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NCT ID: NCT02102646 Completed - Prostate Cancer Clinical Trials

MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism

Start date: April 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate if androgen deprivation therapy in men with prostate cancer increases hepatic fat content and changes visceral/subcutaneous fat distribution.

NCT ID: NCT02102204 Completed - Clinical trials for Hyperparathyroidism, Secondary

Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis

Start date: March 25, 2014
Phase: Phase 3
Study type: Interventional

This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.

NCT ID: NCT02100696 Completed - Ulcerative Colitis Clinical Trials

A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors

HICKORY
Start date: May 21, 2014
Phase: Phase 3
Study type: Interventional

This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors.

NCT ID: NCT02100345 Completed - Bowel Endometriosis Clinical Trials

Conservative Treatment of Rectosigmoid Endometriosis Monitored by Transvaginal Ultrasound

Start date: October 2014
Phase: N/A
Study type: Observational

Background: Endometriosis is a disease affecting 8-15 % of fertile women and is a cause of abdominal pain and suffering during women's menstrual periods. A subgroup of patients with DIE has an infiltration into the rectosigmoid bowel wall (4-37%). Knowledge of the growth pattern of rectosigmoid lesions related to subjective symptoms is mandatory in order to assess the need for follow-up with transvaginal ultrasound during medical treatment. Hypotheses: Symptoms will follow growth of rectosigmoid endometriosis. Material and methods: Two different cohorts of women, based on time of diagnosis of rectosigmoid endometriosis and treatment with hormonal intrauterine device or continuous oral contraceptives will receive a questionnaire and a transvaginal ultrasound scan (measuring size and volume) at inclusion, (6) and 12 months later. Perspectives: Patients treated conservatively may be followed by questionnaires, thereby reducing the need for time consuming clinical controls.

NCT ID: NCT02100228 Completed - Atrial Fibrillation Clinical Trials

Study Of The Blood Thinner, Apixaban, For Patients Who Have An Abnormal Heart Rhythm (Atrial Fibrillation) And Expected To Have Treatment To Put Them Back Into A Normal Heart Rhythm (Cardioversion)

EMANATE
Start date: July 14, 2014
Phase: Phase 4
Study type: Interventional

Some people can develop an abnormal heart beat known as "Atrial fibrillation" or "AF" that puts them at risk of developing clots in the heart. Those clots can travel in the blood circulation to the brain and cause a brain attack ("a stroke"). To prevent those clots forming, blood thinners (anti-coagulants) are used. Apixaban is a blood thinner that works by stopping one of the blood substances required for clotting ("Factor Xa"). It is approved and used to prevent clots forming in people with "AF". Other established blood thinners work by stopping clotting substances being made, known as "Vitamin K antagonists" or "VKAs". An example of this type is Warfarin (Coumadin). The good effects of all blood thinners are preventing clots, and they may also have bad effects of increasing the chance of bleeding. People with "AF", abnormal heart beat, may benefit from changing it back to a normal regular rhythm, known medically as "cardioversion". When this is done, people are currently most commonly treated with a "VKA" blood thinner (e.g. warfarin). The purpose of this study is to assess the good and bad effects ("efficacy" and "safety") of apixaban compared with warfarin in people with "AF" in whom an early cardioversion is planned.

NCT ID: NCT02100098 Completed - Postoperative Pain Clinical Trials

Peripheral Nerve Block Anaesthesia for Ankle Fracture Surgery - an Exploratory Study: Is Rebound Pain a Problem?

Start date: March 2014
Phase: N/A
Study type: Observational

The purpose of this exploratory study is to characterize the postoperative pain profile of patients undergoing operation with internal fixation of an ankle fracture under nerve block anaesthesia. Special attention is payed towards the possible existence and clinical relevance of a rebound pain phenomenon upon cessation of the nerve block. Results are used to guide the set up of a randomized controlled trial on the subject.

NCT ID: NCT02099591 Completed - Clinical trials for Constipation, Signs and Symptoms, Digestive

Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients

Start date: November 2014
Phase: Phase 1
Study type: Interventional

To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through population PK in paediatric patients with opioid induced constipation (OIC) or at risk of OIC.

NCT ID: NCT02098564 Completed - Clinical trials for Hand Related Injuries

The Effect of Activity-based Training in Patients With Hand-related Injuries Grouped Using Sense of Coherence Scores

Start date: February 2014
Phase: N/A
Study type: Interventional

Background Patients with the same type of hand injury often reach different functional levels. Therefore, it is necessary to investigate what kind of rehabilitation is most efficient for each individual patient. Research has shown that a person's "Sense of Coherence" (SOC) affects how he /she deals with disease. Furthermore, SOC can help predict final outcomes after orthopedic injuries and should therefore; be taken into consideration when planning rehabilitation. It was concluded in a study that patients with a weak SOC who have had a hand injury, may benefit from extra support to manage their everyday activities in order to reach the same final outcome as patients with a strong SOC. Purpose To investigate two types of rehabilitation on patients with a hand-related injury (joint mobility exercises vs. activity-based training and joint mobility exercises) and to investigate whether SOC can be used as an indicator of which patients would benefit from activity-based training. Hypotheses 1. Patients with a hand-related injury will benefit from activity-based training in their rehabilitation program. 2. Patients with a weak SOC will achieve the best functional level, if activity-based training is included in their rehabilitation program. 3. Patients with a strong SOC will not achieve a higher functional level, if activity-based training is included in their rehabilitation program. Study design Randomised control trial. Methods Four-hundred-twenty- patients age 18 years or older are included when referred to specialized outpatient occupational therapy after a hand-related injury. To ensure sufficient and balanced patient variation in relation to pre-rehabilitation sense of coherence, a balanced randomisation principle has been implemented. Data will be collected through questionnaires. The questionnaires measure SOC (13 items version), function (DASH), quality of life (EQ5D) and satisfaction. All participants will perform joint mobility exercises which are appropriate for their injury. In addition, participants who will be performing activity-based training will train with specific meaningful activities which they performed prior to the hand-related injury. Clinical relevance The knowledge obtained will be incorporated into the planning of occupational therapy rehabilitation services for this patient group, so that the patients will receive the most optimal conditions in which to achieve their previous level of function after a hand injury.

NCT ID: NCT02098408 Completed - Clinical trials for Patients at Ultra-high Risk of Psychosis

Effects of Neurocognitive and Social Cognitive Remediation in Patients at Ultra-High Risk of Psychosis

FOCUS
Start date: March 2014
Phase: N/A
Study type: Interventional

Cognitive deficits are known to be a core feature of schizophrenia and seem to become manifest in the prodromal or Ultra-High Risk (UHR) state of psychosis. The cognitive deficits are known to pose a critical barrier to functional recovery. Hence it is of vital importance to find intervention strategies that can alleviate these cognitive deficits and consequently improve daily functioning, and quality of life, as well as the prognosis for UHR-patients. The investigators will examine whether: - Cognitive remediation therapy will be superior to standard treatment in improving cognitive functioning in UHR- patients (null hypothesis: No difference between the two groups). - Cognitive remediation therapy will be superior to standard treatment in improving psychosocial functioning and clinical symptoms in UHR-patients (null hypothesis: No difference between the two groups).

NCT ID: NCT02098395 Completed - Diabetes Clinical Trials

The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes

ADJUNCT TWO™
Start date: May 2014
Phase: Phase 3
Study type: Interventional

This trial is conducted in Africa, Europe and North America. The purpose of the trial is to investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes.