There are about 2333 clinical studies being (or have been) conducted in Ireland. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The purpose of this study was to confirm the clinical benefit observed in the pivotal registration study, Hx-CD20-406. The Committee for Medicinal Products for Human Use (CHMP) required that a randomized study be conducted in CLL patients with bulky fludarabine-refractory disease as a specific obligation for grant of conditional approval for ARZERRA™ in the European Union (EU). This study compared ofatumumab with the physicians' choice of therapy.
Total knee replacement (TKR) is associated postoperatively with considerable pain and analgesic requirement. Total knee replacement is routinely performed under spinal anaesthesia with intrathecal bupivacaine plus preservative free morphine. We hypothesize that infiltration of the surgical site with peri- and intraarticular levobupivacaine local anaesthetic would be an efficacious pain management technique and would not be inferior to intrathecal morphine for postoperative pain management. We further hypothesize that the use of this surgical site infiltration technique would decrease post-operative systemic opioid requirements as well as the side effects associated with intrathecal and systemic opioids.
Total hip replacement is a major surgical procedure usually associated with significant pain in the early postoperative period. In our hospital, total hip replacement is routinely performed under spinal anaesthesia with intrathecal bupivacaine local anaesthetic plus opioid in the form of preservative free morphine. The use of 'local infiltration analgesia' as an alternative postoperative analgesic technique has been investigated.In this technique the surgeon infiltrates the surgical site with a long-acting local anaesthetic and places a catheter under direct vision which remains in situ and is used to administer local anaesthetic in the postoperative period until such time as it is removed (when no longer deemed necessary for pain relief or at a pre-set time in the postoperative period e.g. 48 hours). We hypothesize that infiltration of the surgical site with peri- and intraarticular levobupivacaine local anaesthetic would be an efficacious pain management technique and would not be inferior to intrathecal morphine for postoperative pain management.
The primary objective was to evaluate the safety and efficacy of the treatment with BAY81-8973 for prophylaxis and treatment of breakthrough bleeds in children with severe hemophilia A. The secondary objectives were - To assess the safety and efficacy of BAY81-8973 during surgeries. - To assess incremental recovery of BAY81-8973. - To assess pharmacokinetic (PK) parameters in a subset of children (Previously treated patients [PTPs] and previously untreated patients [PUPs] / minimally treated patients [MTPs] - participation in PK sampling was voluntary and required consent).
The primary objective of this study is to substantiate prediction accuracy(with a tighter 95% confidence interval compared to current diagnostic modalities), of a lung cancer biomarker for risk stratification of patients into high and low risk categories to aid in clinical evaluation of the patient.
This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer [AJCC]) metastatic melanoma.
Irritable bowel syndrome (IBS) is a common disorder affecting up to 20% of the general population. Despite the prevalence of the disorder, it remains poorly understood. This is reflected in a symptom based diagnostic scheme, the lack of a suitable biological marker and inadequate treatment options. Current knowledge suggests the disorder is as a result of a dysregulated brain-gut axis, a complex construct describing the bidirectional communication systems underpinning normal gastrointestinal functioning. The investigators hypothesize here that the disruption of this brain-gut axis is facilitated by an increased degradation of tryptophan along the kynurenine pathway. This metabolic abnormality has the potential to impact on both GI and CNS signaling through its effects on serotonergic signaling and the impact of metabolites like kynurenic acid and quinolinic acid on cognitive processes respectively. Previous data from our laboratory indicated increased tryptophan degradation in IBS patients and suggested the metabolites produced as putative biological markers of the condition. In this study the investigators aim to reconcile cognitive impairment in IBS with GI and CNS symptom severity and kynurenine pathway metabolites. The investigators will establish these baseline measures in IBS compared to control subjects. A battery of cognitive assessments will be carried out using a computerized testing system. Standardized rating scales will be used to assess GI and CNS symptom severity. GC-MS/MS, a recently acquired technology platform in our laboratory, will be used to quantify plasma quinolinic acid levels.
To compare, in patients with advanced pancreatic cancer, the effects of IMM-101 in combination with gemcitabine to gemcitabine alone on safety and tolerability (including QoL), clinical signs and symptoms of disease, selected markers of tumour burden and immunological status, and disease outcome.
The primary aim of this study is to determine if a manual based telephone intervention support service for people who support people with Multiple Sclerosis (PwMS), initiated by nurse specialists who provide care to PwMS, has a positive impact on the lives of PwMS and their support persons. For support persons this impact is determined by measurable support person/carer self-efficacy and preparedness to care, burden, quality of life, service utilization and satisfaction with the support service. For PwMS this is determined by their qualitative experience of the type of care they receive from their carer. A secondary aim is to determine the possible economic benefits of the introduction of such an intervention nationally. A support person is the person nominated by the PwMS as the person who provides the most support or physical assistance to a person with MS who is not a paid service provider.
The current standard for biopsy-based diagnoses of dysfunction of kidney transplants is the Banff Classification which represents arbitrary international consensus. Recent data-driven approaches using molecular and conventional technologies indicate that mere consensus produces frequently incorrect diagnoses with potential harm to patients due to inappropriate treatment. To address this unmet need and improve diagnostics in the area of organ transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC) has developed a new diagnostic system that combines the molecular and histopathological features of transplant biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic System. The present study will validate and refine this system in 500 prospectively unselected biopsies for clinical indications from American, Canadian and European centres in addition to 300 biopsies already collected. Due to a considerable interest and support from participating Centers, the study is further extended to 1500 prospective biopsies. Thus this is the extension of the INTERCOM study (INTERCOMEX). In addition to demonstrating the feasibility and value of this System in routine patient care and clinical trials, the study will develop and optimize a transparent and user-friendly reporting format to communicate this information to clinicians and obtain detailed feedback on how this system can best improve patient care.