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NCT ID: NCT06191315 Recruiting - Asthma Clinical Trials

Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)

Start date: January 3, 2024
Phase: Phase 3
Study type: Interventional

This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to <6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to <6 years old with uncontrolled asthma and/or recurrent severe asthmatic wheeze. At the end of Part A, all eligible participants will be offered participation in Part B, an optional open-label extension phase. Study details include: Part A: The study duration of part A will be up to 68 weeks consisting of a 4-week Screening, a 52week treatment period, and a 12-week post-treatment follow-up period. For participants who will chose to participate in Part B, the study duration will be up to 120 weeks (additional 52-week treatment period). Part B: For participants who will choose to participate in Part B, the study duration will be up to 120 weeks (Part A [4-week Screening and a 52-week treatment period] plus additional 52-week treatment period and a 12-week post-treatment follow-up period).

NCT ID: NCT06184490 Recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Prone Position With Different Types of Cushions in Patients With ARDS

PronEIT
Start date: August 15, 2023
Phase: N/A
Study type: Interventional

The prone maneuver is a well-established therapy in ARDS. Traditionally, the maneuver is perform with thoraco-abdominal cushions. The goal of this study is assess, using electrical impedance tomography, whether the arrangement mode of the cushions alters lung recruitment during the prone maneuver in patients with moderate to severe ARDS.

NCT ID: NCT06184451 Recruiting - Clinical trials for Osteoarthritis, Knee

Effects of TENS During the Performance of a Therapeutic Exercise Protocol in Individuals With Knee Osteoarthritis.

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

Research participants diagnosed with knee Osteoarthritis will be randomized through a draw using sealed opaque envelopes indicating two groups: 1. Therapeutic Exercises + Transcutaneous electrical nerve stimulation and 2. Therapeutic Exercises + placebo Transcutaneous electrical nerve stimulation. Therefore, individuals of both sexes, aged 40 years or over, with a clinical diagnosis of unilateral osteoarthritis of the knee, who present with knee pain for more than three months, morning stiffness for less than 30 minutes, crepitus, bone sensitivity and absence of palpable heat, and diagnosis established radiographically (determined by Kellgren and Lawrence grade 1 to 3 on scale 1 to 4). Exclusion criteria are bilateral knee Osteoarthritis, hip Osteoarthritis, severe osteoporosis, fibromyalgia, clinical history of tumors or cancer, active inflammatory joint diseases (rheumatoid arthritis, gout), undergoing any lower extremity joint replacement, neurological disorders (Parkinson's disease, stroke, multiple sclerosis, muscular dystrophies, motor neuron disease, Alzheimer's disease), infected wounds or osteomyelitis in the knee region, deep vein thrombosis or thrombophlebitis, sensory changes in the lower limbs, cognitive impairment, and cardiopulmonary disorders that may prevent or limit the execution of exercises, use of a walking assistance device, history of recent trauma to the knee, having undergone any form of treatment involving physiotherapy, intra-articular corticosteroids, anti-inflammatories or chondroprotective within the six months before the start of interventions.

NCT ID: NCT06183931 Recruiting - Clinical trials for Transthyretin Amyloid Cardiomyopathy

Study of ALXN2220 Versus Placebo in Adults With ATTR-CM

DepleTTR-CM
Start date: January 11, 2024
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the efficacy of ALXN2220 in the treatment of adult participants with ATTR-CM by evaluating the difference between the ALXN2220 and placebo groups as assessed by the composite endpoint of all-cause mortality (ACM) and total cardiovascular (CV) clinical events.

NCT ID: NCT06170892 Recruiting - Newborn Morbidity Clinical Trials

Kangaroo Position in Preterm Newborn Infants Under Oxygen Therapy

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The kangaroo position, which is part of the Kangaroo Method strategy, is widely used in the Neonatal Intensive Care Unit and Neonatal Intermediate Care Units and aims to promote emotional bonding, cardiorespiratory, physiological and body temperature stability, in However, there is still little scientific evidence when it comes to newborns undergoing oxygen therapy. Identify, quantify and analyze the influence of the kangaroo position on the vital signs and respiratory comfort of preterm newborns using supplemental oxygen. To collect data, a physiotherapeutic assessment form suitable for clinical analysis was used. The newborns were placed in the kangaroo position in a single session, and the variables were identified before, during and after the application of the technique.

NCT ID: NCT06169241 Recruiting - Clinical trials for Arterial Hypertension

Effect of Nitrate Supplementation on Blood Pressure and Microvascular Function of Resistant Hypertensive Patients

Start date: November 1, 2023
Phase: Early Phase 1
Study type: Interventional

Arterial hypertension (AH) has been identified as an important public health problem and considered a new epidemic with high mortality and morbidity. High blood pressure (BP) levels increase the chances of coronary artery disease (CAD), heart failure (HF), stroke, chronic renal failure (CRF) and death. Beetroot powder may be an easier way to increase the availability of nitric oxide and consequently vasodilation in these patients. However, studies are needed to evaluate its benefits in patients with AH.

NCT ID: NCT06168006 Recruiting - Clinical trials for Post-Acute COVID-19 Syndrome

Exercise Training Using an App on Physical Cardiovascular Function Individuals With Post-covid-19 Syndrome

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

The aim of this study is to assess the effect of a physical exercise program via a mobile application on functional parameters in individuals with post-COVID-19 syndrome. This is a clinical trial involving 60 individuals with post-COVID syndrome who will be randomly assigned to either a control group (physical activity guideline) or an experimental group (app-based training).

NCT ID: NCT06166030 Recruiting - Inflammation Clinical Trials

IMMUNERECOV CONTRIBUTES TO IMPROVEMENT OF RESPIRATORY AND IMMUNOLOGICAL RESPONSE IN POST-COVID-19 PATIENTS.

IRPC
Start date: December 10, 2023
Phase: Phase 3
Study type: Interventional

Background: COVID-19 left consequences in different organs from months to years requiring different types of rehabilitation. In fact, a severe loss in the lung function, and in the respiratory and peripheral muscle strength is commonly observed in post-COVID-19 patients. Objectives: Thus, the present study investigated whether 30 days of supplementation with a nutritional blend (ImmuneRecov®; composition: whey protein concentrate, astaxanthin, creatine, selenium, vitamin C, glutamic acid, tryptophan, magnesium) would help to minimize the respiratory (lung function) and muscular (respiratory and peripheral muscles) sequelae in post-COVID-19 patients.

NCT ID: NCT06164626 Recruiting - Bone Substitutes Clinical Trials

Evaluation of Bone Preservation After Molar Extraction Using Photobiomodulation Combined With Biomaterial Grafting

Start date: December 10, 2023
Phase: Phase 1
Study type: Interventional

Tooth loss is a global public health problem and is the main cause of occlusal and oral bone deformities. The tooth with the greatest tooth loss can be identified as first molars. The bone graft added to the tooth socket immediately after tooth extraction prevents atrophy and deformity of the bone at the site of tooth loss. Photobiomodulation accelerates bone healing; stimulates blood flow; activates osteoblasts, decreases osteoclastic activity and improves the integration of the biomaterial with bone tissue. The objective of the study is to develop a protocol for the management and preservation of alveolar bone after loss of first and/or second permanent molars in patients age from 18 years, with an indication for extraction associated or not with treatment with an 808 nm infrared laser. . Materials and methods: 60 patients age from 18 years will be randomized and randomly distributed into 4 groups, n= 15: Exo (extraction), Exo+Laser (extraction and laser treatment), Exo+Biomat (extraction with graft of biomaterial), Exo+Biomat+Laser (biomaterial extraction and grafting and laser treatment). The biomaterials of choice will be Plenum® OSShp and Plenum® Guide (Brazil), added to the socket immediately after molar extraction, groups that will receive the laser (λ = 808 nm, power = 100 mW, radiant energy 3J per point in 3 buccal, occlusal and lingual/palatal points), will receive irradiation during surgery and 10 days after surgery, in the Exo and Exo+Biomat groups a similar laser device will be used without emission of irradiation, the operator who will apply the laser and the patient will be blind to the device used and the patient will not know whether or not they received the biomaterial. Analysis: computed tomography and intraoral scanning performed pre-surgery and 4 months after surgery; to assess bone volume by measurements of the height and width of the socket in each group, as well as trabecular bone and the interdental space of the teeth lateral to the missing element. Statistical analysis will be performed using the Shapiro-Wilks test, Student's t-test or Wilcoxon-Mann-Whitney test for parametric and non-parametric data, respectively, will be two-tailed and the significance level adopted will be α = 0.05.

NCT ID: NCT06159387 Recruiting - Cocaine Dependence Clinical Trials

Randomized, Double-blind, Placebo-controlled Cannabis Extract x Placebo for Cocaine Addicts

Start date: October 23, 2023
Phase: Phase 4
Study type: Interventional

2.1. General To evaluate the efficacy and safety of a Cannabis sativa extract (CBD (Cannabidiol) + up to 0.3% THC (Delta-9-tetrahydrocannabinol)), compared to placebo, in the treatment of cocaine/crack use disorder. 2.2. Specifics - Compare the amount and frequency of cocaine use between the group treated with Cannabis sativa extract and the placebo group - Compare adherence to treatment between the group treated with Cannabis sativa extract and the placebo group - Evaluate the prevalence and intensity of depressive and anxious symptoms in patients using Cannabis sativa extract compared to patients using placebo - Evaluate the incidence and severity of side effects in the active group compared to placebo.