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NCT00424411
To determine, in subjects with Type 2 Diabetes Mellitus: 1. Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal EXUBERA™ (inhaled insulin) plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2 mixed Regular/NPH insulin injections per day. 2. The toleration and safety of EXUBERA™ (inhaled insulin) therapy and its effects after 6 months, if any, on measures of pulmonary function.
NCT00048425
The purpose of this study is to evaluate the efficacy of a 24-hour infusion of levosimendan compared with placebo in the treatment of decompensated chronic heart failure.
NCT00161668
This study is designed to assess the safety of Mylotarg therapy in routine practice.
NCT00255528
This was a 4-week, multicenter, double-blind, placebo-controlled, randomized, parallel-group study to determine the antihypertensive dose range, efficacy, safety and tolerability of TOPROL-XL ® (metoprolol succinate) extended-release tablets (metoprolol CR/XL) in hypertensive pediatric subjects. The study population included school age children (age 6 to \< Tanner Stage 3) and adolescents (\> Tanner Stage 3 to age 16) of both genders. No more than 50% of the randomized subjects could be adolescents (\> Tanner Stage 3 to 16 years old). Since response to some therapies in adult hypertension appears to be different in black and non-black populations, recruitment was aimed at a mixture of black and non-black children. The design included a 1-week screening period (for treatment naive subjects), a 1-week single-blind placebo run-in period, and a 4-week double-blind treatment period. Eligible subjects were randomized to the double-blind period with a once daily oral dose of metoprolol CR/XL to one of three target doses: 0.2, 1.0 and 2.0 mg/kg, or placebo. Dosing was weight adjusted. The dose range for this study was 12.5 to 200 mg daily. Subjects were closely monitored and evaluated at the end of Weeks 1, 2, 3 and 4 during the double-blind treatment period.
NCT00139763
This is a questionnaire based study (no study drug is involved) that asks if more patients with uncontrolled type 2 diabetes on diabetes pills will choose insulin as the next treatment choice if inhaled insulin were available in addition to all currently available treatments, compared with if inhaled insulin was not available as part of currently available treatments. This study will also ask if patients with uncontrolled type 2 diabetes currently managed on diabetes pills + once daily insulin will choose as the next treatment choice to take insulin multiple times a day if inhaled insulin were available in addition to all currently available treatments, compared with if inhaled insulin was not available as part of currently available treatments.
NCT00140309
This study is a placebo-controlled factorial study, randomized to study drug (moxifloxacin vs. ethambutol) and treatment frequency (daily vs. thrice weekly after an initial two weeks of daily therapy) during the first two months of standard treatment (with isoniazid, rifampin, and pyrazinamide) for sputum smear-positive pulmonary tuberculosis.
NCT00283361
The main purpose of this study is to see if the experimental drug ZP120, when given with the approved drug furosemide to patients with acute or sub-acute heart failure, can reduce the amount of fluid in the patients' lungs and make breathing easier.
NCT00421031
The purpose of this study is to assess the efficacy and safety of 4 doses of desvenlafaxine-233 sustained release (DVS-233 SR) as compared to placebo for the treatment of moderate to severe vasomotor symptoms associated with menopause, as well as its influence on sleep parameters and other health outcomes indicators.
NCT00090727
The purposes of this study are to determine: * the largest dose of AQ4N that can be safely given once a week for three weeks out of a 4 week cycle * the side effects of AQ4N when given on the above schedule * how much AQ4N is in the blood and urine at specific times after administration and how the body get rids of AQ4N * if AQ4N helps treat cancer
NCT00058656
Patients will have immune cells collected and then expanded outside of the body. Patients will receive an infusion of a large number of expanded immune cells. There will be three dose levels studied. The goal of the study will be to determine the safety as well as potential efficacy of this treatment.
NCT00050830
The purpose of study to determine the activity of CI 1033 against tumors in patients with advanced or metastatic NSCLC who have failed prior platinum-based combination chemotherapy. Another objective is to determine the safety of CI 1033.
NCT00129948
This is a phase 2, single-arm, open-label, multi-center study to establish the safety and efficacy of Troxatyl™ (troxacitabine) administered as a continuous infusion for 5 days to subjects with AML.
NCT00273884
This protocol is designed to assess the safety and efficacy of amonafide in combination with cytarabine in subjects with previously untreated secondary AML.
NCT00062907
The purpose of this trial is to examine the safety and immunogenicity of a therapeutic vaccine regimen with recombinant DNA and adenovirus expressing L523S protein in patients with early stage non-small cell lung cancer. The vaccine regimen will consist of two fixed doses of recombinant DNA (pVAX/L523S) followed by two doses of recombinant adenovirus (Ad/L523S). The trial will evaluate the dose escalation of Ad/L523S through three cohorts of patients.
NCT00449202
The purpose of this study is to evaluate the safety, preliminary efficacy, and pharmacokinetics of two 14-day cycles of escalating oral doses of MP 101 in 100 obese adult subjects.
NCT00141414
To evaluate the long-term safety of pregabalin in refractory partial epilepsy.
NCT00122304
The primary objective is to evaluate the safety of eculizumab in patients with transfusion-dependent hemolytic PNH
NCT00190827
The study evaluates the effectiveness of duloxetine in reducing urinary incontinence occurrences in women due to physical stress(e.g. stomach pressure on bladder). Incontinence is the inability to control bladder function with leakage of urine.
NCT00228592
The purpose of this study is to compare the use of HepeX-B versus HBIg, two anti-viral drugs, in patients who have received liver transplants due to liver failure caused by Hepatitis B infection. Patients will be evaluated over a 6 month to 1.5 year period to evaluate whether or not the drugs prevent the Hepatitis B virus from infecting the new liver.
NCT00191399
The primary objective of this study is to assess the efficacy of olanzapine and fluoxetine combined on all the visits as compared with the baseline visit in patients with bipolar disorder, measured by the total score of the Montgomery-Asberg Depression Rating Scale (MADRS).