Lidocaine -An Old Drug for New Indication
... Bimodal action of inhaled Lidocaine Inhaled Lidocaine has been demonstrated to possess bimodal action as it causes initial airway irritation leading to reflex bronchoconstriction in 10% of patients showing decreased airflow in first 10 minutes followed by bronchodilatation. [13] Initial bronchoconst ...
... Bimodal action of inhaled Lidocaine Inhaled Lidocaine has been demonstrated to possess bimodal action as it causes initial airway irritation leading to reflex bronchoconstriction in 10% of patients showing decreased airflow in first 10 minutes followed by bronchodilatation. [13] Initial bronchoconst ...
Meditation for Migraines: A Pilot Randomized Controlled Trial
... Background.—Stress is a well-known trigger for headaches. Research supports the general benefits of mind/body interventions for migraines, but there are few rigorous studies supporting the use of specific standardized interventions. MBSR is a standardized 8-week mind/body intervention that teaches m ...
... Background.—Stress is a well-known trigger for headaches. Research supports the general benefits of mind/body interventions for migraines, but there are few rigorous studies supporting the use of specific standardized interventions. MBSR is a standardized 8-week mind/body intervention that teaches m ...
5.22 Clinical Trial/Study Reports
... A systematic study on pharmaceutical products in human subjects (including patients and other volunteers) in order to discover or verify the effects of and/or identify any adverse reaction to investigational products, and/or to study the absorption, distribution, metabolism and excretion of the prod ...
... A systematic study on pharmaceutical products in human subjects (including patients and other volunteers) in order to discover or verify the effects of and/or identify any adverse reaction to investigational products, and/or to study the absorption, distribution, metabolism and excretion of the prod ...
IIH:WT Trial Protocol - University of Birmingham
... Fax SAE Forms to: 0121 415 9135 This protocol describes the IIH:WT trial only. The protocol should not be used as a guide for the treatment of patients not taking part in the IIH:WT trial. The study will be conducted in accordance with the protocol, Good Clinical Practice (GCP) and the UK Clinical T ...
... Fax SAE Forms to: 0121 415 9135 This protocol describes the IIH:WT trial only. The protocol should not be used as a guide for the treatment of patients not taking part in the IIH:WT trial. The study will be conducted in accordance with the protocol, Good Clinical Practice (GCP) and the UK Clinical T ...
Saccharomyces boulardii: A Review of an Innovative Bio therapeutic
... dificile-associated colitis and has been found to in a rat loop model, but appears to have no effect have a protective effect if challenged with either on cell tissue layer damage caused by C. dificile toxigenic C. dificile or purified toxin A or B (Table when using human lung (IMR-90) fibroblasts o ...
... dificile-associated colitis and has been found to in a rat loop model, but appears to have no effect have a protective effect if challenged with either on cell tissue layer damage caused by C. dificile toxigenic C. dificile or purified toxin A or B (Table when using human lung (IMR-90) fibroblasts o ...
1
... [see Clinical Studies (14.1)]. Treatment should be initiated with a dose of 10 or 20 mg/day. After 1 week at 10 mg/day, the dose should be increased to 20 mg/day. However, due to higher plasma levels in lower weight children, the starting and target dose in this group may be 10 mg/day. A dose increa ...
... [see Clinical Studies (14.1)]. Treatment should be initiated with a dose of 10 or 20 mg/day. After 1 week at 10 mg/day, the dose should be increased to 20 mg/day. However, due to higher plasma levels in lower weight children, the starting and target dose in this group may be 10 mg/day. A dose increa ...
SPIRIT 2013 explanation and elaboration: guidance for
... and industry sponsors. Model examples were selected to reflect how key elements could be appropriately described in a trial protocol. Some examples illustrate a specific component of a checklist item, while others encompass all key recommendations for an item. Additional examples are also available ...
... and industry sponsors. Model examples were selected to reflect how key elements could be appropriately described in a trial protocol. Some examples illustrate a specific component of a checklist item, while others encompass all key recommendations for an item. Additional examples are also available ...
Long-term treatment of chronic obstructive pulmonary disease
... occurred, i.e. weeks 1±4, 5±8 and 9±12. Mean values during these treatment periods were determined, and compared to baseline values obtained during the run-in period. For individual patients, values obtained in a particular treatment period were considered evaluable only if the number of diary card ...
... occurred, i.e. weeks 1±4, 5±8 and 9±12. Mean values during these treatment periods were determined, and compared to baseline values obtained during the run-in period. For individual patients, values obtained in a particular treatment period were considered evaluable only if the number of diary card ...
022571Orig1s000 MEDICAL REVIEW(S) CENTER FOR DRUG EVALUATION AND RESEARCH
... outcome that the Agency had agreed was acceptable for efficacy demonstration - a statistically significant improvement of three grades on a nine-grade scale that measures drooling. A total of 214 pediatric subjects were exposed to glycopyrrolate solution during this development program; 17 for eight ...
... outcome that the Agency had agreed was acceptable for efficacy demonstration - a statistically significant improvement of three grades on a nine-grade scale that measures drooling. A total of 214 pediatric subjects were exposed to glycopyrrolate solution during this development program; 17 for eight ...
Acute Migraine Treatment in Adults
... and diclofenac potassium), and 7 triptans (almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, and zolmitriptan) have good evidence for efficacy and form the core of acute migraine treatment. NSAID–triptan combinations, dihydroergotamine, non-opioid combination analgesics ( ...
... and diclofenac potassium), and 7 triptans (almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, and zolmitriptan) have good evidence for efficacy and form the core of acute migraine treatment. NSAID–triptan combinations, dihydroergotamine, non-opioid combination analgesics ( ...
Efficacy and safety of agomelatine (10 or 25 mg/day) in non
... center (random effect) with baseline HAM-A total score as covariate. Missing data at week 12 were imputed using the last observation carried forward (LOCF) approach. The Hochberg procedure was used to take into account the multiplicity of comparisons. To assess the robustness of the results of the p ...
... center (random effect) with baseline HAM-A total score as covariate. Missing data at week 12 were imputed using the last observation carried forward (LOCF) approach. The Hochberg procedure was used to take into account the multiplicity of comparisons. To assess the robustness of the results of the p ...
Oral Appliance Treatment for Obstructive Sleep Apnea: An Update
... Sleepiness Score (ESS), improves with OAm compared to inactive appliances in the majority of studies,14-20 although a placebo effect on ESS has been reported.16,18 Objectively measured sleepiness by the multiple sleep latency test (MSLT) was improved only with active OAm.16 Three placebo-controlled ...
... Sleepiness Score (ESS), improves with OAm compared to inactive appliances in the majority of studies,14-20 although a placebo effect on ESS has been reported.16,18 Objectively measured sleepiness by the multiple sleep latency test (MSLT) was improved only with active OAm.16 Three placebo-controlled ...
World Federation of Societies of Biological Psychiatry (WFSBP)
... serotonin-noradrenaline reuptake inhibitors (SNRIs) and the calcium channel modulator pregabalin. Tricyclic antidepressants (TCAs) are equally effective for some disorders, but many are less well tolerated than the SSRIs/ SNRIs. In treatment-resistant cases, benzodiazepines may be used when the pati ...
... serotonin-noradrenaline reuptake inhibitors (SNRIs) and the calcium channel modulator pregabalin. Tricyclic antidepressants (TCAs) are equally effective for some disorders, but many are less well tolerated than the SSRIs/ SNRIs. In treatment-resistant cases, benzodiazepines may be used when the pati ...
Table 1. Randomized Trials on Medical Management of
... due to reflux were SAP positive, while 44% of patients without cough due to reflux were SAP positive. This study also reported that only 39% of cough bursts were not recorded by patients, and those that were recorded were delayed by 28 seconds. (Sifrim 2005) These studies were all small (n ≤ 61) and ...
... due to reflux were SAP positive, while 44% of patients without cough due to reflux were SAP positive. This study also reported that only 39% of cough bursts were not recorded by patients, and those that were recorded were delayed by 28 seconds. (Sifrim 2005) These studies were all small (n ≤ 61) and ...
AusPAR: Eplerenone - Therapeutic Goods Administration
... after the protocol-specified second interim analysis on 6 May 2010, when a total of 501 adjudicated primary endpoint events were reviewed by the Data Safety Monitoring Committee (DSMC), the DSMC and the Executive Steering Committee (ESC) recommended that the study be stopped based on pre-specified s ...
... after the protocol-specified second interim analysis on 6 May 2010, when a total of 501 adjudicated primary endpoint events were reviewed by the Data Safety Monitoring Committee (DSMC), the DSMC and the Executive Steering Committee (ESC) recommended that the study be stopped based on pre-specified s ...
Imlygic : EPAR - EMA
... the tumour-specific 10-year-survival for such tumours is 75–85% 5. The 10-year-survival for patients with micrometastasis in the regional lymph nodes is 30–70%, 30–50% for patients with satellite (defined as up to 2 cm from the primary tumour) and in-transit (located in the skin between 2 cm from th ...
... the tumour-specific 10-year-survival for such tumours is 75–85% 5. The 10-year-survival for patients with micrometastasis in the regional lymph nodes is 30–70%, 30–50% for patients with satellite (defined as up to 2 cm from the primary tumour) and in-transit (located in the skin between 2 cm from th ...
Oral Appliance Treatment for Obstructive Sleep Apnea: An Update
... of patients successfully treated (79% vs. 73%) 25. However in severe OSA, more patients achieved treatment success with 75% compared to 50% maximum advancement (52% vs. 31%) 26, suggesting maximising advancement may be more important in severe disease. A dose dependent effect of mandibular advanceme ...
... of patients successfully treated (79% vs. 73%) 25. However in severe OSA, more patients achieved treatment success with 75% compared to 50% maximum advancement (52% vs. 31%) 26, suggesting maximising advancement may be more important in severe disease. A dose dependent effect of mandibular advanceme ...
Antihistamines Allergic Conjunctivitis and H A del Cuvillo, J Sastre,
... are very effective (probably the most effective of all options), but pose the important risk of frequent side effects (glaucoma, cataracts, corneal ulcers) [3]. Oral antihistamines are also a treatment option to be taken into account, particularly when considering that the isolated presentation of a ...
... are very effective (probably the most effective of all options), but pose the important risk of frequent side effects (glaucoma, cataracts, corneal ulcers) [3]. Oral antihistamines are also a treatment option to be taken into account, particularly when considering that the isolated presentation of a ...
Ginkgo Biloba Extract: A Review
... age, 71 years) with numerous symptoms attributed to “chronic cerebral insufficiency” received ginkgo (40 mg three times a day) for one year. During that time, there were significant improvements in short-term memory, alertness, mood disturbances, vertigo, headaches, and tinnitus. There were no side ...
... age, 71 years) with numerous symptoms attributed to “chronic cerebral insufficiency” received ginkgo (40 mg three times a day) for one year. During that time, there were significant improvements in short-term memory, alertness, mood disturbances, vertigo, headaches, and tinnitus. There were no side ...
Clinical Practice Guidelines on Arterial Hypertension
... diseases can be attributed to arterial hypertension (AHT). In regards to the care of hypertensive people, there is still a wide margin for improvement. The dissemination and implementation of the previous version of the Clinical Practice Guidelines (CPG) were carried out according to some of the str ...
... diseases can be attributed to arterial hypertension (AHT). In regards to the care of hypertensive people, there is still a wide margin for improvement. The dissemination and implementation of the previous version of the Clinical Practice Guidelines (CPG) were carried out according to some of the str ...
Alternative treatments for Clostridium difficile disease
... previous antibiotic exposure. Initial cure rates were similar for all treatments, ranging between 93 % and 96 %. Patients treated with vancomycin or metronidazole had a recurrence rate of 16 %. The recurrence rate in patients receiving teicoplanin (7 %) was lower than those treated with fusidic acid ...
... previous antibiotic exposure. Initial cure rates were similar for all treatments, ranging between 93 % and 96 %. Patients treated with vancomycin or metronidazole had a recurrence rate of 16 %. The recurrence rate in patients receiving teicoplanin (7 %) was lower than those treated with fusidic acid ...
Mary is 44 years old and is complaining of terrible headaches
... 2. Stress management eg relaxation and cognitive coping. This is more effective when combined with antidepressant medication(1). Muscle relaxation techniques with or without biofeedback training can be used to teach the patient awareness of and control of their physiologic responses. In one study ad ...
... 2. Stress management eg relaxation and cognitive coping. This is more effective when combined with antidepressant medication(1). Muscle relaxation techniques with or without biofeedback training can be used to teach the patient awareness of and control of their physiologic responses. In one study ad ...
311.
... • Migraine headaches are common and may often be under-recognized - Think Migraine! • Diagnosis should rely on standardized criteria • Imaging should be guided by “warning signs” with specific criteria used as suggestions ...
... • Migraine headaches are common and may often be under-recognized - Think Migraine! • Diagnosis should rely on standardized criteria • Imaging should be guided by “warning signs” with specific criteria used as suggestions ...
Ongoing Clinical Trials Posters II
... Study Population: Male or female, ≥ 18 years old, treated within 24 hours of symptoms onset, with a measurable focal neurological deficit lasting for a minimum of 60 minutes. Baseline NIHSS score ≥ 8, with a neuroimage compatible with the diagnosis of acute ischemic stroke and symptoms referable to ...
... Study Population: Male or female, ≥ 18 years old, treated within 24 hours of symptoms onset, with a measurable focal neurological deficit lasting for a minimum of 60 minutes. Baseline NIHSS score ≥ 8, with a neuroimage compatible with the diagnosis of acute ischemic stroke and symptoms referable to ...
Placebo-controlled study
Placebo-controlled studies are a way of testing a medical therapy in which, in addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a sham ""placebo"" treatment which is specifically designed to have no real effect. Placebos are most commonly used in blinded trials, where subjects do not know whether they are receiving real or placebo treatment. Often, there is also a further ""natural history"" group that does not receive any treatment at all.The purpose of the placebo group is to account for the placebo effect, that is, effects from treatment that do not depend on the treatment itself. Such factors include knowing one is receiving a treatment, attention from health care professionals, and the expectations of a treatment's effectiveness by those running the research study. Without a placebo group to compare against, it is not possible to know whether the treatment itself had any effect.Patients frequently show improvement even when given a sham or ""fake"" treatment. Such intentionally inert placebo treatments can take many forms, such as a pill containing only sugar, a surgery where nothing efficacious is actually done (just an incision and sometimes some minor touching or handling of the underlying structures), or a medical device (such as an ultrasound machine) that is not actually turned on. Also, due to the body's natural healing ability and statistical effects such as regression to the mean, many patients will get better even when given no treatment at all. Thus, the relevant question when assessing a treatment is not ""does the treatment work?"" but ""does the treatment work better than a placebo treatment, or no treatment at all?"" As one early clinical trial researcher wrote, ""the first object of a therapeutic trial is to discover whether the patients who receive the treatment under investigation are cured more rapidly, more completely or more frequently, than they would have been without it.""p.195 More broadly, the aim of a clinical trial is to determine what treatments, delivered in what circumstances, to which patients, in what conditions, are the most effective.Therefore, the use of placebos is a standard control component of most clinical trials, which attempt to make some sort of quantitative assessment of the efficacy of medicinal drugs or treatments. Such a test or clinical trial is called a placebo-controlled study, and its control is of the negative type. A study whose control is a previously tested treatment, rather than no treatment, is called a positive-control study, because its control is of the positive type.Government regulatory agencies approve new drugs only after tests establish not only that patients respond to them, but also that their effect is greater than that of a placebo (by way of affecting more patients, by affecting responders more strongly, or both). As a result, ""placebo-controlled studies often are designed in such a way that disadvantages the placebo condition"".