Clinical Trial Outcomes

Cross-source consensus on Clinical Trial Outcomes from 2 sources and 9 claims.

2 sources · 9 claims

Benefits

Risks & contraindications

Other

Highlighted claims

The WIDE primary outcome is early delayed gastric conduit emptying incidence assessed on postoperative days 5 and 10. — Intraoperative endoscopic pylorus dilatation during minimally invasive Ivor Lewis oesophagectomy to prevent delayed gastric conduit emptying (DGCE): protocol for the WIDE randomised controlled trial
The trial has four co-primary outcomes focused on feasibility rather than clinical endpoints. — Prevent 6:1 trial: pI rotocol for a feasibility trial of a 6:1 intermittent diet for weight gain prevention in women at increased risk of breast cancer
The co-primary feasibility outcomes are uptake, retention, self-reported adherence, and acceptability. — Prevent 6:1 trial: pI rotocol for a feasibility trial of a 6:1 intermittent diet for weight gain prevention in women at increased risk of breast cancer
A patient meets the WIDE DGCE definition if nasogastric tube output is at least 500 mL in 24 hours on postoperative day 5 or later. — Intraoperative endoscopic pylorus dilatation during minimally invasive Ivor Lewis oesophagectomy to prevent delayed gastric conduit emptying (DGCE): protocol for the WIDE randomised controlled trial
A patient also meets the WIDE DGCE definition if transverse gastric conduit width on upright chest X-ray increases by more than 100% from immediate postoperative baseline. — Intraoperative endoscopic pylorus dilatation during minimally invasive Ivor Lewis oesophagectomy to prevent delayed gastric conduit emptying (DGCE): protocol for the WIDE randomised controlled trial
Exploratory outcomes examine carryover effects of low-calorie days and variation in adherence across menstrual cycle phases. — Prevent 6:1 trial: pI rotocol for a feasibility trial of a 6:1 intermittent diet for weight gain prevention in women at increased risk of breast cancer
Preliminary benefit outcomes include body composition, circumferences, diet quality, alcohol and smoking, and physical activity. — Prevent 6:1 trial: pI rotocol for a feasibility trial of a 6:1 intermittent diet for weight gain prevention in women at increased risk of breast cancer
Preliminary harms include eating behaviours, sleep quality, diet-related adverse events, and menstrual cycle length. — Prevent 6:1 trial: pI rotocol for a feasibility trial of a 6:1 intermittent diet for weight gain prevention in women at increased risk of breast cancer
Secondary WIDE outcomes include late DGCE, anastomotic leak, pulmonary complications, oral intake milestones, hospital stay, ICU stay, and quality of life. — Intraoperative endoscopic pylorus dilatation during minimally invasive Ivor Lewis oesophagectomy to prevent delayed gastric conduit emptying (DGCE): protocol for the WIDE randomised controlled trial