Small-diameter titanium Grade IV and titanium-zirconium implants in edentulous mandibles: three-year results from a double-blind, randomized controlled trial

OBJECTIVE The aim of this study was to compare crestal bone-level changes, soft tissue parameters and implant success and survival between small-diameter implants made of titanium/zirconium (TiZr) alloy or of Grade IV titanium (Ti) in edentulous mandibles restored with removable overdentures. MATERIALS AND METHODS This was a randomized, controlled, double-blind, split-mouth multicenter clinical trial. Patients with edentulous mandibles received two Straumann bone-level implants (diameter 3.3 mm), one of Ti Grade IV (control) and one of TiZr (test), in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 months. RESULTS Of 91 treated patients, 75 completed the three-year follow-up. Three implants were lost (two control and one test implant). The survival rates were 98.7% and 97.3%, and the mean marginal bone level change was -0.78 ± 0.75 and -0.60 ± 0.71 mm for TiZr and Ti Grade IV implants. Most patients had a plaque score of 0 or 1 (54% for test and 51.7% for control), and a sulcus bleeding score of 0 (46.1% for test and 44.9% for control). No significant differences were found between the two implant types for bone-level change, soft tissue parameters, survival and success. CONCLUSIONS After 36 months, similar outcomes were found between Ti Grade IV and TiZr implants. The results confirm that the results seen at 12 months continue over time.

Hypotensive resuscitation versus standard fluid resuscitation for the management of trauma patients in hemorrhagic shock: The safety phase of a randomized controlled trial

Trauma is a leading cause of death worldwide, and is thus a major public health concern. Improving current resuscitation strategies may help to reduce morbidity and mortality from trauma, and clinical research plays an important role in addressing these issues. This thesis is a secondary analysis of data that was collected for a randomized clinical trial being conducted at Ben Taub General Hospital. The trial is designed to compare a hypotensive resuscitation strategy to standard fluid resuscitation for the early treatment of trauma patients in hemorrhagic shock. This thesis examines the clinical outcomes from the first 90 subjects enrolled in the study, with the primary aim of assessing the safety of hypotensive resuscitation within the trauma population. ^ Patients in hemorrhagic shock who required emergent surgery were randomized to one of two arms of the study. Those in the experimental (LMAP) arm were managed with a hypotensive resuscitation strategy in which the target mean arterial pressure was 50mmHg. Those in the control (HMAP) arm were managed with standard fluid resuscitation to a target mean arterial pressure of 65mmHg. Patients were followed for 30 days. Mortality, post-operative complications, and other clinical data were prospectively gathered by the Ben Taub surgical staff and then secondarily analyzed for the purpose of this thesis.^ Subjects in the LMAP group had significantly lower early post-operative mortality compared to those in the HMAP group. 30-day mortality was also lower in the LMAP group, although this did not reach statistical significance. There were no statistically significant differences between the two groups with regards to development of ischemic, hematologic or infectious complications, length of hospitalization, length of ICU stay or duration of mechanical ventilation. ^ Based upon the data presented in this thesis, it appears that hypotensive resuscitation is a safe strategy for use in the trauma population. Specifically, hypotensive resuscitation reduced the risk of early post-operative death from coagulopathic bleeding and did not result in an increased risk of ischemic or other post-operative complications. The preliminary results described in this thesis provide convincing evidence support the continued investigation and use of hypotensive resuscitation in a trauma setting.^

Health outcomes, quality improvement and cost-effectiveness of the Community Diabetes Education (CoDE) program: Results of a randomized controlled trial

The objectives of this dissertation were to evaluate health outcomes, quality improvement measures, and the long-term cost-effectiveness and impact on diabetes-related microvascular and macrovascular complications of a community health worker-led culturally tailored diabetes education and management intervention provided to uninsured Mexican Americans in an urban faith-based clinic. A prospective, randomized controlled repeated measures design was employed to compare the intervention effects between: (1) an intervention group (n=90) that participated in the Community Diabetes Education (CoDE) program along with usual medical care; and (2) a wait-listed comparison group (n=90) that received only usual medical care. Changes in hemoglobin A1c (HbA1c) and secondary outcomes (lipid status, blood pressure and body mass index) were assessed using linear mixed-models and an intention-to-treat approach. The CoDE group experienced greater reduction in HbA1c (-1.6%, p<.001) than the control group (-.9%, p<.001) over the 12 month study period. After adjusting for group-by-time interaction, antidiabetic medication use at baseline, changes made to the antidiabetic regime over the study period, duration of diabetes and baseline HbA1c, a statistically significant intervention effect on HbA1c (-.7%, p=.02) was observed for CoDE participants. Process and outcome quality measures were evaluated using multiple mixed-effects logistic regression models. Assessment of quality indicators revealed that the CoDE intervention group was significantly more likely to have received a dilated retinal examination than the control group, and 53% achieved a HbA1c below 7% compared with 38% of control group subjects. Long-term cost-effectiveness and impact on diabetes-related health outcomes were estimated through simulation modeling using the rigorously validated Archimedes Model. Over a 20 year time horizon, CoDE participants were forecasted to have less proliferative diabetic retinopathy, fewer foot ulcers, and reduced numbers of foot amputations than control group subjects who received usual medical care. An incremental cost-effectiveness ratio of $355 per quality-adjusted life-year gained was estimated for CoDE intervention participants over the same time period. The results from the three areas of program evaluation: impact on short-term health outcomes, quantification of improvement in quality of diabetes care, and projection of long-term cost-effectiveness and impact on diabetes-related health outcomes provide evidence that a community health worker can be a valuable resource to reduce diabetes disparities for uninsured Mexican Americans. This evidence supports formal integration of community health workers as members of the diabetes care team.^

Administration of misoprostol by trained traditional birth attendants to prevent postpartum haemorrhage in homebirths in Pakistan: a randomised placebo-controlled trial

Gynuity

Misoprostol in addition to routine treatment of postpartum hemorrhage: A hospital-based randomized-controlled trial in Karachi, Pakistan

Background: Postpartum hemorrhage (PPH) remains a major killer of women worldwide. Standard uterotonic treatments used to control postpartum bleeding do not always work and are not always available. Misoprostol's potential as a treatment option for PPH is increasingly known, but its use remains ad hoc and available evidence does not support the safety or efficacy of one particular regimen. This study aimed to determine the adjunct benefit of misoprostol when combined with standard oxytocics for PPH treatment. Methods: A randomized controlled trial was conducted in four Karachi hospitals from December 2005 – April 2007 to assess the benefit of a 600 mcg dose of misoprostol given sublingually in addition to standard oxytocics for postpartum hemorrhage treatment. Consenting women had their blood loss measured after normal vaginal delivery and were enrolled in the study after losing more than 500 ml of blood. Women were randomly assigned to receive either 600 mcg sublingual misoprostol or matching placebo in addition to standard PPH treatment with injectable oxytocics. Both women and providers were blinded to the treatment assignment. Blood loss was collected until active bleeding stopped and for a minimum of one hour after PPH diagnosis. Total blood loss, hemoglobin measures, and treatment outcomes were recorded for all participants. Results: Due to a much lower rate of PPH than expected (1.2%), only sixty-one patients were diagnosed and treated for their PPH in this study, and we were therefore unable to measure statistical significance in any of the primary endpoints. The addition of 600 mcg sublingual misoprostol to standard PPH treatments does, however, suggest a trend in reduced postpartum blood loss, a smaller drop in postpartum hemoglobin, and need for fewer additional interventions. Women who bled less overall had a significantly smaller drop in hemoglobin and received fewer additional interventions. There were no hysterectomies or maternal deaths among study participants. The rate of transient shivering and fever was significantly higher among women receiving misoprostol Conclusion: A 600 mcg dose of misoprostol given sublingually shows promise as an adjunct treatment for PPH and its use should continue to be explored for its life-saving potential in the care of women experiencing PPH. Trial Registration: Clinical trials.gov, Registry No. NCT00116480

Two Distinct Oral Routes of Misoprostol in Mifepristone Medical Abortion. A Randomized Controlled Trial

http://pdfs.journals.lww.com/greenjournal/2008/12000/Two_Distinct_Oral_Routes_of_Misoprostol_in.18.pdf?token=method|ExpireAbsolute;source|Journals;ttl|1369920806057;payload|mY8D3u1TCCsNvP5E421JYPPlNl9ZUXrQDsjmMHeXqBgfxP56d5BAis+WhfSrPR1S6lcHrAT5WTvTkrI7Jc1zUq2UlEn8N1x7qr2heZXbSZE2/LnQkUnbAwLtuHlqxiruZhFwwtFf4aeU4rMgwns+8TDbNbAkOUlffcIt0OqswFvWf97qU1+XR+GRM7R1S2drJjlMZyk5umnCyX0ZsO+WQO3OqrC6kWZHGFmwsUyPoy3TkarWdvvy6Y+Y2j71uz08ZT48Kq4FnoD9k2sZ/f2+VtLuq7uoIKDiRliJeppVX+rw4UyT+wiUZhSlAJO7dAyjR9vmyVAWVtaC6WwAPrLYreszSV1KWThE7hh6oMJQ6lmjEbXKC+gaal/PsKlfuCcwBrUqJIORKZEJNXxZBdgr3PQsdpBR5D41VaEH2MOCVFQOReXo4fsg/YHzlI735ThKGKWml7j5Rn+50uie6sSdJqjf0QLWOa0q+IPzv3lP9DbtjtVBzj37I05+xyFEQYy8hkPvrHfu33uPvCYtoLj6J9uZawa0r/hG4jNiOlz9FC7GJdeYruj0bK5VQBSvsgdY/dBIMeG3lNTXUCUcvJSluK0aGIw6Dz6nHkcE/3S4anFLYlT+riIYTCGiEX23hvUO;hash|BM4+yd44xH/IRKdsrM1Wzg==

Exercise during pregnancy reduces the rate of cesarean and instrumental deliveries: results of a randomized controlled trial

Objective: In this study, the authors assessed the effects of a structured, moderate-intensity exercise program during the entire length of pregnancy on a woman’s method of delivery. Methods: A randomized controlled trial was conducted with 290 healthy pregnant Caucasian (Spanish) women with a singleton gestation who were randomly assigned to either an exercise (n=138) or a control (n=152) group. Pregnancy outcomes, including the type of delivery, were measured at the end of the pregnancy. Results: The percentage of cesarean and instrumental deliveries in the exercise group were lower than in the control group (15.9%, n=22; 11.6%, n=16 vs. 23%, n=35; 19.1%, n=29, respectively; p=0.03). The overall health status of the newborn as well as other pregnancy outcomes were unaffected. Conclusions: Based on these results, a supervised program of moderate-intensity exercise performed throughout pregnancy was associated with a reduction in the rate of cesarean sections and can be recommended for healthy women in pregnancy.

Exercise during pregnancy improves maternal glucose screen at 24-28 weeks: a randomised controlled trial

Objective. The influence of an exercise programme performed by healthy pregnant women on maternal glucose tolerance was studied. Study design. A physical activity (PA, land/aquatic activities) programme during the entire pregnancy (three sessions per week) was conducted by a qualified instructor. 83 healthy pregnant women were randomly assigned to either an exercise group (EG, n=40) or a control (CG, n=43) group. 50 g maternal glucose screen (MGS), maternal weight gain and several pregnancy outcomes were recorded. Results. Significant differences were found between study groups on the 50 g MGS. Values corresponding to the EG (103.8±20.4 mg/dl) were better than those of the CG (126.9±29.5 mg/dl), p=0.000. In addition, no differences in maternal weight gain and no cases of gestational diabetes in EG versus 3 in CG (7%) (p>0.05) were found. Conclusion. A moderate PA programme performed during pregnancy improves levels of maternal glucose tolerance.

Exercise during pregnancy and gestational diabetes related adverse effects: a randomized controlled trial

Ejercicio, embarazo y diabetes

Pelvic Floor Muscle Training Included in a Pregnancy Exercise Program Is Effective in Primary Prevention of Urinary Incontinence: A Randomized Controlled Trial

AIMS: To investigate the effect of pelvic floor muscle training (PFMT) taught in a general exercise class during pregnancy on the prevention of urinary incontinence (UI) in nulliparous continent pregnant women. METHODS: This was a unicenter two armed randomized controlled trial. One hundred sixty-nine women were randomized by a central computer system to an exercise group (EG) (exercise class including PFMT) (n = 73) or a control group (CG) (n = 96). 10.1% loss to follow-up: 10 from EG and 7 from CG. The intervention consisted of 70-75 sessions (22 weeks, three times per week, 55-60 min/session including 10 min of PFMT). The CG received usual care (which included follow up by midwifes including information about PFMT). Questions on prevalence and degree of UI were posed before (week 10-14) and after intervention (week 36-39) using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). RESULTS: At the end of the intervention, there was a statistically significant difference in favor of the EG. Reported frequency of UI [Never: CG: 54/60.7%, EG: 60/95.2% (P < 0.001)]. Amount of leakage [None: CG: 45/60.7%, EG: 60/95.2% (P < 0.001)]. There was also a statistically significant difference in ICIQ-UI SF Score between groups after the intervention period [CG: 2.7 (SD 4.1), EG: 0.2 (SD 1.2) (P < 0.001)]. The estimated effect size was 0.8. CONCLUSION: PFMT taught in a general exercise class three times per week for at least 22 weeks, without former assessment of ability to perform a correct contraction was effective in primary prevention of UI in primiparous pregnant women.

Adaptaciones cardiacas hemodinámicas, estructurales y funcionales a un programa de ejercicio físico supervisado durante el embarazo: ensayo clínico aleatorizado = Hemodynamic, structural and functional cardiac adaptations in a supervised physical exercise program during pregnancy: a randomized controlled trial

Introducción: Diversos cambios ocurren en el sistema cardiovascular materno durante el embarazo, lo que genera un gran estrés sobre este sistema especialmente durante el tercer trimestre, pudiendo acentuarse en presencia de determinados factores de riesgo. Los objetivos de este estudio fueron, valorar las adaptaciones cardiovasculares producidas por un programa específico de ejercicio físico; su seguridad sobre el sistema cardiovascular materno y los resultados del embarazo; y su eficacia en el control de los factores de riesgo cardiovascular. Material y métodos: El diseño del estudio fue un ensayo clínico aleatorizado. 151 gestantes sanas fueron evaluadas mediante un ecocardiograma y un electrocardiograma en la semana 20 y 34 de gestación. Un total de 89 gestantes participaron en un programa de ejercicio físico (GE) desde el primer hasta el tercer trimestre de embarazo, constituido principalmente por 25-30 minutos de trabajo aeróbico (55-60% de la frecuencia cardiaca de reserva), trabajo de fortalecimiento general y específico, y un trabajo de tonificación del suelo pélvico; desarrollado 3 días a la semana con una duración de 55-60 minutos cada sesión. Las gestantes aleatoriamente asignadas al grupo de control (GC; n=62) permanecieron sedentarias durante el embarazo. El estudio fue aprobado por el Comité Ético de investigación clínica del Hospital Universitario de Fuenlabrada. Resultados: Las características basales fueron similares entre ambos grupos. A diferencia del GC, las gestantes del GE evitaron el descenso significativo del gasto cardiaco indexado, entre el 2º y 3ºT de embarazo, y conservaron el patrón geométrico normal del ventrículo izquierdo; mientras que en el GC cambió hacia un patrón de remodelado concéntrico. En la semana 20, las gestantes del GE presentaron valores significativamente menores de frecuencia cardiaca (GC: 79,56±10,76 vs. GE: 76,05±9,34; p=0,04), tensión arterial sistólica (GC: 110,19±10,23 vs. GE: 106,04±12,06; p=0,03); tensión arterial diastólica (GC: 64,56±7,88 vs. GE: 61,81±7,15; p=0,03); tiempo de relajación isovolumétrica (GC: 72,94±14,71 vs. GE: 67,05±16,48; p=0,04); y un mayor tiempo de deceleración de la onda E (GC: 142,09±39,11 vs. GE: 162,10±48,59; p=0,01). En la semana 34, el GE presentó valores significativamente superiores de volumen sistólico (GC: 51,13±11,85 vs. GE: 56,21±12,79 p=0,04), de llenado temprano del ventrículo izquierdo (E) (GC: 78,38±14,07 vs. GE: 85,30±16,62; p=0,02) y de tiempo de deceleración de la onda E (GC: 130,35±37,11 vs. GE: 146,61±43,40; p=0,04). Conclusión: La práctica regular de ejercicio físico durante el embarazo puede producir adaptaciones positivas sobre el sistema cardiovascular materno durante el tercer trimestre de embarazo, además de ayudar en el control de sus factores de riesgo, sin alterar la salud materno-fetal. ABSTRACT Background: Several changes occur in the maternal cardiovascular system during pregnancy. These changes produce a considerable stress in this system, especially during the third trimester, which can be increased in presence of some risk factors. The aims of this study were, to assess the maternal cardiac adaptations in a specific exercise program; its safety on the maternal cardiovascular system and pregnancy outcomes; and its effectiveness in the control of cardiovascular risk factors. Material and methods: A randomized controlled trial was designed. 151 healthy pregnant women were assessed by an echocardiography and electrocardiography at 20 and 34 weeks of gestation. A total of 89 pregnant women participated in a physical exercise program (EG) from the first to the third trimester of pregnancy. It consisted of 25-30 minutes of aerobic conditioning (55-60% of their heart rate reserve), general and specific strength exercises, and a pelvic floor muscles training; 3 times per weeks during 55-60 minutes per session. Pregnant women randomized allocated to the control group (CG) remained sedentary during pregnancy. The study was approved by the Research Ethics Committee of Hospital Universitario de Fuenlabrada. Results: Baseline characteristics were similar between groups. Difference from the CG, pregnant women from the EG prevented the significant decrease of the cardiac output index, between the 2nd and 3rd trimester of pregnancy, and preserved the normal left ventricular pattern; whereas in the CG shifted to concentric remodeling pattern. At 20 weeks, women in the EG had significant lower heart rate (CG: 79,56±10,76 vs. EG: 76,05±9,34; p=0,04), systolic blood pressure (CG: 110,19±10,23 vs. EG: 106,04±12,06; p=0,03); diastolic blood pressure (CG: 64,56±7,88 vs. EG: 61,81±7,15; p=0,03); isovolumetric relaxation time (GC: 72,94±14,71 vs. GE: 67,05±16,48; p=0,04); and a higher deceleration time of E Wave (GC: 142,09±39,11 vs. GE: 162,10±48,59; p=0,01). At 34 weeks, the EG had a significant higher stroke volume (CG: 51,13±11,85 vs. EG: 56,21±12,79 p=0,04), early filling of left ventricular (E) (CG: 78,38±14,07 vs. EG: 85,30±16,62; p=0,02) and deceleration time of E wave (CG: 130,35±37,11 vs. EG:146,61±43,40; p=0,04). Conclusion: Physical regular exercise program during pregnancy may produce positive maternal cardiovascular adaptations during the third trimester of pregnancy. In addition, it helps to control the cardiovascular risk factors without altering maternal and fetus health.

Surgical trial in traumatic intracerebral haemorrhage (STITCH) : A randomised controlled trial of early surgery compared with Initial conservative treatment

Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme.

Antibiotic treatment for intermittent bladder catheterisation with once daily prophylaxis (the AnTIC study) : Study protocol for a randomised controlled trial

Funder statement This article/paper/report presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the UK Government’s Department of Health. Acknowledgements We would like to acknowledge Dr Graeme MacLennan, Mr Simon Skene, Mr Julian Shah and Dr Nadine Dougall (past member) for their valuable contribution to the study as DMC members. We would like to thank Professor Chris Butler, Dr Emma Hall, Mr Roland Morley, Mr Dan Wood, Ms Jane Laws and Ms Sarah Bittlestone for their oversight of the AnTIC study as members of the TSC, and we would like to thank Ms Heather Armstrong for her contributions as a patient group representative. We thank all Principal Investigators and site staff for their commitment in recruitment for the AnTIC study. Finally, we would like to thank Hazel Wilde for secretarial support. The trial is funded by the NIHR Health Technology Assessment Programme (project reference: 11-72-01) and will be published in full in the Health Technology Assessment journal series. The authors also acknowledge the support of the National Institute for Health Research through the Comprehensive Clinical Research Network.