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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: NCT03812887 Recruiting - Photoallergy Clinical Trials

Photopatch Test Study (POST Study)

POST
Start date: September 1, 2018
Phase:
Study type: Observational

In the year 2000, a group of specialists with an interest in contact dermatitis and photobiology/photophysics set up a taskforce under the umbrella of the European Society for Contact Dermatitis and the European Society for Photodermatology. This came about as a result of an awareness, that photopatch testing was under-used, there were inconsistencies in methodology and scoring of results, and there was a lack of up-to-date choice of test photoallergens. A consensus on the methodology of photopatch testing arose from this, although some inconsistencies on the methodology could not be solved and variations on the technique were accepted. Since then a European multicentre photopatch test study (EMCPPTS) was conducted in 30 clinics from 2008-2011. The EMCPPTS test agents comprised 19 UV absorbers, and 5 topical non-steroidal anti-inflammatory drugs available in Europe. More than 1,000 patients took part in this study that showed that ketoprofen and related chemicals and classical UV-filters were the main photoallergens. Since then the taskforce have met again (2012) and on the basis of the results of the ECMPPTS, on previous publications reporting cases of photoallergic contact dermatitis, and on the presence or absence of these agents in consumer products within the European market or other accessible markets, 20 substances were chosen to form the baseline European photopatch test series. Fifteen additional substances were chosen to be included in the extended photopatch test series which may be used as an additional screen alongside patients' own product. Twenty-six other agents that are no longer produced or are no longer used in the European markets have been considered to be no longer relevant for regular photopatch testing and were removed. It was suggested from this taskforce that the study should be repeated in approximately five years, as it is expected that new photoallergens will continue to emerge despite pre-marketing screening measures. Therefore members of this taskforce subsequently met in 2015, to discuss the aim of performing a very similar study, commencing in 2016. However, the investigators aim to focus specifically on methodology as in all previous studies a variety of methods of photopatch testing have been utilised. The investigators therefore aim to improve standardisation of this test. This agreed methodology will therefore enable better comparative studies in the future and hopefully encourage greater numbers of would-be users of this form of patch testing, as due to a previous level of uncertainty, many general dermatologists have been discouraged from using this technique.

NCT ID: NCT03809325 Recruiting - Schizophrenia Clinical Trials

A Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly

Start date: November 21, 2018
Phase:
Study type: Observational

The purpose of this study is to explore the experience with paliperidone palmitate 3-month formulation (PP3M) treatment of participants and their corresponding physicians, nurses and carers, to understand the impact of less frequent injections from their perspective.

NCT ID: NCT03807518 Not yet recruiting - Clinical trials for Exercise Intervention

Randomised Controlled Trial for Pre- and Post-Operative Exercise Program in Upper Gastrointestinal Cancers

Start date: January 31, 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: NCT03800251 Recruiting - Pregnancy Clinical Trials

Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section

Start date: June 6, 2018
Phase: N/A
Study type: Interventional

The aim of the study is to use sequential ultrasound evaluation of the gastric volume to determine how long it takes for the stomach of a fasting pregnant woman at term, admitted for elective cesarean section, to empty after ingesting a 400ml carbohydrate drink (Nutricia preOp).

NCT ID: NCT03775291 Recruiting - Sleep Apnea Clinical Trials

Validation of Wrist-worn Sensor Device for Assessment of Sleep Apnea

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

This clinical validation study aims to evaluate the utility of Fitbit's Sleep Apnea Alert software for minimally invasive monitoring of sleep apnea events to alert users of their risk of sleep apnea. The Sleep Apnea Alert software analyses data from a Fitbit commercially available wrist photoplethysmogram (PPG) device. The Sleep Apnea Alert software is an investigational software as medical device (SaMD) and is designed to retrospectively process data and flag users in which have physiological signals consistent with subjects who have an apnea-hypopnea index (AHI) of 10 or greater. This clinical validation study will be used to validate Fitbit's PPGbased sleep apnea algorithm. The outputs of the Fitbit Sleep Apnea Alert software will not be available to study participants, as the scope of this study is to gather validation data only and does not include testing product usability components.

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: NCT03744598 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Self-monitoring of Spirometry & Symptoms Via patientMpower App in Idiopathic Pulmonary Fibrosis

Start date: November 28, 2018
Phase:
Study type: Observational

Single-arm, open-label observational study in idiopathic pulmonary fibrosis (IPF) patients receiving usual care at an interstitial lung disease specialist center. The objectives are [1] to characterise the longitudinal trends of patient-measured Forced Vital Capacity (FVC) and impact of IPF on daily life Patient Reported Outcome Measures (PROM) in a cohort of patients with IPF [2] to determine the correlation (if any) between patient-measured FVC and PROMs with clinic-observed measurements and [3] to assess if longitudinal trends in patient-measured FVC are predictive of clinical health outcomes in IPF. An additional purpose is to assess the acceptability and utility of the patientMpower app in helping IPF patients and their healthcare professional caregivers manage their condition. Patients will record FVC, symptoms (e.g. dyspnea) and activity (step count) daily and PROM once a week on the patientMpower app. The planned observation period is sixteen weeks. No additional clinic visits are required (versus usual care). In-clinic assessments of lung function, dyspnea and PROM will be done at baseline and study end. Patients and healthcare professionals will provide their opinion on utility and acceptability of patientMpower app at study end.

NCT ID: NCT03739515 Recruiting - Clinical trials for ED-based Allied Health Services

Impact of an Allied Health Team in the Emergency Department on Older Adults' Care

Start date: December 3, 2018
Phase: N/A
Study type: Interventional

The study aims to examine the impact of implementing a dedicated team of Health and Social Care Professionals (HSCPs) in the emergency department (ED) of a large Irish hospital on the quality, safety and cost-effectiveness of care for older adults (aged ≥65). Early assessment and intervention provided by the HSCP team will be compared to routine ED care to explore potential benefits related to key ED outcomes, including length of stay as well as hospital admissions and patient satisfaction/quality of life. This study is part of an ongoing interdisciplinary project funded by the Health Research Board of Ireland through the Research Collaborative on Quality and Patient Safety (RCQPS) Grant Call 2017. The project is led by Dr Rose Galvin, Senior Lecturer in Physiotherapy at the University of Limerick (UL, Ireland), and overseen by an interdisciplinary steering group of expert researchers and clinicians in Emergency Medicine and Allied Health.

NCT ID: NCT03735537 Recruiting - Clinical trials for Osteogenesis Imperfecta

Treatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic Acid

TOPaZ
Start date: November 1, 2016
Phase: Phase 4
Study type: Interventional

Osteogenesis imperfecta (OI) is an inherited skeletal disorder characterised by increased risk of fragility fractures. Bisphosphonates are frequently prescribed for adult patients with OI with the aim of preventing fractures but the evidence base for efficacy is poor. Recent evidence suggests that the bone anabolic agent teriparatide (TPTD) increases bone mineral density (BMD) and may have the potential to prevent fractures in OI. The purpose of the TOPaZ Trial is to investigate if a a two-year course of teriparatide (TPTD) followed by antiresorptive therapy with a single infusion of zoledronic acid (ZA) in adults with OI reduces the proportion of patients who experience a fracture as compared with standard care Adult patients with a clinical diagnosis of OI who are willing and able to give informed consent and who do not have contraindications to the study medications will be recruited from participating sites. Participants will be randomised 1:1 to receive either standard care for the duration of the trial or TPTD for 24 months followed by a single infusion of ZA, or another antiresorptive agent in the event that ZA is contraindicated. Participants will attend recruiting centres for a Baseline/Screening visit, at 12 months, 24 months and at the end of the trial for formal study visits with telephone calls every 6 months from a site research nurse. Participants randomised to TPTD will also attend recruiting centre at regular intervals during the 24 month treatment period to collect new supplies of TPTD.