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A total of 40 students mean age: Hip flexion ROM was measured using a digital goniometer with the passive straight leg raise test before and after 4 weeks by two physiotherapists blinded to the groups. Full Text Available Introduction: Endotracheal tube suctioning is essential for improve oxygenation in the patients undergoing mechanical ventilation. There are two types of shallow and deep endotracheal tube suctioning.
This study aimed to evaluate the effect of shallow and deep suctioning methods on respiratory rate RR, arterial blood oxygen saturation SpO2 and number of suctioning in patients hospitalized in the intensive care units of Al-Zahra Hospital, Isfahan, Iran.
Methods: In this randomized controlled trial , 74 patients who hospitalized in the intensive care units of Isfahan Al-Zahra Hospital were randomly allocated to the shallow and deep suctioning groups. RR and SpO2 were measured immediately before, immediately after, 1 and 3 minute after each suctioning.
Number of suctioning was also noted in each groups. Results: RR was significantly increased and SpO2 was significantly decreased after each suctioning in the both groups. However, these changes were not significant between the two groups. The numbers of suctioning was significantly higher in the shallow suctioning group than in the deep suctioning group.
Therefore, it seems that deep endotracheal tube suctioning method can be used to clean the airway with lesser manipulation of the trachea. Comparison the effects of shallow and deep endotracheal tube suctioning on respiratory rate, arterial blood oxygen saturation and number of suctioning in patients hospitalized in the intensive care unit: a randomized controlled trial.
Endotracheal tube suctioning is essential for improve oxygenation in the patients undergoing mechanical ventilation. This study aimed to evaluate the effect of shallow and deep suctioning methods on respiratory rate RR , arterial blood oxygen saturation SpO2 and number of suctioning in patients hospitalized in the intensive care units of Al-Zahra Hospital, Isfahan, Iran. In this randomized controlled trial , 74 patients who hospitalized in the intensive care units of Isfahan Al-Zahra Hospital were randomly allocated to the shallow and deep suctioning groups.
RR was significantly increased and SpO2 was significantly decreased after each suctioning in the both groups. However, shallow suctioning caused further manipulation of patient's trachea than deep suctioning method. Acupuncture and asthma: a review of controlled trials. Controlled trials have been reviewed to determine whether clearer conclusions could be obtained by assessing as many studies as possible according to.
Poison control center - Emergency number image. For a poison emergency call anywhere in the United States. This national hotline number will let you All local poison control centers in the U. Getting DNA copy numbers without control samples. Full Text Available Abstract Background The selection of the reference to scale the data in a copy number analysis has paramount importance to achieve accurate estimates.
Usually this reference is generated using control samples included in the study. However, these control samples are not always available and in these cases, an artificial reference must be created. A proper generation of this signal is crucial in terms of both noise and bias.
It is based on the assumption that genomic regions enriched in SNPs with identical copy numbers in both alleles are likely to be normal. These normal regions are predicted for each sample individually and used to calculate the final reference signal. NSA can be applied to any CN data regardless the microarray technology and preprocessing method. It also finds an optimal weighting of the samples minimizing possible batch effects.
It is shown that using only tumoral samples, NSA is able to remove the bias in the copy number estimation, to reduce the noise and therefore, to increase the ability to detect copy number aberrations CNAs. These improvements allow NSA to also detect recurrent aberrations more accurately than other state of the art methods. Conclusions NSA provides a robust and accurate reference for scaling probe signals data to CN values without the need of control samples.
It minimizes the problems of bias, noise and batch effects in the estimation of CNs. The automatic selection of references makes it useful to perform bulk analysis of many GEO or ArrayExpress experiments without the need of developing a parser to find the normal samples or possible batches within the.
The selection of the reference to scale the data in a copy number analysis has paramount importance to achieve accurate estimates. NSA provides a robust and accurate reference for scaling probe signals data to CN values without the need of control samples. The automatic selection of references makes it useful to perform bulk analysis of many GEO or ArrayExpress experiments without the need of developing a parser to find the normal samples or possible batches within the data.
The method is available in the open-source R package. Rhythm vs. Background: Whenever feasible, rhythm control of atrial fibrillation AF was generally preferred over rate control , in the belief that it offered better symptomatic relief and quality of life, and eliminated the need for anticoagulation.
However, recent trials appear to challenge these assumptions. Aims: To explore the desirability of rhythm vs. Protocol for a double-blind randomised placebo- controlled trial of lithium carbonate in patients with amyotrophic Lateral Sclerosis LiCALS [Eudract number : Full Text Available Abstract Background Amyotrophic lateral sclerosis is a rapidly progressive neurodegenerative disorder characterised by loss of motor neurons leading to severe weakness and death from respiratory failure within years.
Riluzole prolongs survival in ALS. A published report has suggested a dramatic effect of lithium carbonate on survival. In the group treated with lithium, no patients had died i. Although the trial can be criticised on several grounds, there is a substantial rationale from other laboratory studies that lithium is worth investigating therapeutically in amyotrophic lateral sclerosis. All patients will be on the standard treatment for ALS of riluzole mg daily. The primary outcome measure will be death from any cause at 18 months defined from the date of randomisation.
Eligible patients will have El Escorial Possible, Laboratory-supported Probable, Probable or Definite amyotrophic lateral sclerosis with disease duration between 6 months and 36 months inclusive, vital. Protocol for a double-blind randomised placebo- controlled trial of lithium carbonate in patients with amyotrophic lateral sclerosis LiCALS [Eudract number : ].
Amyotrophic lateral sclerosis is a rapidly progressive neurodegenerative disorder characterised by loss of motor neurons leading to severe weakness and death from respiratory failure within years. LiCALS is a multi-centre double-blind randomised parallel group controlled trial of the efficacy, safety, and tolerability of lithium carbonate LiCO3 at doses to achieve stable 'therapeutic' plasma levels 0.
The recovery of the patient should be facilitated as the result of therapeutic research. The basic rule for every therapeutic-clinical trial mist involve a comparison of therapeutic approaches. In acute conditions, such as acute infectious diseases, infarcts, etc. The formation of groups, to be compared one with the other can be justified only if one is reasonably sure that a pathogenic condition indeed exists. In chronic diseases, which extend essentially unchanged over a lengthy period but are nevertheless reversible, therapeutic comparisons may be made between two or more time intervals within the course of the disease in the same individual.
This type of therapeutic trial rests primarily upon a refined! The collective therapeutic comparison, on the one hand, and the individual therapeutic comparison on the other, overlap somewhat in scope. The immediate therapeutic effect is not always an indication of its true value, which may become evident only upon long-term treatment. The short-term trials of therapeutic regimens in an individual must, therefore, be frequently supplemented by long-term trials which can only be carried out by comparing two groups.
For many clinical investigations, therefore, the joint efforts of numerous hospitals are absolutely necessary. The second basic rule of therapeutic research is the elimination of secondary causes. The difficulties introduced by these secondary considerations are far greater in therapeutic trials carried out on ambulatory patients than has been hitherto realized.
In order to remove subjective secondary causes, the author demanded, in , the use of hidden or illusory media placebos, dummies that is, unconscious causative agents. The double blind. Random number generation as an index of controlled processing. Random number generation RNG is a functionally complex process that is highly controlled and therefore dependent on Baddeley's central executive.
This study addresses this issue by investigating whether key predictions from this framework are compatible with empirical data. In Experiment 1, the effect of increasing task demands by increasing the rate of the paced generation was comprehensively examined. As expected, faster rates affected performance negatively because central resources were increasingly depleted.
Next, the effects of participants' exposure were manipulated in Experiment 2 by providing increasing amounts of practice on the task. There was no improvement over 10 practice trials , suggesting that the high level of strategic control required by the task was constant and not amenable to any automatization gain with repeated exposure. Together, the results demonstrate that RNG performance is a highly controlled and demanding process sensitive to additional demands on central resources Experiment 1 and is unaffected by repeated performance or practice Experiment 2.
These features render the easily administered RNG task an ideal and robust index of executive function that is highly suitable for repeated clinical use. ComOn Coaching: Study protocol of a randomized controlled trial to assess the effect of a varied number of coaching sessions on transfer into clinical practice following communication skills training.
Communication skills training has proven to be an effective means to enhance communication of health care professionals in oncology. These effects are well studied in standardized settings. The question of transferring these skills into clinical consultations remains open.
We build up on a previous developed training concept consisting of a workshop and coaching. This training achieved a medium effect size in two studies with standardized patients. In the current study, we expanded and manualized the coaching concept, and we will evaluate effects of a varied number of coaching sessions on real clinical consultations.
Our aim is to determine how much coaching oncologists need to transfer communication skills into clinical practice. Physicians of two German medical centers will participate in a workshop for communication skills and will be randomized to either a group with one coaching session or a group with four coaching sessions following the workshop. The participation is voluntary and the physicians will receive medical education points. Consultations held by the participating physicians with actual patients who gave their informed consent will be filmed at three time points.
These consultations will be evaluated by blinded raters using a checklist based on the training content primary outcome. Secondary outcomes will be the self-evaluated communication competence by physicians and an evaluation of the consultations by both physicians and patients. We will evaluate our communication training concept on three levels - rater, physician and patient - and concentrate on the transfer of communication skills into real life situations.
As we emphasize the external validity in this study design, limitations will be expected due to heterogeneity of data. With this study we aim to gain data on how to improve communication skills training that will result in better patient outcomes. An open trial assessment of "The Number Race", an adaptive computer game for remediation of dyscalculia. Full Text Available Abstract Background In a companion article 1, we described the development and evaluation of software designed to remediate dyscalculia.
This software is based on the hypothesis that dyscalculia is due to a "core deficit" in number sense or in its access via symbolic information. Here we review the evidence for this hypothesis, and present results from an initial open- trial test of the software in a sample of nine 7—9 year old children with mathematical difficulties.
Methods Children completed adaptive training on numerical comparison for half an hour a day, four days a week over a period of five-weeks. They were tested before and after intervention on their performance in core numerical tasks: counting, transcoding, base comprehension, enumeration, addition, subtraction, and symbolic and non-symbolic numerical comparison. Results Children showed specific increases in performance on core number sense tasks.
Speed of subitizing and numerical comparison increased by several hundred msec. Performance on addition and base comprehension tasks did not improve over the period of the study. Conclusion Initial open- trial testing showed promising results, and suggested that the software was successful in increasing number sense over the short period of the study. However these results need to be followed up with larger, controlled studies. The issues of transfer to higher-level tasks, and of the best developmental time window for intervention also need to be addressed.
Background In a companion article , we described the development and evaluation of software designed to remediate dyscalculia. Do randomized controlled trials discuss healthcare costs? Our objective was to assess the frequency and factors associated with the inclusion of costs in RCTs. Two reviewers independently extracted cost data and study characteristics. Frequencies were calculated and potential characteristics associated with the inclusion of costs were explored.
Actual drug costs were included in 4. Journal, study conclusions, study location, primary author's country and product age were not associated with inclusion of cost information. Industry funded trials were less likely to include cost information. No other factors were associated with the inclusion of cost information.
Healthcare costs, particularly pharmaceutical costs, are a dominant issue for most healthcare organizations, but it is unclear if randomized controlled trials RCTs routinely discuss costs. We randomly sampled RCTs spanning three years from six high impact journals. Randomised controlled trial of mesalazine in IBS. Low-grade intestinal inflammation plays a role in the pathophysiology of IBS. In this trial , we aimed at evaluating the efficacy and safety of mesalazine in patients with IBS.
We conducted a phase 3, multicentre, tertiary setting, randomised, double-blind, placebo- controlled trial in patients with Rome III confirmed IBS. The key secondary endpoint was satisfactory relief of overall IBS symptoms. A total of patients with IBS were enrolled from 21 centres. For the primary endpoint, the responder patients were For the key secondary endpoint, overall symptoms improved in the mesalazine group and reached a significant difference of Mesalazine treatment was not superior than placebo on the study primary endpoint.
However, a subgroup of patients with IBS showed a sustained therapy response and benefits from a mesalazine therapy. Clincial Trials. Inadequate description of educational interventions in ongoing randomized controlled trials. Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency.
Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials RCTs of patient education. We included trials evaluating an educational intervention that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers.
We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected of potentially eligible studies and appraised a random sample of records. All selected trials were registered in 4 registers, mainly Clinical Trials. The median [interquartile range] target sample size was [ to ] patients.
Randomised controlled trials in Scandinavian educational research. Specifically, we investigate drivers and barriers for randomised controlled trials in educational research and the differences between the three Scandinavian countries Supporting institutions have now been established in all three countries, and we believe that the use of RCTs in Scandinavian educational research is likely to continue We included both conducted and ongoing trials.
Publications that seemed External validity of randomized controlled trials of glycaemic control and vascular disease: how representative are participants? To describe the proportion of people with Type 2 diabetes living in Scotland who meet eligibility criteria for inclusion in several large randomized controlled trials of glycaemic control to inform physicians and guideline developers about the generalizibility of trial results.
A literature review was performed to identify large trials assessing the impact of glycaemic control on risk of macrovascular disease. Seven trials were identified. The proportion of people with Type 2 diabetes who met the eligibility criteria for the trials ranged from 3. Trial participants were younger at age of diagnosis of diabetes and at time of trial recruitment than in the Scottish study population.
We found that many of the large trials of glycaemic control among people with Type 2 diabetes have limited external validity when applied to a population-based cohort of people with Type 2 diabetes. In particular, the age distribution of trial participants often does not reflect that of people with Type 2 diabetes in a contemporary British population.
A prospective randomised controlled trial. Department of Obstetrics and Gynae If abortion had not taken place Tygerberg Hospital for permission to publish, and Upjohn. Pry Ltd for supplying the Prepidil gel used in the study. Is the randomised controlled trial the best? The randomised controlled trial RCT is recog nised as the gold standard of research methods, particularly to test efficacy.
The primary benefit of the RCT, as everyone knows, is to prevent patient selection bias. And it should also guarantee some rigour of research methodology. It is always prospective. In a nonrandomised Clinical trials involving human subjects give rise to ethical and medico-legal dilemmas. Essential research of new drugs may potentially expose patients to ineffective medications or to placebo.
The complexity of the problem increases when dealing with mentally ill patients, for whom, on the one hand there is no known cure for their disease, and on the other hand, it is sometimes questionable whether or not they are able to provide informed consent to participate in clinical trials.
The Israel Psychiatric Association decided to develop a position paper on the subject of placebo- controlled clinical trials in schizophrenia patients. Discussion groups were established, and the available material in the professional literature was examined, with an emphasis on recent developments.
The Declaration of Helsinki and its amendments were analyzed, and experts in the field were consulted. Clinical drug trials for development of new medications are essential in all fields of medicine, especially in psychiatry.
The requirement for a placebo arm in pharmaceutical trials presents ethical and clinical dilemmas that are especially complicated with regard to mentally ill persons whose free choice and ability to provide informed consent may be questionable. However, we do not believe that this predicament justifies unconditional rejection of placebo use in psychiatry, when it may provide substantial benefit for some patients.
Simultaneously, it is our duty to provide stringent restrictions that will enable strict supervision over the scientific, clinical and ethical aspects of the trials. We propose the following criteria for approval of pharmaceutical trials that include a placebo arm: scientific justification; clinical and ethical justification; provision of informed consent; recruitment of patients hospitalized voluntarily; prevention of harm; administration of additional potential therapeutic interventions; benefit to patients participating in the study; control and follow.
Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years. The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study The Hawthorne Effect: a randomised, controlled trial. Full Text Available Abstract Background The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied.
Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia.
Methods Participants in a dementia trial were randomised to intensive follow-up with comprehensive assessment visits at baseline and two, four and six months post randomisation or minimal follow-up with an abbreviated assessment at baseline and a full assessment at six months. Results We recruited participants, mainly through general practices. The main analysis was based on Intention to treat ITT, with available data. There was no significant difference on carer quality of life. Conclusion We found that more intensive follow-up of individuals in a placebo- controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning.
Control groups in recent septic shock trials. PURPOSE: The interpretation of septic shock trial data is profoundly affected by patients, control intervention, co-interventions and selected outcome measures. We evaluated the reporting of control groups in recent septic shock trials.
The mean data completeness score was 19 out of 36 range Of 18 predefined control group characteristics, a mean of 8 range The collection of information requirements contained in this regulation has Current numerical accounting of approved refugees is maintained for each special group designated by the President.
As refugee status is An email-based intervention to improve the number and timeliness of letters sent from the hospital outpatient clinic to the general practitioner : A pair-randomized controlled trial. Medlock, Stephanie; Parlevliet, Juliette L. Objective: Letters from the hospital to the general practitioner are important for maintaining continuity of care. Although doctors feel letters are important, they are often not written on time.
To improve the number and timeliness of letters sent from the hospital outpatient department to the. An email-based intervention to improve the number and timeliness of letters sent from the hospital outpatient clinic to the general practitioner: A pair-randomized controlled trial. Letters from the hospital to the general practitioner are important for maintaining continuity of care.
To improve the number and timeliness of letters sent from the hospital outpatient department to the general. Design, analysis and presentation of factorial randomised controlled trials. Full Text Available Abstract Background The evaluation of more than one intervention in the same randomised controlled trial can be achieved using a parallel group design.
However this requires increased sample size and can be inefficient, especially if there is also interest in considering combinations of the interventions. An alternative may be a factorial trial , where for two interventions participants are allocated to receive neither intervention, one or the other, or both. Factorial trials require special considerations, however, particularly at the design and analysis stages.
The main design issue is that of sample size. Factorial trials are most often powered to detect the main effects of interventions, since adequate power to detect plausible interactions requires greatly increased sample sizes. The main analytical issues relate to the investigation of main effects and the interaction between the interventions in appropriate regression models. Presentation of results should reflect the analytical strategy with an emphasis on the principal research questions.
We also give an example of how baseline and follow-up data should be presented. Lastly, we discuss the implications of the design, analytical and presentational issues covered. Summary Difficulties in interpreting the results of factorial trials if an influential interaction is observed is the cost of the potential for efficient, simultaneous consideration of two or more interventions.
Factorial trials can in principle be designed to have adequate power to detect realistic interactions, and in any case they are the only design that allows such effects to be investigated. Extinction of Pavlovian conditioning: The influence of trial number and reinforcement history. Pavlovian conditioning is sensitive to the temporal relationship between the conditioned stimulus CS and the unconditioned stimulus US. This has motivated models that describe learning as a process that continuously updates associative strength during the trial or specifically encodes the CS-US interval.
These models predict that extinction of responding is also continuous, such that response loss is proportional to the cumulative duration of exposure to the CS without the US. We review evidence showing that this prediction is incorrect, and that extinction is trial -based rather than time-based. We also present two experiments that test the importance of trials versus time on the Partial Reinforcement Extinction Effect PREE , in which responding extinguishes more slowly for a CS that was inconsistently reinforced with the US than for a consistently reinforced one.
We show that increasing the number of extinction trials of the partially reinforced CS, relative to the consistently reinforced CS, overcomes the PREE. However, increasing the duration of extinction trials by the same amount does not overcome the PREE. We conclude that animals learn about the likelihood of the US per trial during conditioning, and learn trial-by-trial about the absence of the US during extinction.
Moreover, what they learn about the likelihood of the US during conditioning affects how sensitive they are to the absence of the US during extinction. Full Text Available Introduction. Qigong is currently considered as meditative movement, mindful exercise, or complementary exercise and is being explored for relief of symptoms in fibromyalgia. This narrative review summarizes randomized controlled trials , as well as additional studies, of qigong published to the end of and discusses relevant methodological issues.
Controlled trials indicate regular qigong practice daily, 6—8 weeks produces improvements in core domains for fibromyalgia pain, sleep, impact, and physical and mental function that are maintained at 4—6 months compared to wait-list subjects or baselines.
Comparisons with active controls show little difference, but compared to baseline there are significant and comparable effects in both groups. Open-label studies provide information that supports benefit but remain exploratory. An extension trial and case studies involving extended practice daily, 6—12 months indicate marked benefits but are limited by the number of participants.
Benefit appears to be related to amount of practice. There is considerable potential for qigong to be a useful complementary practice for the management of fibromyalgia. However, there are unique methodological challenges, and exploration of its clinical potential will need to focus on pragmatic issues and consider a spectrum of trial designs. Mechanistic considerations need to consider both system-wide and more specific effects. Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten.
The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement.
Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures. May 10, For seed yield per plant, seed weight per fruit, and number of seeds per fruit, a positive hypothetical heterosis was observed when calabash type was a maternal parent.
Randomised controlled trials : important but overrated? Practising physicians individualise treatments, hoping to achieve optimal outcomes by tackling relevant patient variables. The randomised controlled trial RCT is universally accepted as the best means of comparison. Yet doctors sometimes wonder if particular patients might benefit more from treatments that fared worse in the RCT comparisons.
Such clinicians may even feel ostracised by their peers for stepping outside treatments based on RCTs and guidelines. Are RCTs the only acceptable evaluations of how patient care can be assessed and delivered? In this controversy we explore the interpretation of RCT data for practising clinicians facing individualised patient choices.
First, critical care anaesthetists John Boylan and Brian Kavanagh emphasise the dangers of bias and show how Bayesian approaches utilise prior probabilities to improve posterior combined probability estimates. Secondly, Jane Armitage, of the Clinical Trial Service Unit in Oxford, argues why RCTs remain essential and explores how the quality of randomisation can be improved through systematic reviews and by avoiding selective reporting.
Fuzzy Control of Tidal volume, Respiration number and Pressure value. In this study, control of tidal volume, respiration number and pressure value which are arrived to patient at mechanical ventilator device which is used in intensive care units were performed with fuzzy logic controller. The aim of this system is to reduce workload of aneshesiologist. By calculating tidal volume, respiration number and pressure value, the error Pe k between reference pressure value Pref and pressure of gas given ill person Phasta and error change rate ; ;Pe k were co Recent randomized controlled trials in otolaryngology.
To assess recent trends in the prevalence and quality of reporting of randomized controlled trials RCTs in 4 otolaryngology journals. Methodology and reporting analysis. Randomized controlled trials in 4 otolaryngology journals. All RCTs published from to in 4 major otolaryngology journals were examined for characteristics of study design, quality of design and reporting, and funding.
Of articles published in 4 leading otolaryngology journals from to , 3. Based on review of 4 otolaryngology journals, RCTs are still a small proportion of all published studies in the field of otolaryngology. There seem to be trends toward improvement in quality of design and reporting of RCTs, although many quality features remain suboptimal.
A randomized, controlled trial of oral propranolol in infantile hemangioma. Oral propranolol has been used to treat complicated infantile hemangiomas, although data from randomized, controlled trials to inform its use are limited. We performed a multicenter, randomized, double-blind, adaptive, phase trial assessing the efficacy and safety of a pediatric-specific oral propranolol solution in infants 1 to 5 months of age with proliferating infantile hemangioma requiring systemic therapy.
Infants were randomly assigned to receive placebo or one of four propranolol regimens 1 or 3 mg of propranolol base per kilogram of body weight per day for 3 or 6 months. A preplanned interim analysis was conducted to identify the regimen to study for the final efficacy analysis.
The primary end point was success complete or nearly complete resolution of the target hemangioma or failure of trial treatment at week 24, as assessed by independent, centralized, blinded evaluations of standardized photographs. Of infants who underwent randomization, received treatment. On the basis of an interim analysis of the first patients who completed 24 weeks of trial treatment, the regimen of 3 mg of propranolol per kilogram per day for 6 months was selected for the final efficacy analysis.
Funded by. Relevance of randomised controlled trials in oncology. Well-designed randomised controlled trials RCTs can prevent bias in the comparison of treatments and provide a sound basis for changes in clinical practice. However, the design and reporting of many RCTs can render their results of little relevance to clinical practice. In this Personal View, we discuss the limitations of RCT data and suggest some ways to improve the clinical relevance of RCTs in the everyday management of patients with cancer.
RCTs should ask questions of clinical rather than commercial interest, avoid non-validated surrogate endpoints in registration trials , and have entry criteria that allow inclusion of all patients who are fit to receive treatment. Furthermore, RCTs should be reported with complete accounting of frequency and management of toxicities, and with strict guidelines to ensure freedom from bias. Premature reporting of results should be avoided. The bar for clinical benefit should be raised for drug registration, which should require publication and review of mature data from RCTs, post-marketing health outcome studies, and value-based pricing.
A genome-wide screen for large structural variants showed that a copy number variant CNV in the region encoding killer cell immunoglobulin-like receptors KIR associates with HIV-1 control as measured by plasma viral load at set point in individuals of European ancestry. This CNV encompasses t This part applies to the activities of national The collection of information requirements contained in this part have been approved by the Office of The F1 were advanced to F2 and in each cross over F2 plants were used to evaluate for the number of genes controlling resistance using Mendelian genetics and Interferometric control of the photon- number distribution.
Full Text Available We demonstrate deterministic control over the photon- number distribution by interfering two coherent beams within a disordered photonic lattice. By sweeping a relative phase between two equal-amplitude coherent fields with Poissonian statistics that excite adjacent sites in a lattice endowed with disorder-immune chiral symmetry, we measure an output photon- number distribution that changes periodically between super-thermal and sub-thermal photon statistics upon ensemble averaging.
Thus, the photon-bunching level is controlled interferometrically at a fixed mean photon- number by gradually activating the excitation symmetry of the chiral-mode pairs with structured coherent illumination and without modifying the disorder level of the random system itself.
Full Text Available Cortical networks are composed of excitatory projection neurons and inhibitory interneurons. Finding the right balance between the two is important for controlling overall cortical excitation and network dynamics. However, it is unclear how the correct number of cortical interneurons CIs is established in the mammalian forebrain. CIs are generated in excess from basal forebrain progenitors, and their final numbers are adjusted via an intrinsically determined program of apoptosis that takes place during an early postnatal window.
Here, we provide evidence that the extent of CI apoptosis during this critical period is plastic and cell-type specific and can be reduced in a cell-autonomous manner by acute increases in neuronal activity. We propose that the physiological state of the emerging neural network controls the activity levels of local CIs to modulate their numbers in a homeostatic manner.
Full Text Available A large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of "positive" results in randomized controlled trials of mindfulness-based therapy. We also assessed mindfulness-based therapy trial registrations for indications of possible reporting bias and reviewed recent systematic reviews and meta-analyses to determine whether reporting biases were identified.
The number of positive trials was described and compared to the number that might be expected if mindfulness-based therapy were similarly effective compared to individual therapy for depression. Trial registries were searched for mindfulness-based therapy registrations. No trial registrations adequately specified a single primary outcome measure with time of assessment. None of 36 systematic reviews and meta-analyses concluded that effect estimates were overestimated due to reporting biases.
The proportion of mindfulness-based therapy trials with statistically significant results may overstate what would occur in practice. Full Text Available In a recent paper, the authors derived the exact solution for the probability mass function of the geometric distribution of order k, expressing the roots of the associated auxiliary equation in terms of generating functions for Fuss-Catalan numbers.
This paper applies the above formalism for the Fuss-Catalan numbers to treat additional problems pertaining to occurrences of success runs. New exact analytical expressions for the probability mass function and probability generating function and so forth are derived. The case l trials between success runs, is also studied.
Development in the number of clinical trial applications in Western Europe from to Average annual growth rates AAGRs based on linear regressions. Thus, clinical trial designs in diabetic nephropathy using albuminuria Massage therapy is being used in some neonatal intensive care units for its potential beneficial effects on preterm infants.
This article reviews published randomized controlled trials on the effects of massage in preterm infants. Most studies evaluating the effect of massage in weight gain in premature infants suggest a positive effect on weight gain. Increase in vagal tone has been reported in infants who receive massage and has been suggested as a possible mechanism for improved weight gain.
More studies are needed on the underlying mechanisms of the effects of massage therapy on weight gain in preterm infants. While some trials suggest improvements in developmental scores, decreased stress behavior, positive effects on immune system, improved pain tolerance and earlier discharge from the hospital, the number of such studies is small and further evidence is needed.
Further studies, including randomized controlled trials , are needed on the effects of massage in preterm infants. Logan, Jennifer K. Jack; Heymach, John V. Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other.
Methods and Materials: From June to March , patients who were enrolled on 3 prospective institutional protocols an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer were screened for protocol eligibility. Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients.
Results: A total of eligible patients were approached about trial enrollment. Enrolled patients were more likely to be presented trial information at an earlier appointment oligometastatic protocol: 5 vs 3 appointments [P control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.
This CNV encompasses What's your number? The effects of trial order on the one-target advantage. When moving our upper-limb towards a single target, movement times are typically shorter than when movement to a second target is required. This is known as the one-target advantage. Most studies that have demonstrated the one-target advantage have employed separate trial blocks for the one- and two-segment movements. One- and two-segment responses were organized in blocked i.
Similar to previous studies, where only blocked schedules have typically been utilized, the one-target advantage emerged during the blocked and alternate conditions, but not in the random condition. This finding indicates that the one-target advantage is contingent on participants knowing the number of movement segments prior to stimulus onset. At 12 months, health-related QoL was similar regardless of group. Shorter, more frequent mobilisation early after stroke may be associated with a more favourable outcome.
Opioid detoxification : from controlled clinical trial to clinical practice. Controlled clinical trials have high internal validity but suffer from difficulties in external validity. This study evaluates the generalizability of the results of a controlled clinical trial on rapid detoxification in the everyday clinical practice of two addiction treatment centers.
The results. Counting on the mental number line to make a move: sensorimotor 'pen' control and numerical processing. Mathematics is often conducted with a writing implement. But is there a relationship between numerical processing and sensorimotor 'pen' control? We asked participants to move a stylus so it crossed an unmarked line at a location specified by a symbolic number , where number colour indicated whether the line ran left-right 'normal' or vice versa 'reversed'.
The task could be simplified through the use of a 'mental number line' MNL. Many modern societies use number lines in mathematical education and the brain's representation of number appears to follow a culturally determined spatial organisation so better task performance is associated with this culturally normal orientation-the MNL effect. Participants counter-balanced completed two consistent blocks of trials , 'normal' and 'reversed', followed by a mixed block where line direction varied randomly.
Experiment 1 established that the MNL effect was robust, and showed that the cognitive load associated with reversing the MNL not only affected response selection but also the actual movement execution indexed by duration within the mixed trials. Experiment 2 showed that an individual's motor abilities predicted performance in the difficult mixed condition but not the easier blocks.
These results suggest that numerical processing is not isolated from motor capabilities-a finding with applied consequences. Researchers sometimes undertake qualitative research with randomised controlled trials RCTs of health interventions. To systematically explore how qualitative research is being used with trials and identify ways of maximising its value to the trial aim of providing evidence of effectiveness of health interventions.
A sequential mixed methods study with four components. The articles focused on 22 aspects of the trial within five broad categories. Some focused on more than one aspect of the trial , totalling examples. The potential value of the qualitative research to the trial endeavour included improving the external validity of trials and facilitating interpretation of trial findings.
This value could be maximised by using qualitative research more at the pre- trial stage and reporting findings with explicit attention to the implications for the trial endeavour. During interviews. To compare individual efficacy and additive effects of pain control interventions in preterm neonates. Level-3 University affiliated neonatal intensive care unit. Exclusion criteria were neurologic impairment and critical illness precluding study interventions.
Neonates were randomly assigned to Kangaroo mother care with Music therapy, Music therapy, Kangaroo Mother care or Control no additional intervention groups. All groups received expressed breast milk with cup and spoon as a baseline pain control intervention. The mean SD birth weight and gestational age of the neonates was 1. Kangaroo mother care with and without Music therapy with expressed breast milk significantly reduces pain on heel-prick as compared to expressed breast milk alone.
Kangaroo mother care with expressed breast milk should be the first choice as a method for pain control in preterm neonates. Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from to Partner randomized controlled trial : study protocol and coaching intervention.
Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control , identify concerns or problems with management, or provide self-management education.
Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial RCT to evaluate a month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care.
Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management.
Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at and months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months.
Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications. Lessons in participant retention in the course of a randomized controlled clinical trial.
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