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NCT ID: NCT03074942 Completed - Severe Asthma Clinical Trials

Reslizumab in Patients With Severe Asthma Who Failed to Respond to Omalizumab

Start date: April 20, 2017
Phase: Phase 2
Study type: Interventional

Approximately, 5% of the patients with asthma suffer a difficult-to-control severe variant of the disease. Despite being treated with inhaled corticosteroids (ICs), long-acting β2-agonists (LABA), oral corticosteroids or omalizumab, one or more components of the control concept (symptoms, exacerbations, bronchial obstruction) remain to be resolved. Omalizumab has been proven to safely reduce asthma exacerbations and to decease symptoms and quality of life in severe allergic asthmatics. However, approximately 25% of the treated patients fail to respond to this monoclonal antibody. The rest of them show different degrees of response, although the rate of asthmatics who achieve control of the disease is unknown because clinical trials of omalizumab have been carried out to assess the impact of the drug on exacerbations, symptoms or even pulmonary function, but its effect on control was not evaluated. Therefore, there is a need to find new therapeutic options for those severe asthmatics who remain uncontrolled despite having received all the recommended therapies (including omalizumab). Reslizumab is a humanized anti-interleukin-5 (IL-5) monoclonal antibody (mAb) that has been recently found to reduce exacerbations and to improve pulmonary function and symptoms in patients with severe asthma and high peripheral eosinophil counts. It would be important to demonstrate that Reslizumab is able to improve the clinical condition of severe asthma patients with no therapeutic options.

NCT ID: NCT03073200 Completed - Plaque Psoriasis Clinical Trials

Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

Ixora-peds
Start date: March 28, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of ixekizumab in pediatric participants with moderate-to-severe plaque psoriasis.

NCT ID: NCT03072862 Completed - Hearing Loss Clinical Trials

Evaluation of the Benefits for Overall Health Following Cochlear Implant Treatment in the Elderly Population

Start date: November 6, 2017
Phase:
Study type: Observational

The purpose of this study is to show that cochlear implant treatment improves the overall health related quality of life and general well-being in elderly individuals.

NCT ID: NCT03072680 Completed - Clinical trials for Not Flourishing Population

Efficacy of a Positive Psychology Intervention Through a Mobile App

Start date: April 23, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to analyze the efficacy of several variations of an already validated Positive Psychology Intervention (PPI) called Best Possible Self in not flourishing population. This will be done through a mobile app specially designed for this aim. Concretely, the design will permit to compare the classic intervention (BPS Future), a new variation (BPS Past), and a combination of both components (BPS Past+Future). Participants will be randomly assigned to one of 3 conditions, in which they will practice the intervention for two weeks: - BPS-PAST + BPS FUT condition: Participants will practice BPS Past for one week, and then they will switch to BPS future for another week. - BPS-FUT condition: Participants will practice BPS Future for two weeks. - CONTROL condition: Participants will practice DAILY ACTIVITIES for two weeks.

NCT ID: NCT03072238 Completed - Clinical trials for Metastatic Prostate Cancer

Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer

IPATential150
Start date: June 30, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).

NCT ID: NCT03071757 Completed - Clinical trials for Advanced Solid Tumors Cancer

A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors

Start date: March 21, 2017
Phase: Phase 1
Study type: Interventional

The primary purpose of this Phase 1, open-label study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination with ABBV-181 in participants with locally advanced or metastatic solid tumors. The study will consist of 3 parts: ABBV-368 dose escalation, ABBV-368 tumor-specific dose expansion (triple negative breast cancer [TNBC] cohort and head and neck cancer cohort) and 18F-AraG Imaging Substudy.

NCT ID: NCT03069521 Completed - Clinical trials for Chronic Cornel Edema

Study to Evaluate the Safety of the EndoArt™ for Treatment of Subjects Suffering From Corneal Edema

Start date: June 22, 2017
Phase: N/A
Study type: Interventional

Prospective, feasibility study to evaluate the safety of the EndoArt® for treatment of 30 subjects suffering from corneal edema. Followed up for 12 months.

NCT ID: NCT03069365 Completed - Clinical trials for Hepatitis C Virus (HCV)

A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection and Renal Impairment

EXPEDITION-5
Start date: March 28, 2017
Phase: Phase 3
Study type: Interventional

This was a Phase 3b, open-label, non-randomized, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection without liver cirrhosis or with compensated liver cirrhosis and with chronic renal impairment in participants who were either HCV treatment-naïve (TN) or prior treatment-experienced (TE) with interferon (IFN) or pegylated interferon (PegIFN) with or without ribavirin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN.

NCT ID: NCT03069014 Completed - Clinical trials for Mild to Moderate Alzheimer's Disease

Study of LM11A-31-BHS in Mild-moderate AD Patients

Start date: February 15, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the safety of 2 doses of LM11A-31-BHS in 180 patients with Alzheimer's Disease versus placebo and to access biomarker and clinical exploratory endpoints of LM11A-31-BHS

NCT ID: NCT03068780 Completed - Clinical trials for Epidermolysis Bullosa

Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa

EASE
Start date: March 29, 2017
Phase: Phase 3
Study type: Interventional

This was a Phase III, Efficacy and Safety Study of Oleogel-S10 in Participants with Inherited Epidermolysis Bullosa (EB). EB is a rare group of genetic skin fragility disorders characterised by blistering of the skin in response to minor injury. In most cases, onset of EB is at birth or shortly after. All participants affected by any type of EB share the main characteristic of repeatedly developing painful wounds that take days to months to heal. Current treatment of EB is primarily preventative and supportive including protection from mechanical forces by avoiding rubbing, early treatment of wounds to prevent infections, and protection of the wound with adequate non-adhesive dressings to enable healing. The active pharmaceutical ingredient in Oleogel-S10 is a refined birch bark extract, quantified to 72 to 88% betulin. This clinical study of Oleogel-S10 in patients with inherited EB has been carried out to investigate whether Oleogel-S10 is effective for treatment of EB wounds and safe for long-term use. Oleogel-S10 was compared to a control gel. The control gel matched Oleogel-S10 in terms of texture and visual appearance to allow for double-blinding. The packaging for Oleogel-S10 gel and the control gel were identical. The participant received either Oleogel-S10 or control gel for a double-blind study phase of 90 days. The probability that the participant received Oleogel-S10 was 50%, which means that they had a 1 in 2 chance of receiving Oleogel-S10. However, in the follow-up phase of the study all participants were treated with Oleogel-S10 for a period of 24 months. This clinical study was performed at 49 study sites in 26 countries (Argentina, Australia, Austria, Brazil, Chile, Colombia, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hong Kong [China], Hungary, Ireland, Israel, Italy, Romania, Russia, Serbia, Singapore, Spain, Switzerland, Ukraine, United Kingdom, and the United States); 223 participants participated in total.