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NCT ID: NCT03405532 Suspended - Clinical trials for Diabetes Mellitus, Kidney, CPB

Kidney Function in Diabetics During CPB (Cardio Pulmonary Bypass)

DM-ECC
Start date: January 11, 2018
Phase:
Study type: Observational

Filtration of urine in the kidney requires sufficient oxygen supply. The filtration of urine is greater in patents with diabetes. Our theory is that the diabetic kidney has a higher oxygen demand than the non diabetic kidney thereby making the diabetic kidney more sensitive to decreased oxygen delivery following reduced blood flow. With a catheter inserted into the kidney vein we will monitor the blood flow and oxygen saturation before and during CPB, in patient with diabetes.

NCT ID: NCT03404583 Active, not recruiting - Mental Health Clinical Trials

Person-centred eHealth for Treatment and Rehabilitation of Severe Stress and Burnout Syndrome

PROMISE
Start date: February 14, 2018
Phase: N/A
Study type: Interventional

The goal of the research project PROMISE is to translate the person-centred care (PCC) principles into an eHealth (the use of information and communication technologies for health) context. A developed PCC eHealth platform will be used as a tool to identify patients´ resources to enhance coping and living with their illness by means of a dialog and partnership with staff and relatives. The PCC eHealth platform will not replace, but instead be used as add on treatment to usual care (guideline directed care).

NCT ID: NCT03402841 Completed - Clinical trials for Non-Germline BRCA Mutated Ovarian Cancer

Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients

OPINION
Start date: January 30, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the efficacy and safety of single-agent olaparib as a maintenance treatment in patients with relapsed High Grade Serous Ovarian Cancer (including patients with primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer who do not have known deleterious or suspected deleterious germline BRCA mutations (non-gBRCAm) and who had responded following platinum based chemotherapy

NCT ID: NCT03402529 Completed - Breast Cancer Clinical Trials

Added Value of Contrast Enhanced Spectral Mammography, CESM. A Pilot Study.

Start date: November 28, 2017
Phase: N/A
Study type: Interventional

Introduction: To avoid unnecessary mastectomies and reoperations a correct size assessment of malignant lesions in breast is required. Sometimes a supplementary MRI is therefore recommended. However, at our unit MRI is not easily available. Contrast enhanced spectral mammography (CESM) has in smaller studies been shown to be equal to MRI regarding sensitivity and specificity. Size assessment using contrast-based modalities as CESM has also been shown to be significantly more accurate than using mammography. Prospective randomized studies using CESM are lacking. Aim: The aim of the study is to evaluate the added value of CESM in diagnostics of breast cancer and choice of operation; partial mastectomy or mastectomy. A pilot study of 50 patients will be conducted to prepare for a larger prospective randomized study. Method: Patients found with breast cancer after diagnostics with mammography, ultrasound and core biopsy, and whom are recommended primary surgery, will be enrolled in the study. A supplementary examination with CESM will be performed. Preoperative extent of the malignant lesions are estimated with each modality and is later compared with the extent measured in post-operative PAD. Data on weight, length, age at menopaus, use of contraceptive pills, HRT or endocrine therapy, breast volume and density is collected, as well as data of diagnosis (ductal or lobular carcinoma), surrounding DCIS, histological grade, ER, PgR, Her2 expression and Ki67 index. In this pilot study sensitivity and specificity for each modality is calculated. Multivariate analysis will be performed regarding influential factors. Pearson correlation coefficient will be calculated for each modality regarding size assessment of the malignant lesions in comparison with definitive PAD.

NCT ID: NCT03401944 Completed - Wasting;Muscle(S) Clinical Trials

Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.

Start date: January 1, 2005
Phase: N/A
Study type: Interventional

The study investigates effects related to muscle protein metabolism at provision of Total Parenteral nutrition.

NCT ID: NCT03401151 Recruiting - Heart Failure Clinical Trials

CHANges iN skEletal muscLe in Heart Failure

Channel-HF
Start date: February 1, 2018
Phase:
Study type: Observational

The mechanisms behind heart failure are largely unknown. Despite an increasing arsenal of pharmacological therapies, cardiovascular disease is still the most common cause of death in the western world, which demonstrates a pronounced need for more patient-related mechanistic research. Cachexia and limited exercise capacity are the symptoms that best match prediction of heart failure, both of which are symptoms involving a dysfunctional skeletal muscle. An increased understanding of the mechanisms and signaling pathways connects the failure heart with skeletal muscle dysfunction is likely to lead both to discoveries of prognostic factors and possible therapeutic options. The study is a prospective, non-blinded, study. The study will consist of the assignment of patients with heart failure, New York Heart Association (NYHA) III-IV, 60-80 years old. One hundred (100) patients will be enrolled in this study.

NCT ID: NCT03400618 Completed - Clinical trials for Diabetes Mellitus, Type 1

Carbohydrate Content in the Diet in Type 1 Diabetes

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

The aim of this study is to analyse the effect of a diet with a moderate amount of carbohydrates and compare it with a traditional diabetic diet with a higher content of carbohydrates on mean glucose level, high and low glucose levels, and the risk of ketoacidosis in patients with type 1 diabetes. The glucose levels will be measured by blinded continuous glucose monitoring (CGM). The trial has a cross-over design and 12 weeks in duration, where patients will be randomized to; 1) a diet with moderate carbohydrate content for 4 weeks and 2) a traditional diabetes diet for 4 weeks and with a wash-out period between for 4 weeks. The two diets will both be healthy and planned by a dietitian. There will be 50 subjects included in the study.

NCT ID: NCT03400332 Active, not recruiting - Cancer Clinical Trials

A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

Start date: February 12, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.

NCT ID: NCT03398148 Completed - Clinical trials for Ulcerative Colitis (UC)

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis

Start date: March 7, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

NCT ID: NCT03398135 Active, not recruiting - Clinical trials for Ulcerative Colitis (UC)

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

Start date: August 28, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally or can transition to a Continued Treatment for Trial Participants Open-Label Extension study.