phase iii clinical trials with anticancer agents

Báo cáo y học: "A multicenter, double-blind, randomized, controlled phase III clinical trial of chicken type II collagen in rheumatoid arthritis" ppsx

Ngày tải lên : 12/08/2014, 11:22

... rats with CIA were suppressed by CCII [17,18] These experiments in rodents have provided the basis for human clinical trials In a randomized, double-blind, multicenter, and controlled phase II clinical ... patients in the phase II study who were enrolled in this phase III trial Table defines the study population Admission criteria also included patients of either gender with RA with a duration ... group), 49 patients withdrew early Thirty (9.20%) patients withdrew in the CCII group, and 19 (10.73%) patients withdrew in the MTX group There were various reasons for early withdrawal, such as...

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Báo cáo hóa học: " Phase I clinical trial of the vaccination for the patients with metastatic melanoma using gp100derived epitope peptide " pot

Ngày tải lên : 18/06/2014, 16:20

... pulsed with native gp100:209-217 peptide as well as the melanoma cells positive for HLA-A*0201 and gp100 [19] In other clinical trials, HLA-A*0201positive melanoma patients were vaccinated with ... HLA-A*2402-positive melanoma patients We have conducted a phase I clinical trial to treat the HLA-A*2402-positive patients with stage IV melanoma by vaccination with the gp100-in4 peptide In this study, we ... endpoint and clinical and immunological responses as secondary endpoints Six patients with stage IV melanoma were immunized with a vaccine consisting of the epitope peptide emulsified with IFA In...

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báo cáo hóa học: " Adalimumab improves health-related quality of life in patients with moderate to severe plaque psoriasis compared with the United States general population norms: Results from a randomized, controlled Phase III study" pdf

Ngày tải lên : 18/06/2014, 19:20

... for patients with moderate to severe psoriasis [16-19] In a 16-week, Phase III, randomized, double-blind, placebo-controlled trial, adalimumab improved HRQOL outcomes in patients with psoriasis, ... Week Dosing in Moderate to Severe Psoriasis TriAL (REVEAL) study, a 52-week, Phase III clinical trial in adult patients with moderate to severe chronic plaque psoriasis [23] Patients were randomized ... M: Impact of adalimumab treatment on patient-reported outcomes: results from a Phase III clinical trial in patients with moderate to severe plaque psoriasis J Dermatolog Treat 2007, 18(6):341-350...

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Báo cáo y học: "An analysis of correlations among four outcome scales employed in clinical trials of patients with major depressive disorder" pdf

Ngày tải lên : 08/08/2014, 23:21

... studies included adult patients with MDD, defined according to the diagnostic criteria from the Diagnostic and Statistical Manual of Mental Disorders (DSM -III [7], DSM -III- R [8], or DSM-IV [9] depending ... Depression Rating Scale, the Hamilton Depression Rating Scale and the Clinical Global Impressions Rating Scale in antidepressant clinical trials Int Clin Psychopharmacol 2002, 17:281-285 Khan A, Brodhead ... Depression Rating Scale, the Hamilton Depression Rating Scale and the Clinical Global Impressions Rating Scale in antidepressant clinical trials: a replication analysis Int Clin Psychopharmacol 2004,...

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Báo cáo y học: "Circadian phase-shifting effects of a laboratory environment: a clinical trial with bright and dim light" ppsx

Ngày tải lên : 10/08/2014, 09:20

... between aMT6s acrophase and the median aMT6s acrophase, determined at baseline and following the treatments phase dispersion following treatment compared with those who experienced no phase correction ... Treatment Phase- Shifting Effects According to convention, circadian phase shifts following the light treatments were calculated by subtracting the final aMT6s acrophase from the baseline aMT6s acrophase ... negative and positive shifts indicated phase delays and phase advances, respectively Phase- response plots were derived by plotting resultant circadian phase shifts (y-axis) against the circadian...

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Báo cáo y học: "Safety and Effectiveness of two treatment regimes with tranexamic acid to minimize inflammatory response in elective cardiopulmonary bypass patients: a randomized double-blind, dosedependent, phase IV clinical trial." pdf

Ngày tải lên : 10/08/2014, 09:22

... determined by clinical judgment and blood loss as >200 mL/h in three consecutive hours Mortality was defined as death within 30 days of CPB, recorded in medical history or telephone contact with the ... two treatment regimes with tranexamic acid to minimize inflammatory response in elective cardiopulmonary bypass patients: a randomized double-blind, dose-dependent, phase IV clinical trial Journal ... of an opioid-based anesthetic supplemented with volatile anesthetic and muscle relaxants All interventions were performed by the same surgical team with wide experience in these surgical interventions...

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báo cáo khoa học: "Novel histone deacetylase inhibitors in clinical trials as anti-cancer agents" ppt

Ngày tải lên : 10/08/2014, 22:20

... in pre -clinical studies Phase I/II study with MGCD0103 alone or combination with gemcitabine were done in patients with solid tumors recently Phase I part of the trial studied adults with refractory ... was done in ten patients with CLL and 10 patients with AML who were treated with 13 mg/m2 depsipeptide intravenously Table Clinical studies of romidepsin (depsipeptide) Phase Other agent Disease ... Docetaxel is first line therapy for patient with castration-resistant prostate cancer [111] Phase I Clinical study with oral panobinostat alone or in combination with docetaxel in castration-resistant...

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Báo cáo y học: " Maintenance of response with atypical antipsychotics in the treatment of schizophrenia: a post-hoc analysis of 5 double-blind, randomized clinical trials" ppsx

Ngày tải lên : 11/08/2014, 16:23

... response was statistically longer with olanzapine compared to risperidone (p < 001) and quetiapine (p = 003) Though time to loss of response was longer with olanzapine than with ziprasidone, this difference ... treated with olanzapine The NNT with olanzapine rather than comparator to avoid loss of one additional responder over 24 or 28 weeks of treatment is shown by study in Table NNTs were low with a ... double-blind trials of olanzapine versus other atypical antipsychotics, patients treated with olanzapine who responded at Week maintained their treatment response longer than did patients treated with...

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Báo cáo khoa học: " Hemodynamic goals in randomized clinical trials in patients with sepsis: a systematic review of the literature" pptx

Ngày tải lên : 13/08/2014, 03:21

... variation in hemodynamic goals in clinical trials and whether this variation is associated with patient outcomes To better understand the hemodynamic goals in clinical trials in the sepsis research, ... goals in sepsis trials (b) Central venous pressure (CVP) goals in sepsis trials trials (c) Pulmonary artery occlusion pressure (PAOP) goals in sepsis trials (d) Cardiac index in sepsis trials For ... may improve clinical research in the field of sepsis Key messages • Most sepsis clinical trials reviewed did not include hemodynamic goals of therapy Of note, the four largest clinical trials evaluating...

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Báo cáo y học: "rogesterone in traumatic brain injury: time to move on to phase III trials" doc

Ngày tải lên : 13/08/2014, 11:22

... await the results of phase III trials with progesterone in traumatic brain injury In the meantime, the scientific community needs to continue to pursue similar, early phase trials with other candidate ... efficacious, and that expanded multicenter trials are necessary The challenge moving forward will be the design of an appropriate multicenter phase III trial with several questions remaining to be ... neuroprotective agents that have shown benefit in preclinical models [5] Established and appropriately funded clinical networks of investigators working in unison to bring these agents through...

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The use of hypothesis-testing statistics in clinical trials

Ngày tải lên : 01/11/2013, 11:20

... aspect of clinical trials This view is mistaken Rather, as should be clear by now, randomization is the most important feature Placebos usually go along with blinding, though some double-blind trials ... employ drugs only, without placebo Many randomized studies, however, are perfectly valid without the use of any placebo Thus, placebos are not the sine qua non of clinical trials: randomization ... a priori, rather than post hoc The problem with post-hoc analyses is that, almost always, researchers not report how many such 50 Chapter 8: Clinical trials analyses were conducted Thus, if a...

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Tài liệu Clinical trials in gynecological cancer ppt

Ngày tải lên : 13/02/2014, 07:20

... cancer, however, phase III trials are not practical Even phase II trials may often require Intergroup participation to permit accrual in timely fashion Five randomized phase III trials have demonstrated ... permitting only phase II trials Ovarian stromal cancers are the rarest As the risk of recurrence with ovarian stromal cancers is low, we think even phase II trials are impractical for women with ovarian ... Financial support for clinical trials The effective conduct of clinical trials requires a major commitment of time and other resources An ongoing commitment to clinical trials in gynecological...

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SURVEY OF CURRENT GUIDANCE FOR CHILD HEALTH CLINICAL TRIALS pot

Ngày tải lên : 05/03/2014, 10:20

... policies$.mp OR policy.mp AND *clinical trial/ or *phase clinical trial/ or *phase clinical trial/ or *phase clinical trial/ or *phase clinical trial/ or *controlled clinical trial/ AND Limit: recent ... children in clinical investigation of FDA-regulated 13 products 2004 Textbook of clinical trials, chapter: clinical trials in pediatrics Survey of current guidance for child health clinical trials ... European Clinical Trial Directive addresses good clinical practice and ethics of conduct of clinical trials, including recommendations for children.17 The main document on children in clinical trials...

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Access to unapproved therapeutic goods Clinical trials in Australia pdf

Ngày tải lên : 07/03/2014, 08:20

... therapeutic goods Clinical trials - an overview Classification of clinical trials Clinical trials of medicines Medical device trials Regulation of medicine and medical device clinical trials in Australia ... Classification of Clinical Trials Clinical Trials of Medicines Clinical trials of medicines are generally classified according to the phase of the medicine’s development While individual phases may ... administration are considered to be trials for new medicinal products (ie phase I, II or III trials) Medical Device Trials While medical device trials are not formally classified by phase, there are similarities...

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Báo cáo khoa học: The bI/bIII-tubulin isoforms and their complexes with antimitotic agents pptx

Ngày tải lên : 16/03/2014, 13:20

... isotypes I and III of the human b-tubulin We also investigated the complexes involving the bI and bIII isoforms with epothilone A (Fig right) Epothilones are microtubule stabilizing agents, sharing ... replacement of Ser277 in isoform bI with Ala277 in isoform bIII This results in a different and less effective interaction with the C7– C10 moiety of the ligand In comparison with P1, Arg278 is directed ... Magnani et al A Docking of antimitotic agents to tubulin isoforms Table 2, suggest that epothilone A is able to interact with similar afﬁnities with both the bI and bIII isoforms of tubulin As a consequence,...

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CLINICAL TRIALS A Methodologic Perspective pdf

Ngày tải lên : 22/03/2014, 15:21

... the individual Nevertheless, clinical trials are our most powerful tool to counteract dogma 2.2.4 Clinical Trials as Science The use of clinical trials is consistent with, if not at the heart of, ... difﬁcult-to-generalize PRELIMINARIES phase I, II, III, or IV” designations for clinical trials This topic is discussed in Chapter Much of the terminology of clinical trials has been derived directly ... nonrigorous studies Clinical Trials: A Methodologic Perspective, 2E, by S Piantadosi Copyright  2005 John Wiley & Sons, Inc 10 CLINICAL TRIALS AS RESEARCH This places well-performed clinical trials at...

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CANNABINOIDS: POTENTIAL ANTICANCER AGENTS pdf

Ngày tải lên : 22/03/2014, 17:20

... by Phase III clinical trials — include appetite stimulation and pain inhibition In relation to the former, dronabinol is now prescribed for anorexia associated with weight loss in patients with ... that inhibits convulsions, anxiety, vomiting and inflammation; it is now in Phase III clinical trials in combination with tetrahydrocannabinol for the treatment of multiplesclerosis-associated ... Cannabinoid Stage in clinical trials References Inhibition of nausea and emesis THC, nabilone Dronabinol and nabilone approved for cancer chemotherapy Appetite stimulation THC Phase III with THC for...

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Cancer Clinical Trials: Participation by Underrepresented Populations doc

Ngày tải lên : 22/03/2014, 17:20

... About Clinical Trials Accessed March 2008, from http://www.cancer.gov/clinicaltrials/facts-andfigures#patients 18 Newburger PE, Elfenbein DS, Boxer LA Adolescents with cancer: access to clinical trials ... refer their eligible patients to clinical trials. 47 Public Attitudes toward Clinical Trials G Research has shown that the general public is unaware of clinical trials as a treatment/prevention ... in 2003, but only 25% of participants in national cancer clinical trials were over 65 years of age Moreover, in Phase II and III clinical trials, the elderly carried 60% of the disease burden but...

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Textbook of Clinical Trials pdf

Ngày tải lên : 23/03/2014, 01:20

... Textbook of Clinical Trials Textbook of Clinical Trials Edited by D Machin, S Day and S Green  2004 John Wiley & Sons, Ltd ISBN: 0-471-98787-5 Textbook of Clinical Trials Edited by David ... of Clinical Trials S Day and F Ederer General Issues David Machin Clinical Trials in Paediatrics Johan P.E Karlberg Clinical Trials ... t.wykes@iop.kcl.ac.uk Preface This Textbook of Clinical Trials is not a textbook of clinical trials in the traditional sense Rather, it catalogues in part both the impact of clinical trials – particularly the randomised...

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Báo cáo hóa học: " The status of clinical trials: Cause for concern" potx

Ngày tải lên : 18/06/2014, 16:20

... (c) clinical trials, and (d)development of new technologies, (2) Epidemiologic and behavioral studies, (3) Outcomes research and health services research [3] **The NIH-defined Phase III Clinical ... report [10] dealing with the tracking of off-shore clinical trials was telling It reported that the number of foreign clinical investigators conducting clinical research under an IND increased 16fold ... institutions lack people to work with the clinician investigator Almost any clinical investigator in any university system knows that if he/she wishes to initiate a trial with any significant number...

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