Clinical trial for Warm Antibody Autoimmune Hemolytic Anemia , A Phase 3 Multi-Center Randomized Double-Blind Placebo-Controlled Study of Fostamatinib Disodium in the Treatment of wAIHA
A Phase 3 Multicenter Multinational Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Patisiran (ALN-TTR02) in Transthyretin (TTR)-Mediated Polyneuropathy (Familial Amyloidotic Polyneuropathy - FAP) (APOLLO)
Tay, H.H., Yap, I., Guan, R., Koh, P.S.S., LaBrooy, S.J., Kang, J.Y. (1988). Twice daily cimetidine in the initial treatment of chronic gastric ulcer - A double-blind placebo-controlled trial. Medical Journal of Malaysia 43 (2) : 181-185. [email protected] Repository ...
This is a phase 2 multicenter, randomized, placebo-controlled double-blind study. This study is comprised of a single-blind placebo run-in qualifying phase lasting approximately 3 weeks and a double-blind treatment phase lasting 12 weeks. A safety follow-up visit is scheduled for 2 weeks after last dose of study drug.. All participants will undergo 3 visits during a 3 week, run-in phase (Days -21 to Day 1). During the run-in phase, all participants will receive single-blind placebo. Two exercise treadmill tests (ETTs) will be conducted using the modified Bruce Protocol at Day -14 and at Day -7. The results from the Day -7 ETT will be considered as Baseline.. A total of approximately 100 participants will be randomized 1:1 to receive either febuxostat 80 mg once daily (QD) or placebo QD in a double-blind treatment for 12 weeks, and 5 more visits.. All participants will complete the Seattle Angina Questionnaire (SAQ) and Euroqol 5 dimension (EQ-5D) quality-of-life measurements at Day 1, Week 6 and ...
Background and Significance of the Selected Topic Etoricoxib is a cyclo-oxygenase (COX)-2-selective NSAID with a higher COX-1 to COX-2 selectivity ratio than the other COX-2-selective NSAIDs rofecoxib, valdecoxib or celecoxib. In patients with rheumatoid arthritis, improvements in tender and swollen joint counts and patient and investigator global assessment of disease activity were significantly greater in etoricoxib than in placebo recipients in two studies. Etoricoxib was also significantly more effective than naproxen in one of these studies. In patients with osteoarthritis of the hip or knee, etoricoxib was significantly more effective than placebo and had similar efficacy to naproxen with regards to improvements in pain and physical function scores and patient global assessment of disease status scores in two studies. Etoricoxib had similar efficacy to diclofenac in patients with osteoarthritis of the knee. Single-dose etoricoxib relieved pain in patients with postoperative dental pain in ...
Initial cytoreductive surgery followed by 6 cycles of platinum-taxane based chemotherapy (Cx) remains the standard of care for advanced OC. For those patients for whom complete resection is deemed difficult to achieve, IDS after 3 cycles of NACx and followed by 3 others cycles represents an alternative strategy.. Three antiangiogenic drugs (AAD) have been shown to be active and to prolong progression-free survival (PFS) in first-line treatment of OC after initial debulking surgery: bevacizumab (BEV, GOG218&ICON7), nintedanib (NIN, OVAR12) and pazopanib (PAZ, OVAR16). In the setting of NACx, none of these drugs have been tested in a randomized trial despite the potential ability of AAD to increase Cx activity and complete surgical resection rate. NIN offers the advantage of being able to be safely combined with Cx and to have a short half-life (7-19 hours) allowing a rapid clearance of the drug before IDS. ...
PubMed Central Canada (PMC Canada) provides free access to a stable and permanent online digital archive of full-text, peer-reviewed health and life sciences research publications. It builds on PubMed Central (PMC), the U.S. National Institutes of Health (NIH) free digital archive of biomedical and life sciences journal literature and is a member of the broader PMC International (PMCI) network of e-repositories.
Subcutaneous interferon beta-1a is an effective treatment for relapsing/remitting MS in terms of relapse rate, defined disability, and all MRI outcome measures in a dose-related manner, and it is well tolerated. Longer-term benefits may become clearer with further follow-up and investigation.
This pivotal study is designed to evaluate the efficacy and safety of roxadustat for the treatment of anemia in transfusion-dependent lower risk myelodysplastic
1. No vaccine has ever been evaluated through a double blind, placebo controlled study to determine if it actually has any preventive or mitigating effect on the disease of interest. A) As you know, being a doctor, double-blind placebo-controlled trials are not the only way to study medicines. B) See above: vaccines are indeed tested through double-blind placebo-controlled trials. Granted, they dont deliberately expose everyone to the pathogen (at least, not any more) as deliberately killing people is frowned upon. Instead, they make sure the vaccine does what it was meant to do: produce the right antibodies.. 2. Epidemiologists can successfully predict pandemics, epidemics and outbreaks of any given disease by tracking vaccination programs: the larger the program, the more widespread the outbreak of the disease.. This is true in certain circumstances, and the reason for this is very interesting. When a disease is endemic, cases are usually (though not always) mild, and nearly everyone gets ...
PubMed comprises more than 30 million citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.
i.e., soft or watery) stools and >200 g of abnormal stool weight over a 24-h period. Subjects discontinued all antidiarrheal agents >24 h before enrollment. Stool samples were studied for routine pathogens. Subjects received 500 mg p.o. of SP-303 or placebo every 6 h for 96 h (4 days). Stool frequency and weights were recorded. Subjects were monitored for symptoms and side effects and were seen 1 wk later in follow-up. RESULTS: A total of 26 subjects received SP-303, and 25 received placebo. There were no significant demographic differences between treatment arms. A total of 41 subjects (80%) were receiving antiretroviral therapy and 39 subjects (77%) were receiving at least one protease inhibitor. Stool studies revealed no pathogens in 48 of 51 patients (94%). There were no serious adverse events or laboratory abnormalities. The SP-303 treatment group demonstrated a mean reduction from baseline stool weight of 451 g/24 h versus 150 g/24 h with placebo on day 4 of treatment (p = 0.14), and a ...
A Multi-center, Randomized, Double-blind, Double Dummy, Placebo and Active Controlled Crossover Study, to Investigate the 24 Hour FEV1 Profile of a Single Dose of QMF TWISTHALER Device in Adult Patients With Persistent Asthma using fluticasone propionate/salmeterol (250/50 μg b.i.d.) as an active control ...
Background. Thiazolidinediones such as rosiglitazone (RSG) are insulin-sensitizing agents, which may improve inflammation and vascular function, and thus potentially lower cardiovascular risk in patients with chronic kidney disease (CKD). However, there is growing concern about the adverse cardiovascular effects of RSG in diabetic patients without CKD, and the data in patients with CKD remain conflicting. This study examines the effect of RSG on vascular function in patients with CKD.. Methods. A randomized, double-blind placebo-controlled study comparing RSG 4 mg daily (n = 35) with placebo (n = 35) for 8 weeks was performed in CKD subjects. Primary outcome measures were flow-mediated dilatation (FMD), systemic arterial compliance (SAC) and augmentation index (AIx). Secondary outcomes included glyceryl trinitrate-mediated dilatation (GTN-MD), pulse-wave velocity (PWV), lipids, blood pressure, homoeostasis model assessment (HOMA), adiponectin, high-sensitivity C-reactive protein (hs-CRP) and ...
Results of Double Blind Placebo Controlled Trial to Assess the Effect of Vitamin B6 on Managing of Nausea and Vomiting In Pediatrics with Acute Gastroenteritis
Clinical trial for Non-Small Cell Lung Cancer , Double Blind Placebo Controlled Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC
In this Phase II study of patients with RA who had previously failed TNF inhibitor therapy, treatment with OKZ resulted in significantly greater reductions in DAS28(CRP) from baseline levels at Week 12 compared with treatment with PBO. This improvement was demonstrated at all the OKZ doses tested with generally comparable efficacy and across both dosing frequencies, and was statistically significant for all dose group comparisons (60, 120 or 240 mg vs PBO). At low OKZ doses, a posthoc analysis showed greater responses in patients who met the criterion of high CRP at study entry compared to all other patients.. The primary efficacy endpoint was further supported by the secondary efficacy variables. Estimated ACR20 and ACR50 response rates at Week 12 were numerically higher in all OKZ treatment arms than PBO groups, although the study was not powered to show a statistical difference in the ACR response rates. Few patients in any treatment group were ACR70 responders. Comparisons of exploratory ...
Galveston, Tex. To the Editor: Dr. Mathews and colleagues request further information about the randomized, placebo-controlled trial of citalopram for treatment of depression in children and adolescents. Randomization was on a 1:1 basis and was stratified by age group. The random assignment list was concealed from the investigators, which is fundamental to the claim that the study was performed under double-blind conditions. The protocol-specified population for all efficacy analyses, defined as the "intent-to-treat" population, included all patients who received at least one dose of double-blind study medication and had at least one postbaseline efficacy assessment. The analyses we presented in the manuscript were not only conventional in nature; they were, in fact, defined a priori. The justification for defining this population for the efficacy analyses is that the primary analysis was the change from baseline, therefore requiring a postbaseline assessment. Although recently a mixed-model ...
The goal of this clinical research study is to learn if calcium aluminosilicate anti-diarrheal (CASAD) can help to control diarrhea in patients with metastatic colorectal cancer who are receiving irinotecan. The safety of this drug will also be studied.
A new double-blind placebo-controlled study failed to find any benefits of hormone replacement use in relation to Alzheimers Disease. Though the results are disappointing, they do not necessarily rule out a role for estrogen in either the treatment or prevention of Alzheimers disease, according to the studys authors. Estrogen may turn out to be beneficial when used in combination with other drugs or it may help stave off the development of Alzheimers when taken before symptoms begin.. In the study, 50 women with Alzheimers were randomly assigned to a daily dose of an estrogen/progestin supplement or placebo. After 12 weeks, women taking hormones did not perform significantly better on tests of memory, concentration and other intellectual skills.. ...
Six trials investigated the influence of the colour of drug formulation on the specific effect.11 12 13 14 15 16 The methodological quality of these trials, assessed using a previously reported 10 point rating scale,1 was seven points for two trials11 12, six and a half points for one trial,13 and less than five points for three trials.14 15 16 The table with scores and the items of methodological quality are available from AJMdeC and on the BMJs worldwide web page (http://www.bmj.com/bmj/).. All trials had different designs and different outcome measurements, so a meta-analysis was not possible. Overall, the results indicated differences between colours, but a consistent trend could not be detected.. In a double blind crossover study Cattaneo et al gave orange and blue placebos to 120 inpatients awaiting minor surgery who thought that they were receiving tranquillisers.11 In an analysis excluding patients with no preference, they showed that 26 out of 42 men (62%) preferred orange whereas 33 ...
The efficacy of CYMBALTA in the treatment of generalized anxiety disorder (GAD) was established in 1 fixed-dose randomized, double-blind, placebo-controlled trial and 2 flexible-dose randomized, double-blind, placebo-controlled trials in adult outpatients between 18 and 83 years of age meeting the DSM-IV criteria for GAD. In 1 flexible-dose study and in the fixed-dose study, the starting dose was 60 mg once daily where down titration to 30 mg once daily was allowed for tolerability reasons before increasing it to 60 mg once daily. Fifteen percent of patients were down titrated. One flexible-dose study had a starting dose of 30 mg once daily for 1 week before increasing it to 60 mg once daily. The 2 flexible-dose studies involved dose titration with CYMBALTA doses ranging from 60 mg once daily to 120 mg once daily (N=168 and N=162) compared to placebo (N=159 and N=161) over a 10-week treatment period. The mean dose for completers at endpoint in the flexible-dose studies was 104.75 mg/day. The ...
FedBizOpps the Way You Want It - Best listing of FedBizOpps notices, searches and subscriptions with free, on-line Archives back to 1995
...SAN DIEGO Jan. 6 2011 /- Ardea Biosciences Inc. (Nasda...This was a 28-day randomized double-blind placebo-controlled study...,Ardea,Biosciences,Announces,Positive,Top-Line,Results,from,Phase,2b,Combination,Study,of,RDEA594,in,Allopurinol-Refractory,Gout,Patients,biological,advanced biology technology,biology laboratory technology,biology device technology,latest biology technology
8. A sexually active male subject with female partner(s) of childbearing potential (including breastfeeding partner(s)) is eligible if he agrees to use a male condom starting at screening and continue throughout study treatment and for 90 days after the final study drug administration. If the male subject has not had a vasectomy or is not sterile as defined below, his female partner(s) is utilizing 1 form of highly effective birth control*starting at screening and will continue throughout study treatment and for 90 days after the male subject receives the final study drug administration ...
difference between treatment and control No statistical difference found for both the primary safety and efficacy end points or in the secondary end points when comparing continuous versus bolus dosing Less total lasix dosed in continuous group Bolus dosing more likely to require a dose increase at 48 hours, but no difference in switch to oral dosing between bolus and continuous dosing No significant difference in the efficacy end point in low vs high dosing- but note a nonsignificant trend toward greater improvement in the high dosing- this coincides with the secondary end points that were significantly better with high dosing-that of fluid loss, weight loss, and relief from dyspnea. No significant difference in low and high dosing in the primary safety end point (overall difference between groups-change in creatinine) though there was a higher proportion of patients who met the prespecified secondary safety end point (rise in creatinine level of more than 0.3mg/dl at any time during the 72 ...
We tried to find any useful and informative data between the two study designs for AA, OLS and RCT, in the treatment of MDD: OLS may have a potential utility to guide the RCT for proving the effect of AA in the treatment of MDD. According to our results, the pooled SMDs for the primary efficacy measure was statistically significant in both study design, showing a significant reduction of depressive symptoms after AA treatment to current antidepressant treatment in OLSs and in RCTs. The effect sizes measured by SMDs between OLS and RCT design was quite similar and adequately correlated, indicating a practical utility of OLS design to move to RCT conduction in the treatment of MDD. When sensitivity analyses show that the overall result and conclusions are not affected by the different decisions that could be made during the review process, the results of the review can be regarded with a higher degree of certainty. Where sensitivity analyses identify particular decisions or missing information ...
Adverse Events Observed During the Premarketing Evaluation of Immediate-Release Zolpidem Tartrate: Immediate-release zolpidem tartrate was administered to 3,660 subjects in clinical trials throughout the U.S., Canada, and Europe. Treatment-emergent adverse events associated with clinical trial participation were recorded by clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals experiencing treatment-emergent adverse events, similar types of untoward events were grouped into a smaller number of standardized event categories and classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms.. The frequencies presented, therefore, represent the proportions of the 3,660 individuals exposed to zolpidem, at all doses, who experienced an event of the type cited on at least one occasion while receiving zolpidem. All reported treatment-emergent adverse events are included, except those already ...
Both recovery time of post-exercise muscle oxygenation and muscle strength decline with aging. Although beetroot consumption has been shown to improve muscle oxygenation and exercise performance in adults, these effects in the elderly has not been addressed. The aim of the present study was to evaluate the effect of a beetroot-based gel (BG) on muscle O2 saturation, blood volume (tHb) and handgrip strength in the elderly in response to handgrip exercise. In a randomized crossover double-blind design, twelve older subjects consumed BG (100 g of beetroot-based gel containing ~ 12 mmol nitrate) or PLA (100 g of nitrate-depleted gel nitrate-depleted ...
Individual symptoms showed a wide range of RR (1.777 to 0.809). The symptom with the highest RR was utricaria (RR= 1.977, 95% CI [1.857, 2.106]). However, the subjective symptom "strange taste" (RR= 1.923, 95%CI [1.720, 2.151]) was the seventh most specific symptom on the list. Certain symptoms, both subjective and objective, showed no significant association with a positive DBPCFC and were thus non-specific. ...
https://www.cannabisclinicians.org/wp-content/uploads/2020/02/scc-logo-long-hi-res-1-1.png 0 0 Danielle Russell https://www.cannabisclinicians.org/wp-content/uploads/2020/02/scc-logo-long-hi-res-1-1.png Danielle Russell2018-09-12 12:19:502020-03-19 12:26:20Oral cannabinoid-rich THC/CBD cannabis extract for secondary prevention of chemotherapy-induced nausea and vomiting: a study protocol for a pilot and definitive randomised double-blind placebo-controlled trial (CannabisCINV). ...
Data to be presented at the annual meeting of the American College of Rheumatology in November will confirm that oral tofacitinib met all primary efficacy endpoints in a phase III study evaluating the
7. The effects of the current treatment paradigm on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception: hormonal or barrier method of birth control; abstinence prior to study entry and for the duration of study participation, and 30 days after completion of study drug administration. Should a female become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 30 days after completion of study drug administration.. 8. Adequate neurological function defined as:. ...
I agree that correlation does not imply causation, but this is often assumed. The only way to tell in these cases is to do a double-blind placebo-controlled trial. I read somewhere that Omega-3 does have some benefit for autistic children, but thats probably just because Omega-3 is good for you. Theres no evidence of brain damage or malfunction across the board in autism. In fact, more recent evidence suggests its simply low socio-linguistic intelligence coupled with high visio-spatial intelligence. ...
Hi Hanno. Sorry for slow response. I have been experiencing severe levels of pain and I now have intimate knowledge of every tile in my bathroom. My 6 monthly CT scan was brought forward, by two months, to give myself and my Doctor peace of mind. After waiting 3 and a bit weeks for the results Im delighted to say that Im still cancer free, whoopy. They believe the pain, which is sometimes at similar levels as it was 3 weeks after my nephretomy, may be due to my body adjusting to bits missing inside me and the scar left after the operation. I used to get Doctors, nurses and medical students popping into the ward to have a look at my scar. It was somewhat disturbing/funny to hear them say wow, thats a big scar and come and have a look at Mr whites scar. 42cm (16.5 inches) in length, my 5 year old nephew insisted on measuring it (honestly). I guess my plan to be a swimwear model will have to be rethought.. With regard to the side effects - I have never considred leaving the trial. I was ...
Why is Synapse so sexy?. A recent study found preliminary results that UCSF Synapse Editors are 3.6 units sexier than counterpart non-Editor students. Conducted by an anonymous research team in the Synapse masthead, this was a double blind randomized controlled trial with nearly two score participants, a bakers dozen of whom were randomly assigned the role "UCSF Synapse Editor." While legend has it that selection of candidates for these coveted positions falls under great scrutiny, a new insider source suggests that the Editors were actually chosen by a random process in which "Golden Toothpicks" were inserted into free Synapse Thursday meeting sandwiches in the style of the ploy formerly known as Charlie and the Chocolate Factory. Critics of this study claim that Synapse editors were unfairly biased to having voracious appetites.. The assessment of attractiveness was conducted in a double blind fashion where sight-impaired members of the community were invited to score participants. We can ...
This superiority trial is a individually randomized double-blind placebo-controlled parallel group clinical trial to evaluate the role of zinc acting as an adjunct for the treatment of clinical severe infections among infants below two months of age. In India, the study is being conducted at 4 tertiary centres in Delhi (Safdarjung Hospital, Kasturba hospital, MAMC and CNBC). CDSA has taken up the responsibility of quality management to ensure the quality standards of the study as per the project requirements and applicable guidelines.. ...
PubMed comprises more than 30 million citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.
Side Effects are minimal and affects only 5% of users. Most can be managed by adjusting dosing. Discuss with your allergy doctor on how to manage
A novel algorithm for parallel design verification is described. Its data model is that of the data flow computer and is based on the partitioning of the d
The internal validity of double-blinding in randomised placebo-controlled trials (RCT) has become a target of criticism. In several studies, the accuracy of patients and physicians guesses as to the assigned treament was striking.
Learn more about Double-blind, Placebo-controlled Study at Memorial Health The best and most reliable form of research is the double-blind, placebo-controlled study...
Learn more about Double-blind, Placebo-controlled Study at Memorial Health The best and most reliable form of research is the double-blind, placebo-controlled study...
Background:In this prospective, randomized, placebo-controlled, double-blinded clinical trial we tested the hypothesis that preemptive analgesia with bupivacaine applied in the area of the surgical incision in patients undergoing mastectomy for breas...
In this study design, participants are assigned to only 1 treatment group of the study. These trials are generally designed to assess whether 1 or more treatments are superior to the others. Participants and those administering the intervention should all be unaware of which intervention individual participants are receiving (
In this study design, participants are assigned to only 1 treatment group of the study. These trials are generally designed to assess whether 1 or more treatments are superior to the others. Participants and those administering the intervention should all be unaware of which intervention individual participants are receiving (
After 1 week of treatment, heavily treatment-experienced (HTE) patients who received fotemsavir, added to a failing regimen, had a greater reduction in viral load than patients on placebo.
... BARRIE - Anecdotal evidence may not be on a scientific par with a double-blinded clinical trial, but its valuable nonetheless, according to several local physicians and surgeons. Doctors talking to the Advance agree that ...
Hobinizle ilgili bilinmesi gerekenleri öğrenmek mi istiyorsunuz? JBL uzman ekibimiz size düzenli bilgi akışı sağlayacak ve önerilerde bulunacaktır.
DISCLAIMER: Ganjapreneur.com is intended as an educational resource for law-abiding professionals and those who are curious about entrepreneurial and/or investment opportunities in emerging markets. We do not offer investment advice, and we encourage all visitors and readers to do their own due dilligence before investing in any of the companies or markets that we write about. Be advised that possessing, using, distributing and selling cannabis are all federal crimes in the United States of America and the articles, pages, links, and other types of information on this site are not intended to assist you in violating federal law. Ganjapreneur.com and all associated entities and individuals are not responsible for third party content and/or links published on this website.. ...