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NCT ID: NCT03640819 Completed - Breast Cancer Clinical Trials

Carbon Dye Tattooing of Biopsied Axillary Node in Breast Cancer

pre-ATNEC
Start date: April 27, 2018
Phase: N/A
Study type: Interventional

The primary aim of this prospective, multicentre study is to determine whether the involved node can be marked using black carbon dye and successfully identified at the time of surgery. The secondary aims are to determine the concordance between the tattooed node and sentinel node, migration of black dye into other nodes, and false-negative rate of tattooed node (in patients undergoing ALND after NACT).

NCT ID: NCT03640286 Completed - Obesity Clinical Trials

Vestibular Stimulation to Trigger Adipose Loss (VeSTAL) Clinical Trial

VeSTAL
Start date: August 23, 2019
Phase: N/A
Study type: Interventional

A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS), combined with a lifestyle modification program, compared to a sham control and a lifestyle modification program as a means of reducing excess body weight and body fat. The purpose of this investigation device study is to collect data to support regulatory submissions, primarily in the United States of America (USA), but it may also be used to support submissions in other regions, including the European Union (EU).

NCT ID: NCT03639831 Completed - Mood Disorders Clinical Trials

ACUTE AND CHRONIC EFFECTS OF A BOTANICAL EXTRACT ON ANXIETY, PERCEIVED STRESS, MOOD AND CORTISOL IN HEALTHY ADULTS

Start date: November 6, 2017
Phase: N/A
Study type: Interventional

Mood disorders, including depression and anxiety, are one of the main causes of the overall disease burden worldwide. In recent years, the efficacy of certain botanicals as an alternative solution for depression has been evaluated in a number of clinical trials. However, only few studies looked at the effects of these botanicals on mood in healthy subjects. The aim of the proposed randomised, double-blind, placebo-controlled, parallel groups methodology is to assess the acute and chronic effects of daily supplementation with a proprietary and standardized botanical extract in comparison to placebo in healthy adults aged 18-60 years with self-reported low mood.

NCT ID: NCT03638895 Completed - Obesity Clinical Trials

Energy Expenditure From ECAL Indirect Calorimeter in a Multicomponent Weight Management Service

ECAL
Start date: November 28, 2018
Phase: N/A
Study type: Interventional

Whether greater weight loss is as a result of a smaller reduction in energy expenditure with caloric restriction is not known. Resting energy expenditure and 24-hour energy expenditure vary substantially between individuals. In some cases, relatively reduced rates of 24h EE predict weight gain in some populations who have high prevalence of obesity. Obese individuals that lose weight experience a decrease in 24-h EE and resting energy expenditure that is lower than predicted based on changes in body composition. Most weight loss studies have found a large individual variation in the amount of weight change, and whether an individual's response to an intervention can be predicted is not clear. Measurements of 24-hour EE in response to fasting may help predict weight loss. The ECAL indirect calorimeter (ECAL) is a validated device purpose-built to provide the practitioner and patient with energy information that allows for more accurate, reliable method of establishing an obese individuals' metabolic profile. The aim of this study is to determine whether providing energy information from ECAL indirect calorimeter as an adjunct to the multicomponent weight management intervention in non-diabetic obese and severely obese individuals would help predict the response of weight loss.

NCT ID: NCT03638440 Completed - Clinical trials for Opioid Induced Constipation

Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With OIC.

NACASY
Start date: August 16, 2018
Phase:
Study type: Observational

This is a single-arm, open label, multinational, multicentre, prospective, real world observational study of Naloxegol in adult subjects with Opioid Induced Constipation (OIC) in patients receiving Naloxegol in routine clinical practice. Subjects who are receiving Naloxegol (prescribed by their physician according to the SmPC, which recommends that all currently used maintenance laxative therapy should be halted) during the enrolment period may be eligible for enrolment into the study.

NCT ID: NCT03638401 Completed - Transplant Surgery Clinical Trials

Epidural vs. Wound Catheter Following Liver Resection

Start date: March 3, 2014
Phase: N/A
Study type: Interventional

Good postoperative pain control after any major surgery allows early mobilization, minimises postoperative complications and reduces patient distress. Multiple different methods of delivering analgesia have been described. This study aims to compare postoperative pain control between patients with epidural analgesia versus the combination of continuous infiltration of local anaesthetic with wound catheters, TAP block and IV PCA with opiate analgesia following open liver resection. The investigators expect that pain control will be similar between the two groups but that the utilization of wound catheters will confer benefit due to the lack of systemic side effects associated with epidural analgesia

NCT ID: NCT03638349 Completed - Clinical trials for Diabetes Mellitus ( Type 1 and Type 2)

Actions & Insights Evaluating a Novel Diabetes Management Solution

ASCEND
Start date: July 17, 2018
Phase:
Study type: Observational

Single visit outcome study to obtain qualitative and quantitative data for a new BGMS.

NCT ID: NCT03637647 Completed - Clinical trials for Upper Gastrointestinal Disorders

CPET and Outcome After Oesophagogastric Cancer Surgery

Start date: June 1, 2012
Phase:
Study type: Observational [Patient Registry]

Primary Aim: The present study is a retrospective analysis of prospectively collected clinical data. Anonymized data from patients collected during routine clinical care from 9 units in the United Kingdom who undertake upper gastrointestinal (UGI) cancer surgery and perform pre-operative cardiopulmonary exercise testing will be interrogated. Data will be pooled at a central location (University Hospitals Southampton) and used to investigate the relationship between selected cardiopulmonary exercise testing (CPET) variables, in-hospital post-operative and survival outcomes after major UGI cancer surgery. Rationale: Our primary aim is to establish a reliable relationship between post-operative survival (1 and 3 -year) and oxygen uptake (VO2) at peak exercise (VO2 Peak); a secondary aim is to explore the multivariable relationship between selected CPET variables especially VO2 at the estimated lactate threshold/anaerobic threshold (AT), together with other selected CPET derived variables, and other important prognostic variables with post-operative complications (morbidity and mortality) in an attempt to risk stratify patients before major UGI surgery. Trial Design: Multicentre observational Inclusion Criteria: We aim to include all patients aged >18 years considered eligible by the MDT for major curative UGI cancer surgery and undergoing an enhanced recovery programme after surgery. Patients undergoing neoadjuvant chemotherapy or chemoradiotherapies will also be included. Patients having a CPET and initially scheduled for curative surgery, but end up not having surgery due to disease progression or other clinical reasons will be included and analysed separately. Exclusion Criteria: Patients will be excluded if they are physically unable to perform a CPET on a cycle ergometer, patients having emergency surgery, patients lacking complete in-hospital morbidity or mortality data and patients undergoing preoperative exercise interventions. Primary Trial Endpoints: 3 year overall survival

NCT ID: NCT03637036 Completed - Clinical trials for Influenza Vaccination

An Improvement Project Around Staffs' Influenza Vaccine Uptake

Start date: September 24, 2018
Phase: N/A
Study type: Interventional

To reach seasonal vaccination against influenza targets, University Hospitals Birmingham (UHB) already invites staff to take up the vaccination, and every November reminds staff that have not yet vaccinated to do so. The current protocol describes a randomized controlled trial (RCT) in which staff will be sent different reminders, and the investigators will compare the proportion of staff that go on to vaccinate after receiving each reminder.

NCT ID: NCT03636906 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV

Start date: April 8, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to provide critical information on the safety, reactogenicity and immunogenicity profile of the investigational recombinant chimpanzee adenovirus Type 155-vectored RSV (ChAd155-RSV) vaccine in infants likely to be unexposed to RSV and will assess a single lower dose and a higher two dose regimen, before moving to future studies. This study will also assess if there is a risk of 'vaccine-induced enhanced RSV disease' after vaccination of these infants with the ChAd155-RSV vaccine.