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NCT ID: NCT01915602 Completed - Clinical trials for Carcinoma, Hepatocellular

Refametinib in Combination With Sorafenib in RAS Mutant Hepatocellular Carcinoma (HCC)

Start date: September 27, 2013
Phase: Phase 2
Study type: Interventional

This is a study to investigate the potential clinical benefit of refametinib when given in combination with sorafenib as first line treatment in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15 patients at Stage 1 show at least partial response according to an objective criteria to evaluate tumor size based on contrast enhancement [modified response evaluation criteria in solid tumors (mRECIST)] assessed by external independent radiologists. Refametenib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib in combination with sorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib in combination with sorafenib improves the response rate in this patient population compared to historical results observed with the sorafenib only.

NCT ID: NCT01915589 Completed - Clinical trials for Carcinoma, Hepatocellular

Refametinib(BAY86-9766) in RAS Mutant Hepatocellular Carcinoma (HCC)

Start date: September 16, 2013
Phase: Phase 2
Study type: Interventional

This is a study to investigate the potential clinical benefit of refametinib in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15 patients at Stage 1 show at least confirmed partial response (PR) according to modified response evaluation criteria in solid tumors (mRECIST) assessed by central image review. Refametinib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib improves the response rate in this RAS mutation patient population.

NCT ID: NCT01915563 Completed - Weaning Failure Clinical Trials

Rest After Spontaneous Breathing Trial for Prevention of Post-extubation Failure

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

To evaluate if a rest period before extubation after a successful SBT trial could reduce the extubation failure rate.

NCT ID: NCT01915381 Completed - Clinical trials for Intellectual Disability

Improving Adherence Healthy Lifestyle With a Smartphone Application Based on Adults With Intellectual Disabilities

APPCOID
Start date: March 2013
Phase: N/A
Study type: Interventional

AIM: Improve adherence to physical activity in people with Intellectual disabilities with a Smartphone Application DESIGN: Randomized controlled trial SUBJECTS OF THE STUDY: People with intellectual disabilities in Occupational Center ( ASPROMANIS) INTERVENTION: DATA ANALYSIS: descriptive statistics, measuring central tendency and dispersion of the variables study. Inferential statistics will be made between intervention of key variables and outcome

NCT ID: NCT01915043 Completed - Clinical trials for Secondary Prevention

Improving Adherence Healthy Lifestyle With a Smartphone Application Based After Surgery in Cancer Patients

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

Background: The cancer-related lymphedema (BCRL) is the abnormal accumulation of fluid in the lymphatic system and can develop immediately after surgery / radiotherapy of breast cancer, or may appear months later. In the literature there are numerous educational recommendations to avoid the appearance BCRL, but there is a lack of adherence to these recommendations. With the increase of mobile technologies among adults, the mobile devices can be an effective method to meet their education. Objective: To determine the effectiveness of therapeutic adherence a brief educational intervention through a smartphone-based application in the prevention of lymphedema in women with mastectomies. Method: 100 women survivors of breast cancer will be randomized to a group that will receive lymphedema prevention education and an app specific for better adhesion compared to the control group will receive education only. They will be monitored for 28 weeks by specific measures of lymphedema onset, volume and perimeter arm and hand strength lymphedema disability questionnaire and other measures of fatigue, quality of life and mood related to cancer. Discussion: The lack of adherence to health education is the main cause of failure in maintaining these brief educational interventions, whether the program is beneficial, it could be successfully implemented in clinical practice.

NCT ID: NCT01914991 Completed - Health Behaviour Clinical Trials

Combined Static and Dynamic Orthotic Treatment of the PIP Joint

StaDinOrt
Start date: June 2011
Phase: Phase 4
Study type: Interventional

Study Design: Randomized controlled clinical study. Introduction: Physiotherapeutic intervention aiming to restore mobility using different techniques as stretching, hot packs, exercises, therapeutic ultrasound and orthotics. No scientific evidence has been found correlating improved joint mobility and the use of these techniques. Application techniques of orthoses to reshape the soft tissues have been well detailed, however, no scientific evidence supporting their effectiveness on proximal interphalangeal joint (PIPJ) lag extension resolution using them as a single treatment has been found. Purpose of the Study: The purpose of the study was to test the effectiveness of static and dynamic orthosis in patients with a PIPJ flexion retraction using them as a single treatment compared with traditional combined therapies. Method: 63 participants were included in the study. Patients who used splints were compared to a control group who received conventional treatment. Active and passive mobility were measured before the experiment and again three months after. All the patients were measured under the same conditions and treated by the same hand therapist. The relationship between contracture resolution and function was measured using the DASH Spanish Version.

NCT ID: NCT01914393 Completed - Schizophrenia Clinical Trials

Pediatric Open-Label Extension Study

Start date: September 30, 2013
Phase: Phase 3
Study type: Interventional

This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D1050325, and D1050326

NCT ID: NCT01913808 Completed - Clinical trials for Osteoarthritis, Knee

Comparing Intravenous and Oral Iron in Postoperative Anemia

Start date: January 2011
Phase: Phase 4
Study type: Interventional

Postoperative anaemia are common in patients undergoing major orthopaedic surgery. The main consequence of perioperative anaemia is an increased risk of red blood cell (RBC) transfusions. Allogeneic RBC transfusion and anaemia are associated with higher postoperative mortality and morbidity. The aim of this study was to compare the efficacy of postoperative i.v. ferric carboxymaltose (FCM) and oral ferrous glycine sulphate (FS) for early improvement of postoperative anaemia after total knee arthroplasty and whether iron treatment could facilitate recovery from surgery.

NCT ID: NCT01913405 Completed - Hemophilia A Clinical Trials

Phase 3 Efficacy and Safety Study of BAX 855 in Severe Hemophilia A Patients Undergoing Surgical Procedures

Start date: December 20, 2013
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of BAX 855 in severe hemophilia A previously treated (PTP) males, 12 to 65 years of age who are undergoing elective surgical or other invasive procedures.

NCT ID: NCT01912456 Completed - Clinical trials for Hereditary Angioedema Types I and II

A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema

Start date: January 2014
Phase: Phase 3
Study type: Interventional

The aim of this study is to assess the efficacy of C1-esterase inhibitor in preventing hereditary angioedema attacks when it is administered under the skin of subjects with hereditary angioedema. The safety of C1-esterase inhibitor will also be assessed. Each subject will enter a run-in period of up to 8-weeks. Subjects who complete the run-in period and who are eligible will then enter the treatment phase which comprises two sequential treatment periods. In the treatment phase, subjects will be randomized to one of four arms consisting of treatment with low- or higher-volume C1-esterase inhibitor in one treatment period and treatment with low- or higher-volume placebo in the other treatment period. The study will measure the number of hereditary angioedema attacks that subjects experience while receiving each treatment.