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NCT ID: NCT01971970 Completed - Clinical trials for Inflammatory Bowel Diseases

Biomarkers of Anti-TNF Treatment in Inflammatory Bowel Disease (IBD)

Start date: October 2013
Phase:
Study type: Observational

Anti-TNF treatment (infliximab (IFX), adalimumab (ADA)) has become standard therapy for refractory pediatric and adult Crohn's disease (CD) patients, and is used for the induction (primary response) and maintenance of remission. When effective, clinical and endoscopic remission is reached within weeks. However, primary non-response is observed in 20% of pediatric patients, and in 40% of adult CD patients, suggesting a more robust acute response to anti-TNF therapy in children as compared to adults.During maintenance treatment, 60 - 80% of patients have secondary loss of response, necessitating dose adjustments to maintain clinical response. Anti-TNF treatment is also increasingly used in ulcerative colitis (UC), and has been shown to induce remission in active disease. For UC, the comparison between the efficacy in children versus adults is more difficult to report as studies in children are scarce. Anti-TNF treatment is associated with rare but potentially fatal side effects, infusion reactions, and is an expensive treatment. To avoid overtreatment it is necessary to early identify non-responders to treatment, and therefore it is important to develop predictive biomarkers of treatment response.

NCT ID: NCT01971307 Completed - Mental Disorders Clinical Trials

Supporting Primary Care in Diagnosis and Choice of Treatment for Patients With Psychosocial Symptoms: SGEPsyScan.

SGE-PsyScan
Start date: December 2013
Phase: N/A
Study type: Interventional

Although effective treatments for psychosocial symptoms and disorders are available, patients frequently do not receive the most appropriate and effective treatment for their symptoms because of inappropriate and unstructured diagnostics of psychosocial symptoms in general practice. The hypothesis is that by using the intervention SGE-PsyScan the clinical symptoms of patients can be assessed more uniformly and earlier as opposed to the GPs' assessment in usual care. As a result, patients are supposed to start earlier with a treatment that fits the type and severity of their symptoms better. The patients will be randomly assigned to either receive the SGE-PsyScan or usual care.

NCT ID: NCT01970501 Completed - Clinical trials for Current or Recent History of Atrial Fibrillation

Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure

GENETIC-AF
Start date: April 2014
Phase: Phase 2
Study type: Interventional

This study is being done to compare the effects of bucindolol hydrochloride (bucindolol) to metoprolol succinate (Toprol-XL) on the recurrence of symptomatic atrial fibrillation/atrial flutter in patients with heart failure who have a specific genotype for the beta-1 adrenergic receptor.

NCT ID: NCT01970215 Completed - Dyslipidemia Clinical Trials

TA-8995: Its Use in Patients With Mild Dyslipidaemia (TULIP)

TULIP
Start date: August 2013
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of different doses of TA-8995, a cholesteryl ester transfer protein (CETP) inhibitor, on the elevation of high-density lipoprotein cholesterol (HDL-C) and reduction of low-density lipoprotein cholesterol (LDL-C), alone and in combination with statin therapy. The secondary objectives of this study are to determine the safety and tolerability of TA-8995 in patients with mild dyslipidaemia.

NCT ID: NCT01969838 Completed - Clinical trials for Primary Myelofibrosis

Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis

Simplify 1
Start date: December 6, 2013
Phase: Phase 3
Study type: Interventional

This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib (RUX) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a Janus kinase inhibitor (JAK inhibitor). Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a double-blind treatment phase, after which they will be eligible to receive open-label MMB for up to an additional 216 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those participants planning to continue treatment with MMB following the end of the study, the Early Study Drug Discontinuation (ESDD), 30-day, 12-Week, and survival follow-up visits are not required.

NCT ID: NCT01969721 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients

Start date: October 2013
Phase: Phase 3
Study type: Interventional

The objective of the trial is to compare the lung function profile of once daily treatment with tiotropium+olodaterol FDC [2.5/ 5µg and 5/ 5µg] delivered by the RESPIMAT with the lung function profile of twice daily treatment with fluticasone propionate+salmeterol FDC [250/50µg and 500/50µg] delivered by the Accuhaler® after 6 weeks of treatment.

NCT ID: NCT01968980 Completed - Clinical trials for Heterozygous Familial Hypercholesterolemia

A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia

SPIRE-FH
Start date: October 2013
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C.

NCT ID: NCT01968733 Completed - Clinical trials for Community-acquired Bacterial Pneumonia

Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

SOLITAIRE-IV
Start date: November 2013
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.

NCT ID: NCT01968447 Completed - Prostate Cancer Clinical Trials

Effect of Neuromuscular Block and Arterial PCO2 on Surgical Rating Scale (SRS), Following Reversal With Sugammadex

BLISSS2
Start date: February 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to study the effect of variations in the arterial CO2 concentration during deep neuromuscular block on the surgical conditions as assessed by the surgical rating scale

NCT ID: NCT01967979 Completed - Healthy Volunteer Clinical Trials

A Study of the Effect of Multiple Doses of Itraconazole and Fluoxetine on the Pharmacokinetics of a Single Dose of RO5285119 in Healthy Subjects

Start date: October 2013
Phase: Phase 1
Study type: Interventional

This single-center, open-label, one-sequence, 2-period, within-subject study in 2 cohorts will evaluate the effects of multiple doses of itraconazole and fluoxetine on the pharmacokinetics of a single dose of RO5285119 in healthy volunteers. In Cohort 1, subjects will receive a single dose of RO5285119 on Day 1 (Period 1) and, after a wash-out period of 14 days, itraconazole on Days 1-8 of Period 2 with coadministration of RO5285119 on Day 4. In Cohort 2, subjects will receive a single dose of RO5285119 on Day 1 (Period 1) and, after a wash-out period of 14 days, fluoxetine on Days 1-12 of Period 2 with coadministration of RO5285119 on Day 6.