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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

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: NCT03197467 Not yet recruiting - Clinical trials for Non-small Cell Lung Cancer (NSCLC)

Neoadjuvant Anti PD-1 Immunotherapy in Resectable Non-small Cell Lung Cancer

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

NEOMUN is designed as an open-label, single arm, prospective, monocenter, phase II study of pembrolizumab in a neoadjuvant setting in patients with non-small cell lung cancer of Stage II/IIIA suitable for curative intent surgery.

NCT ID: NCT03196960 Recruiting - Critical Illness Clinical Trials

Effects of Mobility Dose in Surgical Intensive Care Unit Patients

Start date: May 22, 2017
Phase: N/A
Study type: Observational

The primary aim of this study is to assess if the mobility dose that patients receive in the surgical intensive care unit (SICU) predicts adverse discharge disposition (primary endpoint), and muscle wasting diagnosed by bedside ultrasound (secondary endpoint).

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

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

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: NCT03196115 Recruiting - Clinical trials for Hyaline Membrane Disease

BioHFS - Biomarker for Hyaline Fibromatosis Syndrome

Start date: June 20, 2017
Phase: N/A
Study type: Observational

Development of a new MS-based biomarker for the early and sensitive diagnosis of Hyaline fibromatosis syndrome from plasma

NCT ID: NCT03196050 Recruiting - Cancer Clinical Trials

Telemonitoring of Geriatric Cancer Patients Using Handheld Devices

Start date: November 2016
Phase: N/A
Study type: Interventional

Cancer is becoming a chronic disease, with the requirement of a lifelong intake of cancer-controlling drugs. While young(er) patients may cope with this, geriatric cancer patients may require a more customized and tailored follow up. Most elderly patients have multiple other diseases ("comorbidities") and, due to many other factors, may per se not tolerate or simply not follow anticancer therapies. This may not only impair quality of life (QoL), but on the long rung also the therapeutic outcome (survival). Handheld devices provide a new reporting/communication tool for patients and health care providers. TeleGraPH will assess if these devices are a suitable communication modality in a cohort of geriatric cancer patients.

NCT ID: NCT03195660 Not yet recruiting - Sleep Apnea Clinical Trials

Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study

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

This study is designed to demonstrate feasibility of study conduct and that acceptable adherence to adaptive servo-ventilation (ASV) therapy can be achieved in recently hospitalized HFpEF patients with moderate to severe sleep apnea. All subjects meeting the criteria will receive ASV therapy.

NCT ID: NCT03195387 Not yet recruiting - Malaria,Falciparum Clinical Trials

Chemoprotective Activity of MMV390048 in PfSPZ Challenge Model

Start date: January 2018
Phase: Phase 1
Study type: Interventional

This study follows a First-In-Human dose-escalation study of MMV390048 (5 to 120 mg MMV390048 powder-in-bottle formulation), a formulation bioavailability study to establish suitable tablet formulation, and a two-part dose-escalation (40 to 120 mg of MMV390048) / induced blood stage malaria (ISBM) challenge study with the new tablet formulation. After identification of the predicted efficacious MMV390048 plasma concentrations in the IBSM model, the current study will evaluate the chemoprotective efficacy of MMV390048 in a standardised and validated controlled human malaria infection (CHMI) model using direct venous inoculation (DVI) of aseptic, purified, cryopreserved, vialed P. falciparum sporozoites (PfSPZ Challenge). Three sequential cohorts of healthy men and women of non-childbearing potential (WONCBP) will be administered the investigational medicinal product (IMP, i.e. MMV390048) under different conditions. This may identify preventative regimens, to be further investigated in a Phase II program. In the first two cohorts, protective administration of the IMP will occur 1 and 7 days before DVI of PfSPZ challenge. The timing of IMP administration and dosage in the last cohort will be determined on the basis of emerging data from the preceding cohorts, but will not exceed 28 days prior to the challenge nor 120 mg MMV390048.

NCT ID: NCT03195088 Not yet recruiting - Healthy Clinical Trials

Evaluation of Safety and Tolerability of Single Rising Doses of BI 473494 in Healthy Subjects

Start date: July 7, 2017
Phase: Phase 1
Study type: Interventional

The primary objective of this trial is to investigate the safety and tolerability of single rising doses of BI 473494 in healthy male subjects. The secondary objective is the exploration of PK including dose proportionality, and PD of BI 473494 after single dosing.

NCT ID: NCT03194503 Not yet recruiting - Clinical trials for Intubation Complication

Tracheal Intubation Coaching in NICUs

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

The purpose of the study is to determine the efficacy of video coaching training for neonatology attending providers on tracheal intubation procedural outcomes in neonatal ICUs.