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NCT ID: NCT03086330 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus

SUSTAIN 9
Start date: March 15, 2017
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. Subjects will remain on their pre-trial medication.

NCT ID: NCT03086096 Completed - Neoplasm Metastasis Clinical Trials

CIRSE Registry for LifePearl Microspheres

CIREL
Start date: February 2, 2018
Phase:
Study type: Observational [Patient Registry]

The application of transarterial chemoembolisation (TACE) using LifePearl Microspheres loaded with Irinotecan in liver-only or liver-dominant metastatic disease in patients with colorectal adenocarcinoma will be observed. The registry has the following objectives: 1. map the exact indications that the device is being used for and at which stage in treatment it is being applied 2. to assess observed treatment outcomes in terms of safety and effectiveness as well as trying to determine any predictive response factors

NCT ID: NCT03085810 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)

Start date: March 24, 2017
Phase: Phase 3
Study type: Interventional

This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will consist of an open-label treatment period of 192 weeks and follow-up period of at least 48 weeks. The optional shorter infusion substudy will evaluate the safety of a shorter infusion of ocrelizumab in a subgroup of participants with early stage RRMS enrolled in the main MA30143 study. Approximately 700 patients will be enrolled in the substudy, and will receive additional 600 mg ocrelizumab administered in a shorter time frame.

NCT ID: NCT03085095 Completed - Prostate Cancer Clinical Trials

A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer

HERO
Start date: April 18, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of relugolix 120 milligrams (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (< 50 nanograms/deciliter [ng/dL]) in participants with androgen-sensitive advanced prostate cancer.

NCT ID: NCT03082066 Completed - Emergencies Clinical Trials

Soft Tissue and Bone Diameter in Children and Adults for Intraosseus Access

Start date: March 15, 2017
Phase:
Study type: Observational

Retrospective observational study: Soft tissue and bone diameters are assessed in MRI and CT scans of patients. Data is compared with recommendations of intraosseus needle producers to assess whether the information provided by the producers can be optimised. Study sites are head of humerus bone, distal femur, proximal and distal tibia in accordance with recommended intraosseus access sites. Primary and secondary outcome parameters will be assessed at one time only, i.e. when the patient has received MRI or CT scan for the diagnostic work up of their primary disease. Data collection for a given patient in this study can be completed within one session, e.g. 5-10 minutes. No additional investigation is required for this retrospective study.

NCT ID: NCT03078907 Completed - Clinical trials for Pulmonary Arterial Hypertension

Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.

TRACE
Start date: November 8, 2017
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to evaluate the effect of selexipag on the physical activity of patients with pulmonary arterial hypertension (PAH) in their daily life, by using a wearable wrist device (actigraph). The actigraph will collect data on daily life physical activity in the patient's real environment. In addition, the PAH symptoms and their impacts will be assessed by using an electronic patient reported outcome measure in the patient's real environment. Patients will be assigned randomly to either selexipag or placebo.

NCT ID: NCT03078101 Completed - Clinical trials for Diabetes Mellitus, Type 2

EMPRA (EMPagliflozin and RAs in Kidney Disease)

EMPRA
Start date: April 15, 2017
Phase: Phase 2
Study type: Interventional

This study will be a prospective, clinical pilot study in CKD patients to show whether Empagliflozin in addition to ACEi treatment significantly increases Ang 1-7 levels compared to ACEi treatment alone. Null and alternative hypotheses: H0: Empagliflozin in addition to ACEi treatment does not increase Ang 1-7 levels more than ACEi treatment alone. H1: Empagliflozin in addition to ACEi treatment significantly increases Ang 1-7 levels compared to ACEi treatment alone Methodology: Two groups of 24 chronic kidney disease (CKD) patients, respectively, with and without type 2 diabetes will be randomized into the study medication or placebo group. The number of patients per treatment arms is n = 12. Included and consented patients will be subjected to an initial 2-week run-in period for conversion of current RAS blocking medications to ACEi therapy with enalapril or ramipril and respective dose titration to 10 mg enalapril 2 x daily and 10 mg ramipril 1 x daily. Additional antihypertensive medication will be standardized as feasible, with the primary goal of keeping blood pressure as recommended by KDIGO. Following the 2-week run-in phase, all study patients will be subjected to blood collection including the first RAS quantification (RAS Fingerprint) and assessment of HDL composition, as well as urinary analysis and bioimpedance fluid status assessment (BCM measurement). Subsequently, patients will be randomized to either receive empagliflozin (at a dose of 10 mg daily) or placebo. Subsequently, biweekly study visits including electrolyte and glucose (plasma and urine) monitoring as well as BCM measurement will take place. After 12 weeks of study medication intake, a concluding study visit will be scheduled for final RAS quantification (RAS Fingerprint) and HDL analyses as well as final blood and urinary analysis and BCM measurement. Initially, blood and urine will be collected at the clinical visit as part of the routine blood obtainment (no additional effort on patients). From these routine measurements we will be able to extract information regarding the patient's current CKD stage as well as other relevant laboratory parameters (e.g. HbA1c, UACR, etc.). Furthermore, we will document the patient's current medication and significant comorbidities. Primary analysis variable/endpoint: The difference of Ang 1-7 increase from baseline between a 3-month treatment with empagliflozin on top of ACEi treatment compared to ACEi treatment alone Most important secondary analysis variables/endpoints: 1. Simultaneous quantitative changes of multiple RAS effector angiotensin levels determined by mass-spectrometry 2. Recurrence of Ang II levels determined by mass-spectrometry 3. HDL parameters (protein composition of HDL) 4. Renal parameters (albuminuria reduction measured by urinary albumin-creatinine ratio (UACR), renal function (estimated glomerular filtration rate (GFR), serum-creatinine) 5. Urinary electrolyte levels 6. Urinary glucose levels 7. Urinary RAS metabolites (angiotensinogen, ACE and ACE2 levels, ACE2 activity) 8. Blood pressure determined by ambulatory blood pressure measurements 9. Body volume determined by bioimpedance fluid status assessment (BCM measurement) 10. OCR and ECAR in PBMCs determined by Seahorse Flux Analyzer 11. Assessment of reduction of salt sensitivity by using salt sensitivity test with empagliflozin

NCT ID: NCT03077412 Completed - Clinical trials for Fistulizing Crohn's Disease

Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease

Divergence2
Start date: April 6, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of filgotinib as compared to placebo in establishing combined fistula response at Week 24. Participants will have the option to enter a separate Long-Term Extension (LTE) study (GS-US-419-3896; NCT02914600) if they meet eligibility requirements.

NCT ID: NCT03077165 Completed - Venous Leg Ulcer Clinical Trials

Dose-response Relationship Study of S42909 on Leg Ulcer Healing

Start date: September 12, 2017
Phase: Phase 2
Study type: Interventional

Dose-response relationship study of S42909 on leg ulcer healing after oral repeated administration in patients with active venous leg ulcer.

NCT ID: NCT03075215 Completed - Heart Failure Clinical Trials

Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry

SMART Registry
Start date: April 14, 2017
Phase:
Study type: Observational [Patient Registry]

To learn in a general Cardiac Resynchronization Therapy Defibrillators (CRT-D) population, which optimization techniques are used and how effective they are. It will compare 12-month response rates among different optimization methods and characterize which selected subject subgroups achieve better response than others. A subset of SMART Registry subjects will contribute to the NG4 Post Market Clinical Follow Up (PMCF) Cohort whose objective is collecting data on the NG4 CRT-D features and device usage in a real world setting and monitor long term safety associated with these devices to support CE Mark.