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NCT ID: NCT03814785 Completed - Follicular Lymphoma Clinical Trials

GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)

ASSIST_FL
Start date: December 1, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive MabThera-treatment.

NCT ID: NCT03807518 Completed - Clinical trials for Exercise Intervention

Pre- and Post-Operative Exercise Program in Upper Gastrointestinal Cancers

PERIOP-OG
Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Esophageal and gastric cancers are a considerable health burden. In the past 10 years the 5-year survival for both cancers has doubled. This is due to a number of factors including advances in neo adjuvant and adjuvant chemotherapy and radiotherapy. However, physical fitness significantly declines as a result of neo adjuvant an adjuvant therapy. From studies in other cancers it is known that peri operative training improves physical fitness, yet there is little research into its effects in those with upper gastrointestinal cancers. The aim of this study is to assess the effect of a pre-and post operative training program on patients with upper gastrointestinal cancers on their physical fitness and consequently their optimism, quality of life and post operative morbidity.

NCT ID: NCT03775200 Completed - Clinical trials for Treatment Resistant Depression

The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression

P-TRD
Start date: March 1, 2019
Phase: Phase 2
Study type: Interventional

The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression

NCT ID: NCT03768193 Completed - Pain, Postoperative Clinical Trials

Deep Serratus Anterior Plane Block vs Surgically-placed Paravertebral Block for VATS Surgery

SAPB
Start date: October 4, 2017
Phase: N/A
Study type: Interventional

Thoracic surgery, and surgery involving the chest wall in general, is associated with poorly controlled acute pain, which may result in delayed functional recovery, and may progress to chronic pain. Multimodal opioid-sparing analgesia regimens are a key component of the thoracic surgery enhanced recovery pathway, the aim of which is to improve outcomes in patients undergoing both minimally invasive and open thoracic surgical procedures. Novel interfascial plane blocks are emerging as feasible alternatives to central neuraxial analgesia techniques in a variety of clinical settings. The aim of this study is to show non-inferiority of serratus anterior blockade compared with surgically placed paravertebral blocks in the management of perioperative acute pain in patients undergoing VATS procedures.

NCT ID: NCT03738397 Completed - Atopic Dermatitis Clinical Trials

A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis

Heads Up
Start date: February 21, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

NCT ID: NCT03734627 Completed - Surgery Clinical Trials

Gastrointestinal Nutrient Transit and Enteroendocrine Function After Upper Gastrointestinal Surgery

EndoGut
Start date: July 1, 2016
Phase:
Study type: Observational

The incidence of oesophagogastric cancer has increased by 400% since the 1970s in Ireland and the United Kingdom. In addition, refinement of perioperative management and the now widespread use of multimodal protocols for patients with locally advanced disease have significantly improved outcomes for patients with oesophagogastric cancer treatable with curative intent. Despite significant advances in chemoradiotherapy, surgical resection remains the primary curative option. Unintentional weight loss and nutritional complications represent serious concerns for patients after radical resection, even among those who remain free from recurrent disease in the long-term. A study from the Swedish Esophageal and Cardia Cancer Registry reported a mean three year weight loss of 10.8% among disease-free patients, with 33.8% of this cohort demonstrating malnutrition at three years post-oesophagectomy. Mechanisms contributing to weight loss for disease-free patients after upper gastrointestinal surgery are poorly understood, however an association between increasing magnitude of weight loss and the presence of increased satiety is described. Our recent studies at SJH have demonstrated four fold elevated postprandial satiety gut hormone concentrations after oesophagectomy, compared with baseline preoperative values. Postprandial gut hormone levels correlate significantly with postprandial symptoms and altered appetite at 3 months postoperatively, and with body weight loss at 2 years postoperatively. However, the mechanism leading to exaggerated postprandial gut hormone production after upper gastrointestinal surgery is poorly understood, limiting targeted therapeutic options. In this study, we aim to characterise the role of altered nutrient transit and enteroendocrine cell function in the pathophysiology of excessive post-prandial gut hormone responses after upper gastrointestinal surgery. To do this, we will measure the gut hormone response to a standardised 400 kcal meal, as per previous studies, while concurrently assessing gastrointestinal transit time, and enteroendocrine cell morphology and function. In this way, we will determine whether the magnitude of the postprandial gut hormone response correlates with the rate of nutrient transit into the enteroendocrine L-cell rich small intestine, and whether enteroendocrine cell adaptation occurs after oesophagectomy. Furthermore, we have previously observed that gut hormone suppression using octreotide is associated with increased ad libitum among subjects after upper gastrointestinal cancer surgery (Elliott JA et al, Annals of Surgery, 2015). The mechanism of action of octreotide may relate to SSTR-5-mediated negative feedback to the enteroendocrine L-cell, but this medication may additionally reduce enteroendocrine L-cell responses through its inhibitory effect on gastrointestinal motility - reducing the rapidity with which nutrients are delivered to the small intestine - and small intestinal nutrient sensing via inhibition of the Na+-dependent glucose transporter SGLT-18-10. Through conduction of this double-blind, randomised, placebo-controlled crossover study, we aim to establish the mechanism of action of octreotide-mediated increased food intake in patients after gastrointestinal surgery. This may inform the design of future targeted interventions for this patient group.

NCT ID: NCT03731195 Completed - Pleasant Touch Clinical Trials

GentleTouch (Study to Evaluate Somatosensory Evoked Potential (SSEP) Responses to Affective Touch and How it Develops in Healthy Term Babies)

Start date: May 9, 2018
Phase:
Study type: Observational

This study will attempt to measure the direct effect of pleasant skin touch on the developing infant brain. The massage intervention stimulates a specific class of unmyelinated C-fibres in the skin called C-touch (CT) afferents, and effects will be assessed by monitoring brain responses (GentleTouch Project) in a prospective cohort study.

NCT ID: NCT03721705 Completed - Alzheimer Disease Clinical Trials

Renew NCP-5 for the Treatment of Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild Dementia of the Alzheimer's Type

Start date: November 12, 2018
Phase: Phase 3
Study type: Interventional

A Randomized Pivotal Study of RenewTM NCP-5 for the Treatment of Mild Cognitive Impairment due to Alzheimer's Disease or Mild Dementia of the Alzheimer's Type is a pivotal, single blind, parallel design, multi-site study intends to examine the efficacy and safety of RenewTM NCP-5 therapy in the treatment of Cognitive Impairment due to Alzheimer's Disease or Mild Dementia of the Alzheimer's Type. Subjects will be prospectively randomized to treatment or sham (in a 1:1 ratio) using stratification for Cognitive Impairment due to Alzheimer's Disease or Mild Dementia of the Alzheimer's Type, and Cardiovascular Risk (CVR) score at multiple sites. Subjects, ages 55-85, will be consented for 13 months and will receive thirty-five 60-minute RenewTM NCP-5 treatment sessions during a 7-to-12-week initial treatment period, and then transition to a lower frequency maintenance period (twice a week) for a total treatment period of 24 weeks.

NCT ID: NCT03721107 Completed - Clinical trials for Irritable Bowel Syndrome

A Trial for New Treatment of Adult Participants With Irritable Bowel Syndrome

Start date: October 11, 2018
Phase: Phase 2
Study type: Interventional

A study to evaluate the effectiveness of oral doses of Blautix in adult participants with irritable bowel syndrome (IBS).

NCT ID: NCT03711552 Completed - Quality of Recovery Clinical Trials

Validation of an Obstetric QoR Score and to Establish Its MCID.

Start date: October 31, 2018
Phase:
Study type: Observational

The ObsQoR-11 is an 11-item survey that was recently developed to evaluate recovery after caesarean section. This has been shown to be valid, feasible, reliable and responsive to changes in health status. The aim of this study to validate the ObsQoR-11 score in an Irish obstetric hospital. The collection of supplemental data will allow its comparison to the QoR-15 score and calculation of the MCID.