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NCT ID: NCT01694745 Completed - Pain Clinical Trials

EUROpean Pain Audit In Neonates

EUROPAINsurvey
Start date: October 2012
Phase: N/A
Study type: Observational

EUROPAIN Survey is an epidemiological study aimed at assessing current clinical practices regarding the use of sedative and analgesic drugs in newborns admitted to NICUs or PICUs in different countries in Europe. This study is conducted as part of the NeoOpiod study. The main objective of this study is to determine the current clinical practices regarding the use of sedative and analgesic drugs in newborns in intensive units in different countries in Europe. The principal criteria are: the frequency of ventilated neonates receiving sedation and analgesia, the medications used for sedation and analgesia in ventilated neonates, the length of use of medications administered for sedation and analgesia in ventilated neonates and similarities and differences in sedation and analgesia practices among European countries. The secondary objectives are: a) to determine the proportion of neonatal units that have developed and implemented local written guidelines to provide continuous sedation and analgesia in ventilated newborn infants as well as to prevent and treat procedural pain, b) to document the published guidelines for neonatal analgesia and sedation in different European countries and develop consensus for common European standards that can be applied in all medical settings, c) to determine the frequency of use of pain assessment tools in ventilated newborn infants and evaluate their impact on pain management practices and d) to determine practices to assess and prevent withdrawal syndromes. The EUROPAIN STUDY is observational and therefore it will not interfere with routine practices of participating units. No changes in diagnostic, therapeutic or any managing strategy of patients are imposed by the participation in this study. This epidemiological study will only collect data on clinical practices in each unit. It will include all neonates up to a corrected age of 44 weeks post conception. The maximum duration of data collection for every included infant is 28 days. Data collection will stop before 28 days if the infant leaves the unit (discharge, death, transfer to another hospital). Data will be entered on a secure web-based questionnaire.

NCT ID: NCT01694485 Completed - Ulcerative Colitis Clinical Trials

Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis

Start date: November 16, 2012
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the effect of abrilumab on induction of remission in adults with moderate to severe ulcerative colitis after 8 weeks of treatment as assessed by a total Mayo Score ≤ 2 points, with no individual subscore > 1 point.

NCT ID: NCT01694160 Completed - Proteinuria Clinical Trials

Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria

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

The main objective of this study is to examine if paricalcitol may reduce progression of graft fibrosis and proteinuria in kidney transplant patients. Cyclosporine and tacrolimus have a detrimental long-term effect by inducing graft fibrosis. About 50% of graft losses are related to interstitial fibrosis. Paricalcitol is a vitamin D receptor activator indicated for treatment of secondary hyperparathyroidism. Paricalcitol is known to exert an anti-inflammatory and antifibrotic and attenuate cyclosporine-induced fibrosis. Paricalcitol is also shown to be renoprotective by reducing proteinuria. No randomized controlled trials with paricalcitol are performed in renal transplant patients examining the effect on proteinuria and graft fibrosis.

NCT ID: NCT01693627 Active, not recruiting - Clinical trials for Arthritis of the Hip

Cemented Marathon/Corail Versus Pinnacle/Corail

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

A randomised, comparative, prospective, single-blinded trial of two hip prosthesis: 1. Marathon cemented all-poly acetabular cup(Depuy, Warsaw, Indiana), Corail uncemented femoral stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy, Warsaw, Indiana) and 2. Pinnacle/Marathon uncemented cup(Depuy, Warsaw, Indiana), Corail uncemented femoral stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy, Warsaw, Indiana) There will be a further in-group randomisation to a Corail femoral stem with or without a collar, creating a number of 4 study-groups in total. The aims of the study are: - To compare polyethylene wear and migration of the moderately cross-linked Marathon polyethylene in a cemented version(Marathon) and in an uncemented cup(Pinnacle/Marathon) - To evaluate micromigration and periacetabular bone mineral density of the 2 cups using radiostereometry(RSA) - To evaluate the migration patterns and proximal femoral bone density changes around the Corail stems with and without a collar

NCT ID: NCT01691144 Completed - Ovarian Cancer Clinical Trials

Follow-up of Gynecological Cancer Patients, Their Needs and Expectations, A Cooperation Project

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

Follow-up of cancer patients accounts for a substantial part of outpatient activity, and alternative models of care are developing. In some countries, low-risk follow-up is already done in primary care, mainly in breast, and colorectal cancer. In this study the investigators will explore gynecological cancer patients about their expectations regarding their future follow-up plan. Further, the investigators will ask about the experience and satisfaction among patients who have already attended a follow-up programme for 2-3 years. In addition, the investigators will especially focus on the cooperation aspect between primary and secondary care. The investigators hypothesize that follow-up of selected gynecological cancer patients can be done by general practitioners.

NCT ID: NCT01689519 Completed - Malignant Melanoma Clinical Trials

A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma

coBRIM
Start date: January 8, 2013
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator.

NCT ID: NCT01689077 Completed - Clinical trials for Out of Hospital Cardiac Arrest

Time-differentiated Therapeutic Hypothermia

TTH48
Start date: January 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if 48 hours of mild therapeutic hypothermia following out of hospital cardiac arrest gives a better cerebral outcome compared to 24 hours therapeutic hypothermia.

NCT ID: NCT01687881 Completed - Clinical trials for Cervicogenic Headache

Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option in Cervicogenic Headache

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

This study will highlight and validate chiropractic spinal manipulative therapy (CSMT) for cervicogenic headache (CEH). If the method proves to be effective, it will provide a new non-pharmacological treatment option for CEH. This is especially important since pharmacological management has minor effect in CEH, and alternative treatment options are warranted. The applied methodology of the study will aim towards the highest possible research standards. This international study is a collaboration between Akershus University Hospital, Innlandet Hospital and University of Oslo (UiO), Norway and Macquarie University, Australia. The multidisciplinary professional backgrounds are physiotherapy, chiropractic and medicine. By increasing the methodological quality of the investigators research to a very high level, the investigators see the method to work as a guide to increase the quality of chiropractic research in the future, as previous randomized clinical trials (RCTs) of CEH used methodology showing room for improvement. Study hypothesis: CSMT using the Gonstead method reduces days with CEH by at least 25% as compared to placebo (sham manipulation, i.e. broad non-specific contact, non-directional, low velocity and low amplitude) and no intervention (control group).

NCT ID: NCT01686581 Completed - Migraine Disorders Clinical Trials

An Observational Study of BOTOX® as Headache Prophylaxis for Chronic Migraine

Start date: July 23, 2012
Phase:
Study type: Observational

This is an observational study to describe the long term use of Onabotulinumtoxin A (BOTOX®) as prescribed by the physician for headache prophylaxis in adults with chronic migraine. All treatment decisions lie with the physician.

NCT ID: NCT01686074 Completed - Fibromyalgia Clinical Trials

Motor Control in Chronic Fatigue Syndrome and Fibromyalgia

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

This project is a comprehensive study, with main focus on motor control, comparing patients with chronic fatigue syndrome / myalgic encephalopathy (CFS/ME) and/or fibromyalgia syndrome (FMS). Focus of the present project will be on detailed movement analysis in a movement laboratory and involve functional tasks such as walking and standing. Investigations will also comprise muscle activity, reaction time and fine motor control.