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NCT ID: NCT03713567 Completed - Gingivitis Clinical Trials

Clinical, Immunological and Microbiological Evaluation of Experimental Gingivitis and Peri-implant Mucositis

Start date: November 7, 2017
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate, through clinical, microbiological and immunological tests, the changes during the experimental gingivitis and mucositis model, between teeth and implants, and between patients with a history of aggressive periodontitis and healthy individuals.

NCT ID: NCT03712215 Completed - Clinical trials for Respiratory Distress Syndrome, Adult

STUDY OF ELECTRICAL STIMULATION IN PULMONARY FUNCTION IN INTENSIVE CARE UNIT

Start date: September 4, 2018
Phase: N/A
Study type: Interventional

Introduction: The Mechanical Ventilation (MV), a support method used in Intensive Care Units (ICU), reaches approximately 90% of critical patients whose withdrawal process represents 40% of the total time of their use. For this purpose Transcutaneous electrical diaphragmatic stimulation (TEDS), which by means of electrodes placed in motor action points on the phrenic nerve tend to provide improvement of the diaphragm muscle function. Objective: To analyze the effect of two protocols of transcutaneous electrical diaphragmatic stimulation on the ventilatory and cardiorespiratory parameters of critically ill patients. Method: Clinical, longitudinal, prospective, quantitative, single center trial will be performed with 30 (thirty) participants in invasive mechanical ventilatory support, randomly divided into three groups: Experimental Group 1 (GE-1; n = 10) where they will be submitted to the TEDS protocol; Experimental Group 2 (GE-2; n = 10), where they will be submitted to the TEDS protocol based on the studies of Cancelliero et al. (2012); Control Group (GC; n = 10) where they will not be submitted to TEDS. All groups will receive physiotherapeutic care from the staff of the adult ICU of the FHCGV. The interventions will consist of ten sessions of Physical Therapy in each participant in the afternoon shift, for ten consecutive days, 1 time a day. For the TEDS procedure, the Orion TENS II (Orion-SP-Brazil) model will be used, the Wright analogue respirometer (Spire-SP-Brazil) will be used for the minute volume evaluation (V'). The variables of systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and peripheral oxygen saturation (SpO2) will also be monitored in order to verify if the TEDS application interferes with the hemodynamic variables of these patients. The data collected will be linked to Microsoft Office Excel® 2010 software and later transformed into tables and graphs. The information collected will be submitted to statistical analysis through the statistical package SPSS 22.0, applying the descriptive statistics for the characterization of the sample and then selecting the specific tests for the respective variances, adopting a level of significance of p≤0.05 for statistical inferences.

NCT ID: NCT03712007 Completed - Clinical trials for Malocclusion, Angle Class III

Comparison of Two Miniscrew Anchored Maxillary Protraction Protocols

Start date: June 9, 2017
Phase: N/A
Study type: Interventional

This study evaluates the dentoskeletal effects produced by two maxillary protraction protocols in adolescent patients. Half of participants will be treated with a tooth-borne and tooth-bone-borne expanders as anchorage in the maxillary arch. Miniscrews will be used as anchorage in the mandibular arch for both groups.

NCT ID: NCT03711708 Completed - Healthy Clinical Trials

Relative Bioavailability Study of Zoloft Oral Solution to Zoloft Tablets

Start date: November 6, 2018
Phase: Phase 4
Study type: Interventional

In Brazil, sertraline is currently available as film coated tablets for oral administration containing sertraline hydrochloride equivalent to 50 mg or 100 mg sertraline. The sponsor has developed an oral solution formulation containing 20 mg/mL of sertraline, which must be diluted with 120 mL of water, ginger ale, lime/lemon soda or orange juice to be palatable before use. The purpose of this study is to evaluate the relative bioavailability of Zoloft oral solution compared to Zoloft tablets in healthy participants under fasted conditions.

NCT ID: NCT03711214 Active, not recruiting - Sjogren's Syndrome Clinical Trials

Immune Profile of Saliva and Serum of Patients With Primary Sjögren´s Syndrome

pSS
Start date: December 1, 2018
Phase: N/A
Study type: Interventional

Primary Sjögren's syndrome (pSS) is a chronic systemic inflammatory disease, which mainly affects the lacrimal and salivary glands, leading to sicca syndrome. pSS has a probable autoimmune etiology, with the production of several autoantibodies such as antinuclear antibodies (ANA), anti-Ro/SS-A, anti-La/SS-B, rheumatoid factor (RF) and cryoglobulins. Recently, our group described a high frequency of antibodies directed to DNase I in the serum of pSS patients and these antibodies were associated with the presence of the anti-Epstein-Barr (EBV) early antigen diffuse (anti-EA-D). This finding becomes interesting considering the recent description of reduction of DNase I activity in the tear of patients with xerophthalmia of different causes, which would result in an accumulation of extracellular DNA and neutrophilic inflammatory infiltrate on the ocular surface. This hypothesis is reinforced by the observation that treatment with DNase I as eye drops results in clinical improvement of dry eye. In addition, it has been shown that periodontal disease is an aggravating factor of xerostomia in pSS, as it leads to a chronic inflammatory process and, consequently, to the destruction of minor salivary glands. Therefore, the objective of the present study will be to evaluate the presence of antibodies directed to DNase I in the saliva and serum of pSS patients and its possible capacity of inhibition of the enzyme before and after treatment of periodontal disease. Such findings will be correlated with the presence of periodontal disease, with the glandular and extraglandular manifestations of SSp and also with the presence of EBV DNA in the serum and oral lavage of these patients.

NCT ID: NCT03711162 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care

ISABELA1
Start date: November 28, 2018
Phase: Phase 3
Study type: Interventional

The main purpose of this study was to see how GLPG1690 works together with your current standard treatment on your lung function and IPF disease in general. The study also investigated how well GLPG1690 is tolerated (for example if you got any side effects while on study drug).

NCT ID: NCT03711032 Recruiting - Clinical trials for High-risk Non-muscle Invasive Bladder Cancer

Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)

Start date: December 24, 2018
Phase: Phase 3
Study type: Interventional

This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS). The primary hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG.

NCT ID: NCT03710499 Recruiting - Physical Activity Clinical Trials

Rehabilitation Program in Patients With Acromegaly

Start date: January 10, 2016
Phase: N/A
Study type: Interventional

Acromegaly is chronic, systemic and highly disabling disease. People with Acromegaly show a significant reduction in peripheral muscle strength associated with a loss resistance and lethargy. They tend the fatigue more easily when compared to individuals without the disease, which involves exercise intolerance and disability resulting in a quality of life impaired. Acromegaly have important functional limitations that adversely affect the performance in the activities of day-to-day and contribute to the worsening of the disease. Based on previous studies, the investigators believe that acromegaly participants with would have benefit from a treatment protocol facing physical performance and improved quality of life. Main Objective: To evaluate the effect of home rehabilitation on quality of life of participants with acromegaly. Methods: In this study of longitudinal intervention, they will undergo a rehabilitation program lasting three months, three times a week lasting 60 minutes each session. The protocol will be the assessment of Acromegaly Quality of Life Questionnaire (AcroQol) questionnaire, functional assessment by the walk test of six minutes (6MWT), peripheral muscle strength and assessment of joint integrity, fatigue will be measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire that evaluates the fatigue in the chronic participants. The assessment will be in 3 different moment (month 0, month 2 month 3). The treatment protocol will consist of warm-up and cool-down, strengthening exercise and muscular endurance, aerobic training, and balance training and proprioception. Prospects: The participants with acromegaly will benefited significantly after undergoing a physical therapy rehabilitation protocol the following parameters: Resistance and muscle strength, pain conditions and disorders skeletal muscle, improvement in activities of daily living and consequent better quality of life.

NCT ID: NCT03710291 Terminated - Clinical trials for Chronic Kidney Disease

Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis

VALOR-CKD
Start date: November 20, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.

NCT ID: NCT03710174 Recruiting - Bruxism, Sleep Clinical Trials

Evaluation of the Effectiveness of Infrared LED Photobiomodulation in Children With Sleep Bruxism

Start date: August 1, 2017
Phase: Phase 2
Study type: Interventional

Sleep bruxism is a masticatory muscle activity characterized as rhythmic (phasic) or non‐rhythmic (tonic). The literature reports the prevalence rates, diverse etiologies and different types of treatment. In children and adolescents, etiological factors, such as breathing pattern and sleep quality, have recently been addressed in studies investigating sleep bruxism. While studies have also reported psychological factors as a causal factor, this aspect requires further research. There are also divergences in opinion regarding the form of treatment. New therapies for adults, such as botulinum toxin, have been investigated, but such techniques are not applicable for individuals in the growth and development phase. Thus, photobiomodulation therapy has piqued the interest of researchers, as this noninvasive method has demonstrated positive results in problems related to muscle tissues. This document describes the protocol for a proposed study to evaluate morphological and psychosocial aspects in children and adolescents with awake bruxism and their responses to photobiomodulation therapy with infrared LED.