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NCT ID: NCT02662998 Completed - Clinical trials for Older Cancer Patients

Validation of uHearâ„¢ as a Screening Tool to Detect Hearing Impairment in Older Cancer Patients Within a Comprehensive Geriatric Assessment - BIS

UHEAR-BIS
Start date: January 2016
Phase: N/A
Study type: Observational

The aim of this study is to validate uHearâ„¢, an iOS-based tool, as a screening tool to detect significant hearing impairment as part of a comprehensive geriatric assessment in patients aged 70 years and older. The pass or fail screening cut-off is defined as having two or more consecutive hearing grades starting from the moderate-severe threshold zone ranging from 0.5 - 2.0 kHz.

NCT ID: NCT02662985 Completed - Psoriatic Arthritis Clinical Trials

Study of Power Doppler Ultrasound (PDUS) to Measure Response of Secukinumab Treatment in Patients With Active Psoriatic Arthritis (PsA)

PDUS
Start date: August 22, 2016
Phase: Phase 3
Study type: Interventional

This study was designed to leverage the sensitivity of ultrasonography available in clinical practice setting to better describe the time course of response to secukinumab (150 mg and 300 mg) on joint synovitis and enthesitis in PsA patients with an inadequate response to non-biologic DMARDs. PDUS changes in joint synovitis will be assessed using the global Outcome Measures in Rheumatology (OMERACT)-European League against Rheumatism (EULAR) synovitis score (GLOESS) and changes in joint enthesitis were assessed using the OMERACT enthesitis score.

NCT ID: NCT02662712 Completed - Healthy Clinical Trials

A Study of Orally Administered JNJ-56136379 to Evaluate Safety, Tolerability and Pharmacokinetics After Single Ascending Doses and One Multiple Dose Regimen in Healthy Participants (Part I), and After Multiple Dose Regimens in Participants With Chronic Hepatitis B (Part II)

Start date: December 17, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate pharmacokinetics and safety data including serious and other adverse events, physical examinations, vital signs, 12-lead electrocardiograms (ECGs) and clinical laboratory results (including biochemistry, hematology, and urine).

NCT ID: NCT02662452 Completed - Healthy Clinical Trials

First-in-Human Single and Multiple Dose of GLPG2222

Start date: January 2016
Phase: Phase 1
Study type: Interventional

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG2222 given to healthy subjects, compared to placebo (Part 1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2). Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics) will be characterized. The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222 will be explored as well.

NCT ID: NCT02662322 Completed - Anaesthesia Clinical Trials

Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE)

KTHYPE
Start date: March 10, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to compare three communications during peripheral intravenous catheterization and measure pain patient: one hypnotic, confusion (HYPNOSIS), an other with negative connotation (NOCEBO) and at least with neutral connotation (NEUTRAL).

NCT ID: NCT02662179 Completed - Clinical trials for Elderly Patients With a Solid Tumor

Are the Fried Criteria Predictive of a Functional Decline in Older People With Solid Malignant Tumors?

Start date: November 1, 2015
Phase:
Study type: Observational

Identifying the frail elderly patients or those at risk of becoming frail has become a cornerstone of modern geriatric medicine. Many instruments have been developed to identify fragility at the individual level. The 'Fragile' phenotype defined by Fried is based on 5 criteria: weakness, slowness, low level of activity, exhaustion, and unintentional weight loss. The patient is fragile if it meets at least three out of five criteria. It is 'pre-fragile' if it meets one or two criteria. In onco-geriatrics, the International onco-geriatrics society recommends the implementation of a 'G8 scale' to detect elderly patients at risk of fragility. People with a positive G8 are then referred to the geriatric team to benefit from a comprehensive geriatric assessment. This evaluation is interpreted by the geriatrician, who proposes an action plan to overcome the various problems of the elderly patient. The evaluation can also help the oncologist in the choice of treatment for the patient: palliative care, standard treatment or adapted treatment (No-go, Go-go or slow-go). The investigators would like to assess if fragility as defined by the Fried criteria is predictive of a functional, physical or cognitive decline, or a loss of quality of life in patients treated for a solid malignant tumor. Furthermore, they will assess if the frailness categorization has an impact on the oncologic treatment decision. Does the oncologist switches the patient's oncologic treatment after being informed of the frailness status ?

NCT ID: NCT02661217 Completed - Clinical trials for Heart Failure With Reduced Ejection Fraction

Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event

TRANSITION
Start date: February 12, 2016
Phase: Phase 4
Study type: Interventional

To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an ADHF episode.

NCT ID: NCT02660216 Completed - Jaw Abnormalities Clinical Trials

A Modified Minimally Invasive Approach Towards Le Fort I Osteotomy: a Prospective Study

MILF-I
Start date: November 2014
Phase:
Study type: Observational

Nowadays, maxillary Le Fort I osteotomy is a safe and routinely performed procedure. The conventional approach is characterized by a vestibular incision extending from molar-to-molar, associated with a pterygomaxillary disjunction performed with a curved chisel. Adequate mobilization of the maxilla during Le Fort I osteotomy requires an effective separation of the maxillary tuberosity from the pterygoid plates of the sphenoid bone. However, as initially described by Precious (1991) and later by Hernandez-Alfaro (2013), a true pterygomaxillary osteotomy is not necessary to achieve successful disjunction. Furthermore, Hernandez-Alfaro combined his technique of pterygomaxillary disjunction, the so-called "Twist technique", to a minimally invasive protocol, performing the complete Le Fort I osteotomy through a 20 to 30 mm long horizontal vestibular incision. Although promising, the technique remains highly sensitive from a technical standpoint, and its true accuracy has not been comprehensively evaluated. The purpose of this study is to present and validate a minimally invasive approach towards Le Fort I osteotomy, using a modified pterygomaxillary (PTM) disjunction technique. The primary outcome is to evaluate the accuracy of the technique using rigid voxel-based registration of the 3D virtual treatment planning and the 4 weeks postoperative CBCT images. Secondary outcomes include the surgical time necessary to complete the procedure and the presence of intraoperative and early postoperative complications.

NCT ID: NCT02659735 Completed - Influenza A Virus Clinical Trials

A Study to Assess the Relative Oral Bioavailability of JNJ-63623872 Administered as Oral Concept Formulations Compared to the Current Tablet Formulation

Start date: December 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare the rate and extent of absorption of JNJ-63623872 following administration of a single dose as three different concept formulations with that following administration of the current formulation, under both fed and fasted conditions, in healthy adult participants.

NCT ID: NCT02658825 Completed - Healthy Clinical Trials

A Study to Evaluate the Effect of JNJ-63623872 on Cardiac Repolarization Interval in Healthy Participants

Start date: January 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effect of JNJ-63623872 on the QT/QTc interval at supratherapeutic exposure in healthy participants (Panel 2).