Clinical Trials Logo

Filter by:
NCT ID: NCT01897623 Completed - Clinical trials for Abdominal Aortic Aneurysm

Prevalence and Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease

CAD-AAA
Start date: July 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the prevalence of abdominal aortic aneurysms (AAA) among male patients with coronary artery disease (CAD) verified in coronary angiography. Ethiology of AAA is known to be common with atherosclerotic arterial diseases (coronary artery disease, peripheral artery disease and carotid artery disease), so the hypothesis is that AAA should be more common among these CAD patients, thus making screening of these patients (for AAA) more cost-efficient. Study will be carried out as a multi-center prospective screening study. Data will be collected in North Karelia Central Hospital, Kuopio University Hospital and Tampere University Hospital. Data consists of 200 consecutive coronary angiography patients in each hospital, resulting in 600 patients in total. All male patients with diagnosed CAD will be recruited for the study and screened for AAA with ultrasound. Nevertheless, patients with previously known AAA will be excluded from the study.

NCT ID: NCT01895777 Completed - Clinical trials for Venous Thromboembolism

Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)

Start date: September 25, 2013
Phase: Phase 3
Study type: Interventional

The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate dosing algorithm for use in patients from birth to less than 18 years of age.

NCT ID: NCT01895335 Completed - Multiple Sclerosis Clinical Trials

Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients

TERI-PRO
Start date: June 2013
Phase: Phase 4
Study type: Interventional

Primary Objective: To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Patient Reported Outcomes (PROs). Secondary Objectives: To describe disease progression using Patient Reported Outcomes (PROs). To describe clinical outcomes (ie, treated relapses) in teriflunomide treated patients. To describe the change in cognition in teriflunomide treated patients. To describe safety of teriflunomide in patients treated (based on adverse events reporting). To describe adherence and persistence to teriflunomide treatment. To describe quality of life, activity and leisure over the period of teriflunomide treatment. To compare Patient Determined Disease Steps (PDDS) and Expanded Disability Status Scale (EDSS) in assessing Multiple Sclerosis (MS) disease progression.

NCT ID: NCT01893203 Completed - Clinical trials for Actinic Keratoses (gr I-III)

Treating Actinic Keratoses With Natural Daylight PDT: Comparing Two Light Sensitizers (ALA and MAL)

2013-002108-15
Start date: August 2013
Phase: Phase 4
Study type: Interventional

Actinic keratoses (AKs) are superficial premalignant skin lesions that can progress into an invasive or metasthatic squamous cell carcinoma. AKs can be treated with photodynamic therapy (PDT), of which cure rate compares to cryo surgery with an excellent cosmesis. In PDT the AK lesions are first curettaged, then a photosensitizer is applied on the skin and let to absorb for 3 hours. The skin is illuminated using a blue or red light source light source depending on the sensitizer, which induces activation of protoporphyrin IX (PpIX) and phototoxic reaction destroying the cancer cells. The approved photosensitizers in Europe are methylaminolevulenic acid cream, (MAL, Metvix™, Galderma), a patch containing 5-aminolevulenic acid (5-ALA, Alacare®, Spirig AG) and aminolevulenic acid gel (BF-200 ALA, Ameluz®, Biofrontera AG) to be used with a red LED light (630-635 nm). In North America a 5-aminolevulinic acid stick (5-ALA, Levulan® Kerastick) can also be used with a blue light source (417 nm). PpIX absorption peaks are within the visual spectrum of light, which allows PpIX daylight activation. During natural daylight PDT (NDL-PDT) protocol, PpIX is continuously activated during its development, whereas in conventional PDT (LED-PDT) using red LED lamps, large amounts of accumulated PpIX are momentarily activated. Since skin field cancerization refers to presence of different degrees of visible and invisible dysplastic changes, the whole area should be treated to prevent the development of non-melanoma skin cancers (NMSCs). NDL-PDT enables treatment of field cancerization in one sitting whereas LED-PDT may need repeated illuminations to cover the whole area. NDL-PDT results in enhanced cost-efficacy due to reduced staff expenses, since there's no need for policlinical sensitizer absorption and illumination. At the moment two photosensitizers have marketing authorization in Finland, ALA (Ameluz®) and MAL (Metvix™). Ameluz® holds a lower unit price and it's clearance rate compares to Metvix™ in LED-PDT. We are piloting a study comparing the cost-efficacy of these two light sensitizers in NDL-PDT. Our hypothesis is that there will be at least 0,30 difference in the histopathological curing of the lesions. Our other hypothesis is that Ameluz® with it's lower unit price results in reduced treatment costs and better cost-efficacy compared to Metvix™. The efficacy of the treatments will be assessed clinically, histopathologically, immunohistochemically and by hyper spectrum camera imaging.

NCT ID: NCT01893190 Completed - Clinical trials for Ruptured Cerebral Aneurysm

Safety and Tolerability Study of EG-1962 in Aneurysmal Subarachnoid Hemorrhage

NEWTON
Start date: September 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Phase 1/2a Multicenter, Controlled, Randomized, Open Label, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study Comparing EG-1962 and Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage

NCT ID: NCT01893008 Completed - Clinical trials for Esophageal Resection Candidates

Preoperative Inspiratory Muscle Training in Esophageal Resection

PREPARE
Start date: September 2013
Phase: N/A
Study type: Interventional

The PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection.

NCT ID: NCT01892319 Completed - Clinical trials for Diabetes Mellitus, Type 2

An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry

Start date: September 30, 2013
Phase:
Study type: Observational

This study is conducted in Europe and Asia. The purpose of the study (Diabetes Pregnancy Registry) is to evaluate the safety of treatment with insulin detemir in pregnant women with diabetes mellitus.

NCT ID: NCT01890655 Completed - Clinical trials for Relapsing-remitting Multiple Sclerosis

Extension Study of MT-1303

Start date: August 2013
Phase: Phase 2
Study type: Interventional

To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing remitting multiple sclerosis (RRMS).

NCT ID: NCT01890551 Completed - Clinical trials for Affected and Unaffected Knee in Adoloescent

Kine-Mri in Patellofemoral Instability

Knee- MRI 2012
Start date: January 1998
Phase: N/A
Study type: Interventional

Purpose: The impact of kinematic-MRI (KINE-MRI) in the patellofemoral instability and anterior knee pain of the adolescents is rarely reported.Interest was to evaluate the patellofemoral joint biomechanics with KINE-MRI in adolescents with affected and unaffected knees in a case-control study.Methods: KINE-MRI was performed in 29 adolescents (affected knee group, AKG, n=29 and n=26 unaffected knee group, UAKG, n=26) aged 11-16 years with unilateral patellofemoral instability. For the control group invvestigators enrolled ten healthy age- and sex-matched volunteers (healthy knee group, HKG, n=19 ).The study parameters, Bisect Offset (BSO), Lateral Patellar Displacement (LPD), Patellar Tilt Angle (PTA), Sulcus Angle and Insall-Salvati ratio at 0, 10, 20 and 30 degrees of flexion-extension, were measured for the AKG patients (n=29), and UAKG patients (n=26) and the HKG subjects (n=19). Results: In a comparison between the AKG patients and the HKG subjects there was a significant difference in the BSO-ratio, LPD-test and PTA-test. In these parameters the difference between the AKG patients and the HKG subjects progressively increased towards the full extension of the knee. In the AKG and UAKG patients BSO-ratio at 0 degree ranged between 0.5 and 1.2 in both groups, whereas the BSO-ratio in the HKG subjects ranged between 0.33 and 0.75 (P < .001). At the zero degree the LPD-test ranged between 0 and 10 mm in the AKG patients and between 0 and 35 mm in the UAKG patients, whereas the lateral displacement-test ranged between 0 and 5 mm in the HKG subjects (P = .003). Patellar tilt angle-test ranged between -30 and 20 degrees in the AKG patients and between -30 and 24 degrees in the UAKG patients and in the HKG subjects the PTA-test ranged between 10 and 24 degrees (P < .001).Conclusion: The KINE-MRI could be a feasible method for the evaluation of patellar tracking in adolescents.

NCT ID: NCT01889004 Completed - Clinical trials for Consciousness, Level Altered

The Neural Mechanisms of Anesthesia and Human Consciousness

LOC-2013
Start date: February 2014
Phase: Phase 4
Study type: Interventional

The explanation of consciousness poses one of the greatest challenges to science and philosophy in the 21st century. It remains unclear what consciousness is and how it emerges from brain activity. By studying anesthesia and sleep, the investigators aim to reveal what happens in the brain when consciousness is lost and when it returns. During the study, a series of Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI) and electroencephalography (EEG) studies will be carried out on healthy male subjects to reveal the neural correlates of consciousness. Consciousness of the subjects will be manipulated with normal sleep and anesthetic agents dexmedetomidine and propofol. First, various neurophysiological tools to separate consciousness, connectedness and responsiveness during normal sleep will be tested. The most suitable methods and subjects will be selected and then tested during anesthetic-induced sedation and loss of responsiveness (LOR). The anesthetics (dexmedetomidine or propofol) will be administered as target-controlled infusions (TCI) with step-wise concentration-increments until LOR is detected. Then, TCIs are repeated in the same subjects but adjusted according to the individual drug target concentrations sufficient for LOR, and a series of PET perfusion imaging measurements will be performed to obtain the brain activity information in various states of consciousness. The same subjects will then be imaged with PET for brain activity after sleep deprivation (awake), during various sleep stages and immediately after awakening. Finally, ten dexmedetomidine subjects will be given the drug once more, and functional MRI (fMRI) data will be collected at various states of consciousness before and during verbal and nonverbal vocalizations. EEG will be continuously collected in all sessions. The depth of anesthesia will be measured using quantitative EEG and bispectral index (BIS) monitoring. The results may lead to the discovery of new and better objective indicators of the depth of anesthesia and consciousness, and new insights into the understanding of neural mechanisms behind drug-induced loss of consciousness and ultimately the mechanisms of action of (general) anesthetics as well as consciousness itself.