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NCT ID: NCT02031302 Completed - Clinical trials for Aortic Valve Stenosis

RESPOND Post Market Study

RESPOND
Start date: May 27, 2014
Phase:
Study type: Observational

The purpose of the RESPOND post market study is to collect real world clinical and device performance outcomes data with the Lotus Valve System used in routine clinical practice to demonstrate that the commercially available Lotus Valve System is a safe and effective treatment for patients with severe calcific aortic stenosis.

NCT ID: NCT02031094 Completed - Liver Resection Clinical Trials

Energy Expenditure and Regeneration Following Liver Resection Resection

EAGLE
Start date: January 2014
Phase: N/A
Study type: Observational

This observational study will measure resting energy expenditure in patients who have undergone liver resection and compare methods of measuring resting energy expenditure.

NCT ID: NCT02030912 Completed - Clinical trials for Antibiotic Resistant Bacteria

Effect of Minocycline & Amoxicillin on Antibiotic Resistant Bacteria and Indigenous Microbiotas

ANTIRESDEV
Start date: December 2009
Phase: Phase 4
Study type: Interventional

A randomised, open labelled study design is selected in order to determine the emergence and persistence of antibiotic resistant bacteria in humans and on the composition of the indigenous microbiotas at various body sites. These will involve the administration to volunteers of minocycline and amoxicillin- a control group will receive a placebo. Microbiology of the skin, saliva, faecal, skin and nasal micro flora, safety and adverse events, vital signs, will be evaluated. The objectives of metagenomic analysis are: - To identify the in vivo molecular mechanisms responsible for antibiotic resistance and its transfer in the indigenous oral and faecal microbiotas using metagenomics resistome analysis. - To determine the impact of the use of antimicrobial agents on the oral resistome - To determine the impact of the use of antimicrobial agents on the faecal resistome - To determine the ecological impact of the use of antimicrobial agents on the relative abundance of phylotypes of the indigenous oral microbiota - To determine the ecological impact of the use of antimicrobial agents on the relative abundance of phylotypes of the indigenous faecal microbiotas

NCT ID: NCT02030730 Completed - Parenting Clinical Trials

RCT of Brief Universal Parenting Program to Prevent Child Behavioural and Emotional Difficulties in Greece

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

This study investigates the impact of a Triple P Seminar Series on positive parenting for universal prevention of behavioural and emotional difficulties in a general Greek sample of parents with children aged 2 to 12. It is predicted that, compared to an attention control condition, parents randomised to the Seminar Series will report lower levels of children's disruptive and emotional difficulties at post-intervention. At the same time, it is postulated that parents will show a decrease in dysfunctional discipline styles, greater feelings of self-efficacy as well as lower levels of distress. Lastly, it is hypothesized that the effects observed at post-intervention will remain at the 6-month follow-up.

NCT ID: NCT02029482 Completed - Clinical trials for Safety and Tolerability

Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-128800 in Healthy Subjects

Start date: April 2010
Phase: Phase 1
Study type: Interventional

This was a single-center, randomized, double-blind, placebo-controlled, up-titration Phase 1 study. Sixteen subjects in two groups (at least 40% of subjects of either male or female sex), with 12 subjects in the active treatment group with an up-titration scheme from 10 to 100 mg, and 4 subjects in the placebo treatment group. Subjects were administered ascending doses of ACT-128800/placebo once daily for 3 days at each dose level: 10 mg, 20 mg, 40 mg, 60 mg, 80 mg, and 100 mg.

NCT ID: NCT02028884 Completed - Clinical trials for NMO Spectrum Disorder (NMOSD)

Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

Start date: February 20, 2014
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic, and immunogenic profiles of satralizumab, compared with placebo, in addition to baseline immunosuppressive treatment in participants with NMO and NMOSD.

NCT ID: NCT02028117 Completed - Clinical trials for Recurrent Platinum Resistant Ovarian Cancer

Phase I / Dose Expansion Study of Enadenotucirev in Ovarian Cancer Patients

OCTAVE
Start date: June 2014
Phase: Phase 1
Study type: Interventional

This study is a Phase I / Dose Expansion open label clinical study in patients with platinum-resistant epithelial ovarian cancer. The Phase Ia part of the study will determine the dose of enadenotucirev to be recommended for further studies and will examine primarily the safety and tolerability but also the pharmacokinetics of administering enadenotucirev intraperitoneally. In Phase Ib, the safety and tolerability and the pharmacokinetics of administering enadenotucirev intravenously in combination with weekly paclitaxel will be determined. The Dose Expansion Phase will begin as an open label dose expansion of that regimen and aims to determine whether intravenous enadenotucirev in combination with weekly paclitaxel has a risk benefit profile that supports further investigation in the treatment of patients with platinum-resistant epithelial ovarian cancer.

NCT ID: NCT02027896 Completed - Hip Fractures Clinical Trials

HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial

HIP ATTACK
Start date: March 14, 2014
Phase: N/A
Study type: Interventional

HIP ATTACK is an international randomized controlled trial of 3000 patients with a hip fracture that requires a surgical intervention. This trial will determine the effect of accelerated medical clearance and accelerated surgery compared to standard care on the 90-day risk of mortality and major perioperative complication (i.e., a composite of mortality, nonfatal myocardial infarction, nonfatal pulmonary embolism, nonfatal pneumonia, nonfatal sepsis, nonfatal stroke, and nonfatal life-threatening and major bleeding).

NCT ID: NCT02027701 Completed - Clinical trials for Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Start date: July 30, 2014
Phase: Phase 3
Study type: Interventional

This study is an extension study to the pivotal study IgPro20_3003 (NCT01545076). The purpose of this extension study is to investigate the long-term treatment of CIDP with IgPro20, with regard to safety and efficacy. Subjects who have completed subcutaneous (SC) Week 25 or were successfully rescued from a CIDP relapse during the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076) will have the option to receive open-label low-dose IgPro20 (0.2 g/kg bodyweight [bw]) weekly for up to 48 weeks. Subjects relapsing on low-dose IgPro20 will either return to high-dose IgPro20 (0.4 g/kg) immediately or be discontinued, depending on investigator's judgment. Subjects returning to high-dose IgPro20 will continue on high-dose until they have completed a total of 48 weeks of IgPro20 treatment. If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn. The treatment duration will be up to 48 weeks, followed by a completion visit (week 49).

NCT ID: NCT02027428 Completed - Clinical trials for Squamous Cell Carcinoma, Non-Small-Cell Lung

Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB / IV Squamous Cell Non-small Cell Lung Cancer

Start date: February 11, 2014
Phase: Phase 3
Study type: Interventional

Maintenance treatment of advanced stage squamous cell NSCLC. Phase III, randomized, open-label, multi-center study of nab-paclitaxel with best supportive care (BSC) or BSC alone as maintenance treatment after response or stable disease (SD) with nab-paclitaxel plus carboplatin as induction in subjects with stage IIIB/IV squamous cell NSCLC. Subjects who discontinued treatment from the maintenance part for any reason other than withdrawal of consent, lost to follow-up, or death, were entered into a Follow-up period that had a visit 28 days after progression or discontinuation. Those who entered Follow-up without progression continued with follow-up scans according to standard of care (SOC) until documentation of progression of disease. Additionally, subjects were followed for OS by phone approximately every 90 days for a minimum of 18 months, for up to approximately 5 years after the last subject was randomized.