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NCT ID: NCT01851668 Completed - Preterm Birth Clinical Trials

Preterm Infant Transport Stress (PremiTranS) Study

PremiTranS
Start date: June 2013
Phase: N/A
Study type: Observational

This is an observational pilot study to quantify the amount of vibration, noise, physiological and biochemical instability that premature babies are exposed to during inter-hospital transport.

NCT ID: NCT01851564 Completed - Clinical trials for Acute Bleeding Esophageal Varices

RCT of Stent Versus Standard Therapy in Oesophageal Variceal Haemorrhage

SOV
Start date: August 2012
Phase: N/A
Study type: Interventional

The mortality rates from Acute Variceal Haemorrhage remain significant and first line therapy may fail in 15-25% of patients. The self-expandable metal stent has been described in case series as having a very high efficacy at control of haemorrhage from oesophageal varices when used as rescue therapy. This randomised controlled trial aims to assess for any potential superiority of the stent over 'standard' endoscopic techniques as primary or rescue therapy for bleeding oesophageal varices.

NCT ID: NCT01851551 Completed - Clinical trials for Non-Hodgkin's Lymphoma

Phase 1/2 Study of VSLI Plus Rituximab in Patients With Relapsed and/or Refractory NHL

Start date: September 2001
Phase: Phase 1/Phase 2
Study type: Interventional

This was a Phase 1/2 study performed at two clinical centers in the US and UK. It was a single arm, open label study evaluating VSLI plus rituximab in adults with aggressive relapsed or refractory non-Hodgkin's lymphoma.

NCT ID: NCT01851265 Completed - Solid Tumours Clinical Trials

D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours

Start date: July 4, 2013
Phase: Phase 1
Study type: Interventional

This is a 2 part study for patients with solid tumours. The purpose of Part A is to measure the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after eating 3 different breakfasts (high calorie, regular and none). In Part B Patients can take olaparib capsules daily and study assessments will be recorded for 6 months (minimum). Treatment can continue for as long as the patient is benefitting. Throughout the study patients will be monitored for any side effects.

NCT ID: NCT01850927 Completed - Clinical trials for Perioperative Myocardial Injury

Perioperative Reduction of Inapparent Myocardial Injury

PRIME
Start date: June 2013
Phase: N/A
Study type: Interventional

Recent data suggests that subclinical myocardial injury occurs in patients undergoing major abdominal surgery, and the degree of damage is proportionally linked to morbidity and mortality in the short and medium terms. Therefore, new methods of limiting myocardial damage are urgently needed. Ischemic preconditioning is a phenomenon whereby a brief non-lethal ischemia-reperfusion stimulus gives a protective effect to further ischemic insults. In remote ischemic preconditioning (RIPC), this initial stimulus is carried out away from the region of interest, normally a limb. In meta-analysed syntheses the effect size of RIPC in reducing cardiac damage during bypass grafting, as characterised by troponin release, seems to be about 35%. The PRIME Study will assess the value of RIPC in reducing subclinical myocardial injury in patients undergoing major abdominal surgery. Post-operative troponin release will be used as a surrogate marker of myocardial damage. There is no good data on which to build a reliable sample size calculation, therefore we estimated samples sizes using supplementary data from the recent VISION study. The investigators intend to build a clinically powered study from the results of this study. Study design will be by single-centre single-blind randomised control trial. Allocation will be 1:1. All treatments will be carried after induction of anaesthesia, prior to surgery. In the RIPC-treatment group, a blood pressure cuff inflated on an upper limb to 200mmHg for 5 minutes, and then deflated for 5 minutes, repeated in three cycles. In the control group, the blood pressure cuff will not be inflated, but the patient will remain under anaesthesia for the same amount of time. Primary endpoint will be peak post-operative 5th generation hs-TnT (highly sensitive Troponin-T, ng/ml). Secondary endpoint will be hs-TnT area-under-the-curve, major adverse cardiovascular events, serious surgical complications, non-cardiovascular death, quality of life, and length of stay.

NCT ID: NCT01850849 Completed - Atopic Dermatitis Clinical Trials

Safety, Tolerability and Pharmacokinetics in AD Subjects and Healthy Subjects of Cutaneous Application of LEO 39652 Cream

Start date: May 2013
Phase: Phase 1
Study type: Interventional

The principle aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 39652 cream is administered cutaneously as single dose to subjects with atopic dermatitis and to healthy subjects.

NCT ID: NCT01850212 Completed - HIV Infections Clinical Trials

A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects

Start date: February 2013
Phase: Phase 4
Study type: Observational

A Phase 4 study is to characterize the profile of low bone mineral density (BMD) in ≥ 50 year old male subjects and post-menopausal female subjects on any tenofovir disoproxil fumarate (TDF)-based regimen

NCT ID: NCT01849445 Completed - Clinical trials for Osteoarthritis of the Knee

Targeted Rehabilitation to Improve Outcome After Knee Replacement- A Physiotherapy Study

TRIO-Physio
Start date: September 2013
Phase: N/A
Study type: Interventional

The TRIO-physio study is looking at how well patients with osteoarthritis recover after knee replacement surgery (also known as Total Knee Arthroplasty (TKA)). Currently around 20% of patients are not satisfied after TKA. This project will look to find out if the research team can identify patients who will not recover well at an earlier stage, so that these patients can be helped sooner. The study will try to determine if doing intense physiotherapy with patients who are not doing well at the first review (6 weeks after their operation) can improve how well they have recovered at one year.

NCT ID: NCT01849016 Completed - Sickle Cell Disease Clinical Trials

N-Acetylcysteine in Patients With Sickle Cell Disease

NAC
Start date: April 2013
Phase: Phase 3
Study type: Interventional

The primary aim of this study is to evaluate the effect of the drug N-Acetylcysteine on the frequency of pain in daily life in patients with Sickle Cell Disease (SCD). Pain is an invalidating hallmark of this disease and has a considerable impact on the Quality of Life of patients and the medical health care system. Oxidative stress is hypothesized to play a central role in its pathophysiology. In pilot studies the administration of N-Acetylcysteine (NAC) resulted in a reduction of oxidative stress. Moreover, administration of NAC seemed to decrease hospitalization for painful crises in a small pilot study in patients with SCD. This study will be performed as a multicenter, randomized, controlled trial where patients will be treated with either NAC or placebo for a period of 6 months. The investigators expect that NAC can reduce the frequency of pain in patients with SCD, thereby improving their quality of life and participation in society.

NCT ID: NCT01848002 Completed - Healthy Clinical Trials

Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers

Start date: May 2003
Phase: Phase 1
Study type: Interventional

This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of multiple doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.