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NCT ID: NCT03548987 Completed - Obesity Clinical Trials

Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

STEP 4
Start date: June 4, 2018
Phase: Phase 3
Study type: Interventional

This study will look at the change in participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what a participant can do to lose weight. The participant will get semaglutide for the first 20 weeks. Then the participant will get either semaglutide or "dummy" medicine - which treatment the participant gets after the 20 weeks is decided by chance. The participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years.

NCT ID: NCT03547271 Completed - Clinical trials for Meningococcal Infections

Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe

Start date: December 14, 2018
Phase: Phase 3
Study type: Interventional

Primary objective is to demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of a 3-dose series of MenACYW conjugate vaccine compared to a 3-dose series of a licensed meningococcal vaccine when each vaccine is given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b [DTaP-IPV-HB-Hib vaccine]) to infants and toddlers 6 weeks to 18 months old Secondary objectives are: - To demonstrate the non-inferiority of the antibody (Ab) response against meningococcal serogroups A, C, Y, and W following the administration of 2 doses in infancy of MenACYW conjugate vaccine compared to 2 doses of a licensed meningococcal vaccine when each vaccine is given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and DTaP-IPV-HB-Hib vaccine) to infants and toddlers 6 weeks to 18 months old. - To describe the Ab responses against meningococcal groups A, C, Y, and W and the antigens of the routine pediatric vaccines administered in the study.

NCT ID: NCT03546036 Completed - Insomnia Clinical Trials

Controlled Study of Chain Blanket for Insomnia

Start date: March 4, 2015
Phase: N/A
Study type: Interventional

The aim of the study is to compare an intervention with a weighted metal chain blanket of 8 kg with a control plastic chain blanket of 1,5 kg for patients with Major depressive disorder, bipolar disorder, Generalized Anxiety Disorder (GAD) and/or attention deficit hyperactivity disorder (ADHD) and co-occurring insomnia. Patients are evaluated by a rater blind to treatment allocation with Insomnia Severity Index (ISI), Fatigue Symptom Inventory (FSI), Hospital Anxiety and Depression Scale (HAD) and actigraphy before, during and at primary end-point after 4 weeks use of the blanket.

NCT ID: NCT03545659 Completed - Recurrence Clinical Trials

Childhood Acute Lymphoblastic Leukaemia: Follow-Up

Start date: September 4, 2018
Phase:
Study type: Observational

Over the past decades, advances in treatment have led to an increasing number of children who survive cancer, resulting in a growing population of childhood cancer survivors. After end of cancer treatment on common protocols survivors are enrolled in non-harmonized follow-up programs with frequent visits and blood samples. However, the evidence for the value of these follow-up programs with respect to the effect on detecting relapse and the effects on overall survival is scarce. The aim of the study is to give a comprehensive description of the detection mode of relapsed acute lymphoblastic leukaemia (ALL), including symptoms and blood test results. Further, we aim to evaluate if the mode of detection affects survival.

NCT ID: NCT03543371 Completed - Insomnia Clinical Trials

Neuropsychological Outcome After Cardiac Arrest

Start date: July 13, 2018
Phase:
Study type: Observational

This study is a sub-study to the large pragmatic Target Temperature Management 2 Trial (TTM2-trial, ClinicalTrials.gov Identifier: NCT02908308), assessing effectiveness of controlled hypothermia after out-of-hospital cardiac arrest (OHCA). This study is designed to provide detailed information on cognition after OHCA and its relationship to associated factors as emotional function, fatigue, and sleep. A secondary aim is to utilize this information to validate a neurocognitive screening battery used 6 months after OHCA in the TTM2-trial. Approximately 7 and 24 months after OHCA, survivors at selected TTM2 study sites will perform a standardized neuropsychological assessment including performance-based tests of cognition and questionnaires of behavioral and emotional function, fatigue, and insomnia. At 1:1 ratio, a control group of myocardial infarction (MI) patients but no occurrence of cardiac arrest will be recruited and perform the same test battery. Group differences at 7 and 24 months will be analyzed per cognitive domain (verbal, visual/constructive, short-term working memory, episodic memory, processing speed, executive functions). Results of the OHCA survivors on the TTM2 neurocognitive screening battery will be compared with neuropsychological test results at 7 months time.

NCT ID: NCT03543332 Completed - Physical Activity Clinical Trials

Physical Activity After Cardiac Arrest; a Sub-study in the Target Temperature Management Trial 2

Start date: July 21, 2018
Phase:
Study type: Observational

The Target Temperature Management trial 2 (TTM2) is an international multi-center study, that randomize patients with OHCA of a presumed cardiac or unknown cause to target temperature management at 33°C or normothermia but avoiding fever (37.8°C) for the first 24 hours after the OHCA. The TTM2 study (clinicaltrials.gov Identifier NCT02908308) includes a detailed follow-up of functional outcome, health-related quality of life and neurocognitive function at 6 and 24 months post-arrest. This protocol describes a sub-study within the TTM2 trial that specifically focus on physical activity among the OHCA survivors.

NCT ID: NCT03542136 Completed - Colorectal Cancer Clinical Trials

Peripheral Neuropathy in Colorectal Cancer Patients Under Adjuvant Chemotherapy With FOLFOX, FLOX or XELOX Regime

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

Oxaliplatin is a cytotoxic platinum compound and is one of the chemotherapeutic agent used in advanced colorectal cancer. It is used combined with Fluorouracil (5 FU) and Leucovorin. The main and most suffering side effect of oxaliplatin is polyneuropathy. Oxaliplatin-induced polyneuropathy (OIPN) can be acute and/or chronic neurotoxicity. The early detection of the neurotoxicity and changing the medication dose and/or schedule can prevent its development. It has been used different neurotoxicity scales in grading OIPN. In this study the investigators try to investigate whether the evaluation of the vibrotactile perception VTP, by using a multi frequency tactilometry in a patients hand and foot is a good indicator and superior to the standard of care to detect the underlying OIPN in patients undergoing adjuvant chemotherapy treatment with FOLFOX, FLOX or XELOX regime.

NCT ID: NCT03540524 Completed - Cystic Fibrosis Clinical Trials

A Study Looking at the Safety, Tolerability and Efficacy of the Combination of the Study Drugs GLPG2451 and GLPG2222 With or Without GLPG2737 in Patients With Cystic Fibrosis.

FALCON
Start date: May 31, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase Ib, multi-center, open-label, nonrandomized multiple cohorts study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of a combination treatment of GLPG2451 and GLPG2222, with and without GLPG2737, in adult subjects with Cystic Fibrosis.

NCT ID: NCT03536078 Completed - Clinical trials for Neonatal Hyperbilirubinemia

Home Phototherapy for Term Newborns With Icterus

Start date: June 30, 2016
Phase: N/A
Study type: Interventional

The study is designed as a randomised controlled multicenter study.The primary aim is to investigate if home phototherapy improves parent-child bonding compared to if treatment is performed at the hospital. The investigators will also istudy how home phototherapy is perceived by the parents, impact on breastfeeding and parents stress levels, if the method can be implemented etc. Patients are included at 5 hospitals in Sweden. The plan is to include 250 term newborns with neonatal icterus at a level that needs phototherapy treatment.

NCT ID: NCT03532919 Completed - Hip Fractures Clinical Trials

Heart and Renal Failure in Hip Fracture Surgery

Start date: February 1, 2018
Phase:
Study type: Observational [Patient Registry]

Patients with acute hip fractures are old and vulnerable. With a majoriry classified as being ASA 3 or more. Frequently they receive spinal anesthesia perioperatively inducing hypotension. Even a short hypotensive period may induce postop cardiac T roponinT leakage as well as renal failure noted by Changes in Serum Creatinin or Cýstatin C This will be investigated and correlated to intraoperative hypotension as step one. Preliminary this will be followed by an intervention with vasopressor treatment perioperatively to preserve an adequte MABP