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NCT ID: NCT04109976 Completed - Psoriatic Arthritis Clinical Trials

A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Active Psoriatic Arthritis

Start date: August 13, 2019
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate for each self-injecting device presentation the ability of subjects with psoriatic arthritis (PsA) to safely and effectively self-inject bimekizumab at study start and 4 weeks after training in self-injection technique using the bimekizumab safety syringe (SS) or the bimekizumab auto-injector (AI).

NCT ID: NCT04109547 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Research Study Comparing a New Medicine Oral Semaglutide to Placebo in People With Type 2 Diabetes

PIONEER 11
Start date: October 1, 2019
Phase: Phase 3
Study type: Interventional

The study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and placebo (a dummy medicine). Researchers will test semaglutide to see how well it works compared to placebo. The study will also test if semaglutide is safe. Participants will either get semaglutide or placebo - which treatment is decided by chance. Participants will get 1 tablet a day to take with up to half a glass of water. Participants must take the tablet first thing in the morning on an empty stomach. After taking the tablet, participants must not eat or drink anything for at least 30 minutes. After the 30 minutes, participants can have their first meal of the day and take any other medicines they may need. The study will last for about 8 months (36 weeks). Participants will have 9 clinic visits and 2 phone calls with the study doctor. At all 9 of the clinic visits, participants will have blood samples taken. At 5 of the clinic visits, participants must arrive fasting. This means they cannot eat for 8 hours before the visit. It is fine to drink water up to 2 hours before the visit. This is for some of the blood samples that will be taken at the visit. Women cannot take part if pregnant, breastfeeding or planning to become pregnant during the study period.

NCT ID: NCT04109391 Completed - Breast Cancer Clinical Trials

Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03

Start date: August 20, 2019
Phase: Phase 3
Study type: Interventional

This is an extension study to provide adjuvant treatment with single agent Herceptin or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer following neoadjuvant treatment and surgical resection in Protocol TX05-03.

NCT ID: NCT04109378 Completed - Quality of Life Clinical Trials

The Impact of NOSE-colectomy on Fertility and Quality of Life Among Patients With Colorectal Endometriosis

NOSERES
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Deep infiltrating endometriosis (DIE) represents the most severe form of endometriosis and is present in 20-35% of all women suffering from the disease. Intestinal nodules are observed in 3% to 37% of endometriosis patients. In cases of colorectal DIE, adequate therapy depends on the depth of infiltration and the size of the lesion as well as the woman's quality of life. Removal of the specimen after segmental bowel resection can be performed by either mini-laparotomy or by the natural orifice specimen extraction (NOSE) technique . The assessment of the quality of life and fertility outcome of the patients was done by using electronic questionnaires before and after surgery.

NCT ID: NCT04109313 Completed - Clinical trials for Chronic Spontaneous Urticaria

An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU

Start date: October 24, 2019
Phase: Phase 2
Study type: Interventional

The main objective to assess the long-term safety and tolerability of LOU064 in patients with chronic spontaneous urticaria (CSU) who have participated in study CLOU064A2201 (NCT03926611)

NCT ID: NCT04108884 Completed - Atrial Fibrillation Clinical Trials

RedStroke - Reducing Europe's Stroke Incidence

RedStroke
Start date: October 22, 2019
Phase: N/A
Study type: Interventional

In the RedStroke study, the effect of a smartphone application in detecting Atrial Fibrillation (AF) will be assessed in a double-blind randomised controlled multicenter trial. Outpatients with an elevated risk for atrial fibrillation will be randomized to an intervention arm (app group) and to a standard-of-care arm (control group). Both groups will have the app installed on their private smartphones and will be asked to perform a predefined measurement protocol. All patients will continue their prior therapy with their general practitioner and obtain every medical treatment indicated. This study will not cause any restrictions on the usual treatment of the study patients. The only difference between the two groups will be, that patients in the app group will be informed by their local PI, if the recordings of the app indicate AF (and obtain a 14 day Holter ECG for AF verification), whereas the patients in the "usual care" group will obtain the read out of the app at the end of the study.

NCT ID: NCT04101721 Completed - Clinical trials for Retinopathy of Prematurity

Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity

BUTTERFLEYE
Start date: October 30, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP). The secondary objectives of the study are to assess the need for a second treatment modality, to assess the recurrence of ROP in the study and to assess the safety and tolerability of aflibercept.

NCT ID: NCT04093024 Completed - Clinical trials for Lung Diseases, Interstitial

A Study to Find Out How Nintedanib is Taken up in the Body and How Well it is Tolerated in Children and Adolescents With Interstitial Lung Disease (ILD)

InPedILD®
Start date: December 3, 2019
Phase: Phase 3
Study type: Interventional

The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing Interstitial Lung Disease (ILD).

NCT ID: NCT04090411 Completed - Clinical trials for Moderate to Severe Ulcerative Colitis

A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis

Start date: December 19, 2019
Phase: Phase 2
Study type: Interventional

This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.

NCT ID: NCT04089566 Completed - Clinical trials for Muscular Atrophy, Spinal

Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy

DEVOTE
Start date: March 26, 2020
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA), as measured by change in Children's Hospital of Philadelphia-Infant Test of Neuromuscular Disorders (CHOP-INTEND) total score (Part B); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C). The secondary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A, B and C); to examine the effect of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA, to examine the effect of nusinersen administered intrathecally at higher doses compared to the currently approved dose in participants with SMA (Part B).