人体研究入选标准

数据集获取（Figshare）

• 源站标题：Human study eligibility criteria.
• DOI：10.1371/journal.pone.0281340.t002
• 发布日期：2023-03-14
• 文件数：1 个
• 文件总体积：13.82 KB
• 源站页面：https://plos.figshare.com/articles/dataset/Human_study_eligibility_criteria_/22271648

命令行下载

curl -L -o "Table 2.xls" "https://ndownloader.figshare.com/files/39604103"

文件清单

• Table 2.xls（13.82 KB）

文件总体积 13.82 KB（源站 API 实测）。

数据加载示例（图像类）

from PIL import Image
import glob, os

files = (glob.glob(os.path.join(path, "**", "*.png"), recursive=True)
       + glob.glob(os.path.join(path, "**", "*.jpg"), recursive=True)
       + glob.glob(os.path.join(path, "**", "*.tif"), recursive=True))
print("图像文件数:", len(files))
img = Image.open(files[0]); print("尺寸/模式:", img.size, img.mode)

# torchvision Dataset 方式:
# from torchvision import datasets
# ds = datasets.ImageFolder(path)  # 要求 子目录=类别

目录组织与标注格式以源站说明和下载后实际文件为准。

数据说明

Introduction
The wearable cardioverter defibrillator (WCD) is used to protect patients at risk for sudden cardiac arrest. We examined defibrillation efficacy and safety of a biphasic truncated exponential waveform designed for use in a contemporary WCD in three animal studies and a human study.
Methods
Animal (swine) studies:
#1: Efficacy comparison of a 170J BTE waveform (SHOCK A) to a 150J BTE waveform (SHOCK B) that approximates another commercially available waveform. Primary endpoint first shock success rate.
#2: Efficacy comparison of the two waveforms at attenuated charge voltages in swine at three prespecified impedances. Primary endpoint first shock success rate.
#3: Safety comparison of SHOCK A and SHOCK B in swine. Primary endpoint cardiac biomarker level changes baseline to 6 and 24 hours post-shock.
Human Study: Efficacy comparison of SHOCK A to prespecified goal and safety evaluation. Primary endpoint cumulative first and second shock success rate. Safety endpoint adverse events.
Results
Animal Studies
#1: 120 VF episodes in six swine. First shock success rates for SHOCK A and SHOCK B were 100%; SHOCK A non-inferior to SHOCK B (entire 95% CI of rate difference above -10% margin, p #2: 2,160 VF episodes in thirty-six swine. Attenuated SHOCK A was non-inferior to attenuated SHOCK B at each impedance (entire 95% CI of rate difference above -10% margin, p #3: Ten swine, five shocked five times each with SHOCK A, five shocked five times each with SHOCK B. No significant difference in troponin I (p = 0.658) or creatine phosphokinase (p = 0.855) changes from baseline between SHOCK A and SHOCK B.
Human Study: Thirteen patients, 100% VF conversion rate. Mild skin irritation from adhesive defibrillation pads in three patients.
Conclusions
The BTE waveform effectively and safely terminated induced VF in swine and a small sample in humans.
Trial registration
Human study clinical trial registration: URL: https://clinicaltrials.gov; Unique identifier: NCT04132466.

许可

CC BY 4.0

引用

学术使用请引用 DOI 10.1371/journal.pone.0281340.t002（source: https://plos.figshare.com/articles/dataset/Human_study_eligibility_criteria_/22271648）。