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NCT ID: NCT01756339 Completed - Clinical trials for Community-acquired Bacterial Pneumonia

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

SOLITAIRE-ORAL
Start date: December 2012
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: NCT01756235 Completed - Clinical trials for Rheumatoid Arthritis

Physical Activity in Patients With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice

PACE
Start date: December 2012
Phase: N/A
Study type: Observational

Physical activity has positive impacts upon pain, disease activity and functional status in patients with rheumatoid arthritis (RA). Additionally, it may decrease the augmented cardiovascular risk in this patient population. Despite these apparent benefits of physical activity in RA, very little is known about physical activity in patients on biologic therapy. It could be hypothesized that improved control of RA signs and symptoms, better physical function and inhibition of structural damage all make the ground for an increased physical activity in patients treated with biologic agents after inadequate response to conventional Disease Modifying Antirheumatic Drugs (DMARDs). Adalimumab is the biologic agent which demonstrated unsurpassed efficacy in improving physical function, as well as short- and long-term work productivity outcomes in patients with RA. Therefore, adalimumab is a good candidate biologic agent to evaluate the impact on physical activity in RA.

NCT ID: NCT01754727 Completed - Clinical trials for Ankylosing Spondylitis

Impact of Adalimumab (Humira) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice

IDEA
Start date: December 2012
Phase: N/A
Study type: Observational

Ankylosing Spondylitis (AS) is a disease that represents a considerable economic burden to the health care system as well as the whole society. The introduction of biologic therapy, though allowing for superior clinical and work productivity outcomes, has significantly increased direct medical costs of AS. Therefore it is important to weight the benefits against the costs to gain a basis for decisions on health care resource allocation. Due to differences in the health care systems, health insurance and general country settings, health economic data cannot be generalized across countries. Such data is generally lacking in Central and Eastern European countries, especially in the field of rheumatology. This study will evaluate selected health care resource utilization and productivity losses in patients with AS during and before the treatment with adalimumab in clinical practice. The impact of adalimumab therapy on the extent of outpatient attendance, hospitalizations and sick leave, which could be influenced by relatively short-term adalimumab therapy, will be taken into account, and in relation to treatment response. There is no published data on the impact of adalimumab therapy on hospitalizations and outpatient attendance in patients with AS. Further, data on health care resource utilization and sick leave before and during adalimumab therapy could be translated into financial cost estimates (potential cost savings) by each participating country, based on their own country specific cost per resource.

NCT ID: NCT01754714 Completed - Clinical trials for Non Alcoholic Fatty Liver Disease

Study to Investigate the Effects of Different Doses of S-adenosyl-L-methionine (SAMe) in Subjects With Nonalcoholic Fatty Liver Disease and Non-treated Matched Healthy Volunteers as Control Group

EXPO
Start date: December 2012
Phase: Phase 3
Study type: Interventional

Investigation the Effects of Different Doses of SAMe in Subjects with Nonalcoholic Fatty Liver Disease and non-treated matched healthy volunteers as control group

NCT ID: NCT01754480 Completed - Clinical trials for Parenchymous Tissue Surgical Bleeding

Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries

Start date: December 2012
Phase: Phase 3
Study type: Interventional

This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in patients undergoing open surgical procedures where bleeding may be present on parenchymous tissue (e.g., solid abdominal organs such as the liver). The purpose of this study is to demonstrate that FS Grifols is not inferior to commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for study teams to become familiar with the application of FS Grifols and a Primary Part (II) to assess the safety and efficacy of FS Grifols. In both parts of the study, patients will be randomized in a 1:1 ratio to either FS Grifols or Surgicel.

NCT ID: NCT01753349 Completed - Cervical Dystonia Clinical Trials

Phase IV-Cervical Dystonia-INTEREST IN CD2

INTEREST_INCD2
Start date: December 2012
Phase:
Study type: Observational

The purpose of the study is to document long-term response in real-life practice after injection cycles with BoNT-A in subjects suffering from idiopathic cervical dystonia (Long-term clinical and pharmaco-economic data).

NCT ID: NCT01753297 Completed - Prostate Cancer Clinical Trials

A Study of Immediate 9 Months Adjuvant Hormone Therapy With Triptorelin 11.25 mg Versus Active Surveillance After Radical Prostatectomy in High Risk Prostate Cancer Patients.

PRIORITI
Start date: December 11, 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the benefit of immediate hormonal treatment after Radical Prostatectomy in Chinese and Russian patients with high risk prostate cancer. To reach this target, the trial will compare a group of patients treated with triptorelin at 8 weeks after the surgery and for a duration of 9 months (3 injections) versus another group (called "active surveillance group") who will be not receiving triptorelin. Both groups will be followed every 3 months to monitor any sign of disease progression during a minimum of 36 months

NCT ID: NCT01752647 Completed - Lung Cancer Clinical Trials

CT Screening For Lung Cancer in High Risk Patients: the Russian Study.

Start date: November 2012
Phase: N/A
Study type: Interventional

This prospective cohort trial was planned to assess the feasibility of establishing a lung cancer screening program in Russian Federation using low-dose CT scanning in asymptomatic patients with at least a 30 pack-year history of cigarette smoking.

NCT ID: NCT01752634 Completed - Psoriatic Arthritis Clinical Trials

Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis

FUTURE 2
Start date: April 14, 2013
Phase: Phase 3
Study type: Interventional

This study was to provide 24 - 52 week efficacy, safety and tolerability data to support the registration of the secukinumab (AIN457) prefilled syringe (PFS) for subcutaneous self administration in subjects with active PsA despite current or previous NSAID, DMARD and/or anti-TNFα therapy. An additional 4 years of long-term efficacy and safety data were collected during the post Week 52 period of the study.

NCT ID: NCT01749046 Completed - Epilepsy Clinical Trials

Remegal Fixed Dose as Adjunctive Therapy in Patients With Partial Seizures

Start date: March 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine weather Remegal in fixed dosage 1500 mg/daily is effictive and safe in patients with epilepsy with partial seizures