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NCT01305564
The Bard® Denali™ Retrievable Inferior Vena Cava (IVC) study is a prospective, multi-center study which is intended to provide evidence of safety of the placement and retrieval of the Bard® Denali™ Retrievable Inferior Vena Cava Filter in subjects requiring IVC interruption to protect against pulmonary embolism (PE).
NCT01565850
This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA \< 50 copies/mL at Week 24.
NCT00936676
Eligible participants, who participated in the ADAGIO trial and who sign an approved informed consent form, will be enrolled into the study at their original study locations. participants who have stopped rasagiline therapy and in the opinion of the investigator will gain clinical benefit from restarting treatment can also be considered for enrollment in the Core follow-up study period. Use of any other anti-PD treatment is permitted as deemed necessary by the treating physician (according to the participants clinical status).
NCT00595166
This new invention addresses the inadequate and incomplete visualization of the cervix in patients with excessive vaginal tissue. In general these patients are obese, or are multiparous with a history of multiple vaginal deliveries. A vaginal speculum is a vital medical instrument that allows a health care provider to visualize the interior aspects of the vagina, as well as the distal portion of the uterus, the cervix. It is composed of 2 blades assembled together and held by a handle. The blades and the handle form a 90 degree-angle. As the user holds the handle, a lever attached to the top blade allows it to open away from the inferior blade. When the instrument is inserted into the vagina, the two blades are separated in order to keep the anterior and posterior vaginal walls apart. In that position, the cervix and the walls of the vagina can be seen if the patient does not have an excess of loose vaginal tissue. However, in patients with excessive tissue, the sidewalls of the vagina simply collapse toward the midline between the blades because of the fact that no part of the speculum is in direct contact with the lateral walls of the vagina. This collapse prevents the complete and crucial visualization of the cervix for purposes of cervical cultures, pap smears, visual assessment of ruptured membranes, visual assessment of the degree of dilation, biopsies, and other procedures requiring access to the cervix or the uterus. When clinicians face this dilemma, they may try the largest speculum available, and will open it as wide as possible in order to keep the lateral walls apart. Most often, they have to improvise by cutting the tip of a condom, or the thumb off a glove, or they use a sterile lateral-wall retractor. These other creative solutions can take several minutes of precious times and may still result in an inadequate visualization and suboptimal access. A vaginal speculum sheath for retaining vaginal tissue in a lateral direction conforms to a pair of blades that are movable between an opened position and a closed position. The blades in the closed position are adapted for insertion into a vagina, and in the open position, they allow dilating the vagina in order to provide access to the cervix. This new design includes a flexible, transparent polyurethane sleeve structure that extends between the blades when the speculum is opened. The stretched sheath is adapted to retain the lateral walls of the vagina in the open position. The elastic sleeve is designed to remain in a collapsed configuration when the blades are in a closed position to avoid interfering with insertion or withdrawal of the speculum \[Reference: U.S. patent 6432048 (2002-8-13)\]. Polyurethane material is FDA approved for vaginal use. The purpose of this study is to compare standard of care speculum vs. sheathed speculum in the examination of patients with collapsing vaginal sidewalls during a gynecological speculum exam. The primary hypothesis testing for this study will be to compare the standard of care speculum exam to a sheathed speculum exam in a prospective, randomized clinical trial.
NCT00120289
The purpose of this study is to determine whether raising "good cholesterol" with a drug based on the vitamin niacin, while lowering "bad cholesterol" with a statin drug, can prevent more heart disease than the statin alone.
NCT00543725
The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors ( investigator choice of ABC/3TC, TDF/FTC or AZT/3TC) in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics and Medical resource utilization and treatment adherence.
NCT00608881
The goals of this trial are to determine if coenzyme Q10 is effective in slowing the worsening symptoms of Huntington's disease and to learn about the safety and acceptability of long-term coenzyme Q10 use by determining its effects on people with Huntington's disease.
NCT01128452
This study is a 4-week, randomized, double-blind, parallel-group, placebo-controlled monotherapy study in patients with treatment-resistant major depression. After confirmation of treatment-resistance in a prospective treatment period with citalopram, each patient will be treated with either EVT 101 once daily or placebo for 28 consecutive days.
NCT01456195
The purpose of this study is to determine the efficacy and safety of TAK-875 (fasiglifam), once daily (QD), in participants with type 2 diabetes mellitus (T2DM).
NCT00396097
To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment
NCT01778049
The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.
NCT01423253
Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features over time.
NCT01825330
The study tests the effect of the NeuroAD on Alzheimer patients' cognitive function. The NeuroAD uses non-invasive stimulation of both magnetic and cognitive training.
NCT01727141
This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to severe airflow limitation.
NCT00609804
This is a randomized, open-label, multi-center, Phase II study of treatment of patients with advanced NSCLC who have progressed on erlotinib with the combination of sorafenib and erlotinib or sorafenib alone.
NCT00960531
The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, plus QS-21 in subjects with mild to moderate Alzheimer's disease.
NCT02013531
The purpose of this study is to investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment in subjects with major depressive disorder and anxiety symptoms, who are experiencing an inadequate selective serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI) response.
NCT02293265
This will be a non-drug interventional cross-sectional study, where the screening visit and study visit can occur on the same day. Investigational product will not be administered. Approximately 790 subjects with severe asthma will be screened to achieve a total of at least 750 evaluable study subjects. The study will not include a run-in or follow-up period. This study will provide a more reliable description of the severe asthma patient landscape with respect to the potential eligibility for treatment with mepolizumab, omalizumab, and reslizumab. This study aims to estimate the potential overlap of patients eligible for treatment with mepolizumab and those eligible for treatment with omalizumab and/or reslizumab. Additionally, the current study will also ascertain and describe reslizumab eligibility with respect to both mepolizumab and omalizumab, in the severe asthma patient population.
NCT02064829
The purpose of this study is to demonstrate bioequivalence of IG-001 versus nab-paclitaxel in female patients with metastatic or locally recurrent breast cancer. In addition, the study will compare the safety and tolerance of IG-001 and nab-paclitaxel during the bioequivalence 2-period crossover portion of the study. The study will also evaluate the long-term safety of IG-001 over repeated cycles, up to 4 additional cycles of administration.
NCT02723071
This study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of ocrelizumab in participants with progressive follicular NHL.
