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NCT ID: NCT03066804 Completed - Clinical trials for Heart Failure With Preserved Ejection Fraction

A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients

PARALLAX
Start date: August 22, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the superiority of LCZ696 over individualized medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide (NT-proBNP) and improving exercise capacity and HF symptoms in patients with heart failure with preserved ejection fraction (HFpEF).

NCT ID: NCT03065491 Completed - Clinical trials for Hypercholesterolemia

Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function

Start date: November 15, 2016
Phase: N/A
Study type: Interventional

A large body of evidence confirm the cholesterol lowering effect of red yeast rice, phytosterols and L-tyrosol. Because their mechanisms of action mime the ones of chemical statins and cholesterol absorption inhibitors, it is plausible that their association will provide a more relevant (and safe) LDL cholesterolemia reduction.

NCT ID: NCT03064659 Completed - Respiratory Failure Clinical Trials

Driving Pressure And EFL in Adult Cardiac Surgery

Start date: November 2015
Phase: N/A
Study type: Observational [Patient Registry]

During general anesthesia, functional residual capacity (FRC) is reduced. If the FRC is lower than the minimum volume required to maintain the opening of the airways, there is a derecruitment of the lung parenchyma, leading to the phenomenon of expiratory flow limitation (EFL). The Driving Pressure (DP) is the difference between the plateau pressure (Pplateau) and the Positive End-Expiratory Pressure (PEEP), and estimates the lung strain. The incidence of EFL and the importance of DP are not known in adult cardiac surgery, so it's necessary a study to assess both. The primary end-point of the study is to evaluate the correlation of DP and EFL with PPCs in adult cardiac surgery. The secondary end-point of the study is to evaluate: the mechanical ventilation time, the length of ICU and hospital stay, the rehospitalization and mortality. It will be a prospective, observational, non-pharmacological study. It will enroll 200 patients undergoing elective adult cardiac surgery.

NCT ID: NCT03063762 Completed - Clinical trials for Renal Cell Carcinoma

Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6874281 as a Combination Therapy in Participants With Unresectable Advanced and/or Metastatic Renal Cell Carcinoma (RCC)

Start date: March 20, 2017
Phase: Phase 1
Study type: Interventional

This is an open-label, multi-center, randomized, Phase 1b, adaptive, clinical study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic activity of RO6874281 in combination with atezolizumab with/without bevacizumab in participants with unresectable advanced and/or metastatic RCC. The study will consist of a dose-escalation part and an extension part.

NCT ID: NCT03062943 Completed - Clinical trials for Lymphangioleiomyomatosis

A Study of Nintedanib for LymphAngioleioMyomatosis (LAM)

LAM
Start date: December 6, 2016
Phase: Phase 2
Study type: Interventional

This trial is conducted locally. The aim of this trial is assess the efficacy and a favorable benefit-risk ratio for nintedanib in the treatment of LAM at the dose of 150 mg bid

NCT ID: NCT03062046 Completed - Clinical trials for Paroxysmal Atrial Fibrillation

Evaluation of Ablation Index and VISITAG™ (ABI-173)

VISTAX
Start date: January 27, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the safety, acute and long term effectiveness, during standard RF ablation procedures while using Ablation Index and VISITAG™ software in combination with a Thermocool SmartTouch® (ST) or SmartTouch Surroundflow® (STSF) catheter. Furthermore, the role of Ablation Index and VISITAG™ workflow in creating contiguous ablation lines is assessed. The study is a prospective, non-randomized, post-market clinical evaluation. Up to 330 patients will be included in this study. All patients who qualify based on the study specific requirements will be invited to participate. The total duration of the study is estimated to be about 24 months (12 months enrollment period and 12 months of follow up). The clinical investigation population include subjects undergoing RF ablation for treatment of drug resistant symptomatic paroxysmal AF. Prior to enrollment in the clinical investigation, all subjects must meet the inclusion/exclusion criteria and are suitable candidates for enrollment in a clinical investigation in the opinion of the investigator. Subjects must have failed at least one antiarrhythmic drug (AAD) (Type I or III, including β-blocker) as evidenced by recurrent or are intolerant of the AAD.

NCT ID: NCT03061812 Completed - Clinical trials for Small Cell Lung Cancer

Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)

TAHOE
Start date: April 11, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this randomized, open-label, 2-arm, phase 3 study is to assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic SCLC with high levels of DLL3, who have first disease progression during or following front-line platinum-based chemotherapy.

NCT ID: NCT03060746 Completed - Weight Loss Clinical Trials

Helicobacter Pylori Sample Collection Protocol Pre Therapy Subjects

Start date: February 14, 2017
Phase:
Study type: Observational

The primary objective is to obtain stool samples from pre-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.

NCT ID: NCT03060733 Completed - Weight Loss Clinical Trials

Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects

Start date: February 14, 2017
Phase:
Study type: Observational

The primary objective is to obtain stool samples from post-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.

NCT ID: NCT03059823 Completed - Clinical trials for Metastatic Solid Tumors

A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors

Start date: November 15, 2016
Phase: Phase 1
Study type: Interventional

The primary goal of this Phase 1 study is to characterize the safety and tolerability of INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on either every two week or every four week schedules of administration among patients with solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of INCMGA00012 will also be assessed. The purpose of Amendment 5 is to obtain additional safety experience at the newly defined recommended Phase 2 dose of 500 mg every 4 weeks in patients with endometrial cancer, specifically either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Additionally, every 3 week (Q3W) flat-dosing will be studied in an additional tumor agnostic cohort.