Background: Due to the increase of crime in South Africa and the overcrowding of correctional facilities, there has been increasing pressure on courts to find and implement alternatives to imprisonment. In this regard, the so-called "desirability of prosecution" reports and diversion for youths is in general use throughout the country. A new trend is, however, an increase in requests of "desirability of prosecution" reports for adults by some courts, while others are still unaware of their potential use and its accompanying diversion for adults. This state of affairs has caused some uncertainty amongst probation officers regarding what precisely is expected of this type of investigations and the reports that must be presented to the courts. Objective: The primary aim of the study was to determine the nature and required content of the so-called "desirability of prosecution" report for adults. Method: The empirical research focused on magistrates' and control prosecutors' expectations regarding the particular type of report. It utilised a combination of quantitative and qualitative research methods and involved three magistrates and seven control prosecutors from three different towns in three different provinces in central South Africa. Results: From the questionnaires and interviews it, first of all, became clear that not all the respondents were aware of the fact that the so-called "desirability of prosecution" reports and accompanying diversion can also be used for adults. It, secondly, showed that the vast majority of respondents viewed it as a mechanism that showed great promise and that it has already been utilised with some success by some courts. The study also produced a variety of guideline for the compilation of such reports. / Thesis (M.A. (MW))--North-West University, Potchefstroom Campus, 2007.

The pharmaceutical industry is spending more and more on Research and Development (R&D) every year. In addition, these R&D costs are increasing at a faster rate than sales. In order to resolve this dilemma a significant increase in R&D productivity is required. One of the main contributions to these R&D costs is the acquisition of data during clinical trials. The most important objective of a clinical trial is the collection of high quality data. No matter how well a clinical trial is conducted, if the data quality is poor, a meaningful analysis is not possible. The data acquisition method therefore plays a significant role in the overall outcome of a clinical trial. In this study a Mobile Clinical Data Acquisition System (MCDAS) was developed for the electronic collection of high-quality Patient-Reported Outcome (PRO) data. The system consisted of a cellular phone based electronic Diary (eDiary) for capturing data, and a website for administering the collected data. The system was designed so that it could be implemented on any clinical trials, no matter what data was collected. The MCDAS was successfully implemented on two clinical trials. The study shows that electronically capturing clinical data improves the quality of data obtained, thereby reducing the time and costs associated with clinical trials. / Thesis (M.Ing. (Electrical Engineering))--North-West University, Potchefstroom Campus, 2007.

Introduction: Thromboprophylaxis recommendations for hospitalized cancer are based on trials done for the general medically patients, as there are no randomized clinical trials(RCTs) looking at thromboprophylaxis in medically ill patients with cancer. Methods: To determine if thromboprophylaxis is safe and effective to prevent VTE these patients, a Systematic Review(SR) was done. A survey was performed to assess: clinical equipoise, trial design and minimally clinically important difference(MCID) for a potential trial. Lastly, a pilot study for an RCT was designed. Results: The pooled RR of VTE was 0.91 (95%CI:0.21 to 4.0;I2:68%) among hospitalized cancer patients receiving thromboprophylaxis compared to placebo. 63.9% believe there is clinical equipoise and 58.3% would consider participating in a RCT comparing different agents/dosing. The MCID for absolute reduction in symptomatic VTE between two arms was 2% and for “acceptable” increase in major bleeding events was 1%. Conclusion: The risk-benefit ratio of current doses of thromboprophylaxis administered to hospitalized cancer patients is unclear and additional RCTs are necessary.

The pharmaceutical industry is spending more and more on Research and Development (R&D) every year. In addition, these R&D costs are increasing at a faster rate than sales. In order to resolve this dilemma a significant increase in R&D productivity is required. One of the main contributions to these R&D costs is the acquisition of data during clinical trials. The most important objective of a clinical trial is the collection of high quality data. No matter how well a clinical trial is conducted, if the data quality is poor, a meaningful analysis is not possible. The data acquisition method therefore plays a significant role in the overall outcome of a clinical trial. In this study a Mobile Clinical Data Acquisition System (MCDAS) was developed for the electronic collection of high-quality Patient-Reported Outcome (PRO) data. The system consisted of a cellular phone based electronic Diary (eDiary) for capturing data, and a website for administering the collected data. The system was designed so that it could be implemented on any clinical trials, no matter what data was collected. The MCDAS was successfully implemented on two clinical trials. The study shows that electronically capturing clinical data improves the quality of data obtained, thereby reducing the time and costs associated with clinical trials. / Thesis (M.Ing. (Electrical Engineering))--North-West University, Potchefstroom Campus, 2007.

The aim of this study was to investigate and analyze similarities and differences in trials and punishment from a gender perspective, during the inquisition in the episcopate of Linköping. A inquisition initiated by duke Karl but performed by archbishop Abraham Angermannus in the year 1596.During the working process a quantitive method was used in the purpose of getting statistic data considering number of men and women that were trialed and punished. A hermeneutic qualitive method was also used in the purpose of closer investigating certain cases that men and women were involved in. The theoretical concepts that have been of importance and used in this study are the individual and the female subject that is based on gender in judicial procedures.The results showed that 49 % of the men were trialed for quarrel. Not as many men were trialed for contempt towards the church and witchery.The most frequently used corporal punishment in this cases were flogging that were executed for totally 38 % of the men.The investigation also proved that men were punished with these forms of corporal punishments for showing their contempt towards the church. Although flogging were the most sentenced punishment for quarrelsome husbands, some were set free from this, even if they had behaved very badly towards their wife.Not many noblemen was affected by Angermannus inquisition and only six out of seven in total calculations, were trialed for contempt against the church. None of them were punished. In the case of women whom lived in the episcopate, witchery were the most trialed crime.As for the men, the most usual form of corporal punishment for women, were flogging that was executed for 51 %. However, flogging in comparison with number of men punished a greater number of women. But not as many noblewomen were trialed or punished, in comparison with the number of nobleman. Only two were trialed for contempt towards the church.Considering fornication and adultery, a much larger number of men were trialed for adultery. When it comes to certain forms of punishment, more men than women were sentenced to pay various forms of fines to the church. At the same time, a smaller amount of men were sentenced to flogging followed by a number of buckets with water, that were poured over the condemned. Considering the nobles and the cases of sexual crimes more men than women were trialed.Between the sexes, more men than women were sentenced with conditional sentences. In some cases the conditional sentences were identical between the sexes, meanwhile another case proved that a conditional sentence were sentenced for the household.How did the inquisition affect women with different social status? In this case considering farm girls and widows? 112 farm girls and widows were trialed in the episcopate. The quantitative study showed that 94 farm girls in contrast with 18 widows was trialed. Not many widows had to suffer the corporal punishment in comparison with farm girls, whom not only got more punishment, but also were sentenced to flogging, a punishment that never was attested to widows. Keywords: Archbishop Angermannus, gender, 16th century, inquisition, protocol, trial, corporal punishment

Background: There are a plethora of potential statistical designs which can be used to evaluate efficacy of a novel cancer treatment in the phase II clinical trial setting. Unfortunately, there is no consensus as to which design one should prefer, nor even which definition of efficacy should be used and the primary endpoint conclusion can vary depending on which design is chosen. It would be useful if an all-encompassing methodology was possible which could evaluate all the different designs simultaneously and allow investigators an understanding of the trial results under the varying scenarios. Methods: Finite Markov chain imbedding is a method which can be used in the setting of phase II oncology clinical trials but never previously evaluated in this scenario. Simple variations to the transition matrix or end-state probability definitions can be performed which allow for evaluation of multiple designs and endpoints for a single trial. A computer program is written in R which allows for computation of p-values and conditional power, two common statistical measures used for evaluation of trial results. A simulation study is performed on data arising from an actual phase II clinical trial performed recently in which the study conclusion regarding the efficacy of the potential treatment was debatable. Results: Finite Markov chain imbedding is shown to be useful for evaluating phase II oncology clinical trial results. The R code written for evaluating the simulation study is demonstrated to be fast and useful for investigating different trial designs. Further detail regarding the clinical trial results are presented, including the potential prolongation of stable disease of the treatment, which is a potentially useful marker of efficacy for this cytostatic agent. Conclusions: This novel methodology may prove to be an useful investigative technique for the evaluation of phase II oncology clinical trial data. Future studies which have disputable conclusions might become less controversial with the aid of finite Markov chain imbedding and the possible multiple evaluations which is now viable. Better understanding of activity for a given treatment might expedite the drug development process or help distinguish active from inactive treatments

Breastfeeding is recommended as the optimal source of nutrition for newborns for the first 6 months of life and beyond with the addition of complementary foods. While breastfeeding initiation rates have been increasing, duration rates remain a concern as many women prematurely discontinue due to difficulties encountered rather than maternal choice. In addition, there is a sizable gap between rates of exclusive breastfeeding and current recommendations. Targeting modifiable variables that may be amenable to intervention is one strategy to improve breastfeeding outcomes. One such modifiable variable is breastfeeding self-efficacy. Although research has clearly shown that breastfeeding self-efficacy is predictive of breastfeeding duration and exclusivity, it is unknown whether it can be enhanced to improve breastfeeding outcomes. The purpose of this pilot randomized controlled trial was to examine the feasibility and compliance of a newly developed trial protocol and the acceptability of an intervention to increase breastfeeding self-efficacy in the immediate postpartum period. Secondary outcomes included determining whether there were any trends between groups related to breastfeeding self-efficacy, duration, and exclusivity. Participants included 150 primiparous mothers who were breastfeeding their healthy, full-term infants. Eligible and consenting mothers were randomized to either a control group (standard postpartum care) or an intervention group (standard postpartum care plus the self-efficacy intervention). Participants allocated to the intervention group received three individualized, self-efficacy enhancing sessions with the researcher; two sessions were conducted in hospital, and one was administered via telephone 1 week following hospital discharge. A research assistant blinded to group allocation collected outcome data at 4 and 8 weeks postpartum. The results suggested that the administration of the intervention was feasible and that there was a high degree of protocol compliance; the majority of participants reported that the intervention was beneficial. Secondary outcomes identified that there was a trend among participants in the intervention group to have improved breastfeeding outcomes, including higher rates of breastfeeding self-efficacy, duration, and exclusivity at 4 and 8 weeks postpartum. Preliminary evidence also suggested that the self-efficacy intervention may have assisted to decrease perceptions of insufficient milk supply among the intervention group participants. Overall, the findings from this pilot trial indicated that a larger trial is warranted.

Neuropathic pain (NPP) is a chronic syndrome suffered by patients with multiple sclerosis (MS), for which there is no cure. Underlying cellular mechanisms involved in its pathogenesis are multifaceted, resulting in significant challenges in its management. In addition to its complex pathophysiology, the clinical management of MS-induced NPP is further complicated by the lack of clinical therapeutics trials specific to this population. The primary aim of the work underlying this thesis was to contribute to the evidence-based management of individuals with MS-induced NPP through the completion of two clinical therapeutics trials in this population. A secondary aim was to describe pain variability in this patient population through the development and validation of a pain variability algorithm tool. Resulting from this work, we demonstrated that nabilone – a synthetic oral cannabinoid – represents an effective, well-tolerated and novel treatment for MS-induced NPP. Additionally, we show that the SSRI paroxetine was poorly tolerated in our patient population, with a correspondingly high attrition rate. As a result, we were unable to determine any treatment effect in this trial due to insufficient recruitment due to drop-out. Lastly, we were able to define and describe pain instability in this cohort, noting that approximately 30% of individuals with MS-induced NPP experiencing highly variable daily pain. The results of these projects provide novel information for this patient population. Patients currently living with the daily burden of MS-induced NPP would benefit from additional trials ensuing from this, and other, research in order to initiate a momentum for much-needed clinical research in this complicated patient cohort.

Age-related macular degeneration (AMD) is the leading cause of Government-registered blindness in the elderly of the Western world and has two forms: wet and dry. No current AMD therapies are curative, and most are provided after retinal damage from the disease has already occurred (to preserve what is left of the retina). We have constructed a multi-factorial Phase II randomized, controlled clinical trial, titled: “Omega-3 docosahexaenoic acid(DHA) and eicosapentaenoic acid (EPA) nutritional supplementation to delay the progression of age-related macular degeneration (AMD): The OMEGAlberta Study”. Each day, participants in the experimental arm of this study will receive 600mg DHA and 1200mg EPA, plus Vitalux AREDS antioxidant formula. Based on the physicochemical properties of DHA, EPA, and Vitalux, our aim is to delay the 5-year incident rate of progression of intermediate dry AMD to wet AMD. Several tests will be performed, not only to quantify the incident rate of progression of AMD, but also to gain insight of the physiological mechanisms behind the supplements being provided. If the supplements are proven to delay AMD progression, this knowledge should be implemented by changes in health services and policy relating to public education and the treatment of AMD.

No description available.