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What is a clinical trial?

Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. We have both interventional & observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.

Current & upcoming clinical trials - Updated 3/1/2015
February 2015 - June 2016
Short Rationale: Risk-reducing salpingo-oophorectomy (RRSO) is a mainstay in preventing ovarian cancer in BRCA1/2 mutation carriers, as ovarian cancer screening is ineffective in detecting ovarian cancer in an early and curable stage. Women who underwent RRSO experienced bothersome menopausal symptoms and worsening of sexual functioning related to acute surgical menopause. Hormone replacement therapy (HRT) will mitigate some of the RRSO induced menopausal complaints, however it does not reduce the complaints to a premenopausal level and the sexual symptoms are not alleviated. Mindfulness interventions were found to improve sexual functioning and alleviate menopausal symptoms in various populations. It has not been investigated whether mindfulness-based stress reduction (MBSR) is effective in mitigating the RRSO-induced menopausal complaints in BRCA1/2 mutation carriers and if this effect is sustained over a longer period of time. Objective: To examine the effect of MBSR training on the menopause-specific quality of life in BRCA1/2 mutation carriers who experience RRSO-induced menopausal complaints. Study population: Female BRCA1/2 mutation carriers who were younger than 52 years at the time of RRSO reporting two or more moderate to severe menopause related complaints after undergoing RRSO. Study design: Prospective randomized controlled trial with a follow-up time of twelve months conducted at the University Medical Center Groningen (UMCG) Intervention: Eight-week MBSR training consisting of a weekly class of two and half hours and a full retreat day. Furthermore participants are asked to practice mindfulness exercises at home for 45 minutes, six days a week. Main study parameters/endpoints: Menopause specific quality of life score measured by the Menopause-specific quality of life questionnaire (MENQOL). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no risks associated with taking part in a MBSR training or filling out the questionnaires that will be used in this study. The content of the questionnaires concerns intimate matters and could be considered burdensome. A possible benefit for the participants of the MBSR training is that participants will be more able to cope with their complaints after RRSO. The group relatedness is reflected in the fact that RRSO is specifically performed in women with a hereditary risk of ovarian cancer such as BRCA1/2 mutation carriers.
Sponsor: University Medical Centre Groningen
Study type: Interventional
February 2015 -
The goal of this clinical research study is to learn if giving metformin in combination with radiation therapy is more effective than radiation therapy alone. In this study, participants will receive either metformin or a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Sponsor: M.D. Anderson Cancer Center
Study type: Interventional
February 2015 - June 2017
Tenofovir continues to play a vital role in the treatment of HIV and as the age of the HIV-infected population increases in the United States and worldwide, there is an urgent need to understand the extent to which older age influences the way this antiretroviral medication works in the body. The investigators study aims to characterize and compare the pharmacology of tenofovir in older versus younger HIV-infected adults and to assess kidney function over the course of approximately one year. The investigators will be analyzing tenofovir levels in different compartments of the blood and in hair samples, and will be assessing the relationship between tenofovir concentrations and changes in kidney function over time in the older and younger cohorts. Lastly, the investigators will be evaluating the relationship between tenofovir concentrations and functional status (including body composition, bone mineral density, and frailty) in study participants.
Sponsor: University of Colorado, Denver
Study type: Observational
February 2015 - July 2017
The energy burning capacity of brown adipose tissue makes it an attractive target for anti-obesity therapies. Sympathetic nervous system (SNS) is the classical regulator of brown adipose tissue; however, recent findings show a pool of novel brown adipose tissue activators that sidestep the need for stimulating the SNS, including cardiac natriuretic peptides. Of interest is that both SNS and non-SNS brown adipose tissue activators are sensitive to physical exercise, which opens new horizons and opportunities to study the potential effect of exercise-based therapeutic interventions. Moreover, a new protein released by exercise-stimulated skeletal muscle, irisin, seems to play a key role in the browning program of white adipose tissue. Most of the available evidence comes from animal studies, which is sometimes difficult to infer to human physiology. The overall objective of the ACTIBATE randomized controlled trial is to study the effect of long-term exercise training (6 months) on brown adipose tissue activity and quantity (primary outcomes) in young overweight and obese adults. The clinical significance of activating and recruiting brown adipose tissue on resting metabolic rate and cardiometabolic profile in humans will be determined. The investigators will also study at the molecular level the benefits of exercise on the regulation pathways in two different tissues: white adipose tissue and skeletal muscle, as well as identifying possible cross-talk between the exercising muscle and heart, and fat. Information from exercise-induced signaling on brown adipose tissue, white adipose tissue and skeletal muscle will help on identifying potential molecular therapeutic candidates.
Sponsor: Universidad de Granada
Study type: Interventional
February 2015 - December 2016
This is a phase II open label, single arm clinical trial on safety and efficacy exploring an short-course regimen of intra-operative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) as upfront therapy for patients with advanced Epithelial Ovarian Cancer (EOC) undergoing Cytoreductive Surgery (CRS).
Sponsor: Professor Fernando Figueira Integral Medicine Institute
Study type: Interventional
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