SMA-TB: study protocol for the phase 2b randomized double-blind, placebo-controlled trial to estimate the potential efficacy and safety of two repurposed drugs, acetylsalicylic acid and ibuprofen, for use as adjunct therapy added to, and compared with, the standard WHO recommended TB regimen
DiscussionSMA-TB will provide proof of concept of the HDT as a co-adjuvant treatment and identify the suitability of the intervention for different population groups (different epidemiological settings and drug susceptibility) in the reduction of tissue damage and risk of bad outcomes for TB patients. This regimen potentially will be more effective and targeted: organ saving, reducing tissue damage and thereby decreasing the length of treatment and sequelae, increasing cure rates and pathogen clearance and decreasing transmission rates. It will result in better clinical practice, care management and increased well-being of...
Source: Trials - June 28, 2023 Category: Research Source Type: clinical trials

The effects of an e-health brisk walking intervention in increasing moderate-to-vigorous physical activity in physically inactive older people with cognitive frailty: study protocol for a randomized controlled trial
This study employs a single-blinded, two-parallel-group, non-inferiority, randomized controlled trial design with a 1:1 group allocation ratio. Eligible participants are aged 60  years or above, have cognitive frailty and physical inactivity, and possess a smartphone for more than six months. The study will be conducted in community settings. In the intervention group, participants will receive a 2-week brisk-walking training followed by a 12-week e-health intervention. In the control group, participants will receive a 2-week brisk-walking training followed by a 12-week conventional behavioural change intervention. The pr...
Source: Trials - May 17, 2023 Category: Research Source Type: clinical trials

Effect of a customized digital adherence tool on retention in care and adherence to antiretroviral treatment in breastfeeding women, children and adolescents living with HIV in Tanzania: a mixed-methods study followed by clinical trials
DiscussionIf the intervention improves adherence to ART and the devices are acceptable, accurate and sustainable, the intervention can be scaled up within the National Aids Control Programmes.Trial registrationPACTR202301844164954, date 27 January 2023. (Source: Trials)
Source: Trials - April 21, 2023 Category: Research Source Type: clinical trials

Safety and effectiveness of standardized exercise training in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (TRAIN-HFpEF-PH): study protocol for a randomized controlled multicenter trial
This study is designed to investigate whether a standardized low-intensity exercise and respiratory training program is safe and may improve exercise capacity, QoL, hemodynamics, diastolic function, and biomarkers in patients with HFpEF-PH.MethodsA total of 90 stable patients with HFpEF-PH (World Health Organization functional class II –IV) will be randomized (1:1) to receive a 15-week specialized low-intensity rehabilitation program, including exercise and respiratory therapy and mental gait training, with an in-hospital start, or standard care alone. The primary endpoint of the study is a change in 6-min walk test dist...
Source: Trials - April 19, 2023 Category: Research Source Type: clinical trials

Evaluation of the  impact of continuous Kangaroo Mother Care (KMC) initiated immediately after birth compared to KMC initiated after stabilization in newborns with birth weight 1.0 to  & lt;  1.8 kg on neurodevelopmental outcomes: Protocol for a follow-up study
DiscussionImmediate KMC can potentially reduce low-birth-weight-associated complications such as respiratory disease, hypothermia, hypoglycemia, and infection that can result in impaired neurocognitive development. Neuroprotection may also be mediated by improved physiological stabilization that may lead to better maturation of neural pathways, reduced risk of hypoxia, positive parental impact, improved sleep cycles, and improved stress responses. The present study will help in evaluating the overall impact of KMC by investigating the long-term effect on neurodevelopmental impairment in the survivors.Trial registrationClin...
Source: Trials - April 10, 2023 Category: Research Source Type: clinical trials

The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
Conditions:   Labor Dystocia;   Labor Complication;   Labor Onset and Length Abnormalities;   Labor (Obstetrics)--Complications;   Experience, Life;   Progression;   Cesarean Section Complications;   Apgar; 4-7 at 1 Minute Intervention:   Other: the labour care guide (LCG) Sponsor:   Ostfold Hospital Trust Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - March 30, 2023 Category: Research Source Type: clinical trials