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NCT ID: NCT03672903 Completed - Obesity Clinical Trials

Effect of Different Weight Vests on Body Weight in Obese Individuals

EVO
Start date: September 27, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Obesity related ailments, such as cardiovascular diseases (CVD) and metabolic disorders are major causes of death in the Western World. The proposed research may result in improved prevention, diagnosis and treatments of obesity and obesity-related disorders. Recently published data show that if a weight is carried by a rodent, this animal will lose body weight and gain an improved glucose control. We aim to confirm these findings in a human model. We plan to let obese subjects carry weight vests and monitor their change in body weight. We will also measure appetite, physical activity and insulin sensitivity to further examine the potential beneficial effects of loading. Blood sampling will be performed to investigate the mechanism of action.

NCT ID: NCT03671122 Completed - Clinical trials for Heart Failure, Diastolic

PREFERS (Preserved and Reduced Ejection Fraction Epidemiological Regional Study) Stockholm Heart Failure Study

PREFERS
Start date: January 1, 2015
Phase:
Study type: Observational

Heart failure (HF) with preserved (HFpEF) or reduced (HFrEF) ejection fraction is associated with poor prognosis and quality of life. While the incidence of HFrEF is declining and HF treatment is effective, HFpEF is increasing, with no established therapy. PREFERS Stockholm is an epidemiological study with the aim of improving clinical care and research in HF and to find new targets for drug treatment in HFpEF starting with a cardiac biopsy study in elective CABG patiens.

NCT ID: NCT03665597 Completed - Melanoma Clinical Trials

Relative Bioavailability Study of Subcutaneous Injection Versus Intravenous Infusion of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-555/KEYNOTE-555)

Start date: November 19, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the pharmacokinetic (PK) profile of pembrolizumab (MK-3475) following single subcutaneous (SC) injection of pembrolizumab Dose A versus pembrolizumab Dose C in adults with advanced melanoma. Additionally, the safety and tolerability of pembrolizumab SC injections will be assessed. And, finally, the efficacy of pembrolizumab intravenous (IV) infusion administration will be assessed.

NCT ID: NCT03665363 Completed - Clinical trials for Autism Spectrum Disorder

Evaluating the Efficacy and Effectiveness of SCOPE - RCT

SCOPERCT
Start date: September 1, 2016
Phase: N/A
Study type: Interventional

The study will entail an evaluation of the feasibility, acceptability, efficacy and effectiveness of SCOPE coach supported internet-delivered psychoeducative program using a randomized controlled design in a clinical health care context. An estimated n=175 will be needed to enable block randomisation according a 2:1:1 ratio to: 1) SCOPE internet-based psychoeducation intervention, 2) Self-study controls, who receive eight weekly emails containing informative and relevant websites about Autism Spectrum Disorder (ASD), 3) Wait-list controls.

NCT ID: NCT03664934 Completed - Whiplash Injuries Clinical Trials

Pathophysiological Mechanism Behind Prolonged Whiplash Associated Disorders

Start date: October 4, 2018
Phase: N/A
Study type: Interventional

The knowledge of pathophysiological mechanisms behind prolonged Whiplash Associated Disorders (WAD) is insufficient and whether changes can be restored by rehabilitation or not is unknown. The aim of these studies are to investigate different parameters to further learn about pathophysiological mechanisms (neck muscle fatty infiltration, cross-sectional area, volume, inflammation and function, brain structure and activity, biomarkers for stress and inflammation, cervical kinaesthesia and balance before and after intervention) and the association for clinical outcomes in individuals with chronic WAD (n=30) compared with age and gender matched healthy individuals (n=30). Measurements will be made at baseline (patients and healthy) and at 3 months (patients only, at the end of treatment). However, for the blood and saliva samples, they will be re-investigated in the healthy group as well. The study results may contribute to the development of improved understanding and diagnostics in chronic WAD that may improve future rehabilitation.

NCT ID: NCT03664258 Completed - Clinical trials for Non-muscle-invasive Bladder Cancer

A Multi-National Study In Bladder Cancer Patients to Detect Recurrences After TURB (Trans-urethral Resection of the Bladder) Earlier With the Xpert Bladder Cancer Monitor Assay (ANTICIPATE X)

ANTICIPATE X
Start date: June 6, 2018
Phase:
Study type: Observational

Bladder cancer is the 5th most common cancer in Europe, with more than 151,000 new cases diagnosed in 2012 (4% of the total). Bladder cancer has the highest recurrence rate of any malignancy, often as high as 70% within 5 years of successful treatment. This high recurrence rate requires diligent and accurate monitoring as a means for early diagnosis and treatment. Considering the burden associated to repeated invasive cystoscopies, there is a need for robust but accurate tests for surveillance. In that prospect, urinary molecular tests have been developed although none were deemed adequate in the European clinical guidelines to replace cystoscopies. The Xpert Bladder Cancer Monitor Assay is a qualitative in vitro diagnostic test designed to monitor for the recurrence of bladder cancer in patients previously diagnosed with this cancer. The test provides a fast and accurate result, is non-invasive and easy to perform. The aim of this study is to assess the non-inferiority of the Xpert Bladder Cancer Monitor assay in detecting recurrences in comparison to cystoscopy in the follow-up of patients with low or intermediate risk non-muscle-invasive bladder cancer (NMIBC).

NCT ID: NCT03663335 Completed - Clinical trials for Kidney Transplant Rejection

Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients

CIRRUS I
Start date: November 28, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of three CFZ533 dose regimens in kidney transplant recipients. This study will allow assessment of the ability of CFZ533 to replace Calcineurin inhibitors (CNIs) in terms of anti-rejection efficacy, while providing better renal function with a better safety and tolerability profile. Results of this study will be used to inform the CFZ533 dose and regimen selection for investigation in later phases of clinical development.

NCT ID: NCT03663075 Completed - Quality of Life Clinical Trials

Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women

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

Background: Stress-related ill health is today the most common cause of long-term sick leave in women in the middle of life and a common cause of visits to primary health care. Objective: To implement and investigate the effect of education in group and/or individually held in primary health care clinics embracing aspects of mental health, quality of life, sick leave and the needs women aged 45-60 with stress-related symptoms have. Method The study is a randomized controlled trial with a two-factor design. The study evaluates both group information (GI) and structured person-centered support (PCS) and possible interaction effects between these two treatment modalities. The group education consists of four information sessions discussing myths around menopause, physiology, local estrogen deficiency symptoms, women's cardiovascular health, stress-related ill health, mental health, relationships, sexuality, lust and possible treatment options. In addition, conversations about insight into obstacles and resources, coping strategies and behavioral changes will be included. The individually structured person-centered support comprises of five meetings consisting of dialogue on symptoms of stress-related ill health, physiology and coping strategies. Participants will be block randomized into four groups; GI, PCS, GI+PCS or control. Expected result Implementation of group and individual support calls is expected to improve health for women seeking primary care care. The results are expected to increase the knowledge of how women's health is affected by short-term care in primary care through reduced sick leave days, reduced care needs, return to work and increased quality of life. The result may improve existing primary care routines for women, and if needed, for a more individualized care contact and support.

NCT ID: NCT03661528 Completed - Clinical trials for Acute Intracranial Hemorrhage

Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor

Start date: June 6, 2019
Phase: Phase 4
Study type: Interventional

Randomized, controlled clinical trial evaluating the efficacy and safety of andexanet alfa versus usual care in patients with intracranial hemorrhage anticoagulated with a direct oral FXa anticoagulant

NCT ID: NCT03660280 Completed - Depression Clinical Trials

Probiotics to Treat "Inflammatory Depression"

Start date: November 6, 2018
Phase: N/A
Study type: Interventional

The main aims of this project are to test if: i) Specific probiotic lactobacilli (added to stabilized ongoing treatment) are efficacious in treating depressive symptoms in individuals with low-grade inflammation, defined using high sensitivity C-reactive protein (hs-CRP) and BMI. ii) This effect is mediated through decrease of inflammation, estimated by treatment-associated changes in blood and faeces biomarkers. Secondary aims are to investigate the relationship between specific depressive symptoms and inflammation and if there is a correlation between certain pro-inflammatory or metabolic markers and depression.