Internet-based cognitive therapy for women with antenatal depressive symptoms during the COVID-19 pandemic: protocol for a multi-center randomized controlled trial across China
The objective of this trial is to evaluate the short-term and long-term effects of iCBT on reducing depressive symptoms among pregnant women during the COVID-19 pandemic with the overall goal of preventing depression recurrence in the first 12 months postpartum.MethodsA multi-site randomized controlled trial will be conducted where 300 pregnant women early in their third trimester will be screened for depression symptoms using the Edinburgh Postnatal Depression Scale (EPDS) during a routine obstetrical visit. Eligible and consenting women with a score greater than 9 will be randomly allocated (1:1) to either intervention g...
Source: Trials - September 21, 2022 Category: Research Source Type: clinical trials

The iHealth-T2D study: a cluster randomised trial for the prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes —a statistical analysis plan
DiscussionThe iHealth-T2D trial will provide evidence of whether an intensive family-based lifestyle modification programme for South Asians who are at high risk for T2D is effective in the prevention of T2D. The data from the trial will be analysed according to this pre-specified SAP.Ethics and disseminationThe trial was approved by the international review board of each participating study site. Study findings will be disseminated through peer-reviewed publications and in conference presentations.Trial registrationEudraCT2016 –001,350-18. Registered on 14 April 2016. ClinicalTrials.govNCT02949739. Registered on 31 Octo...
Source: Trials - September 6, 2022 Category: Research Source Type: clinical trials

Recruitment interventions for trials involving adults lacking capacity to consent: methodological and ethical considerations for designing Studies Within a Trial (SWATs)
ConclusionsDesigning a SWAT to evaluate a recruitment intervention for non-emergency trials with adults lacking capacity to consent has raised a number of methodological and ethical considerations. Explicating these challenges, and some potential ways to address them, creates a starting point for discussions about conducting these potentially more challenging SWATs. Increasing the evidence base for the conduct of trials involving adults lacking capacity to consent is intended to improve both the ability to conduct these trials and their quality, and so help build research capacity for this under-served population. (Source: Trials)
Source: Trials - September 6, 2022 Category: Research Source Type: clinical trials

Infliximab in the treatment of patients with severe COVID-19 (INFLIXCOVID): protocol for a randomised, controlled, multicentre, open-label phase II clinical study
DiscussionThe results of this study could influence the therapy of patients with COVID-19 and affect the course of the disease worldwide, as infliximab is globally available and approved by several international drug agencies.Trial registrationThe trial was registered (NCT04922827, 11 June 2021) and at EudraCT (2021-002098-25, 19 May 2021). (Source: Trials)
Source: Trials - September 2, 2022 Category: Research Source Type: clinical trials

A Study of ECHELON 3000 (Next Generation Powered Stapler) in General Abdominal and Thoracic Lung Resection Procedures
Conditions:   Laparoscopic Sleeve Gastrectomy (LSG);   Thoracic Lung Resection Procedure Intervention:   Device: ECHELON 3000 Stapler Sponsor:   Ethicon Endo-Surgery Not yet recruiting (Source:
Source: - August 29, 2022 Category: Research Source Type: clinical trials