Clinical Trials Logo

Filter by:
NCT ID: NCT02808286 Completed - Chronic Pain Clinical Trials

A Hybrid Emotion-focused Treatment for Chronic Pain Patients With Emotional Problems

Start date: January 2016
Phase: N/A
Study type: Interventional

The aim of this project is to evaluate a hybrid emotion-focused treatment protocol, specifically developed for individuals who suffer from co-occurring chronic pain and clinical levels of anxiety and/or depressive symptoms. Specific questions relating to treatment outcome: 1. Does a hybrid emotion-focused treatment lead to a decrease in comorbid emotional symptoms (pain-related fear, anxiety, depression)? 2. Does a hybrid emotion-focused treatment lead to an increase in functional ability, improvement in work status and decrease in medication use? 3. Does a hybrid emotion-focused treatment lead to better treatment effect on the above outcome variables compared to an active comparison group? Specific questions relating to the process of change: 4. Are therapeutic effects of the hybrid emotion-focused treatment mediated by changes in proposed transdiagnostic emotion regulation process variables (worry, rumination, cognitive and behavioral avoidance, emotional suppression)?

NCT ID: NCT02808000 Completed - Clinical trials for Complications; Catheter, Urinary Infection or Inflammation

BIP Foley in Prevention of CAUTI at Rehab Station

CDOC
Start date: April 21, 2016
Phase: Phase 4
Study type: Interventional

This is a prospective, cross-over, randomized, controlled, partly blinded study evaluating safety and performance of noble metal alloy urinary Catheters (BIP Foley, Bactiguard AB) of both latex and silicone. The included patients are permanently catheterized spinal cord injured patients at the Spinalis clinic at Rehab station in Stockholm, Sweden. Primary Outcome Measures: • The primary objective is to evaluate the efficacy of long term suprapubic use of BIP Foley catheters, compared to the use of standard catheters for the same time period, on re-current symptomatic catheter associated urinary tract infection (CAUTIs). Secondary Outcome Measures: • to evaluate safety/performance of the catheter, i.e. antibiotic use, bacteriuria, bacteremia, urosepsis and ICU stay. Exploratory Outcome Measures: • assessment of levels of immunological markers in urine, urinary bacterial type and resistance pattern, catheter comfort, stability of the coating, and bacterial biofilm on the catheter surface after use.

NCT ID: NCT02807454 Terminated - Multiple Myeloma Clinical Trials

A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma

FUSIONMM-003
Start date: July 7, 2016
Phase: Phase 2
Study type: Interventional

This is an open-label, multicenter study to confirm the safety and efficacy of durvalumab + daratumumab (D2) in subjects with relapsed and refractory multiple myeloma. This study will also explore the safety and efficacy of the addition of pomalidomide + dexamethasone to durvalumab + daratumumab (PD3). On 05 Sep 2017, a Partial Clinical Hold was placed on this study by the United States (US) Food and Drug Administration (FDA). The decision by the FDA was based on data related to risks of anti-programmed cell death-1 (PD-1) antibody, pembrolizumab, in combination with IMiDs® immunomodulatory drugs in patients with multiple myeloma. As a result, enrollment into this study has been discontinued. Subjects who are receiving clinical benefit, based on the discretion of the investigator, may remain on study treatment after being reconsented.

NCT ID: NCT02806986 Completed - Clinical trials for Primary Immunodeficiency

Efficacy, Pharmacokinetics, Safety, and Tolerability of IGSC 20% in Subjects With Primary Immunodeficiency

Start date: June 2016
Phase: Phase 3
Study type: Interventional

Approximately 60 subjects will be enrolled in order to have approximately 20 adult subjects and 20 pediatric subjects treated with subcutaneously administered Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) who complete the entire study. This study will include 3 study stages: Screening/Previous Regimen Phase, IGSC 20% Treatment Stage 1 (13 IGSC 20% weekly doses), and IGSC 20% Treatment Stage 2 (39 IGSC 20% weekly doses). A total of 52 doses of IGSC 20% will be administered with a final follow-up visit 1 week after the last dose at Week 53. Subjects/caregivers will be trained on self-administration of IGSC 20% by the clinical site personnel.

NCT ID: NCT02805751 Completed - Clinical trials for Achilles Tendon Rupture

Early Controlled Loading on Conservative Treated Achilles Tendon Ruptures

Start date: October 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to measure the mechanical properties of the tendon after conservative treated Achilles tendon ruptures with or without early controlled loading. This is done in a randomized trial and the mechanical properties are measured using roentgen stereometric analysis (RSA). The hypothesis is that early weightbearing improves mechanical properties of conservative treated Achilles tendon ruptures without causing elongation of the tendon.

NCT ID: NCT02805387 Completed - Arrested Labor Clinical Trials

Bicarbonate Given During Dystocic Labor

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

Dystocic deliveries and the use of bicarbonate

NCT ID: NCT02804789 Terminated - Clinical trials for Alzheimer's Dementia

European Prevention of Alzheimer's Dementia (EPAD) Longitudinal Cohort Study (LCS)

EPAD-LCS
Start date: May 2016
Phase:
Study type: Observational [Patient Registry]

Brain changes associated with Alzheimer's disease may precede symptoms of Alzheimer's Dementia by over 20 years. The Investigators hope to be able to identify Alzheimer's disease at its very earliest stages when in theory treatments are most likely to be successful in preventing further spread of the disease in the brain and causing dementia. The aim of EPAD programme is to develop new treatments more quickly to prevent Alzheimer's dementia. A major component of the EPAD programme is the EPAD Longitudinal Cohort Study which can provide subjects for the EPAD trial as well as data to improve understanding of disease before dementia develops. The Investigators will approach a broad range of people over the age of 50 who have previously taken part in various research studies and consented to being recontacted for further research. Participants will be asked questions to assess their memory and other cognitive function. The participants will also undertake a brain scan, provide a sample of spinal fluid, blood, urine and saliva to look at markers in these bodily fluids that may change in Alzheimer's disease. The Investigators will then follow these participants until December 2019 repeating these tests annually. This will be called the EPAD Longitudinal Cohort Study (EPAD LCS). The main reasons for EPAD developing a cohort are to help the Investigators understand more about what happens to people before dementia develops, and to help recruit people more quickly into the EPAD trials of new medications or other interventions expected to prevent dementia. People in the EPAD LCS may be invited to take part in the EPAD Proof of Concept prevention studies to see if interventions can modify the probability of developing dementia or cognitive problems (this will be subject to separate ethics approval and consent). Together EPAD LCS and EPAD PoC make up the full EPAD Programme.

NCT ID: NCT02802618 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Interactive 3D Visualization Technique Used in Pulmonary Rehabilitation Programme in COPD

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

A new education material with 3D technique was developed, by integrating 3D technology in an existing evidence-based pulmonary educational program, to enable an increased personalized education within a group setting. The investigators believe that this educational model will lead to increased adherence to treatment, and suggested lifestyle changes, which in turn improves patients' HRQL The purpose of this study was therefore to develop a pulmonary educational program in interactive 3D visualization technology and to evaluate differences between education with 3D technique or conventional technique in patient with COPD. Furthermore the LCQ will be translated and culturally adapted into Swedish and tested for validity and reliability.

NCT ID: NCT02799602 Completed - Clinical trials for Metastatic Hormone-sensitive Prostate Cancer

Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

ARASENS
Start date: November 30, 2016
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.

NCT ID: NCT02799238 Completed - Glioblastoma Clinical Trials

Autologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma

ALECSAT
Start date: March 2016
Phase: Phase 2
Study type: Interventional

This is a randomised, open-label, multi-centre, Phase II study in patients with newly diagnosed glioblastoma. 62 patients with newly diagnosed glioblastoma are enrolled in the study in a 1:2 allocation (standard of care (SOC): ALECSAT as an adjunct therapy to SOC). Patients recruited into this study will receive either: - ALECSAT as an adjunct therapy to standard of care for newly diagnosed glioblastoma (first line therapy: Stupp regimen, followed by second line therapy at the Investigator's discretion) or - Standard of care therapy for newly diagnosed glioblastoma (first line therapy: Stupp regimen, followed by second line therapy at the Investigator's discretion).