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Clinical trial with previously developed methods

Clinical evaluation of a newly developed automated hemodialysis system as a clinical trial

Clinical evaluation of a newly developed automated hemodialysis system as a clinical trial

... good clinical practice (GCP) guidelines and approved by the respective institutional review ...of clinical events, including blood pressure decline, residual blood, and error in fluid removal, was not ...

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Developed by the Clinical Trial Unit at the University Hospital Basel (CTU Basel)

Developed by the Clinical Trial Unit at the University Hospital Basel (CTU Basel)

... Clinical research professionals usually start their careers with background knowledge from diverse graduate trainings but mostly lack structured training in clinical research. Still, they are facing highly ...

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A randomised clinical trial of intrapartum fetal monitoring with computer analysis and alerts versus previously available monitoring

A randomised clinical trial of intrapartum fetal monitoring with computer analysis and alerts versus previously available monitoring

... Diogo Ayres-de-Campos 1* , Austin Ugwumadu 2 , Philip Banfield 3 , Pauline Lynch 4 , Pina Amin 5 , David Horwell 6 , Antonia Costa 7 , Cristina Santos 8 , João Bernardes 9 , Karl Rosen 10 Abstract Background: Intrapartum ...

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Guidelines for the conduct of clinical trials for spinal cord injury (SCI) as developed by the ICCP panel: clinical trial outcome measures

Guidelines for the conduct of clinical trials for spinal cord injury (SCI) as developed by the ICCP panel: clinical trial outcome measures

... 1 trial is specifically designed to evaluate the safety of the intervention and expose any adverse or toxic side effects, usually in small numbers of subjects with a simple open label ...I trial may ...

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Clinical trial designs for rare diseases: studies developed and discussed by the International Rare Cancers Initiative

Clinical trial designs for rare diseases: studies developed and discussed by the International Rare Cancers Initiative

... Recruitment rate was the main concern during design stage; anticipated enrolment is only 30 pts/year, despite international collaboration. The primary outcome mea- sure is response rate, estimated as 40% with cis- platin ...

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Monoclonal Antibodies Developed as Anticancer Drugs: EU Clinical Trial Application With Focus on IMPD Requirements

Monoclonal Antibodies Developed as Anticancer Drugs: EU Clinical Trial Application With Focus on IMPD Requirements

... first-in-human trial in March 2006 in the UK with TeGenero´s antibody TGN1412 showed that there are molecules with higher risk potential than others for first human ...the clinical trial. However, ...

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Statistical analysis of clinical trial data using Monte Carlo methods

Statistical analysis of clinical trial data using Monte Carlo methods

... LOTS trial, the distribution and the associated power of the usual fixed-entry-order re-randomization test following unequal allocation minimization were characterized in this ...

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Advantages of Bayesian monitoring methods in deciding whether and when to stop a clinical trial: an example of a neonatal cooling trial

Advantages of Bayesian monitoring methods in deciding whether and when to stop a clinical trial: an example of a neonatal cooling trial

... illustrate how these three components can be specified in practice using the Optimizing Cooling Trial as an example. We performed a Bayesian reanalysis of predischarge mortality data from the 364 infants enrolled ...

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Planning policy, sustainability and housebuilder practices: The move into (and out of?) the redevelopment of previously developed land

Planning policy, sustainability and housebuilder practices: The move into (and out of?) the redevelopment of previously developed land

... production methods that would allow them to stop production and exit the market very quickly if the market takes a downwards trend and at the same time would allow them to speed up the production cycle if the ...

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SLT versus ALT in Glaucoma Patients Treated Previously with 360-degree SLT—A Randomised, Single-Blind, Equivalence Clinical Trial

SLT versus ALT in Glaucoma Patients Treated Previously with 360-degree SLT—A Randomised, Single-Blind, Equivalence Clinical Trial

... therapeutic IOP response was comparable with the two lasers, which was 0.84 (95% CI, 0.61 to 1.38; p = 0.05). One of the limitations of this review is the information bias. First, it included the study of Júnior et al. ...

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Developing the clinical components of a complex intervention for a glaucoma screening trial: A mixed methods study

Developing the clinical components of a complex intervention for a glaucoma screening trial: A mixed methods study

... ‘moderate’ between the trained technical operators and the expert ophthalmic diagnostic role. Overwhelmingly, and primarily out of financial consid- eration, clinicians suggested that ‘technicians’ supported by ...

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Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder

Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder

... This trial attempts to promote weight loss in depressed, obese women by administering behavioral activation treatment for depression directly prior to an evidence-based weight loss ...

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Developing the clinical components of a complex intervention for a glaucoma screening trial : a mixed methods study

Developing the clinical components of a complex intervention for a glaucoma screening trial : a mixed methods study

... ‘moderate’ between the trained technical operators and the expert ophthalmic diagnostic role. Overwhelmingly, and primarily out of financial consid- eration, clinicians suggested that ‘technicians’ supported by ...

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Original Article Comparing two methods of orthodontics space closure: a randomized clinical trial

Original Article Comparing two methods of orthodontics space closure: a randomized clinical trial

... 1 Department of Orthodontics, West China Stomatology Hospital of Sichuan University, State Key Laboratory of Oral Diseases (Sichuan University), Chengdu, Sichuan, PR China; 2 Hospital of Stomatology, Guangxi Medical Uni- ...

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Clinical trial simulation methods for estimating the impact of DPP-4 inhibitors on cardiovascular disease

Clinical trial simulation methods for estimating the impact of DPP-4 inhibitors on cardiovascular disease

... cases, clinical trial simulation may still be valuable, quantifying the magnitude of newly discovered effects, versus those associated with traditional risk factor ...Second, clinical trial ...

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Effectiveness of Two Instruction Methods in Improving Tooth Brushing Skills in Children: A Clinical Trial

Effectiveness of Two Instruction Methods in Improving Tooth Brushing Skills in Children: A Clinical Trial

... instruction methods for tooth brushing demonstration: verbal instruction using posters and demonstration using life-sized models in plaque reduction over a four-weeks period in third and fourth grade school ...

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The Effect of Two Educational Methods on Knowledge and Adherence to Treatment in Hemodialysis Patients: Clinical Trial

The Effect of Two Educational Methods on Knowledge and Adherence to Treatment in Hemodialysis Patients: Clinical Trial

... the methods of teaching these patients are ...training methods and the results obtained in different cultures and regarding the importance of preventing dialysis adverse effects and their relation to the ...

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Development of robust methods of assessment of clinical competency in ophthalmic dispensing – results of a pilot trial

Development of robust methods of assessment of clinical competency in ophthalmic dispensing – results of a pilot trial

... the methods used to conduct the assessment and arrive at the passing score are both justifiable and defensible (Wilkinson, Newble et ...Although methods to assess clinical competency have existed in ...

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Clinical Trial Logistics

Clinical Trial Logistics

... the clinical research industry in 1998 at the CRO ICRC ...and Clinical Trial Logistics, holding different ...and developed innovative systems in the area of Inventory Management, Dynamic ...

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trial update clinical

trial update clinical

... CLL. Methods: All patients had active relapsed or refractory CLL, were at least 18 years of age, had received prior purine analog-based chemother- apy (with the exception of one elderly patient), had an Eastern ...

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