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NCT ID: NCT02549170 Completed - Clinical trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Start date: December 15, 2015
Phase: Phase 3
Study type: Interventional

The aim of this study is to learn more about the following treatment options in adults with CIDP: - Subcutaneous self-infusion with HyQvia. - Intravenous infusion with Gammagard/Kiovig. Gammagard and Kiovig are the brand names for the same immunoglobulin compound. The study is in two parts. In Part 1, participants receive either HyQvia or a placebo subcutaneously. In Part 2 (only for participants who have a CIPD relapse during Part 1), participants will receive Gammagard Liquid/Kiovig intravenously. US participants will receive Gamunex-C. The first SC infusion will be given in the study clinic. The remaining SC infusions may be given in the study clinic or the participant's home. This will be decided by the study doctor and whether the participant or their caregiver can do the self-infusion.

NCT ID: NCT02549092 Completed - Clinical trials for Advanced Parkinson's Disease

A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)

Start date: October 26, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to examine the effect of LCIG relative to that of OMT on NMS associated with PD.

NCT ID: NCT02549001 Completed - Onychomycosis Clinical Trials

Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Toenail Onychomycosis

Start date: August 20, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether P-3058 nail solution is a safe and effective treatment for onychomycosis.

NCT ID: NCT02548780 Completed - Clinical trials for Hepatocellular Carcinoma

LifePearl-Doxo Pharmacokinetic (PK) Study

Start date: April 2016
Phase: N/A
Study type: Interventional

The primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and efficacy of LifePearl™ microspheres loaded with Doxorubicin in the treatment of unresectable HCC.

NCT ID: NCT02545049 Completed - Clinical trials for Diabetic Kidney Disease

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

FIGARO-DKD
Start date: September 17, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.

NCT ID: NCT02544165 Completed - Clinical trials for Hemodynamic Instability

Non Invasive Measurement of the Haemodynamic Parameters and of the Advanced Glycation End Products (AGEs) Levels

NONINVASHEMO
Start date: November 2012
Phase: N/A
Study type: Interventional

The aim of this study was to investigate the difference in accumulation of AGEs (advanced glycation end-products) in the tissues of individuals who smoke in comparison with individuals who do not as well as of individuals who consume caffeine versus those who do not, and finally to examine the probable differences concerning participants' haemodynamic parameters.

NCT ID: NCT02543684 Completed - Clinical trials for Diabetes Mellitus, Type 2

Post-prandial Glucose and Insulin Levels in Type 2 Diabetes Mellitus Patients After Consumption of Ready-to-eat Mixed Meals

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

The aim of the current study was to compare the effects of three ready-to-eat mixed meals, with a high fiber content and low glycemic index, on postprandial glycemic and insulinemic response in patients with Type 2 diabetes mellitus (T2DM).

NCT ID: NCT02543671 Completed - Hypovitaminosis D Clinical Trials

Investigation of Vitamin D3 Enriched, Reduced-fat Yellow Cheese Efficacy to Prevent Vitamin D Deficiency

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

The primary aim of the current study was to investigate whether the consumption of vitamin D3 enriched, reduced-fat yellow cheese can counterbalance the expected decrease in serum 25-hydroxyvitamin D concentration during winter in postmenopausal women in Greece, and in what degree it can contribute as a potential food-based strategy for the prevention of vitamin D deficiency. A secondary aim was also to investigate any potential effect of the intervention in several quality of life (QoL) indices in the population of postmenopausal women under study.

NCT ID: NCT02543476 Completed - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

SUPREME-HN A Retrospective Cohort Study of PD-L1 in Recurrent and Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)

SUPREME-HN
Start date: September 16, 2015
Phase: N/A
Study type: Observational

This is a retrospective international, multi-center, non-interventional cohort study based on use of data derived from established medical records and secondary analysis of archival tumor samples. The study will collect data on patient and tumor characteristics, PD-L1 status, patterns of treatment, and clinical outcomes, in up to 600 adult patients with recurrent/metastatic SCCHN. SCCHN of interest for this study are defined as the diseases falling into specific ICD-10 or International Classification of Diseases, Ninth Revision (ICD-9) codes (Table 1), depending on anatomical sub-site of the primary tumor. For patient selection, the date of diagnosis of recurrent/metastatic disease will be used as the index date. The patient selection period extends from the 1st March 2011 to the 30th June 2015. This allows for the inclusion of patients with tumor samples of approximately ≤ 5 years age, and ensures approximately 10 months follow-up for living patients recruited at last day of the enrollment window. All patients with a diagnosis of recurrent/metastatic SCC of the oral cavity (tongue, gum, floor of mouth, and other/unspecified part of the mouth), oropharynx, hypopharynx, or larynx during that period will be considered for inclusion in the study (Figure 1). Patients will be identified and followed up through their medical records until death or end of data collection in approximately 20 centers in the US, Asia and Europe. Patients' demographic, clinical characteristics, and medical history will be described. Clinical outcomes including PFS, best response, duration of response, and ORR will be described for the first line and second line of therapy (if any), and OS will be collected A mandatory archived tumor samples will be used to determine PD-L1 status. If a patient has more than one suitable tissue sample, the most recent sample will be used as the mandatory tissue sample. Where available, additional tumor samples obtained at any other time points of the disease will be also collected (optional). The enrolment target is up to 600 patients. Statistical analyses will be performed for the whole cohort, per PD-L1 status and for predefined subgroups.

NCT ID: NCT02541942 Completed - Clinical trials for Congenital Bleeding Disorder

Pharmacogenetic Testing of Saliva Samples From Patients With Five or More Exposure Days to rFVIIa Analogue in the Adept™2 Trial

Start date: April 3, 2015
Phase: Phase 2
Study type: Interventional

This study is conducted globally. This study describes pharmacogenetic testing of saliva samples from patients who participated in the NN1731-3562 trial (adept™2) (NCT01392547). The objective is to determine the HLA (human leukocyte antigen) type and polymorphisms in the FVII gene in patients previously exposed to rFVIIa analogue.