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NCT ID: NCT00818363 Completed - Postoperative Pain Clinical Trials

A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery

Start date: December 2008
Phase: Phase 2
Study type: Interventional

This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain. The purpose of this study is to investigate safety (if there are any side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following shoulder surgery.

NCT ID: NCT00811356 Terminated - Malaria Clinical Trials

A First Time in Human Study in Healthy Volunteers to Investigate a New Medicine to Treat Malaria

Start date: December 11, 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if the study drug (antimalarial medication) is safe when given to healthy subjects as a single dose or as repeated doses, to understand the effect of food on single doses of study drug and to determine if the study drug has an effect on other approved medications such as rosiglitazone and rosuvastatin.

NCT ID: NCT00811213 Completed - Clinical trials for Sleep Apnea, Obstructive

SensAwake™ Sleep Quality Trial

SASQT
Start date: October 2008
Phase: Phase 4
Study type: Interventional

The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns that differentiate between sleep and wake. Upon sensing that the patient is awake the device is able to reduce positive airway pressure PAP aiming to improve patient comfort which should result in more consolidated sleep. This study will investigate Obstructive Sleep Apnea (OSA) and a automatically Adjusting Positive Airway Pressure (APAP) device with new technology called SensAwake™. This requires experimental confirmation in a randomised controlled trial. Double−blind randomised crossover trial comparing WASO on standard APAP with WASO using APAP modified by the addition of the SensAwake™ modification on consecutive nights in participants with moderate−to−severe OSA. A total number of 45 participants will be recruited from an OSA population, aged 18−65. Participants will consist of male and female patients diagnosed with moderate−severe OSA (Apnea Hypopnea Index (AHI) greater than or equal to 15 per hour. Eligible participants, according to the protocol approved by the HREC, providing written informed consent will be enrolled into the study. Patients will be enrolled sequentially according to the randomisation list. Patients will be randomised to APAP or APAP with the addition of the SensAwake™ modification. The investigator and study staff will be blinded to the treatment of any participant.

NCT ID: NCT00811018 Terminated - Clinical trials for Pulmonary Arterial Hypertension

A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension

STRIDE-3
Start date: March 2003
Phase: Phase 3
Study type: Interventional

This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for the treatment of PAH or the study is closed.

NCT ID: NCT00810836 Completed - Clinical trials for Rheumatoid Arthritis

Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis

Start date: December 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate whether the drug BG00012 can improve the symptoms of rheumatoid arthritis (RA) in patients who are already taking methotrexate for RA, but who still suffer symptoms of RA. The purpose is also to ensure that the combination of methotrexate is safe for patients to take and that any side effects are acceptable to patients with RA.

NCT ID: NCT00810693 Completed - Clinical trials for Pulmonary Hypertension

A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)

PATENT-1
Start date: December 17, 2008
Phase: Phase 3
Study type: Interventional

The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).

NCT ID: NCT00809965 Completed - Clinical trials for Myocardial Infarction

An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome

Start date: November 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.

NCT ID: NCT00809861 Completed - Clinical trials for Distal Radius Fractures

Volar Locking Plate Versus External Fixator/Cast Fixation for the Treatment of Distal Radius Fractures

Start date: August 2008
Phase: N/A
Study type: Interventional

Aim: Osteosynthesis with locking plate/screws has become increasingly popular in recent years. It is the only treatment option which allows immediate postoperative immobilization. However, compared to conservative treatment or treatment with external fixators, locking plates are very expensive and the operation can be very challenging, even for experienced surgeons. The long-term results of all treatment modalities are equal, which has been shown in numerous studies. However, there are no evidence based studies published yet which look at short-term outcomes. The investigators do feel but do not know that patients who do not need postoperative immobilization return to work significantly earlier or are independent faster than patients whose wrists are immobilized for up to 6 weeks. If that is the case, then the higher costs and risks of the operation are justified, if not, then we have to re-evaluate our indications for using locking distal radius plates distal radius Methods: Group 1: Treatment of distal radius fractures with either volar or dorsal locking plates. No fixation postoperatively, immediate ROM (range of motion) exercises and usage of the wrist in activities of daily life (ADL) allowed. Radiological and clinical controls 2 weeks, 6 weeks and 12 weeks postoperatively. Endpoints are time to return to work / return to independency (in older people), ROM; Grip strength (with Jamar Dynamometer). Outcome scores are DASH (Disability of Arm, Shoulder and Hand Score)and PRWE (Patient related wrist evaluation). Group 2 Treatment of distal radius fractures with either an external fixator +/- K-wires or with K-wires and forearm cast or by cast alone. Main issue is that the wrist is immobilized for a period of 6 weeks. Radiological and clinical controls 2 weeks, 6 weeks and 12 weeks postoperatively. Endpoints are time to return to work / return to independency (in older people), ROM; Grip strength (with Jamar Dynamometer). Outcome scores are DASH and PRWE. Both plating and external fixation / cast fixation are standard and accepted treatment modalities for distal radius fractures. A power analysis indicated that a total sample size of 52 patients randomized equally (1:1) to each treatment arm without any blocking or stratification would provide 80 % statistical power (alpha = .05, beta = .20) to detect a 20% difference in mean DASH and PRWE scores.

NCT ID: NCT00809666 Completed - Hypertension Clinical Trials

Measuring Blood Pressure in Pregnancy Using Mercury and Automated Device

PRAM
Start date: May 2000
Phase: N/A
Study type: Interventional

The aim of the PRAM study was to determine whether women diagnosed with hypertension in pregnancy, using the traditional mercury device, have the same pregnancy outcomes when blood pressure is measured by either an automated device or a mercury device throughout the pregnancy.

NCT ID: NCT00809068 Completed - HDL Cholesterol Clinical Trials

High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone

TibFen
Start date: August 2005
Phase: Phase 4
Study type: Interventional

Tibolone (Livial) has been shown in previous studies to lower HDL cholesterol by up to 40%. This study aims to study the effects of fenofibrate on HDL and subfractions in women taking tibolone.