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NCT ID: NCT01698385 Completed - Clinical trials for Gestational Diabetes

Prevention of Gestational Diabetes Through Lifestyle Modification

RADIEL
Start date: February 2008
Phase: N/A
Study type: Interventional

OVERALL OBJECTIVES: 1. To assess the efficacy of a diet and exercise intervention before and/or during pregnancy in the prevention of GDM and its fetal complications in women with high diabetes risk. 2. To assess the cost-effectiveness of a diet and exercise intervention in the prevention of GDM from a socio-economic point of view. To find out whether the intervention can be used to reduce health care costs due to GDM and T2DM. 3. To determine the long-term effectiveness of the above-mentioned lifestyle intervention in the reduction of T2DM incidence among women with prior GDM and their offspring STUDY SUBJECTS Group 1: Women planning pregnancy with a history of diet/insulin-treated GDM or BMI >30 kg/m2. N= 250 + 250. Group 2: Women in early pregnancy with a history of diet/insulin-treated GDM or BMI >30 kg/m2. N= 250 + 250 METHOD The Finnish multi-center randomized controlled intervention trial started in the maternity hospitals of Helsinki and Uusimaa District Area 1/2008 and in the South-Karelia Central Hospital in Lappeenranta in 9/2008. 1000 women at high GDM risk will be recruited. Half of the subjects are randomized into the intervention group and the other half act as controls receiving only standard antenatal care in addition to the laboratory tests taken and questionnaires administered by the RADIEL study. The active intervention arm of the study will be carried out in a structured, standardized manner by diabetes nurses and nutritionists specifically trained for their tasks. The intervention includes: 1. Structured visits to diabetes nurse every 3 months before and during pregnancy as well as at 6 weeks, 6 and 12 months post partum. Visits include e.g. structured counseling on diet and exercise, setting of specific goals, follow-up of achievements, laboratory tests and measurements 2. Structured group visits to nutritionist at the moment of enrollment in the study, at the beginning of pregnancy as well as at 6 and 12 months post partum. Additional individual visits are booked if needed. 3. Services of physical activity advisors are provided by the study subjects' cities of residence free of charge to all who wish to receive extra counseling on exercise. If exercise goals are not met, study subjects book an appointment with the physical activity advisor. LIFESTYLE TARGETS: 1.Weight: A weight loss of 5-10% before pregnancy if BMI > 25 and/or limited weight gain during the first two trimesters in pregnancy if BMI > 30. 2.Exercise: A minimum of 30 min. of exercise 5 times per week or 50 min. 3 times per week of moderate intensity exercise (Borg 11-15). Daily household and/or transportation physical activity. 3.Diet: Increased intake of vegetables, legumes, fruits and berries, whole grain and fiber, low-fat dairy, vegetable fats; and use of "plate model". Total energy intake: 1600-1800 kcal/day, with 40-50 E% carbohydrates, 30-40 E% fats, 20-25 E% protein. MEASUREMENTS of maternal variables: AT THE MOMENT OF ENROLMENT TO THE STUDY, and every 3 months before pregnancy: (1) Waist circumference, blood pressure, pulse, weight, height (2) i.e. 2-hour OGTT, fP-insulin, fP-glucose, , GHbA1c, lipids, P-hCRP, P-IL-6, S-A1Glypr, leptin. (3) Background questionnaire (4) 15-D-questionnaire: health-related quality of life. (7) Food diary (2+1). Exercise diaries daily for one week. PREGNANCY At the end of each trimester: (1) The same tests and measurements as in pre-pregnancy period. 2h-OGTT at H10-14 and at H24-28. (2) Questionnaire, 15-D questionnaire, EDPS (=Edinburgh post-partum depression scale) questionnaire for screening mood disorders at H10-13. (4) Food diaries (2+1), and exercise diaries daily for one week at H10-13 and H34-36. POST PARTUM PERIOD (Groups 1-2) At 6 weeks, 6 and 12 months post partum: (1) The same follow-up tests and measurements as at the beginning. Lipids checked only at 12 months post partum. (2) 2-hour OGTT 6 weeks and 12 months post partum (3) Questionnaires at all visits. (5) Food and exercise diaries at 12 months post partum. MEASUREMENTS of child's variables at birth (1) weight (2) height (3) head circumference (4) From delivery records: Mode of delivery, Apgar scores, any perinatal complications, operations, need of neonatal intensive care and length of hospital. (3) Laboratory tests from cord blood. TIMETABLE Recruitment started in February 2008 and ended in autumn 2011 when about 800 subjects had been recruited to the study. Intervention will continue until 2014 (including pre- and postpartum periods). Long-term follow up of both mothers' and children's cohorts starts in 2014 and has been planned to continue up to 10 years postpartum. Data analysis starts in autumn of 2013 and results will be reported from 2014 onwards in international peer-reviewed journals.

NCT ID: NCT01697189 Completed - Driver Sleepiness Clinical Trials

An Educational Intervention to Promote Safe Driving

Start date: August 2010
Phase: N/A
Study type: Interventional

The general aim of the study is to promote safe, economic, and environmental-friendly driving among long-haul truck drivers. To do this, the investigators will conduct an on-road study on i) the relationship of driver sleepiness and stress with driving behaviour and fuel consumption and ii) effectiveness of an educational intervention in mitigating sleepiness at the wheel. The educational intervention is designed to be employed by occupational health care professionals in the future. This solution clearly facilitates the implementation of the intervention into practice if it turns out to be effective. The investigators specified research questions are the following: - Do truck driver sleepiness and stress at the wheel reach levels that affect driving behaviour, fuel consumption and carbon emissions? - What are the sources of sub-optimal arousal at the wheel in truck drivers? - Can truck driver sleepiness be mitigated by an educational intervention, and if yes, does it improve driving behaviour and decrease fuel consumption and carbon emissions as well?

NCT ID: NCT01697085 Completed - Mucous Membranes Clinical Trials

Effects of Sea Buckthorn Oil on Mucous Membranes

SBMM
Start date: October 2012
Phase: N/A
Study type: Interventional

Aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous membranes

NCT ID: NCT01696266 Completed - Clinical trials for Diabetes Mellitus, Type 2

An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

Start date: September 5, 2012
Phase:
Study type: Observational

This study is conducted in Europe. The aim of the study is to gather information about hypoglycaemia (low blood glucose) among patients with Type 1 or Type 2 diabetes mellitus. The study is both retrospective and prospective.

NCT ID: NCT01694745 Completed - Pain Clinical Trials

EUROpean Pain Audit In Neonates

EUROPAINsurvey
Start date: October 2012
Phase: N/A
Study type: Observational

EUROPAIN Survey is an epidemiological study aimed at assessing current clinical practices regarding the use of sedative and analgesic drugs in newborns admitted to NICUs or PICUs in different countries in Europe. This study is conducted as part of the NeoOpiod study. The main objective of this study is to determine the current clinical practices regarding the use of sedative and analgesic drugs in newborns in intensive units in different countries in Europe. The principal criteria are: the frequency of ventilated neonates receiving sedation and analgesia, the medications used for sedation and analgesia in ventilated neonates, the length of use of medications administered for sedation and analgesia in ventilated neonates and similarities and differences in sedation and analgesia practices among European countries. The secondary objectives are: a) to determine the proportion of neonatal units that have developed and implemented local written guidelines to provide continuous sedation and analgesia in ventilated newborn infants as well as to prevent and treat procedural pain, b) to document the published guidelines for neonatal analgesia and sedation in different European countries and develop consensus for common European standards that can be applied in all medical settings, c) to determine the frequency of use of pain assessment tools in ventilated newborn infants and evaluate their impact on pain management practices and d) to determine practices to assess and prevent withdrawal syndromes. The EUROPAIN STUDY is observational and therefore it will not interfere with routine practices of participating units. No changes in diagnostic, therapeutic or any managing strategy of patients are imposed by the participation in this study. This epidemiological study will only collect data on clinical practices in each unit. It will include all neonates up to a corrected age of 44 weeks post conception. The maximum duration of data collection for every included infant is 28 days. Data collection will stop before 28 days if the infant leaves the unit (discharge, death, transfer to another hospital). Data will be entered on a secure web-based questionnaire.

NCT ID: NCT01691820 Completed - Clinical trials for Infections, Cytomegalovirus

A Study in Adolescent Females to Explore Cytomegalovirus Infection

Start date: October 5, 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to estimate the incidence of Cytomegalovirus (CMV) secondary infections (re-infections/re-activations) and the incidence of CMV primary infections in adolescent females.

NCT ID: NCT01690676 Completed - Clinical trials for Borderline Hypertension

Effect of an Apple Polyphenol Extract on Brachial Artery Flow-mediated Vasodilatory Function

Start date: August 2012
Phase: Phase 2
Study type: Interventional

Effect of apple polyphenols on FMD.

NCT ID: NCT01690104 Completed - Clinical trials for Blood Pressure Regulation

The Effect of PXR Activation on Blood Pressure Regulation

Start date: August 2012
Phase: Phase 4
Study type: Interventional

We are investigating the effects of pregnane X receptor (PXR) activation on the regulation of blood pressure in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR activator) and placebo will be given for a week to volunteers and blood pressure is measured 24 hours using an ambulatory blood pressure monitor. Blood pressure regulating hormones will be measured in blood. Our hypothesis is that PXR is involved in the regulation of blood pressure.

NCT ID: NCT01689233 Completed - Alzheimer's Disease Clinical Trials

Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild Alzheimer's Disease

Start date: October 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment of subjects with mild Alzheimer's Disease.

NCT ID: NCT01689077 Completed - Clinical trials for Out of Hospital Cardiac Arrest

Time-differentiated Therapeutic Hypothermia

TTH48
Start date: January 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if 48 hours of mild therapeutic hypothermia following out of hospital cardiac arrest gives a better cerebral outcome compared to 24 hours therapeutic hypothermia.