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NCT ID: NCT02597933 Completed - Clinical trials for Scleroderma, Systemic

A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis

Start date: November 12, 2015
Phase: Phase 3
Study type: Interventional

Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.

NCT ID: NCT02586259 Completed - Ulcerative Colitis Clinical Trials

Effectiveness of Cortiment® in Patients With Ulcerative Colitis

CORE Practice
Start date: December 2015
Phase:
Study type: Observational

The purpose of this study is to evaluate Cortiment® with regard to its use by clinicians in routine clinical practice and its effectiveness and tolerability in a real-life setting.

NCT ID: NCT02580591 Completed - Clinical trials for Diabetes Mellitus, Type 1

Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)

Start date: December 22, 2015
Phase: Phase 3
Study type: Interventional

The study will investigate the efficacy, safety, tolerability and Pharmacokinetic(PK) of 3 doses of empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes mellitus as adjunctive therapy to insulin

NCT ID: NCT02580058 Completed - Ovarian Cancer Clinical Trials

A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)

Start date: December 21, 2015
Phase: Phase 3
Study type: Interventional

A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.

NCT ID: NCT02576574 Completed - Clinical trials for First Line Non-Small Cell Lung Cancer

Avelumab in First-line NSCLC (JAVELIN Lung 100)

Start date: October 29, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) participants with Programmed death ligand 1+ (PD-L1+) tumors.

NCT ID: NCT02573324 Completed - Glioblastoma Clinical Trials

A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification

Intellance1
Start date: January 4, 2015
Phase: Phase 3
Study type: Interventional

This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification. In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.

NCT ID: NCT02571777 Completed - Asthma Clinical Trials

Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma

Start date: December 8, 2015
Phase: Phase 3
Study type: Interventional

The purpose of the trial was to evaluate the efficacy and safety of two different doses of QVM149 (QVM149 150/50/80 μg and QVM149 150/50/160 μg via Concept1) over two respective QMF149 doses (QMF149 150/160 μg and QMF149 150/320) μg via Concept1 in poorly controlled asthmatics as determined by pulmonary function testing and effects on asthma control.

NCT ID: NCT02570685 Completed - Happiness Clinical Trials

Psychosocial Benefits of Gratitude Journals

Start date: October 2015
Phase: N/A
Study type: Interventional

This randomized controlled study will examine the effects of different interpersonal gratitude journals compared to a neutral control journal on psycho social outcomes.

NCT ID: NCT02570048 Completed - Tinnitus Clinical Trials

1 Tinnitus Alleviation Via Sensory Substitution

Start date: June 2012
Phase: N/A
Study type: Observational

This is a novel experimental device 'MuteButton' can affect the awareness of tinnitus. Sound that arrives at the ears naturally will be presented in the form of touch patterns on the tongue. By learning to associate the sounds in the ears with the sound patterns on the tongue, investigators aim to demonstrate that the brain will learn to discriminate the real sounds from legitimate external sounds from the imaginary tinnitus sounds that are created inside the brain. Tinnitus is an audiological condition most commonly described as 'ringing in the ears' that affects an estimated 40 million people globally (American Tinnitus Association; Royal National Institute for Deaf). More accurately, tinnitus is the perception of illusory sound that has no legitimate external source and normally arises from a small number of underlying neuropathologies. There are broadly two categories of tinnitus Somatic Tinnitus and Hearing Loss Related Tinnitus. MuteButton is indicated for the treatment of permanent intractable subjective tinnitus. The study is intended to show the efficacy of MuteButton treatment in alleviating tinnitus. The objective of the study will be to determine the impact of acoustic and tactile multi-modal neuromodulation on symptoms of permanent intractable tinnitus as measured by objective and subjective measures including Minimum Masking Level (MML), Tinnitus Loudness Masking (Tinnitus Loudness Masking), Tinnitus Handicap Inventory (THI) and Visual Analogue Scale (VAS).

NCT ID: NCT02568722 Completed - Acute Kidney Injury Clinical Trials

Standard vs. Accelerated Initiation of RRT in Acute Kidney Injury (STARRT-AKI: Principal Trial)

Start date: October 2015
Phase: N/A
Study type: Interventional

The objectives of this trial are to determine whether, in critically ill patients with severe acute kidney injury (AKI), randomization to accelerated initiation of renal replacement therapy (RRT), compared to standard initiation, leads to: 1. Improved survival (primary outcome); and 2. Recovery of kidney function (principal secondary outcome), defined as independence from RRT at 90 days