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NCT ID: NCT01208519 Active, not recruiting - Clinical trials for Bacterial Resistance

SATURN 04 Nosocomial Acquisition Study

SATURN
Start date: November 2010
Phase: N/A
Study type: Observational

The study is the WP4 of the EU-funded (7th FW) project SATURN (Impact of Specific Antibiotic Therapies on the prevalence of hUman host ResistaNt bacteria). A total of 6 surgical and 6 medical wards will participate in the study. Sites of the study are located in 3 countries (Italy, Serbia, Romania). This WP will compare nosocomial acquisition rates of methicillin-resistant Staphylococcus aureus (MRSA) and extended-spectrum beta-lactamase (ESBL)-producing gram-negative bacteria (E.coli, Klebsiella spp. and Proteus spp.) among different treatment groups and define the temporal relationship between the start of antibiotic therapy, the acquisition of new colonisation in patients previously not colonised, and the development of a bacterial infection caused by the same strain isolated in a screening sample. This goal will be achieved by completing the following primary objectives: - To determine the rate of acquisition of target antibiotic-resistant bacteria by 1,000 antibiotic-days according to different classes of antibiotics, duration of therapy and antibiotic combination (monotherapy versus combination therapy); - To determine genotypic relation between colonising and infecting strain in the same patient and patients' and hospital staff colonising strains (to be performed in collaboration with WP1 of the SATURN project); - To study the virulence and fitness of the isolates (i.e. new colonising strains) causing subsequent nosocomial infections (to be performed in collaboration with WP1 of SATURN project); - To predict the risk for nosocomial infections due to target bacteria after a single treatment therapy adjusted by length of hospitalisation and ward colonisation pressure.

NCT ID: NCT01208090 Completed - Psoriasis Clinical Trials

ACT-128800 in Patients With Moderate to Severe Chronic Plaque Psoriasis

Start date: October 31, 2010
Phase: Phase 2
Study type: Interventional

This study will assess the efficacy, safety and tolerability of two doses of ACT 128800 in patients with moderate-to-severe chronic plaque psoriasis.

NCT ID: NCT01207388 Completed - Clinical trials for B-cell Acute Lymphoblastic Leukemia

Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)

BLAST
Start date: November 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to confirm whether the bispecific T cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease.

NCT ID: NCT01205438 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

Start date: January 2011
Phase: Phase 3
Study type: Interventional

The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in addition to standard of care therapy in participants with active SLE.

NCT ID: NCT01204749 Completed - Ovarian Cancer Clinical Trials

TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer

Start date: November 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.

NCT ID: NCT01204671 Completed - Influenza Clinical Trials

Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)

Start date: October 4, 2010
Phase: Phase 3
Study type: Interventional

This study is designed to assess the safety and immunogenicity of a GSK Biologicals' investigational vaccine GSK2321138A in adults 18 years old and older. This study is also designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be double blind for all groups except for the GSK2604409A Group which will be open.

NCT ID: NCT01203917 Active, not recruiting - Clinical trials for Caucasian Patients With EGFR Mutation Positive Advanced NSCLC

Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients With EGFR Mutation Positive Advanced NSCLC

IFUM
Start date: September 2010
Phase: Phase 4
Study type: Interventional

This study is carried out to see how Caucasian patients with lung cancer which has EGFR mutation will respond to gefitinib (IRESSAâ„¢) as a first line treatment. Safety data will also be collected and analysed to confirm that treatment with gefitinib is safe and well tolerated.

NCT ID: NCT01203605 Completed - Non-cardiac Surgery Clinical Trials

European Surgical Outcomes Study

EuSOS
Start date: April 2011
Phase: N/A
Study type: Observational

The European Surgical Outcomes Study (EuSOS) is a multi-centre, international cohort study of peri-operative care and clinical outcomes for patients undergoing non-cardiac surgery. Participating centres throughout Europe will contribute routine clinical data describing all eligible patients who undergo surgery from 4th April 2011 to 11th April 2011. Patients will then be followed until hospital discharge (or for a maximum of 60 days) for duration of hospital stay and hospital mortality. Routine clinical data will also be collected for those patients admitted to critical care at any stage after surgery but during the same hospital admission. Specific objectives are to describe clinical outcomes and standards of peri-operative care for patients undergoing non-cardiac surgery in Europe.

NCT ID: NCT01202760 Completed - Clinical trials for Rheumatoid Arthritis

A Rheumatoid Arthritis Study in Participants

FLEX O
Start date: January 2011
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis with or without background disease-modifying anti-rheumatic drug (DMARD) therapy. This study is comprised of 2 periods: Period 1 - 24-week blinded treatment Period 2 - 48-week post-treatment follow-up

NCT ID: NCT01202591 Completed - ER+ Breast Cancer Clinical Trials

Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients

GLOW
Start date: December 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and effectiveness of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1 polysomy (FISH4/5) or gene amplification (FISH 6)