overview of phase ii clinical trials

... day of event occurrence (for OS the date of death or the date of termination of the trial for patients alive at the time end of the study, Caponigro et al BMC Cancer (2016) 16:918 or the date of ... Institute of Naples Biological analyses are centralized at the Experimental Pharmacology Unit of the NCI of Naples Discussion In spite of improvements in the treatment of squamous cell carcinoma of ... principles of the Good Clinical Practice guidelines of the International Conference on Harmonization (ICH) and the Declaration of Helsinki are respected in the conduct, evaluation and documentation of...

Ngày tải lên: 20/09/2020, 18:51

... specification of an alpha level of 0.1 and a one-sided test were used in the calculation of the power Both choices of an alpha level greater than 0.05 and a onesided test are justifiable in phase II studies, ... patients Design overview We are conducting a monoistitutional phase II, randomized, double blind, placebo controlled trial to assess the efficacy and the safety of a daily administration of nimesulide ... subjects carrying a mutation of BRCA1 or with high probability of BRCA1/2 mutation on the basis of the geneticist evaluation are contacted by the staff of the Division of Cancer Prevention and Genetics...

Ngày tải lên: 05/11/2020, 07:59

... special edition of Controlled Clinical Trials The edition was finally published in 1995 That collaboration expanded my knowledge of clinical trials beyond my own specialized area of cancer trials, and ... kinds of trials If I was aware of differences in systems for different types of trials and trials done in different countries, I have tried to point out these differences in the text The goal of ... which impact on clinical trials, and there have been a lot of changes in the implementation of Good Clinical Practice legislation in many countries The information should be of use to anyone...

Ngày tải lên: 03/09/2021, 22:54

... [32] The likelihood of publication bias was assessed by drawing a funnel plot of standard error of the mean difference (y-axis) as a function of the mean difference (x-axis) of our primary outcome ... route or without LAs; (4) retracted articles; (5) Lack of relevant outcomes Four trials [20–23] investigated the effect of different dose of perineural DEX with LA by allocating patients into ... standard deviations (SDs), number of events, and total number of participants If the trials just provided graphs, we extract data using GetData Graph Digitizer software [30] The median and interquartile...

Ngày tải lên: 12/01/2022, 22:20

... Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)-Good Clinical Practice (GCP)-registered phase I /II clinical trial of rh-HGF As this application ... pharmacokinetics of recombinant human hepatocyte growth factor (rh-HGF) in patients with fulminant hepatitis: a phase I /II clinical trial, following preclinical studies to ensure safety Journal of Translational ... Infusion of 100 mL of saline prior to rh-HGF administration prevented a decrease in BP during exposure to rh-HGF of capacitance vessels is a cause of HGF-induced BP reduction Evaluation of renal...

Ngày tải lên: 18/06/2014, 19:20

... efficacy and safety of CCII in RA patients further, we treated two groups of RA patients with oral CCII or MTX in a randomized, double- blind, multicenter, and controlled phase III clinical trial. ... In this phase III trial, CCII at 0.1 mg daily and MTX at 10 mg once weekly effectively alle- viated signs and symptoms of active RA. However, the efficacy of CCII did not exceed that of MTX. ... http://arthritis-research.com/content/11/6/R180 Page 1 of 10 (page number not for citation purposes) Vol 11 No 6 Research article A multicenter, double-blind, randomized, controlled phase III clinical trial of chicken type II collagen...

Ngày tải lên: 12/08/2014, 11:22

... single-center, single-arm, phase interventional clinical trial, the objective of the study was to explore the efficacy and toxicity of the combination chemotherapy of Page of 12 Methotrexate and ... prior therapy The origin of pathology included 13 cases of bone lesion (36.1%), cases of both lung (13.9%) and lymph node (13.9%), cases of thyroid (11.1%), and cases of soft tissue (8.3%), skin/mucosa ... acts as a potent inhibitor of dihydrofolate reductase (DHFR), and inhibition of thymidylate results in lack of DNA synthesis [17] According to the current knowledge of LCH, central nervous system...

Ngày tải lên: 30/05/2020, 21:28

... enrolled in earlyphase clinical trials with a specific and strict set of eligibility criteria [38] Based on a systematic review of past experience, most phase II osteosarcoma trials are conducted ... versus attained design in phase II clinical trials Stat Med 1992;11(7):853–62 34 Jung SH, Owzar K, George SL, Lee T P-value calculation for multistage phase II cancer clinical trials J Biopharm Stat ... rates on type I and type II errors, in a phase II Simon design Eur J Cancer 2011;47(11):1647–52 55 Simon R Optimal two-stage designs for phase II clinical trials Control Clin Trials 1989;10(1):1–10...

Ngày tải lên: 17/06/2020, 11:32

... 15:237 Page of 13 Figure Schematic view of the application sequences of the IMPs (A) Patients in group of phase I or II will receive the IMPs in the sequence depicted here (B) Group of phase II, which ... Department of Clinical Oncology of the University of Munich and the apceth GmbH &Co KG based in Munich, Germany It is an uncontrolled, single arm trial consisting of a phase Ifollowed by a phase II study ... ethics committee of the University of Munich has approved the study and it has been registered at European Union Drug Regulating Authorities Clinical Trials Database/EU Clinical Trials Register...

Ngày tải lên: 30/09/2020, 12:37

... feature of clinical trials is that they are designed to answer a single question, but we humans force them to answer hundreds This is the source of both their power and their debility The value of clinical ... criteria” of a study 55 Section 3: Chance One way in which generalizability is discussed is often by using the term efficacy for the results of the samples of patients in clinical trials, and ... of depressive episodes (one of the frequently emphasized secondary outcomes) (Goodwin et al., 2004) Another example of the issue of generalizability involves studies of combination therapy, often...

Ngày tải lên: 01/11/2013, 11:20

... 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 10 years Survey of ... 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 ... Survey of current guidance for child health clinical trials Introduction Need for clinical trials in children At present, between 50 and 90% of daily prescriptions for sick children use ‘off label’...

Ngày tải lên: 05/03/2014, 10:20

... (73.8%) of the employees were full-time employees � Almost half (45.7%) of the employees were women � One-third (30.2%) of the employees were members of a racial/ethnic minority group  � 18.1% of ... employers tackle an array of workforce demands.” (Klaff, 2006, p.1 of 6) Overview of Strategic Priorities What strategies “top” employers’ lists? Approximately half of the respondents indicated ... recruitment package As Table indicates, many employers are offering a range of benefits to all of their employees Table 4: Profiles of Available Benefits % respondent organizations reporting...

Ngày tải lên: 23/03/2014, 02:20

... BioMed Central Page 1 of 11 (page number not for citation purposes) Journal of Translational Medicine Open Access Research Phase II trial of Modified Vaccinia Ankara (MVA) virus ... The clinical protocol was approved by the Institutional Review Board. Vaccine preparation 5T4-MVA vaccine was produced by homologous recombi- nation of human 5T4 cDNA into deletion region III of ... booster immunizations were supported by the addition of high-dose bolus IL-2. Methods Patients This phase II trial was an open label study of MVA-5T4 vaccine in patients with metastatic clear...

Ngày tải lên: 18/06/2014, 15:20

... 121 v List of Figures 2.1 An illustration of the system model of a DDBS 11 3.1 Illustration of the concurrent control mechanism 25 3.2 Illustration of phase partition ... services the requests in each phase of σo to minimize the cumulative servicing cost 3.2.3 Servicing of Phases Servicing of P (0) As mentioned earlier, P (0) in σo consists of all the read requests ... indirectly helped me during the course of my research with their ideas, inputs or moral support ii Contents List of Figures List of Tables Summary Introduction v vii ix 1.1 Motivation ...

Ngày tải lên: 16/09/2015, 17:11

... Type II sub-schedule The number of reading processors of Np (i) We have |Np (i)| = np (i) np (i) Na (i) The set of all different reading processors of the ith sub-schedule ψo (i) The number of all ... the beginning of win(o) Then, we show that the cost of DWM-NR on both types of sub-schedules is at most (1 + Cc + Cd ) times as much as the cost of an optimum offline algorithm Proof of Part A (for ... locality of reference Furthermore, if one of the processors fails, a copy of the object is still available on another processor on the network If we focus on the servicing cost of the set of read-write...

Ngày tải lên: 04/10/2015, 10:24

... others of its kind, we consider multipath fading as part of the channel impairments instead of using an orthogonality factor (OF) in (1) Authors of [13] argue that OF is defined as the fraction of ... soft handoff algorithm Mobile transfers pilot to active set and sends back HCM Terminate (b) Proposed soft handoff procedure Figure 6: Soft handoff algorithm and procedure 4.2 Soft handoff One of ... specifications of WCDMA Multiple access technique Direct-spread code Number of slots/frame 15 Number of chips/slot 2560 4.4–5.2 MHz Intrasystem handoff Soft/softer handoff Chip rate of spreading...

Ngày tải lên: 22/06/2014, 22:20

... Costs The message costs of Flood+Reply, and thus of Shout, are simple to analyze As mentioned before, Flood+Reply consists of an execution of Flooding(Q) with the addition of a reply (either Yes ... spanning tree T[s] of the network; Starting from the leaves of T[s] , the entities perform a convergecast on T At the end of the convergecast, s becomes aware of the global termination of the broadcast ... tree of G; furthermore, this tree is rooted in the initiator s 56 BASIC PROBLEMS AND PROTOCOLS Theorem 2.5.1 Protocol Shout correctly terminates Proof This protocol consists of the flooding of...

Ngày tải lên: 12/08/2014, 16:21

... downtown will be the one of a and b that has smaller id (recall that we are working under the ID restriction) (ii) The name of the new city will be the name of the new downtown (iii) The level will ... Because of its complexity and the variety of scenarios that can be created, there is no satisfactory complete proof of the correctness of the Mega-Merger protocol We will discuss here a partial proof ... messages regardless of the location and the number of the initiators Exercise 3.10.55 Show that the effect of rounding up α i does not affect the order of magnitude of the cost of Protocol MarkBorder...

Ngày tải lên: 12/08/2014, 16:21

... set of Reduction Tools Summarizing, Protocol REDUCE, composed of the application of Reduction Tools and 2, reduces the search space from N to at most ⌬2 Protocol CUT, composed of a sequence of ... FIGURE 5.10: Diagram of operations of OddEven-LineSort in a line of size n = 301 SORTING A DISTRIBUTED SET Data Exchange At the basis of the technique there is the exchange of data between two ... the number of iterations is at most n − (instead of N − 1) This means that the cost of computing the AND is O(n2 ) (instead of O(N n)) Surprisingly, even in this case, the total number of messages...

Ngày tải lên: 12/08/2014, 16:21

... variations of this solutions; for example, each pair of neighbors could use a different type of communicator There exists a way of drastically reducing the time without increasing the number of bits ... more than any strategy of any type which uses the same maximum number of corruptible bits Consider now the case of incorruptible transmissions Let α(t, b) denote the size of the largest set for ... causal time complexity, and the size of the largest message, respectively, of A in G Recall that the causal time complexity is the length of the longest chain of causally related message transmissions...

Ngày tải lên: 12/08/2014, 16:21