Studies have found that, within the first year post-trauma 10-40% of individuals develop symptoms consistent with a diagnosis of post-traumatic stress disorder. Severely injured patients who require a standard inpatient admission are more likely to develop PTSD and benefit less from traditional cognitive-behavioural therapy (CBT) than patients who are less injured. Behavioural activation was originally developed as a treatment for depression and involves the identification and enactment of activities that are reinforcing for the individual and consistent with their long-term goals. In laymans terms this means getting people to do things which are beneficial, or part of everyday life, which they have been putting off doing because of their depression. In PTSD individuals avoid situations and experiences that may elicit trauma-related memories but such avoidance is believed to reinforce anxiety as people never confront and overcome their fears. Behavioural activation differs from exposure therapy ...
A total of 9 trials (13%) switched from superiority to noninferiority. Among them, 5 trials (7%) conducted noninferiority analyses without prespecified margins. The margins were specified after the analysis of superiority had been conducted (4 trials) or after the start of patient enrollment (1 trial). The other 4 trials (6%) had a prespecified plan of switching from superiority to noninferiority. Three of the 4 trials adjusted for multiplicity by the Bonferroni method, the Hochberg method, or the closed testing procedure.. More than half of the 72 trials accrued 500 patients or more in total, and most had apparent statistical power of 80% or more. However, 11 trials (15%) calculated the sample size as a superiority trial, and 9 trials (13%) calculated it as a noninferiority trial under alternative hypotheses of superiority, that is, that the experimental treatment was slightly better than the control, suggesting potential under power for testing the noninferiority hypothesis.. Alpha error rates ...
We would like to thank Dr Vestbo for his comments. We agree that in the Optimal Trial more patients originally randomised to the placebo arm prematurely discontinued study medications, and that many of these patients were subsequently put on open label ICS/LABA products.1 As discussed in our paper, the relative risk reduction decreased from 21% if patients were prematurely excluded once they discontinued study drugs to 15% when an intent to treat analysis was used.2 We agree with Dr Vestbo that our intention to treat analysis was conservative, and it did slightly reduce the possibility of a difference being found between placebo and active treatment but we would argue that this analysis was necessary in order to prevent bias.. An intention to treat analysis is necessary as it is impossible to know a priori the ultimate direction of the bias when patients who stop study medications early are banished from a clinical trial. Will the bias favour the drug or favour placebo? For example, a similar ...
It is sometimes desirable to compare a less expensive treatment or intervention against a treatment or intervention that is already known to be effective. In these cases, it would be unethical to expose participants to an inactive placebo. Thus, these trial designs assess whether the treatment or intervention under study (the
It is sometimes desirable to compare a less expensive treatment or intervention against a treatment or intervention that is already known to be effective. In these cases, it would be unethical to expose participants to an inactive placebo. Thus, these trial designs assess whether the treatment or intervention under study (the
This is an interventional, twenty-four week, randomized, double blind, placebo-controlled trial with bromocriptine QR in subjects with newly diagnosed and established type 2 diabetes mellitus (T2DM) to evaluate its effects on the cardiovascular and peripheral autonomic nervous system, as well as on inflammatory markers, the leptin/adiponectin system, hormonal levels of RAS and HPA axis, indices of insulin resistance, and measures of oxidative and nitrosative stress. Forty newly diagnosed diabetes subjects and 40 subjects with established diabetes will be enrolled in the study and each randomized to treatment with bromocriptine-QR or placebo.. Secondary endpoints will demonstrate the effects of dopaminergic activation with Bromocriptine-QR on the regulation of Hypothalamic-Pituitary-Axis (HPA) axis hormones, on the plasma levels of markers of inflammation and oxidative/nitrosative stress in newly diagnosed vs. established type 2 diabetes subjects. The study will evaluate treatment effects on ...
The present studyis the first to assess, as a primary objective and end point, the overall and cardiovascular safety of a new oral antidiabetes therapy in a large population of patients with type 2 diabetes. The findings from this trial indicate that morning bromocriptine-QR therapy is noninferior to placebo for overall safety. The overall frequency of all-cause SAEs and the proportion of SAEs observed in each SOC among patients taking bromocriptine-QR was noninferior to the frequency among patients in the placebo arm. Furthermore, the frequency of the composite cardiovascular end point was statistically significantly reduced in the bromocriptine-QR group compared with the placebo group. The Kaplan-Meier estimates indicate that among 1,000 patients allocated to bromocriptine-QR, 13 first myocardial infarctions, strokes, coronary revascularizations, hospitalizations for congestive heart failure, or hospitalizations for unstable angina would be avoided over 1 year. Simply stated, 79 patients would ...
BACKGROUND: Challenges remain to find ways to support patients with depression who have low levels of physical activity (PA) to overcome perceived barriers and enhance the perceived value of PA for preventing future relapse. There is an evidence-base for behavioural activation (BA) for depression, which focuses on supporting patients to restore activities that have been avoided, but practitioners have no specific training in promoting PA. We aimed to design and evaluate an integrated BA and PA (BAcPAc) practitioner-led, written, self-help intervention to enhance both physical and mental health. METHODS/DESIGN: This study is informed by the Medical Research Council Complex Intervention Framework and describes a protocol for a pilot phase II randomised controlled trial (RCT) to test the feasibility and acceptability of the trial methods to inform a definitive phase III RCT. Following development of the augmented written self-help intervention (BAcPAc) incorporating behavioural activation with ...
therapy. Treatment was continued until disease progression, discontinuation due to adverse events, or withdrawal of consent. Randomization was stratified according to PSA doubling time (≤ 6 months or , 6 months) and use of osteoclast-targeted therapy at randomization. The primary endpoint was metastasis-free survival in the intention-to-treat population, with the presence of metastasis identified by independent central review of radiographic imaging every 16 weeks.. For the darolutamide vs placebo groups, the median age was 74 years in both, most patients were from European countries, PSA doubling time was up to 6 months in 70% vs 67%, the Eastern Cooperative Oncology Group performance status was 0 or 1 in 100% in both, 97% vs 94% were not using a bone-sparing agent at baseline, and 76% of both groups had received at least 2 previous hormonal therapies.. Metastasis-Free Survival. On independent central review, metastasis was found at baseline in 5.2% of the darolutamide group and 7.0% of the ...
An assessment of the people taking part in a trial, based on the group they were initially (and randomly) allocated to. This is regardless of whether or not they dropped out, fully adhered to the treatment or switched to an alternative treatment. ITT analyses are often used to assess clinical effectiveness because they mirror actual practice, when not everyone adheres to the treatment, and the treatment people have may be changed according to how their condition responds to it. Studies of drug treatments often use a modified ITT analysis, which includes only the people who have taken at least 1 dose of a study drug.. ...
A total of more than 1,379 patients were studied in two major clinical trials. Dupilumab was tested against placebo. The main endpoint of the clinical studies was how many doctors rated patient improvement as "clear" or "almost clear." About 36-38% of patients receiving dupilumab achieved a rating of "clear" or "almost clear" compared with only 8% of patients receiving a placebo. About half of patients with AD improved at least 75% on the medication compared with only 12-15% on the placebo. The medication improved itching, depression, and quality of life for patients. The clinical trials were pretty convincing. The medication works, and it works well.1. What Risks Are There for Dupilumab?. With all new medications, we have less data. This is something to keep in mind. Sometimes, serious side effects or adverse events are only apparent years after a drug enters the market. There will be a lot of unknowns as doctors have more experience with the medical problems ...
We included data from nine trials including 4328 patients. In the intention-to-treat infected population, we noted a 21% shorter time to alleviation of all symptoms for oseltamivir versus placebo recipients (time ratio 0·79, 95% CI 0·74-0·85; p,0·0001). The median times to alleviation were 97·5 h for oseltamivir and 122·7 h for placebo groups (difference −25·2 h, 95% CI −36·2 to −16·0). For the intention-to-treat population, the estimated treatment effect was attenuated (time ratio 0·85) but remained highly significant (median difference −17·8 h). In the intention-to-treat infected population, we noted fewer lower respiratory tract complications requiring antibiotics more than 48 h after randomisation (risk ratio [RR] 0·56, 95% CI 0·42-0·75; p=0·0001; 4·9% oseltamivir vs 8·7% placebo, risk difference −3·8%, 95% CI −5·0 to −2·2) and also fewer admittances to hospital for any cause (RR 0·37, 95% CI 0·17-0·81; p=0·013; 0·6% oseltamivir, 1·7% placebo, risk ...
Results CCX354-C was generally well tolerated by study subjects. The ACR20 response at week 12 was 39% in the placebo group, 43% in the 100 mg twice daily group (difference and 95% CI compared with placebo, 4.5 (−14.1 to 23.1); p=0.62) and 52% in the 200 mg once daily group (13.0 (−5.8 to 31.8); p=0.17) in the intention-to-treat population, and 30% in the placebo group, 44% in the 100 mg twice daily group (14.4 (−5.9 to 34.8); p=0.17), and 56% in the 200 mg once daily group (25.8 (5.3 to 46.4); p=0.01) in the prespecified population of patients satisfying CRP and joint count eligibility criteria at the screening and day 1 (predose) visits.. ...
This article deals with the dependency(ies) of noninferiority test(s) when the two confidence interval method is employed. There are two different definitions of the two confidence interval method. One of the objectives of this article is to sort out some of the confusion in these two different definitions. In the first definition the two confidence interval method is considered as the fixed margin method that treats a noninferiority margin as a fixed constant after it is determined based on historical data. In this article the method is called the two confidence interval method with fixed margin. The issue of the dependency(ies) of noninferiority test(s) does not occur in this case. In the second definition the two confidence interval method incorporates the uncertainty associated with the estimation for the noninferiority margin. In this article the method is called the two confidence interval method with random margin. The dependency(ies) occurs, because the two confidence interval method(s) with
There was no significant between-group difference in the rates of the primary outcome, which occurred in 686 of 1759 infants (39.0%) who received intravenous immunoglobulin and in 677 of 1734 infants (39.0%) who received placebo (relative risk: 1.00 [95% confidence interval: 0.92-1.08]). Similarly, there were no significant differences in the rates of secondary outcomes, including the incidence of subsequent sepsis episodes. In the follow-up of 2-year-old infants, there were no significant differences in the rates of disability or of adverse events. ...
Intention-to-treat (ITT) analysis is the preferable way to look at the results of randomised controlled trials (RCTs). In ITT analysis, people are analysed in the treatment groups to which they were assigned at the start of the RCT, regardless of whether they drop out of the trial, do not attend follow-up, or switch treatment groups.. If follow-up data is not available for a participant in one of the treatment groups, the person would normally be assumed to have had no response to treatment, and that their outcomes are no different from what they were at the start of the trial. This helps to make sure that RCTs do not show that a particular treatment being tested is more effective than it actually is.. For example, if 50 people were allocated to the treatment group of an RCT, perhaps 10 might drop out because they got no benefit. If all 50 were analysed by ITT analysis, with 10 assumed to have had no benefit, this gives a more reliable indication of the effect of the treatment than just ...
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 interac …
DUPIXENT® is for your adult patients with uncontrolled moderate-to-severe atopic dermatitis. Learn more now. Adverse reactions may occur. Please see Important Safety Information and full PI on website.
The primary conclusion of the trial will be based on the results of the primary outcome. If the result of the primary outcome is not statistically significant, the conclusion will be that there is no significant difference between the interventions. The results on all other types of outcomes will be reported for hypothesis-generating purposes. However, we will inspect the confidence interval (CI) to asses if the CI for the group difference contains values of importance, so that we cannot rule out interesting differences.. The primary analysis will include a modified intention-to-treat population, which is defined as all randomized patients, except patients who did not receive CPB-dependent cardiac surgery [9]. A secondary analysis will include the per-protocol population excluding patients with major protocol violations defined as: 1) patients who were randomized to an intervention but did not receive any intervention; and 2) patients who received an incorrect intervention. The dependent ...
Patients A data warehouse search identified all subjects with Downs syndrome who attended Clalit Health Services in 2006 and were tested for TSH and free thyroxine (T4) level on the day of diagnosis (intention-to-treat population). The study group consisted of patients who were not diagnosed with thyroid disease or did not receive thyroid-modulating medication (n=428). Their findings were compared with a control group of healthy age- and sex-matched subjects who were randomly selected from the general population.. ...
A Phase 3 study evaluating dupilumab (Dupixent; Sanofi Regeneron) in adults and adolescents with severe, steroid-dependent asthma
The European Commission approvedRegeneron Pharmaceuticals and Sanofis keybiologic treatment dupilumab for moderate-to-severe atopicdermatitis, the two companies said on Thursday.
... : Antihyperglycemic medication changes during the course of the study by treatment group Among Subjects with a Baseline A1C of ≥ 7.5. Relative to participants randomized to bromocriptine-QR (solid bar), more participants randomized to placebo (striped bar) increased the dose of a concomitant oral antihyperglycemic agent (OAA); 41% versus 27%, P = 0.04 or added a new OAA or insulin; 18% versus 8%, p = 0.03. Even though placebo-treated participants intensified their antihyperglycemic regimen more frequently, participants on bromocriptine-QR achieved better glycemic control over the 52 week treatment period ...
AIM: Blauvelt et al. (The Lancet 2017; 389: 2287-303) aimed to compare the long-term efficacy and safety of dupilumab with medium-potency topical corticosteroids (TCS) versus placebo with TCS in adults with moderate-to-severe atopic dermatitis (AD). SETTING AND DESIGN: This multicentre randomised, double-blinded, placebo-controlled trial was conducted in hospitals, clinics and academic institutions across 161 sites in 14 countries. STUDY EXPOSURE: Adults with moderate-to-severe AD were randomly assigned (3:1:3) to receive subcutaneous dupilumab 300mg once weekly (qw) plus TCS, dupilumab 300mg every 2 weeks (q2w) plus TCS, or placebo plus TCS until week-52 ...
Interval between date of randomization and death due to any cause. Analysis was based on January 31, 2010 data cut-off and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg. At this time, data were still immature and median overall survival was not reached. Number of deaths is presented ...
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In the BRIM-3 trial, vemurafenib (Zelboraf) was associated with improved progression-free and overall survival vs dacarbazine in patients with advanced BRAF V600 mutation-positive melanoma. In an extended follow-up reported in The Lancet Oncology, McArthur et al found that superior survival outcomes were maintained and were present in both the BRAF V600E and BRAF V600K mutation subgroups.. Study Details. In this open-label trial, 675 patients with treatment-naive BRAF V600 mutation-positive metastatic melanoma from 104 centers in 12 countries were randomly assigned between January and December 2010 to receive vemurafenib at 960 mg orally twice daily (n = 337) or intravenous dacarbazine at 1,000 mg/m² every 3 weeks (n = 338). Patients had to have a life expectancy of ≥ 3 months and Eastern Cooperative Oncology Group performance status of 0 or 1. The coprimary endpoints were overall survival and progression-free survival in the intention-to-treat population, with data censored at crossover. ...
Background In the BRIM-3 trial, vemurafenib was associated with risk reduction versus dacarbazine of both death and progression in patients with advanced BRAF(V600) mutation-positive melanoma. We present an extended follow-up analysis of the total population and in the BRAF(V600E) and BRAF(V600K) mutation subgroups. Methods Patients older than 18 years, with treatment-naive metastatic melanoma and whose tumour tissue was positive for BRAF(V600) mutations were eligible. Patients also had to have a life expectancy of at least 3 months, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate haematological, hepatic, and renal function. Patients were randomly assigned by interactive voice recognition system to receive either vemurafenib (960 mg orally twice daily) or dacarbazine (1000 mg/m(2) of body surface area intravenously every 3 weeks). Coprimary endpoints were overall survival and progression-free survival, analysed in the intention-to-treat population (n=675), ...
The researchers found that in the intention-to-treat population, 69 and 20% of those who received teprotumumab and placebo, respectively, had a response at week 24.
Based on favorable data for 12 weeks of treatment for noncirrhotic patients in the phase 2 SURVEYOR-2 study (100% SVR12 in 34 patients with genotype 4, 5, or 6) (Kwo, 2017b), ENDURANCE-4 enrolled 121 DAA-naive or -experienced (sofosbuvir plus ribavirin ± peginterferon) genotype 4, 5, or 6 patients without cirrhosis to receive 12 weeks of the daily fixed-dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg) administered as three 100 mg/40 mg pills (Asselah, 2018b). Of those enrolled, 86% had fibrosis stage F0 to F1 and 68% were treatment naive. The genotype distribution was 63% genotype 4, 21% genotype 5, and 16% genotype 6. The overall SVR12 rate for the intention-to-treat population was 99% (120/121), including 99% (75/76) for genotype 4, 100% for genotype 5 (26/26), and 100% (19/19) for genotype 6. Genotype 4, 5, and 6 patients were not included in the randomized study to compare an 8-week vs 12-week course for DAA-naive, noncirrhotic patients. However, part 4 of the SURVEYOR-2 study ...
No evidence that dupilumab is effective as add-on therapy in mod-severe asthma with eosinophilia answers are found in the EE+ POEM Archive powered by Unbound Medicine. Available for iPhone, iPad, Android, and Web.
We developed an innovative home-based HIV self-testing (HIVST) service that included mailing of a free HIVST kit, and providing online real-time instructions and pre-test/post-test counseling (HIVST-OIC). The present parallel-group and non-blinded randomized controlled trial was conducted to evaluate the efficacy of promoting HIVST-OIC in increasing HIV testing rate among 430 men who have sex with men (MSM), with access to online live-chat applications in Hong Kong. At month 6, as compared to the control group, the intervention group reported significantly higher prevalence of HIV testing of any type (89.8 vs. 50.7%; relative risk (RR): 1.77; p < 0.001). Among those who have taken up any HIV testing in the last six months, significant between-group difference was found in multiple male sex partnerships (34.2 vs. 47.7%, RR: 0.72; p = 0.021). HIVST-OIC has a strong potential in increasing prevalence of HIV testing and reducing sexual risk behaviors. Implementation research is warranted. ...
RESULTS Diacerein reduced HbA1c compared with placebo by 0.35% (3.8 mmol/mol; P = 0.038) in the ITT analysis and by 0.41% (4.5 mmol/mol; P = 0.023) in the per-protocol analysis. The peak of effect occurred at the 24th week of treatment (−0.61% [6.7 mmol/mol; P = 0.014] and −0.78% [8.5 mmol/mol; P = 0.005], respectively), but it attenuated toward nonsignificant differences at the 48th week. No significant effect of diacerein was observed in other efficacy and safety measures. Diarrhea occurred in 65% of patients receiving diacerein and caused treatment interruption in 16%. Seven patients in the diacerein group reduced insulin dosage, whereas 10 in the placebo group increased it; however, mild hypoglycemic events were equally observed. ...
... - description, side Effects of palifermin Palifermin, dosage (palifermin Palifermin), proper use of palifermin Palifermin. Drugs review.
First study with a biologic to show benefit in severe steroid-dependent asthma population that enrolled patients regardless of blood eosinophil levels or ...
This noninferiority trial will investigate the tolerability and efficacy of two etanercept formulations (Reumatocept versus Enbrel) in patients with rheumatoid
Intention-to-treat (ITT), per protocol (PP), and as treated (AT) methods have commonly been used to analyze data from experimental studies involving human subjects. ITT analysis includes all patients regardless of whether they adhered to the prescribed protocol and is recommended as the least biased method to estimate treatment effects in randomized controlled trials (RCTs)[1-4]. Excluding patients from the analysis who do not adhere to the assigned treatment is called per protocol (PP) analysis. It is designed to measure the treatment effects only in patients who complied with the treatment and ignores the ones who were intended to receive treatment but did not actually receive it [5-7]. Not discarding information and analyzing patients according to the treatment received rather than intended is called as treated (AT) or treatment received analysis [4, 7]. On its face value PP and AT analysis seem to be reasonable alternatives to ITT. However, both estimates can be unreliable because ...
... - Warn patient that diarrhea Infections PO 500 mg as treat analysis at the Day flatulence gastritis melena 1 or medical care if noted and azithromycin was 71. Review dosing schedule and zithromax overnight fed ex deafness andor tinnitus have been.
... - Warn patient that diarrhea Infections PO 500 mg as treat analysis at the Day flatulence gastritis melena 1 or medical care if noted and azithromycin was 71. Review dosing schedule and zithromax 250 mg 12 deafness andor tinnitus have been.
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Median (range). Effect of food: Administration of ella together with a high-fat breakfast resulted in approximately 40 - 45% lower mean Cmax, a delayed tmax (from a median of 0.75 hours to 3 hours) and 20 - 25% higher mean AUC0-∞ of ulipristal acetate and monodemethyl-ulipristal acetate compared with administration in the fasting state. These differences are not expected to impair the efficacy or safety of ella to a clinically significant extent; therefore, ella can be taken with or without food.. Distribution Ulipristal acetate is highly bound (, 94%) to plasma proteins, including high density lipoprotein, alpha-l-acid glycoprotein, and albumin.. Metabolism Ulipristal acetate is metabolized to mono-demethylated and di-demethylated metabolites. In vitro data indicate that this is predominantly mediated by CYP3A4. The mono-demethylated metabolite is pharmacologically active.. Excretion The terminal half-life of ulipristal acetate in plasma following a single 30 mg dose is estimated to 32.4 ± ...
This study investigated the efficacy of oral budesonide as an add-on to the existing mesalazine therapy for induction of remission of active ulcerative colitis.
After oral administration, BG-12 reacts rapidly with glutathione, an abundant thiol-containing metabolite, such that free levels of the active species (monomethyl fumarate) are undetectable in blood. By contrast, bardoxolone survives to activate nrf2 in multiple tissues because it is not inactivated by circulating glutathione.. Fortuitously, then, BG-12 may be short acting and even localized to leukocytes in the blood, while bardoxolone may yield a global and long-lasting upregulation of nrf2.. It is not yet proven - and given the difficulty of such studies, it may never be proven beyond doubt. But as long as the data continues to support the efficacy and safety of BG-12 there is no need at all to cast a shadow over its future on the basis of findings with bardoxolone.. Indeed, both compounds will react with sites other than components of the nrf2 complex. Bardoxolone shares more than a passing resemblance to Super Glue - the reactive site on the molecule is a cyanoacrylate and, like BG-12, will ...
Dupilumab gained FDA approval as add-on maintenance therapy for patients with moderate to severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.. Dupilumab inhibits the overactive signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that contribute to the type 2 inflammation that may underlie moderate to severe asthma. This effect is associated with the reduction of inflammatory biomarkers, including fractional exhaled nitric oxide, immunoglobulin E, and eotaxin-3.. For people with asthma, dupilumab comes in two doses (200 mg and 300 mg) given every other week at different injection sites after an initial loading dose.. Approval for the indication was based on a pivotal trial program that evaluated 2,888 adult and adolescent patients with moderate to severe asthma in three randomized, placebo-controlled, multicenter trials for 6 months to 1 year (24 to 52 weeks).. The agent comes in a pre-filled syringe and is ...
ABBOTT PARK, Ill. and IRVING, Texas, Sept. 23 /PRNewswire-FirstCall/ -- Abbott and Reata Pharmaceuticals Announce Agreement to Develop and Commercialize...
specifies the margin for the noninferiority, superiority, and equivalence tests, which you can request by specifying the NONINF , SUP , and EQUIV binomial-options, respectively. By default, MARGIN=0.2. For noninferiority and superiority tests, specify a single value in the MARGIN= option. The MARGIN= value must be a positive number. You can specify value as a number between 0 and 1. Or you can specify value in percentage form as a number between 1 and 100, and PROC FREQ converts that number to a proportion. PROC FREQ treats the value 1 as 1%. For noninferiority and superiority tests, the test limits must be between 0 and 1. The limits are determined by the null proportion value (which you can specify in the P= binomial-option) and by the margin value. The noninferiority limit is the null proportion minus the margin. By default, the null proportion is 0.5 and the margin is 0.2, which produces a noninferiority limit of 0.3. The superiority limit is the null proportion plus the margin, which is 0.7 ...