tbuckley/cabot-search huggingface dataset:
An observation on clinical effectiveness of early rehabilitative training program in patients with acute myocardial infarction
Authors: 周磊, 温国明, 黄霞, 何万红, 张春蓉, 龚小兰
Journal: BMJ (2006)

目的 探讨早期康复训练对急性心肌梗死(AMI)患者病情的影响.方法 将122例急性心肌梗死低危患者平行随机分为康复组(62例)和对照组(60例).两组除予以临床常规治疗外,康复组采用为期2周以步行为主的康复训练.结果 两组患者在室性心律失常(Lown≥Ⅲ级)、梗死延展的发生率和心率变异性(HRV)测定等方面,差异无统计学意义(P＞0.05).入院第3～4周康复组左心室射血分数(LVEF)≥50%者的比例为64.5%(40/62),显著高于对照组的45.0%(27/60,P＜0.01).第4周末的平板运动试验阳性率,康复组显著低于对照组(25.8%比38.3%,P＜0.01).康复组住院期间心绞痛、再梗死和死亡率均低于对照组.康复组平均住院天数为(16±3)d,对照组为(27±4)d,两组差异有统计学意义(P＜0.05).结论 对无明显并发症的AMI患者采取早期康复训练是安全可行的,有利于促进患者病情恢复,提高生存质量。
Remdesivir for 5 or 10 Days in Patients with Severe Covid-19
Authors: Jason D Goldman, David C B Lye, David S Hui, Kristen M Marks, Raffaele Bruno, Rocio Montejano, Christoph D Spinner, Massimo Galli, Mi-Young Ahn, Ronald G Nahass, Yao-Shen Chen, Devi SenGupta, Robert H Hyland, Anu O Osinusi, Huyen Cao, Christiana Blair, Xuelian Wei, Anuj Gaggar, Diana M Brainard, William J Towner, Jose Muñoz, Kathleen M Mullane, Francisco M Marty, Karen T Tashima, George Diaz, Aruna Subramanian
Journal: New England Journal of Medicine (2020)

Remdesivir is an RNA polymerase inhibitor with potent antiviral activity in vitro and efficacy in animal models of coronavirus disease 2019 (Covid-19). We conducted a randomized, open-label, phase 3 trial involving hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less while they were breathing ambient air, and radiologic evidence of pneumonia. Patients were randomly assigned in a 1:1 ratio to receive intravenous remdesivir for either 5 days or 10 days. All patients received 200 mg of remdesivir on day 1 and 100 mg once daily on subsequent days. The primary end point was clinical status on day 14, assessed on a 7-point ordinal scale. In total, 397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 days). The median duration of treatment was 5 days (interquartile range, 5 to 5) in the 5-day group and 9 days (interquartile range, 5 to 10) in the 10-day group. At baseline, patients randomly assigned to the 10-day group had significantly worse clinical status than those assigned to the 5-day group (P = 0.02). By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group. After adjustment for baseline clinical status, patients in the 10-day group had a distribution in clinical status at day 14 that was similar to that among patients in the 5-day group (P = 0.14). The most common adverse events were nausea (9% of patients), worsening respiratory failure (8%), elevated alanine aminotransferase level (7%), and constipation (7%). In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit cannot be determined. (Funded by Gilead Sciences; GS-US-540-5773 ClinicalTrials.gov number, NCT04292899.).
Evidence base of clinical diagnosis: The architecture of diagnostic research
Authors: D L Sackett, R B Haynes
Journal: BMJ (2002)

Considerable effort has been expended at the interface between clinical medicine and scientific methods to achieve the maximum validity and usefulness of diagnostic tests. This article focuses on the specific kinds of questions that arise in diagnostic research and the study architectures (the conversions of these clinical questions into appropriate research designs) used to answer them. As an example we shall take shall take assessment of the value of the plasma concentration of B-type natriuretic peptide (BNP) in the diagnosis of left ventricular dysfunction.1 Randomised controlled trials are dealt with elsewhere.


As in other forms of clinical research, there are several different ways studying the potential or real diagnostic value of a physical sign or laboratory test, and each is appropriate to one kind of question and inappropriate for others. Among the possible questions about the relation between a putative diagnostic test and a target disorder (for example, the concentration of BNP and left ventricular dysfunction), four are most relevant. 


Summary points


Diagnostic studies should match methods to diagnostic questions






Do test results in affected patients differ from those in normal individuals?


Are patients with certain test results more likely to have the target disorder?


Do test results distinguish patients with and without the target disorder among those in whom it is clinically sensible to suspect the disorder?


Do patients undergoing the diagnostic test fare better than similar untested patients?






The keys to validity in diagnostic test studies are






independent, blind comparison of test results with a reference standard among a consecutive series of patients suspected (but not known) to have the target disorder


inclusion of missing and indeterminate results


replication of studies in other settings






Both specificity and sensitivity may change as the same diagnostic test is applied in primary, secondary, and tertiary care
Barrett食管54例临床分析
Authors: 李荣宽, 姜春萌
Journal: BMJ (2006)

回顾分析54例Barrett食管患者的临床资料.结果示患者中男35例,女19例;以反酸(38例,70.4%)、烧心(36例,66.7%)及胸骨后痛(21例,38.9%)等为主要临床症状.镜下形态以岛型为主(41例,占77.4%),病变长度0.5～5.5 cm,其中19例患者(35.8%)伴有食管裂孔疝.食管压力检查提示屏障压及食管中下段压力明显降低,酸反流总时间、总次数以及酸清除时间均明显增加.提示Barrett食管的临床症状与胃食管反流病无明显差别,是胃食管反流病的严重并发症;抑酸联合内镜下治疗为其提供了新的治疗方法。
Nurse, oncologist, and patient impressions of electronic symptom monitoring via patient-reported outcomes in community oncology practices: Qualitative results from the U.S. national PRO-TECT trial (AFT-39, NCT03249090).
Authors: Ethan M. Basch, Randall Teal, Amylou C. Dueck, Jennifer Jansen, Sydney Henson, Maihan Vu, Jessica Carda-Auten, Philip M Carr, Mian Wang, Antonia Vickery Bennett, Angela M. Stover
Journal: Journal of Clinical Oncology (2020)

7044 Background: There is growing interest to implement electronic patient-reported outcomes in oncology practices for symptom monitoring. It is not well known what nurse, physician, and patient impressions of benefits, acceptability, and challenges are in routine care use. Methods: PRO-TECT is an ongoing U.S. national trial including 26 community oncology practices across 15 states that implemented PRO symptom monitoring [NCT03249090]. Patients complete weekly PROs between visits, nurses receive alerts for severe/worsening symptoms, and oncologists review PROs at office visits. Interviews were conducted with 147 stakeholders including nurses (N = 46), oncologists (N = 27), data managers (N = 15), and patients (N = 59). Each stakeholder group had different interview guides with overlapping topics to explore experiences with the PRO system. Interviews lasted 15-60 minutes, were digitally recorded, transcribed, and entered into a qualitative analysis software program. A codebook was developed from the research questions, interview guides, and discussions with the project team. Standardized coding methods were applied, with transcripts double coded for thematic analysis. Feedback surveys were also completed by nurses (N = 57), oncologists (N = 38), and patients (N = 435). Results: Key benefits perceived across stakeholder groups included increased patient self-awareness of symptoms; improved direct communication of patients with care teams; more open and honest conveying of symptom experiences; ability to track symptoms over time; and increased involvement of patients in their own care. Most stakeholders felt PRO symptom monitoring had a positive impact on quality of care delivery, and believed benefits of PROs outweighed necessary staff efforts. Challenges included additional work by nurses to review and respond to alerts, staff turnover requiring retraining, and limited time of oncologists. In the survey, 39/56 (70%) nurses felt the PRO system improved quality of care; 27/33 (82%) oncologists noted PROs were useful for team discussions and care delivery; and 320/434 (74%) patients agreed that weekly PRO reporting improved discussions with their care team. Conclusions: Clinicians and patients perceived weekly PRO symptom monitoring between visits to be valuable despite added staff effort. Results of additional analyses are forthcoming. Clinical trial information: NCT03249090 .
Adoption of behavioral restrictions as anti-infective measures: A survey among solid tumor patients.
Authors: Eliya Shachar, Leora Ferro, Shira Peleg Hasson, Waller Emmanuel, Ido Wolf
Journal: Journal of Clinical Oncology (2020)

2081 Background: Despite lack of evidence, a wide range of rigorous behavioral and social restrictions are recommended in various guidelines and websites in an attempt to mitigate infections. These include patient guided sites. We aimed to study the practices of patients with solid tumors treated with active therapy. Methods: We conducted an anonymous survey among cancer patients treated at a tertiary care center, addressing behavioral approach to infection prevention, by assessing adopted social (seven items), environmental (five items), and dietary (eight items) limitations, as well as compliance to influenza vaccinations. Clinical data included neutropenic fever (NF), and therapy myelosuppressive potential. Multivariable Poisson regression adjusted for sex, age, disease status, therapy to estimate the impact of these restrictions. Results: 214 patients with solid tumors responded to the survey, the majority female (59%), with a median age of 63. The most common tumor types included breast (28%), lung (14%), and colon (9.3%). Most (68%) were treated with chemotherapy, 17% with immunotherapy, 11% with biologicals and 3% with chemo-immunotherapy. Only 6% were admitted for NF. Sources of information regarding restrictions included physicians (4%), nurses (32.9%), and internet (9.8%); the majority were self-imposed. 53% maintained environmental limitations (traveling, sun exposure, hair dying), 37% adopted social restrictions (abstained from children, public places), and 21% affirmed dietary constraints (raw vegetables, tap water consumption). Females practiced stricter environmental and dietary restraint (p &lt; 0.05), with a numerical trend reflecting stricter female social measures (p &lt; 0.4). With no difference in practices among patients treated for a malignant disease and curative intent, and no difference in practice across therapies, in those treated with chemotherapy and immuno-therapy. 37% affirmed difficulty in adherence to these limitations. Conclusions: Our findings indicate that despite lack of evidence, cancer patients adopt anti-infective behavioral measures, which have a deleterious impact on quality of life. These practices are being used even among patients at low or no risk of NF. These findings call for implementation of an education program and development of practical instructions enabling patients to resume their normal life
A phase III, randomized, multicenter, open-label study of venetoclax or pomalidomide in combination with dexamethasone in patients with t(11;14)-positive relapsed/refractory multiple myeloma.
Authors: Maria-Victoria Mateos, Philippe Moreau, Meletios A. Dimopoulos, Wan-Jen Hong, Scott Cooper, Yao Yu, Muhammad Jalaluddin, Jeremy A. Ross, Sudeep Karve, Sheryl Coppola, Paulo Cesar Maciag, Orlando Bueno, Emma Louise Arriola, Shaji Kumar
Journal: Journal of Clinical Oncology (2020)

TPS8554 Background: BCL-2 is an anti-apoptotic protein important for myeloma cell survival. Venetoclax (Ven) is a highly selective, potent, oral BCL-2 inhibitor, that has shown promise in clinical studies as monotherapy or in combination with other agents in patients with t(11;14)-positive relapsed/refractory multiple myeloma (RRMM; Kumar et al. Blood. 2017; Costa et al. ASH 2018. Abstr. #303; Harrison et al. ASH 2019. Abstr. #142; Bahlis et al. ASH 2019. Abstr. #925; Kaufman et al. ASH 2019. Abstr. #926). Notably, t(11;14)-positive MM is more dependent on BCL-2 for cell survival, which, together with these clinical data, suggests that Ven combined with dexamethasone (Dex) may provide greater clinical benefit versus standard therapies, like pomalidomide (Pom), in this biomarker-defined patient population. This ongoing Phase 3 study (CANOVA; NCT03539744) aims to evaluate the safety and efficacy of VenDex vs PomDex in t(11;14)-positive RRMM. Methods: Eligible patients (≥18 years) must have t(11;14)-positive RRMM per central lab, an ECOG performance status ≤2, received ≥2 prior lines of therapy, previously received a proteasome inhibitor, and must be refractory to lenalidomide and last line of therapy. Patients cannot have history of treatment with Ven, Pom, or other BCL-2 inhibitors. Patients will be randomized 1:1 to Ven (800 mg orally, once-daily) or Pom (4 mg orally, once-daily on days 1-21 of 28-day cycles). Patients in both groups will receive 40 mg Dex (20 mg for patients ≥75 years) once weekly. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal from study. Patients will be stratified based on age at randomization ( &lt; 65 vs ≥65 years), prior lines of therapy (2 to 3 vs ≥4), and International Staging System stage at screening (I vs II vs III). The primary endpoint is progression-free survival (PFS) per independent review committee (IRC) assessment based on International Myeloma Working Group criteria. The final PFS analysis will be performed when approximately 147 PFS events per IRC are observed. Secondary endpoints are response rate, patient-reported outcomes, overall survival, duration of response, times to response and progression, minimal residual disease negativity rate, safety, and Ven pharmacokinetics. Approximately 244 patients will be enrolled; as of January 21, 2020, 28 patients have been randomized (from 19 sites in 12 countries) and enrollment is ongoing. Clinical trial information: NCT03539744 .
Clinical analysis for 22 cases of esophago-tracheal fistula treated with Sigma stent
Authors: Feng-rui Zhao, Zhen-dong Ma, Guang-jun Tan
Journal: BMJ (2008)

Objective To evaluate the application of Sigma stent in treatment for esophagn-tracheal fistula. Methods Clinical data of 22 cases of esophago-tracheal fistula treated with Sigma stent were retrospectively analyzed, including 17 cases of esophageal cancer and 5 cases of benign esophageal diseases, with length of 4 days to 2 months. One single stent was placed in 5 cases, two stents ( both in trachea and esophagus each) in 15 cases, and three stents in 2 cases, and 18 eases with tube-type trachea stent, 3 with obtuse angle L-type and 1 with Y-type. Placement of stent was by interventional method or/and endoscopy. Results Forty-one stents were successfully placed in 22 patients with no death in the procedure. And, all patients with fistula were healed successfully and could have normal eating 2 to 4 days after operation, except 1 patient who received a tracheal stent inserted first, but an esophageal stent inserted again due to incomplete seal of the fistula and another benign case who received surgical operation 1 year after stent placement due to protracted unsealed fistula, with an overall cure rate of 91% (20/22). Conclusions Placement of Sigma stent in the esophagus or/and trachea could effectively heal esophago-tracheal fistula. All the patients can eat normally after the procedure. Stent can be recycled and formation of secondary esophago-traeheal fistula can be prevented effectively with such procedure.

Key words: 
Tracheoesophageal fistula;  Stents;  Esophagus;  Trachea
Factors influencing patients’ decision to undergo scalp cooling in breast and gynecological cancer.
Authors: Elizabeth Elliott, Sarah Fracci, Mary Lee, Morgan Ferris, Karen Rychlik, Ronald Potkul, Shelly S. Lo, Sarah Thilges
Journal: Journal of Clinical Oncology (2020)

e24175 Background: Chemotherapy-induced alopecia is a common and distressing side effect associated with the treatment of breast cancer (BC) and gynecological cancer (GC). Scalp cooling (SC) during chemotherapy decreases hair loss; why patients opt in or out of SC is unknown. A pilot study was conducted to determine reasons for opting in or out of SC. Methods: Patients at Loyola University's Cardinal Bernardin Cancer Center with BC and GC who were offered SC from 4/11/18 to 6/26/19 were asked to complete a survey ranking the importance of pre-specified factors behind their decision to (or not) pursue SC. The study was approved by the IRB. Chi-squared and Fisher’s exact tests were used on categorical variables; Wilcoxon rank sum test was used on continuous variables to determine any difference between those who opted in or out of SC. Results: 23/31 patients who were offered SC completed the survey (n = 12 [52.2%] opted to pursue SC, n = 11 [47.8%] opted out of SC). The average patient age was 51. Among patients who opted to pursue SC, maintenance of a sense of “normalcy” ranked as the most important factor behind their decision, followed by the impact of hair loss on children and family. Among the patients who opted not to pursue SC, patients ranked the cost of SC as the most important factor behind their decision. There were no statistically significant differences between patients who opted to pursue SC and those who did not in age, cancer type, relationship status, income, ethnicity, employment status away from the home, or presence of children or partners living in the home. Conclusions: Maintenance of a sense of “normalcy” and cost of treatment were the most important reasons behind patients’ decision to undergo or not undergo SC. Data from this pilot study will be used in a larger prospective study to inform how reasons for and expectations of SC impact distress and QOL.
Costs of extended immune check point inhibitors treatment in advanced/metastatic lung cancer: Bundling of costs proposal.
Authors: Helmy M. Guirgis
Journal: Journal of Clinical Oncology (2020)

e21738 Background: Pembrolizumab (Pembro) demonstrated remarkable 5-year overall survival (OS) and hazard ratios (HR) in 1 st -line advanced/metastatic lung cancer (amLC) lacking EGFR and ALK alterations. After 35 cycles or 2 years, there is no consensus on whether to continue or stop the immune check point inhibitors (ICI). In contrast to ICI receiving no cost adjustment, CAR T-cell were contained at $375,000-$400,000. Probability of survival (PoS) was previously expressed as (1.0- HR) and used as surrogates of outcome. Our objective was to weigh ICI costs at one year and beyond vs PoS. Methods: Costs of Durvalumab (Durv) 10mg/Kg iv were calculated in US dollars q2 weeks. Pemetrexed (Peme) 500 mg/m2, Atezolizumab (Atezo) 1200 mg and Pembro 200 mg were computed q3 weeks. HR at the 95% confidence levels were quoted and PoS calculated. Results: The average ICI yearly-costs were $153,053, increasing annually by 2-4%. Peme were $108.108 and PoS 0.22. One-year adjuvant Durv in unresectable stage III were $145,808 at PoS 0.47. Pembro were $157,213 and PoS 0.40 in PD-L1 &gt; 50%. Pembro costs beyond 5-years exceeded $786,065. Pembro- Peme-carboplatin in non-squamous histology were $265,321. PoS was 0.41 in PD-L1 &lt; 1% and 0.58 in &gt; 50%. Atezo+Bev 4-drug-costs were higher at $389,134 with modest 0.22 PoS. Setting mono-theray ICI yearly-costs at $160,000, one patient treated for 3 years would pay $480,000. Bundling costs at $400,000-$450,00 would save $30,000-$80,000. Savings would multiply with further years of extension. Conclusions: At 0.47 PoS, the one-year cost of adjuvant Durv was worth the dollars spent. The runaway ICI costs beyond 2 years would support the cost bundling proposal.
Risk factors of decreased glomerular filtration rate in patients with primary aldosteronism
Authors: Jian Zeng, Nan-fang Li, Xin-ling Wang, Fei-ya Zu, De-lian Zhang, Gui-juan Chang, Ke-ming Zhou
Journal: BMJ (2012)

One hundred and fifty-six patients with primary aldosteronism(PA)and 189 patients with essential hypertension (EH) were included in this study.The value of estimate glomerular filtration rate (eGFR) was calculated by MDRD equation.The plasma levels of aldosterone,triglycerides,creatinine and fasting glucose were measured.The plasma creatine,24 hour urine albumin excretion in PA patients were higher and eGFR and plasma aldosterone were lower than those in EH patients ( all P ＜ 0.01 ).Multiple regression analysis revealed that the plasma concentrations of aldosterone ( P =0.003 ) and creatinine ( P =0.001 ) were independent predictors of eGFR.

Key words: 
Hyperaldosteronism;  Glomerular filtration rate
Efficacy of C-arm fluoroscopy guided sacroiliac joint ozone injection for sacroiliac pain
Authors: Ruifang Zhang, Huirong Yin, Yunze Li, Jiangang Luo
Journal: BMJ (2014)

Retrospective analysis was performed for 68 sacroiliac joint pain patients treated at our hospital from June 2007 to March 2012. And 27 patients received sacroiliac joint ozone injection, and others anti-inflammatory and analgesic solution. Both methods can significantly relieve sacroiliac joint pain (P 0.05). No difference existed in efficacy [(0.51±0.03) vs. (0.34±0.06) cm], treatment frequency (1.98±0.94) vs.(1.82±0.88) or hospitalization duration [(14.6±7.0) vs.(14.9±6.4) days] between two groups (P>0.05). Thus sacroiliac joint ozone injection can significantly relieve sacroiliac joint pain and its effect is similar to anti-inflammatory analgesic injection.


Key words: 
Sacroiliac joint; Ozone
Assessment of the significance of cysteine proteinase inhibitor C and β2 microgiobulin in the diagnosis and prognosis of sepsis-induced acute kidney injury
Authors: Jun-yu Wang, Chun-sheng Li
Journal: BMJ (2012)

Objective To assess the significance of serum cysteine proteinase inhibitor C (Cys-C) and β2 microglobulin (β2MG) concentrations in the diagnosis and prognosis of sepsis-induced acute kidney injury.Methods Two hundred and fifty patients presenting to the Emergency Department of Beijing Chaoyang Hospital from October 2008 to October 2009 with sepsis were assessed.Serum creatinine (SCr),β2MG and Cys-C concentrations and Acute Physiology and Chronic Health Evaluation Ⅱ ( APACHE Ⅱ ) scores were determined when the septic patients presented to the hospital. The 28-day mortality was recorded.The study patients were retrospectively divided into acute kidney injury ( n =63 ) and no acute kidney injury groups (n =187 ).The predictive accuracies of Cys-C and β2MG for acute kidney injury were analyzed by plotting a relative operating characteristic (ROC) curve.The Spearman interclass correlation method was used to analyze the correlation between Cys-C concentration and APACHE Ⅱ score in sepsisinduced acute kidney injury.Results Cys-C and β2 MG concentrations were significantly greater in the acute than in the no acute kidney injury group [ ( 1189 ± 214) μg/L vs.(678 ± 118) μg/L,P =0.007 ; (3705 ±599)μg/L vs.(2365 ±446) μg/L,P =0.004,respectively].SCr concentrations and APACHE Ⅱ scores were significantly greater in the acute than in the no acute kidney injury group [ (145 ±49) vs.(73 ±25),P=0.013,(19 ±4) vs.(13 ±4),P=0.016].There was a significant correlation between Cys-C concentration and APACHEII score in the acute kidney injury group (P ＜0.01).The 28-day mortality was significantly greater in the acute than in the no acute kidney injury group.The areas under the ROC curve for Cys-C and β2MG concentrations were 0.909 ( OR =1.006,95％ CI =1.002 - 1.009) and 0.82 ( OR =1.001,95％ CI =1.000 -1.001),respectively.Conclusions Monitoring of Cys-C and β2MG concentrations can effectively predict the occurrence of acute kidney injury in septic patients.Cys-C concentration is a more accurate predictor of this diagnosis than β2MG concentration.An increasing Cys-C concentration is an indicator of poor prognosis.

Key words: 
Sepsis;  Cysteine proteinase inhibitors C;  beta 2-Microglobulin;  Acute physiology and chronic health evaluation Ⅱ score