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 ...

New life-saving treatments for Heart failure in clinical trial on A multicenter, randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy, safety and tolerability of Serelaxin when added to standard therapy in acute heart failure patients

The sum of the frequencies of tonic seizures and atonic seizures was defined as the tonic-atonic seizure frequency and the percent change in tonic-atonic seizure frequency per 28 days was assessed. The percent change in tonic-atonic seizure frequency was calculated using the tonic-atonic seizure frequency per 28 days of the Observation Period as the baseline and the tonic-atonic seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in tonic - atonic seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline].. The frequency of epileptic seizures was recorded in the seizure diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner, and continued these practices throughout the study period. ...

The objective of this Phase III, randomized, double-blind, placebo-controlled study in patients with immunologic deficiency is to determine the effect of isoprinosine in producing an immuno-restorative response within the study observation period (including the 2-month period following cessation of the 28 days of treatment), measured by one or more of the following immunologic parameters:. ...

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

Seventy-five patients meeting international diagnostic criteria for narcolepsy enrolled in a 6-week, three-period, randomized, crossover, placebo-controlled trial. Patients received placebo, modafinil 200 mg, or modafinil 400 mg in divided doses (morning and noon). Evaluations occurred at baseline a …

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 ...

Objective: Inflammatory back pain (IBP) in Ankylosing Spondylitis (AS) and Undifferentiated Spondyloarthritis (UspA) adversely affects the quality of life. Herein combina..

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. ...

This trial, entitled "A phase 3, randomised, active-controlled, double-blind trial evaluating the safety, tolerability, and immunogenicity of manufacturing

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 ...

Lerner, Fred N, et. al. A doubleblind comparative study of microstimulation and placebo effect in short term treatment of the chronic back pain patient. Journal of the American Chiropractic Association, 15(11):101-106, 1981. Download article. This was the first published report introducing bioconductive therapy using the Alpha-Stim when it was still a prototype. 40 subjects were selected from the first authors practice, from 19 to 63 years old (mean of 38.3 years), 58% females, with chronic (more than 12 months), persistent back pain with few, if any, remissions. 25 (63%) had low back pain, 15 (37%) had pain above T7, 31 (78%) had headaches, and 26 (65%) had extremity pain. After providing informed consent, they were divided into 2 matched groups based on a 2 week pre-study analyses of hourly 0 - 5 pain evaluation charts: one group received Alpha-Stim stimulation, and the other placebo. The same hourly pain charts were used during the actual 2 week treatment period, 2 weeks after treatment, and ...

TY - JOUR. T1 - A double-blind placebo-controlled study of the effectiveness and tolerability of oral stevioside in human hypertension. AU - Chan, Paul. AU - Tomlinson, Brian. AU - Chen, Yi Jen. AU - Liu, Ju Chi. AU - Hsieh, Ming Hsiung. AU - Cheng, Juei Tang. PY - 2000. Y1 - 2000. N2 - Aims: Stevioside is a natural plant glycoside isolated from the plant Stevia rebaudiana which has been commercialized as a sweetener in Japan for more than 20 years. Previous animal studies have shown that stevioside has an antihypertensive effect. This study was to designed to evaluate the effect of stevioside in human hypertension. Methods: A multicentre, randomized, double-blind, placebo-controlled study was undertaken. This study group consisted of 106 Chinese hypertensive subjects with diastolic blood pressure between 95 and 110 mmHg and ages ranging from 28 to 75 years with 60 subjects (men 34, women 26; mean ± s.d, 54.1±3.8 years) allocated to active treatment and 46 (men 19, women 27; mean ±s.d, ...

Our randomised, double-blind, placebo-controlled pilot study showed for the first time that a combination of memantine and L-dopa was associated with a slight, beneficial effect on axial motor handicap and LID in advanced PD patients with severe axial symptoms. Memantines good safety profile and its observed association with a lower motor symptom score (vs placebo) confirmed the findings of two open-label studies12 ,13 and two double-blind, placebo-controlled studies. One of the double-blind studies used non-validated scales14 and the other adopted a crossover paradigm with a very small number (n=12) of PD patients.15. This pilot study had both strengths and limitations. The main limitation was the small sample size, which encompassed patients with and without STN stimulation. However, the lack of significant differences between these subgroups suggests that memantine may have clinical benefit in both stimulated and non-stimulated patients. Furthermore, the lack of off-L-dopa data (due to ...

TY - JOUR. T1 - Randomised placebo-controlled cross-over study examining the role of anamorelin in mesothelioma (The ANTHEM study). T2 - Rationale and protocol. AU - Hoon, Siao Nge. AU - Fyfe, Katrina. AU - Peddle-Mcintyre, Carolyn J.. AU - Bowyer, Samantha. AU - Hawkins, Felicity. AU - Jeffery, Emily. AU - Chih, Hui Jun. AU - Creaney, Jenette. AU - Nowak, Anna. AU - Brims, Fraser. PY - 2020/3/25. Y1 - 2020/3/25. N2 - Introduction Cachexia is common in malignant mesothelioma (MM); half of patients have malnutrition and low skeletal muscle mass. Malnourished patients have worse quality of life (QoL). Weight loss is strongly associated with poor survival. Anamorelin is an oral ghrelin receptor agonist that improves appetite, body weight and QoL in advanced cancer. The aim of this study is to examine the efficacy of anamorelin in improving appendicular skeletal muscle mass (ASM) and patient-reported outcomes in patients with MM with cachexia. Methods and analysis A single-centre, phase II, ...

A randomized, double-blind comparative trial evaluating the safety of liposomal amphotericin B versus amphotericin B lipid complex in the empirical treatment of febrile neutropenia

TY - JOUR. T1 - Acute and chronic effects of flavanol-rich cocoa on vascular function in subjects with coronary artery disease. T2 - A randomized double-blind placebo-controlled study. AU - Farouque, H. M Omar. AU - Leung, Michael. AU - Hope, Sarah A.. AU - Baldi, Mauro. AU - Schechter, Clyde B.. AU - Cameron, James D.. AU - Meredith, Ian T.. PY - 2006/7. Y1 - 2006/7. N2 - Evidence suggests that flavonoid-containing diets reduce cardiovascular risk, but the mechanisms responsible are unclear. In the present study, we sought to determine the effect of flavanol-rich cocoa on vascular function in individuals with CAD (coronary artery disease). Forty subjects (61+8 years; 30 male) with CAD were recruited to a 6-week randomized double-blind placebo-controlled study. Subjects consumed either a flavanol-rich chocolate bar and cocoa beverage daily (total flavanols, 444 mg/day) or matching isocaloric placebos daily (total flavanols, 19.6 mg/day) for 6 weeks. Brachial artery FMD (flow-mediated dilation) ...

O:13:\PanistOpenUrl\:36:{s:10:\\u0000*\u0000openUrl\;N;s:6:\\u0000*\u0000idc\;N;s:6:\\u0000*\u0000fmt\;s:7:\journal\;s:6:\\u0000*\u0000doi\;s:0:\\;s:6:\\u0000*\u0000pii\;s:0:\\;s:7:\\u0000*\u0000pmid\;s:0:\\;s:9:\\u0000*\u0000atitle\;s:134:\A DOUBLE-BLIND CROSS-OVER TRIAL OF INDOMETHACIN, FENOPROFEN AND PLACEBO IN ANKYLOSING SPONDYLITIS, WITH COMMENTS ON PATIENT ASSESSMENT\;s:9:\\u0000*\u0000jtitle\;s:0:\\;s:9:\\u0000*\u0000stitle\;s:0:\\;s:7:\\u0000*\u0000date\;s:4:\1980\;s:9:\\u0000*\u0000volume\;s:0:\\;s:8:\\u0000*\u0000issue\;s:0:\\;s:8:\\u0000*\u0000spage\;s:0:\\;s:8:\\u0000*\u0000epage\;s:0:\\;s:8:\\u0000*\u0000pages\;s:0:\\;s:7:\\u0000*\u0000issn\;s:0:\\;s:8:\\u0000*\u0000eissn\;s:0:\\;s:9:\\u0000*\u0000aulast\;s:7:\SHIPLEY\;s:10:\\u0000*\u0000aufirst\;s:1:\M\;s:9:\\u0000*\u0000auinit\;N;s:10:\\u0000*\u0000auinitm\;N;s:5:\\u0000*\u0000au\;a:3:{i:0;s:9:\SHIPLEY M\;i:1;s:7:\BERRY H\;i:2;s:7:\BLOOM ...

Study Objective: To determine the efficacy and safety of recombinant human erythropoietin (r-HuEPO) in predialysis renal patients.. Design: Randomized, double-blind, placebo-controlled trial for 8 weeks.. Setting: Inpatient and outpatient facility in the Clinical Research Center of a university-based hospital.. Patients: Fourteen adult subjects with renal insufficiency (mean serum creatinine, 473 µmol/L ± 61 [6.2 µ 0.8 mg/dL] ) and anemia (mean hematocrit, 0.27 ± 0.01).. Interventions: Recombinant human erythropoietin, 50, 100, or 150 IU/kg body weight or placebo given intravenously three times per week.. Measurements and Main Results: Subjects who received active r-HuEPO showed a dose-dependent rise in hematocrit; mean hematocrit increased 41% from 0. 27 ± 0.01 to 0.38 ± 0.01. At the same time, erythrocyte mass rose 43% from 13.7 ± 0.6 mL/kg in the baseline state to 19.6 ± 1.0 mL/kg after treatment. Maximal oxygen consumption during exercise increased 9% from 16.0 mL/min · kg ± 1.8 to ...

INTRODUCTION: Overactive bladder syndrome (OAB) is a chronic disorder that often requires long-term treatment. There is a growing interest in new substances. In vitro experiments of Bryophyllum pinnatum (BP) on porcine bladder muscle have shown a muscle-relaxing effect. In this clinical trial we evaluated BP versus placebo regarding efficacy and safety. MATERIALS AND METHODS: Prospective, double-blind randomized, placebo-controlled study with 20 patients (10 BP, 10 placebo); medication over 8 weeks; dosage 3×2 capsules BP 50% (350mg)/day or placebo (lactose). Primary aim: reduction of the micturition frequency/24h. Secondary aim: change in quality of life, alterations of parameters in the bladder diary and adverse events (AE). Statistical analysis was performed with IBM SPSS Statistics 20. The groups were compared using Fishers exact test and the Mann-Whitney test; the visits using the Wilcoxon signed ranks test. RESULTS: Both groups did not differ significantly in demographical data. For the ...

Shouldnt the title be, as to double blind studies, about the efficacy of a homeopathic remedy, not of homeopathy. Homeopathy practice involves a lot more than the remedies, but its probably impossible to do a double blind study in the effectiveness of homeopathy itself; it might work for reasons completely separate from the theory and any specific efficacy of the remedies themselves. As an example, it might work (be effective) if something about the whole process is effective in amplifying the placebo effect or other consciousness-mediated effect, compared to other modalities or no modality. The distinction between efficacy of a remedy and the effectiveness of the treatment is covered in the British review of homeopathy but seems to have been missed in reporting on that review here. A remedy may be useless, by itself, but be effective in context, and studying this double-blind is far from simple. The requirements of double-blind might interfere with the modality. If what RationalWiki wants ...

There is substantial evidence that the prevalence of sleep disorders is an important occupational health problem, especially among health care professionals on night or on rotating work shifts [1-10]. An important aspect of the work environment of nurses is that they are required to work at any point in the 24 hour day [11]. Night work is associated with disturbed sleep and impaired alertness. The impact of sleep is the result of the circadian interference with sleep during daylight hours and circadian suppression of pineal gland by light at night [12].. The definition of insomnia is a complaint of disturbed sleep, manifested as difficulties in sleep initiation, sleep maintenance, early morning awakenings, or nonrestorative sleep. Many sources also add the presence of associated daytime impairments, such as fatigue, irritability, decreased memory and concentration, and pervasive malaise affecting many aspects of daytime functioning [13]. In a recent study, 32% of night-shift workers reported ...

bß (95% confidence intervals) and P values for trend in mean change in mammographic breast density, and Pinteraction, are estimated from regression models. Study arm is treated as a continuous variable, and ß represents mean difference in change in percent mammographic breast density for increments of 1,000 IU/day vitamin D3. Models are adjusted for sites. ...

Moclobemide produces some improvement in key symptoms experienced by patients with chronic fatigue syndrome. This effect is not dependent on the prese

BACKGROUND: Enterovirus (EV) meningitis is common in infants and may have neurologic complications. Treatment of older children and adults with pleconaril has been associated with reduced severity and duration of symptoms. This study evaluated the pharmacokinetics, safety and efficacy of pleconaril in infants with EV meningitis. METHODS: Infants < or =12 months old with suspected EV meningitis were randomized 2:1 to receive pleconaril, 5 mg/kg/dose orally three times a day or placebo for 7 days. Evaluations included pharmacokinetic determinations, safety laboratory testing, serial culture and PCR assays and clinical evaluations. RESULTS: Of 21 evaluable subjects 20 were confirmed with EV infection (12 pleconaril, 8 placebo). Among pleconaril-treated subjects 26 of 29 peak and trough pleconaril levels exceeded the 90% inhibitory concentration for EVs. A median 3.5-fold drug accumulation occurred between Days 2 and 7. Pleconaril was well-tolerated, although twice as many adverse events occurred ...

OBJECTIVES: OSKIRA-4 evaluated the efficacy of fostamatinib monotherapy versus placebo on the signs and symptoms of rheumatoid arthritis over 6 weeks by Disease Activity Score C reactive protein (DAS-28(CRP)) and assessed non-inferiority to adalimumab monotherapy at Week 24 by DAS-28(CRP). METHODS: Overall, 279 patients not currently taking disease-modifying antirheumatic drugs were randomised to: (A) fostamatinib 100 mg twice daily for 24 weeks plus placebo injection every 2 weeks (PBOI); (B) fostamatinib 100 mg twice daily for 4 weeks, then 150 mg once daily up to Week 24, plus PBOI; (C) fostamatinib 100 mg twice daily for 4 weeks, then 100 mg once daily up to Week 24, plus PBOI; (D) adalimumab 40 mg every 2 weeks for 24 weeks, plus oral placebo twice daily; or (E) oral placebo twice daily for 6 weeks, plus PBOI, then a switch to arm A or B. RESULTS: Fostamatinib demonstrated a significant improvement in DAS-28(CRP) score from baseline versus placebo at Week 6 for arms A and B, but not C. Fostamatinib

The phase III placebo-controlled BRAVO study assessed laquinimod effects in patients with relapsing-remitting MS (RRMS), and descriptively compared laquinimod with interferon beta (IFNβ)-1a (Avonex(®) reference arm). RRMS patients age 18-55 years with Expanded Disability Status Scale (EDSS) scores of 0-5.5 and documented pre-study relapse (≥ 1 in previous year, 2 in previous 2 years, or 1 in previous 1-2 years and ≥ 1 GdE lesion in the previous year) were randomized (1:1:1) to laquinimod 0.6 mg once-daily, matching oral placebo, or IFNβ-1a IM 30 μg once-weekly (rater-blinded design), for 24 months. The primary endpoint was annualized relapse rate (ARR); secondary endpoints included percent brain volume change (PBVC) and 3-month confirmed disability worsening. In all, 1,331 patients were randomized: laquinimod (n = 434), placebo (n = 450), and IFNβ-1a (n = 447). ARR was not significantly reduced with laquinimod [-18 %, risk ratio (RR) = 0.82, 95 % CI 0.66-1.02; p = 0.075] vs. placebo. ...

Centonze D Mori F Koch G et al.: Lack of effect of cannabis-based treatment on clinical and laboratory measures in multiple sclerosis. Side Effects Of Giving Up Smoking Weed neurol Sci 2009; 30: 531-4. MEDLINE e4.. Pain 2003; 106: 169-72 MEDLINE e99. Seeling W Kneer L Buchele B et al.: Delta-9-tetrahydrocannabinol and the opioid receptor agonist piritramide do not act synergistically in postoperative pain. Anaesthesist 2006; 55: 391-400 MEDLINE e100.. Pain 2007; 133: 210-20 MEDLINE e79. Selvarajah D Side Effects Of Giving Up Smoking Weed Gandhi R Emery CJ Tesfaye S: Randomised Placebo Controlled Double Blind Clinical Trial of Cannabis Based Medicinal Product (Sativex) in Painful Diabetic Neuropathy: Depression is a Major Confounding Factor. Diabetes Care 2010; 33: 128-30 CrossRef MEDLINE PubMed Central e80.. MEDLINE e38. Crawford SM Buckman R: Nabilone and metoclopramide in the treatment of nausea and vomiting Side Effects Of Giving Up Smoking Weed due to cisplatinum: a double blind study. Med ...

Seventy-seven patients with endoscopically verified duodenal ulcers were randomized to treatment with either 2 g sucralfate daily at bedtime or 1 g sucralfate q.d.s. in a controlled double-blind comparative study. After a 4-week treatment period, the healing rate was 68% for the former and 69% for the latter treatment ...

TY - GEN. T1 - Double blind placebo controlled exposure to moulds. AU - Meyer, H.W.. AU - Nielsen, Kristian Fog. AU - Jensen, K.A.. AU - Kildesø, J.. AU - Norn, S.. AU - Permin, H.. AU - Poulsen, L.. AU - Malling, H.J.. AU - Gravesen, S.. AU - Gyntelberg, F.. PY - 2002. Y1 - 2002. M3 - Article in proceedings. SP - 19. EP - 22. BT - Indoor Air 2002, The 9th International Conference on Indoor Air Quality and Climate. A2 - Levin, H.. PB - The International Academy of Indoor Air Sciences. CY - Santa Cruz, CA. ER - ...

This open-label extension study will permit patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who previously were responsive to treatment with

New life-saving treatments for Bipolar disorder in clinical trial on A Double Blind Study To Evaluate the Dose Tolerance and Safety of Equetro (Carbamazepine) Versus Placebo Followed by a Long-Term Maintenance in Children and Adolescents Aged 10-17 Years With Acute Manic or Mixed Bipolar I Disorder

To assess the effectiveness and safety of ABT-126 in the treatment of cognitive impairment, researchers from Cairo University in Egypt and AbbVie Inc., manufacturer of ABT-126, randomly assigned 207 clinically stable patients with schizophrenia to receive 10 mg of ABT-126, 25 mg of ABT-126, or placebo once daily for 12 weeks. The primary efficacy measure was the change from baseline to study endpoint on the MATRICS Consensus Cognitive Battery (MCCB) composite score. Secondary measures included changes in specific domains scores on the MCCB such as verbal learning and working memory. ...

Throughout human evolution, infectious diseases have been a primary cause of death. Detection of subtle cues indicating sickness and avoidance of sick conspecifics would therefore be an adaptive way of coping with an environment fraught with pathogens. This study determines how humans perceive and integrate early cues of sickness in conspecifics sampled just hours after the induction of immune system activation, and the underlying neural mechanisms for this detection. In a double-blind placebo-controlled crossover design, the immune system in 22 sample donors was transiently activated with an endotoxin injection [lipopolysaccharide (LPS)]. Facial photographs and body odor samples were taken from the same donors when sick (LPS-injected) and when healthy (saline-injected) and subsequently were presented to a separate group of participants (n = 30) who rated their liking of the presented person during fMRI scanning. Faces were less socially desirable when sick, and sick body odors tended to lower ...

Nineteen patients, 6 to 17 years of age, completed treatment: 12 in the active group and 7 in the placebo group. One dropped out because of persistent eczema during dose escalation. Baseline median milk IgE levels in the active (n = 13) versus placebo (n = 7) groups were 34.8 kUa/L (range, 4.86-314 kUa/L) versus 14.6 kUa/L (range, 0.93-133.4 kUa/L). The median milk threshold dose in both groups was 40 mg at the baseline challenge. After OIT, the median cumulative dose inducing a reaction in the active treatment group was 5140 mg (range 2540-8140 mg), whereas all patients in the placebo group reacted at 40 mg (P = .0003). Among 2437 active OIT doses versus 1193 placebo doses, there were 1107 (45.4%) versus 134 (11.2%) total reactions, with local symptoms being most common. Milk-specific IgE levels did not change significantly in either group. Milk IgG levels increased significantly in the active treatment group, with a predominant milk IgG4 level increase.. ...

Our primary aim is to determine whether perioperative NMDA-receptor antagonism has differential effects on postoperative pain, hyperalgesia and morbidity in younger and older patients. In order to achieve this aim, we propose to conduct the first randomized, double-blind placebo-controlled study designed to investigate age differences in the effects of perioperative oral administration of an NMDA-receptor antagonist (amantadine) in men undergoing radical prostatectomy. In addition, age differences in psychosocial factors and the pharmacological properties of amantadine and morphine will be measured to control for, and clarify, their contribution to the differences found. ...

Background: Functional dyspepsia (FD) is a common disorder but there is currently little efficacious drug therapy. Itopride, a prokinetic approved in several countries, showed promising efficacy in FD in a phase IIb trial. The aim of this study was to test the efficacy and safety of this drug in FD.. Methods: Two similar placebo-controlled clinical trials were conducted (International and North America). Males and females, 18-65 years old, with a diagnosis of FD (Rome II) and the absence (by upper endoscopy) of any relevant structural disease were recruited. All were negative for Helicobacter pylori and, if present, heartburn could not exceed one episode per week. Following screening, patients were randomised to itopride 100 mg three times daily or identical placebo. The co-primary end points were: (1) global patient assessment (GPA) of efficacy; and (2) Leeds Dyspepsia Questionnaire (LDQ). Symptoms were evaluated at weeks 2, 4 and 8. Secondary measures of efficacy included Nepean Dyspepsia ...

Molecular hydrogen (H2) improves body composition, metabolic profiles and mitochondrial function in overweight women, yet no studies so far evaluated the effectiveness of H2 for improving exercise capacity in this population.. PURPOSE: To examine the effects of 28-days supplementation with 1 L per day of hydrogen-rich water (HRW) on exercise capacity and quality of life in overweight mid-age women.. METHODS: Twelve women (age 53.8 ± 13.0 years, BMI 28.8 ± 3.3 kg/m2, VO2max 22.3 ± 3.7 ml/kg/min) participated in this randomized, placebo-controlled, cross-over, repeated-measure interventional study. All participants were allocated in a double-blind design to receive two randomly assigned trials: first group received 1 L per day of HRW (supplying ~ 9 ppm of H2), while the second group received placebo (tap water). Participants were evaluated at baseline, and following 28 days of intervention. The primary endpoint was the change in cardiorespiratory endurance (VO2max) assessed at baseline and at ...

This 24-week double-blind placebo-controlled multicenter randomized phase 2 trial evaluated efficacy and safety of onabotulinumtoxinA (onabotA; BOTOX) vs. placebo for major depressive disorder (MDD) [NCT02116361]. Primary endpoint was the change in Montgomery-Åsberg Depression Rating Scale (MADRS); …

Guidelines recommend inhaled corticosteroids (ICS) for patients with severe chronic obstructive pulmonary disease (COPD). Most COPD patients are managed in primary care and receive ICS long-term and irrespective of severity. The effect of withdrawing ICS from COPD patients in primary care is unknown. In a pragmatic randomised, double-blind, placebo-controlled trial in 31 practices, 260 COPD patients stopped their usual ICS (median duration of use 8 years) and were allocated to 500 mcg fluticasone propionate twice daily (n = 128), or placebo (n = 132). Follow-up assessments took place at three monthly intervals for a year at the patients practice. Our primary outcome was COPD exacerbation frequency. Secondary outcomes were time to first COPD exacerbation, reported symptoms, peak expiratory flow rate and reliever inhaler use, and lung function and health related quality of life. In patients randomised to placebo, COPD exacerbation risk over one year was RR: 1.11 (CI: 0.91-1.36). Patients taking placebo

Guidelines recommend inhaled corticosteroids (ICS) for patients with severe chronic obstructive pulmonary disease (COPD). Most COPD patients are managed in primary care and receive ICS long-term and irrespective of severity. The effect of withdrawing ICS from COPD patients in primary care is unknown. In a pragmatic randomised, double-blind, placebo-controlled trial in 31 practices, 260 COPD patients stopped their usual ICS (median duration of use 8 years) and were allocated to 500 mcg fluticasone propionate twice daily (n = 128), or placebo (n = 132). Follow-up assessments took place at three monthly intervals for a year at the patients practice. Our primary outcome was COPD exacerbation frequency. Secondary outcomes were time to first COPD exacerbation, reported symptoms, peak expiratory flow rate and reliever inhaler use, and lung function and health related quality of life. In patients randomised to placebo, COPD exacerbation risk over one year was RR: 1.11 (CI: 0.91-1.36). Patients taking placebo