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NCT ID: NCT01723280 Completed - Laparotomy Clinical Trials

Supplemental Oxygen - Effect on Occurrence of Subsequent Cancer After Abdominal Surgery (Follow-up of the PROXI Trial)

PROXI
Start date: October 2006
Phase: N/A
Study type: Observational

Aim: to investigate the effect of a high inspiratory oxygen fraction (FiO2) given during and after laparotomy procedures on occurrence of a subsequent, new or recurrent, cancer diagnosis at a long-term follow-up. Background: A high inspiratory oxygen fraction (FiO2 = 0.80) has been linked to prevention of surgical site infection, but the Danish randomized clinical multicenter trial, the PROXI trial, found no difference in frequency of surgical site infection. In fact, long-term mortality was significantly increased with a hazards ratio of 1.30 in patients receiving 80% oxygen, and this appeared to be statistically significant in patients undergoing cancer surgery, but not in non-cancer patients. At this point, no convincing mechanism explains the observed increased mortality after hyperoxia, as the long-term pathophysiological effects of oxygen are not fully understood. Primary hypothesis of this follow-up study of the PROXI trial: Use of 80% oxygen increase the frequency of patients with a subsequent, new or recurrent, cancer.

NCT ID: NCT01722760 Completed - Clinical trials for Bronchopulmonary Dysplasia

Tidal Neonatal NO, Vitamins A and D, and Infant Lung Disease - The AD-ON Study

Start date: August 2013
Phase: N/A
Study type: Observational

Children born prematurely are of greater risk of developing chronic lung disease (Bronchopulmonary Dysplasia). With an increase in the amount of premature children, we expect an increasing number of children with BPD. Today we do not have many ways of predicting or treating this condition, and the children are usually in hospital for several months after birth. Many are dismissed with home oxygen. Children with BPD are typically often re-submitted to hospital with respiratory disease the first couple of years, and some of them have problems throughout childhood and into adulthood. Other scientists have found a correlation between BPD and Chronic Obstructive Pulmonary Disease (COPD). The condition as well as the treatment (steroids), are associated with great risk of adverse effects as Cerebral Palsy, blindness, deafness and mental retardation. The investigators wish to find a safe way to identify the children in greater risk of developing BPD, who could therefore benefit from a more intensive treatment.An early diagnosis would increase the possibility of predicting the prognosis. Other studies have proven a connection between both low vitamin A and D and high exhaled nitrogen oxide (NO) with lung disease. With this trial the investigators wish to make a reference material for NO and vitamins A and D in infants admitted to the neonatal department at two hospitals in Denmark, both with and without treatment with nasal Continuous Positive Airway Pressure. The investigators furthermore wish to describe an eventual connection between BPD and these factors by examining a large group of children on 7 specific occasions within the first two months of life and at a one year follow up.

NCT ID: NCT01722344 Completed - Clinical trials for Bipolar Affective Disorder

Improving Work Outcome for People With Severe Mental Illness

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

The purpose of this study is to investigate the efficacy of IPS in Denmark and compare effects of 1. Individual Placement and Support (IPS) vs. 2. IPS + cognitive remediation and work-related social skills training vs. 3. standard intervention, among individuals with severe mental illness.

NCT ID: NCT01722097 Completed - Pain Clinical Trials

Recovery After Laparoscopic Hysterectomy With Deep Neuromuscular Blockade and Low Intra-abdominal Pressure

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

The purpose of this study on laparoscopic hysterectomy is to investigate postoperative pain. Patients are allocated to either deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) or moderate neuromuscular blockade and usual intra-abdominal pressure (12 mmHg). Primary hypothesis: Deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) reduces postoperative pain compared to moderate neuromuscular blockade and intra-abdominal pressure (12 mmHg).

NCT ID: NCT01721824 Completed - Clinical trials for Major Depressive Disorder

The Effect of IPS-MA- A Modified Early Supported Employment Intervention for Individuals With Mood or Anxiety Disorders

Start date: October 2011
Phase: N/A
Study type: Interventional

The aim of the present study, is to evaluate the effect of a supported employment intervention, IPS-modified for people with mood and anxiety (IPS-MA) on employment or education, when offered to people with onset mood or anxiety disorders who are not likely to be able to return to work within three month. The hypothesis is that the IPS-MA method is associated with a shorter recovery period and more people returning to work or education, compared to treatment as usual.

NCT ID: NCT01721772 Completed - Melanoma Clinical Trials

Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma

CheckMate 066
Start date: January 18, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the clinical benefit, as measured by overall survival, of nivolumab with that of. dacarbazine in patients with previously untreated, unresectable, or metastatic melanoma

NCT ID: NCT01721746 Completed - Clinical trials for Unresectable or Metastatic Melanoma

A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)

Start date: December 21, 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel

NCT ID: NCT01721629 Completed - Prematurity Clinical Trials

Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants

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

The aim of this study is to investigate two different strategies for the withdrawal of CPAP in preterm infants born before 32 weeks of gestation.

NCT ID: NCT01721239 Completed - Clinical trials for Intensive Care (ICU) Patients

Recovery and Aftercare in Post Intensive Care Therapy Patients - RAPIT Study

RAPIT
Start date: December 1, 2012
Phase: N/A
Study type: Interventional

In 2010 alone were admitted 33,361 patients for treatment in Danish intensive care units. There is evidence to former intensive care patients have a significant symptom burden that affect recovery, function and activity for up to several years after admission to the intensive care unit. For the individual patient involves the low quality of life, delayed recovery, prolonged illness and healing process, and increased mortality. It requires that health professionals should provide support so patients quicker return to their usual life. Follow-up interviews with the staff after hospitalization in ICU have been shown to support the patient and identify individual needs and symptoms that can lead to more realistic expectations and increased well-being after admission in ICU. Follow-up in Denmark is being inconsistent in both the number of hospitals that offer this service, and in the offered type of service. Follow-up interviews with and without diaries suggest to improve physical and mental well-being and health, with limited scientific evidence of the efficacy of these interventions. We will investigate the effect of a standardized follow-up program after admission to the intensive care unit, consisting of written information, patient photos taken during hospitalization and three follow-up calls compared with standard care (discharge without follow-up). During a clinical study conducted in several intensive care units in Denmark examined whether follow-up calls can improve patients' well-being and health, as well as the meaning of the follow-up program has on the patient's everyday life in the first year after hospitalization in the ICU. The investigation contribute knowledge to the international research by revealing symptom burden and efficacy of a follow-up program for up to 1 year after admission to the ICU in order to be able to target rehabilitation efforts and improved the quality of life. It will be innovative to use the results from a clinical study as a foundation for a database, and the method can serve as a precedent for evidence-based introduction of guidelines, database registration and create the groundwork for future research in intensive care. This study is expected to be profitable to society by preventing frequent readmissions, reduce medication costs and fewer referrals to specialists and have a positive effect on retention to the labor market. This will provide overall better use of society's expenses.

NCT ID: NCT01721161 Completed - Clinical trials for Acute Optic Neuritis

215ON201 BIIB033 In Acute Optic Neuritis (AON)

RENEW
Start date: December 2012
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of BIIB033 in subjects with their first episode of unilateral Acute Optic Neuritis (AON). The secondary objective of this study in this study population is to assess the safety, tolerability, and pharmacokinetics (PK) of BIIB033.