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NCT ID: NCT00984217 Withdrawn - Clinical trials for Adenoma, Pleomorphic

Trial of Radiotherapy and Panitumumab in Salivary Gland Malignancies

Start date: August 2011
Phase: Phase 2
Study type: Interventional

Standard therapy for high-risk or locally advanced salivary gland malignancies is surgery followed by postoperative radiation therapy. Retrospective studies have shown the superiority of combined modality therapy compared to surgery alone for patients with advanced T or N stage. Despite the addition of postoperative radiation therapy, the five-year survival for locally advanced salivary gland malignancies is poor (less than 60%). In salivary gland malignancies, the epidermal growth factor receptor (EGFR) is expressed in 25-85%; in certain histological types, like salivary duct carcinomas, the expression is higher. EGFR is a promising target of anticancer therapy. In squamous cell carcinoma of the head and neck, a phase III trial utilizing cetuximab added to radiation therapy improved both locoregional control and overall survival compared to radiation alone. Panitumumab is a novel, human, IgG2 EGFR monoclonal antibody that may be better tolerated and more efficacious than cetuximab. Here, the investigators suggest that the addition of panitumumab to standard radiotherapy in locally-advanced salivary gland malignancies will improve recurrence-free survival (RFS).

NCT ID: NCT00984152 Withdrawn - HIV-1 Infections Clinical Trials

Trial of TDF/FTC + Raltegravir Versus TDF/FTC + Efavirenz in HIV-1-Infected Women

ICE-002
Start date: June 2011
Phase: Phase 3
Study type: Interventional

Raltegravir not only has a unique mechanism of action, but may also have other unique effects on suppression of viral replication, viral reservoir, and immune reconstitution in blood and other important compartments. This may in part be due to the pharmacokinetics of Raltegravir in blood and gut tissue. Efavirenz will be the comparator antiretroviral drug in this study, with both drugs being used as part of a three-drug regimen with tenofovir and emtricitabine. The primary objectives are to determine differences in the effects of 2 anti-retroviral regimens, Raltegravir + Truvada versus Atripla, with respect to: 1. Viral load in plasma, genital tract (vaginal secretions), and gut (by in situ hybridization). 2. Latent viral reservoir (pro-viral DNA) in the peripheral blood and genital tract. 3. Immune effects (CD4/CD8 immunophenotypes) in gut and PBMCs and plasma cytokine profiles. The secondary objective is to determine the pharmacokinetics of Raltegravir in blood and gut tissue; relative tissue/compartment penetration compared to Efavirenz.

NCT ID: NCT00984087 Withdrawn - Clinical trials for Major Depressive Disorder

rTMS for Adolescents and Young Adults

JHU
Start date: October 2009
Phase: Phase 2
Study type: Interventional

rTMS is a promising, though largely untested, option for treating adolescent and young adult depression. This study hypothesizes that rTMS will safely and significantly alleviate depression and decrease suicidal ideation in adolescents and young adults based on previous studies.

NCT ID: NCT00982787 Withdrawn - Partial Epilepsy Clinical Trials

Safety and Anticonvulsant Efficacy of Passiflora Incarnata Extract in Patients With Partial Epilepsy

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

The purpose of the Phase II clinical trial will be to see if a botanical extract from the plant Passiflora incarnata can improve seizure control and reduce anxiety in patients diagnosed with partial epilepsy. The investigators will randomize approximately 25 participants with partial epilepsy for this placebo controlled, double blind, and crossover study. All patients will be scheduled for 10 clinic visits and four telephone visits during the 32-week period of the trial. After enrollment into the study, all participants will begin a 9-week observation phase, which serves as an individual baseline control. After 9 weeks participants will be randomized to receive either study drug or placebo for an 11 week study period. After completion of the 11 week study period, patients will crossover to the other study drug/placebo arm for another 11 weeks. Epilepsy participants will continue taking their anti-epileptic medication as currently prescribed. The investigators will find participants through the OHSU clinics, by notifying local neurologists, anthroposophical and naturopathic practices, and by advertising the study via the local chapter of the American Epilepsy Society. Routine blood tests, physical examinations and tests to monitor heart, brain and muscle activities will screen for any adverse effects. The primary outcome measure will be seizure frequency through seizure diaries. Attention and performance tests, neurological and quality of life questionnaires will be completed to assess the secondary outcome measures of anxiety, cognitive function and quality of life.

NCT ID: NCT00981266 Withdrawn - Augmentation Clinical Trials

Spectra Breast Implant Study

Start date: June 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate safety and effectiveness of Mentor's Spectra/Becker 80 Adjustable Breast Implants in women who are undergoing primary or revision breast augmentation. Safety information on the rate of complications, such as infection, will be collected and used to help determine device safety. These implants are investigational devices. Approximately 450 patients at sites across the United States will be enrolled in this research study by up to 30 sites. These patients will be implanted with Spectra/Becker 80 implant and monitored for 10 years to collect information on risks associated with the implant surgery as well as changes in the way these patients feel about themselves.

NCT ID: NCT00980993 Withdrawn - Prostate Cancer Clinical Trials

Quantification of Respiratory-induced Prostate Motion

Start date: September 2012
Phase:
Study type: Observational

Patient anatomy and position during the course of radiation therapy can vary from those used for treatment planning; a function of patient movement, uncertainty in positioning system, and organ motion. Traditionally, treatment margins are designed to compensate for interfraction prostate setup variability. This approach has the potential to lower the overall effectiveness of treatment because the prostate gland is a continuously moving target whose motion cannot be accurately accounted for solely on the basis of interfraction movement. More recently, the dosimetric relevance of intra-fraction prostate motion has been recognized, and may be compensated for by continuous real-time adaptive radiation therapy afforded by the Calypso 4D Localization Systemâ„¢. In the current study, the investigators propose to characterize intrafraction prostate motion. The investigators hypothesize that intrafraction prostate motion is correlated with respiratory motion.

NCT ID: NCT00980551 Withdrawn - Retinoblastoma Clinical Trials

Pilot Study of Topotecan/Vincristine With Subconjunctival Carboplatin for Patients With Bilateral Retinoblastoma

RELRB1
Start date: May 2010
Phase: N/A
Study type: Interventional

The investigators are testing subtenon carboplatin in combination with vincristine and topotecan given by vein in the hopes of finding a drug combination that may be effective against retinoblastoma that has come back (recurrent) or is resistant to other treatment (refractory). The goals of this study are: - To decide if the drug combination is a useful treatment for recurrent or refractory retinoblastoma - To test the safety of the drug combination and to see what kind of effects (good and bad) can be expected from the drug combination - To measure visual changes before and after the study therapy - To use a special MRI scan to measure brain function involved in vision processing, both before and after the study therapy In this study, the investigators are also testing a new experimental way of giving carboplatin "subtenon carboplatin". The carboplatin will be given directly in the eye through a needle placed under the covering of the eye. This is to try to get more carboplatin to the retinoblastoma inside the eye.

NCT ID: NCT00979693 Withdrawn - Anxiety Clinical Trials

Psilocybin-Assisted Psychotherapy for Anxiety in People With Stage IV Melanoma

Start date: January 2012
Phase: Phase 2
Study type: Interventional

This study is to find out about whether two sessions of psilocybin-assisted psychotherapy are safe and will help people who are anxious as a result of having stage IV melanoma and will involve two sessions of psychotherapy combined with either 4 or 25 mg psilocybin. The study will measure anxiety, depression, quality of life and spirituality before and after psilocybin-assisted psychotherapy, natural killer cells (a type of immune cell) will be counted from blood samples taken the day after psilocybin-assisted psychotherapy, and people will keep daily diaries reporting on how anxious they feel for each day in the study.

NCT ID: NCT00979186 Withdrawn - Cholecystectomy Clinical Trials

A Trial to Evaluate Natural Orifice Transgastric Endoscopic Cholecystectomy With Laparoscopic Assistance

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

The study will document being able to successfully perform transgastric cholecystectomy (laparoscopic visualization) using a small collection of study surgical tools.

NCT ID: NCT00977158 Withdrawn - Cystic Fibrosis Clinical Trials

Microbiota of the Respiratory Flora in Children With Cystic Fibrosis During the First Year of Life

Start date: May 2011
Phase: N/A
Study type: Observational

The goal of this study is characterize the changes in bacterial diversity of the upper respiratory tracts of infants with cystic fibrosis (CF). Another goal is to determine when CF patients become colonized with pathogenic bacteria that are responsible for the lethal lung damage in children with CF. Ten subjects will be recruited into the study. Throat swabs will be collected at 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age in order to chart any changes in the bacterial populations of the respiratory tract. Clinical data will also be collected to evaluate the possible influence of external factors on changes in the microbial communities. This study will provide preliminary data on whether probiotics can eradicate the colonization of the respiratory tract by pathogenic bacteria.