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NCT ID: NCT01006460 Completed - Depression Clinical Trials

A Study With Arctic Root Compared With the Extract When Combined With Schizandra and Russian Root (Adapt 232), Standardized Ginseng Extract and Placebo Regarding Impact on the Level of Energy, Ability to Work Under Stress, Quality of Life and Wellbeing, in Middleaged Women Who Are Still Employed

Start date: November 2009
Phase: N/A
Study type: Interventional

This is clinical trial to document the efficacy of a proprietary standardized extract of Arctic root in comparison to a standardized commercial extract of ginseng and placebo from an every day consumer perspective to ameliorate mild depression, reduce stress and improve quality of life. A newly developed adaptogenic formulation, Adapt 232, was included into the study in order to evaluate its effect in comparison to the others.

NCT ID: NCT01006330 Completed - Physical Activity Clinical Trials

Dysphagia in Elderly Medical Patients

DEM
Start date: November 2009
Phase: Phase 4
Study type: Observational

Dysphagia in hospitalized elders is associated with less positive outcomes in rehabilitation, increased likelihood of readmission, increased comorbidity and mortality, and increased length of hospital stay. In light of an increase in the elderly population in Denmark, the consequences of dysphagia, and the importance of minimizing the risk of disability and frailty, it is vital to emphasize safe participation of the elderly dysphagic patient in eating, drinking and swallowing. Danish occupational therapists have an important role in the dysphagia management, but no Danish evidence-based occupational therapy assessments for dysphagia of elderly medical patients exist. In order to oblige this lack, the objective of the study is to provide an assessment tool with operational definitions of dysphagia which includes the complexity of performance in eating, drinking and swallowing, is evidence-based, and guides occupational therapists in the treatment planning in a client-centred and purposeful manner. The study involves a quantitative approach, and is initiated by a translation and cultural adaptation of the Canadian "The McGill Ingestive Skills Assessment" (MISA). Hereafter, the psychometric qualities are tested. On basis of the data collected for the psychometrics, the prevalence and characteristics of dysphagia in the study population are investigated. Provided that the psychometric testing of the MISA reveals satisfactory levels, the effect of using the MISA in the treatment planning is investigated. It is hypothesized that: The Danish translation of the MISA will demonstrates satisfactory content validity, reliabilities, convergent validity, known-groups validity, predictive validity, criterion validity, high levels of sensitivity/specificity and are responsive to change. Dysphagia is prevalent in elderly medical patients at the time of admission to acute medical care and there can be found a correlation between dysphagia severity and the presence of comorbidity, disability, frailty, the length of hospital stay, the place of discharge and the number of readmissions for elderly medical patients.

NCT ID: NCT01004250 Completed - Clinical trials for Non-Small Cell Lung Cancer

A Study of Pemetrexed and Bevacizumab for Participants With Advanced Non-Small Cell Cancer

Start date: October 2009
Phase: Phase 2
Study type: Interventional

Participants with advanced non-small cell lung cancer (NSCLC) will receive a first-line treatment of Pemetrexed, Cisplatin and Bevacizumab as induction therapy followed by a maintenance treatment of Pemetrexed and Bevacizumab. Treatment will continue until disease progression or unacceptable toxicity occurs. The primary objective of this study is to measure how long this treatment could prevent the disease progression.

NCT ID: NCT01003756 Completed - Osteoarthritis Clinical Trials

Preoperative Exercise in Patients Undergoing Total Hip or Knee Replacement

Start date: November 2009
Phase: N/A
Study type: Interventional

This study is conducted in the Community Hospital in Svendborg (OUH Svendborg Sygehus) in collaboration with University of Southern Denmark and Odense University Hospital. The overall purpose of this study is to evaluate the effects of preoperatively delivered neuromuscular exercise on self perceived physical function, pain and Quality of Life in patients undergoing total hip or knee replacement. Secondary area of interest is physical performance, muscle function, and level of physical activity. The project will be conducted in two phases: - A pilot project focusing on the logistics of the upcoming randomized controlled trial (RCT) and determination of test-retest reliability of specific muscle strength variables for the patients of interest - A randomized and controlled trial where the intervention is preoperative neuromuscular exercise and the controls receive standard instructions.

NCT ID: NCT01002261 Completed - Liver Cirrhosis Clinical Trials

Hepatic Metabolism of Galactose and the Galactose Analog FDGal in Patients With Liver Disease and Healthy Subjects

Start date: October 2009
Phase: N/A
Study type: Observational

The elimination of the carbohydrate galactose is used in daily clinical work with liver patients as a quantitative measure of metabolic liver function, as the liver test "The Galactose Elimination Capacity", GEC. We are working to develop a PET/CT scanning procedure for providing 3D images of the hepatic galactose elimination and measurement of regional values. This may be used for example for planning resection or stereotactic radiotherapy of a patient with malignant tumor in the liver. Will the patient be able to tolerate removal of the necessary part of the liver? We will include 10 patients with liver cirrhosis and 6 healthy human subjects. Direct measurements of the hepatic galactose elimination (successive constant iv infusions of galactose in increasing doses with measurements of blood concentrations of galactose in blood from an artery and a liver vein, and measurements of liver blood flow by indocyanine green, Ficks principle) are compared with PET/CT measurements after iv injection of a 18F-labelled galactose analog, FDGal. Based on previous studies in pigs, we perform detailed calculations of the hepatic galactose elimination kinetics by the two methods, including estimation of a factor ("lumped constant") for recalculating PET/CT data to data for natural galactose. Besides possible practical clinical importance, the project elucidates basic problems concerning liver metabolism using PET.

NCT ID: NCT01001663 Completed - Clinical trials for Coronary Angiography Via Femoral Artery Access

Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography

CLOSE-UP I
Start date: September 2009
Phase: Phase 4
Study type: Interventional

Is the FemoSeal® closure device safer and more comfortable than manual compression for femoral artery access closure after coronary angiography?

NCT ID: NCT01000727 Completed - Clinical trials for Acute Coronary Syndrome

The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial

SOLID-TIMI 52
Start date: December 2009
Phase: Phase 3
Study type: Interventional

This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or urgent coronary revascularization (e.g. medical procedures performed to restore the normal blood flow in patients with atherosclerosis)) when treatment is started within 30 days after an acute coronary syndrome (also called ACS).

NCT ID: NCT01000649 Completed - Septic Shock Clinical Trials

Effects of the V1a Agonist FE 202158 in Patients With Septic Shock

Start date: November 2009
Phase: Phase 2
Study type: Interventional

The purpose of this trial was to examine the safety and tolerability, pharmacokinetics of FE 202158 and to assess whether it can stabilize blood pressure and reduce vascular (blood vessel) leakage. FE 202158 had previously been tested in healthy volunteers.

NCT ID: NCT01000389 Completed - Headache Clinical Trials

A Clinical Trial of the Optimal Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism

Start date: October 2009
Phase: N/A
Study type: Interventional

To investigate the effect of the treatment with Grindcare® on the parafunction of the muscles- and jaw activity (Bruxism) during sleep.

NCT ID: NCT01000116 Completed - Inguinal Hernia Clinical Trials

Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP)

Start date: September 2009
Phase: N/A
Study type: Interventional

In this study the researchers want to compare fibrin glue versus tacked fixation in fixation of the mesh in laparoscopic groin hernia repair. The primary endpoints are early pain in the first 3 days postoperative days. Moreover, the researchers investigate general well-being, fatigue, seroma, haematoma, postoperative nausea and vomiting. Thirdly, they are investigating chronic pain and clinical recurrence.