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NCT ID: NCT03751657 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to Compare Insulin 287 Once a Week to Insulin Glargine (100 Units/mL) Once a Day in People With Type 2 Diabetes.

Start date: November 29, 2018
Phase: Phase 2
Study type: Interventional

The study compares 2 medicines for people with type 2 diabetes: insulin 287 (a new medicine) and insulin glargine (a medicine doctors can already prescribe). The study doctors will test insulin 287 to see how well it works compared to insulin glargine. The study will also test if insulin 287 is safe. The study participants will either get insulin 287 or insulin glargine (100 units/mL) - which treatment the participants get is decided by chance. The participants will need to inject their selves every day about the same time. Once a week the participant will need to take 1 extra injection on the same day of the week. The participants will have 16 clinic visits and 14 phone calls with the study doctor. During the study, the doctors will ask you to: 1) measure your blood sugar every day with a blood glucose meter using a finger prick, 2) write down different information in a paper diary daily and return this to your doctor, 3) wear a medical device to measure your blood sugar all the time for 2 weeks 5 times during the study.

NCT ID: NCT03747432 Completed - Clinical trials for Transcatheter Aortic Valve Replacement

Comparison of Procedural Sedation With Propofol and Dexmedetomidine During Transcatheter Aortic Valve Implantation

Start date: January 15, 2019
Phase: Phase 4
Study type: Interventional

Aortic valve stenosis is the most common valvular heart disease in the developed world, affecting 3,9% of population over 70 years of age. If untreated it carries a poor prognosis, leading to heart failure and death in 2 years after first symptom presentation. Treatment of choice for severe aortic stenosis is surgical aortic valve replacement. A new treatment option for severe aortic stenosis emerged in the last decade - Transcatheter Aortic Valve Replacement (TAVR). This minimally invasive method was formerly reserved for high risk patients deemed unfit for surgical aortic valve replacement. Increasing use throughout the developed world and recent studies have established TAVR as a safe and viable treatment option also for intermediate-risk patients. TAVR not only enables a less aggressive surgical approach, but also a less invasive type of anaesthesia. Anaesthesiologists are trying to modify the type of anaesthesia in the way of minimally invasive approach, aiming to improve the overall outcome. TAVR can be performed under general anaesthesia or procedural sedation (PS). From the start, TAVR was performed solely under general anaesthesia. Over time the procedure became routine and the anaesthesiologists started to commonly decide for PS. Many US and European retrospective studies have established PS to be a safe and compelling method of anaesthetic care for TAVR procedures with a favorable perioperative course, less complications, shorter intensive care unit and in-hospital stay and lower early mortality, when performed by an experienced anaesthesia team. There are many anaesthesia agents currently accepted for PS in everyday anaesthesia practice. Presently, reliable data from studies comparing different agents for PS for TAVR procedures is scarce. Most of it comes from retrospective nonrandomized trials. Propofol is a popular anaesthetic agent for PS. According to current studies, it is a safe anaesthetic agent with favorable pharmacokinetic and pharmacodynamic profiles with quite low incidence of side effects. In recent years, dexmedetomidine has been commonly used for PS having analgesic properties inclusive of its anaesthetic properties. In addition, dexmedetomidine is associated with a lesser degree of respiratory depression as to other anaesthetic agents. Patient comfort is also believed to be improved with dexmedetomidine. Studies comparing outcomes of PS with propofol versus dexmedetomidine for different non-cardiac and interventional procedures showed benefits of dexmedetomidine, owing to its analgesic properties and preferable respiratory parameters. The aim of this study is to compare the outcome of patients undergoing TAVR under PS with dexmedetomidine against those undergoing TAVR under PS with propofol. With the results the investigators aim to aid in defining the optimal anaesthetic agent for PS for TAVR and possibly other interventional cardiology procedures.

NCT ID: NCT03746275 Completed - Atherosclerosis Clinical Trials

Study to Gain Insights in Treatment Patterns and Outcomes in Patients With Atherosclerosis Prescribed to Xarelto in Combination With Acetylsalicylic Acid

XATOA
Start date: November 13, 2018
Phase:
Study type: Observational

In this study researchers want to gain more information on treatment patterns of patients treated with Xarelto in combination with acetylsalicylic acid (ASA). Both drugs reduce the risk of blood clots via different pathways. The study will enroll adult patients suffering from coronary artery disease (narrowing or blockage of vessels that supply the heart with blood) or peripheral artery disease (narrowing or blockage of vessels that supply the legs or head with blood). The study will focus on information on when and why physicians are starting to treat patients with Xarelto in addition to ASA, treatment duration, reasons to discontinue treatment and previous therapies. The study will also look into treatment outcomes for patients being treated with a combination of Xarelto and ASA by their physicians.

NCT ID: NCT03738761 Completed - Hypertension Clinical Trials

Management of Newly Diagnosed and Uncontrolled Hypertension With Fixed-Dose Combination of Perindopril/Amlodipine and Perindopril/Indapamide/Amlodipine

PRECIOUS
Start date: February 13, 2018
Phase: Phase 4
Study type: Interventional

PRECIOUS Study aims to evaluate the efficacy and safety of therapy with fixed-dose combination (FDC) of perindopril/amlodipine (Amlessa®) and FDC of perindopril/indapamide/amlodipine (Co-Amlessa®) on blood pressure reduction in both previously untreated patients and patients with previous antihypertensive therapy. Adult patients with AH who are treatment-naïve with systolic blood pressure (SBP) from 150 mmHg or higher AND/OR diastolic blood pressure (DBP) from 95 mmHg or higher (SBP ≥ 150 mm AND/OR DBP ≥ 90 mmHg for patients with type 2 diabetes mellitus ) and uncontrolled patients on mono, dual or triple antihypertensive therapy with systolic blood pressure (SBP) from 140 mmHg or higher AND/OR diastolic blood pressure (DBP) from 90 mmHg or higher (SBP ≥ 140 AND/OR DBP ≥ 85 mmHg for patients with type 2 diabetes mellitus) will be invited to participate in this study. During 16-week trial, seven study visits are planned. At first study visit physical examination, medical history, BP measurement, electrocardiogram (ECG), laboratory analysis and of Ambulatory Blood Pressure Measurement (ABPM) will be performed. Based on their previous antihypertensive therapy, patients will receive to treatment with either Amlessa® or Co-Amlessa® for the duration of 16 weeks and blood pressure measurements, laboratory investigations and patient interviews will be performed at study follow-up visits to assess the treatment efficacy (proportion of patients reaching normal office blood pressure after 16 weeks of treatment) and safety.

NCT ID: NCT03733366 Completed - Clinical trials for Office Desk Ergonomics

Thermal Comfort of Different Desktop Materials

Materials
Start date: November 5, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to test the suitability of different types of desk surfaces. The investigators will test 10 different surfaces (oak-ruff, oak-varnished, oak-oiled, spruce-ruff, spruce-varnished, spruce-oiled, particleboard laminate, particleboard veneer, corian and glass). Firstly, the investigators will perform tests to assess physical characteristics of the materials (thermal conductivity, hardness, roughness, skid measures). Secondly, the investigators will measure the participants' forearm skin temperature after 20-minutes of using each desk surface. During those 20 minutes the participants will solve an attention test.

NCT ID: NCT03729362 Completed - Clinical trials for Pompe Disease (Late-onset)

A Study Comparing ATB200/AT2221 With Alglucosidase Alfa/Placebo in Adult Subjects With Late-onset Pompe Disease

PROPEL
Start date: December 4, 2018
Phase: Phase 3
Study type: Interventional

This is a phase 3 double-blind randomized study to study the efficacy and safety of intravenous ATB200 Co-administered with oral AT2221 in adult subjects with Late Onset Pompe Disease compared with Alglucosidase Alfa/placebo.

NCT ID: NCT03689374 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes

SUSTAIN 11
Start date: October 1, 2018
Phase: Phase 3
Study type: Interventional

This study will compare the effect of semaglutide once weekly to insulin aspart 3 times daily as add on to metformin and insulin glargine in people with type 2 diabetes. Participants will either get insulin glargine and semaglutide or insulin glargine and insulin aspart - which treatment the participant get is decided by chance. Insulin glargine is taken once a day and semaglutide once a week. Insulin aspart is taken three times per day before a meal. All three medicines come in pre-filled pens for injection under the skin. The study will last for about 71 weeks. If participant's blood sugar gets under or over certain values participant will only participate in 14 weeks. The study doctor will inform the participant about this. The participant will have 15 clinic visits and 22 phone calls with the study doctor.

NCT ID: NCT03684148 Completed - Clinical trials for Osteo Arthritis Knee

Effects of Motor Imagery Intervention on Functional Recovery Following Total Knee Arthroplasty

KSV2017
Start date: August 21, 2017
Phase: N/A
Study type: Interventional

The knee osteoarthritis becoming a leading cause of disability among older adults' population. When conventional treatments fail, a total knee arthroplasty (TKA) is suggested. Although TKA treatment significantly reduces pain and improve mobility of patients, there is still high prevalence of patients whose neuromuscular function is impaired up to three years following TKA, which can be directly prescribed to poor or/and inadequate rehabilitation practice. Thus, motor imagery (MI) is proposed as additional rehabilitation tool to convention physical therapy to reduce decline of neuromuscular function in early days post-surgery. Recent studies showed that MI could facilitate learning and acquisition of motor skills, as well as maintain and retain previously acquired motor skills, which may be beneficial for those who undergo TKA. It represents an incentive in the process of motor learning and the transfer of the mental scheme of the motion pattern into the process of movement execution. Measuring neuromuscular function pre- and post-TKA could be unique opportunity to provide empirical evidence about its additional therapeutic effects. Outcomes of proposed research project could serve to improve existing intervention programs applied in rehabilitation protocols following TKA surgery as well as other orthopedic interventions. This would also contribute to the successful return of individuals after an injury to their everyday working routine. We hypothesized that MI practice group will experience better both subjective and objective measures of functional performance compared to control group that will be subjected to routine physical therapy only.

NCT ID: NCT03667053 Completed - Hypoglycemia Clinical Trials

Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children

Start date: September 28, 2018
Phase: Phase 3
Study type: Interventional

A phase 3, randomized, double-blind, placebo- and active-controlled, parallel-arm trial to assess the efficacy, safety, and pharmacokinetics of dasiglucagon relative to placebo and GlucaGen® when administered as a rescue therapy for severe hypoglycemia in children with type 1 diabetes mellitus (T1DM) treated with insulin

NCT ID: NCT03663569 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Study on the Control of Chronic Obstructive Pulmonary Disease (COPD) in Patients Taking the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler

Start date: August 15, 2018
Phase:
Study type: Observational

Open-label observational study which includes COPD patients that are receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations.