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NCT ID: NCT03197935 Not yet recruiting - Clinical trials for Triple-negative Breast Cancer

A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer

IMpassion031
Start date: July 31, 2017
Phase: Phase 3
Study type: Interventional

This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) and nab-paclitaxel followed by doxorubicin and cyclophosphamide (nab-pac-AC), or placebo and nab-pac−AC in participants eligible for surgery with initial clinically assessed triple-negative breast cancer (TNBC).

NCT ID: NCT03197701 Recruiting - Lung Function Clinical Trials

Maximal Effort-dependent Respiratory Flow Rates

Start date: September 2015
Phase: N/A
Study type: Observational

The general objective of this project is to determine the best method to measure maximal inspiratory flow rates, to study their reproducibility and create reference equations in healthy subjects.

NCT ID: NCT03197350 Recruiting - Clinical trials for Fibrosis Estimated by cMR Ant Biomarkers

Characterization of Heart Failure With Preserved Ejection Fraction

Start date: January 2015
Phase: N/A
Study type: Interventional

The goals of this research will be to define some of the mechanisms underlying the progression and complications of heart failure (HF) with preserved left ventricular ejection fraction (HFPEF) Aim 1: to evaluate the differences in cardiac structure, function and fibrosis markers through the spectrum of HF stages in order to deepen the understanding of the pathophysiology driving HF progression. Aim 2: to define the mechanisms by which HF risk factors, such as hypertension, diabetes, obesity, and renal insufficiency, interact with age to increase HF risk, and to evaluate the role of precipitating factors such as myocardial ischemia, atrial fibrillation in HFPEF. Aim 3: to determine prognostic factors in HFPEF patients, by following these patients over time. Accordingly the investigators will correlate baseline data (echocardiographic, MRI or biomarkers) with incident cardiovascular events and determine whether these measures provide incremental prognostic information beyond clinical characteristics.

NCT ID: NCT03196596 Recruiting - Clinical trials for Aortic Valve Stenosis

Added Value of Patient-specific Computer Simulation in Transcatheter Aortic Valve Implantation (TAVI)

TAVIguide
Start date: May 23, 2017
Phase: N/A
Study type: Observational

Transcatheter aortic valve implantation is increasingly used to treat patients with severe aortic stenosis who are at increased risk for surgical aortic valve replacement and is projected to be the preferred treatment modality. As patient selection and operator experience have improved, it is hypothesised that device-host interactions will play a more dominant role in outcome. This, in combination with the increasing number of valve types and sizes, confronts the physician with the dilemma to choose the valve that best fits the individual patient. This necessitates the availability of pre-procedural computer simulation that is based upon the integration of the patient-specific anatomy, the physical and (bio)mechanical properties of the valve and recipient anatomy derived from in-vitro experiments. Patient-specific computer simulation may improve outcome of TAVI by proposing the valve size that best fits the individual patient. The aim of this study is to assess the added value of patient-specific computer simulation in valve size selection.

NCT ID: NCT03194425 Not yet recruiting - Overactive Bladder Clinical Trials

Standardization of Lead Placement for Sacral Neuromodulation. Part 1

Start date: August 2017
Phase: N/A
Study type: Interventional

Retrospective case-control study. A substantial number of patients do not respond favourably to sacral neurostimulation (SNS) although clinically, they appear to have the same lower urinary tract dysfunction characteristics as the ones with good responses. This may be due to methodological issues (lead position) or patient selection. The purpose of this study is to improve and standardize lead position, in order to increase the patient response to test stimulation and to SNS treatment, and to decrease adverse events. This study consist out of two parts. In this first part, we will measure the pelvic floor electromyography (EMG) template in 15 patients with overactive bladder (OAB) and 15 patients with urinary retention already on SNM treatment with a >90% improvement ("perfect responders) compared to baseline. Likewise, measurements will be done in 15 OAB patients and 15 urinary retention patients that have <50% response upon sacral neuromodulation ("loss of efficacy"). The pelvic floor EMG will be measured by an intravaginal (women) or intra-anal (men) probe that measures independently left, right, anterior and posterior part. Based upon the differences in EMG activity between perfect-responders and non-responders, the pattern for optimal stimulation will be determined which will be used as template for lead placement in patients that present for test stimulation with the tined lead.

NCT ID: NCT03192969 Not yet recruiting - Clinical trials for Giant Cell Arteritis

A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA)

Start date: July 15, 2017
Phase: Phase 3
Study type: Interventional

To investigate the safety and efficacy of abatacept with steroid treatment in comparison to steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission of Giant Cell Arteritis in adults.

NCT ID: NCT03191799 Not yet recruiting - Hemophilia A Clinical Trials

A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors

STASEY
Start date: July 27, 2017
Phase: Phase 3
Study type: Interventional

This is a phase IIIb, single arm, open-label, multi-center study to evaluate the safety and tolerability of emicizumab in participants with congenital hemophilia A who have documented inhibitors against Factor VIII (FVIII) at enrollment. Approximately 200 participants, aged 12 or older, will be enrolled in this study and are expected to be enrolled at approximately 85 sites globally. Participants will receive an initial weekly dose of prophylactic emicizumab subcutaneously for 4 weeks, followed by a weekly maintenance dose subcutaneously for the remainder of the 2-year treatment period.

NCT ID: NCT03191786 Not yet recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study of Atezolizumab Compared With Chemotherapy in Treatment Naïve Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Containing Therapy

Start date: September 1, 2017
Phase: Phase 3
Study type: Interventional

This Phase III, global, multicenter, open-label, randomized, controlled study will evaluate the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 [anti-PD-L1] antibody) compared with a single agent chemotherapy regimen by investigator choice (vinorelbine or gemcitabine) in treatment-naïve participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are deemed unsuitable for platinum-containing therapy due to poor performance status (Eastern Cooperative Oncology Group [ECOG] performance status of 2-3).

NCT ID: NCT03190096 Recruiting - Clinical trials for Paroxysmal Atrial Fibrillation

Safety and Feasibility of Electrical Isolation of the Superior Vena Cava for Paroxysmal Atrial Fibrillation

SAFE-SVC
Start date: June 7, 2017
Phase: N/A
Study type: Observational

The present study is designed as a observational prospective, multicentre, international. The main aim of this study is to evaluate the safety and feasibility of SVC isolation with the CB in a prospective manner.

NCT ID: NCT03188302 Enrolling by invitation - Healthy Clinical Trials

Evaluation of New Method for Measuring Stool Consistency

Start date: June 2, 2017
Phase: N/A
Study type: Interventional

This study is designed to validate a new direct method for the measurement of stool consistency, using Texture Analyser. Forty healthy subjects are enrolled in this trial for collection of stool samples. Every stool produced during 2 collection periods of approximately 60 hours each is collected and subjected to the measurement of consistency using Texture Analyser. The stool consistency results are compared with the Bristol Stool Form Scale scores for each stool. The relationships of stool consistency with other stool parameters, bowel habit and sleeping habit are also evaluated.