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NCT ID: NCT01455792 Completed - Prostate Cancer Clinical Trials

Biopsy Study Comparing MRI and Ultrasound Soft Image Fusion Guided Biopsies and Gold Standard Prostate Biopsies.

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

Background: Prostate biopsies are usually performed due to accidentally discovered elevated prostate specific antigen (PSA) and/or abnormal digital rectal examination. Transrectal ultrasound (TRUS) guided biopsy is standard procedure, but possibility for precise documentation concerning the localization of the biopsies are lacking. Therefore, the same locations might be subject to multiple negative biopsies. There is a growing confidence that magnetic resonance imaging (MRI) of the prostate gland can identify significant, high-grade tumours, and studies have shown value in performing MRI before biopsies. Because image documentation is lacking, it is not possible to know which region actually being biopsied with conventional TRUS biopsy. MRI and 3D ultrasound soft image fusion guided biopsy, is a new promising method that will ascertain all regions of the prostate gland to be biopsied, and it is possible to perform accurate targeted biopsies when combined with MRI. Aims of the study Compare the biopsy results in the two groups: 1. To evaluate the overall rate of positive biopsies. 2. To evaluate the rate of re-biopsies. 3. To evaluate the detection rate of Gleason grade 4 and 5 tumours. 4. To evaluate the rate of positive targeted biopsies. 5. To evaluate the rate of positive random biopsies 6. To compare targeted and random biopsies between groups. 7. To compare patient tolerance, time consumption and cost of the two methods. 8. To evaluate the diagnostic accuracy of performing cytological imprints of targeted biopsies. Material and methods: A prospective randomized study including 300 consecutive patients referred to the initial biopsy. The patients are randomized to conventional TRUS biopsies and image fusion guided biopsy. All patients undergo a minimum 12-core re-biopsy procedure. In addition a targeted biopsy will be obtained in case of positive MRI of ultrasound.

NCT ID: NCT01453972 Completed - Obesity Clinical Trials

Effects of Exercise-intensity on Physiological Adaptations in Overweight and Obese

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

The main purpose of our study is to examine the physiological adaptations in oxygen transport chain for high-intensity exercise and moderate exercise in overweight and obese humans. The main goals are: 1. To investigate the most effective short-and long-interval training in terms of VO2max, pulmonary diffusion, cardiac output, endothelial function and mitochondrial function. 2. How these physiological adaptations affect the aerobic endurance and performance, and how this training can reduce the risk of cardiovascular diseases related to overweight and obesity.

NCT ID: NCT01452815 Completed - Clinical trials for Diabetes Mellitus, Type 2

Affects of Once-daily Oral Administration of TZP-102 on the Treatment of Symptoms Associated With Diabetic Gastroparesis

Start date: September 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test the safety and effectiveness of two dosage levels (10mg and 20mg) of TZP-102 compared to placebo (capsule that looks like the study drug but contains no active drug), administered once-daily for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis.

NCT ID: NCT01452347 Terminated - Clinical trials for Heart Valve Diseases

Dabigatran Etexilate in Patients With Mechanical Heart Valves

RE-ALIGN
Start date: October 2011
Phase: Phase 2
Study type: Interventional

To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.

NCT ID: NCT01448941 Completed - Lisfranc Injuries Clinical Trials

Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury

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

The purpose of this study is to compare arthrodesis of the first TMT-joint to extraarticular bridge plate fixation of the same joint in acute Lisfranc injuries.

NCT ID: NCT01446861 Active, not recruiting - Cystic Fibrosis Clinical Trials

Exocrine Pancreatic Function Testing in Cystic Fibrosis

Start date: January 2011
Phase: N/A
Study type: Observational

Purpose The purpose of this study is to develop and validate multimodal testing of exocrine pancreatic function (EPF). The investigators will be testing exocrine pancreatic function in patients with cystic fibrosis (CF). Exocrine pancreatic function and imaging will be correlated to age group, genotype, nutritional status and quality of life. Earlier detection of exocrine pancreatic failure in the non classical form of cystic fibrosis may be of therapeutically benefit. Hypotheses Endoscopic short test can be applied in diagnosing and monitoring exocrine pancreatic function in patients with cystic fibrosis. New functional testing of exocrine pancreatic function is superior to traditional testing with fecal elastase. MRI and ultrasound methods can give volume output estimate in cystic fibrosis patients. Contrast enhanced ultrasound can quantify reduced or delayed pancreatic perfusion and parenchymal changes in cystic fibrosis patients. Elastography/ CEUS can be used in prediction and monitoring of fibrosis development and development of hepatocellular carcinoma in the liver of cystic fibrosis patients. Immunohistochemical quantification of secretin/ cholecystokinin (CCK) producing cell in duodenum can be utilized as a model hormonal signaling in cystic fibrosis patients with exocrine pancreatic function.

NCT ID: NCT01446328 Completed - Schizophrenia Clinical Trials

Bergen Psychosis Project 2 - The Best Intro Study

BP2
Start date: October 2011
Phase: Phase 4
Study type: Interventional

In the Bergen Psychosis Project 2 the antipsychotic drugs aripiprazole, amisulpride, and olanzapine will be compared head-to-head in patients with schizophrenia and related psychoses and followed for 12 months. The study is independent of the pharmaceutical industry, and in accordance with a pragmatic design a clinically relevant sample will be included with as few exclusion criteria as possible. The patients will be assessed repeatedly with regards to symptoms, side effects, and cognitive functioning, as well as laboratory parameters. The study hypothesis is that clinically meaningful differences among the drugs will be disclosed in a pragmatic design.

NCT ID: NCT01446172 Completed - Agoraphobia Clinical Trials

Longterm Outcome of Inpatient Cognitive and Behavioral Therapies for Agoraphobia

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

While cognitive therapy and exposure therapy are both proven to be effective for panic disorder and/or agoraphobia when outcome is assenssed up to one year after treatment (Gould et al., 1995) the scientific knowledge about long-term course of these disorders is still scanty. Although several long-term outcome studies have been conducted, the quality of these studies has been questioned. The aim is to conduct a follow-up study of patients with either panic disorder with history of agoraphobia or agoraphobia without history of panic disorder. the patients were treated in a group format at Modum Bad during the years 1989 to 1997. Four subsamples will be included in the study. Subsample 1 (76 patients treated in 1989 and 1990) received combined cognitive and psychodynamic treatment. Subsample 2 and 3 (46 patients treated in 1992 - 1993) were allocated to either cognitive therapy or guided mastery treatment. Subsample 4 (45 patients treated in 1994 - 1996) received cognitive and schema focused therapy. In the follow-up study the participants will be requested to complete the same self report measures as they completed at intake, discharge and at previous follow-up times. the participants will also be interviewed using the SCID-I and II as they were at the previous assessments. The present sample is relatively unique in having received pure psychosocial experimental treatments. The very long term efficacy of cognitive therapy relative to behavioural treatmetns for agoraphobia can be evaluated, and the potential moderating effects of personality disorders can be assessed.

NCT ID: NCT01444729 Completed - Clinical trials for Dupuytren's Contracture

Post Approval Commitment Study

Start date: March 2012
Phase: N/A
Study type: Observational

An agreement has been made to conduct a post-approval commitment study that provides supplementary information relating to the use of Xiapex® as well as other non-pharmacological treatments for Dupuytren's contracture by health care professionals in a real world clinical setting.

NCT ID: NCT01444014 Terminated - Clinical trials for Chronic Atrophic Gastritis

YF476 and Type I Gastric Carcinoids (Norway)

Start date: June 2011
Phase: Phase 2
Study type: Interventional

The aim of the study is to find out if the experimental medicine, YF476, can make gastric carcinoids, a rare type of stomach tumour, shrink and disappear. Gastric carcinoids occur mainly in patients with chronic atrophic gastritis (CAG), a condition in which the acid-producing cells in the lining of the stomach can't make acid. Acid production is controlled by gastrin, a hormone (chemical messenger) that's released into the bloodstream. If the stomach can't make acid, blood levels of gastrin rise. High blood levels of gastrin in patients with CAG can cause other cells (ECL cells) in the lining of the stomach to grow and, over the years, to give rise to gastric carcinoids. Gastric carcinoids are usually benign, but they can become malignant. Therefore, patients with CAG and gastric carcinoids have the inside of their stomach checked regularly, by gastroscopy, to see if the gastric carcinoids need removing surgically. A gastroscope is a thin (1 cm), flexible tube at end of which is a mini video camera, which enables the user to inspect the lining of the stomach and a 'snare' to take samples of tissue (biopsies). YF476 (netazepide) is a gastrin receptor antagonist (blocks the effects of gastrin), so it's a potential new medical treatment for gastric carcinoids in patients with CAG. Up to 10 of these patients will take YF476 daily for up to 12 weeks. They'll make up to seven outpatient visits for tests, including checks on the safety of YF476 and up to four gastroscopies. At each gastroscopy, the gastric carcinoids will be measured and biopsies taken for laboratory tests. Patients will take up to 24 weeks to finish the study.