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NCT ID: NCT02157662 Completed - Atherosclerosis Clinical Trials

GISSI Outliers CAPIRE

CAPIRE
Start date: January 2011
Phase:
Study type: Observational

The risk of developing clinical manifestations of ischemic heart disease is currently assessed by using integrated multifactorial prediction models based on the presence of non-modifiable risk factors, such as age, gender and a family history of early ischemic heart disease along with risk factors which are defined as conventional, such as arterial hypertension, hypercholesterolemia, cigarette smoking and diabetes mellitus. However, if the relationship between risk factors and ischemic heart disease clinical manifestations shows some limitations, the relation between risk factors and the coronary atherosclerosis process underlying most ischemic syndromes seems to be even weaker. In fact there is significant individual variability and the limits of such relationship are demonstrated by a non negligible number of subjects at the outliers of mean behaviour of the prediction model. At one outlier, in the presence of multiple risk factors, these subjects do not develop neither coronary events nor coronary atherosclerosis whereas, at the other, coronary events and disease occur in the absence of risk factors.This study aims at detecting new protection and susceptibility factors, thus enabling to formulate new etiopathogenetic hypotheses concerning coronary atherosclerosis and to identify new therapeutic targets.

NCT ID: NCT02157415 Terminated - Clinical trials for Complications; Catheter, Urinary (Indwelling Catheter) (Suprapubic)

Prospective Cohort Study on Tolerability & Safety of Uro-Tainer® Polihexanide 0.02%

Start date: August 2013
Phase: N/A
Study type: Interventional

It is the first clinical study aimed at assessing the safety and tolerability of UT-P as routine rinsing and bacterial decolonization solution device for urinary catheters. The study will be conducted in hospitalized adult patients who had an urethral or suprapubic catheter in place for longer than two consecutive weeks and who are able to provide written consent. This is an open-label prospective observational cohort study. No comparative control group is planned as no other preventing infection solution is commercially available at this time.

NCT ID: NCT02156804 Completed - Melanoma Clinical Trials

A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)

Start date: October 7, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the rate and frequency of high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select adverse events in subjects with histologically confirmed stage III (unresectable) or stage IV melanoma and progression post prior treatment containing an anti-Cytotoxic T Lymphocyte Antigen (CTLA-4) monoclonal antibody, treated with Nivolumab (BMS-936558) at a dose of 3 mg/kg every two weeks.

NCT ID: NCT02156011 Completed - Clinical trials for Total Knee Arthroplasty

Comprehensive Assessment of the Musculoskeletal System

CAMS-Knee
Start date: June 2014
Phase: N/A
Study type: Observational

The objective of this research is to synchronously assess in vivo loading data of the knee joint, tibio-femoral 3D kinematics by means of automated video-fluoroscopy, whole leg kinematics by means of skin markers, ground reaction forces, as well as muscle activity patterns in 4 to 6 subjects with instrumented total knee arthroplasty (TKA) during dynamic functional activities of daily life. The comprehensive in vivo dataset will provide unique information to evaluate the relationship between the kinematics, respectively the alignment of the TKA, and the resulting loading of the implant in vivo. The whole data package will be made available for download on a public database, such that it can be utilized for the testing and improvement of TKA designs as well as for the validation and improvement of musculoskeletal modelling by researchers around the world.

NCT ID: NCT02155114 Completed - Inflammation Clinical Trials

Iron Homoeostasis in Inflammation

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

The purpose of this study is to survey iron storage levels and their prognostic consequences in the context of acute inflammation. The impact of iron substitution in inflammatory states is controversial. We hypothesize that iron substitution may influence outcome in patients in inflammatory states.

NCT ID: NCT02154425 Completed - Clinical trials for Rheumatoid Arthritis

A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers

CRADLE
Start date: September 2014
Phase: Phase 1
Study type: Interventional

The primary objectives of this study are to assess whether there is transfer of Certolizumab Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing regimen of CZP by evaluating the concentration of CZP in mature breast milk, and to calculate the daily infant dose of maternal CZP.

NCT ID: NCT02154217 Completed - Glaucoma Clinical Trials

Comparison of the Effects of Bimatoprost and a Fixed Combination of Latanoprost and Timolol on 24-hour Blood and Ocular Perfusion Pressures

Start date: n/a
Phase: Phase 3
Study type: Interventional

This is a data revision with a focus on 24 hour perfusion pressures of data from a previous randomized, double masked, multicenter clinical trial. The aim was to compare the effect of bimatoprost and the fixed combination of latanoprost and timolol (LTFC) on 24-hour mean intraocular pressure (IOP) after patients are switched from a nonfixed combination of latanoprost and timolol. The main findings of the original trial had been published on Ophthalmology [2007;114: 2244-2251].

NCT ID: NCT02153697 Completed - Solar Lentigines Clinical Trials

Comparative Study of the Therapy of Solar Lentigines With a Q-switched Rubin Laser Versus a Bleaching Cream

Start date: March 2014
Phase: N/A
Study type: Interventional

Benign pigmented lesions as solar lentigines are a common finding in Caucasian individuals. Their removal may be requested for aesthetic reasons. The goal of the study is comparing the efficacy and tolerance of two different therapy modalities established for treating solar lentigines. The right back of the hand side will be treated with the Q-switched SINON Rubin 694nm Laser, the left back of the hand side with a hydrochinon containing bleaching cream (Pigmanorm® cream). The investigators estimate that a physical therapy with a Q-switched Rubin laser system is more effective in the removal of solar lentigines than a topical chemical therapy with a hydrochinon containing bleaching cream.

NCT ID: NCT02152761 Completed - Clinical trials for Muscle Wasting (Atrophy) After Hip Fracture Surgery

Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery

Start date: September 16, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study was to assess if bimagrumab is safe and effective in patients with muscle wasting (atrophy) after hip fracture surgery.

NCT ID: NCT02151383 Terminated - Acute Heart Failure Clinical Trials

Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure

RELAX-PEDS-PK
Start date: September 5, 2014
Phase: Phase 2
Study type: Interventional

The purpose of the study was to evaluate the safety, tolerability and pharmacokinetics of an intravenous infusion of serelaxin on top of standard of care therapy, in pediatric patients with acute heart failure (AHF)