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NCT ID: NCT03738397 Not yet recruiting - Atopic Dermatitis Clinical Trials

A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis

Heads Up
Start date: December 13, 2018
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, multi-center study that will evaluate upadacitinib versus dupilumab in adults (18-75 years of age) with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy. The study is comprised of a 35-day screening period, a 24-week blinded treatment period, and a 12-week follow-up period.

NCT ID: NCT03737253 Recruiting - Female Infertility Clinical Trials

Hormone Evaluation in Artificial Reproductive Technology

HEART
Start date: September 1, 2016
Phase: Phase 4
Study type: Interventional

The aim is to be able to predict the hormonal response according to gonadotropin receptor genotype and hormone type used for treatment of women undergoing in vitro fertilization or egg donation. Outcome will be measured as pregnancy success, live born babies and unwanted side effects.

NCT ID: NCT03737019 Recruiting - Clinical trials for Medical Certificates for Sick Leave and Drug Prescriptions

Effects of Acceptance and Commitment Therapy in Primary Health Care

ACTPrimary
Start date: October 31, 2018
Phase: N/A
Study type: Interventional

How does education of health personnel with Acceptance and Commitment Therapy affect the extent of medical certificates of sick leave and drug prescriptions in primary health care centers in Kalmar compared with similar centers in Jönköping in which the personnel do not get such therapy?

NCT ID: NCT03734211 Not yet recruiting - Clinical trials for Cardiac Allograft Vasculopathy

Cholesterol Lowering With EVOLocumab to Prevent Cardiac Allograft Vasculopathy in De-novo Heart Transplant Recipients

EVOLVD
Start date: November 1, 2018
Phase: Phase 3
Study type: Interventional

The main goal of this study is to evaluate the effect of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab on cardiac allograft vasculopathy in de novo heart transplant recipients. Secondary objectives are to assess the impact of treatment on: i) cholesterol levels, ii) renal function, iii) inflammation, iv) quality of life, v) cardiac function as assessed by biomarkers and echocardiography, vi) the number of rejections, and (vii) safety and tolerability. As an exploratory outcome, the investigators will asses the effect of treatment on clinical events (death, myocardial infarction, cerebral stroke, cancer, end stage renal disease).

NCT ID: NCT03732612 Not yet recruiting - Atherosclerosis Clinical Trials

Inflammation in Vascular Disease

REBEL
Start date: February 1, 2019
Phase:
Study type: Observational

Increasing evidence suggests that systemic low-grade inflammation may be a driving force of cardiometabolic complications, such as vascular dysfunction, atherosclerosis and ischemic heart disease. Thus, we will investigate the role of inflammation in cardiovascular disease.

NCT ID: NCT03729947 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

CLOSED SUCTION DRAIN VS. NO DRAIN IN ADOLESCENTS UNDERGOING PEDICLE SCREW INSTRUMENTATION FOR IDIOPATHIC SCOLIOSIS (DAISY 2018). A Randomized Clinical Trial

DAISY 2018
Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Abstract Background - Closed suction drain is typically used worldwide after instrumented posterior spinal fusion for adolescent idiopathic scoliosis (AIS). Postoperative drain leakage has been associated with up to 50% of total blood loss in these patients. Previous studies on adult patients with degenerative lumbar spine disorders have shown that leaving out subfascial drain does not increase the risk of deep wound infection or epidural hematoma. However, there has been no studies evaluating the need for subfascial drain in adolescents undergoing instrumented spinal fusion for idiopathic scoliosis. Study Design - A randomized, multicenter clinical trial on children and adolescents undergoing posterior spinal fusion for idiopathic scoliosis using pedicle screw technique. Sixty consecutive adolescents will be randomized into drain vs. no drain group at the time of wound closure using the sealed envelope technique (1:1). Aims and hypothesis - To compare drain vs. no drain use groups for the change in postoperative hemoglobin or hematocrit in children undergoing posterior spinal fusion for AIS. We hypothesize that postoperative hemoglobin change will be larger in the group receiving subfascial drain and there will no change in the risk of postoperative complications (deep surgical site infection, need for hematoma evacuation or other re-operation) between the study groups. Inclusion criteria - Adolescents (aged 10 to 21 years of age) undergoing surgery for idiopathic scoliosis using pedicle screw technique. Exclusion criteria - Coagulation disorder, smoking, unwilling to consent, vertebral column resection, need for anteroposterior surgery. Main outcome parametres - Postoperative change in hemoglobin or hematocrit; Secondary parametres: need for blood transfusion, need for re-operation, need for change in the dressings. Ethical aspects - Ethical committee approval will be obtained both in Finland and in Sweden. An informed consent will be obtained from all children and their parents. In case of major intraoperative blood loss (>50% of blood volume) a subfascial drain can be inserted based on the decision of the treating physician. Time schedule and budget - This study will be started after ethical committee approval (estimated 10/2018). There will be no extra costs as all information gathered will be part of normal surgical treatment of AIS. A part-time research nurse has been hired to take care of data collection into the database.

NCT ID: NCT03729739 Not yet recruiting - Clinical trials for Coronary Artery Disease

Functional Assessment by Virtual Online Reconstruction. The FAVOR III Europe Japan Study

FAVOR III EJ
Start date: November 2, 2018
Phase: N/A
Study type: Interventional

Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. QFR is estimated based on two angiographic projections. Studies have shown a good correlation with the present wire-based standard approach Fractional Flow Reserve (FFR) for assessment of intermediate coronary stenosis. The purpose of the FAVOR III Europe Japan study is to investigate if a QFR-based diagnostic strategy will results in non-inferior clinical outcome after 12 months compared to a standard pressure-wire guided strategy in evaluation of patients with chest pain (stable angina pectoris) and intermediate coronary stenosis.

NCT ID: NCT03729687 Recruiting - Rectal Cancer Clinical Trials

Short Course Radiation Therapy Followed by Pre-operative Chemotherapy and Surgery in High-risk Rectal Cancer

LARCT-US
Start date: July 4, 2016
Phase: Phase 2
Study type: Interventional

Patients with a primary rectal cancer without detectable distant metastasis who after locoregional therapy only, meaning preoperative radio(chemo)therapy plus surgery have at least a 40% risk of not having a CRM negative resection or a recurrence, local or distant, within three years will be treated with the short course 5 x 5 Gy radiation scheme followed by four cycles of combination chemotherapy (capecitabine and oxaliplatin) and TME surgery

NCT ID: NCT03729050 Recruiting - Rehabilitation Clinical Trials

Rehabilitation Coordinators in Specialist Psychiatry

Start date: October 24, 2018
Phase: N/A
Study type: Interventional

REKO-A is a randomized controlled intervention study that addressed women and men on sick leave in Uppsala County. Participants which are on sick leave due to mental illness.

NCT ID: NCT03728868 Recruiting - Healthy Individuals Clinical Trials

Tolerability and Risk of Adverse Events With a Probiotic Supplement

Start date: October 10, 2018
Phase: N/A
Study type: Interventional

The butyrate-producing bacterium Faecalibacterium prausnitzii is abundant in the human bowel and can make up to 5% of the gastrointestinal flora in healthy individuals. A reduced presence of it has been associated with an imbalance in the gastrointestinal flora of metabolic syndromes such as type 2 diabetes, fat liver, and in inflammatory bowel disease. The present double-blind, placebo-controlled, randomized study is designed to investigate if dietary supplementation with F.prausnitzii (combined with D. piger) once a day for 8 consecutive weeks is tolerated compared to placebo and if it can affect the metabolism in a positive way.