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dose in Medical Technology

Cancer Centers of North Carolina Offers HDR Brachytherapy for Treatment of Cancerous Tumors

... to its patients through the addition of High dose Rate (HDR) brachytherapy. This latest advance in ... delivery system is used to optimize the dose distribution to the target. As a result of this ... side effects may be reduced. Unlike low dose rate brachytherapy treatment, HDR therapy can be ...

Radius' Investigational Bone Anabolic Agent, BA058, Increased Bone Mineral Density (BMD) at Key Fracture Sites in Phase 2 Clinical Trial in Postmenopausal Osteoporosis

... percent for placebo at six months for the highest dose tested. By comparison, the mean percent change in ... treatment period, patients receiving the highest dose of BA058 increased lumbar spine BMD by 12.9 ... was half that of Forteo(R) in the highest dose of BA058 tested. Radius will submit additional ...

Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia

... study (n=636). All patients received a dose of 234 mg on Day 1 in the deltoid muscle. From ... increase with the length of therapy and the total dose received. This condition can also develop after a ... in milligrams (mg) of paliperidone palmitate in dose strengths of 39 mg, 78 mg, 117 mg, 156 mg and 234 ...

Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA

... was a multicenter, randomized, double-blind, two dose study of velaglucerase alfa in patients with Type ... The magnitude of changes in the 45U/kg dose was also clinically important, and a trend in liver volume reduction was observed. The 60U/kg dose performed numerically as well or better than ...

Pharmasset Reports Positive Preliminary Antiviral Data With PSI-7851 for the Treatment of Hepatitis C

... HCV. PSI-7851 Phase 1 Multiple Ascending dose Study Overview In June 2009, Pharmasset initiated a phase 1 multiple ascending dose study with PSI-7851. The trial was conducted at ... cohort) or placebo (2 patients per cohort). Three dose cohorts of PSI-7851 (50mg QD, 100mg QD, 200mg QD) ...

R788 in TASKi3 Clinical Trial Does Not Meet Efficacy Endpoints in RA Patients Who Had Previously Failed Biologic Therapies - Results Incongruent

... noted in TASKi3 were diarrhea and hypertension. dose reduction options were pre-specified in the trial ... evenly distributed among the placebo and active dose group. The mean increase in blood ... methodology, was 3.2-3.6 mmHg for the 100 mg bid dose group. In TASKi3, approximately 17% of patients ...

First Skin Cancer Patients Treated With Electronic Brachytherapy (eBx) At University of Wisconsin Riverview Cancer Center

... eBx(TM) , delivers a high therapeutic dose to a cancer tumor while sparing nearby normal ... of treatment and precisely conform the radiation dose to the cancerous cells to preserve healthy ... Axxent treatment platform provides a therapeutic dose of radiation directly to the region at risk with ...

Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma

... ASMANEX TWISTHALER is available in two dose strengths, 110 mcg for children between 4 and 11 ... by any route, and reduce each patient's dose to the lowest dose that effectively controls his/her symptoms. ...

Exenatide Once Weekly Provided Superior Glucose Control Compared to Lantus(R) in Head-to-Head DURATION-3 Study

... weekly was administered once a week in a fixed dose while Lantus was administered daily in a variable dose determined by patient blood sugar levels. ... injections administered daily in a variable dose determined by patient blood sugar levels. There ...

Analysis of Edoxaban Phase II Data Provides Insight Into Reduced Bleeding Events Seen in Once-Daily Dosing

... in this case, those that received their total dose once daily, would have the most bleeding events. ... assigned to receive either one of the four fixed dose regimens of edoxaban (30mg/N=235 or 60mg/N=234 ... In the treatment groups receiving a once-daily dose of edoxaban, the lowest bleeding rates were ...

Keryx Biopharmaceuticals, Inc. Commences Phase 1 Study of KRX-0401 (Perifosine) in Recurrent Pediatric Solid Tumors at Memorial Sloan-Kettering Cancer Center

... for this study. The study has been designed as a dose escalation study to determine the maximum tolerated dose (MTD) of perifosine alone in recurrent/progressive pediatric tumors. A standard 3+3 dose escalation design will be employed with 3 to 6 ...

ASMANEX(R) (Mometasone Furoate Dry Powder Inhaler) Now Approved in Japan for the Treatment of Bronchial Asthma in Adult Patients

... of age. In the U.S., it is available in two dose strengths, 110 mcg for children between 4 and 11 ... by any route, and reduce each patient's dose to the lowest dose that effectively controls his/her symptoms. ...

Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial

... noted in TASKi2 were diarrhea and hypertension. dose reduction options were pre-specified in the trial ... evenly distributed among the placebo and active dose groups. The mean increase in blood pressure ... was less than 0.5 mmHg for the 150 mg qd dose group and approximately 1 mmHg for the 100 mg ...

Procter & Gamble Pharmaceuticals Launches Asacol(R) HD (mesalamine) Delayed-Release Tablets

... the Safety and Clinical Efficacy of a New dose of 5-ASA (4.8 g/day 800 mg tablet)]. In ... TID, with or without food, for a total daily dose of 2.4 g for 6 weeks. For the maintenance of ... of moderately active UC. The recommended dose in adults is two 800 mg tablets TID, with or ...

ThromboGenics and BioInvent Start Recruitment of Second 100 Patient Cohort in Phase II DVT Prophylaxis Study With TB-402

... safety monitoring board to proceed using a higher dose of TB-402. The Phase II trial is an active ... agent, which means it could be given as a single dose after surgery to prevent the development of DVT. ... recommended that we proceed to a higher dose of TB-402. It is testament to the strength of our ...

King Pharmaceuticals Showcases Data From Pain Pipeline of Medicines Designed to Deter Common Methods of Non-Therapeutic Use

... small amounts, when detected, were not dose related and not associated with clinically ... relief. Phase II Study to Evaluate the dose Response for Flushing , Safety and ... A Phase II study was conducted to evaluate the dose response for niacin-induced flushing, the effect ...

Spherix Announces Positive Phase 2 Study Results

... With Doses an Order of Magnitude Lower than the dose Used in the Current Phase 3 Trial. BETHESDA, ... study designed to establish the minimum dose of Naturlose capable of causing a beneficial ... study of efficacy is being conducted at a 15 g dose (TID), and is powered to detect a 0.5% reduction ...

HCPC Calls for Greater Healthcare Savings Through Improved Adherence to Prescription Drug Regimens

... group was given the exact same drug in a unit dose blister card with compliance-prompting features. ... of research which points to the role that unit dose formats can play in improving pharmaceutical ... currently dispensed by manufacturers in a unit dose format with compliance-prompting features is ...

New Bisphenol A Study Is of Very Limited Relevance to Human Health

... that their study is significant because it used a dose equal to the EPA reference dose for BPA, which is a science-based lifetime daily ... to be safe by EPA. However, the EPA reference dose is specifically applicable only to oral exposure, ...

HEALTHPOINT-Sponsored Venous Leg Ulcer Clinical Trial Enrolls First Subject for Second Phase II Study

... first of a planned 235 subjects into a Phase II dose response study investigating an experimental, ... trial protocol. "This is the largest cell therapy dose ranging trial ever undertaken in the area of ... two planned-dose response trials, extending the dose range being tested and exploring two ...

Study Demonstrates Efficacy of Pitavastatin in Elderly Patients

... of pitavastatin at the recommended starting dose of 2 mg once daily, and the need for up-titration ... superior to pravastatin across all three dose comparisons as measured by percent change from ... and tolerability profile at the proposed starting dose and offers a low-dose alternative for vulnerable ...

Two-Year Data Show Patients Receiving SIMPONI(TM) (golimumab) Experienced Sustained Improvement in Signs and Symptoms of Psoriatic Arthritis and Ankylosing Spondylitis

... of 130 patients in the SIMPONI 50 mg and 100 mg dose groups, respectively. In a similar ... receiving SIMPONI 50 mg who did not change dose and 73 of 96 patients receiving SIMPONI 100 mg. ... combined SIMPONI groups and individual SIMPONI dose groups vs. placebo. At week 16, patients with ...

Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily

... a pivotal 16-week study showing that a once-daily dose of tadalafil was generally well tolerated, ... 6MWD in a dose-dependent manner, only the 40 mg dose met the pre-specified level of statistical ... Improvements in the tadalafil 40 mg dose group, compared to placebo, from baseline to Week ...

Tolerx Presents Data at 69th Scientific Sessions of the American Diabetes Association

... Oral Presentation Details dose Optimization of Pre-Clinical Otelixizumab ... studies to establish the minimum effective dose and to investigate pharmacodynamic (PD) ... a preclinical model of diabetes. Evaluation of a dose of 8ug (0.0004mg/kg) of anti-CD3 antibody, a ...

Trius Announces Positive Results From Phase 2 Clinical Trial of Torezolid in Patients With Complicated Skin and Skin Structure Infections

... by the size of lesions. Clinical cure rates by dose in the clinically evaluable population were 98%, ... white blood cell counts. The fact that the lowest dose of 200 mg was as efficacious as the higher doses ... key markers of oxazolidinone safety, the 200 mg dose of torezolid was comparable to placebo while the ...

Afinitor(R) Phase II Data Show Positive Results for Patients With Multiple Types of Lymphoma, Leading to Phase III Trial

... 10 mg daily and were evaluated monthly. dose reductions to 5 mg daily and 5 mg every other day ... non-infectious pneumonitis may require temporary dose reduction and/or interruption or discontinuation. ... inhibitors should be avoided. An increase in the dose of Afinitor is recommended when co-administered ...

Exenatide Once Weekly Provided Sustained Improvements in Glycemic Control With Weight Loss Over Two Years: DURATION-1 Interim Long-Term Data Presented at ADA 2009

... patients with type 2 diabetes with just one dose per week." Study Design and Findings The ... side effect. To reduce this possibility, the dose of sulfonylurea medicine may need to be reduced ... of food eaten, and body weight. No changes in dose are needed for these side effects. These are not ...

PARI Pharma Reports Successful Phase Ib Clinical Results for Inhaled Liposomal Cyclosporine A and Gains FDA Orphan Drug Designation for the Prevention and Treatment of Bronchiolitis Obliterans

... lung transplants. Patients were given a single dose application of 10mg or 20mg of liposomal L-CsA, ... lung deposition of 2mg for a nominal, 10mg dose that was nebulized in less than ten minutes. Once daily administration of a nominal dose of 10mg L-CsA with an Investigational eFlow ...

CuraGen Updates CR011-vcMMAE Data at ASCO

... a bridging phase to confirm the maximum tolerated dose and has expanded into a Phase II open-label, ... in the Phase II portion of the study at a dose of 1.88mg/kg given once every three weeks, with ... melanoma were presented at ASCO. Thus far, a dose of 1.0 mg/kg given once every week has been ...

Pixantrone Produces High Rates of Complete and Partial Remissions Even Among Aggressive NHL Patients With Extensive Prior Doxorubicin Treatment or Prior Rituximab Treatment

... The lifetime cumulative doxorubicin equivalent dose following pixantrone was 579 mg/m2 (with a range ... Cumulative dose Dose ... with a high incidence of CHF if the cumulative dose levels were solely with a standard anthracycline. ...

Proteolix Presents Positive Clinical Data for Carfilzomib in Multiple Myeloma at the 2009 ASCO Annual Meeting

... agents. Of 39 evaluable patients who received a dose of 20mg/m(2), 18 percent achieved an overall ... neuropathy was rare and did not result in dose reductions or discontinuation of therapy. ... with continued therapy. A maximum-tolerated dose has not yet been established and dose-escalation ...

Trubion Announces Positive Data From a Phase 1 / 2 Study of TRU-016 for the Treatment of Chronic Lymphocytic Leukemia (CLL)

... clinical activity. Patients received either one dose weekly for four weeks, or three doses the first ... available for 26 patients enrolled in the Phase 1 dose escalation trial, all of whom had received an ... reported that all occurred in different dose cohorts. A maximum ...

Ironwood and Forest Present Additional Positive Phase 2b Study Results for Linaclotide in Patients With Irritable Bowel Syndrome With Constipation

... for each pairwise comparison of a linaclotide dose group to the placebo group). For patients ... week of linaclotide treatment (p<0.05 for all dose groups and p<0.001 for the 300 ug dose group). These levels of improvement were ...

New Preliminary Data from Two Studies Show Clinical Activity of Neratinib in Combination with Trastuzumab and in Combination with Paclitaxel in Advanced HER-2 Positive Breast Cancer

... daily plus weekly trastuzumab (4 mg/kg IV loading dose then 2 mg/kg). In the second part of the study, patients receive a weekly dose of trastuzumab with daily neratinib (240 mg). ... in 25 percent of patients. Fourteen patients had dose reductions and one patient withdrew from the ...

Celladon Provides MYDICAR(R) Program Update of First-In-Human Trial for Advanced Heart Failure at American Society of Gene Therapy Annual Meeting

... study." The Phase 1 open-label, sequential dose escalation, multi-center phase of the trial was ... double-blind, placebo-controlled, parallel-group, dose ranging portion of the study is designed to evaluate the use of MYDICAR at two or three dose levels compared to placebo in 37 patients. CUPID ...

Intercell AG Announces First Subject Enrolled in a Phase II Trial for the Further Development of Its Investigational Vaccine Enhancement Patch to Improve Pandemic Influenza Prevention in Collaboration With U.S. Department of Health and Human Services (HHS

... pandemic influenza outbreak with only a single dose vaccine application VIENNA and GAITHERSBURG, ... when combined with each other in a single dose regimen. The trial will be conducted in the U.S. ... to achieve full protection with only a single dose plus patch this means an enormous logistical ...

Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types

... objective was to define the maximum tolerated dose and pharmacokinetics of everolimus(3). The ... to approved targeted therapies: a Phase I/II dose finding and biomarker study This ... The change in HSP70 observed at the highest dose of AUY922 exceeded the level needed to inhibit ...

New Phase 3 Study of Tapentadol Immediate Release Tablets Published in Current Medical Research and Opinion Journal

... nausea and/or vomiting compared with a comparable dose of oxycodone IR, a standard pain treatment," said ... medical supervision at the lowest effective dose in such patients. If respiratory depression ... When such combined therapy is contemplated, a dose reduction of one or both agents should be ...

PARI Pharma's Nebulized DSCG Shows Results Similar to Inhaled Steroids in Asthma Studies Presented at ATS

... when administered via a dry powder or metered dose inhaler (DPI or MDI). This assumption is ... to inhale either IsoCrom, delivered at a dose of 60 mg per day administered in three ... System, or inhaled corticosteroids (ICS) without dose adjustments administered in two inhalations using ...

Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)

... volume and Six-Minute Walk Test distance. dose Relationships In the CAPACITY 2 study, patients were randomized 2:2:1 to receive a total daily dose of 2403 mg pirfenidone, or placebo, or a total daily dose of 1197 mg pirfenidone, respectively. The ...
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