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
CNMC0599 A Multicenter Randomized Placebo-Controlled Double-Blind Study to Assess the Efficacy and Safety of Glutamine and Creatine in ...
Duloxetine, 60 mg/day, is a well-tolerated and effective treatment for MDD that reduces painful physical symptoms. These findings suggest that duloxetine may be a first-line treatment for patients with MDD and associated painful physical symptoms.
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 ...
The HCG Diet Losing weight with the HCG diet has been found to be one of the quickest ways to lose weight without sacrificing your health or metabolism. Some people lose 3-5 pounds per week and even more. Imagine weighing 15 pounds less a month from now!. ...
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 ...
Open-label placebo is significantly better than no-pill control and is similar to double-blind placebo for improving symptoms among patients with IBS.
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 ...
AT THE AHA SCIENTIFIC SESSIONS. CHICAGO (FRONTLINE MEDICAL NEWS) - Driving LDL cholesterol below 25 mg/dL for a year or more in high-cardiovascular-risk patients using the investigational human monoclonal antibody alirocumab proved well tolerated and displayed a treatment-emergent adverse event profile reassuringly comparable to that of placebo in an interim analysis of the largest double-blind phase III clinical trial to date involving any PCSK9 inhibitor. While this is encouraging preliminary evidence that it may prove safe to pharmacologically maintain unnaturally low LDL concentrations - levels below those seen in newborns - in high-risk patients, Dr. Jennifer G. Robinson nonetheless urged her cardiology colleagues to curb their enthusiasm as she presented an interim analysis of the 2,341-patient ODYSSEY Long Term trial at the American Heart Association scientific sessions. Were all concerned about the long-term safety of very low LDL levels. The fact that there are no signals so far is ...
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.. ...
1. Juneja LR, Chu D-C, Okubo T, et al. L-theanine - a unique amino acid of green tea and its relaxation effect in humans. Trends Food Sci Technol. 1999;10:199-204. http://dx.doi.org/10.1016/S0924-2244(99)00044-8.. 2. Ritsner MS, Miodownik C, Ratner Y, et al. L-theanine relieves positive, activation, and anxiety symptoms in patients with schizophrenia and schizoaffective disorder: an 8-week, randomized, double-blind, placebo-controlled, 2-center study. J Clin Psychiatry. 2011 Jan;72(1):34-42. [PMID: 21208586]. 3. Kimura K, Ozeki M, Juneja LR, Ohira H. L-Theanine reduces psychological and physiological stress responses. Biol Psychol. 2007 Jan;74(1):39-45. [PMID: 16930802]. 4. Park SK, Jung IC, Lee WK, et al. A combination of green tea extract and l-theanine improves memory and attention in subjects with mild cognitive impairment: a double-blind placebo-controlled study. J Med Food. 2011 Apr;14(4):334-43. [PMID: 21303262]. 5. Cho HS, Kim S, Lee SY, et al. Protective effect of the green tea ...
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
A double-blind placebo-controlled study found that elderly people with hearing loss can triple their understanding of words in noisy situations by training on a custom audiomotor game.
TY - JOUR. T1 - Evaluation of nimodipine in the treatment of severe diffuse head injury. T2 - A double-blind placebo-controlled trial. AU - Pillai, Shibu V.. AU - Kolluri, V. R S. AU - Mohanty, Aaron. AU - Chandramouli, B. A.. PY - 2003/9. Y1 - 2003/9. N2 - Aims: The aim of this study was to establish whether nimodipine given orally soon after severe diffuse head injury for a period of three weeks improved outcome. Material and methods: The present report analyzes the results of a prospective randomized double-blind placebo-controlled trial of nimodipine in 97 severe head injury patients (GCS Score ,\=8) treated at the Department of Neurosurgery, NIMHANS, between January 1995 and June 1996. The patients were randomly assigned to two groups which were matched for age, sex, mode of injury, time interval from injury to admission, neurological status and CT scan findings. One group was given nimodipine 30 mg Q6H and the other group was given a placebo. The outcome of these patients at 6 months was ...
TY - JOUR. T1 - Low Level Laser Therapy (LLLT) ed efficacia clinica. Studi in doppio cieco randomizzato a confronto. AU - Fortuna, D.. AU - Zati, A.. AU - Mondardini, P.. AU - Ronconi, L.. AU - Paolini, C.. AU - Bilotta, T. W.. AU - Masotti, L.. PY - 2002. Y1 - 2002. N2 - Background. There are several studies in the literature regarding the clinical efficacy of Low Level Laser Therapy (LLLT), however the very few randomized, double blind clinical trials available present contrasting views. The purpose of this trial is to understand whether the efficacy of inefficacy of laser can be correlated to the type and management of the equipment used. Our intention has not been to evaluate the quality of the bibliographical studies and therefore we have not proceeded with methanalytical techniques. Methods. We have only selected randomized, double blind clinical trials in which diode lasers have been used. The data contained in the articles were recorded on an electronic sheet and then analyzed. In order ...
Now, lets state the needed obvious: nothing in this framework mandates double-blind, placebo control group procedure. Indeed, it points to the underlying principle of case-based reliable inference. Where control groups can ethically and effectively be deliberately set up and used, fine. But that is by no means always the case, with Astronomy perhaps the capital example as a sub-discipline that uses case-based observational studies as a part of the hardest of the hard sciences, Physics. There is a reason why we speak of Astronomical OBSERV-atories, not LABOR-atories. (Ditto for Volcanology; and that was the pivot of my public warning here, 25 years ago. Looong story.). In short, we must be humble enough to recognise that we cannot prescribe an investigative panacea.. Linked, we may ask, how does this work?. First, by applying the principle of distinct identity. A is A i/l/o its key characteristics, some in common with near and increasingly distant neighbours, some more specific to its class then ...
The clinical effects of mucolytics in patients with chronic obstructive pulmonary disease (COPD) are discussed controversially. Cineole is the main constituent of eucalyptus oil and mainly used in inflammatory airway diseases as a mucolytic agent. We hypothesised that its known mucolytic, bronchodilating and anti-inflammatory effects as concomitant therapy would reduce the exacerbation rate and show benefits on pulmonary function tests as well as quality of life in patients with COPD. In this double-blind, placebo-controlled multi-center-study we randomly assigned 242 patients with stable COPD to receive 200 mg of cineole or placebo 3 times daily as concomitant therapy for 6 months during winter-time. The frequency, duration and severity of exacerbations were combined as primary outcome measures for testing as multiple criteria. Secondary outcome measures included changes of lung function, respiratory symptoms and quality of life as well as the single parameters of the exacerbations. Baseline
Another well-known aspect of citrulline is the breakdown of citrulline into L-arginine. L-arginine then can be converted into nitric oxide and increase blood flow. In a small study of only 8 men, supplementing with 2 and 15g of citrulline increased arginine levels in the blood, and in a dose dependent manner13.. In a double-blind placebo-controlled trial of healthy men, citrulline supplementation did in fact increase serum nitric oxide and decrease a measure of arterial stiffness, indicating possible vasorelaxation14.. Given the large effect of citrulline on cardiovascular parameters and recent evidence from individuals with heart failure, L-citrulline may be an ideal supplement for individuals with cardiovascular problems15. Besides changes in fatigue, soreness, and cardiovascular parameters there may be some positive effect of citrulline supplementation on growth hormone.. In one double-blind placebo-controlled study conducted in 17 young men, 6 grams of citrulline prior to exercise increased ...
The trial did not prove clinical efficacy of ISIS-2302 based on the primary endpoint. Positive trends were observed in some of the secondary endpoints.Only 2 of 60 (3.3%) ISIS-2302-treated and no placebo patients reached the primary endpoint. Steroid-free remission at week 26 (secondary endpoint) was reached in 8 of 60 (13.3%) active treatment and 1 of 15 (6.7%) placebo patients. A greater proportion of ISIS-2302-treated than placebo patients achieved a steroid dose ,10 mg/day at weeks 14 and 26 (48.3% vs. 33.3% and 55.0% vs. 40.0%, respectively, and a glucocorticoid dose of 0 mg [prednisone equivalent] at week 26 [23.3% vs. 6.7%, respectively]). Treatment with ISIS-2302 was safe. The most common side effects were injection site reactions in the active treatment group (23% in ISIS-2302-treated patients vs. none in placebo patients). No statistically significant differences in the frequency of side effects were detected between dose groups.A dose-interval, multicenter, placebo-controlled trial ...
Background: Surgical bypass techniques and percutaneous catheter-based interventions may be used to successfully revascularize the limbs of patients with claudication. In many patients, however, the anatomic extent and distribution of arterial occlusion is too severe to permit relief of pain. Limited medical therapy is available for these pts.. Methods: A phase IIa randomized, double-blind, placebo-controlled clinical trial of autologous CD34+ stem cell (CD34) therapy was performed in pts with Rutherford class 3 at 3 centers in US. 3 treatment groups: placebo, low (1x10^5 CD34/kg body wt) and high dose (1x10^6 CD34/kg). All pts underwent mobilization with GCSF 5 mcg/kg/day SC for 5 d, followed by apheresis on d5 followed by selection for CD34 with Isolex 300i device. CD34 were injected IM at 8 locations in the ischemic limb. Placebo injections consisted of identical volumes of the diluent only.. Results: A total of 17 pts have been randomized, completed the injection procedure and completed the ...
Forty patients diagnosed as suffering from senile dementia of the Alzheimer type received either 80 mg Ginkgo biloba special extract (GBE)* or matching placebo t.i.d. for three months in a randomized, double blind study of the efficacy and tolerance of GBE. The patients were assessed using a test battery at baseline and at 1, 2 and 3 months. The test battery included the SKT (a brief test of cognitive function, memory and attention), the Sandoz Clinical Assessment Geriatric Scale, choice reaction time, saccadic eye movements and EEG. Memory and attention, as measured by the SKT, improved significantly in the active treatment group after one month, as did psychopathology, psychomotor performance, functional dynamics and neurophysiology as measured by the above tests. The drug was well tolerated and no adverse drug reactions were recorded during the trial. ...
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.
OBJECTIVE: To examine the pharmacological interaction of salmeterol and salbutamol and to derive an estimate of dose equivalence of salmeterol for airway and systemic effects in patients with asthma. DESIGN: Randomised double blind crossover study. SUBJECTS: 12 patients with mild asthma. INTERVENTION: Placebo or salmeterol 50, 100, 200 micrograms given on separate days followed two hours later by inhaled salbutamol in cumulative doses up to 3600 micrograms. MAIN OUTCOME MEASURES: Change in forced expiratory volume in one second (FEV1), heart rate, plasma potassium concentration, QTc interval, tremor amplitude, and creatine kinase myocardial isoenzyme concentration. RESULTS: Compared with placebo, the mean (95% confidence interval) changes in FEV1 and heart rate after salmeterol 200 micrograms were 0.61 (0.32 to 0.90) l and 7.0 (3.8 to 10.2) beats/min. Adding salbutamol caused a large increase in FEV1 after placebo (0.69 l) with progressively smaller changes after increasing doses of salmeterol (0.19 l
0060] A mixed-effects ANCOVA model with treatment as a fixed effect, center as a random effect, and baseline as a covariate is used to test the primary null hypothesis. The treatment difference in HbA1c change from baseline to week 16 endpoint between WelChol® and placebo is evaluated by the LS mean, standard error, the 2-tailed 95% CI and the 2-sided p-value. The treatment-by-center interaction and treatment-by-covariate interaction is evaluated for the primary efficacy variable at a significance level of 0.10. If a significant treatment-by-center interaction and treatment-by-covariate interaction is suggested by the data, further analyses are implemented to assess the qualitative or quantitative nature of the interaction. The approach used for analysis of the primary efficacy variable is also applied to analysis of the secondary efficacy variables. To further evaluate the efficacy results, change in HbA1c from baseline to week 16 endpoint is summarized by five subgroups of patients: patients ...
Modulation of abdominal aortic aneurysm (AAA) expansion by HMG-CoA reductase inhibitors (statins) might be linked to reducing IL-6 and MMP-9, which may be consequent on reducing plasma cholesterol. Ezetimibe is a novel cholesterol absorption inhibitor used in combination with statins. This pilot study compared the biological effects of ezetimibe combination therapy with simvastatin alone on parameters relevant to aneurysm expansion including cytokines and proteolytic enzymes ...
OBJECTIVE: To evaluate the efficacy and safety of alpha-lipoic acid given intravenously, followed by oral treatment in type 2 diabetic patients with symptomatic polyneuropathy. RESEARCH DESIGN AND METHODS: In a multicenter randomized double-blind placebo-controlled trial (Alpha-Lipoic Acid in Diabetic Neuropathy [ALADIN] III Study), 509 outpatients were randomly assigned to sequential treatment with 600 mg alpha-lipoic acid once daily intravenously for 3 weeks, followed by 600 mg alpha-lipoic acid three times a day orally for 6 months (A-A; n = 167); 600 mg alpha-lipoic acid once daily intravenously for 3 weeks, followed by placebo three times a day orally for 6 months (A-P; n = 174); and placebo once daily intravenously for 3 weeks, followed by placebo three times a day orally for 6 months (P-P; n = 168). Outcome measures included the Total Symptom Score (TSS) for neuropathic symptoms (pain, burning, paresthesias, and numbness) in the feet, and the Neuropathy Impairment Score (NIS). Data ...
In a placebo-controlled, double-blind, randomized clinical trial, the tolerability of a proprietary larch arabinogalactan preparation (ResistAidTM) was investigated. METHODS: 199 healthy participants were randomly assigned to receive either placebo (n = 98) or an arabinogalactan preparation (n = 101) over a period of 12 weeks. As safety parameters the total number of adverse events, changes in various biochemical and laboratory parameters as well as the global evaluation of tolerability by investigator and subjects compared to placebo were evaluated. RESULTS: In total 16 adverse events were observed in 16 subjects, with no difference between the arabinogalactan and the placebo group (p = 0.935). There were no differences in the mean changes of the measured biochemical and laboratory parameters. The tolerability of the arabinogalactan extract was rated as
Hoeger K, Davidson K, Kochman L, et al: The impact of metformin, oral contraceptives, and lifestyle modification on polycystic ovary syndrome in obese adolescent women in two randomized, placebo-controlled clinical trials, J Clin Endocrinol Metab 2008(Nov);93(11):4299-306 (PMID 18728175). Sathyapalan T, Kilpatrick ES, Coady AM, Atkin SL: The effect of atorvastatin in patients with polycystic ovary syndrome: A randomized double-blind placebo-controlled study, J Clin Endocrinol Metab 2009(Jan);94(1):103-8 (PMID 18940877). Chlebowski RT, Kuller LH, Prentice RL, et al: Breast cancer after use of estrogen plus progestin in postmenopausal women, N Engl J Med 2009(Feb);360(6):573-87 (PMID 19196674). The Practice Committee of the American Society for Reproductive Medicine: Obesity and reproduction: An educational bulletin, Fertil Steril 2008(Nov);90(5 Suppl):S21-9 (PMID 19007633). [Please contact the library and we will be happy to request a copy of this article for you.]. Dovey S, Sneeringer RM, ...
In contrast, right midfrontal gyrus connectivity did not differentiate between responders and nonresponders to active medication (duloxetine).. Connectivity with the right parahippocampal gyrus, however, predicted active drug responses after accounting for the placebo response.. By modeling the expected placebo response in subjects receiving active drug treatment, we uncover a placebo-corrected drug response predictive brain signal and show that in some subjects the active drug tends to enhance predicted placebo response, while in others it interferes with it, the researchers write.. Together, these results provide some evidence for clinical placebo being predetermined by brain biology and show that brain imaging may also identify a placebo-corrected prediction of response to active treatment, they add.. Dr. Karin Jensen from Karolinska Institute in Stockholm, Sweden, told Reuters Health by email, It is fascinating to see studies with more and more detailed knowledge about the neural basis ...
The core study will be considered completed for an individual patient, when he/she completes the Double-blind Treatment Phase. The study as a whole will be considered completed when all randomized patients remaining in the core study have completed the Double-blind Treatment Phase.. Patients who complete the 24-month Double-blind Treatment Phase may be eligible for participation in an extension phase which will be provided as a separate protocol. Patients who do not enter the Extension Phase should return for the Follow-up visit 3 months after the last dose of study drug. The investigator also must provide follow-up medical care for all patients who are prematurely discontinued from the study, or must refer them back to their referring physician for appropriate care.. Enrollment is scheduled to begin the end of June, 2006 and continue until all subjects are enrolled at all sites and continue for 2 yrs beyond that last subject.. Key Inclusion Criteria. ...
Loss of motor function is common after stroke and often leads to significant long-term disability. Stem cells can be mobilised into the circulation using granulocyte-colony stimulating factor (G-CSF), an approach that has been found to be effective in experimental stroke. We aim to perform a pilot randomised placebo-controlled dose-escalation trial of G-CSF (1 x 10^5 - 3 x 10^6 µ/kg given once or once daily for 5 days, in dosing blocks: 1 dose or 5 doses 1 x 10^5 µkg - 3 x 10^6 µ/kg, with level of 5 dose blocks depending on single dose data) in patients with motor weakness following ischaemic stroke, investigating its safety, feasibility of administration, tolerability, and effects on stem cell mobilisation, impairment, disability and dependency. The interaction between G-CSF and routine rehabilitation will be examined ...
Health,... HAYWARD Calif. Feb. 10 /- Arete Therapeutics Inc. t... Our AR9281 Phase II clinical trial program breaks new ground in t... The Phase IIa multicenter double-blind placebo-controlled study ...,Arete,Therapeutics,Initiates,Phase,IIa,Clinical,Trial,for,AR9281,,a,Novel,s-EH,Inhibitor,to,Treat,Type,2,Diabetes,medicine,medical news today,latest medical news,medical newsletters,current medical news,latest medicine news
This is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial to compare the efficacy and safety of Fruquintinib plus BSC versus placebo plus BSC in patients with metastatic colorectal cancer who have progressed after second-line or above standard chemotherapy. After checking eligibility criteria, subjects will be randomized into Fruquintinib plus BSC group (treatment group) or placebo plus BSC group (control group) in a ration of 2:1. Primary Efficacy Endpoint: Overall Survival (OS). Secondary Efficacy Endpoints: Progression free survival (PFS) (According to RECIST Version 1.1), Objective Response Rate (ORR), Disease Control Rate (DCR), . Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.0 ...
Section 4.8 (undesirable effects), The following text has been amended The table below reflects data obtained with Reminyl in seven placebo-controlled, double blind clinical trials (N=4457), five open-label clinical trials (N=1454), and from postmarketing spontaneous reports. The most commonly reported adverse drug reactions were nausea (25%) and vomiting (13%). They occurred mainly during titration periods, lasted less than a week in most cases and the majority of patients had one episode. Prescription of anti-emetics and ensuring adequate fluid intake may be useful in these instances. Hypersensitivity was also added as an uncommon side effect under SOC Immune system disorders ...
Background Previous research has shown positive effects of Omega 3/6 fatty acids in children with inattention and reading difficulties. We aimed to investigate if Omega 3/6 improved reading ability in mainstream schoolchildren. Methods We performed a 3-month parallel, randomized, double-blind, placebo-controlled trial followed by 3-month active treatment for all subjects. Mainstream schoolchildren aged 9-10 years were randomized 1:1 to receive three Omega 3/6 capsules twice daily or identical placebo. Assessments were made at baseline, 3 months, and 6 months. The primary outcome measure was the Logos test battery for evaluating reading abilities. The trial is registered with ClinicalTrials.gov, number NCT02557477. Results The study enrolled 154 children (active n = 78; placebo n = 76), of whom 122 completed the first 3 months (active n = 64; placebo n = 58) and 105 completed the whole study (active/active n = 55; placebo/active n = 50). Outcomes were assessed by per protocol (PP) and
van Veldhuisen DJ, Man in t Veld AJ, Dunselman PH; et al. (November 1993). Double-blind placebo-controlled study of ibopamine and digoxin in patients with mild to moderate heart failure: results of the Dutch Ibopamine Multicenter Trial (DIMT). J. Am. Coll. Cardiol. 22 (6): 1564-73. doi:10.1016/0735-1097(93)90579-P. PMID 7901256 ...
D. M. Philbin, J. Moss, C. E. Rosow, C. W. Akins, K. Kono, J. J. Savarese, R. C. Schneider, T. R. VerLee, C. W. Emerson; THE USE OF H1and H2HISTAMINE BLOCKERS WITH MORPHINE: A DOUBLE BLIND STUDY. Anesthesiology 1980;53(3 Suppl):S67. Download citation file:. ...
Read more One of those clinical studies taking place in Austria, Belgium, Canada, Denmark, England, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Scotland, Spain, Sweden, United Kingdom, and USA is a phase III, multicenter, rRandomized, double-blind placebo-controlled study to assess the efficacy and safety of tocilizumab in subjects with giant cell arteritis. This trial sponsored by Roche is active and no longer recruiting subjects. Results from this study were presented at the American College of Rheumatology (ACR) and Association for Rheumatology Health Professionals (ARHP) Annual Meeting and published in the New England Journal of Medicine. The trial met the primary endpoint with a significant increase in the proportion of patients achieving sustained remission at one year (56% in the weekly treatment group [QW; p , 0.0001] and 53.1% in the bi-weekly treatment group [Q2W; p , 0.0001]) versus 14% in a six-month steroid taper regimen given alone. The secondary endpoint were ...
The involvement of COX activity has been implicated in a number of epithelial cancers, including oropharyngeal cancer, and has been recognized as an important chemoprevention target based on epidemiological and biological data (33, 34, 35) . Efforts to inhibit COX with minimal side effects have led to the development of COX-2-selective inhibitors. COX-1 activity is thought to be essential to maintaining normal organ function, especially in the stomach, where the chronic use of pan-COX inhibitors is associated with a low frequency occurrence of serious gastric hemorrhage. Although a major step in rational drug design, the strategy of narrowing the spectrum of inhibition of COX activity still has been associated with clinically important side effects (22 , 36) . A growing body of evidence suggests that because COX-1 activity also produces prostaglandins as COX-2, it too can contribute to the carcinogenic process (37 , 38) . We explored a different strategy to enhance the therapeutic index for ...