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NCT ID: NCT01954862 Completed - Pain Clinical Trials

Comparison of Methods to Distend the Colon During Insertion: CO2, Air Insufflation, Water-aided Colonoscopy

Start date: October 2013
Phase: N/A
Study type: Interventional

Insufflation of the colon, usually with room air, is necessary to distend the lumen for exploration. Carbon dioxide (CO2) insufflation instead of room air insufflation (AI) has been shown to decrease symptoms of abdominal pain or discomfort during the procedure and particularly during the following 24 hours. CO2 is is rapidly absorbed by the intestinal mucosa and exhaled through respiration. AI colonoscopy has usually been the reference standard to compare colonoscopy using CO2 insufflation. In two recent articles AI was compared to either CO2 insufflation and Water-aided colonoscopy (WAC), which entails infusion of water to facilitate insertion to the cecum. WAC can be categorized broadly in Water Immersion (WI) and Water Exchange (WE). In WI water is infused during the insertion phase of colonoscopy, with removal of infused water predominantly during withdrawal. Occasional use of insufflation may be allowed. WE entails complete exclusion of insufflation, removal of residual colonic air pockets and feces, and suction of infused water predominantly during insertion to minimize distention. During the withdrawal phase insufflation is used to distend the colonic lumen. In the WAC arms of the two mentioned articles the insertion method used was WI, with infusion of water at room temperature or at 37°C. During withdrawal, air insufflation or either air or CO2 insufflation were employed. Compared to AI, CO2 insufflation and WI (using room air insufflation or CO2 insufflation during withdrawal) were effective in both studies in decreasing sedation requirement, pain and tolerance scores, with patients' higher willingness to repeat the procedure. Until now no direct comparison has been made within a single study about pain score during colonoscopy using AI, CO2 insufflation, WI/CO2, WE/CO2, WI/AI and WE/AI. In this study we test the hypothesis that, compared to AI, CO2 insufflation and WAC/CO2-AI methods will decrease pain score during colonoscopy, with reduction of sedation requirement, and that WE will achieve the best result. This comparative study has also the aim to test the respective peculiarities of each method.

NCT ID: NCT01950871 Terminated - Prostate Cancer Clinical Trials

Prostate Guided Biopsy Study Evaluating the Diagnostic Performance of Prostate HistoScanning

PHSTT-01
Start date: October 2013
Phase: Phase 4
Study type: Interventional

The primary objective of the PHSTT-01 trial is to determine if prostate HistoScanning (HS) analysis can be used to improve the detection of clinically significant prostate cancer (PCa), and potentially reduce the burden and number of biopsies in routine clinical practice. Prostate HS is an ultrasound-based tissue characterization technology specifically developed to detect, visualize, and locate tissue suspected of harboring PCa. These suspicious tissues are displayed as red areas on an imaging monitor. Recently a new biopsy guidance tool has been developed that uses the results of the prostate HS analysis. The subjects that will participate in this study are all scheduled for a first biopsy of the prostate. They will initially be imaged using transrectal ultrasound (TRUS) to obtain data for prostate HS analysis. The results of HS analysis will be used later in the procedure. Subjects will then undergo a routine systematic 10- to 12-core biopsy procedure using TRUS. This will be followed by a TRUS-guided biopsy that uses the result of prostate HS analysis and new biopsy guidance tool.

NCT ID: NCT01949805 Completed - Polycythemia Vera Clinical Trials

Pegylated Interferon Alpha-2b Versus Hydroxyurea in Polycythemia Vera

PROUD-PV
Start date: September 2013
Phase: Phase 3
Study type: Interventional

Phase III study to compare the efficacy and safety of the novel monopegylated interferon alpha 2b AOP2014 versus Hydroxyurea (the current licensed therapy for this disease). One year treatment of patients with polycythemia vera. Objective is to demonstrate non-inferiority of AOP2014 vs. HU in terms of disease response rate in both HU naïve and currently treated patients, diagnosed with Polycythemia Vera. Response is measured as normalisation of key lab parameters as well as normalized spleen size.

NCT ID: NCT01947907 Completed - Clinical trials for Growth Hormone Deficiency (GHD)

Safety, PK/PD and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)

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

A six month study of ACP-001, a long-acting growth hormone product, versus standard human growth hormone therapy. ACP-001 will be given once-a-week, standard human growth hormone (hGH) will be given on a daily basis. The primary aim is to demonstrate safety, pharmacokinetics and pharmacodynamics over a period of six months. A secondary objective is the comparison of height velocity (HV) of the ACP-001 treated groups to the daily hGH treatment group.

NCT ID: NCT01946347 Completed - Type 2 Diabetes Clinical Trials

Endothelial Function in Patients With Type 2 Diabetes Versus Healthy Subjects

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

The aim of the study is to evaluate the effect of hyperinsulinemia and postprandial changes in plasma glucose and lipids concentrations on the endothelial function together with other metabolic parameters in patients with type 2 diabetes (T2D) and in healthy subjects. Hypothesis: Different changes in endothelial function to acute in vivo induced hyperinsulinemia and after the meal test will be found in patients with T2D compared to healthy subjects. A significant relationships between insulin sensitivity, selected adipokines intramyocellular fat content, hepatic fat content and high energy phosphates in soleus muscle will be documented in both groups.

NCT ID: NCT01943396 Active, not recruiting - Clinical trials for Age Related Macular Degeneration

Treatment of AMD With Rheohemapheresis /RHF/

TARHF
Start date: September 2013
Phase: Phase 4
Study type: Interventional

In this research rheohemapheresis will be used for the treatment of patients with high-risk dry form of age-related macular degeneration. Correction of rheologic parameters and activation of retinal functional reserves after the therapy will positively influence functional condition of retina. The newest special electrophysiologic methods will be used to determine retinal changes in time. The investigators will also evaluate some important immunologic factors and complement changes as well as define indication criteria more precisely.

NCT ID: NCT01933867 Completed - Clinical trials for Inflammatory Bowel Disease

Water-aided Colonoscopy in Inflammatory Bowel Disease Patients

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

Water-aided insertion of the colonoscope has been repeatedly proven to beneficial in terms of lower discomfort and need for sedation during colonoscopy. Patients with inflammatory bowel diseases (IBD) undergo repeated colonoscopy in course of their disease. According to our preliminary experience, water immersion could be beneficial while scoping these patients. As far as the investigators know, water-aided colonoscopy has never been studied in this indication. Results of our trial might support use of water-aided colonoscopy in common practice and decrease associated discomfort in IBD patients.

NCT ID: NCT01931839 Completed - Clinical trials for Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis

Start date: October 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of long-term treatment with lumacaftor in combination with ivacaftor in people 12 years and older with Cystic Fibrosis.

NCT ID: NCT01928771 Completed - Asthma Clinical Trials

Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

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

The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.

NCT ID: NCT01926951 Completed - Hypertension Clinical Trials

Renal Denervation Using Externally Focused Therapeutic Ultrasound

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

This study will evaluate the effects of renal denervation using externally focused therapeutic ultrasound with external targeting and tracking on patients with refractory hypertension.