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NCT ID: NCT02073032 Completed - Clinical trials for Cancer of the Head and Neck

Incidence and Risk Factors of Refeeding Syndrome

Start date: February 2011
Phase: N/A
Study type: Observational

The main objective of this observational survey was to determine the incidence rate of refeeding phenomena (RFF) (defined as any decline in p-phosphate) and RFS (defined as any decline in p-phosphate with additional development of any of the following clinical symptoms: oedema, confusion, dyspnoea, hypotension, arrhythmia, seizures) among recently admitted or referred HNC patients to the Department of Otorhinolaryngology for surgery. The second objective was to determine if informations at admittance could identify HNC patients at high risk of developing RFF and RFS.

NCT ID: NCT02072798 Completed - Clinical trials for Surgical Wound Infection

Antibiotics and Gut Microbiota Among Newborn Infants

Start date: February 2014
Phase: Phase 4
Study type: Interventional

Background Women undergoing Caesarean Section (CS) have an increased risk of postpartum infections compared to women undergoing vaginal delivery. In Denmark the incidence of post-CS infections is 7-10%. The most common infections are endometritis, Urinary tract infections (UTI) and wound infections (WI). Prophylactic antibiotics are effective in preventing postoperative infections and national guidelines recommend that antibiotics should be administered as a single dose immediately before surgical incision. CS is an exception to this pre-incision administration approach. National guidelines recommend administration of antibiotics after umbilical cord clamping to avoid exposure of the child to antibiotics before birth. Recent studies of antibiotic prophylaxis for CS suggest that prophylactic antibiotics administered before incision compared to after umbilical cord clamping may reduce post-CS infections by up to 50%. Two Cochrane reviews from 2012 criticize these types of studies for lack of data for outcomes on the baby and on late infection in the mother. At birth, all mammals must rapidly adapt to intake of complex milk nutrients via the gut and simultaneously tolerate the invasion of billions of microbes. This requires rapid maturation of the digestive and immune functions to avoid gut disorders and infections. Full-term, breast-fed infants normally adapt well, but factors such as caesarean birth, high hygiene levels, antibiotics treatment and formula feeding may inhibit immune development both short and long term. Birth by caesarean section in high-hygiene hospital environments, and widespread use of antibiotics, are factors that reduce gut microbiota density and diversity in the newborn for some time after birth. On the other hand, high-hygiene environments and antibiotics are essential tools to combat infections, especially for the weakest newborn infants. This pilot study will be a feasibility study to the original study, which examines the effect of change in timing of prophylactic antibiotics on the rate of post-CS infections (endometritis, UTI and WI). The pilot study focus on antibiotic and changes in the gut microbiota of newborn infants. The feasibility study will only include pregnant women in Odense with a body mass index below 30, and planned cesarean section.

NCT ID: NCT02072733 Completed - Cancer Clinical Trials

Suitability of an Organization With an Onco-geriatric Team to a Whole Region (Region Midt) of Denmark

Start date: January 2015
Phase: N/A
Study type: Interventional

A Feasibility study Geriatric assessment applied to patients with cancer of the head and neck, lung cancer, upper gastrointestinal cancer or colo-rectal cancer. On the day of planning the oncologic treatment Comprehensive Geriatric Assessment (CGA) will be offered to patients aged 70 years and up. Based on the CGA a tailored multidisciplinary intervention is planned with the patients. The study aims 1) to investigate if it is feasible to offer CGA to all elderly (+70 years) patients with the relevant cancer diagnoses as mentioned above in The Central Denmark Region (Region Midt) , 2) to estimate the proportion of frail, vulnerable or fit elderly cancer patients, 3) to investigate the impact of a CGA on the planned oncologic treatment intensity, and 4) to investigate the ability of CGA to predict complications to cancer treatment within a three months period.

NCT ID: NCT02072434 Completed - Atrial Fibrillation Clinical Trials

Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF)

ENSURE-AF
Start date: March 25, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare edoxaban to warfarin (with enoxaparin, if needed). It will see if edoxaban prevents stroke and other blood clotting problems as well and as safely as warfarin. People with atrial fibrillation (irregular heartbeat) might be able to join. Their doctors must plan to use shock to make their hearts beat normally. About 2200 people from different countries will join. They will have an equal chance of receiving either treatment. They are anticipated to be in the study for around 82 days. Tests will include physicals and finger-pricks. Participants will provide blood and urine samples.

NCT ID: NCT02070081 Completed - Obesity Clinical Trials

Weight Loss Following Gastric Bypass or Sleeve Surgery

Start date: March 2014
Phase: N/A
Study type: Interventional

The overall aim is to study the multiple factors determining the variation of weight loss after Roux-en-Y Gastric Bypass (RYGB) and Sleeve surgery. The specific aims are to evaluate: a) what explains the large individual differences in weight loss seen after RYGB and Sleeve surgery, b) if it is possible pre-operatively to identify which patients will not obtain beneficial effects of bariatric surgery in relation to weight loss and quality of life and c) if patients in need of improved care can be identified pre- and/or early post-operatively.

NCT ID: NCT02069951 Completed - Surgery Clinical Trials

Procedure-to-procedure Transfer Trial

Start date: February 2014
Phase: N/A
Study type: Interventional

Surgical training programs using virtual reality simulators often only use basic skills training and the use of procedural training is very limited. Procedural training differs from basic skills training by requiring integration of isolated skills and decision making and planning components. However, it is unknown if it is necessary to practice all procedures before operating on actual patients or whether it is simply a matter of learning psychomotor skills and if these skills are transferable between different tasks. The main hypothesis is that practicing a laparoscopic procedure on a simulator makes it easier to reach proficiency on a different laparoscopic procedure on the simulator because participants have already practiced the integration of isolated skills.

NCT ID: NCT02069470 Completed - Cancer Clinical Trials

The Effect of CME on Early Cancer Diagnosis in General Practice

Start date: September 2012
Phase: N/A
Study type: Interventional

Background Denmark has a lower survival of cancer compared to most European countries. Fast track pathways for organ specific cancers were established in the years 2008-2010. In 2011 further a fast track pathway for non-specific serious symptoms. Cancer in general practice is a low prevalence condition. Each general practitioner (GP) will see 8-10 new cancer patients per year. The investigators know that cancer patients have an increased use of general practice prior to diagnosis and that 25% of them wait for more than 20 days in general practice for referral according to the GPs. The latest Danish Cancer Plan therefore includes a CME as a key strategy to lower the GP threshold to refer patients to cancer fast track pathways. The aim of this study was to investigate the effect of this CME in early cancer diagnosis. This is measured by changes in GP knowledge, attitude and risk assessment. GP referral behavior assessed by primary care interval and use of fast track referrals. GP´s cancer hit rate, cancer patients´ tumor stage at treatment and 1 year survival. Methods/Design The study is conducted as a stepped wedge controlled design based on a quasi-cluster randomization. In august 2012 an invitation to participate in the present study were sent to 859 general Practitioners (GPs) from the Central Denmark Region. GPs completed a form for each patient they referred to a fast-track diagnostic pathway for cancer within an 8-month period. Every other week, we received data from a regional database. We reminded the referring GP-practice about non included patients. The collected data will be linked to registries. The CME-intervention The CME-course was a 3-hour meeting after work. Guided by the available evidence from the literature following the investigators ensured a multifaceted interactive teaching method including case-based education. The content included by other topics positive predictive values, false reassurance from negative testing and other pit-false. Statistical analyses The outcomes will be analyzed in a generalized linear random-effects model with random effect of GPs. Based on data it will be assessed whether further modeling of inter correlation within practices and within clusters is required, and whether the intervention effects are assumed equal for all GPs, or in random interaction with them. Analyses will be performed both in the full GP-population ("intention to intervening ") and in the 3 subgroups of GPs.

NCT ID: NCT02068950 Completed - Clinical trials for Head and Neck Cancer

Progressive Resistance Training Program in Head and Neck Cancer Patients

Start date: February 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the feasibility of a 12-week progressive resistance training (PRT) during concurrent chemoradiotherapy in head and neck cancer patients compared to usual care.

NCT ID: NCT02068573 Completed - Allergy Clinical Trials

AsthmaVent - Effect of Mechanical Ventilation on Asthma Control in Children

AsthmaVent
Start date: August 2012
Phase: N/A
Study type: Interventional

AsthmaVent is a multi-center study, investigating the association between indoor air quality and childhood asthma. In Denmark, we spend more and more time indoors. Our houses are built airtight to save energy and are difficult to ventilate. We are thus more exposed to our indoor air than ever before. We know that indoor air contains many different components that can affect our airways inappropriately and particularly children with asthma, who have sensitive airways are sensitive to these components. The AsthmaVent project examines whether increased ventilation is able to improve the indoor environment to such an extent that the asthma disease control, for children with asthma and house dust mite allergy improves, resulting in need for less medication. Previous studies have pointed towards a beneficial effect of mechanical ventilation, on both the indoor air quality and on children's health and quality of life. There is not currently a consensus in this area, as studies so far have not been large or good enough to confidently determine the effect. This project is big and is designed so that it takes into account the sources of error seen in previous studies on the topic. We include, over a 3-year period (2012-2014), a total of 80 children with asthma and house dust mite allergy aged 6-18 years, from pediatric departments in Aarhus, Odense, Kolding, Randers and Herning. They are divided into two groups, receiving either active ventilation or placebo ventilation, meaning a non-functioning ventilation system that just recirculates the air in the room. Ventilation systems are installed in the fall and winter and ventilate the child's bedroom during 9 months. Indoor air quality and asthma control are assessed every 3 months, both at home visits were air quality and allergen levels of house dust mites are studies and at visits to the outpatient clinics with control of asthma parameters and quality of life. The project involves collaboration between several institutions with an interest in indoor air quality in relation to allergies and asthma and with great expertise in the field.The project was initiated by CISBO (Centre for Indoor Environment and Health in Dwellings), a center consisting of several institutions in Denmark dealing with indoor environment: Department of Public Health at Aarhus University and University of Copenhagen, Danish Building Research Institute and the Technical University of Denmark. Since asthma is the most common chronic childhood disease in Denmark and since the development of allergies and asthma has high social and personal costs, it is important for both society and the individual family, to find out whether simply improving the indoor air quality by increased ventilation can lead to an improvement in asthma disease control.

NCT ID: NCT02068560 Completed - Nocturia Clinical Trials

The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion

Start date: May 2012
Phase: N/A
Study type: Interventional

There is substantial evidence that women throughout life have significantly lower plasma levels of the antidiuretic hormone vasopressin (pAVP) compared to men. The importance of this is not yet fully elucidated, but in relation to the observations of lower pAVP levels, no significant difference in renal response parameters was found. This could be interpreted an increased renal sensitivity in females compared to males. The theory of increased renal sensitivity in females is supported by a few pharmacodynamic studies currently available on this topic. However none of the studies was designed with the purpose of investigate the gender difference. The aim of this study is to investigate possible gender differences in the renal sensitivity to dDAVP and the effect of age on these differences. This will be done by low dose graded infusion of the synthetic AVP analog dDAVP. Participants are 80 healthy volunteers equally distributed between four age groups, 8-10 years of age, 16-18 years of age, 25-40 years og age and 65+ years of age.