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NCT ID: NCT01038804 Completed - Breast Cancer Clinical Trials

A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer

Start date: December 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel as first-line treatment in subjects with human epidermal growth factor 2 non-overexpressing (HER2 negative) metastatic breast cancer.

NCT ID: NCT01037868 Completed - Depression Clinical Trials

Usefulness of Supportive Text Messages in the Treatment of Depressed Alcoholics

Start date: September 2009
Phase: N/A
Study type: Interventional

Background: There is abundant evidence that rates of comorbidity between substance use and depression are high (1, 2) and the risk of poor outcome is higher among individuals with the dual disorder compared with those with a single disorder (3, 4, 5, 6). Previous research has shown that about 50% of persons studied with severe mental illness and past substance abuse are likely to have a recurrence of substance abuse within 1 year of discharge from treatment (7). There is therefore a clear clinical challenge in treating patients with the dual disorder which may calls for further research and the possible introduction of new and innovative strategies including the use of mobile phone technology to provide increased support for patients with the dual diagnosis. There are established research evidence for using Short Message Service (SMS) text messages to remind patients of scheduled medical appointments (8,9,10,12, 13), coordinate medical staff,(14) deliver medical test results,(15,16) , promote smoking cessation ( 17), improve self-monitoring among the youth with type 1 diabetes( 18), promote weight loss among obese subjects (19 ) and monitor patient side effects following treatment(20). Relevance of the research: To date, after an extensive review of the literature using MEDLINE, Pub Med, ERIC, Web of Science, Science Direct and PsycINFO, no studies was found on the use of SMS text messages as an intervention to address abstinence amongst alcohol dependent subjects who are co-morbid for a depressive disorder. Thus, the investigators seek to determine if text messaging is a useful and effective strategy to help maintain abstinence, improve adherence with medication and ultimately promote mental stability in depressed patients discharged from an in-patient dual diagnosis programme. The investigators hypothesize that, daily supportive/reminder SMS text messages to depressed patients discharged from an in-patient dual diagnosis programme would increase alcohol abstinence rates , improve medication adherence rates and improve the overall mental well being of patients compared with those receiving treatment as usual.

NCT ID: NCT01033305 Completed - Clinical trials for Mild to Moderate Ulcerative Colitis

Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™)

Start date: March 2010
Phase: Phase 2
Study type: Interventional

This is a multi-center study in Ireland and United Kingdom to determine the effects, safety and tolerability of a drug called CyCol™ in improving mild to moderate ulcerative colitis (UC). Informed consent will be obtained and following confirmation of eligibility and disease assessment, study participants will be randomised (allocated by chance) to take either CyCol™, or placebo, orally once every day for four weeks. Study visit assessments will include blood and stool tests, physical examinations and flexible sigmoidoscopies (inspection of the bowel wall using a flexible camera). Half the participants will receive CyCol™ and half will receive placebo. At the end of treatment (4 weeks) study participants will be reassessed again and the findings in those who received CyCol™ will be compared with those who received placebo. Any side effects experienced during the study and the safety of treatment with CyCol™ will also be evaluated.

NCT ID: NCT01032460 Completed - Immobilization Clinical Trials

Comparison of Two Novel Indirect Laryngoscopes to the Macintosh Laryngoscope in Patients With Cervical Spine Immobilization.

Start date: January 2010
Phase: N/A
Study type: Interventional

It is essential that anaesthetists successfully perform orotracheal intubation in scenarios in which intubation is potentially more difficult, such as where the neck is immobilized. The Airtraq® Laryngoscope and the CMAC are new intubating devices. They are designed to provide a view of the glottis without alignment of the oral, pharyngeal and tracheal axes. These devices may be especially effective in situations where intubation of the trachea is potentially difficult. The efficacy of these devices in comparison to the traditional Macintosh laryngoscope in situations where the cervical spine is immobilized is not known. The investigators aim to compare the performances of the Airtraq® Laryngoscope and the CMAC to that of the Macintosh laryngoscope, the gold standard device, in patients in which the cervical spine has been immobilized by means of a Manual in-line stabilization of the spine. Hypothesis: The primary hypothesis is that, in the hands of experienced anaesthetists, time to intubation would be shorter using the indirect laryngoscopes, than using the Macintosh laryngoscope in simulated difficult laryngoscopy.

NCT ID: NCT01030887 Completed - Cancer Clinical Trials

PEACH Trial: Prescribed Exercise After Chemotherapy

PEACH
Start date: January 2010
Phase: Phase 3
Study type: Interventional

Many cancer survivors suffer symptoms such as fatigue and dyspnea which may persist for years or months after their chemotherapy has finished. Despite the known benefits of exercise and its potential to address many of the symptoms after cancer, the type of practical exercise programme which best suits this population is not known. Many exercise programmes performed in cancer survivors take place over many weeks or months and include people with specific types of cancer. Such programmes may therefore not be suitable for the majority of cancer survivors and would pose serious practical difficulties with high drop-out rates and expensive resource consumption if they were extended into clinical practice. We propose to run an 8-week exercise intervention in a mixed cancer population. Hypothesis: A brief, individually tailored 8-week intervention will increase fitness and improve other physical symptoms in a mixed cancer survivor population after chemotherapy.

NCT ID: NCT01030432 Completed - Hepatitis C Virus Clinical Trials

Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

Start date: February 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).

NCT ID: NCT01030380 Completed - Clinical trials for Facial Muscle Toning

Determination of the Efficacy of Slendertone® Face to Tone the Muscles of the Face and Reduce the Signs of Facial Aging

Face
Start date: February 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study was to determine the efficacy of Slendertone® Face™, to tone the muscles of the face and reduce the signs of facial aging among the following characteristics: radiance, tone, lift, firmness and complexion, following a 12-week programme of facial muscle toning. Slendertone® Face is a neuromuscular electrical stimulation (NMES) device which features a headset unit designed for application to the face for facial toning. The purpose of the headset is to locate and support a pair of stimulation electrodes on each side of the face, over the facial nerve just anterior to the ear.

NCT ID: NCT01027949 Completed - Clinical trials for Pulmonary Arterial Hypertension

An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension

FREEDOM-EXT
Start date: January 16, 2007
Phase: Phase 3
Study type: Interventional

This study provided/continued to provide oral treprostinil (UT-15C SR; treprostinil diethanolamine) to eligible subjects who participated in Studies TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, and TDE-PH-308. The study assessed the long term safety of oral treprostinil and the effect of continued treatment with oral treprostinil on exercise capacity after 1 year of treatment.

NCT ID: NCT01014208 Completed - Clinical trials for Lymphoma, Large-Cell, Diffuse

Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell Lymphoma

ORCHARRD
Start date: March 2010
Phase: Phase 3
Study type: Interventional

This study is being conducted to compare the efficacy and safety of ofatumumab in addition to salvage chemotherapy versus rituximab in addition to salvage chemotherapy in CD20 positive DLBCL subjects relapsing, or with persistent disease, after first-line treatment with rituximab combined with an anthracycline-based chemotherapy regimen and be eligible for ASCT.

NCT ID: NCT01011868 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes

Start date: November 2009
Phase: Phase 2
Study type: Interventional

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.