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NCT ID: NCT01442636 Completed - Clinical trials for Peripheral Arterial Disease

Drug Eluting Stents In The Critically Ischemic Lower Leg 2

DESTINY 2
Start date: July 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The objective of this clinical evaluation is to evaluate the immediate and long term (up to 12 months) outcome of the XIENCE PRIME Everolimus Eluting Coronary Stent System (Abbott Vascular) in a controlled prospective investigation for the treatment of patients with critical limb ischemia due to the presence of lesions between 3cm and 10cm in length at the level of the below the knee arteries. Specifically the trial aims to illicit angiographic and ultrasound patency, clinical improvement, and adverse events associated with the use of this stent. The trial design is single armed, prospective, controlled trial run over 12 months of follow-up.

NCT ID: NCT01442038 Completed - Clinical trials for Coronary Artery Disease

Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI)

RIVER-PCI
Start date: October 2011
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of ranolazine as compared with placebo when used as part of standard medical therapy in chronic angina subjects with incomplete revascularization post-PCI on the composite of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization.

NCT ID: NCT01441791 Completed - Clinical trials for Postoperative Respiratory Complications

PROVHILO:Protective Ventilation During General Anesthesia for Open Abdominal Surgery

PROVHILO
Start date: February 2011
Phase: N/A
Study type: Interventional

The purpose of this international, multicentre, double-blinded randomized controlled trial is to determine if the "open lung approach" providing recruitment maneuvers and PEEP(Positive End Expiratory Pressure) during general anesthesia reduces atelectasis formation and improves respiratory function in the immediate post-operative period after major abdominal surgery. Participating centres throughout the world will include a total of 900 adult patients undergoing general anesthesia for open abdominal surgery with high or intermediate risk for post-operative pulmonary complications. Patients are randomized and intra-operatively ventilated with either a lung protective strategy (PEEP at 12 cmH2O with recruitment maneuvers) or a conventional strategy (PEEP at maximum 2 cmH2O without recruitment maneuvers). Patients will be assessed on the first 5 post-operative days, on day of discharge and on day 90 post-operative. Primary endpoint is any post-operative pulmonary complication (see below). Secondary endpoints are post-operative extra-pulmonary complications, intra-operative mechanical ventilation related complications, unscheduled ICU (Intensive Care Unit) (re-) admission, and length of hospital stay.

NCT ID: NCT01441583 Completed - Heart Failure Clinical Trials

Ingenio Device Algorithm Study

IVORY
Start date: October 2011
Phase: N/A
Study type: Interventional

The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.

NCT ID: NCT01440426 Completed - Gingival Recession Clinical Trials

Connective Tissue Graft Versus Mucograft Collagen Matrix for Coverage of Multiple Gingival Recession Defects

Start date: September 2011
Phase: Phase 4
Study type: Interventional

This study deals with coverage of multiple denuded roots. The current standard treatment requires surgical correction and uses soft tissue taken from the roof of the mouth to enhance results. The hypothesis of this trial is that a synthetic collagen matrix (called Mucograft) can be used to replace soft tissue taken from the subject. If the collagen matrix will prove to be equally as effective as the patient own tissue, it will be possible to avoid a more extensive surgery and decrease pain and discomfort.

NCT ID: NCT01440088 Completed - Soft Tissue Sarcoma Clinical Trials

A Trial of TH-302 in Combination With Doxorubicin Versus Doxorubicin Alone to Treat Patients With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma

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

The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma.

NCT ID: NCT01439997 Completed - Nocturia Clinical Trials

Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study

Start date: March 26, 2012
Phase: Phase 4
Study type: Interventional

The objective of this study is to find out what the pharmacodynamic (PD) characteristics of desmopressin melt are in nocturia patients (compared to healthy volunteers and children). The main questions the investigators want to answer are: - Are differences related to the pathophysiological factors involved in nocturia? - Are there age/gender/size differences? - Can the investigators identify patients who are likely to develop hyponatraemia? - Can the investigators individualize treatment and reduce risk for hyponatraemia? The patient will be given a prescription to buy Minirin Melt 60µg at the local pharmacy. During 30 days, the patient has to take Minirin Melt 60µg in the evening before going to bed. There are two groups of patients: Group A: Patients that still have to undergo an evaluation phase, according to standard procedures (e.g. osmolality test, blood sample). This procedure is not a part of this study. The study starts when the 1st Minirin Melt tablet has been taken (= day 1). Group B: This group already went through the evaluation phase (by participation to study 1 or study 3 as mentioned above) and they have been prescribed Minirin Melt 60 µg ambulatory. The study starts when the patients takes his first prescribed Minirin Melt tablet: - On day 3 and day 7 a blood sample will be taken at the UZ Ghent for safety control (Na+, K+, creatinin, osmolality = good clinical practice guideline). These first 2 visits (day 3 and day 7) are standard procedure. If the patient is at high risk for side effects, blood has to be taken during the first 7 days. - On day 3 the patient has to give a urine sample. - Patients have to fill out a frequency/volume chart during the first 14 days. - On day 30, a 3rd blood sample will be taken

NCT ID: NCT01439971 Completed - Hemophilia A Clinical Trials

Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia

Start date: December 2011
Phase: Phase 1
Study type: Interventional

This study hypothesizes that the study drug, PF-05280602 (at the selected doses) will be safe to administer to subjects with severe Hemophilia A or B with or without inhibitors and will demonstrate evidence of hemostatic activity. This is supported by the preclinical findings in hemophilic animal models.

NCT ID: NCT01439880 Completed - Clinical trials for Hypercholesterolemia

Open Label Study of Long Term Evaluation Against LDL-C Trial

OSLER
Start date: October 7, 2011
Phase: Phase 2
Study type: Interventional

The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.

NCT ID: NCT01439360 Completed - Influenza Clinical Trials

An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children

Start date: October 1, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine comparators in children 6 to 35 months of age. Recruitment will encompass at least 4 independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort in subtropical countries (2012), third cohort in the Northern Hemisphere (2012-2013) and a fourth cohort and additional independent cohorts possibly in NH countries (end 2013) and subtropical countries (beginning 2014).