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NCT ID: NCT02929446 Completed - Clinical trials for Respiratory Insufficiency

Mobilization Immediate After Abdominal Surgery

Start date: December 2016
Phase: N/A
Study type: Interventional

Advances in surgical technique have led to a more complex surgery on patients with more serious comorbidities and the risk of postoperative pulmonary complications (PPC) is considerable . The isolated effect of mobilization immediately after surgery has previously not been studied. The aim of the study is to evaluate the effects of immediate mobilization (within 2 hours after arrival to the postoperative recovery unit) after abdominal surgery and also the patients and the staffs experiences of early mobilization. Methods: A randomized controlled trial will be conducted. A total of 300 Swedish-speaking, adult patients (≥18 years) planned for elective open or robot assisted laparascopic abdominal surgery with an expected anesthetic duration exceeding 2 hours are eligible for consecutive enrollment in the study. Patients who cannot mobilize independently before surgery, will be excluded. Procedure: Randomization to: 1. Mobilization within 2 hours after arrival to the postoperative recovery unit after surgery - to sit up as long as they can in a chair, or on the bedside + breathing exercises standardized every hour, with a PEP-device or to 2. Mobilization within 2 hours after arrival to the postoperative recovery unit after surgery - to sit up as long as they can in a chair, or on the bedside. or to 3. No mobilization - laying or sitting in bed with a maximum of 30° elevation of the head rest. No mobilization out of the bed or breathing exercises until discharge or a maximum of 6 hours. Outcome assessment: The primary outcomes are arterial oxygen pressure (PaO2), and peripheral oxygen saturation (SpO2) over time and between groups. Secondary outcomes are arterial carbon dioxide pressure (PaCO2), pH, bGlu, lactate (arterial blood gas sample) over time and between groups; lung function assessed as forced vital capacity (FVC), forced expiratory flow in the one second (FEV1) and peak expiratory flow (PEF) by a micro spirometer ( preoperatively and the day after surgery); postoperative pneumonia and total length of stay at the postoperative recovery unit and at the hospital. After the intervention both patients (n 25) and staff (n 20) will be interviewed about experiences of early mobilization. Clinical significance: If a fairly simple and cheap intervention, such as mobilization immediately after open abdominal surgery, can lead to imporved oxygen saturation, shortened stay at hospital in total, it should be included as a routine in postoperative care.

NCT ID: NCT02929329 Completed - Heart Failure Clinical Trials

Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction

GALACTIC-HF
Start date: January 6, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with omecamtiv mecarbil when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in adults with chronic heart failure with reduced ejection fraction (HFrEF).

NCT ID: NCT02927262 Completed - Clinical trials for Acute Myeloid Leukemia (AML)

A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission

Start date: January 10, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study was to compare relapse-free survival (RFS) between participants with FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia (AML) in first complete remission (CR1) and who were randomized to receive gilteritinib or placebo beginning after completion of induction/consolidation chemotherapy for a two-year period.

NCT ID: NCT02926365 Completed - Clinical trials for Obsessive-Compulsive Disorder

BIP in Jämtland Härjedalen: Increased Access to CBT Within Regular Health Care in Northern Sweden

BIPBJÖRN
Start date: October 1, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to test internet-delivered cognitive behavior therapy for children and adolescents with anxiety disorders and obsessive-compulsive disorder in a routine clinical setting in a rural part of Sweden.

NCT ID: NCT02925871 Completed - Stroke Clinical Trials

The Missing Link- Development and Feasibility Evaluation of Person-centred Transitions From the Stroke Unit to the Home

Missing Link
Start date: April 2016
Phase: N/A
Study type: Interventional

The aim is to design, implement and evaluate new person-centred transitions between stroke units and the home. The development of person-centred transition will be performed together by people with stroke, significant others, stroke unit staff and interdisciplinary teams. Phase 1, a prospective observational study of current transitions from stroke units to rehabilitation in the home without coordination. The aim is to identify factors that are facilitators or barriers to transitions, patient and caregiver outcomes, use of health care during the first year after stroke. In phase 2, a co-design process of new person-centred transitions will be carried out by people with stroke, significant others, stroke unit staff and interdisciplinary home rehabilitation teams. In phase 3 new person-centred transitions will be implemented and evaluated in a feasibility study.

NCT ID: NCT02925104 Completed - Clinical trials for cMET Dysegulation Advanced Solid Tumors

A Dose Escalation Study to Assess PK, Safety and Tolerability of INC280 When Taken With Food in cMET Dysregulated Advanced Solid Tumors.

Start date: December 14, 2016
Phase: Phase 1
Study type: Interventional

Dose escalation study to assess PK, safety and tolerability of INC280 when taken with food in patients with cMET dysregulated advanced solid tumors.

NCT ID: NCT02924727 Completed - Clinical trials for Acute Myocardial Infarction

Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI

PARADISE-MI
Start date: December 9, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg twice daily.

NCT ID: NCT02923843 Completed - Elderly Clinical Trials

Are Geriatric Out-patient Care Better Than Usual Care?

Start date: November 2016
Phase: N/A
Study type: Interventional

Frailty and multimorbidity is one of the biggest challenges of todays health care due to the demographic development with more and more elderly surviving many diseases that was mortal just a few decades ago. Health care in Sweden is one of the best in the world, yet many frail older people do not receive appropriate health care. Several reports have described a fragmented care with lack of good quality due to lack of a holistic view on the patient and her situation. At the same time the care given is costly and ineffective with a lack of continuity. Additionally, there are a lack of hospital beds in Sweden due to the ageing population and a cut down of beds in the last decades. There is though a method, Comprehensive Geriatric Assessment (CGA), where studies have shown many benefits for older patients including less need of hospital beds, better functional outcomes and a better chance of living at home after an Acute Hospital Discharge, but this method is not much used in Sweden. The aim of this study is to show that CGA in an Out-patient Care Setting save hospital beds without decreasing the quality of care measured by sustained functional capacity. Other parameters to be evaluated are mortality, degree of frailty, health economy, quality of life, and cognition.

NCT ID: NCT02922803 Completed - Clinical trials for Vitamin D Deficiency

Vitamin D and Physical Performance Before and After Intervention and Birth Outcome in Pregnant Somali and Swedish Women

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

Somali migrant women, often in veiled clothing, living in a town in mid Sweden on the 60:th parallel were observed to be weak and to have a waddling gate. Study 1 was carried out in the setting of an antenatal clinic administered from a primary care center in Borlänge, a Swedish middle-sized industrial town at the 60:th parallel in Sweden. The investigators chose an initial study period in late spring to reflect the effects of the dark season with little ultraviolet B radiation that affects vitamin D production. Study 1 was carried out in a short period of time. The recruitment was performed in a retrospective design in order to neglect the seasonal effects of ultraviolet B radiation. Study 1 was carried out in year 2010. It was a cross sectional baseline study of blood levels of vitamin D measured as 25-hydroxyvitamin D (25-OHD) and physical performance in 123 pregnant and new mothers from Somalia (n=52) and Sweden (n=71). Study 2: Examines the results on muscular performance, i.e. grip strength and squatting ability, from intervention with advice and prescription of vitamin D3 and calcium for 10 months, in all the women from study 1 with 25-OHD levels <50 nmol/L or 50 nmol/L of 25-OHD. Study 3: The recruitment to Study 1 also serves as recruitment for a cohort study on delivery outcome in birth protocols starting 2016. Study 4: The aim is to study the emic perspective and lifestyle related to vitamin D and strength in the group of Somali women by focus interviews among the Somali women from above. A possible fifth study will explore correlations between 25-OHD and pain distribution and pain parameters.

NCT ID: NCT02921750 Completed - Venous Leg Ulcer Clinical Trials

Investigation to Evaluate the Efficacy and Safety of Exufiber Versus Aquacel Extra in Moderately or Strongly Exuding Venous and Mixed Ulcers of Predominantly Venous Origin

PD-497314
Start date: October 2016
Phase: N/A
Study type: Interventional

The investigation is designed as an open, randomized, non-inferiority, multi-centre investigation. 212 evaluable subjects will be randomised. Subjects to be included will suffer from an exuding venous or mixed ulcer of predominantly venous origin. Subjects will either be randomized to Exufiber®Gelling Fibre Dressing or Aquacel®Extra Hydrofiber® Dressing with Strengthening Fibre using, centralized randomization