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NCT ID: NCT01691235 Withdrawn - Clinical trials for Chronic Hepatitis C Virus

SIMpill Medication Dispensing Device in the Treatment of HCV

SIMpill HCV
Start date: September 2012
Phase: N/A
Study type: Observational

Subjects are being asked to participate in this study because they have genotype 1 Hepatitis C Virus (HCV) and will be taking the standard of care drugs pegylated interferon, ribavirin, and telaprevir as part of their routine care. The purpose of this study is to see if the SIMpill automated pill dispensing device can help subjects take their medications at the times the doctor has instructed them to take it. The SIMpill device is an automated pill dispensing device that records a time stamp each time the device is opened and a dose of medication is taken. Physicians can download this data and generate a precise account of when you have taken your medication. In addition, if a dose is missed, the SIMpill device can be set to automatically notify you by text message if a dose is overdue. The Simpill device is a new way to keep track of when you take your HCV medications and will also help remind you when you forget to take a dose. In addition, this information will help your doctors understand how taking medication on time effects the success of the therapy.

NCT ID: NCT01691196 Withdrawn - Obesity Clinical Trials

Inflammation in Peritoneal Dialysis Patients: Effect of Obesity

Start date: September 2012
Phase:
Study type: Observational

Our study addresses the following research question: What is the role of obesity in modulating inflammation and innate immune function, as well as the overall responsiveness of innate immune cells (such as macrophages, neutrophils, and other peripheral leukocytes) in patients undergoing peritoneal dialysis? The investigators hypothesize that obesity will lead to increased inflammation in patients undergoing peritoneal dialysis.

NCT ID: NCT01689896 Withdrawn - Pain Clinical Trials

Testosterone and Pain Sensitivity

Start date: August 2012
Phase: Phase 4
Study type: Interventional

This research is being done to see whether testosterone replacement in men who take opioid-based pain medications and have low testosterone levels will show improvement in pain tolerance, pain perception and quality of life. Some men who take opioid-based medications (narcotics) for pain develop low testosterone levels. Research has shown that low testosterone levels may make a person more sensitive to pain. This means that if a person with a painful condition develops low testosterone level as a result of his pain medications, he might become more sensitive to pain and so may need higher doses of pain medications for pain control. Testosterone is a male hormone that is important for sperm production and the development of male characteristics such as muscle mass and strength, fat distribution, bone mass and sex drive. Testosterone hormone replacement therapy has been used for decades to treat men with low testosterone levels (male hypogonadism). Testosterone replacement therapies are available in the form of an injection into the muscle, implants under the skin, oral capsules taken by mouth, topical gels applied to the skin, and skin patches. This study will use Fortesta®, a topical testosterone gel (T-gel) absorbed into the skin. Fortesta® is currently on the market as an FDA-approved treatment of male hypogonadism (low testosterone levels). Men with non-cancer related pain who take opioid-based medications for pain and have low testosterone levels may join this study. (A low testosterone level is defined as early morning (before noon) blood testosterone level of 300 ng/dl or less, or a free testosterone of 50 ng/dl or less)).

NCT ID: NCT01685489 Withdrawn - Prostatic Neoplasms Clinical Trials

A Phase 1b Dose Escalation Trial of PSK®/Placebo With Docetaxel to Treat Metastatic Castration-resistant Prostate Cancer

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

This is a phase 1b study that follows a 3+3 dose escalation design and consists of a 21-day lead-in period of oral Polysaccharide Krestin (PSK)/placebo (study drug) alone followed by the addition to study drug of standard intravenous docetaxel at 75 mg/m2 every 3 weeks for three cycles. Study drug will be discontinued on day 15 of the third docetaxel cycle to allow for a 7-day washout period before the fourth dose of docetaxel. Pharmacokinetic (PK) analysis of docetaxel will be conducted during docetaxel cycle 1 (combination therapy) and cycle 4 (docetaxel alone). Serum for future PSK PK analysis will be collected on days 1, 3, and 15 of PSK/placebo lead-in and during cycles 1 and 4.

NCT ID: NCT01684696 Withdrawn - Lung Neoplasms Clinical Trials

Virtual Intervention for Lung Cancer

VILC
Start date: August 2016
Phase: N/A
Study type: Interventional

Lung cancer is the leading cause of cancer death in both men and women. Lung cancer is unique because of racial disparity, persistent mortality rate, and social stigma. Lung cancer stigma (LCS) and difficult patient-clinician communication may be an underlying factor in health disparities in lung cancer. The purpose of this study is to PILOT test, in a diverse sample of lung cancer patients the effectiveness of the mHealth Tool for Lung Cancer patients (mHealthTLC), an interactive, immersive 3-dimensional iPad application that allows individuals to experience first person virtual visits with their clinicians, to improve patient-clinician communication, decrease LCS, and promote optimal self-management. The study hypotheses are that patients who receive the mHealth TLC will improve their ability to communicate effectively with their clinicians and will report decreased stigma related to their lung cancer diagnosis compared to the attention control group.

NCT ID: NCT01682525 Withdrawn - Infertility Clinical Trials

Ovarian Tissue Cryopreservation for Fertility Preservation

Start date: May 2012
Phase: N/A
Study type: Interventional

To provide a novel fertility preservation option for patients facing a fertility threatening cancer diagnosis or treatment regimen by establishing an ovarian tissue cryopreservation program. To determine if ovarian tissue cryopreservation provides women with a useful, successful option for fertility preservation The hypothesis is that ovarian tissue cryopreservation for fertility preservation provides an alternative option for fertility preservation.

NCT ID: NCT01681888 Withdrawn - Cerebral Palsy Clinical Trials

Surface EMG Biofeedback for Children With Cerebral Palsy

Start date: May 2012
Phase: N/A
Study type: Interventional

Movement disorders such as dystonia, hypertonia, and spasticity interfere with or prevent voluntary movement. Studies have suggested that using biofeedback to increase awareness of muscle activation can improve motor function in patients with motor deficits. The investigators hypothesize that the daily use of a surface electromyographic (SEMG) biofeedback device for one month will improve motor function in children and young adults with dystonia, hypertonia, and/or spasticity. The SEMG biofeedback device is worn over the muscle(s) the subject has difficulty in controlling and provides vibratory feedback about muscle activation. Groups of children and young adults (ages 3-21), with dystonia, hypertonia, and/or spasticity will be asked to wear a small (approx 1 square inch) sensory feedback device on their affected muscle(s) for 5 hours a day for one month. The device will vibrate and emit a blue light when the muscle is activated. At the start of the experiment, subjects will be tested on the Goal Attainment Scale (GAS), the Pediatric/Adolescent Outcomes Data Collections Instruments (PODCI), and the Barry Albright Dystonia Scale (BAD). For one month, subjects will practice goals without device. After a month, subject will be assessed again and be given device to practice goals for a month. After one month, the subjects will be tested on the outcome measures again and return device.

NCT ID: NCT01680809 Withdrawn - Clinical trials for Venous Insufficiency

Compliance of Compression Therapy in Healed Venous Ulcerations

Start date: September 2012
Phase: N/A
Study type: Interventional

This study seeks to determine if compliance with compression therapy is increased in patients with healed venous insufficiency ulcerations when lower levels of compression therapy are prescribed. This study will measure compliance with compression therapy at low levels of compression. It will also seek to determine if compression therapy aids in the prevention of venous insufficiency ulcer recurrence.

NCT ID: NCT01680757 Withdrawn - Atrial Fibrillation Clinical Trials

Study of Left Atrial Appendage Closure in Patients With Atrial Fibrillation - III

PLACE III
Start date: September 2012
Phase: Phase 4
Study type: Interventional

This study is a prospective, multicenter, non‐randomized trial of a stand‐alone procedure for left atrial appendage exclusion in patients with atrial fibrillation at risk for embolic events who are contraindicated for or intolerant of oral anticoagulation therapy. This study will enroll 100 participant, who will receive the LAA ligation study treatment. The objective of this registry is to assess the effectiveness of permanent exclusion of the LAA using the LARIAT Suture Delivery Device and Accessories in patients unable to be treated with standard anticoagulation therapy. The results of the study will be used to assess outcomes within the first year, post‐treatment.

NCT ID: NCT01680380 Withdrawn - Clinical trials for Sleep Apnea Syndromes

Tracking Breathing During Sleep With Non-contact Sensors

Start date: October 2012
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the feasibility of tracking breathing during sleep with non-contact sensors (for example, microphones or wireless movement sensors). The investigators will use the data collected with these sensors to develop algorithms for tracking breathing during sleep. The investigators will assess the performance of the algorithms by comparing automatic output against manually-generated labels.