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NCT ID: NCT06469437 Not yet recruiting - Frailty Clinical Trials

The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With T2DM

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Introduction: With the aging of the world population and the increasing incidence of type 2 diabetes mellitus (T2DM) with age, the number of elderly individuals living with diabetes has been considerably rising. It is known that uncontrolled T2DM negatively impacts various health outcomes, including geriatric outcomes such as sarcopenia, frailty, immobility, incontinence, and infections. Current medical literature fails to establish appropriate glycemic targets for different elderly profiles. Although guidelines emphasize the need to individualize targets, there is no concise tool to identify which individuals benefit from each therapeutic approach. Data suggest that frailty is the best predictor of negative outcomes in elderly patients living with T2DM. The Clinical Frailty Scale (CFS) and the 10-minute Targeted Geriatric Assessment (TaGA-10) are validated tools for prognosis in elderly patients and for identifying frail elderly individuals. Methods: Randomized controlled trial. Elderly individuals diagnosed with T2DM at a tertiary care outpatient clinic will be included. All enrolled patients will undergo geriatric assessment using CFS, TaGA-10, and Charlson Comorbidity Index. Patients will be randomized into usual care and intervention groups, and the intervention involves providing the geriatric assessment to the care team to support their decisions. The adequacy of the therapeutic approach will be measured in one week by reviewing the consult record or interviewing the physician. The clinical impact on the frequency of hypoglycemia, falls, infections, hospitalizations, and mortality will be evaluated at 3 and 6 months by telephone interviews. Discussion: Current guidelines recommend using age, comorbidities, cognitive, and functional status to individualize therapeutic targets in elderly patients with T2DM; however, it is possible that these variables alone may not be sufficient to classify all elderly individuals in their complexity adequately. A tool with such power and easy to use in clinical practice is necessary.

NCT ID: NCT06469294 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Evaluation of Chlorhexidine Gel Associated With Photodynamic Therapy in the Treatment in Diabetic Participants

Start date: June 15, 2024
Phase: N/A
Study type: Interventional

The objective of this clinical trial is to evaluate chlorhexidine gel associated with photodynamic therapy in the treatment of chronic periodontitis in diabetic participants. The main questions it aims to answer are: • To evaluate the clinical and microbiological response of conventional periodontal treatment associated with photodynamic therapy in diabetic participants. Participants will receive periodontal treatment carried out with the use of 2% chlorhexidine gel associated with 0.005% methylene blue and laser therapy, associated with conventional periodontal treatment, as well as the use of photodynamic therapy associated with conventional periodontal treatment in diabetic participants with periodontitis. So, twenty periodontitis patients will be selected and will separated in two groups compared with placebo. And, Clinical and microbiological parameters were evaluated at baseline and 3 months after periodontal treatment: Plaque Index, Bleeding On Probe, Probing depth, Gingival Recession and Clinical Attachment Level.

NCT ID: NCT06467474 Recruiting - Clinical trials for Major Depressive Disorder (MDD

Psychoeducational Group for Depression

PEG-D
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The study aims to investigate the efficacy of a psychoeducational program as an adjunctive treatment for depression. The study will involve 338 patients diagnosed with Major Depressive Disorder (MDD) of moderate severity. Participants will be randomly assigned to receive either Treatment as usual (TAU) alone or TAU plus the psychoeducational program. The program consists of six weekly group sessions covering information and techniques for coping with depression. Primary outcomes include a reduction in depressive symptoms measured by the Beck Depression Inventory-II (BDI-II) and increased knowledge of depression. Secondary outcomes include improvements in functionality and quality of life. The study aims to provide insights into the effectiveness of psychoeducation in improving outcomes for individuals with depression

NCT ID: NCT06467357 Not yet recruiting - Clinical trials for Biliary Tract Cancer

Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer

DESTINY-BTC01
Start date: June 26, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.

NCT ID: NCT06465056 Recruiting - Skin Scarring Clinical Trials

Use of Botulinum Toxin A in Direct Eyebrow Lift Scar

Start date: January 1, 2024
Phase: Phase 2
Study type: Interventional

Prospective, controlled and randomized study in which participants indicated for surgery to direct eyebrow lift will be randomized into two groups. In addition to surgery, the patients will be treated with botulinum toxin in one eyebrow and saline (placebo) in the other site. The patients participate as treatment and placebo at the same time. Assessments will be carried out through non-invasive exams.

NCT ID: NCT06464510 Not yet recruiting - Septic Shock Clinical Trials

Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent Sepsis

NoVa
Start date: July 2024
Phase: Phase 3
Study type: Interventional

The norepinephrine and vasopressin for rescue versus early vasopressin for vasopressor dependent sepsis (NoVa) is a phase 3, multicenter, open-label, randomized controlled trial comparing an early vasopressin initiation strategy versus norepinephrine plus vasopressin initiation only as a rescue strategy for hemodynamic management of critically ill patients with vasopressor dependent sepsis.

NCT ID: NCT06464276 Completed - Stable Angina Clinical Trials

Effectiveness and Tolerability of Trimetazidine 80mg Once Daily in Patients With Chronic Coronary Syndrome: The V-GOOD Study

V-GOOD
Start date: October 31, 2021
Phase:
Study type: Observational [Patient Registry]

The objective of this non-interventional multicentric study (NIS) is to investigate the efficacy and tolerability of treatment with Vastarel Caps LP® in symptomatic patients with angina over 3 months under conditions of daily practice. The main questions it aims to answer are data collection on antianginal efficacy, symptom class, adherence, and overall tolerability in patients treated with Vastarel Caps LP®. Patients diagnosed with chronic coronary syndrome and persistent stable angina, for whom the cardiologist chose to prescribe Trimetazidine 80mg once daily, were included in the study. Clinical information was collected in three distinct visits at baseline (V1), 1 month (V2), and 3 months (V3). During these visits, cardiologists collected the following variables based on a weekly occurrence: number of angina crises, short-acting nitrates (SAN) consumption, Canadian Cardiovascular Society (CCS) classification, level of self-reported daily physical activity, adherence, and tolerability to the treatment. Physical activity was measured using a scale from 1 to 10 (1 = no limitations, 5 = moderate limitations, and 10 = very marked limitations). Adherence was assessed by a previously validated six-item questionnaire. Assessment of therapy efficacy and tolerability were rated by the physician as "very satisfactory", "satisfactory", "not sufficiently satisfactory", and "unsatisfactory".

NCT ID: NCT06464224 Recruiting - Weaning Failure Clinical Trials

Extremes of Respiratory Effort in Weaning Failure From Mechanical Ventilation: a Prospective Observational Study

Start date: April 1, 2024
Phase:
Study type: Observational

The presence of high levels of respiratory effort in patients under mechanical ventilation may worsen the adjacent lung injury even after adapting protective ventilation. Primary outcome: To evaluate the failure rate of weaning from IMV and its relationship with the lower and upper extremes of respiratory effort and the upper extreme of dynamic pulmonary stress during the first 7 days of spontaneous ventilation. Analyze the influence of these extremes based on the thresholds of Pocc, P0.1 and their derivatives Pmus, Ptp, din and MP: in relation to days off MV (in the 28-day interval); Total weaning time; Rate and time for tracheostomy; Length of stay in the ICU and hospital; In-hospital mortality rate. CAAE: 78185823.4.0000.5249. Prospective observational study, carried out in the ICUs of Hospital Glória D'or, from January 2024 to July 2026, in patients over 18 years old, undergoing orotracheal intubation and IMV, in their first 7 days on spontaneous ventilation. Hypothesis: Extremes of respiratory effort and dynamic pulmonary stress would be associated with a higher rate of weaning from IMV, as well as longer time on IMV and subsequent longer hospital stay.

NCT ID: NCT06463925 Recruiting - Acne Clinical Trials

Evaluation of Effaclar Duo+M on Acne Lesions in Subjects With Mild to Moderate Acne on Face and Trunk

Start date: December 7, 2023
Phase: N/A
Study type: Interventional

This single-center, open, non-randomized study aims the efficacy evaluation of Effaclar Duo+M and Effaclar+M Purifying foaming gel on total acne lesion count, pigmented lesions and scars for 6 months in subjects with mild to moderate facial and truncal acne.

NCT ID: NCT06460415 Not yet recruiting - Pain Clinical Trials

Effects of Photobiomodulation on Pain and Sexual Function in Women With Dyspareunia: Randomized Clinical Trial

Start date: June 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the effects of vulvar and intravaginal application of PBM compared to the sham group on pain and sexual function in women with dyspareunia . The main question [s] it aims to answer are: - What are the effects of vulvar and intravaginal application of photobiomodulation (PBM) compared to the sham group on the sexual function of women with dyspareunia in the immediate post-intervention moments and in follow-ups of 15, 30, 90 and 180 days? - What are the effects of vulvar and intravaginal application of photobiomodulation (PBM) compared to the sham group on pain in women with dyspareunia in the immediate post-intervention moments and in follow-ups of 15, 30, 90 and 180 days? Participants will The GPBM photobiomodulation group will receive, during the 8 days of intervention, application in 8 points (4 red and 4 infrared) in the vulvar region and 8 points (4 red and 4 infrared) in the intravaginal pelvic floor region of PBM while the GS group will receive simulation application of PBM in the same number of vulvar and intravaginal points, in the same places where it was applied in the GPBM group. To see if 8 applications of photobiomodulation are really capable of reducing pain and improving sexual function in women with dyspareunia