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NCT ID: NCT02719639 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

OTIVACTO Regional Center Vienna (RCV) Non-Interventional Study (NIS)

Start date: April 1, 2016
Phase:
Study type: Observational

Real-world data on the effects of a fixed-dose combination Long-acting beta agonists + long-acting antimuscarinic agent (LABA+LAMA) therapy with tiotropium and olodaterol administered in a single device, in COPD patients who need treatment with two long-acting bronchodilators, is not available. This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto Respimat according to the approved Summary of Product Characteristics (SmPC).

NCT ID: NCT02717195 Completed - Schizophrenia Clinical Trials

Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia

DayBreak
Start date: April 2016
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in patients with treatment-resistant schizophrenia (TRS)

NCT ID: NCT02709486 Completed - Clinical trials for Osteoarthritis, Knee

Study of the Analgesic Efficacy and Safety of Subcutaneous Tanezumab in Subjects With Osteoarthritis of the Hip or Knee.

Start date: March 2, 2016
Phase: Phase 3
Study type: Interventional

Tanezumab is a monoclonal antibody that binds to and inhibits the actions of nerve growth factor (NGF). The Nerve Growth Factor Inhibitor (NGFI) class may offer an important breakthrough in the treatment of chronic pain and is under clinical investigation for the treatment of pain associated with osteoarthritis or other chronic pain conditions. The primary objective of this study is to demonstrate superior efficacy of tanezumab 5 mg and 2.5 mg administered subcutaneously (SC) every 8 weeks versus placebo at Week 24 in subjects with osteoarthritis of the knee or hip. The 2.5 mg dose was shown to provide efficacy benefits with a favorable safety profile when administered intravenously in previous Phase 3 clinical trials. The 5 mg dose is expected to provide added efficacy benefit over the 2.5 mg dose based on data from previous studies.

NCT ID: NCT02706873 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate

SELECT-EARLY
Start date: February 23, 2016
Phase: Phase 3
Study type: Interventional

The objectives of Period 1 were the following: - To compare the safety and efficacy of upadacitinib 7.5 mg once daily (QD) monotherapy (for participants in Japan only), 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate monotherapy for the treatment of signs and symptoms of RA in methotrexate-naïve adults with moderately to severely active RA; - To compare the efficacy of upadacitinib 15 mg QD monotherapy and upadacitinib 30 mg QD monotherapy versus weekly methotrexate monotherapy for prevention of structural progression in methotrexate-naïve adults with moderately to severely active RA. The objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 7.5 mg QD (for participants in Japan only), 15 mg QD, and 30 mg QD in adults with RA who have completed Period 1.

NCT ID: NCT02706847 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs

SELECT-BEYOND
Start date: March 15, 2016
Phase: Phase 3
Study type: Interventional

The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD. The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1.

NCT ID: NCT02705209 Completed - Low Back Pain Clinical Trials

Cayenne Pepper Cataplasm - Effect Study

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

The beneficial analgesic effects of Rubefacenciae (redden skin substances), is known since 1830 as a treatment for pain, cramps, and disorders of the musculoskeletal system. Herbal cataplasms containing rubefacient substances, such as Cayenne pepper, are commonly used as natural medications to treat painful or aching areas in the case of acute or chronic back pain, and rheumatisms. In Vienna and lower Austria, a Cayenne Pepper Cataplasm (CPC) application containing Cayenne pepper and Kaolin powder in mixed proportion, is commonly used to treat musculoskeletal conditions of pain especially of the low back. Therefore, the aim of the present study was to test effects of a series of ten applications of CPC prepared with 5% of pepper, investigating the resulting effect on: skin temperature, skin sensory functions, pain threshold, and proprioception. Placebo control condition (0% cayenne pepper) was also tested. It was hypothesized that a series of 20-minute application of a CPC will have significant effects on the measured parameters. 40 subjects will be randomized into Treatment/control group.

NCT ID: NCT02702180 Completed - Clinical trials for Autoimmune Pulmonary Alveolar Proteinosis

Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis

IMPALA
Start date: March 21, 2016
Phase: Phase 2
Study type: Interventional

This study evaluates inhaled molgramostim (recombinant human granulocyte macrophage-colony stimulating factor [rhGM-CSF]) in the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) patients. A third of the patients will receive inhaled molgramostim once daily for 24 weeks, a third will receive inhaled molgramostim intermittently (7 days on, 7 days off) for 24 weeks and a third will receive inhaled matching placebo for 24 weeks.

NCT ID: NCT02698956 Completed - Aortic Stenosis Clinical Trials

SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice

SOURCE 3
Start date: July 2014
Phase:
Study type: Observational

This is an international, mutli-center, prospective, consecutively enrolled, observational registry. 2000 patients are planned to be enrolled over one year at up to 150 participating sites. 300 patients out of the 2000 patients enrolled in the main registry are planned to be consecutively enrolled in a select few sites for studying the valve performance. Echocardiogram and angiogram will be taken routinely.

NCT ID: NCT02680574 Completed - Anemia Clinical Trials

Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

Start date: February 2016
Phase: Phase 3
Study type: Interventional

A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

NCT ID: NCT02676089 Completed - Asthma Clinical Trials

TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)

TRIGGER
Start date: April 6, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the superiority of CHF 5993 200/6/12.5 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) versus CHF 1535 200/6 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate) and to compare the effect of CHF 5993 200/6/12.5 µg pMDI vs CHF 5993 200/6/12.5 µg plus open-label Tiotropium 2.5µg, in terms of lung functions parameters and rate of exacerbations, as well as to assess its safety and some health economics outcomes.