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NCT ID: NCT01756443 Completed - Clinical trials for Open Reduction Internal Fixation(ORIF) of Lateral Malleolus

Sciatic Nerve Block for Ankle/Foot Surgeries. A Comparison Between a Premixed Solution of Lidocaine Plus Bupivacaine and Consecutive Infiltration of Lidocaine and Bupivacaine

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

Regional anaesthesia has become the cornerstone of multimodal analgesia. With the advent of ultrasound guided nerve blocks regional anaesthesia has achieved both greater efficacy and a better safety profile as the injection of local anaesthetic is performed under direct vision. This has allowed a reduction of the amount of local anaesthetic injected as compared to peripheral nerve stimulation technique . Blockade of sciatic nerve combined with saphenous nerve provides anaesthesia and analgesia for ankle/foot surgeries. Various combinations of local anaesthetics have been used to provide optimal blockade . A mixture of lidocaine with a long acting local anaesthetic is commonly used. This provides a rapid onset of blockade, but of a consistently shorter duration compared to a long acting local anaesthetic alone. We hypothesize that sequential perineural injection of lidocaine and bupivacaine provides similar onset but a longer duration of sensory block compared to the same dose and volume of local anaesthetic mixed in advance.

NCT ID: NCT01753635 Completed - Clinical trials for Performance and Safety of an Airway Management Device

Comparison of the Baska Mask Airway to a Single-use LMA Device in Low-risk Female Patients

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

The purpose of this study is to compare the performance of the Baska mask supraglottic airway device with a single use laryngeal mask device (LMA) in low-risk female patients. The investigators have performed a number of studies on novel airway devices, including 3 studies on the Baska mask. This trial will compare some performance characteristics of the studied devices, including airway seal pressures, insertion success rates, device use difficulty scores. Additional performance and device safety data will be accumulated. The investigators have two primary hypotheses, namely 1.Non-inferiority of first placement attempt success rate of the Baska mask vs LMA; and 2.greater seal pressure of the Baska mask vs LMA.

NCT ID: NCT01746225 Completed - Clinical trials for Metastatic Breastcancer

Schedules of Nab-Paclitaxel in Metastatic Breast Cancer

SNAP
Start date: April 2013
Phase: Phase 2
Study type: Interventional

Longer first line chemotherapy duration has recently been associated with a modest, but significant improvement in overall survival and a clinically meaningful and statistically significant improvement in progression-free survival, in metastatic breast cancer patients. Prolonging chemotherapy until disease progression, however, must be weighed against the detrimental effects of continuous chemotherapy delivery. The SNAP trial seeks to improve the tolerability of prolonged chemotherapy administration strategy by studying alternative treatment schedules, while preserving and possibly improving treatment efficacy in this disease setting. The availability of a new nanoparticle albumin-bound taxane, nab-Paclitaxel (Abraxane®), represents an opportunity to test this hypothesis. Nab-Paclitaxel has been developed in an attempt to reduce the toxicity associated with standard taxane administration (caused by the use of chemical solvents) while increasing antitumor efficacy. The SNAP randomized phase II trial evaluates three schedules of nab-Paclitaxel as prolonged chemotherapy administration strategy. Each of three arms will be compared to a historical reference of seven-month median progression-free survival (PFS) based on the most recent trial with docetaxel as control arm to determine whether any of the three arms are worthy of further investigation.

NCT ID: NCT01741896 Completed - Clinical trials for Contrast Induced Nephropathy

Can Remote Ischaemic Preconditioning Reduce Contrast Induced Nephropathy in Patients Receiving Contrast for Computed Tomography?

CT RIPC CIN
Start date: November 2012
Phase: N/A
Study type: Interventional

Computated tomography (CT) is an invaluable medical resource for both physicians and surgeons. Contrast media are an aid to improve the diagnostic yield of CT. While an incredibly powerful means of imaging the human body, there are possible complications to the use of contrast including a hypersensitive response and contract induced nephropathy (CIN). The latter will typically occur 48-72 hours after administration. One recent meta - analysis of serum creatinine levels following contrast enhanced CT found 6.4% of those undergoing this investigation developed CIN. Although typically transient, 1 % had a persisting reduced renal function, with a small minority needing renal replacement therapy (RRT). The development of CIN was influenced by co morbidities and by the amount of contrast given. The mechanism of injury to the kidney is not definitively established, but is thought most likely due to hypoxia resulting from reduced blood flow, thereby giving rise to oxygen free radicals causing direct damage to the kidney and also direct tubular damage. Remote conditioning ischaemia has been hypothesized to be nephroprotective, whereby induced transient ischaemia at another site could buffer the impact of the contrast medium's effects. This was first demonstrated during cardiac angiograms, with those patients whom received multiple balloon inflations in the coronary arteries were found to have a lower incidence of CIN than those with fewer balloon inflations. Thus it could be hypothesised that any ischaemia temporarily induced could be nephroprotective. This can be at a point of extremity, rather than involving central organs, such as the arm, with ischaemia induced by the use of a blood pressure cuff, inflated to above systolic blood pressure levels. No studies have been found in the literature attempting to demonstrate this effect in relation to contrast CT studies. Consequently, a randomised control clinical trial of patients to assess the effectiveness of remote ischaemic preconditioning is proposed. Study Hypothesis: That performing remote ischaemic preconditioning on those undergoing CTs involving IV contrast is nephroprotective.

NCT ID: NCT01740427 Completed - Breast Neoplasms Clinical Trials

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

Start date: February 22, 2013
Phase: Phase 3
Study type: Interventional

The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.

NCT ID: NCT01734928 Completed - Multiple Myeloma Clinical Trials

Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

OPTIMISMM
Start date: January 7, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone.

NCT ID: NCT01732796 Completed - Clinical trials for Hepatitis C, Chronic

IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1

Start date: December 2012
Phase: Phase 3
Study type: Interventional

The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

NCT ID: NCT01730404 Completed - COPD Clinical Trials

Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI in COPD Patients

Start date: October 2012
Phase: Phase 2
Study type: Interventional

Phase IIa study in COPD patients aimed to evaluate the safety, tolerability ,pharmacodynamics (effect on biological markers of inflammation in induced sputum and in blood, and on pulmonary function) and on pharmacokinetics of CHF 6001 (a PDE4 inhibitor) after 28-days of daily inhaled dosing.

NCT ID: NCT01728922 Completed - Multiple Sclerosis Clinical Trials

Dose-related Effects of Vitamin D3 on Immune Responses in Patients With Clinically Isolated Syndrome

CISAVID
Start date: November 6, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The primary purpose of this study is to assess the immune response to vitamin D supplementation at two doses (5,000 IU and 10,000 IU daily) in both healthy controls and patients with clinically isolated syndrome compared to placebo. Secondary endpoints include (1) disease outcome in the clinically isolated syndrome in terms of clinical relapses and evidence of new lesions on MRI (McDonald's MS), 2) Safety of doses used

NCT ID: NCT01728558 Completed - Clinical trials for Critical Illness and Mechanical Ventilation

Early Goal-Directed Sedation Compared With Standard Care in Mechanically Ventilated Critically Ill Patients

SPICE III RCT
Start date: November 2013
Phase: Phase 3
Study type: Interventional

The Use of sedative drugs in intensive care is widespread. A cohort study conducted in Australia and New Zealand in 2010 revealed a high prevalence of deep sedation within the first 48 hours of mechanical ventilation which was independently linked to prolonged ventilation, hospital and 180 days mortality. Clinical practice is moving towards the use of lighter levels of sedation. Recent RCTs in Europe (JAMA 2012) and previous RCTs (JAMA 2009) supports growing evidence that dexmedetomidine facilitates rousable sedation, shortens ventilation time and attenuates delirium when compared to midazolam and propofol. The investigators confirmed in a pilot study the feasibility, efficacy and safety of a process of care known as Early Goal Directed Sedation (EGDS) that delivers: 1. Early randomization after intubation or arrival in the ICU (intubated). 2. Early Adequate analgesia after randomization. 3. Goal directed sedation titrated to achieve light sedation. 4. Dexmedetomidine based algorithm as the primary sedative agent with avoidance of benzodiazepines. The aim of this study is to assess the effectiveness of Early Goal Directed Sedation when compared to standard care sedation in critically ill patients. The study hypothesis is that Early Goal-Directed Sedation (EGDS), compared to standard care sedation, reduces 90-day all-cause mortality in critically ill patients who require mechanical ventilation.