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NCT ID: NCT05542173 Not yet recruiting - Aphthous Stomatitis Clinical Trials

Efficacy and Safety of BALI Association in the Treatment of Aphthous Ulcerations

Start date: September 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of BALI association in the treatment of aphthous ulceration.

NCT ID: NCT05534308 Not yet recruiting - Edema Clinical Trials

Effect of Intraoperative Taping on the Control of Edema Resulting From Stripping

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the effects of the Contensive Taping technique on the control of edema of patients submitted to Phleboextraction Surgery including Saphenectomy.

NCT ID: NCT05515770 Not yet recruiting - HIV Infections Clinical Trials

The Implementation of Pre-exposure Prophylaxis of Injectable Cabotegravir

ImPrepCab
Start date: September 20, 2022
Phase: Phase 3
Study type: Interventional

Although CAB LA PrEP has been proven efficacious in blinded randomized controlled clinical trials, additional research is needed to evaluate effectiveness in real world settings as well as to identify effective implementation strategies. The proposed implementation study will assess the safety and effectiveness of open label CAB LA PrEP when offered at public health facilities to cisgender men and transgender or gender non-binary individuals who have sex with persons assigned male at birth. The study will also evaluate two nested implementation strategies, an mHealth education and decision support tool and a WhatsApp injection appointment reminder. The study will also assess overall facilitators and barriers to integrating CAB LA into existing oral PrEP services.

NCT ID: NCT05477901 Not yet recruiting - Inflammation Clinical Trials

Impacts of Cash Transfers on Child Neurodevelopment (Auxilio Brasil)

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

This study examines the impact of Auxilio Brasil (AB), a cash transfer program to mothers of school-age children, on resource-deprived populations in Brazil and its protective effects on child neurodevelopment and mental health. The investigators will conduct a randomized clinical trial (RCT) among those already receiving AB in which 300 families will be randomized in a 1:1 ratio to receive either a high ($40/month) or low ($2/month) supplemental transfer for 2 years. Three hundred children (index child participants; 7-10 years old) will be enrolled across both study arms. Additionally, up to 150 siblings ("sibling participants;" 7-10 years old) will be enrolled. Eligible families who decide to participate will sign a study-specific informed consent (mother) and assent (child) form. The UNIFESP team will conduct the respective assessments at baseline, approximately 8- and 16- months, 24-months and approximately 6-months post-RCT. Aim 1: Determine the impact of high vs low cash transfers on children's exposure to adversities (ACEs) and neurodevelopment. Aim 2: Determine the impact of cash transfers on children's inflammatory markers and HPA activity/cortisol. Exploratory Aim: The investigators will explore (i) whether sex/gender of the children moderates the pathways in the above mediation model; and (ii) whether cash transfer-related effects persist 6 months post-RCT.

NCT ID: NCT05470803 Not yet recruiting - COVID-19 Clinical Trials

An Observer-blind, Cohort Randomized, Exploratory Phase 3 Study to Evaluate the Safety and Immunogenicity of Recombinant Covid-19 Vaccine, mRNA Covid-19 Vaccine and Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine as 4th Dose in Individuals Primed/ Boosted With Various Regimens

Start date: August 2022
Phase: Phase 3
Study type: Interventional

This is an exploratory phase 3, cohort randomized, observer-blind, multi-center study to evaluate the safety and immunogenicity of a 4th dose of various SARS-CoV-2 vaccines. There will be 04 study cohorts, that have previously received 03 doses of the indicated vaccine (s), divided into 10 groups; and each one of the 10 study groups will receive the 4th dose. This exploratory study will enroll up to 360 participants in 4 cohorts and a total of 10 groups: Cohort A (N=90), Cohort B (N= 90), Cohort C (N=150) and Cohort D (N=30). In cohorts A-C participants will be randomized 1:1:1 to three different 4th dose regimens. The number of proposed participants will provide a reasonable accurate descriptive summary of the safety and immunogenicity of the tested vaccination regimens.

NCT ID: NCT05459376 Not yet recruiting - Low Back Pain Clinical Trials

Effect of Dry Cupping Therapy Associated With the McKenzie Method in Patients With Chronic Low Back Pain

MDTDryCup
Start date: January 1, 2025
Phase: N/A
Study type: Interventional

Introduction: Currently, clinical practice guidelines recommend exercise as a first-line approach to the treatment of chronic low back pain (LBP). On the other hand, passive techniques such as cupping therapy have gained space in the management of this population, however, important gaps regarding the combination of cupping therapy with active exercises in individuals with nonspecific chronic low back pain are still present in the literature. In this context, this protocol describes a sham-controlled, randomized and blinded study that aims to evaluate the additional effects of cupping therapy in association with McKenzie method exercises on pain and functional outcomes of individuals with nonspecific chronic low back pain. Methods: 108 individuals with nonspecific and localized chronic low back pain in the age group of 18 to 59 years will be recruited and evaluated, regarding the inclusion and exclusion criteria. Subsequently, they will be randomized to one of 2 groups: intervention group, in which they will be submitted to the McKenzie method intervention and later the addition of the dry suction cup; and sham group, in which, after the intervention of the McKenzie method, the application of the sham cup will be added.

NCT ID: NCT05456152 Not yet recruiting - Chronic Insomnia Clinical Trials

Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia

Start date: June 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of sublingual zolpidem during the long-term treatment of insomnia.

NCT ID: NCT05450614 Not yet recruiting - Clinical trials for Depressive Disorder, Major

Smartphone App Based CBT Versus Online Group CBT: Randomized, Non-inferiority Clinical Trial

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The present research project aims to compare the efficacy and safety of an intervention based on a smartphone application, which uses CBT techniques, to online group cognitive behavioral therapy (CBCT), in improving depressive symptoms. The project also has supplemental analysis to predict who will respond to the CBT intervention using the application. For this analysis, machine learning algorithms, a set of techniques from the field of artificial intelligence, will be used to create a predictive calculator for response to interventions. The analysis protocol used for this analysis will be in accordance with that proposed in task Force of the International Society for Bipolar Disorders.

NCT ID: NCT05408156 Not yet recruiting - Hallux Valgus Clinical Trials

Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus

Start date: August 1, 2025
Phase: N/A
Study type: Interventional

Hallux valgus is one of the most common forefoot deformities. Its prevalence increases with age, representing approximately 23% in adulthood, being more common in females. Some studies indicate that the use of the insole associated with the finger separator promotes pain relief and that this may be related to better alignment of the hallux. However, there is still no consensus about the ideal insole or how long it should be used to relieve pain or improve function in patients with hallux valgus. Therefore, the objective of this study will be to evaluate the effect of the customized insole on pain and function of individuals with symptomatic hallux valgus.

NCT ID: NCT05401513 Not yet recruiting - Low Back Pain Clinical Trials

Pilates Method in Helicopter Pilots With Low Back Pain

Start date: June 20, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to analyze the effects of an exercise program, based on the Pilates method, on the low back pain and muscle fatigue of Brazilian Air Force helicopter pilots.