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NCT ID: NCT01542580 Recruiting - Clinical trials for Rheumatoid Arthritis

A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

Start date: March 2012
Phase:
Study type: Observational

The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.

NCT ID: NCT01538316 Recruiting - Clinical trials for Primary Prevention of Prostate Cancer

Prostate Cancer Prevention Trial With Quercetin and Genistein

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

The aim of the randomized controlled double-blind crossover trial is to evaluate the effectiveness of two dietary supplements containing polyphenolic phytochemicals (isoflavonoid genistein and flavonoid quercetin) in comparison with placebo on the rate of increase in prostate-specific antigen (PSA). In addition, secondary objective is to evaluate the incidence of prostate cancer and to analyze malondialdehyde and protein carbonyle as indicators of the oxidative status.

NCT ID: NCT01537263 Recruiting - Clinical trials for Aneurysmal Subarachnoid Hemorrhage

Ultrasound Perfusion Imaging After Aneurysmal Subarachnoid Hemorrhage

PSAB
Start date: January 2012
Phase: N/A
Study type: Observational

The purpose of this study is to examine wether delayed cerebral ischemia can be predicted by ultrasound brain perfusion imaging in patients with aneurysmal subarachnoid hemorrhage (SAH).

NCT ID: NCT01537016 Recruiting - Clinical trials for Diabetic Foot Ulcers

WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test on DFU

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

The purpose of this trial is to determine if wounds with elevated protease activity (EPA) treated with targeted interventions such as protease modulating therapies can improve clinical and economic outcomes. It is hypothesized that protease modulating dressings may provide significantly better clinical outcomes on EPA wounds over current standard of care.

NCT ID: NCT01537003 Recruiting - Venus Leg Ulcers Clinical Trials

WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test

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

The purpose of this trial is to determine if wounds with elevated protease activity (EPA) treated with targeted interventions such as protease modulating therapies can improve clinical and economic outcomes. Multi-centre VLU study to investigate efficacy of WOUNDCHEK™ on EPA wounds

NCT ID: NCT01534702 Recruiting - Clinical trials for Acute Myeloid Leukemia

Dose Escalation of Clofarabine in Combination With Cytarabine and Idarubicin as Induction Therapy in High Risk AML

CIARA
Start date: January 2012
Phase: Phase 1/Phase 2
Study type: Interventional

With current chemotherapy protocols, in 60-80% of patients with acute myeloid leukemia (AML) the leukemic blasts in the bone marrow can be reduced to < 5%. This is called "complete remission (CR)" and is the prerequisite for cure of the disease. During the last years, several genetic and biologic risk factors for the achievement of CR have been defined, and the remission rates vary considerably between patient groups with different risk profiles. On one hand, patients with certain chromosomal or molecular aberrations have very high CR rates of approximately 90%. Moreover, in some of these patients, molecularly targeted therapies for specific genetic aberrations are currently evaluated in clinical trials. However, these genetic aberrations account for only 50-60% of the overall patient population in AML. The remaining patients have a significantly inferior CR rate of only 50-60% with 30% resistant disease after two cycles of standard induction chemotherapy. In conclusion, there is need for improved induction regimens in a large number of adult patients with AML. An improved CR rate in this patient population will increase the number of patients eligible for intensive consolidation such as an allogeneic stem cell transplantation and might thereby be the basis for a better overall outcome. However, there is no clear evidence that this goal can be achieved with the currently available chemotherapy protocols. Clofarabine (2-chloro-2-fluoro-deoxy-9-D-arabinofuranosyladenine) is a nucleoside analogon which combines properties of fludarabine and cladribine. Due to the lack of neurological side effects, clofarabine could be explored in higher doses than other nucleoside analogues and has shown considerable antileukemic activity in patients with relapsed or refractory acute leukemias and elderly AML patients alone or in combination with cytarabine. In addition, the combination of clofarabine, cytarabine and idarubicin has produced promising results with acceptable toxicity in patients with relapsed or refractory AML. Based on these initial studies, there is need for a further optimization of the clofarabine dose in this combination. The aim of the AMLSG 17-10 study is therefore to evaluate the tolerability and safety of increasing doses of clofarabine in combination with idarubicin/cytarabine in patients with high risk AML defined by the genetic and molecular risk profile.

NCT ID: NCT01534299 Recruiting - Hypertension Clinical Trials

Global SYMPLICITY Registry (GSR) DEFINE

Start date: February 2012
Phase:
Study type: Observational

This is a prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document the long-term safety and effectiveness of renal denervation in a real world patient population with hypertension GSR DEFINE is the continuation of the Global SYMPLICITY Registry and collectively will enroll approximately 5000 patients with hypertension who undergo the renal denervation procedure, from over 300 sites worldwide. Subjects included in GSR DEFINE will be followed for a minimum of 1 year and up to 5 years post-procedure. Patients with uncontrolled hypertension will be enrolled in accordance with the inclusion criteria specified in the protocol.

NCT ID: NCT01524276 Recruiting - Clinical trials for Coronary Artery Disease

Product Surveillance Registry

PSR
Start date: January 2012
Phase:
Study type: Observational

The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

NCT ID: NCT01522508 Recruiting - General Anaesthesia Clinical Trials

Evaluation of Analgesia Nociception Index (ANI) During Propofol/Remifentanil and Sevoflurane/Remifentanil Anesthesia

Start date: June 2011
Phase: N/A
Study type: Observational

The aim of this prospective randomized study was to evaluate the ability of the new Analgesia Nociception Index ANI, derived by heart rate variability, to detect painful stimulation during either propofol or sevoflurane anesthesia and changing remifentanil concentrations.

NCT ID: NCT01522183 Recruiting - Clinical trials for Atypical Hemolytic-Uremic Syndrome

Atypical Hemolytic-Uremic Syndrome (aHUS) Registry

Start date: April 30, 2012
Phase:
Study type: Observational [Patient Registry]

Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.