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NCT ID: NCT04906265 Recruiting - Fracture of Hip Clinical Trials

Rehab After Hip Fracture With Wearable Device

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

A randomized control trial, including two intervention arms with different methods for rehabilitation after hip fracture, conducted among persons with the need of rehabilitation in their own home.

NCT ID: NCT04905797 Recruiting - Clinical trials for Personality Disorders

Aspects of Self-harm - Cognition, Imaging and Treatability

Start date: April 30, 2021
Phase:
Study type: Observational

Deliberate self-harm (DSH) is a common symptom in psychiatric disorders. This study aim at increased understanding of parameters associated with DSH with the long term goal to potentially improve and possibly personalise its treatment. In short, the study will characterise cognitive, psychiatric and demographic factors with focus on executive function and will compare results from individuals with DSH, individuals who have ceased DSH as well as psychiatric patients without DSH and individuals who never engaged in DSH. Adequate statistical tests will be used to compare groups. Participants will be interviewed by a trained physician for basic medical history, history of self-harm and treatment for that, demographic data and diagnostic evaluation. Thereafter the participants will undergo standardised neuropsychological testing focusing on emotional response inhibition, decision making and risk taking, attention set shifting, working memory, inhibition and planning. Some participants will redo parts of this testing during fMRI, as well as undergo DTI and volumetry.

NCT ID: NCT04904146 Recruiting - Mycosis Fungoides Clinical Trials

Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome.

BIO-MUSE
Start date: April 2, 2021
Phase:
Study type: Observational

A translational study for identification of prognostic and treatment-predictive biomarkers in Mycosis fungoides and Sézary syndrome.

NCT ID: NCT04903899 Recruiting - Neuroblastoma Clinical Trials

177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma

LuDO-N
Start date: May 19, 2021
Phase: Phase 2
Study type: Interventional

The LuDO-N Trial is a multi-centre phase II clinical trial on 177Lu-DOTATATE treatment of recurrent or relapsed high-risk neuroblastoma in children. The LuDO-N Trial builds on the experience from the previous LuDO Trial and utilises an intensified dosing schedule to deliver 2 doses over a 2-week period, in order to achieve a maximal effect on the often rapidly progressing disease. This strategy requires a readiness for autologous stem cell transplantation in all patients, but is not anticipated to increase the risk of long-term sequelae, since the cumulative radiation dose remains unchanged. The primary aim of the study is to assess the response to 177Lu-DOTATATE treatment at 1 and 4 months after ende of treatment. Secondary aims are to assess survival and treatment-related toxicity. Additional aim are to correlate tumour dosimetry with response, correlate SSTR-2 expression with 68Ga-DOTATATE uptake and to correlate the uptake with the treatment response.

NCT ID: NCT04902859 Recruiting - Clinical trials for Retinopathy of Prematurity

Clonidine as Pain Relief During ROP Eye Examinations

cloROP
Start date: April 25, 2022
Phase: Phase 4
Study type: Interventional

Preterm infants are at risk of developing ROP (retinopathy of prematurity), an eye condition that can cause blindness. Preterm infants born before gestation week (GA) 30 are therefor screened regularly with eye examinations. These eye examinations are painful and despite a lot of research no clear method of pain relief have been found. Since pain in the preterm infant can lead to both short- and longterm negative consequences an effective pain relief during these examinations are of importance. In this study we will investigate if Clonidine can be effective as pain-relief during ROP eye examinations.

NCT ID: NCT04900064 Recruiting - Depression Clinical Trials

Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial

KAIROS
Start date: June 14, 2021
Phase: N/A
Study type: Interventional

In this multicenter study, the investigators want to find out if an addition of an diagnostic assessment and possibility of treatment with guided self-help CBT can increase the treatment effects of PCBH on patient functioning and symptoms, compared to standard PCBH which uses contextual assessment and brief interventions. In addition to this, the study will investigate the overall effect of PCBH on both patient and organisation level outcomes.

NCT ID: NCT04899336 Recruiting - Clinical trials for Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years

Start date: June 30, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the efficacy of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) compared to placebo in the prevention of the first invasive extraintestinal pathogenic Escherichia coli disease (IED) event caused by ExPEC9V O-serotypes.

NCT ID: NCT04898335 Recruiting - Clinical trials for Mitral Regurgitation

Tendyne European Experience Registry

TENDER
Start date: April 15, 2021
Phase:
Study type: Observational [Patient Registry]

TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population.

NCT ID: NCT04896853 Recruiting - Clinical trials for COVID-19 Acute Respiratory Distress Syndrome

Treatment of Respiratory Complications Associated With COVID19,Influenza ,Metapneumovirus,RSV Infection Using ProTrans®

Start date: May 18, 2021
Phase: Phase 1
Study type: Interventional

To investigate the safety and tolerance of a single infusion of ProTrans® in subjects with "severe" respiratory complications associated with pneumonia caused by COVID-19, Influenza A, Metapneumovirus or RSV infection.

NCT ID: NCT04895241 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus

TOPAZ-1
Start date: May 25, 2021
Phase: Phase 3
Study type: Interventional

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: - How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS). Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: - After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. - All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications. - Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. - There will be a follow-up safety period that lasts up to 24 weeks. - In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.