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NCT ID: NCT04200716 Active, not recruiting - Prehypertension Clinical Trials

Arterial Function After Two Different Physical Exercise Intensities in Prehypertension

PREHTEXVAS
Start date: July 3, 2018
Phase: N/A
Study type: Interventional

Individuals with prehypertension, diagnosed according to the 7th Brazilian Guidelines on Hypertension with the presence of systolic blood pressure (SBP) between 121 and 139 and / or diastolic (DBP) between 81 and 89 mmHg, are more likely to become hypertensive and to develop cardiovascular complications. Moreover, they already have alterations in the function of large arteries that may play a role in the development of the disease in the future. An option in the prevention / treatment of hypertension is the moderate intensity physical training, but high intensity interval training offers the possibility of greater exercise adherence, since it can be performed with less volume and less time spent, with the same benefits than moderate exercise, or even higher, being preferred by the population. Among these benefits, the investigators can mention the post-exercise hypotension (PEH) which occurs in normotensive, prehypertensive, and hypertensive individuals, due the decreased in sympathetic nerve activity and improved in vascular function. Also, selected participants with prehypertension can present a profile of masked hypertension, identified only by 24 hours ambulatory BP monitoring (ABPM). Given the possible differences between vascular responses to exercise intensities, the investigators intend to compare, in prehypertensive patients, the vascular responses of large arteries by noninvasive methods and PEH to a session of high intensity exercise and a session of moderate intensity continuous exercise. In addition, to study some of the possible physiological variables involved in this response by measuring heart rate variability. It is expected to find differences in vascular responses according to the presence of masked hypertension. Twenty two prehypertensive individuals aged between 30 and 60 years of both sexes will be studied. Subjects will perform cardiopulmonary testing and baseline vascular measurements (central pressure and pulse wave velocity measurements by three different methods), as well as 24 -hour ABPM. The vascular measurements will be repeated immediately after, and 24 hours after each session. Each participant will perform the session of one type of exercise in one day, and after three days will perform the other, with random distribution to the sequence of exercise type. Participants will perform 24-hour ABPM prior to exercise and for 24 hours after each exercise session. Data will be compared by appropriate statistical analysis.

NCT ID: NCT04200677 Completed - Clinical trials for Electrical Stimulation

Influence of Electrode Positioning and Current Type on Fatigue, Force and Discomfort

Start date: January 10, 2020
Phase: N/A
Study type: Interventional

Introduction: Neuromuscular electrical stimulation (NMES) has the purpose of generating muscle contractions to minimize muscular atrophy and to improve neuromuscular performance. NMES has been performed using monophasic or biphasic currents, applied over a nerve trunk or muscle belly, and both can generate contractions by the peripheral and central nervous system. Pulse width (wide or narrow) is an essential parameter for NMES. Although NMES studies using wide pulses have been performed with monophasic currents, it is known that this current induces discomfort during NMES. Therefore, it is necessary to analyze if biphasic currents have the same effect as monophasic currents using the same parameters. Objectives: To compare the effects of NMES with narrow and wide pulse widths associated with monophasic and biphasic currents, applied over a tibial nerve and triceps surae muscles in healthy individuals in terms of muscle fatigue, central and peripheral contribution, voluntary and evoked force and sensory discomfort. Methods: A crossover, experimental controlled and randomized study will be developed with healthy male and female (age: 18-45 years). The following dependent variables will be: amplitude of H-reflex and M-wave (single and double pulses), voluntary and evoked triceps surae muscles torque, fatigability (force time integral), perceived discomfort and neuromuscular adaptations. The independent variables will be related to current phase, pulse width and location of electrical stimulation electrodes. There will be a familiarization session followed by 9 sessions with 7 rest days between them (10 weeks). Data will be reported as mean and standard deviation (± SD). Parametric tests will be used for the normally distributed data (Shapiro-Wilk test) that show homogeneous variations (Levene test). A repeated measure mixed-model ANOVA will be performed and, in the case of major effects or significant interactions, the Tukey post-hoc test will be applied. In addition, the power and size of the effect (reported as partial eta square, partial η2) will be calculated. The significance threshold will be set at p <0.05 for all procedures. Expected results: Biphasic currents will be more comfortable and will generate less muscle fatigue when compared to monophasic currents. There will be less fatigue and greater central contribution when wider pulse currents will be applied over a nerve trunk concerning the application with a wide pulse over a muscle belly.

NCT ID: NCT04199689 Active, not recruiting - Clinical trials for Papillomavirus Infections

Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)

Start date: February 27, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9-valent human papillomavirus (9vHPV) vaccine in men 20 to 45 years of age. The primary hypothesis tested after the primary database lock is that administration of a 3-dose regimen of 9vHPV vaccine will reduce the incidence of HPV 16/18/31/33/45/52/58-related oral persistent infection (6 months or longer) compared with placebo. There will also be an Extension Study to offer an opportunity to complete the 3 dose regimen of 9vHPV vaccine for participants who received placebo in the Base Study, or received less than 3 doses of 9vHPV vaccine in the Base Study.

NCT ID: NCT04199104 Active, not recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010) (MK-7902-010)

LEAP-10
Start date: February 5, 2020
Phase: Phase 3
Study type: Interventional

This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma. Hypotheses include: - Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). - Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR. - Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).

NCT ID: NCT04198571 Completed - Clinical trials for Community Acquired Pneumonia

Retrospective Chart Review Study to Assess Characteristics, Treatment Outcomes and Resource Use of Adults Hospitalized for CAP and CSSTi Treated With Zinforo in Multiple Countries

Start date: May 17, 2020
Phase:
Study type: Observational

MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalized for Community-Acquired Pneumonia (CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) Treated with Zinforo® (ceftaroline fosamil) in a Usual Care Setting

NCT ID: NCT04198519 Recruiting - Obesity Clinical Trials

Effects of Weight Loss on Vascular Function in Obese Subjects

Start date: November 21, 2019
Phase: N/A
Study type: Interventional

To evaluate the effect of weight loss on vascular function in obese with poor cardiovascular health. The investigators will evaluate the effects of weight loss on total and central body adiposity, blood pressure, central hemodynamic parameters, arterial stiffness, endothelial function, apnea-hypopnea index, insulin resistance and inflammatory markers.

NCT ID: NCT04195750 Active, not recruiting - Clinical trials for Carcinoma, Renal Cell

A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)

Start date: February 27, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare belzutifan to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS.

NCT ID: NCT04195412 Recruiting - Stroke Clinical Trials

Imaging the Effects of Bihemispheric Transcranial Stimulation and Motor Training After Stroke.

Start date: October 29, 2019
Phase: Phase 2
Study type: Interventional

Functional and structural magnetic resonance imaging (MRI) will be used to investigate neural correlates of bihemispheric transcranial direct current stimulation (tDCS) associated with upper limb rehabilitation in chronic stroke patients. For this purpose, patients included will be submitted to 10 sessions with active or sham bihemispheric tDCS associated with intensive and individualized rehabilitation. Neuroimage will be employed before and after the intervention to investigate neural correlates of expected changes in motor function.

NCT ID: NCT04195386 Recruiting - Clinical trials for Dental Caries in Children

Efficacy of a Chemically Activated Composite Resin Alkasite in Atypical Caries Lesions of Deciduous Teeth

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Atypical cavities, which involve more than two surfaces being one of them vestibular or lingual/palatine, are a challenge for restorative dentistry, since the risk of failure of the restorations are related to the number of surfaces involved. Thus, the objective of this project is to conduct a randomized clinical trial in order to evaluate the efficacy and patient-centered outcomes of a chemically-activated alkasite composite resin in atypical lesions of deciduous molars. Deciduous molars of children between 4 and 7 years of age with at least one atypical cavity lesion in deciduous molars will be selected for the ECR. The selected teeth will be randomly divided into two groups: Chemically activated composite resin Alkasite and resin-Modified glass ionomer cement. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The efficacy of the treatments will be evaluated by the longevity of the restoring procedures and the arrestment of the caries lesions. Patient-centered outcomes will also be evaluated.

NCT ID: NCT04195022 Recruiting - Clinical trials for Dental Caries in Children

Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Atypical cavities, which involve more than two surfaces, one being buccal or lingual/palatal, are a challenge for restorative dentistry, since the risk of restorative failure is related to the number of surfaces involved. Thus, the purpose of this umbrella project is to conduct a randomized controlled trial (RCT) to evaluate the efficacy and patient-centered outcomes of a chemically activated composite alkasite resin in atypical deciduous molar lesions. Primary molars of children aged 4 to 7 years with at least one atypical cavitary lesion in primary molars will be selected for the RCT. The selected teeth will be randomly divided into: Alkasite chemically activated composite resin and Bulk fill composite resin. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The effectiveness of the treatments will be evaluated by the longevity of the restorative procedures and paralysis of the lesions. Patient-centered outcomes will also be evaluated.