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NCT ID: NCT03036514 Completed - Pain, Postoperative Clinical Trials

Sublingual Sufentanil Tablet System (SSTS) Versus Intravenous Patient Controlled Analgesia After Back Surgery.

Start date: April 5, 2017
Phase: N/A
Study type: Interventional

In this study, numeric rating scale (NRS) and side effects are measured after usage of a sublingual sufentanil tablet system (SSTS) in comparison to intravenous patient controlled analgesia (PCIA).

NCT ID: NCT03036384 Completed - Pregnant Women Clinical Trials

Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery

Start date: March 2016
Phase: Phase 2
Study type: Interventional

Hyperbaric bupivacaine 0.5% associated with opioids is the local anesthetic the most commonly used for spinal injection in cesarean section. Nevertheless, its use often results in a long duration of motor nerve block and a haemodynamical instability. Recently developped, the Prilocaine, with its new 2% hyperbaric formulation, seems to offer a good alternative for hyperbaric bupivicaine. A first study has determined the ED95 of hyperbaric prilocaine 2% for intrathecal anesthesia in scheduled cesarean delivery. As opioid adjuvants potentiate the effect of the local anesthetics while decreasing their dose-related side effects, the aim of this study is to determine the ED95 of hyperbaric prilocaine 2% with sufentanyl for scheduled cesarean delivery under spinal anesthesia,by using the Continual Reassessment Method (CRM)

NCT ID: NCT03034980 Completed - Clinical trials for Coronary Artery Disease

Influence of Training Intensity in Coronary Artery Disease

Start date: December 20, 2016
Phase: N/A
Study type: Observational

Coronary artery disease (CAD) is associated with high mortality worldwide. Narrowing of the coronary arteries can cause an acute myocardial infarction. Patient with cardiac ischemia are often treated with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Following hospitalisation, the patients are offered to attend a classical rehabilitation program with moderate exercise intensity. Current exercise program for cardiac rehabilitation has proven to reduce cardiovascular risk factors 1. Is it possible to improve the exercise capacity and risk profile even more if the exercise program includes more vigorous training? The program starts one week after the cardiac incident (AMI, PCI or CABG) and takes 12 weeks to complete. Patients with heart failure and valvular disease are excluded. First ventilatory threshold (VT1) and second ventilatory threshold (VT2) are determined during cycloerometry. VT2 reflects aerobic-anaerobic transition and therefore the aerobic functional capacity2. Exercise load reached at VT2 is used to determine the training load during rehabilitation. The research goal is to investigate the influence of training intensity on the exercise capacity and risk profile of CAD patients.

NCT ID: NCT03034148 Completed - Clinical trials for Coronary Artery Disease

Platelet Acetyl Coenzyme A Carboxylase Phosphorylation in Coronary Artery Disease

ACCTHEROMA
Start date: March 2015
Phase: N/A
Study type: Interventional

In human purified platelets, only thrombin, and not the other platelet agonists, leads to a transient activation of the protein kinase activated by AMP (AMPK) and to phosphorylation of its "bona fide" substrate, ACC on its Ser79. ACC phosphorylation (P-ACC) can be an interesting marker of thrombin action on platelets. Indeed platelet and coagulation interplay, though undoubtedly present in atherosclerosis and atherothrombosis, remains difficult to assess. Our group showed that atherosclerotic mice (SRBI/Apolipoprotein E knock-out) had higher platelet P-ACC compared to corresponding control mice (C57BL6). In agreement with these data, preliminary results showed increased platelet P-ACC in a small cohort of patients admitted for coronary angiogram, with demonstrated coronary artery disease (CAD). In the light of our preliminary results, we sought to analyze platelet P-ACC in a large prospective clinical trial (ACCTHEROMA) in patients admitted for coronary angiogram. The aim of the study is to compare platelet P-ACC in platelets of patients with CAD and more particularly in unstable CAD patients to non-CAD patients. This study could potentially identify patients at high risk of future ischemic cardiovascular events, because of a higher level of thrombin generation.

NCT ID: NCT03034070 Completed - Clinical trials for Prostate Adenocarcinoma

Whole-Body 3D T1-weighted MR Imaging Anatomical Sequences: GE mDixon vs FSE (View) Approaches in Prostate Cancer.

TFE-TVE
Start date: December 2016
Phase: N/A
Study type: Interventional

This study will assess and compare the diagnostic performances and image quality of two WB 3D T1-weighted MR imaging sequences for bone and node staging in patients with prostate cancer : the FSE sequence and a gradient echo (GE) sequence. The latter sequence's main feature is its acquisition time of approximately 1.5 minutes, compared to 18 min for the FSE sequence, reducing the exam's acquisition time, patient discomfort and increasing machine availability.

NCT ID: NCT03032588 Completed - Healthy Clinical Trials

A First in Human Study to Assess the Safety, Tolerability and Immunogenicity of a Single Dose of a Trivalent Inactivated Poliovirus Vaccine Based on Sabin Strains (sIPV) Given Intramuscularly in Healthy Adults

Start date: October 9, 2017
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to assess the safety and tolerability of a single dose of JNJ-64152348, inactivated poliovirus vaccine produced from Sabin poliovirus strains on PER.C6 cells (sIPV) in healthy adults, using conventional inactivated poliovirus vaccine produced from Salk poliovirus strains (cIPV) as reference.

NCT ID: NCT03032380 Completed - Clinical trials for Ventilator Associated Pneumonia (VAP)

Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens

APEKS-NP
Start date: October 24, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare all-cause mortality at Day 14 in participants receiving cefiderocol with participants receiving the comparator, meropenem, in adults with hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or healthcare-associated bacterial pneumonia (HCABP) caused by Gram-negative pathogens.

NCT ID: NCT03031782 Completed - Clinical trials for Juvenile Psoriatic Arthritis

Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA)

Start date: May 23, 2017
Phase: Phase 3
Study type: Interventional

This was a double-blind, placebo-controlled, event-driven randomized withdrawal study to investigate the efficacy and safety of secukinumab treatment in the Juvenile Idiopathic Arthritis (JIA) categories of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA). The study was divided into 3 parts (plus a post-treatment follow-up period) consisting of open-label, single-arm active treatment in Treatment Periods 1 and 3 and a randomized, double-blind, placebo controlled, event-driven withdrawal design in Treatment Period 2

NCT ID: NCT03031119 Completed - Healthy Volunteers Clinical Trials

Multiple Ascending Dose and DDI Study

Start date: January 2017
Phase: Phase 1
Study type: Interventional

Part A will investigate the safety, tolerability, PK and PD of PF-06835919 administered for 14 days in a multiple ascending dose design. Part B will assess the effect of PF-06835919 co-administration at low and high doses on the PK of atorvastatin in a single cohort.

NCT ID: NCT03030599 Completed - Clinical trials for Narcolepsy With Cataplexy

A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy

Start date: March 14, 2017
Phase: Phase 3
Study type: Interventional

This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the efficacy and safety of JZP-258.