Limeira

Researchers are evaluating a 12-week face-to-face group exercise program focused on foot and ankle care for people with diabetes who have diabetic neuropathy. This type 2 hybrid implementation effectiveness trial aims to introduce a preventive intervention in primary care settings in Limeira, Brazil, by training primary care workers. The study will assess both how well the intervention is carried out and its effects on clinical symptoms, functional status, and quality of life. The study involves four phases: pre-implementation to understand local needs and prepare the team; structuring and adapting the intervention and training strategies; delivering the intervention via software or booklet with supervised exercises by physiotherapists; and maintenance where the municipality supports ongoing improvement and expansion. During the 12-week intervention phase, participants will be randomly assigned to either a control group receiving standard foot care recommendations or an intervention group performing supervised foot and ankle exercises 1-2 times per week. Exercises progressively increase in difficulty and are guided by individual effort levels. Participants will be evaluated at the start and end of the 12 weeks for changes in neuropathy symptoms, ankle and foot range of motion, neuropathy severity, mobility, foot muscle strength, presence of ulcers or pre-ulcer lesions, and quality of life. The study uses various clinical tools and functional tests to assess these outcomes. Researchers will also monitor the implementation process and participant adherence to understand the intervention's reach and effectiveness in routine primary care.

Researchers are evaluating whether patients with ventilator-associated tracheobronchitis (VAT) in intensive care units benefit from a 7-day course of antibiotics compared to clinical observation without antibiotic treatment. This trial is a national, multicenter, single-blinded, randomized non-inferiority study aiming to determine if monitoring without antibiotics is as effective as antibiotic therapy for VAT, given the current uncertainty and conflicting guidelines about antibiotic use for this condition. Participants diagnosed with VAT will be randomly assigned to one of two groups. One group will receive standard care plus a 7-day antibiotic course, while the other group will have clinical observation without antibiotics unless they develop new organ dysfunction or infections other than VAT. The study focuses on comparing these two approaches to see if withholding antibiotics is noninferior in managing VAT. During the study, patients will be monitored for ventilator-free days within 28 days after randomization. Researchers will assess clinical status, chest imaging, and tracheal secretion cultures. Safety and treatment effects will be carefully tracked, with data analysis conducted in a blinded manner. The trial encompasses ICU patients who have been mechanically ventilated for at least 48 hours and meet specific clinical and laboratory criteria for VAT.