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NCT ID: NCT01703741 Completed - Clinical trials for Adult Male Hypogonadism

A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel

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

This is a multicenter extension trial in adult hypogonadal males. The purpose of this study is to evaluate the safety of testosterone gel delivered using an applicator over an extended period of time.

NCT ID: NCT01703585 Completed - Breast Cancer Clinical Trials

Feasibility Study of Genomic Profiling Methods and Timing in Tumor Samples

Start date: October 4, 2012
Phase:
Study type: Observational

This is a feasibility study to look for genetic alterations in tissue and blood samples that may be useful in determining what treatments may be useful in the patient's cancer care.

NCT ID: NCT01703312 Completed - Allergic Asthma Clinical Trials

A Study Evaluating the Efficacy of QGE031 Compared to Omalizumab in Patients With Allergic Asthma

Start date: November 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the efficacy of QGE031 compared to omalizumab in patients with allergic asthma. Each treatment's effect in changing the concentration of inhaled allergen that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at 12 weeks compared to baseline will be evaluated.

NCT ID: NCT01702922 Completed - Clinical trials for Parents of Children With Cancer

Relationship Stressors in Parents of Children With Cancer or Neurofibromatosis Type 1 (NF1)

Start date: September 13, 2012
Phase:
Study type: Observational

Background: - Serious illnesses like cancer or Neurofibromatosis Type 1 (NF1), can cause high levels of stress in a family. When a child is diagnosed with cancer or NF1, parents face numerous stressors, each of which can strain relationships. Many parents struggle to effectively cope with the changes in parenting roles that often accompany treatment of childhood cancer or NF1. How parents cope with this stress can influence whether the relationship is strengthened or weakened. Stress levels can also affect the care of the child who has cancer or NF1. Researchers want to better understand the critical time points and events during the child s treatment when the relationship becomes most stressed and/or strengthened. Objectives: - To study how stress affects the relationship between parents who have a child with cancer or Neurofibromatosis Type 1 (NF1). Eligibility: - Parents of a child (between 1 and 24 years of age) who has been diagnosed with cancer or NF1. - Participants must have been in a partnership at the time the child was diagnosed with cancer or NF1. At least one of the parents must be a biological or legal parent of the child. Design: - Participants will fill out a questionnaire either online or by paper and pencil. It will take about 20 minutes to complete. The questions ask about the experience of dealing with a child s cancer OR NF1 diagnosis and how it affects participants relationship with their spouse/partner. - Some participants will also have an in-depth interview. It will last about an hour. It will ask further questions about the cancer OR NF1 diagnosis and treatment and its effect on the relationship. - Treatment will not be provided as part of this study.

NCT ID: NCT01702831 Completed - Multiple Myeloma Clinical Trials

Busulfan & Melphalan Conditioning for Autologous Stem Cell Transplant (ASCT) and Lenalidomide Maintenance

BuMelMCRN001
Start date: October 1, 2013
Phase: Phase 2
Study type: Interventional

A number of strategies have been proposed to improve the outcome of ASCT. The three main strategies are to incorporate novel agents into the induction regimen, using maintenance therapy following ASCT and the final strategy is to enhance conditioning regimens. Investigators would like to explore all these three strategies in this study: Investigators propose to take patients who have had standard novel agent (bortezomib) based induction regimens into this study and then use a dose-adjusted combination of busulfan and melphalan as conditioning regimen and finally Investigators would like to incorporate lenalidomide maintenance post ASCT until disease progression.

NCT ID: NCT01702818 Completed - Clinical trials for Hypoactive Sexual Desire Disorder (HSDD)

Stress Hormones, Mood and Women's Sexual Desire (MODEST)

MODEST
Start date: February 2012
Phase:
Study type: Observational

Women with Hypoactive sexual desire disorder (HSDD) have all measures of testosterone activity comparable to controls but lower levels of dehydroepiandrosterone (DHEA). Although DHEA is a precursor of testosterone it has other actions including involvement in the stress system. It is also linked to mood. This study focuses on measures of childhood stress, current mood and salivary stress hormones, in women with and without HSDD. We hypothesize that low levels of DHEA reflect dysfunction of the neuroendocrine stress response system involving the brain, pituitary and adrenal glands where DHEA is produced.

NCT ID: NCT01702610 Completed - Clinical trials for Glioblastoma Mutliforme

Phase II Trial of Neo-adjuvant Temozolomide Prior to Combined Temozolomide and Concurrent Accelerated Hypofractionated External Beam Radiotherapy Followed by Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

Start date: December 2008
Phase: N/A
Study type: Interventional

Patients with GBM, who were deemed ineligible for any active protocols at our centre, received accelerated hypofractionation EBRT if 60Gy/20Fx using an IMRT technique with conventional dose of concomitant and adjuvant TMX as per the STUPP's TMZ schedule. Thirty five patients, 15 females and 20 males with a median age of 63 (range 31-78) were treated with a median KPS of 90 (range 50-100). Four patients had multicentric disease at presentation. Eight patients had biopsy only while the rest had a near total resection (n=14) and partial resection (n=13) with a median follow-up of 12.1 months, the median survival was 14.4 months.

NCT ID: NCT01702571 Completed - Breast Cancer Clinical Trials

A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment

Start date: November 27, 2012
Phase: Phase 3
Study type: Interventional

This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants.

NCT ID: NCT01702207 Completed - Clinical trials for Cardiovascular Diseases

Evaluation Of Switching From Twice Daily Tacrolimus To Once Daily Formulation On Cardiovascular Risk

ESTTEROD
Start date: October 2012
Phase: Phase 4
Study type: Interventional

Current standard prophylactic immunosuppression in renal transplantation includes tacrolimus, a calcineurin inhibitor, dosed twice daily. In Canada, oral tacrolimus has been available as a twice daily formulation marketed as Prograf® since 1997. It has recently become available in an extended release formulation called Advagraf®, which is dosed once daily. Advagraf® has been demonstrated to be therapeutically equivalent to Prograf® in the renal transplant maintenance population, and as a result it has been is approved as an alternative to the twice daily formulation in these patients. There is an evolving and expanding positive clinical experience with Advagraf® in kidney transplantation and it has shown to be preferred by many patients, due to the diminished dosing frequency. In clinical trials, Advagraf® has been shown to have other potential benefits over Prograf® such as less inter and intra-patient variability, improved cardiovascular profiles, and improved kidney function. Compared to Prograf®, Advagraf® also has a lower Cmin or 'trough' concentration as well as a lower Cmax or 'peak' concentration. The purpose of this study is to convert stabilized renal transplant patients currently receiving Prograf® to Advagraf®, to investigate these potential therapeutic benefits. The Framingham Risk Score and the Reynold's Risk Score are currently recommended by the Canadian Cardiovascular Society (CCS) to predict 10-year cardiovascular risk in the general population. Surrogate markers are widely used in clinical trials to shorten follow-up durations. In this study, the investigators will use the Framingham Risk Score and Reynold's Risk Score to quantify changes in estimated cardiovascular risk. The investigators also intend to examine novel inflammatory markers to investigate cardiovascular risk. The investigators hypothesize that the more consistent drug exposure and lower Cmax noted with Advagraf® will decrease Framingham Risk Score, Reynolds Risk score as well as markers of inflammation in kidney transplant recipients.

NCT ID: NCT01701362 Completed - Neuropathic Pain Clinical Trials

Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain

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

This study is designed to investigate if pregabalin is effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.