. The key outcome was time to recurrence (TTR) – defined as the time to any recurrence in the urinary tract or regional/distant metastasis, with death (in the absence of recurrence) considered a competing risk. Cox regression analysis was used to analyze the impact of clinical factors on recurrence. Results: A total of 506 pts were available. Median age was 66 years (range 33-86) and 78% (n = 396) were male; median follow-up after RC was 2.6 years. The majority of patients had pure urothelial histology (n = 371, 73%), and baseline stage was cT2N0 (n = 368, 73%), cT3-4N0 (n = 95, 19%) and TanyN1 (n = 43, 9%). NAC regimens were gemcitabine-cisplatin (GC, n = 296, 59%), dose-dense methotrexate-vinblastine-doxorubicin-cisplatin (ddMVAC, n = 141, 28%), split-dose GC (n = 29, 6%), MVAC (n = 29, 6%) and non-cisplatin based regimens (n = 11, 2%). At RC, 304 patients (60%) had ypT0N0 disease, 32 (6%) had ypTaN0, 107 (21%) had ypTisN0 and 63 (13%) had ypT1N0. Overall, 43 patients (8%) recurred with a median TTR of 56 weeks (range 7-251); 5-year freedom from recurrence was 87% (95% CI 83-91). The majority (n = 38) recurred outside the urinary tract. On multivariable analysis, ypTa (HR = 3.36 [1.24-9.11]) and ypT1 (HR = 2.88 [1.33-6.22], p = 0.013) disease at RC were predictors of shorter TTR, while female sex was associated with longer TTR (HR = 0.52 [0.27-0.98], p = 0.043). The type of NAC was not predictive of TTR (GC vs. other, HR = 1.49 [0.75-2.97], p = 0.26). Conclusions: To our knowledge, this is the largest study to quantify the risk of recurrence in pts achieving pathologic response after NAC and RC for MIBC. 8% of patients undergoing NAC and achieving &lt; ypT2N0 at RC recurred. Residual ypTa and ypT1 disease conferred a significantly higher risk of recurrence, while ypTis did not; female sex was associated with a lower risk of recurrence. Importantly, the type of cisplatin-based NAC regimen used was not an independent predictor of recurrence.