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NCT ID: NCT01773057 Completed - Heart Failure Clinical Trials

Effects of 'NHGDoc' on Quality of Care

NHGDoc
Start date: April 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the computerized decision support system 'NHGDoc' is effective in improving quality of primary care in terms of processes of care (e.g. prescribing behavior of physicians) as well as outcomes of care (e.g. hospital admissions, mortality).

NCT ID: NCT01772108 Terminated - Clinical trials for Cardiovascular Diseases

A Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation

RESHAPE-HF
Start date: April 2013
Phase: N/A
Study type: Interventional

This trial is a randomized study of the MitraClip device in heart failure patients with clinically significant functional mitral regurgitation. A hierarchical composite of all-cause mortality and recurrent heart failure hospitalizations is hypothesized to occur at a lower rate with the use of the MitraClip device in addition to optimal standard medical therapy compared to optimal standard of care therapy alone.

NCT ID: NCT01771809 Completed - Ulcerative Colitis Clinical Trials

Long-Term Safety Of PF-00547659 In Ulcerative Colitis

TURANDOT II
Start date: March 18, 2013
Phase: Phase 2
Study type: Interventional

Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.

NCT ID: NCT01770951 Completed - Clinical trials for Atypical Hemolytic Uremic Syndrome (aHUS)

A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

Start date: August 31, 2009
Phase:
Study type: Observational

The objective of this retrospective trial is to assess safety and efficacy of eculizumab in aHUS patients treated outside of an Alexion-sponsored controlled clinical trial.

NCT ID: NCT01768572 Completed - Clinical trials for Rheumatoid Arthritis

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

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

Primary Objective: To assess, in the same study, the safety of sarilumab and tocilizumab in participants with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.

NCT ID: NCT01767857 Terminated - Clinical trials for Metastatic Colorectal Cancer

A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer

XCITE
Start date: March 31, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if the True Human Monoclonal antibody Xilonix (MABp1) can prolong the life of colorectal carcinoma patients that are refractory to standard therapy.

NCT ID: NCT01767558 Completed - Atrial Fibrillation Clinical Trials

PRECISION GOLD Post Market Study in Europe of Pulmonary Vein Ablation Catheter (PVAC GOLD)

Start date: January 2013
Phase: N/A
Study type: Interventional

PRECISION GOLD is a prospective, multi-center, single arm, unblinded interventional post market clinical study conducted in Europe. The purpose of the study is to evaluate asymptomatic cerebral embolic (ACE) lesions in subjects with symptomatic paroxysmal atrial fibrillation undergoing ablation with the Pulmonary Vein Ablation Catheter (PVAC) GOLD.

NCT ID: NCT01767311 Active, not recruiting - Alzheimer's Disease Clinical Trials

A Study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects With Early Alzheimer's Disease

Start date: December 20, 2012
Phase: Phase 2
Study type: Interventional

This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group study using a Bayesian design with response adaptive randomization across placebo or 5 active arms of lecanemab to determine clinical efficacy and to explore the dose response of lecanemab using a composite clinical score (ADCOMS). BAN2401-G000-201 Core study is an 18-month study in which 3 dose levels (2.5, 5, and 10 mg/kg) are given biweekly (once every 2 weeks) to separate groups of participants and 2 dose levels (5 and 10 mg/kg) are given monthly (once every 4 weeks) to separate groups of participants. Participants will be from 2 clinical subgroups: mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild Alzheimer's disease dementia. Frequent interim analyses will be conducted to continually update randomization allocation on the basis of the primary clinical endpoint. Any participant who completes the study treatment (Visit 42 [Week 79] of the Core study) or discontinues the Core Study will be eligible to participate in the Extension Phase, provided they meet the Extension Phase inclusion and exclusion criteria. Participants will receive 10 mg/kg biweekly for up to 60 months or until the drug is commercially available in the country, where the subject resides, or until the benefit-to-risk ratio from treatment with lecanemab is no longer considered favorable, whichever comes first. The Follow-up Visit in the Extension Phase will take place 3 months after the last dose of study drug.

NCT ID: NCT01767155 Completed - Endometrial Cancer Clinical Trials

Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer

ZoptEC
Start date: April 2013
Phase: Phase 3
Study type: Interventional

Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy and safety of AEZS-108 and doxorubicin.

NCT ID: NCT01767051 Completed - Clinical trials for Cardiovascular Health

Children Follow-up of PCOS Women

CHOPS
Start date: November 2012
Phase: N/A
Study type: Observational

Polycystic ovary syndrome (PCOS) is a complex and frequent disorder with a heterogeneous clinical presentation varying throughout life, from birth up to post-menopause. Although mostly known for its reproductive consequences, PCOS is associated with metabolic abnormalities related to insulin resistance and obesity. Children born from PCOS mothers are considered to be at risk for early insulin resistance, leading to development of PCOS and metabolic abnormalities in childhood and adolescence. Obesity and insulin resistance are considered as states of low- and pro-inflammation associated with endothelial dysfunction. In addition, it has been shown that endothelial dysfunction develops from the first decade of life in response to genetic and environmental risk factors. Therefore, offspring of women with PCOS may be at increased risk for vascular disease later in life. Moreover, some evidence suggests that early life respiratory disease also contributes to later life cardiovascular consequences. The number of studies on offspring of PCOS mothers is low and a systematic follow up of children born form PCOS mothers has not been performed yet. the investigators propose a systematic evaluation of cardiometabolic and pulmonary health characteristics of children (aged 2,5-8 years) born from mothers diagnosed with PCOS. A saliva sample will be performed to determine the biochemical androgenic status of the children. Mothers of these children have undergone standardized phenotyping prior to conception; the investigators will therefore be able to correlate the metabolic status of the mother around the time of conception and the cardiometabolic and pulmonary health of their offspring.