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NCT ID: NCT02010255 Completed - Clinical trials for Chronic HCV Infection

Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant

Start date: January 2014
Phase: Phase 2
Study type: Interventional

This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection. - Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant; - Cohort B: post-liver transplant, with or without cirrhosis; - Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups) - Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.

NCT ID: NCT02009878 Completed - Clinical trials for Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

A PK Study of 3 Dosages of Tolvaptan in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

Start date: November 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This is a study to evaluate how the body handles and metabolizes (PK) the various doses of the drug Tolvaptan, and what the effect (PD) of the various doses of Tolvaptan are on the content of "salt" in blood and urine

NCT ID: NCT02009306 Completed - Terminal Cancer Clinical Trials

Nasal Fentanyl and Buccal Midazolam for Dying Patients

Start date: January 23, 2017
Phase: Phase 4
Study type: Interventional

When patients are dying they become unable to take oral medication and if they develop symptoms (e.g. pain or agitation) they need to be given a subcutaneous injection of medication. If they are at home this requires that a District Nurse is called and it can take a long time (sometimes hours) for the Nurse to arrive. This can be a very stressful time for the patient and family. There are 2 drug preparations which could potentially be given by family members in the home: Nasal fentanyl (PecFent) Buccal midazolam (Epistatus) If these preparations helped symptoms this would give much quicker symptom control for patients and might mean the District Nurse visit was not needed. In advance of a community based randomised trial of these modes of administration, it is important to assess the feasibility of such an approach in terms of carer acceptability and patient tolerability as well as determine appropriate sample sizes and sampling methods. There are 2 work packages which would help assess feasibility of a community trial: 1. An open label randomised controlled trial comparing the use of PecFent with or without Epistatus versus standard subcutaneous breakthrough medication for the management of breakthrough pain (with or without agitation) in dying hospice patients who either remain in the hospice or go home. 2. A qualitative interview study to capture the thoughts of relatives of these patients about the use of these preparations.

NCT ID: NCT02008916 Completed - Clinical trials for Spondylitis, Ankylosing

16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients

MEASURE 3
Start date: January 14, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.

NCT ID: NCT02008890 Completed - Clinical trials for Palmoplantar Pustular Psoriasis

Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab

Start date: December 26, 2013
Phase: Phase 3
Study type: Interventional

A one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks

NCT ID: NCT02008227 Completed - Clinical trials for Non-Squamous Non-Small Cell Lung Cancer

A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy

OAK
Start date: March 11, 2014
Phase: Phase 3
Study type: Interventional

This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death−ligand 1 [anti-PD-L1] antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

NCT ID: NCT02007629 Completed - Clinical trials for Hypertension, Pulmonary

Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 Inhibitor

RESPITE
Start date: February 18, 2014
Phase: Phase 3
Study type: Interventional

BAY63-2521 Riociguat leads to the relaxation of smooth muscle cells in pulmonary arteria and may also inhibit abnormal remodeling of lung blood vessels. In patients with pulmonary arterial hypertension Riociguat showed to reduce the pulmonary blood pressure and improved the right heart function without unacceptable side effects. Here dose of Riociguat will be adjusted over 8 weeks then a Maintenance Phase of 16 weeks follows. Patients with Pulmonary Arterial Hypertension treated with stable doses of Phosphodiesterase Type-5 Inhibitors (Eg Sildenafil, Tadalafil) not appropriately responding to therapy will be included. Based on previous evidence and on the different modes of action an improvement of exercise capacity, heart function and quality of life may be expected if PDE5i treatment is transitioned to riociguat. Where Riociguat is pending market approval or reimbursement once the treatment phase is completed drug can be made available for another 18 months (Extended Drug Supply Phase - EDSP) under study conditions. Patients may also transition at the end of the maintenance period or any time during the EDSP to any program that is intended to provide riociguat until drug approval/reimbursement, e.g. a long-term extension study, compassionate use or named patient program. Study termination is also possible at any time.

NCT ID: NCT02007590 Completed - COPD Clinical Trials

Aerosure and Six Minute Walk Distance in Severe COPD

ACCORD
Start date: February 2014
Phase: N/A
Study type: Interventional

To investigate whether high frequency airflow oscillation (HFAO), delivered using Aerosure, increases six minute walk distance (6MWD) and reduces exertional breathlessness in patients with severe chronic obstructive pulmonary disease (COPD).

NCT ID: NCT02007473 Completed - Clinical trials for Adverse Effects in the Therapeutic Use of Plasma Substitutes

A Prospective Non-interventional Study to Evaluate the Safety of Methylene Blue Plasma

Start date: July 2013
Phase: N/A
Study type: Observational

The objective of this non-interventional study is to gather data on adverse reactions occurring with Methylene Blue plasma administered in a routine clinical practice environment; to know more about their characteristics and behaviour and the possible factors that may influence their presentation and evolution.

NCT ID: NCT02007460 Completed - Clinical trials for Neuromuscular Function

The Influence of High Impact Exercise on Musculoskeletal Health in Older Men

Hiphop
Start date: January 2010
Phase: N/A
Study type: Interventional

Osteoporotic fractures are an extremely common and serious public health issue which contribute substantially to pain, impaired mobility and morbidity in the elderly. Declines in bone strength combined with an increase risk of falls (associated with decline in muscular function with age) are the main determinants of fracture risk. Exercise that is novel and involves impact loading has the potential to improve bone strength and neuromuscular function (strength, power and balance). It is thus imperative to evaluate potential benefits of exercise in older people. The musculoskeletal responses to exercise may also be influenced by vitamin D status. It is the purpose of this study to consider the influence of a one year unilateral (one limb) high impact exercise programme on musculoskeletal health, specifically bone structure, muscle strength and power in older caucasian men. It is also the purpose of this study to determine whether this differs according to vitamin D status. The findings will reveal whether exercise can improve bone health and/or neuromuscular function, and whether improvements are dependent upon vitamin D status.