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NCT ID: NCT01748500 Completed - Prostate Cancer Clinical Trials

Pantoprazole and Docetaxel for Men With Metastatic Castration-Resistant Prostate Cancer

Start date: January 2013
Phase: Phase 2
Study type: Interventional

The main objectives of this trial are: 1. To assess the activity and safety of pantoprazole and docetaxel (with prednisone) in men with metastatic CRPC who have not received prior chemotherapy. 2. To evaluate archival prostate cancer tissue of men included in the clinical trial for evidence of autophagy using IHC for LC3B, ATG5, p62 as well as ERG. 3. To evaluate pharmacokinetic interactions of pantoprazole with docetaxel.

NCT ID: NCT01748487 Completed - Clinical trials for Diabetic Macular Edema

The Effect of Intravitreal Ozurdex on DME After Cataract Surgery

Start date: December 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of OZURDEX (dexamethasone intravitreal implant) 0.7 mg administered immediately after phacoemulsification and intraocular lens implantation in type 1 or 2 diabetic patients to prevent the occurrence of post-surgical macular edema (ME). Treatment group: 24 patients will receive an intravitreal injection of OZURDEX at the end of cataract surgery Patients will be seen at 1 week pre-operatively (baseline visit), and on the same day post-surgery (visit 1), at 1 week (visit 2), 1 month (visit 3) and 3 months (visit 4). BCVA, IOP and SD-OCT will be performed at each visit.

NCT ID: NCT01747902 Completed - Rotator Cuff Tear Clinical Trials

Biceps Tenodesis Versus Tenotomy

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

The long head of biceps brachii tendon has been known to be a pain generator and a common cause of shoulder pain and dysfunction in patients with rotator cuff pathology. Both biceps tenotomy and tenodesis have been shown to produce comparable results, but there is no consensus to date due to a lack of level I evidence. The aim of this prospective, randomized, clinical trial is to compare subjective patient-reported outcomes and objective clinical results between biceps tenotomy and biceps tenodesis for treating lesions of the long head of the biceps brachii.

NCT ID: NCT01747863 Completed - Brain Injury Clinical Trials

Prospective Research in Infants With Mild Encephalopathy

PRIME
Start date: December 2012
Phase: N/A
Study type: Observational

A multicenter observational pilot study will be conducted to determine the natural history of infants with early diagnosis (≤ 6 hrs of age) of mild neonatal encephalopathy (NE) who are not qualified for therapeutic hypothermia. The intervention includes: neurologic examination by using modified Sarnat score at ≤ 6 hrs of age, 24 hrs and before discharge home, amplitude-integrated electroencephalography (aEEG) at 6 ± 3 hrs of age, brain MRI at before discharge home to 30 days of age and follow-up at 18-22 months of age. Primary outcome is the percentage of mild NE infants with evidence of brain injury defined by the presence of at least 1 abnormality of brain MRI, aEEG or neurologic examination in the neonatal period. Secondary outcome is the percentage of brain MRI, aEEG and neurological exam abnormalities, seizure, length of hospital stay, need of gavage feeds or gastrostomy at discharge home, death and long-term outcome.

NCT ID: NCT01747850 Completed - Cannabis Dependence Clinical Trials

Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence

Start date: March 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is assess Sativex as a treatment for Cannabis dependence. Initially a pilot study will be conducted in five subjects seeking treatment for cannabis dependence to ensure that our planned self-titration regimen is appropriate using Sativex. This phase will be open label, with no placebo control. Then, there will be a twelve-week, double-blind, placebo-controlled study in male and female subjects seeking treatment for cannabis dependence (n=40). All participants will receive a combination of pharmacotherapy (Sativex Spray or Placebo Spray) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT). The subjects will have to come daily to the centre to assess usage of medication. Following the medication phase, participants will have a follow-up weekly for another four weeks and then monthly until the 6 month follow up visit after the target quit date. The investigators are planning to enroll 45 subjects over the two-year period.

NCT ID: NCT01747720 Completed - Breast Cancer Clinical Trials

Vitamin D and Mammographic Breast Density

EVIDENSE
Start date: October 2012
Phase: N/A
Study type: Interventional

There is some evidence that vitamin D could be used to reduce breast cancer risk. Randomized controlled trials would provide definitive evidence about this effect. However, trials with breast cancer as outcome are expensive and time-consuming. Use of surrogate outcomes has been advocated to accelerate progress in the identification of interventions that could prevent breast cancer. Mammographic breast density is one of the strongest breast cancer risk indicators and is already used as a surrogate outcome in several breast cancer prevention trials. The aim of this double-blind randomized controlled trial is to determine whether daily oral supplementation with vitamin D3 (1,000, 2,000 or 3,000 IU) over a period of 1 year reduces breast density in premenopausal women compared to placebo. A total of 376 women (94 per arm) who live in Quebec City will be recruited. Showing that vitamin D reduces breast density would provide strong support for the idea that vitamin D can be a safe and inexpensive approach for the prevention of breast cancer.

NCT ID: NCT01746901 Completed - Healthy Clinical Trials

A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers

Start date: February 2013
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused.

NCT ID: NCT01746459 Completed - Clinical trials for Knowledge Translation

Sustaining Transfers Through Affordable Research Translation (START)

START
Start date: February 2013
Phase: N/A
Study type: Interventional

Currently, the health care that people receive is approximately 20 years behind up-to-date research findings. Developing ways to narrow the gap between evidence and practice is an important research focus in continuing care facilities, especially when one considers that the demand for these facilities is estimated to increase ten-fold in the next 25 years. In Alberta, there are an estimated 27,400 healthcare aides working in the continuing care sector. Developing reminders targeting these care providers will increase the likelihood that the significant resources invested to promote the uptake of research findings will lead to sustained practice change and, ultimately, improved client outcomes. The purpose of the START project (Sustaining Transfers through Affordable Research Translation) is to help bridge this gap between research and practice in supportive living and long-term care facilities by studying the effectiveness of reminder interventions to support the sustainability of a research-based mobility innovation. In particular, the project will evaluate the frequency and intensity of reminders that maintain the daily practice of healthcare aides to carry out a mobility innovation with clients in 24 supportive living and long-term care facilities. We will compare monthly versus every three month reminders, and we will compare paper-based reminders (like a sticker on a chart) and reminders provided by a healthcare aide peer. Using interviews, questionnaires and observations, the START project will also evaluate the processes that inhibit or promote the uptake of the mobility innovation by healthcare aides in their daily practice. In building this bridge between research evidence and practice, we will work closely with stakeholders at all levels of healthcare delivery (e.g. healthcare aides, facility leaders, policy makers and researchers) throughout the study. We expect our collaboration to contribute to sustainable innovations in the continuing care sector and, in particular, to the sustained use of an affordable mobility innovation in supportive living and long-term care settings.

NCT ID: NCT01746381 Completed - Clinical trials for Amyotrophic Lateral Sclerosis (ALS)

Non-invasive Ventilation in Amyotrophic Lateral Sclerosis (ALS) Using the iVAPS Mode

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

Home non-invasive ventilation (NIV) is the standard-of-care as initial therapy for patients with ALS with worsening symptoms or deteriorating respiratory function, and has been recommended by the American Academy of Neurology (AAN) practice parameter for ALS. This study will compare the current standard BiST mode of ventilation with the new iVAPS mode. The main study hypothesis is that the iVAPS mode, initiated in a single daytime trial, will result in a reduction of the number of respiratory therapist interventions and changes in ventilator settings as compared with the standard BiST mode. This will be assessed over a period of one year. In addition this study will test whether the iVAPS mode is superior to BiST mode with respect to: comfort and ease of use; improvement in nighttime and daytime symptoms of hypoventilation; compliance (hours used per day); physiologic parameters (daytime and overnight oxygen saturation and transcutaneous CO2 level).

NCT ID: NCT01746342 Completed - Clinical trials for Obstructive Sleep Apnea-hypopnea in Multiple Sclerosis Patients

Sleep Apnea in Multiple Sclerosis Positive Airway Pressure Trial

SAMSPAP
Start date: February 2013
Phase: N/A
Study type: Interventional

Fatigue is highly prevalent among multiple sclerosis (MS) patients and has pervasive adverse effects on daily functioning and quality of life. The investigators found in a recent study that obstructive sleep apnea-hypopnea (OSAH) is the most common sleep abnormality in multiple sclerosis (MS) patients. There was also a significant relationship between OSAH and higher fatigue scores in MS patients. Preliminary work from the investigators in this group of subjects shows that treatment of sleep disorders (mostly OSAH) can improve fatigue and other symptoms in some MS patients. However, it is now necessary to systemically test the effect of OSAH treatment in a randomized, controlled study, to be sure that it really does improve fatigue and other symptoms. The best treatment for OSAH in the general population is continuous positive airway pressure (CPAP). This treatment has been well tolerated by most MS patients who have used the device at the investigators' center. This project will therefore be a randomized, controlled, clinical trial of CPAP in MS patients with OSAH. The effects of six months of CPAP treatment on fatigue as well as sleep quality, somnolence, pain, disability, and quality of life will be studied.