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NCT ID: NCT02350673 Completed - Solid Tumors Clinical Trials

A Study of Intravenous (IV) Cergutuzumab Amunaleukin and Atezolizumab in Combination in Participants With Locally Advanced and/or Metastatic Solid Tumors

Start date: June 29, 2015
Phase: Phase 1
Study type: Interventional

This is an open-label, multi-center, Phase Ib clinical study of cergutuzumab amunaleukin, in combination with atezolizumab, to investigate the safety, pharmacokinetics, and therapeutic activity in participants with locally advanced and/or metastatic carcinoembryonic antigen (CEA)-positive solid tumors, whose disease has progressed on or who are intolerant to the standard of care therapy. Enrolled participants who continue treatment will be treated until loss of clinical benefit, unacceptable toxicities, or withdrawal of consent. The study will include 2 parts: a dose-escalation Part I and a dose expansion Part II. The anticipated treatment period is 24 months for both cergutuzumab amunaleukin and atezolizumab and may be modified if emerging data suggest a benefit.

NCT ID: NCT02350348 Completed - Children Clinical Trials

NEonate-Children sTudy of Anaesthesia pRactice IN Europe Epidemiology of Morbidity and Mortality in Neonatal Anaesthesia

NECTARINE
Start date: March 2016
Phase:
Study type: Observational

To study the 30-day morbidity and mortality after neonatal anaesthesia, and predictive factors that can be responsible for poor outcome.

NCT ID: NCT02350296 Completed - Pain Disorders Clinical Trials

Crossover, Single Dose Randomized, Bioequivalence of Ketoprofen Lysine Salt Immediate Release vs Oral Solution

Start date: November 26, 2014
Phase: Phase 1
Study type: Interventional

Objectives: The objective of the study was to investigate the bioequivalence between two formulations containing ketoprofen lysine salt (KLS) when administered as single oral doses in two consecutive study periods to healthy male and female volunteers under fasting conditions. Primary end-point: to evaluate the bioequivalent rate (Cmax) and extent (AUC0-t) of absorption of ketoprofen after single dose administration of test and reference products. Secondary end-points: - to describe the pharmacokinetic (PK) profile of ketoprofen after single dose administration of test and reference products; - to collect safety and tolerability data after single dose administration of test and reference products.

NCT ID: NCT02349737 Recruiting - Clinical trials for Electromagnetic Interference

Evaluation of Interference Between Bioelectrical Impedance Analysis and Implantable Cardioverter Defibrillators

Start date: October 2014
Phase: N/A
Study type: Observational

Evaluation of electromagnetic interference between Bioelectrical Impedance Analysis (BIA) and implantable cardioverter defibrillators (ICDs).

NCT ID: NCT02348931 Recruiting - Nose Deformity Clinical Trials

Clinical Effect of a Nasal Former in Nasal Deformities

Start date: December 2013
Phase: Phase 3
Study type: Interventional

Investigation of the effect of customized nasal braces in the correction of nasal deformities with and without prior corrective surgery. - Trial with medicinal product

NCT ID: NCT02347657 Completed - Cystic Fibrosis Clinical Trials

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor

Start date: January 2015
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene mutation.

NCT ID: NCT02346968 Completed - Clinical trials for Kidney Transplantation

Evaluation of CAF22 After Renal Transplantation

Start date: October 8, 2014
Phase:
Study type: Observational

Established markers of kidney function, such as creatinine, have considerable limitations in the diagnosis of delayed graft function (DGF) after kidney transplantation (KT). Indeed, creatinine does not accurately reflect minor changes of renal function as its levels change only upon significant fluctuations of the latter. CAF22 is a molecule which arises from the degradation of a larger protein and it is proposed to be a reliable and more sensitive marker of renal function. This study aims to further clarify this issue by measuring blood and urine concentrations of CAF22 and comparing them with creatinine levels before and after KT. The main assumption is that blood CAF22 levels could serve as a more sensitive kidney function biomarker than creatinine post-KT to detect DGF.

NCT ID: NCT02346149 Completed - Hyperglycemia Clinical Trials

Effect of Acute Hyperglycemia on Renal Tissue Oxygenation

Glucox
Start date: June 2015
Phase: Early Phase 1
Study type: Interventional

Diabetes Mellitus (DM) includes several metabolic diseases all characterized by high sugar levels in the blood. Although diabetic nephropathy is widespread, its underlying pathophysiological mechanisms remain poorly understood and, so far, little progress has been made to prevent the development of diabetic nephropathy and to delay kidney functions decline. Increasing amount of data based on animal studies support the pathogenic role of tissue hypoxia in the development and progression of diabetic nephropathy. Blood Oxygenation-Level Dependent Magnetic Resonance Imaging (BOLD-MRI) is increasingly used in research to measure cortical and medullary oxygenation in a non-invasive manner. Interestingly, in two cross-sectional clinical studies, we have recently found a positive correlation between high circulating blood glucose levels and cortical R2* levels in type 2 DM patients. This discovery suggests that an increase in glycemia might acutely decrease renal tissue oxygenation. The goal of this study is to investigate the impact of serum glucose on renal tissue oxygenation in healthy subjects and subjects with glucose intolerance.

NCT ID: NCT02345954 Recruiting - Uterus Prolapse Clinical Trials

Laparoscopic Supracervical Hysterectomy and Sacropexy Versus Hysteropexy Study

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

The purpose of this study is to compare the operative, anatomic functional outcome as well as the subjective outcome of laparoscopic supracervical hysterectomy and sacropexy compared to laparoscopic hysteropexy (conserving the uterus). The investigators expect that both laparoscopic procedures are equal in regards to operation time, complication rate, anatomic and functional outcome as well as subjective outcome.

NCT ID: NCT02345577 Terminated - Clinical trials for Kidney Transplantation

Whole-body Vibration Physiotherapy in Kidney Transplantation

Start date: December 16, 2014
Phase: N/A
Study type: Interventional

Kidney recipients loose significant amounts of muscle mass and skeleton minerals in the early post-transplantation period and suffer from increasing abnormalities of neuromuscular functions. Stochastic whole body vibration (WBV) therapy is a relatively new form of movement physiotherapy that is used for strength training. Various clinical studies have shown that in addition to muscle function, WBV also improved body balance and bone mineral density. To study the impact of stochastic WBV physiotherapy on musculoskeletal parameters after renal transplantation, kidney transplant recipients will be enrolled and undergo WBV. The investigators hypothesize that WBV physiotherapy improves both maximum muscle strength and muscular performance