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NCT ID: NCT02568995 Completed - Clinical trials for Rescue Pain Requirements

Pain Management Following Total Hip Arthroplasty

FEMORALIA
Start date: May 2014
Phase: Phase 3
Study type: Interventional

Total hip arthroplasty (THA) is a common and standardized procedure. Postoperative mortality after hip joint replacement is low but some complications remain, including chronic post-surgical pain (1), hip dislocation (2), infection (3), and deep vein thrombosis (4). Strategies that have been identified to reduce morbidity and mortality include: posterior surgical approach, mechanical and pharmacological prophylaxis of deep vein thrombosis, and the use of spinal anesthesia (5). One of the important factors for patient satisfaction with lower limb arthroplasty is good postoperative pain management (6). Poorly managed postoperative pain can lead to chronic post-surgical pain and therefore aggressive postoperative pain management is important (7). Several different methods have been used to treat postoperative pain following THA. Recently, local infiltration analgesia (LIA) using a combination of large volume local anesthetics (LA) and non-steroidal anti-inflammatory agents (NSAID) injected systematically peri-articularly has been used for pain management with variable success (8). We found that better analgesia could be achieved when using LIA compared to intrathecal morphine during the first few days postoperatively (9,10). Ultrasound techniques are commonly used for peripheral nerve blocks and have been shown to reduce pain intensity and may be considered by many to be a standard of care. Specifically, the 3-in-1 block has been commonly used because of its ease of application and good pain management following total hip arthroplasty. The present study aims to compare postoperative pain intensity following local infiltration analgesia with a standardised 3-in-1 block for total hip arthroplasty.

NCT ID: NCT02568943 No longer available - Multiple Myeloma Clinical Trials

An Expanded Treatment Protocol of Panobinostat in Combination Therapy for Relapsed, and Relapsed and Refractory Multiple Myeloma

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this study is to provide oral panobinostat (PAN) treatment to relapsed or relapsed and refractory multiple myeloma patients who are without satisfactory treatment alternatives prior to the commercial availability* and reimbursement of panobinostat during the regulatory approval process. This protocol will acquire additional safety data on the use of panobinostat in combination with bortezomib (BTZ) and dexamethasone (Dex) in patients with relapsed or relapsed and refractory multiple myeloma. In this protocol, PAN must be administered in the defined regimen in combination with both BTZ and DEX. *(Note: throughout this protocol "commercially available" means local health authority approval and a functional method for reimbursement)

NCT ID: NCT02568839 Active, not recruiting - Clinical trials for HER-2 Positive Breast Cancer

Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer

PREDIX HER2
Start date: November 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this trial is to evaluate efficacy and toxicity of either the combination of docetaxel, trastuzumab sc and pertuzumab (arm A) or trastuzumab emtansin (arm B). Switch of therapy to the opposite treatment alternative is applicable in case of lack of response after two courses of treatment, or for medical reasons under exceptional circumstances (drug reaction, other medical conditions) at any point. After termination of the primary treatment follow-up for five years. A translational subprotocol is a mandatory part of the study protocol, with exception for the use of PET-CT evaluations.

NCT ID: NCT02567890 Completed - Eating Disorders Clinical Trials

Swedish Body Project for Prevention of Eating Disorders

sBodyProject
Start date: September 2015
Phase: N/A
Study type: Interventional

Women in general and young girls in particular are constantly exposed to unhealthy body and appearance ideals through media that contribute to body dissatisfaction and unhealthy behaviors such as rigid dieting, which in interaction with genes and other factors increase the risk of developing eating disorders such as anorexia nervosa and bulimia nervosa. The investigators aim is to investigate the extent to which an interactive prevention program, delivered through Internet, called the Swedish Body Project (sBody Project) can decrease the emergence of eating disorders among young females. The sBody Project is based on a "Dissonance-Based Intervention: (DBI)" that has shown very promising results. The adaptations and changes in the format of delivery accomplished in this study might help to disseminate the program on a broad basis, and consequently affect the health of young females on a much larger scale the ever before.

NCT ID: NCT02567188 Completed - Anemia Clinical Trials

A Study of MIRCERA in Participants With Chronic Kidney Disease Stage 3-4 and Not on Dialysis

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

An observational, longitudinal, multi-center, non-interventional study in participants with chronic kidney disease (CKD) stage 3-4, assessed by Modification of Diet in Renal Disease (MDRD) to collect data regarding safety and efficacy in participants with pre-dialysis situation who are treated with MIRCERA in normal clinical environment.

NCT ID: NCT02565914 Completed - Cystic Fibrosis Clinical Trials

A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Participants With Cystic Fibrosis Who Have an F508del-CFTR Mutation

Start date: August 2015
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, open-label, 3-part rollover study in subjects with CF who are homozygous or heterozygous for the F508del-CFTR mutation and who participated in studies VX13-661-103 (Study 103, NCT02070744), VX14-661-106 (Study 106, NCT02347657), VX14-661-107 (Study 107, NCT02516410), VX14-661-108 (Study 108, NCT02392234), VX14-661-109 (Study 109, NCT02412111), VX14-661-111 (Study 111, NCT02508207), VX15-661-112 (NCT02730208), and VX16-661-114 (NCT03150719). The study is designed to evaluate the safety and efficacy of long-term treatment of VX-661 in combination with ivacaftor.

NCT ID: NCT02564289 Recruiting - Tobacco Dependence Clinical Trials

Cardiovascular Effects of Chronic Snus Use

CHROS
Start date: September 2015
Phase: N/A
Study type: Observational

The current study proposes to investigate the effects of chronic snus use on the blood vessels. Several cardiovascular endpoints are measured using various methods in healthy daily snus users as well as in healthy matched controls.

NCT ID: NCT02563756 Recruiting - Knee Osteoarthritis Clinical Trials

Unicondylar- or Total Knee Replacement? Patient Satisfaction, Function and Muscle Mass

UKA or TKA?
Start date: September 2015
Phase: N/A
Study type: Interventional

Patients with medial gonarthritis are randomised to a unicompartmental or a total knee replacement. Primary outcome: Thigh muscle cross sectional area and radiological attenuation measured by CT Secondary aims: functional tests, gait analysis, health related quality of life and patient related outcome.

NCT ID: NCT02563743 Completed - Clinical trials for Common Mental Disorders and/or Stress Related Symptoms

Stress and Mental Ill-health in the Workplace: Evaluation of an Intervention for the Prevention of Sick Leave

Start date: August 25, 2015
Phase: N/A
Study type: Interventional

Purpose Common mental disorders (CMD:s) are the leading cause of sick-leave spells in Sweden, resulting in suffering for the individual and financial costs for the employer as well as for society at large. Studies on interventions that address stress and mental ill-health and that focus on sick leave and return to work (RTW) show little or no effect of commonly used methods such as medication or psychological approaches. Furthermore, these interventions often focus on the individual's symptoms without considering their work situation. The occupational health services (OHS) has knowledge of the employee's work environment and can offer treatment facilitating the employee's RTW and improving the employee's work ability while taking into account both the individual and the work situation. The intervention in the current study will be performed at the OHS. The study aim is two-fold: first, an intervention that addresses both individual and workplace related aspects among employees with work-related CMD:s and/or stress related symptoms will be evaluated. In particular, the treatment's cost-effectiveness and impact on sick leave and mental health will be studied. Secondly, the concerned OHS staff's adherence to the intended treatment and associations with the outcome of the intervention will be assessed.

NCT ID: NCT02563717 Completed - Clinical trials for Infant, Premature, Diseases

Comparison Of Respiratory Support After Delivery on Infants Born Before 28 Weeks Gestational Age

CORSAD
Start date: March 2016
Phase: N/A
Study type: Interventional

Trial purpose: For infants born <28 weeks of age, can initial respiratory resuscitation with new system (low imposed work of breathing and prongs) reduce the frequency of delivery room intubations compared to standard treatment with T-piece resuscitator system (high imposed work of breathing and face mask)? Trial summary: This is a randomised controlled trial of delivery room intubation rates comparing a new system and T-piece resuscitation system for initial stabilisation of infants born <28 weeks.