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NCT ID: NCT03503448 Completed - Malocclusion Clinical Trials

Comparison of 2 Techniques of Surgically Assisted Rapid Maxillary Expansion

SARME
Start date: May 7, 2018
Phase: N/A
Study type: Interventional

This study evaluates 2 Techniques of Surgically Assisted Rapid Maxillary Expansion (SARME) in the treatment of maxillary transverse deficiency. Half of participants will undergo an osteotomy between the maxillary central incisors, while the other half will undergo an osteotomy between the maxillary lateral incisors and canines (bilateral osteotomies).

NCT ID: NCT03503422 Completed - Clinical trials for Chronic Low Back Pain

Optimizing Chronic Low Back Pain Exercise Therapies With Cerebral Electrical Stimulation

Start date: April 10, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Chronic low back (CLBP) pain is an important public health and socioeconomic problem worldwide and, despite the volume of research in the area, it remains a difficult condition to treat. The Neuromatrix pain model and new findings on the pain chronification process point to a greater efficacy of treatments that address central and peripheral rather than only peripheral structures. Transcranial direct current (tDCS) stimulation is a noninvasive neuromodulation technique that has been presenting recent advances in the treatment of chronic pain. However, when applied alone the magnitude of its effect is small in chronic musculoskeletal conditions such as chronic non-specific back pain. One option that could optimize the analgesic effect of tDCS would be the combination with therapeutic exercises, which play a central role in spinal rehabilitation programs as well as higher levels of evidence. The combination of these treatments (tDCS and exercise) may present an analgesic effect superior to the isolated interventions. This study aims to investigate the efficacy of tDCS combined with therapeutic exercises in people CLBP for pain relief, affective aspect of pain, disability, kinesiophobia and global perception. Sixty patients will be randomized into two distinct groups to receive either tDCS (anodal) + therapeutic exercises or tDCS (sham) + therapeutic exercises for 12 sessions over a four-week period. The primary clinical outcome (pain relief) and secondary outcomes (disability, affective aspect of pain, kinesiophobia, and perception of overall effect) will be collected before treatment and four weeks, three months and six months post randomization. The data will be collected by a blind examiner to the treatment allocation.

NCT ID: NCT03501225 Completed - Clinical Trial Clinical Trials

Effects of Ozonated Water on Pain, Swelling, Trismus and Quality of Life in Third Molar Surgery

Start date: November 8, 2017
Phase: N/A
Study type: Interventional

The aim of this study was to evaluate the effect of ozonated water on pain, edema and trismus after third molar removal. Patients were submitted to extraction of lower third molar under irrigation with ozonated water or doubly distilled water. Data were collected at baseline, 24 hours, 48 hours, 72 hours and 7 days after intervention.

NCT ID: NCT03500185 Completed - Clinical trials for Urinary Incontinence

Effectiveness of Pelvic Floor Muscles Training in Group for Women With Urinary Incontinence

Start date: April 17, 2018
Phase: N/A
Study type: Interventional

The aim of the study is to compare the efficacy of a protocol, pelvic floor muscle training (PFMT), applied in a group and at home for urinary incontinence (UI) in women. Probably, the group-applied PFMT protocol is more effective in women with UI than the home protocol.

NCT ID: NCT03498716 Completed - Clinical trials for Triple Negative Breast Cancer

A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer

IMpassion030
Start date: August 2, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)

NCT ID: NCT03498404 Completed - Clinical trials for Chronic Periodontitis

Evaluation of Antimicrobial Photodynamic Therapy in Multiple Applications as a Coadjuvant in the Surgical Therapy of Access to Scaling

Start date: April 7, 2018
Phase: Phase 4
Study type: Interventional

Chronic periodontitis is an infectious disease resulting in inflammation of the teeth support structures, progressive periodontal attachment loss and bone loss. The aim of this study is to evaluate the effects of antimicrobial photodynamic therapy (TFDA) in multiple applications as an adjunct to surgical periodontal therapy in patients with generalized severe chronic periodontitis. A total of twenty patients will be submitted to this split-mouth trial, receiving initial periodontal basic nonsurgical treatment that is scaling and root planing. After the sites are indicated for surgical therapy, they receive surgical access therapy associated with scaling and root planing and TfdA using the treatment protocol during periods of 0, 7, 14 and 30 postoperative days, or only surgical access therapy associated with scaling and root planing. As protocol, TfdA will be used laser light source 660nm wavelength in combination with phenothiazine, a photosensitizer with 10 seconds of exposure per site during surgery and 60 seconds in other applications. All patients will be oral hygiene care and follow-up for 90 days. In the baseline period, basic post-therapy, 30 and 90 days after surgical therapy will be performed the clinical evaluation of plaque index, depth of probing pocket, level of clinical insertion relative and bleeding on probing, beyond the collection plate samples subgingival 40 for counting microbial species using the method of DNA-DNA hybridization checkerboard. For the same periods are also collected samples of gingival crevicular fluid for evaluating fluid volume (Periotron) and the levels of Interleukin 1 beta, Interleukin 10, MMP-8, tumor necrosis factor alpha, RANK-L and Osteoprotegerin (OPG). The data are statistically analyzed with the tests to the sample.

NCT ID: NCT03496207 Completed - Clinical trials for Pulmonary Arterial Hypertension

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)

PULSAR
Start date: June 13, 2018
Phase: Phase 2
Study type: Interventional

Study A011-09 is designed to assesses the efficacy and safety of sotatercept (ACE-011) relative to placebo in adults with pulmonary arterial hypertension (PAH). Eligible participants will receive study treatment for 24 weeks during the placebo-controlled treatment period, and then will be eligible to enroll into a 30-month extension period during which all participants will receive sotatercept. All treated patients will also undergo a follow-up period after last study drug treatment.

NCT ID: NCT03495882 Completed - Cervical Cancer Clinical Trials

Subjects With Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors (Cervical)

Start date: December 18, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, open-label study of AGEN1884 in combination with AGEN2034 in subjects with locally advanced, recurrent and/or metastatic solid tumors including cervical cancer. AGEN2034 is a novel, fully human monoclonal immunoglobulin G4 (IgG4) antibody, designed to block program cell death-1 (PD-1). AGEN1884 is a novel, fully human monoclonal immunoglobulin G1 (IgG1) antibody, designed to block cytotoxic T-lymphocyte antigen-4 (CTLA-4).

NCT ID: NCT03494400 Completed - Healthy Clinical Trials

Aerobic Training in Treatment for Breast Cancer

ATTBC
Start date: July 1, 2018
Phase: N/A
Study type: Interventional

Introduction. Treatment with hormone therapy reduced the likelihood of tumor recurrence and metastasis in the patient. However, it has adverse effects such as: loss of bone mineral density, increase in body weight, metabolic changes and, consequently, lower quality of life. Physical training has been used as a means of reducing these and other adverse effects, but there is no definite protocol on which training model is effective, especially in patients who only use Tamoxifen or Aromatase Inhibitor as an adjuvant therapy for treatment of breast cancer. Objective: To compare the effect of aerobic training on body composition, metabolic and inflammatory variables, physical activity level, sleep, anxiety, depression, body image, fatigue, strength, flexibility and quality of life of women undergoing breast cancer treatment use Tamoxifen and Aromatase Inhibitor and women without cancer. Method. The sample will be formed by women without cancer and under treatment with hormone therapy being accompanied by the public service for treatment of breast cancer of the city of Presidente Prudente. A 24-week notification in which the face-to-face training group will undergo aerobic training three times a week on interspersed days and the group accompanied at a distance will perform as a preferred activity under a distance supervision of professionals every 14 days of return to attend the UNESP for the adequacy of the analysis and selection of attendance to the proposed activities. Evaluations of the variables of interest at the baseline of the intervention will be performed after 12 weeks and soon after the intervention. The investigators will analyze: biomarkers (TNFα, LDL, HDL, VLDL, as well as in the lipid profile (triglycerides, total cholesterol and LDL fractions ), glycemia, insulin, anthropometric measurements, physical activity level, sleep, pain, anxiety, depression, body image, fatigue, strength, flexibility. Trainings will be performed within the target zone of maximum heart rate. Comparisons between groups at each time point will be performed using Student's T-test for independent samples. The comparisons of the variables of interest at the initial moment and after 12 and 24 weeks will be made through the multivariate analysis, where the group effects, time and interaction of both will be compared. All analyzes will be performed in SPSS software version 24.0 and significance of 5%.

NCT ID: NCT03493854 Completed - Early Breast Cancer Clinical Trials

A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer

FeDeriCa
Start date: June 14, 2018
Phase: Phase 3
Study type: Interventional

This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC) administration in combination with chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant/adjuvant setting.