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NCT ID: NCT03726879 Completed - Breast Cancer Clinical Trials

A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer

IMpassion050
Start date: January 11, 2019
Phase: Phase 3
Study type: Interventional

This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab compared with placebo when given in combination with neoadjuvant dose-dense anthracycline (doxorubicin) + cyclophosphamide followed by paclitaxel + trastuzumab + pertuzumab (ddAC-PacHP) in patients with early HER2-positive breast cancer (T2-4, N1-3, M0).

NCT ID: NCT03726060 Completed - Clinical trials for Temporomandibular Disorder

Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders

Start date: October 31, 2018
Phase: N/A
Study type: Interventional

The aim of study is evaluate the effectiveness of physical therapy in of the treatment myogenic temporomandibular disorders. They will enrolled 100 patient which will be divided into two groups. The primary objective is evaluate the effectiveness of physiotherapy on pain (measured with the Visual Analogic Scale - VAS scale). The second objective is evaluate mandibular motion (by measuring the range of motion - ROM) and investigate the presence of psychosocial factors (using the Anxiety and Depression Scale - HADS questionnaire).

NCT ID: NCT03725657 Completed - Exercise Clinical Trials

Correlation Between Exercise and Insulin Dose in a Camp for Pediatric Type 1 Patients

inCamp
Start date: October 29, 2018
Phase:
Study type: Observational

Intense exercise is a major challenge to the management of type 1 diabetes. The management is even more difficult, during a camp, probably due to increased hypoglycemia maybe from increase of intensity of physical activity. The investigators want to evaluate steps, energy expenditure, sleep time and glycemic control and insulin dosage, through use of a wrist accelerometer, in pediatric type 1 patients attending a camp. Finding a correlation between these parameters could be useful not only for educational purposes but also in the development of algorithms for artificial pancreas.

NCT ID: NCT03725410 Completed - Clinical trials for Vulvovaginal Atrophy

Multi-polar RF and PEMF for Treatment of Symptoms Associated With Vulvovaginal Atrophy

Start date: September 25, 2018
Phase: N/A
Study type: Interventional

This is a multicenter, single-blind, randomized, sham-controlled study utilizing the Venus Fiore™ (MP)2, a table-top device designed to deliver multi-polar RF energy and pulsed electromagnetic fields for use in dermatological and general surgical procedures to temporarily improve blood circulation and to induce modification of collagen structure, neocollagenesis and angiogenesis for the treatment of symptoms associated with vulvovaginal atrophy.

NCT ID: NCT03724864 Completed - Dental Caries Clinical Trials

Edulcorants Effect in Caries Risk Schoolchildren

STEVIA
Start date: February 1, 2017
Phase: N/A
Study type: Interventional

This double-blind RCT aimed to evaluate the effect of sugar-free snacks on caries risk in 6-9 years-old schoolchildren. Considering a 20% difference among groups, the number of subjects needed per group was set in 87. Two-hundred-seventy-one children at risk for caries measured through Cariogram were selected and randomly assigned to three groups consuming twice a day snacks containing Stevia or Maltitol or sugar for 42 days. Parents filled out a standardized questionnaire regarding personal, medical and oral behavioural information. Bleeding on probing, plaque pH and cariogenic microflora were assessed at baseline (t0), after 21 (t1) and 42 days of snacks' use (t2) and 120 days after the end of use (t3). Cariogram was also repeated at t2.

NCT ID: NCT03724812 Completed - Clinical trials for Symptomatic Severe Aortic Stenosis

FlexNav EU CE Mark Study

Start date: February 26, 2019
Phase: N/A
Study type: Interventional

The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic stenosis patients who are considered of high or extreme risk for surgical aortic valve replacement. Data from the study will be used to support CE Mark of the FlexNav™ Delivery System and Loading System in Europe.

NCT ID: NCT03723538 Completed - Clinical trials for Postoperative Sedation

Dexmedetomidine Use for Sedation in Patients Submitted to Tracheal Surgery

Start date: February 1, 2018
Phase:
Study type: Observational

Patients undergoing tracheal resection and reconstruction surgery are enrolled in this prospective observational pilot study to evaluate dexmedetomidine-based sedation after tracheal surgery in an Intensive Care Unit (ICU). Patients remain electively intubated with an uncuffed nasal endotracheal tube, awake and exhibit spontaneous breathing The neck was maintained in flexion through chin-to-chest sutures. Infusion of dexmedetomidine was started from a dosage of 0.7 μg kg-1 h-1 followed by dose titration to the target level of the sedation Richmond Agitation Sedation Scale, (RASS) score -1/-2 using a dose range of 0.2-1.4 μg kg-1 h-1.

NCT ID: NCT03723512 Completed - C3 Glomerulopathy Clinical Trials

Non-contrast Enhanced MRI in Patients With C3 Glomerulopathy (C3G) or Immune-complex Membranoproliferative Glomerulonephritis (IC-MPGN) Enrolled in the ACH471-205 Study

Start date: December 6, 2018
Phase: N/A
Study type: Interventional

Functional and quantitative renal magnetic resonance imaging (MRI) has seen a number of recent advances, and techniques are now available that can generate quantitative imaging biomarkers with the potential to improve the management of kidney disease. However, there are knowledge gaps that must be addressed before renal MRI methods could be more widely adopted in clinical research and ultimately be transferred to clinical practice, including the biological basis of different MRI biomarkers, and how the application of these biomarkers will improve patient care. Among renal MRI techniques, renal diffusion weighted MRI (DWI) has been increasingly used in the last decade, showing high potential as a surrogate and monitoring biomarker for interstitial fibrosis in chronic kidney disease (CKD), as well as a surrogate biomarker for the inflammation in acute kidney diseases that may impact patient selection for renal biopsy in acute graft rejection. Within the ready-to-start ACH471-205 clinical trial, an Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) treated with ACH-0144471, aimed at evaluating the efficacy of 12 months of oral ACH-0144471 in patients with C3G or IC-MPGN, patients will undergo baseline and 12-month follow-up renal biopsies, and renal function will be assessed over time by estimated or measured (when available) glomerular filtration rate (GFR). Adding multi-parametric NCE-MRI to the examinations under the ACH471-205 study protocol will give the opportunity to elucidate, in a well-defined cohort of patients, the potential of NCE-MRI as biomarker of renal microstructure and functional change.

NCT ID: NCT03723265 Completed - Heart Failure Clinical Trials

Personalized CRT - PSR

Start date: January 2012
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to evaluate the cardiac resynchronization therapy (CRT) response in a real-world patient population and evaluate options to address non-response and patient management.

NCT ID: NCT03721653 Completed - Clinical trials for Metastatic Colorectal Cancer

FOLFOXIRI + Bev + Atezo vs FOLFOXIRI + Bev as First-line Treatment of Unresectable Metastatic Colorectal Cancer Patients

AtezoTRIBE
Start date: November 30, 2018
Phase: Phase 2
Study type: Interventional

The scope of this study is to evaluate the efficacy of the addition of atezolizumab to FOLFOXIRI plus bevacizumab as first line treatment of patients with metastatic colorectal cancer in terms of Progression Free Survival.