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NCT ID: NCT03290781 Not yet recruiting - Ulcerative Colitis Clinical Trials

Study of the Effect of SHP647 as Maintenance Treatment in Participants With Moderate to Severe Ulcerative Colitis Who Achieved Clinical Response in Induction Studies

FIGARO UC 303
Start date: February 22, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of SHP647 as maintenance therapy in participants with moderate to severe ulcerative colitis (UC) who achieved clinical response in induction studies. This is a phase 3, randomized, double-blind, placebo-controlled, parallel-group efficacy and safety study.

NCT ID: NCT03283085 Not yet recruiting - Ulcerative Colitis Clinical Trials

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis (AIDA)

Start date: January 22, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of long-term treatment with SHP647 in participants with moderate to severe Ulcerative Colitis (UC).

NCT ID: NCT03268005 Recruiting - Diabetes Clinical Trials

Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes

onset 9
Start date: September 19, 2017
Phase: Phase 3
Study type: Interventional

The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe). Fast-acting insulin aspart will be tested to see how well it works and if it is safe. Participants will get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is decided by chance. Both medicines will be taken together with insulin degludec. Participants will need to take 1 injection 4 times every day (all insulins will be provided in pens). The study will last for about 8 months (34 weeks).

NCT ID: NCT03259334 Not yet recruiting - Ulcerative Colitis Clinical Trials

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

Start date: November 30, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).

NCT ID: NCT03253237 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

Primary Care - Continuous Glucose Monitoring

PC-COSMO
Start date: August 1, 2017
Phase: N/A
Study type: Observational

Introduction and objective: The key to optimal diabetes management is tight glucose control. Hemoglobin A1c is the gold standard to assess glycemic control but in cases of unrecognized hypoglycemia, confusing nighttime events or in cases of large variations in blood glucose, a haemoglobin A1c can not detect specific movement of blood glucose. Continuous glucose monitoring (CGM) provides informations of glucose levels in a real-time format and may be helpful for making the personalized therapy decisions desired in the era of precision medicine. Our aim is to analyse the benefit of tracking patterns of glucose values by using continuous glucose monitoring (CGM) in patients with T2DM in family medicine office.

NCT ID: NCT03231813 Completed - Clinical trials for Irritant Contact Dermatitis

Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery

Start date: August 29, 2017
Phase: N/A
Study type: Interventional

Irritant contact dermatitis induced by sodium lauryl sulphate (SLS) is often used as a model for testing efficacy of various topical preparations. Aforementioned model is standardized and described in guidelines, but it is not explicitly stated where the irritation should be induced. Published clinical trials usually irritate volar aspect of forearms or upper back. Also, lower back and dorsal aspect of forearm are sometimes used. Skin parameters vary depending on anatomic location of measured skin. There is a difference in stratum corneum thickness, hydration and transepidermal water loss across different locations, including between volar forearm and upper back. Furthermore, regional difference in skin response to irritation by tape stripping and benzalkonium chloride were observed. Such differences are also possible in SLS irritation model. One study has shown higher, but not statistically significant, response of back in comparison to forearms, but it had a very small sample size (n=9). Moreover, there are regional variations of topical preparations absorption. Hydrocortisone had 1,7 times higher absorption when applied to upper back in comparison to forearms. Those variations could be explained by different corneocyte size and number of their layers between back and hands. Skin baseline properties and response to irritation seem to be dependent on anatomic position. Those differences could mean different response to treatment. Since published trials only tested efficacy of various preparations on one anatomic location, it is possible their results would be different if tested on other body parts. It could limit validity and usefulness of conducted trials. The aim of this study is to determine if there are regional differences of skin response to irritation and emollient cream treatment in irritant contact dermatitis model.

NCT ID: NCT03222596 Completed - Pain Clinical Trials

The Impact of Exercise Training on Living Quality in Multiple Sclerosis Individuals

Start date: July 14, 2017
Phase: N/A
Study type: Interventional

The most common symptom displayed in patients with multiple sclerosis (MS) is a pronounced sense of fatigue that can have negative effect on functional ability and quality of life (QOL). An important goal of researchers and clinicians involves improving the QOL of individuals with MS, and the exercise therapy represents potentially modifiable behavior that positively impacts on pathogenesis of MS and thus the QOL. However, the main barrier for its application is low motivational level that MS patients experience due to fatigue with adjacent reduced exercise tolerability and mobility, and muscle weakness. Getting individuals with MS motivated to engage in continuous physical activity may be particularly difficult and challenging, especially those with severe disability or Expanded Disability Status Scale (EDSS 6-8). Till now, researchers have focused their attention mainly on the moderate or vigorous intensity of exercise and on cardiorespiratory training in MS patients to achieve improvements in daily life quality, less indicating the exercise content, and most importantly, breathing exercises. In addition, it is investigators intention to make exercise for MS patients more applicable and accessible, motivational and easier, but most important, productive. Investigators think that MS patients experience more stress with aerobic exercise or moderate to high intensity programme exercise, and can hardly keep continuum including endurance exercise, or treadmill. Hypothesis: Investigators hypothesis is that 4-weeks of continuous low demanding or mild exercise programme with specific content and an accent on breathing exercise can attenuate primary fatigue in MS patients, especially in those with more severe disability or EDSS from 6-8, and provide maintenance of exercise motivation. Investigators also propose that important assistant factor for final goal achievement is social and mental support of the exercise group (EDSS from 0-8) led by a physiotherapist. This will help to maintain exercise motivation and finally make better psychophysical functioning, and thus better QOL.

NCT ID: NCT03203343 Recruiting - Surgery Clinical Trials

Inflammatory Stress Response in Pediatric Inguinal Hernia Repair

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

Today there are various surgical techniques for inguinal hernia. In this study, investigators want to compare the ''PIRS'' operating technique laparoscopy and modified "Marcy" operating technique with open inguinal access. Investigators would compare both groups to find out witch one does the lesser inflammatory stress response on the organism.

NCT ID: NCT03196284 Recruiting - Clinical trials for Congenital Bleeding Disorder

A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors

explorerâ„¢4
Start date: August 10, 2017
Phase: Phase 2
Study type: Interventional

This trial is conducted in Africa, Asia, Europe and North America. The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in haemophilia A and B patients with inhibitors.

NCT ID: NCT03179137 Recruiting - Clinical trials for Coronary Artery Disease

Mitochondrial Bioenergetics and Role in Cellular Damage in Ischemic Myocardium

Start date: October 1, 2016
Phase: N/A
Study type: Observational

Cardiac ischemia is a common pathological condition, known to elicit multiple pathological processes at the cellular level. One of the most affected is thought to be cellular metabolism, key for the adequate cardiac function. The aim is to study mitochondrial bioenergetic function, interaction with other cellular systems and influence of several co-morbidities in myocardium of the affected patients.