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NCT ID: NCT02565576 Completed - Clinical trials for Myasthenia Gravis, Generalized

Safety,Tolerability,Pharmacokinetics and Efficacy of CFZ533 in Moderate to Severe Myasthenia Gravis

Start date: September 29, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics/pharmacodynamics and efficacy of CFZ533 as an add-on therapy to standard of care in patients with moderate to severe myasthenia gravis (MG).

NCT ID: NCT02563353 Completed - Osteoporosis Clinical Trials

PTH and Vibration in OSteoporosis Study

PaVOS
Start date: November 2015
Phase: N/A
Study type: Interventional

Objective: This is a randomized controlled trial (RCT) in osteoporosis patients randomized to standard parathyroid hormone (PTH) treatment alone or to standard PTH treatment and Whole-body vibration (WBV). PTH is an effective but expensive anabolic treatment for osteoporosis. WBV stimulates muscles and bones. A combined treatment might have synergistic or additive beneficial effects on bone, reducing fracture risk making treatment more effective and cost-effective. A beneficial effect on muscles and thereby falls risk of WBV may improve fracture risk even further. If the results of this pilot study are promising then a strong case can be made for a large multi-centre RCT using strong endpoints including fractures and falls.

NCT ID: NCT02561533 Completed - Clinical trials for Papillary Thyroid Carcinoma

Detection of BRAF Mutation on FNAB From Papillary Thyroid Carcinoma

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

Immunohistochemical detection of the BRAF-V600E mutation on pre-operative fine needle aspiration biopsy (FNAB) from patients suspected for papillary thyroid carcinoma, using the mutation specific antibody VE1.

NCT ID: NCT02560337 Completed - Ovarian Cancer Clinical Trials

Cabazitaxel in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy.

CaTo-ROC
Start date: September 2015
Phase: Phase 2
Study type: Interventional

Many ovarian cancer patients have been offered different standard cytostatics and gradually develop chemo-resistance. However, a considerable fraction of these patients are still in good general health and have a strong wish for further treatment. Cabazitaxel (Jevtana®) is a new taxane with effect in breast and prostatic cancer. In both tumors it has shown effect in patients refractory to docetaxel. Therefore, it could be anticipated that cabazitaxel may also have an effect in chemo-resistant ovarian cancer. The aim of the study is to investigate whether cabazitaxel could be a reasonable treatment option in patients with chemo-resistant and refractory ovarian cancer with regard to effect and toxicity.

NCT ID: NCT02558296 Completed - Clinical trials for Type 2 Diabetes Mellitus

Bexagliflozin Efficacy and Safety Trial

BEST
Start date: October 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and increased risk of cardiovascular adverse events. The data from this study will be combined with the data from other bexagliflozin studies in a meta-analysis of CV safety outcomes.

NCT ID: NCT02558231 Completed - Clinical trials for Pulmonary Arterial Hypertension

The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension

TRITON
Start date: May 1, 2016
Phase: Phase 3
Study type: Interventional

The objective of this clinical trial is to compare the efficacy and safety of an initial triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension.

NCT ID: NCT02558088 Completed - Clinical trials for Pharmacokinetics in Healthy Young Men

Pharmacological Properties of Salmeterol

Start date: September 2014
Phase: Phase 4
Study type: Interventional

The objective of the study is to help establish a urinary threshold for salmeterol on the World Anti-doping Agency prohibited list, to avoid supratherapeutic of this substance in competitive sports. Hence, there is no hypothesis as such.

NCT ID: NCT02556437 Completed - Clinical trials for Multifocal Motor Neuropathy

Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN)

Start date: June 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of HyQvia (Immunoglobulin 10% with recombinant hyaluronidase) with conventional subcutaneous immunoglobulin treatment in patients with Multifocal Motor Neuropathy (MMN).

NCT ID: NCT02555683 Completed - Asthma Clinical Trials

Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.

Start date: December 11, 2015
Phase: Phase 3
Study type: Interventional

This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations: - patient with inadequately controlled severe asthma and high eosinophil counts at baseline (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population) - patients with inadequately controlled severe asthma (overall study population) Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).

NCT ID: NCT02554747 Completed - Clinical trials for Diabetic Macular Oedema

Aflibercept anD navigateD vErsus coNvensional Laser in Diabetic macUlar edeMa

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

Diabetic macular edema (DME) in diabetic retinopathy (DR) is the leading cause of visual impairment among the 300,000 Danish patients with diabetes (DM) and will in time affect 29% of patients. Because of DME, 550 intravitreal injections were given at Odense University Hospital in 2014 with medicine expenses approximating 3.3 million DKK. With an increasing prevalence of diabetes, the number is expected to rise significantly for the years to come. The investigators hypothesize that combination therapy with intravitreal aflibercept and a new computer navigated photocoagulations system (Navilas®) leads to a decreased need for intravitreal injections. Further, the investigators wish to identify retinal risk markers for DME treatment outcome to assist individualized treatment planning. The evaluation of the baseline level of macular ischemia as marker of successful treatment outcome is of particular interest as this is still highly debatable and may prove a significant prognostic factor of anatomical and functional outcome to anti-VEGF treatment. The ADDENDUM study (four-year part-time PhD study) is a 12-month prospective randomized 1:1 study to compare intravitreal aflibercept and Navilas® laser (Group A) with intravitreal aflibercept and conventional Pascal laser (Group B) in the treatment of DME. Eligibility criteria: DM, age 18-99, clinically significant macular edema, central retinal thickness > 300 μm, best corrected visual acuity 35-75 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. The investigators believe that this study holds the potential to set precedent for a new gold standard of DME-treatment with increased treatment effect, reduced risks and a more cost-effective approach.