Expanded Access For An Unapproved Drug
... Expanded Access refers to non-emergency treatment INDs or Individual Patient Access to investigational drugs or devices for serious diseases. These mechanisms are intended to give seriously ill patients access to experimental drugs or devices where no comparable or satisfactory alternative treatment ...
... Expanded Access refers to non-emergency treatment INDs or Individual Patient Access to investigational drugs or devices for serious diseases. These mechanisms are intended to give seriously ill patients access to experimental drugs or devices where no comparable or satisfactory alternative treatment ...
- Journal of Vascular Surgery
... within 30 days of randomization. Therefore, only 97 patients underwent infrarenal vascular surgery under general anesthesia (44 in the placebo arm and 53 in the metoprolol arm). The principal remaining results are reported for these 97 patients only: the other 6 patients did not have the Holter moni ...
... within 30 days of randomization. Therefore, only 97 patients underwent infrarenal vascular surgery under general anesthesia (44 in the placebo arm and 53 in the metoprolol arm). The principal remaining results are reported for these 97 patients only: the other 6 patients did not have the Holter moni ...
Infliximab Therapy in Patients with Chronic Sarcoidosis and
... The chest radiograph scoring system (24) used in this study allowed quantitative comparison of chest radiographs obtained at baseline and Weeks 6 and 24. Chest radiographs were scored by two independent reviewers who remained blinded to the time point the radiograph was performed and the patient’s t ...
... The chest radiograph scoring system (24) used in this study allowed quantitative comparison of chest radiographs obtained at baseline and Weeks 6 and 24. Chest radiographs were scored by two independent reviewers who remained blinded to the time point the radiograph was performed and the patient’s t ...
Preface - Condrosulf
... Current pharmacological interventions of OA consist mainly of analgesics and non-steroidal antiinflammatory drugs (NSAIDs). Although these are the most commonly prescribed agents for this condition, they may cause serious gastrointestinal and cardiovascular adverse events and do not seem to affect t ...
... Current pharmacological interventions of OA consist mainly of analgesics and non-steroidal antiinflammatory drugs (NSAIDs). Although these are the most commonly prescribed agents for this condition, they may cause serious gastrointestinal and cardiovascular adverse events and do not seem to affect t ...
Addyi REMS
... Data from Five 24-Week, Randomized, Double-Blind Placebo-Controlled Trials in Premenopausal Women with HSDD The data presented below are derived from five 24-week randomized, double-blind, placebo-controlled trials in premenopausal women with acquired, generalized HSDD. In these five trials, the fre ...
... Data from Five 24-Week, Randomized, Double-Blind Placebo-Controlled Trials in Premenopausal Women with HSDD The data presented below are derived from five 24-week randomized, double-blind, placebo-controlled trials in premenopausal women with acquired, generalized HSDD. In these five trials, the fre ...
Safety and efficacy of ustekinumab or golimumab in patients with chronic sarcoidosis
... the safety and efficacy of ustekinumab or golimumab in patients with chronic pulmonary and/or skin sarcoidosis. Following 1–4 weeks of screening, patients were randomly assigned in a 1:1:1 ratio stratified by baseline disease (pulmonary involvement only, skin involvement only, and both pulmonary and ...
... the safety and efficacy of ustekinumab or golimumab in patients with chronic pulmonary and/or skin sarcoidosis. Following 1–4 weeks of screening, patients were randomly assigned in a 1:1:1 ratio stratified by baseline disease (pulmonary involvement only, skin involvement only, and both pulmonary and ...
Intravenous dexamethasone to prevent the recurrence of benign headache after discharge
... for migraine. We felt this to be more representative of the everyday practice of EM. Furthermore, if migraine, tension and mixed-type headaches are variations of the same disease process, similar treatment is appropriate. We considered any patient with “no change” or a “worse” headache or a return o ...
... for migraine. We felt this to be more representative of the everyday practice of EM. Furthermore, if migraine, tension and mixed-type headaches are variations of the same disease process, similar treatment is appropriate. We considered any patient with “no change” or a “worse” headache or a return o ...
Some caveats for outcome adaptive randomization in clinical trials
... trial of two chemotherapy regimes, T = G+D (gemcitabine+ docetaxel) and T = G (gemcitabine alone) for advanced or metastatic unresectable soft tissue sarcoma. The design was quite ambitious. It accounted for up to four stages of therapy, each stage lasting six weeks, with stage k having ordinal outc ...
... trial of two chemotherapy regimes, T = G+D (gemcitabine+ docetaxel) and T = G (gemcitabine alone) for advanced or metastatic unresectable soft tissue sarcoma. The design was quite ambitious. It accounted for up to four stages of therapy, each stage lasting six weeks, with stage k having ordinal outc ...
Zomig Rapimelt - EPGonline.org
... rapid, reliable and sustained relief from headache pain and migraineassociated symptoms, by administration of well-tolerated and patient-friendly medications.The emergence of the migraine-specific treatments known as 5-Hydroxytryptamine 1B and 1D (5-HT1B/1D) receptor agonists or ‘triptans’ in the ea ...
... rapid, reliable and sustained relief from headache pain and migraineassociated symptoms, by administration of well-tolerated and patient-friendly medications.The emergence of the migraine-specific treatments known as 5-Hydroxytryptamine 1B and 1D (5-HT1B/1D) receptor agonists or ‘triptans’ in the ea ...
Therapeutic Update on Seborrheic Dermatitis
... Also in this issue: Current Management of Actinic Keratoses (on Page 5) & Update on Drugs (on Page 8) ...
... Also in this issue: Current Management of Actinic Keratoses (on Page 5) & Update on Drugs (on Page 8) ...
Use of phosphatidylcholine for the correction of lower lid bulging
... countries for the parenteral treatment of hyperlipidemia, peripheral vascular disease, cardiac ischemia, and liver disease. However, in several countries, such as the UK and Ireland, the subcutaneous use of the medication has been criticized (14). This is partly due to a lack of any published collec ...
... countries for the parenteral treatment of hyperlipidemia, peripheral vascular disease, cardiac ischemia, and liver disease. However, in several countries, such as the UK and Ireland, the subcutaneous use of the medication has been criticized (14). This is partly due to a lack of any published collec ...
Antibiotic therapy in autoimmune disorders
... Tetracyclines are a group of broad-spectrum antibiotics used in the treatment of infections of the respiratory tract, urinary tract and intestines. They were first advocated as therapeutic candidates in RA by scientists who presumed that mycoplasma infection triggers the disease and proposed prolong ...
... Tetracyclines are a group of broad-spectrum antibiotics used in the treatment of infections of the respiratory tract, urinary tract and intestines. They were first advocated as therapeutic candidates in RA by scientists who presumed that mycoplasma infection triggers the disease and proposed prolong ...
Oral Diosmectite Reduces Stool Output and Diarrhea Duration in
... stool output reduction, the key outcome for pediatric antidiarrheal drugs, have not been shown. Methods: Two parallel, double-blind studies of diosmectite efficacy on stool reduction were conducted in children 1 to 36 months old in Peru (n ⴝ 300) and Malaysia (n ⴝ 302). Inclusion criteria included 3 ...
... stool output reduction, the key outcome for pediatric antidiarrheal drugs, have not been shown. Methods: Two parallel, double-blind studies of diosmectite efficacy on stool reduction were conducted in children 1 to 36 months old in Peru (n ⴝ 300) and Malaysia (n ⴝ 302). Inclusion criteria included 3 ...
3.1.1.Experimental arm: OA and PTMC
... become an effective and safe alternative to surgical treatment of severe MS but the presence of left atrial thrombus (LAT) is generally considered a contraindication to this procedure. Additionally, in developing countries, surgical treatment is not only far too expensive but also can not meet the i ...
... become an effective and safe alternative to surgical treatment of severe MS but the presence of left atrial thrombus (LAT) is generally considered a contraindication to this procedure. Additionally, in developing countries, surgical treatment is not only far too expensive but also can not meet the i ...
HE Robbins06
... Discussion • The best management of chronic disorders (poverty, mental illness, other medical conditions) requires multi-stage decision making. • Avoid myopic decision making! – Allow for longer term effects of the treatment – When comparing treatment options take into account the effect of future ...
... Discussion • The best management of chronic disorders (poverty, mental illness, other medical conditions) requires multi-stage decision making. • Avoid myopic decision making! – Allow for longer term effects of the treatment – When comparing treatment options take into account the effect of future ...
Chapter 2: Anti-tuberculosis treatment in children
... until their clinical status has stabilised. Children with TB meningitis are at high risk of long-term disability, and will therefore benefit from specialist care where this is available. Retreatment cases In childhood TB cases when anti-tuberculosis treatment has failed or a relapse occurs, every ef ...
... until their clinical status has stabilised. Children with TB meningitis are at high risk of long-term disability, and will therefore benefit from specialist care where this is available. Retreatment cases In childhood TB cases when anti-tuberculosis treatment has failed or a relapse occurs, every ef ...
James Yang, MD, PhD
... “Although OS was selected as the primary end point by all working groups, this does not diminish the value of progression-free survival (PFS) and other surrogate end points as valid end points in certain clinical situations. “We are now able to identify secondary mutations that drive tumor growth af ...
... “Although OS was selected as the primary end point by all working groups, this does not diminish the value of progression-free survival (PFS) and other surrogate end points as valid end points in certain clinical situations. “We are now able to identify secondary mutations that drive tumor growth af ...
Teplizumab for treatment of type 1 diabetes (Protégé study): 1
... continuous outcomes. If normality assumptions relating to the ANOVA or ANCOVA models were not met, then post‐hoc exploratory analyses used non‐parametric Wilcoxon rank‐sum tests to detect differences between treatment groups. Two‐sided testing was done at an α level of 0∙05. All efficacy analyse ...
... continuous outcomes. If normality assumptions relating to the ANOVA or ANCOVA models were not met, then post‐hoc exploratory analyses used non‐parametric Wilcoxon rank‐sum tests to detect differences between treatment groups. Two‐sided testing was done at an α level of 0∙05. All efficacy analyse ...
Comparative effectiveness of a complex Ayurvedic treatment and conventional standard
... ama-derived situations (ama-vata) or the effects of a ‘hotacidic blood tissue’ (vata-rakta). However, in conventional medicine, the diagnosis osteoarthritis of the knee would remain the same in all three cases. Ultimately, an experienced Ayurvedic physician would treat the principles of vata, ama, o ...
... ama-derived situations (ama-vata) or the effects of a ‘hotacidic blood tissue’ (vata-rakta). However, in conventional medicine, the diagnosis osteoarthritis of the knee would remain the same in all three cases. Ultimately, an experienced Ayurvedic physician would treat the principles of vata, ama, o ...
clinical investigations
... respiratory symptoms, and bronchial hyperresponsiveness characterize the disease.1 Early intervention with inhaled corticosteroid therapy is emphasized for patients with persistent asthma. For patients that remain symptomatic while using inhaled corticosteroids, adding salmeterol, a long-acting bron ...
... respiratory symptoms, and bronchial hyperresponsiveness characterize the disease.1 Early intervention with inhaled corticosteroid therapy is emphasized for patients with persistent asthma. For patients that remain symptomatic while using inhaled corticosteroids, adding salmeterol, a long-acting bron ...
1. protocol synopsis
... qualify for randomization based on office BP entry criteria and an additional 25% of patients will not qualify based on ABPM entry criteria. The study will randomize approximately 180 patients into the double-blind treatment. The study population will include males and females ≥ 18 years of age with ...
... qualify for randomization based on office BP entry criteria and an additional 25% of patients will not qualify based on ABPM entry criteria. The study will randomize approximately 180 patients into the double-blind treatment. The study population will include males and females ≥ 18 years of age with ...
Adjunct prednisone therapy for patients with community
... Methods In this double-blind, multicentre, randomised, placebo-controlled trial, we recruited patients aged 18 years or older with community-acquired pneumonia from seven tertiary care hospitals in Switzerland within 24 h of presentation. Patients were randomly assigned (1:1 ratio) to receive either ...
... Methods In this double-blind, multicentre, randomised, placebo-controlled trial, we recruited patients aged 18 years or older with community-acquired pneumonia from seven tertiary care hospitals in Switzerland within 24 h of presentation. Patients were randomly assigned (1:1 ratio) to receive either ...
Subjective Orthodontic Treatment Outcomes in a Medicaid Population
... However, in recent years, there has been a trend toward measuring treatment ...
... However, in recent years, there has been a trend toward measuring treatment ...
CROATIAN SOCIETY FOR NEUROVASCULAR DISORDERS OF CROATIAN MEDICAL ASSOCIATION
... the CNS, current or historical, with duration of at least 24 hours, in the absence of fever or infection. It should be documented by contemporaneous neurological examination, but some historical events with symptoms and evolution characteristic of MS, but for which no objective neurological findings ...
... the CNS, current or historical, with duration of at least 24 hours, in the absence of fever or infection. It should be documented by contemporaneous neurological examination, but some historical events with symptoms and evolution characteristic of MS, but for which no objective neurological findings ...
Benefits and harms in clinical trials of duloxetine
... The primary outcome and type of analysis used were consistent between protocols and clinical study reports. For one of seven trials with information in the protocol on analysis population, there were inconsistencies between the protocol (subgroup of patients with negative results on urine drug scree ...
... The primary outcome and type of analysis used were consistent between protocols and clinical study reports. For one of seven trials with information in the protocol on analysis population, there were inconsistencies between the protocol (subgroup of patients with negative results on urine drug scree ...
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"".