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NCT ID: NCT05123911 Completed - Healthy Clinical Trials

A Study of 3 Investigational Products on the Microbiome and Scalp Attributes in Children With Curly Hair

Start date: November 13, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the topical safety (tolerability/acceptability) of a kit of cosmetic products (shampoo, conditioner, and combing cream), the presence of residues on the scalp through visual assessment and image capture, the skin barrier, pH, and sebum level. All these evaluations will be performed before and after 28 plus minus (+-) 2 days of use under normal conditions, under the supervision of dermatologist and pediatrician.

NCT ID: NCT05123703 Recruiting - Clinical trials for Relapsing-Remitting Multiple Sclerosis

A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis

Operetta 2
Start date: February 4, 2022
Phase: Phase 3
Study type: Interventional

This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with relapsing-remitting multiple sclerosis aged between 10 and < 18 years over a duration of at least 96 weeks.

NCT ID: NCT05122637 Completed - Clinical trials for Acute Ischemic Stroke

Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Stroke Patients

RapidPulseFS
Start date: January 31, 2022
Phase: N/A
Study type: Interventional

A Feasibility Study to evaluate the initial safety and performance of the RapidPulseTM Aspiration System in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO).

NCT ID: NCT05122455 Recruiting - AMI Clinical Trials

Effects of Edoxaban on Platelet Aggregation

Edoxaban
Start date: September 14, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Rationale: The interaction between nonvitamin K oral anticoagulants (NOACs) and platelet aggregation is complex. The direct activated factor X inhibitors (factor Xa inhibitors) an NOAC antagonizes thrombin generation, one of most important platelet agonist, so that, factor Xa inhibitors has a potential effect in decreasing thrombin-mediated platelet aggregation. On the other hand, patients who experience ACS continue to have a hypercoagulable state for long periods after the index event. The COMPASS trial showed that, in patients with stable coronary artery disease (SCAD), Rivaroxaban (a direct anti-Xa inhibitor) in addition to antiplatelet agent, compared to antiplatelet therapy alone, reduced the composite endpoint of myocardial infarction, stroke and death. Objective: Analyze the role of edoxaban on platelet aggregation in SCAD patients. Methods and Results: This is a prospective, non-randomized, interventional study of SCAD patients taking low-dose acetylsalicylic acid (ASA). Subjects initially will receive in the following sequence: ASA 100 mg once daily (QD) plus edoxaban 60 mg QD, clopidogrel 75 mg QD alone, clopidogrel 75 mg QD plus edoxaban 60 mg QD, and edoxaban 60 mg QD alone. Platelet function will be assessed by standard of care technology, at baseline and after each intervention phase, by Multiplate-ADP® (primary endpoint), Multiplate-Aspi® and Multiplate-TRAP®. In addition to immature platelets fraction (% IPF) and count (IPC). Coagulability will be assessed, at baseline and after each intervention phase, by thromboelastogram (TEG) assessment. Specifically, after the phases in which edoxaban will be administered activated factor X (FXa) level and Plasminogen activator inhibitor-1 (PAI-1) will be evaluated in addition to previous. Finally, inflammatory markers will be, at same way, assessed at baseline and after intervention each phase: ultrasensitive C-reactive protein (us-PCR). Keywords: edoxaban, direct factor Xa inhibitor, stable coronary artery disease, aspirin, clopidogrel, platelet aggregation.

NCT ID: NCT05121155 Completed - Stroke Clinical Trials

Brain Skull Deformation as a Non-invasive Intracranial Pressure (ICP) Measure

Start date: March 1, 2019
Phase:
Study type: Observational [Patient Registry]

Background: Although placement of an intra-cerebral catheter remains the gold standard method for measuring intracranial pressure (ICP), there are several limitations to the method. Objectives: The main objective of this study was to compare the correlation and the agreement of the wave morphology between the ICP (standard ICP monitoring) and a new nICP monitor in patients admitted with stroke. Our secondary objective was to estimate the accuracy of four non-invasive methods to assess intracranial hypertension. Methods: We prospectively collected data of adults admitted to an intensive care unit (ICU) with subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH) or ischemic stroke (IS) in whom invasive ICP monitoring placed. Measures had been simultaneously collected from the following non-invasive indices: optic nerve sheath diameter (ONSD), pulsatility index (PI) using transcranial Doppler (TCD), a 5-point visual scale designed for Computed Tomography (CT) and two parameters (time-to-peak [TTP] and P2/P1 ratio) of a non-invasive ICP wave morphology monitor (Brain4care[B4c]). Intracranial hypertension was defined as an invasively measured ICP > 20 mmHg for at least five minutes.

NCT ID: NCT05120349 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection

ADAURA2
Start date: February 21, 2022
Phase: Phase 3
Study type: Interventional

This is a global study to assess the effects of osimertinib in participants with EGFRm stage IA2-IA3 non-small cell lung cancer following complete tumour resection.

NCT ID: NCT05120167 Completed - Cervical Cancer Clinical Trials

Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy

Start date: September 29, 2021
Phase: N/A
Study type: Interventional

cervical cancer is the fourth most frequent cancer in women worldwide and in Brazil, it occupies the third position for the triennium 2020/2022, with a high mortality rate and maintained in the last 10 years. It is associated with persistent human papillomavirus (HPV) infection. Primary prevention can be accomplished through vaccines that prevent HPV infection of the epithelial cells of the cervix. Secondary prevention in screening for precursor lesions through periodic repeat cervical sampling in a population of asymptomatic women. Women with abnormal cytology are more likely to have pre-invasive or invasive lesions and are referred for further testing, colposcopy. Colposcopy identifies suspicious areas and guides the best site for biopsy. In the situation of negative colposcopy and abnormal cytology, suspicion for high-grade lesion (HSIL). It recommends further investigation of the endocervical canal before the possible excisional procedure and obtaining an additional canal sample by brushing or curettage. However, to date, there is no consensus and studies lack consistent results on which is the best method for further investigation of the endocervix. Objectives: To compare the performance of additional strategies in the investigation and detection of precursor or invasive lesions in the endocervical canal in women with abnormal cytology (ASC H+) and with initial colposcopy without suspicious images.

NCT ID: NCT05119283 Recruiting - Periodontitis Clinical Trials

Clinical Study of a Formulation Containing Phtalox® in Periodontal Disease

Start date: March 7, 2022
Phase: N/A
Study type: Interventional

Periodontitis is a chronic and destructive inflammation that leads to the loss of tissue supporting the teeth, the periodontium, and possibly tooth loss and edentulism. Its etiology is related to an overload on the host's defense mechanisms, consequent to the accumulation of plaque or suppression of the immune system. Standard treatment for periodontitis includes scaling and root planing (RAR) and possible association with therapeutic adjuvants such as systemic and local antimicrobials. However, the use of these drugs supporting the treatment of periodontitis, has shown adverse effects such as loss of taste, soft tissue burn, pain, xerostomia, supragingival calculus formation and change in staining of teeth, restorations, prostheses and tongue. Other effects not as common as mucosal ulcerations, desquamative lesions, urticaria, dyspnea, anaphylactic shock and swellings reversible effects in the parotid glands and lips have also been observed and reported in the literature. Thus, there is a need for new adjuvant therapies, which cause less effects side effects and that are more effective in the treatment of periodontitis and in the maintenance of oral health. The commercial product PHTALOX® is a phthalocyanine dental mouthwash that has a spectrum of action based on the formation of reactive oxygen that acts by inhibiting odor-causing substances, on microorganisms and on the mechanisms of coagulation and healing. Your supporting action in periodontal treatment may have promising potential. Thus, the purpose of this study clinical trial will be testing a formulation containing PHTALOX® for disease prevention and control Periodontal (PD). 30 patients will be recruited who will undergo scaling and straightening coronaroradicular (RAR), and after basic periodontal treatment will be randomly divided into 3 groups according to the supporting treatment: G1 - patients who will receive mouthwashes with physiological solution; G2 - patients who will receive 0.12% chlorhexidine mouthwash; G3 - patients who will be treated with PHTALOX®. Clinical reassessments of patients will be carried out before the treatments, and at 15, 30 and 60 days after the performance of the RAR and beginning of the respective mouthwash. After data collection, intra and intergroup analyzes will be performed comparing the therapeutic results for the periodontal condition through the "Bioestat" program.

NCT ID: NCT05118971 Completed - Spinal Cord Injury Clinical Trials

Comparison of Muscle Activity in Exercise Bike and Elliptical Trainer in Individuals With Spinal Cord Injury

Start date: August 1, 2020
Phase:
Study type: Observational

Spinal cord injury is caused by any harmful process in the spinal cord, impairing its function, generating loss of muscle strength, impairing orthostatism and walking. In rehabilitation, some strategies are used to activate the muscles involved in the gait of these individuals, including the ergometric bicycle and the elliptical. Understanding the pattern of muscle activation generated by these methods is important to answer questions arising from clinical practice. Thus, we seek to verify the pattern of muscle activation of the vastus laterals, vastus medialis, gluteus medius, tibialis previous, rectus abdominis and paravertebral muscles during exercises with ellipticals and ergometric bicycle with and without electromyography biofeedback in individuals with spinal cord injury. Cross-sectional study of the type crossover. Individuals will sign the Informed Consent Form (FICF) and answer the identification form. They will be evaluated for functionality using the Functional Independence Measure (FIM), injury classification by the American Spinal Injury Association (ASIA) and muscle tone by the modified Ashworth scale. Later, they will be randomized to define the order of the devices in which they will be evaluated. Muscle activity will be verified with electromyography of the paravertebral, abdominal, vastus laterals, vastus medialis, gluteus medius and tibialis anterior unilateral muscles on the right side of individuals, comparing muscle activation during exercise cycling, elliptical and adding biofeedback in both modalities. The wash-out interval between each evaluation will be 7 days. We hypothesize that the elliptical with biofeedback will cause greater activation of the assessed muscles.

NCT ID: NCT05118672 Not yet recruiting - Cold Clinical Trials

Phase 3 Clinical Trial to Evaluate Paracetamol /Fexofenadine /Phenylephrine in Flu and Cold Treatment

RESFRIN
Start date: November 30, 2024
Phase: Phase 3
Study type: Interventional

A Phase 3, multicenter, Randomized, Double-blind, comparative clinical trial to evaluate the association of paracetamol 500mg + Fexofenadine 60mg + Phenylephrine 20mg in the flu and common cold treatment. ⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).