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NCT ID: NCT04009720 Terminated - Clinical trials for Aortic Valve Stenosis

RESPOND EDGE Post Market Study

RESPOND EDGE
Start date: October 11, 2019
Phase:
Study type: Observational [Patient Registry]

The purpose of the RESPOND EDGE post market study is to collect real world clinical and device performance outcomes data with the Lotus Edge™ Valve System used in routine clinical practice to demonstrate that the commercially available Lotus Edge Valve System is a safe and effective treatment for patients with severe calcific aortic stenosis.

NCT ID: NCT03976557 Terminated - Clinical trials for Vascular Access Complication

BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden

IMPROWE
Start date: April 11, 2019
Phase: N/A
Study type: Interventional

Primary objective of the study is to establish the incidence of all any catheter related complications in BIP CVC and standard CVC groups in patients requiring CVC. (CVC - Central Venous Catheter; BIP - Bactiguard Infection Protection)

NCT ID: NCT03967587 Terminated - Oxygen Saturation Clinical Trials

Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients

IMPROVE
Start date: November 19, 2020
Phase: N/A
Study type: Interventional

The study is a non-blinded trial with one single intervention in sick newborn infants. The Neosense umbilical catheter will be used instead of the routinely used umbilical catheter on infants where the treating physician has ordered use of an umbilical catheter. The catheter will be connected to the Neosense monitor/measuring unit. Blood samples for blood gas analysis are collected from the patients according to the clinical routine (every 4th to 6th hour). Oxygen tension data from the Neosense measuring system, from the time points when a blood gas sample was collected, will be recorded. This data will be compared to the oxygen tension value from the blood gas sample collected at the same time point. The blood gas samples will be analysed according to clinical and laboratory routine. The infants will remain in the study as long as the Neosense measuring system is used.

NCT ID: NCT03948178 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

Effects of Oral Levosimendan on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (ALS): Open-Label Extension

REFALS-ES
Start date: June 26, 2019
Phase: Phase 3
Study type: Interventional

This study provides an opportunity for subjects in the REFALS (3119002; NCT03505021) study to continue treatment with oral levosimendan. The study will also provide more information about long-term safety and effectiveness of oral levosimendan in patients with ALS. This is an open-label study, so that all eligible subjects that complete the double-blind REFALS study (48-weeks of treatment) will have the opportunity to receive oral levosimendan treatment. The primary objective, in addition to continuing treatment for subjects enrolled in the REFALS study, is to evaluate long-term safety of oral levosimendan in ALS patients. Another important objective is to explore long-term effectiveness of oral levosimendan in the treatment of patients with ALS. This study is open only to patients taking part in the REFALS study.

NCT ID: NCT03919045 Terminated - Chronic Migraine Clinical Trials

Saline Injections for Prophylactic Treatment of Chronic Migraine

Start date: June 17, 2019
Phase: Phase 4
Study type: Interventional

In this study, the investigators want to investigate whether saline injections in the neck and head muscles can reduce symptoms of chronic migraine. In existing studies, saline injections (used as placebo treatment) have given patients with chronic migraine an average of 7 headache-free days per month.

NCT ID: NCT03917719 Terminated - Clinical trials for Duchenne Muscular Dystrophy

An Open-Label Extension Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy

GalaxyDMD
Start date: March 14, 2019
Phase: Phase 3
Study type: Interventional

The GalaxyDMD study is a global Phase 3, open-label, treatment extension study to evaluate the safety, tolerability, and durability of effect in long-term dosing of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Patients who completed CAT-1004-201 or CAT-1004-301 or siblings of these boys from 4-12 years of age (up to 13th birthday) will be enrolled. Edasalonexent is an orally administered small molecule that inhibits NF-kB, which is a key link between loss of dystrophin and disease pathology and plays a fundamental role in the initiation and progression of skeletal and cardiac muscle disease in DMD.

NCT ID: NCT03914066 Terminated - Clinical trials for Overweight and Obesity

A Group-based Treatment of Overweight and Obesity in Primary Care

Start date: September 3, 2019
Phase: N/A
Study type: Interventional

Overweight and obesity is a growing problem in the world. Today more than 50 % of all people over 18 years in Sweden are overweight or obese. Main reasons for this are changes in lifestyle habits regarding diet and physical exercise. Overweight and obesity increases risk of different diseases such as type 2 diabetes, arthrosis and cancer; it also affects quality of life. Losing 5-10 % of your body weight improves metabolic health and quality of life. Lifestyle changes are very important in order to lose weight but it can be challenging to carry through with these changes on your own without support. In the primary care in Region Orebro län a group treatment, "Step by step", has been in use since 2010. It comprises of six group sessions over 6-8 months with different themes such as diet, physical exercise and stress. Between the group sessions there are home assignments, such as writing a diet or exercise diary. This observational study will evaluate "Step by step" and the effect the group treatment has on the participants' weight, dietary habits, physical activity, quality of life, eating habits and metabolic health.

NCT ID: NCT03912649 Terminated - Clinical trials for Removal Contraceptive Implant

Investigation to Evaluate Performance and Safety of RemovAid ™ in Removal of Contraceptive Implants

REVALID03
Start date: June 11, 2019
Phase: N/A
Study type: Interventional

The safety and efficacy of a subdermal implant retrieval device (RemovAid) is investigated in a population of 25 women seeking removal of their palpable contraceptive implants. The primary endpoint of the device is to evaluate the performance of the device, specifically its success rate in removing palpable contraceptive implants. The device shall be able to fixate at least 80% of palpable implants, and successfully remove at least 90% of these implants.

NCT ID: NCT03907072 Terminated - Clinical trials for Duchenne Muscular Dystrophy

Efficacy and Safety Study of WVE-210201 (Suvodirsen) With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy

DYSTANCE 51
Start date: September 4, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This is a Phase 2/3, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension period to evaluate the safety and efficacy of WVE-210201 (suvodirsen) in ambulatory male pediatric patients with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping intervention (DYSTANCE 51)

NCT ID: NCT03894007 Terminated - Clinical trials for HER2-positive Breast Cancer

Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer

PREDIXIIHER2
Start date: May 23, 2019
Phase: Phase 2
Study type: Interventional

This is a phase 2 study evaluating medical treatment before surgery in HER2-amplified early breast cancer patients. Patients receive chemotherapy with HER2-targeted antibodies and are randomised to receive the checkpoint inhibitor atezolizumab or not.