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NCT ID: NCT02776072 Completed - Multiple Sclerosis Clinical Trials

Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis (RRMS)

EFFECT
Start date: May 2016
Phase: N/A
Study type: Observational

The primary objective of the study is to evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with dimethyl fumarate (DMF). Secondary objectives of the study are: To evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with DMF, glatiramer acetate (GA), teriflunomide, or fingolimod both in the overall participant cohort and in a subset of participants who were naïve to disease-modifying therapy (DMT) and were diagnosed with multiple sclerosis (MS) within 3 years of starting the index therapy; To compare relapse activity, defined as annualized relapse rate (ARR), among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare MS-related hospitalizations among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare intravenous corticosteroid use among participants treated with DMF, GA, teriflunomide, or fingolimod.

NCT ID: NCT02773108 Completed - Schizophrenia Clinical Trials

Somatic Comorbidities in Psychiatric Patients

SCPP
Start date: May 2016
Phase:
Study type: Observational

Prevalence of somatic comorbidities in psychiatric patients hospitalized in Psychiatric hospital or treated ambulatory or in daily hospital. Comparison of prevalence of somatic comorbidities in psychiatric patients population and the general Croatian population.

NCT ID: NCT02764489 Completed - Clinical trials for Hemophilia A or B With Inhibitors

FEIBA Reconstitution Volume Reduction and Faster Infusion Study (FEIBA STAR)

Start date: February 12, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to: - 1. To evaluate the tolerability and safety of infusing reduced volume Factor Eight Inhibitor Bypassing Activity (FEIBA) at the standard infusion rate of 2 U/kg/min - 2. To evaluate the tolerability and safety of infusing reduced volume FEIBA at increased rates of 4 and 10 U/kg/min, in comparison to the standard rate of 2 U/kg/min at the regular volume

NCT ID: NCT02761252 Completed - Asthma Clinical Trials

Efficacy of Co-administration of Bilastine and Montelukast in Patients With SARC and Asthma

SKY
Start date: April 13, 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare concomitant administration of Montelukast and Bilastine to Montelukast and Bilastine monotherapies in patients with SARC and asthma

NCT ID: NCT02753946 Completed - Clinical trials for Acute Pyelonephritis

Safety and Efficacy of ZTI-01 (IV Fosfomycin) vs Piperacillin/Tazobactam for Treatment cUTI/AP Infections

ZEUS
Start date: April 2016
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to demonstrate the safety and efficacy of ZTI-01 (IV fosfomycin) as non-inferior to piperacillin/tazobactam in overall success (clinical cure and microbiologic eradication) for the treatment of hospitalized patients with complicated urinary tract infections (cUTI) or acute pyelonephritis (AP).

NCT ID: NCT02751931 Completed - Clinical trials for Neurogenic Detrusor Overactivity

Open-label Phase 3 Study With Mirabegron in Children From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity

Crocodile
Start date: June 17, 2016
Phase: Phase 3
Study type: Interventional

The objective of the study was to evaluate the efficacy, safety, tolerability and pharmacokinetics of mirabegron after multiple-dose administration in the pediatric population.

NCT ID: NCT02740218 Completed - Psoriasis Clinical Trials

A Study of Real-World Experience of Psoriasis Patients Treated With Apremilast in Clinical Dermatology Practice

APPRECIATE
Start date: June 30, 2016
Phase:
Study type: Observational

This is a retrospective, multi-center observational cohort study. This study will be implemented first in Germany (approximately 50 sites), the United Kingdom (approximately 20 sites) and Sweden (approximately 25 sites), followed by a selected number of countries in Europe, depending on apremilast local availability. The design of this apremilast retrospective study aims to provide clinical information regarding the treatment initiation and outcomes in psoriasis patients when prescribed apremilast in real world settings. In addition, this study is aiming at capturing physicians' and patients' treatment goals when initiating apremilast and whether these goals are achieved following apremilast use. This study is primarily descriptive in nature, and no a priori hypotheses are specified. Patients must voluntarily sign an informed consent form, be 18 or over, have been diagnosed with plaque psoriasis and have been treated with apremilast during the previous 5-7 months to participate in this study. They must not be involved in any other clinical study involving apremilast.

NCT ID: NCT02738151 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist

BRIGHT
Start date: May 19, 2016
Phase: Phase 4
Study type: Interventional

Primary Objective: To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated hemoglobin (HbA1c) change from Baseline to Week 24. Secondary Objectives: Change From Baseline in HbA1c to Week 12 To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® at week 12 and week 24 on: - Change in Fasting plasma glucose (FPG); - Change in Fasting self-monitored plasma glucose (SMPG) and 4-point SMPG and 8-point SMPG profile; - Percentage of participants reaching HbA1c targets <7% or ≤6.5%; - Percentage of participants reaching HbA1c targets <7% or ≤6.5% without severe and/or confirmed hypoglycemia - Frequency of occurrence and diurnal distribution of hypoglycemia by American Diabetes Association (ADA) category of hypoglycemia. To assess the safety in each treatment group. To assess the treatment effects in each treatment group on Patient Reported Outcomes (PRO). Percentage of participants requiring rescue therapy.

NCT ID: NCT02732145 Completed - Vulvodynia Clinical Trials

Diagnostic Accuracy of "Three Rings Vulvoscopy" for Detection of Vulvar Dermatosis

DATRIV
Start date: December 2011
Phase: N/A
Study type: Interventional

The objective of the study was to determine sensitivity, specificity and diagnostic accuracy of "Three Rings Vulvoscopy" for detection of vulvar dermatosis using histopathology as the reference standard.

NCT ID: NCT02714595 Completed - Sepsis Clinical Trials

Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens

CREDIBLE - CR
Start date: September 7, 2016
Phase: Phase 3
Study type: Interventional

This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.