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NCT ID: NCT03524092 Active, not recruiting - Ulcerative Colitis Clinical Trials

A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis

LUCENT 2
Start date: October 19, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).

NCT ID: NCT03523039 Completed - Cardiac Arrest Clinical Trials

Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome

CATCH
Start date: February 18, 2019
Phase: N/A
Study type: Interventional

This prospective single-centre randomized control trial aims at evaluating the safety and efficacy of hemoadsorption with CytoSorb® in 40 patients with Post-Cardiac Arrest Syndrome admitted to the ICU.

NCT ID: NCT03522519 Completed - Stroke Clinical Trials

Predicting Real World Physical Activity and Upper Limb Use After Stroke

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

Poststroke recovery mainly takes place within the first weeks to months and about 95% of the patients reach their maximum recovery 3 months after stroke onset. Poststroke rehabilitation is initiated as early as possible and aims to reduce functional consequences of stroke, allowing patients to integrate into the community. However, up to 75% of the patients remain disabled in the long term. Strikingly, about 20 to 30% of the patients show functional decline (i.e., learned-nonuse) in the long term - most often after having finished their intensive rehabilitation period - and even stroke survivors who have little or no residual disability are less physically active when compared to their age-matched peers. Poststroke outcomes can be well predicted early after stroke. However, the deficits early after stroke and the outcomes are measured by standardized clinical tests performed in the laboratory. The drawback of these tests is that they provide information about the best possible abilities of the patients, as they are encouraged by therapists in testing situations. This so called "capacity" does not necessarily reflect what patients do in daily life situations (i.e., "performance" or "real world use"). With the growing interest in the patients' performance, various assessments that objectively measure activities in daily life situations have been developed in the last few years. These devices capture movement in daily life situations in a sensitive and objective way. An additional benefit is that they are less hampered by floor or ceiling effects when compared to clinical laboratory measurements (i.e., clinimetrics). Nevertheless, outcome of real world performance is hardly ever used in clinical trials aiming to determine the effectiveness of stroke rehabilitation interventions. Actually, until today, the natural course of performance remains largely unknown, as are predictors for this course. It is also unknown to which extend patients' subjective reporting of performance matches objectively measured performance. Finally, although it is believed that there is a threshold for, for example, real life use of the paretic arm and further improvement, there is no evidence as to what this threshold is in terms of clinical laboratory measurements. The present prospective longitudinal cohort study fills in the gap regarding knowledge about the profile and predictability of two performance outcomes during the first year poststroke: engagement in physical activities and the use of the paretic upper limb. In addition, it will provide insight in how physical activity engagement and upper limb use measured by daily life assessments relate to standard clinical laboratory assessments. This knowledge is a prerequisite for the identification of patients' phenotypes and a first essential step towards the development of tailored (i.e., precision medicine), innovative rehabilitation interventions which enhance performance in terms of physical activities or upper limb use in daily life. The ultimate goal is to reduce poststroke disability and associated costs. RE-USE is a prospective longitudinal observational cohort study of 120 first-ever stroke patients, who will be assessed 3, 10, 28, 90 and 365 days after stroke onset, as well as at discharge of the rehabilitation center.

NCT ID: NCT03522259 Completed - Bariatric Surgery Clinical Trials

Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery

BARIVA
Start date: July 19, 2018
Phase: Phase 2
Study type: Interventional

The aim of this study is to investigate the efficacy and safety of rivaroxaban in obese patients undergoing bariatric surgery. The objectives are to assess the safety and feasibility of venous thromboembolism (VTE) prophylaxis and lung embolism with Rivaroxaban 10mg as an oral anticoagulant. After bariatric surgery patients receive the study medication Xarelto 10mg QD for 7, resp. 28 days. All clinically thromboembolic events will be assessed by ultrasound or CT, respectively, as soon as apparent. In addition, patients are screened for VTE at day 28 by ultrasound to detect clinically inapparent thromboses. In a subgroup of study patients (patients from the University Hospital Inselspital, Bern) PK/PD parameters are assessed following the last intake of rivaroxaban at day 28.

NCT ID: NCT03522025 Active, not recruiting - Clinical trials for Osteoarthritis, Knee

GMK-UNI Anatomical UKA: Fixation of Cemented vs Cementless Designs

Start date: February 15, 2019
Phase: N/A
Study type: Interventional

Unicompartmental knee arthroplasty (UKA) is the principal surgical alternative to the total knee arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current comparative randomized study aims to evaluate the fixation of cemented and cementless designs of GMK-UNI unicompartmental knee prosthesis over a 5-year time period.

NCT ID: NCT03521934 Terminated - Heart Failure Clinical Trials

Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)

Start date: June 15, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: To compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable participants after admission for worsening heart failure (WHF) Secondary Objectives: To compare the effects of sotagliflozin to placebo on: - The total occurrences of HHF and urgent visit for HF - The occurrence of CV death - The occurrence of all-cause mortality - The total occurrences of CV death, HHF, urgent visit for HF, non-fatal myocardial infarction (MI), and non-fatal stroke - Change in Kansas City Cardiomyopathy Questionnaire-12(KCCQ-12) score - Change in estimated glomerular filtration rate (eGFR)

NCT ID: NCT03521648 Recruiting - Clinical trials for Benign Prostatic Hyperplasia

Database for the Assessment of Efficacy and Safety of BPH Treatment

KSSG-BPH-REG
Start date: July 7, 2017
Phase:
Study type: Observational [Patient Registry]

This registry study aims to collect data on efficacy and safety of different treatments of benign prostatic enlargement (BPE) and lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH-LUTS).

NCT ID: NCT03521050 Recruiting - Defibrillators Clinical Trials

LUKS-Leads Registry on Long-term Performance of ICD Leads

Start date: December 2016
Phase:
Study type: Observational [Patient Registry]

All patients having an implantable cardiac defibrillator (ICD) implanted and having follow-up at the Cantonal Hospital Lucerne (LUKS), the investigator center, are included in this retrospective ICD lead registry from 2006 onwards. Data is collected prospectively from december 2016 onwards. After certain ICD-leads tended to fail early the investigators aimed for a registry monitoring our patient population with defibrillator leads and evaluating their long-term performance.

NCT ID: NCT03520985 Terminated - Clinical trials for Refractory Multiple Myeloma

Alternate Day Dosing of Pomalidomide in Patients With Refractory Multiple Myeloma

OptiPOM
Start date: October 1, 2018
Phase: Phase 2
Study type: Interventional

Pomalidomide is an approved treatment for refractory multiple myeloma. Toxicity of pomalidomide in the pivotal MM-003 trial, was considerable, with 60% of patients experiencing drug-related G3/4 toxicity. Neutropenia (48% vs 16%) and pneumonia (13% vs 8%) were significantly more common in the pomalidomide arm. This resulted in frequent dose interruptions (67%) and dose reductions (27%). This suggests that for the majority of patients the 4 mg daily dosing schedule is too toxic, and that strategies to deliver reduced dosing of pomalidomide are of high practical relevance. The aim of this trial therefore is to establish that alternate day dosing of pomalidomide (4 mg q2d, d1-28) is non-inferior to daily dosing (4 mg d1-21 q28) in terms of efficacy of the drug with potentially less side effects.

NCT ID: NCT03520582 Terminated - Healthy Volunteers Clinical Trials

Placement of Novel Endoscopic Enteral Feeding Tube

LEGEND
Start date: November 6, 2017
Phase:
Study type: Observational

The aim of this study is to evaluate the technical feasibility of the new tube placement technology in healthy volunteers and, if proven feasible, in critically ill patients requiring placement of a feeding tube.