computational considerations in clinical trial simulations

... phase I clinical trials Biometrics 45:925– 937 Thall, P F., Simon, R M., Estey, E H (1996) New statistical strategy for monitoring safety and efficacy in single-arm clinical trials Journal of Clinical ... Longitudinal Data with Missingness Paul S Albert and Margaret C Wu 12 Statistical Issues Emerging from Clinical Trials in HIV Infection Abdel G Babiker and Ann Sarah Walker Index of Abbreviations Index ... phase I study of PNU214565 (PNU) involving patients with advanced adenocarcinomas of gastrointestinal origin (Babb and Rogatko, 2001) Previous clinical and preclinical studies demonstrated that...

Ngày tải lên: 08/04/2014, 13:10

... standard concentration of insulin (Humulin R, Eli Lilly and Company, Indianapolis, IN, USA) was 100 units in 100 ml of 0.9% saline solution In the standard insulin group, insulin infusion was started ... standard insulin group and 83 of 254 (32.7%) in the intensive insulin group The mean calorie intake in 24 hours was 23.1 ± 12.7 kcal/kg in the standard insulin group and 25.5 ± 14.4 kcal/kg in the intensive ... 14 patients in the standard insulin group (5.6%) and 14 in the intensive insulin group (5.5%) The remaining patients received total-enteral feeding exclusively In the standard insulin group 47%...

Ngày tải lên: 25/10/2012, 10:35

... Visit Visit Randomization Clinical assessments as indicated; first dose in clinic Clinical assessments as indicated Clinical assessments as indicated Clinical assessments as indicated 30 60 Treatment ... instructed to take two “sugar pills” in the morning to protect blinding and two UC-II capsules in the evening accounting for a daily dose of 40 mg UC-II containing 10 mg of bioactive undenatured ... capsules (providing 10 mg of undenatured collagen II) is based on efficacy demonstrated in earlier studies (8,9) Blinding In order to protect blinding, subjects were given bottles containing product...

Ngày tải lên: 26/10/2012, 09:48

... enrolled in this pilot trial All patients enrolled in the trial met the protocol eligibility criteria, including: histologically proven CCRC; tumors expressing mutated VHL gene resulting in a new amino ... resulting in a change from thymine to cytosine which led to a substitution in valine to alanine at position 166 Patient had a mutation at nucleotide number 332 resulting in a change from guanine ... by side in the same experiment and were done from frozen samples This testing strategy was used to minimize variability from day to day in staining or thawing The samples were tested in independent...

Ngày tải lên: 18/06/2014, 16:20

... I clinical study with only six patients completing all three cycles of vaccine and cytokine administration, this precludes any conclusion regarding the clinical efficacy Further complicating interpretations ... the first amino acid in the Her2 protein) were in computer modelling predicted to bind multiple human leukocyte antigen (HLA)-DR molecules and indeed found to exhibit high-affinity binding to a ... immunization in humans Notably, vaccine efficacy in animal models has been improved by including cytokines or plasmids coding for these as adjuvants [21-24] Here we present a pilot clinical trial to...

Ngày tải lên: 18/06/2014, 16:20

... (ICH)-Good Clinical Practice (GCP)-registered phase I/II clinical trial of rh-HGF As this application is the first clinical trial to administer rh-HGF to humans, we performed additional preclinical ... ends of rh-HGF administration (day 14) and the observation period (day 28) to evaluate renal involvement, including serum creatinine and histological findings A phase I/II clinical trial for patients ... of 12 The secondary endpoints were the pharmacokinetics of intravenously injected rh-HGF and clinical efficacy, including survival period and outcome To examine pharmacokinetics of rh-HGF, blood...

Ngày tải lên: 18/06/2014, 19:20

... study examines perceptions of sleep in an international clinical trial aimed at evaluating the efficacy and safety of the pregabalin, a treatment for pain relief in patients with painful DPN ... to thank all patients and clinical investigators who participated in this clinical trial We also thank Christine de la Loge for her involvement in the analysis and interpretation of the results ... record pain during the next days of the baseline phase The diary consists of a single item with an 11-point numeric self-administered rating scale ranging from (no pain) to 10 (worst possible pain)...

Ngày tải lên: 18/06/2014, 19:20

... patient to play in standing or in sitting position to improve balance control in both conditions In standing position the patients are required to maintain their soles on the WBB In sitting position, ... only in the field of motor domain [47] but also in those processes involving perceptual learning [48] and cognitive recovery [49] According to these principles, the greatest effects of training in ... cm in front of the individual’s feet 1-minute walking test (1MWT) Walking distance within a minute along an 8-shaped path that is 20 m long defined on a straight and nonslip surface 10-m walking...

Ngày tải lên: 19/06/2014, 08:20

... stavudine and lamivudine, in combination with nevirapine, are available in a few African countries [10] Practical aids, including calendars and pill boxes, are also encouraged based on findings ... making it attractive for evaluation in resource-limited settings There is an increasing pool of literate caregivers caring for HIV-1-infected children in Kenya, which makes diary use feasible in ... self-report in this cohort We observed comparable growth, clinical morbidity and viral levels in children in the two trial arms Given the generally good adherence and clinical responses observed in the...

Ngày tải lên: 20/06/2014, 08:20

... identifying patients who are at increased risk of a mental health hospitalization In the 1-year follow-up periods in these clinical trials, the assessments were performed monthly In clinical practice, ... abuse within months before screening (not including nicotine and caffeine addiction) Additional inclusion and exclusion criteria are presented in the previous reports from the randomized blinded ... intent-to-treat sample included 1,077 patients from the 1,665 patients who enrolled in the double-blind randomized portion of the clinical trials The intent to treat analysis set was defined as open-label...

Ngày tải lên: 08/08/2014, 23:21

... prolactin levels increased from baseline to end point in the markedly to severely ill population, with a greater increase observed in women The incidence of AEs potentially related to prolactin in ... the placebo group at baseline at each time point (including end point), using the ITT analysis set Mean (SD), median, minimum, and maximum were used for summary of continuous variables; percentage ... reported in detail [19] The overall study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical...

Ngày tải lên: 09/08/2014, 01:21

... anti-inflammatory drug Clinical ulcers and bleeds Clinical ulcers and bleeds in the company clinical trial reports were as reported by investigators, and were not subjected to independent, blinded ... gastrointestinal adverse events, we included an overall measure of gastrointestinal tolerability as well as individual gastrointestinal adverse events of nausea, vomiting, abdominal pain, dyspepsia, ... company clinical trial reports Deeks and co-workers [29] examined 15,000 patients in nine of the earlier trials of celecoxib, and Edwards and co-workers [30] examined some 5,700 patients in nine trials...

Ngày tải lên: 09/08/2014, 06:22

Ngày tải lên: 09/08/2014, 07:20

... in clinical trials that is paramount There are few comparisons on which to draw, although it is generally assumed that discontinuation rates are higher in clinical practice than in clinical trials ... discontinuations with placebo in This does not prevent discontinuations from being a useful measure, perhaps as much or more so in clinical practice as in clinical trials, although discontinuations ... in clinical trials in rheumatology, as with meloxicam in ankylosing spondylitis [37] In clinical practice, discontinuation rates for adverse events and lack of efficacy has been used to distinguish...

Ngày tải lên: 09/08/2014, 10:23

... events included seizure and stroke Acute kidney injury was assessed applying RIFLE [15] criteria (>100% creatinine increase, using preoperative and highest creatinine concentration during the ... inhibitor of plasmin and plasminogen [2], is effective in reducing bleeding after cardiac surgery, its anti-inflammatory effect in fibrinolysis blockade has been less studied In vitro studies ... primary end-point outcome (IR) Mixed ANOVA was used to compare means between groups in clinical signs (bleeding) and laboratory parameters (D-dimer, creatine kinase and troponin I) at baseline, h and...

Ngày tải lên: 10/08/2014, 09:22

... expression of myelin proteins involved in the maintenance of myelin multilamellar structure, such as myelin protein zero and peripheral myelin protein 22 These actions may result in the protection ... finger-wrist; M4 ring fringerwrist) and ulnar (U4 ring finger-wrist) nerves are determined The difference between U4-M4 SCV is also calculated Skin temperature was maintained > 32°C with an infrared ... including in the trial from 01.06.2008 Patients will be recruited if they will complain at least three months of the following symptoms: nocturnal awaking or activity-related numbness, tingling,...

Ngày tải lên: 10/08/2014, 10:20

... prescribing is defined differently depending on the region; it can range from prescribing by protocol to independent prescribing The Canadian province of Alberta has been a pioneer in the area of independent ... pharmacist prescribing and on the value of training programs for pharmacist prescribing authority [15-17] With Alberta being the first province in Canada to allow independent prescribing by pharmacists, ... http://www.epicore.ualberta.ca Investigator meetings In April 2009, the first investigator meeting and training session was held It consisted of a didactic component on the current guidelines for the treatment...

Ngày tải lên: 10/08/2014, 11:20

... forefoot pain intensity scored by the participant on an 11-point pain numerical rating scale (PI-NRS, where = no pain and 10 = worst possible pain), foot function using the point Foot Function Index ... between interventions for chronic foot pain In a previous study it was estimated that a reduction of approximately two points on an 11point pain intensity numerical rating scale represents a clinically ... recruitment) Finally, all people visiting the general practice (for any reason) will be informed about the study by putting up posters in the waiting area of the GP clinics inviting patients to...

Ngày tải lên: 10/08/2014, 21:24

... taking a history, performing a physical examination, ordering laboratory examinations, giving guidance and advice, delivering medication and therapy, specifying follow-up [17] Reports combining ... meeting the inclusion criteria for the review based their measures of behaviour on whether a clinician had performed one or more clinical actions, e.g., prescribing a specific drug, ordering ... EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, Science/Social science citation index, Current contents (social and behavioural med/ clinical med), ISI conference proceedings, and Index...

Ngày tải lên: 11/08/2014, 05:21