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NCT ID: NCT03681054 Not yet recruiting - Clinical trials for Dietary Modification

Dietary Management of Gestational Diabetes

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

eMOM is a randomized, controlled trial to compare the effects of two different dietary interventions during pregnancy. The comparison is based on tissue glucose content (using continuous glucose monitoring system) in pregnant women and on neonate body composition. The recruited women (n=60) have been diagnosed with gestational diabetes mellitus, are obese (BMI≥30 kg/m2) and of Caucasian origin. Of the study diets, one is moderately carbohydrate restricted and the other one is high on plant-based protein with an emphasis on healthy Nordic foods. The study has two two-week study periods that are carried out on approximately gestational weeks 24-28 (period I) and 34-36 (period II). Continuous glucose monitoring and other measurements (accelerometer, 3-day food record, gut microbiota, serum lipids, metabolomics, epigenetics etc.) are done during these study periods. At the beginning of the study, before study period I, the participants are randomized to either one of the intervention diets. The first study period consists of a crossover phase in which the participants receive three days' worth of food according to one of the intervention diets (according to the randomization) after which there is a three-day wash-out period. After the wash-out period, the participants receive three days' worth of food according to the other diet. After the first study period, a nutritionist advises the lastly followed intervention diet to the participant and the diet is followed until delivery. To ensure the diet is followed, the participants gets at least three personal face-to-face counseling sessions, phone calls, mobile reminders, recipes and food items. After delivery, the infant's body composition, epigenetic markers of cord blood and placenta, gut microbiome and urine metabolomics are measured.

NCT ID: NCT03675152 Recruiting - Low Back Pain Clinical Trials

Treatment of Spondylolysisin Pediatric Patients.

Start date: June 12, 2016
Phase: N/A
Study type: Interventional

A clinical trial comparing healing of unilateral or bilateral spondylolysis in children treated with a Boston thoracolumbar orthosis (brace) or with a soft spinal brace (Porostrap lumbar support) for four months. Inclusion criteria will be a child or adolescent aged between 8 and 20 years with an early uni- or bilateral defect (fracture line) in the pars interarticularis in the CT-scan with no signs of bony sclerosis. Additionally, bone marrow edema has to be confirmed in MR images (T2 sagittal) as a sign of an early lesion. Exclusion criteria will be spondylolisthesis on standing spinal radiograph, systemic skeletal disorder or lack of interest. Patient's preference defines the treatment method. Minimum follow-up time will be 2 years for all patients. According to statistical power analysis a total of 60 patients will be needed to provide evidence for the effectiveness or no effectiveness of rigid thoracolumbar orthosis on the natural history of early spondylolysis. Measured outcome parameters are 1) Bony healing on CT-scan, 2) SRS-24-score at the beginning of the treatment and during the 2-year follow-up, 3) Back and lower extremity pain at the beginning of the treatment and during the 2-year follow-up (Pain drawing including VAS-score in children under 16 years old, Oswestry disability index including VAS-score in patients over 16 years old), 4) Thoracolumbar radiographs at 2-year follow-up: Evidence of spondylolisthesis, 5) Trunk strength and spinal mobility at follow-up visits. As part of this study, the investigators will also evaluate patients with spondylolysis treated in our hospitals before this clinical trial begun. In this retrospective study they will evaluate all patients between 8 and 20 years of age with spondylolysis, which have been treated with thoracolumbar orthosis after year 2009 and are not participating in to prospective study. Main focus will be in bony healing in CT-scans after brace treatment.

NCT ID: NCT03669016 Recruiting - Stress Clinical Trials

MIndfulness for Students

Mindfulstud
Start date: August 22, 2018
Phase: N/A
Study type: Interventional

The aim of the study is to find out, weather the students' wellbeing and functional ability can be enhanced by two different type of mindfulness interventions: 1) face-to-face group-based training, and 2) internet-based training based in mindfulness and acceptance and commitment therapy. Study results may be used to decide whether it is worth offering mindfulness training for medical faculty students, and what kind of training would be most suitable and effective in the medical education context.

NCT ID: NCT03668405 Enrolling by invitation - Alzheimer's Disease Clinical Trials

A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)

Start date: June 26, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the long-term safety, tolerability and antibody response of Lu AF20513 in patients with Alzheimer's disease who have completed the 16026A study.

NCT ID: NCT03668236 Not yet recruiting - Septic Shock Clinical Trials

The Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care Trial

CLASSIC
Start date: November 2018
Phase: Phase 4
Study type: Interventional

The purpose of this trial is to assess patient important benefits and harms of IV fluid restriction vs. standard care fluid therapy in patients with septic shock.

NCT ID: NCT03664869 Not yet recruiting - Bladder Cancer Clinical Trials

Electromotive Mitomycin-C (EMDA-MMC) in Preventing Recurrences in High-risk Non-muscle-invasive Bladder Cancer

FB10
Start date: October 26, 2018
Phase: Phase 3
Study type: Interventional

Disease recurrence and progression is a major issue in high risk non-muscle-invasive bladder cancer (NMIBC). The current study compares two adjuvant instillation therapies in the treatment of high risk NMIBC. After resection of the tumour(s), patients will receive either traditional regimen of Bacillus Calmette-Guérin (BCG) instillations or combination treatment consisting of sequential BCG-instillations and mitomycin C instillations administered with electromotive drug administration (EMDA) device.

NCT ID: NCT03658967 Recruiting - Clinical trials for Secondary Lymphedema

Clinical Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema (AdeLE)

AdeLE
Start date: June 7, 2018
Phase: Phase 2
Study type: Interventional

This study evaluates the efficacy of Lymfactin® in patients with secondary lymphedema associated with the treatment of breast cancer by comparing the effects of active study treatment Lymfactin® to placebo. The study product will be administered in combination with a surgical lymph node transfer operation. In addition, the safety and tolerability of the Lymfactin® treatment will be evaluated.

NCT ID: NCT03657901 Enrolling by invitation - Stress Clinical Trials

Sleep, Stress and Learning: an Experimental Pilot Study

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

To investigate the efficiency and effect of a programmed slow-breathing exercise in the evening to the heart rate variability, sleep quality and memory performance over night.

NCT ID: NCT03654742 Not yet recruiting - Tonsillitis Clinical Trials

Intracapsular Tonsillectomy in Adults

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

Comparing the classical tonsillectomy performed with electrocautery, to modern intracapsular approaches of coblation and microdebrider.

NCT ID: NCT03653026 Not yet recruiting - Clinical trials for Ulcerative Colitis (UC)

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis

Start date: September 11, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of Upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in subjects with moderately to severely active ulcerative colitis (UC).