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NCT ID: NCT03905395 Recruiting - Clinical trials for Recurrent Pregnancy Loss

Meditation and Mindfulness for Recurrent Pregnancy Loss

Start date: February 2, 2019
Phase: N/A
Study type: Interventional

In the Danish Recurrent Pregnancy Loss Unit in Rigshospitalet in Copenhagen recurrent pregnancy loss (RPL) is defined as three og more consecutive pregnancy losses in accordance with current European guidelines. RPL affects approximately 3% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the chance of a live birth. 42% of the women referred to RPL Unit in Rigshospitalet has a high stress level where as it's 22% in the background population trying to achieve parenthood. It's also known that 8,8 % of RPL patients have a depression at referral where as it's 2,2 % in the background population trying to achieve parenthood. The study is a RCT including 62 patients - 31 in each arm. One arm will be taught in meditation and mindfulness three courses over a 7 week period. This group will also do meditation every day for 7 weeks. The other arm will have no intervention. This study will investigate if a 7 weeks course in meditation and mindfulness is a useful tool to reduce stress and the psychological consequences for women and their partner treated in RPL Unit in Rigshospitalet, Copenhagen. Furthermore this study will investigate if there's a marital benefit such as reinforcement in their relationsship from practicing meditation and mindfulness. There is no previous study that has investigated meditation and mindfulness for RPL. This study has the potential to establish mental health support as a supplement to the medical and clinical treatment for RPL patients.

NCT ID: NCT03904212 Recruiting - Crohn Disease Clinical Trials

Adipose Tissue Injection in Perianal Fistulas in Crohn´s Disease

Start date: March 27, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This randomized and placebo controlled study investigates the efficacy of injections with freshly harvested autologous adipose tissue in CD patients with complex perianal fistulas refractory to standard surgical and/or medical treatment. 140 CD patients will be included and randomized to either treatment with freshly harvested autologous adipose tissue or placebo (saline). Primary outcome measures are clinical healing 6 months after treatment evaluated by clinical examination and pelvic MRI.

NCT ID: NCT03902106 Recruiting - Healthy Clinical Trials

Physiological Response to Salbutamol and Exercise

Start date: March 28, 2019
Phase: N/A
Study type: Interventional

The scope of the study is to investigate the physiological response to salbutamol and exercise. A particular focus is on the metabolic response and amine metabolism.

NCT ID: NCT03899792 Recruiting - Soft Tissue Sarcoma Clinical Trials

A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors

LIBRETTO-121
Start date: June 13, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, multi-center Phase 1/2 study of oral LOXO-292 in pediatric participants with an activating rearranged during transfection (RET) alteration and an advanced solid or primary CNS tumor.

NCT ID: NCT03899155 Recruiting - Cancer Clinical Trials

Pan Tumor Rollover Study

Start date: August 9, 2019
Phase: Phase 2
Study type: Interventional

Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.

NCT ID: NCT03886922 Recruiting - Headache Clinical Trials

The Hemodynamics Effect of Glibenclamide on Levcromakalim Assessed by High Resolution Magnetic Resonance Angiography (MRA) Technique in a Randomized Double-blind Cross-over Placebo-controlled Study With Healthy Volunteers

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

To investigate the effect of levcromakalim/placebo infusion on cranial arteries after glibenclamide administration.

NCT ID: NCT03886363 Recruiting - Mental Well-being Clinical Trials

Effectiveness of MBSR Among School Teachers

Start date: December 18, 2018
Phase: N/A
Study type: Interventional

The aim is to evaluate the effectiveness of Mindfulness-Based Stress Reduction among school teachers in Danish schools on mental weii-being in the teachers and their pupils. The study is a cluster-randomised trial including 150 schools; 200 teachers; 4000 pupils from the five geographical regions in Denmark.

NCT ID: NCT03878992 Recruiting - Clinical trials for Growth Hormone Deficiency

Effects of Growth Hormone and IGF-1 on Anabolic Signals and Stem Cell Recruitment in Human Skeletal Muscle

Start date: April 30, 2019
Phase: N/A
Study type: Interventional

12 adult hypopituitary patients with newly diagnosed Growth hormone (GH)-deficiency will be studied two times. The first examinations will be performed shortly after time of diagnose before initiation of exogenous GH treatment, where each subject will receive a single intravenous bolus of 0.5 mg GH. The examination day will be repeated after prolonged GH replacement therapy (>3 month after treatment initiation).

NCT ID: NCT03878225 Recruiting - Clinical trials for Alcohol Use Disorder

Does a Ketogenic Dietary Supplement Reduce Alcohol Withdrawal Symptoms in Humans?

KME
Start date: June 15, 2020
Phase: N/A
Study type: Interventional

A ketogenic diet (KD) is high in fat and low in carbohydrates and induces ketosis. KD is an approved non-pharmacological therapy for drug-resistant child epilepsy. Research has shown that a KD can reduce the behavioral measures of alcohol withdrawal symptomatology in rats. Ketosis is also possible to achieve without adherence to a KD, by ingestion of a ketogenic dietary supplement. In this study, we want to investigate if the attenuating effect of the KD observed in rodents, is also applicable in humans, i.e. whether a ketogenic dietary supplement, here a ketone monoester, would be effective in suppressing alcohol withdrawal symptoms in humans. Objective: To test the effect of a ketogenic dietary supplement on the need for benzodiazepines in managing alcohol withdrawal syndrome in humans. Eligibility: Adults 18-70 years who are alcohol dependent and are seeking treatment for alcohol withdrawal syndrome in an out-patient setting. Design: Double blinded, randomized clinical trial. The participants will be randomized to receive either the ketone ester beverage, or a placebo beverage. The study will be conducted over three days (72 hours), with follow-up at 1 month and 1 year after completion. A sub-set of patients will undergo Magnetic Resonance Spectroscopy (MRS) following withdrawal treatment, and again after 1 month.

NCT ID: NCT03876769 Recruiting - Clinical trials for B-Cell Acute Lymphoblastic Leukemia

Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients

CASSIOPEIA
Start date: June 24, 2019
Phase: Phase 2
Study type: Interventional

This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in de novo HR pediatric and young adult B-ALL patients who received first-line treatment and are EOC MRD positive. The study will have the following sequential phases: screening, pre-treatment, treatment & follow-up, and survival. After tisagenlecleucel infusion, patient will have assessments performed more frequently in the first month and then at Day 29, then every 3 months for the first year, every 6 months for the second year, then yearly until the end of the study. Efficacy and safety will be assessed at study visits and as clinically indicated throughout the study. The study is expected to end in approximately 8 years after first patient first treatment (FPFT). A post-study long term follow-up safety will continue under a separate protocol per health authority guidelines.