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Definition of Investigational Medicinal Product (IMP)
... For instance, some clinical trial protocols require the use of medicinal products such as rescue medication, challenge agents, medicinal products used to assess end-points in the clinical trial and background treatment. According to the definition, an AMP must first be a medicinal product. Consequen ...
... For instance, some clinical trial protocols require the use of medicinal products such as rescue medication, challenge agents, medicinal products used to assess end-points in the clinical trial and background treatment. According to the definition, an AMP must first be a medicinal product. Consequen ...
Pr CLIMARA® 25 Pr CLIMARA® 50 Pr CLIMARA® 75 Pr
... in the rate of invasive breast cancer in hysterectomized women treated with conjugated equine estrogens versus women treated with placebo.2 It is recommended that estrogens not be given to women with existing breast cancer or those with a previous history of the disease (see CONTRAINDICATIONS). Ther ...
... in the rate of invasive breast cancer in hysterectomized women treated with conjugated equine estrogens versus women treated with placebo.2 It is recommended that estrogens not be given to women with existing breast cancer or those with a previous history of the disease (see CONTRAINDICATIONS). Ther ...
Traumeel - Healing*Edge Sciences
... Injection solution (Rx): For the temporary relief of symptoms, including mild to moderate pain, associated with inflammatory, exudative and degenerative processes due to acute trauma, repetitive or overuse injuries, or arthritic conditions. See product insert for full prescribing information. (Inter ...
... Injection solution (Rx): For the temporary relief of symptoms, including mild to moderate pain, associated with inflammatory, exudative and degenerative processes due to acute trauma, repetitive or overuse injuries, or arthritic conditions. See product insert for full prescribing information. (Inter ...
Cancer Association of South Africa (CANSA) Fact Sheet on
... X-rays use high-energy radiation to take pictures inside the body. They can show the location, size, and shape of a bone tumour o Bone scans use a scanner and low-level radioactive material. They detect cancer cells in bones o Computed tomography (CT) scans use a rotating x-ray camera. They take det ...
... X-rays use high-energy radiation to take pictures inside the body. They can show the location, size, and shape of a bone tumour o Bone scans use a scanner and low-level radioactive material. They detect cancer cells in bones o Computed tomography (CT) scans use a rotating x-ray camera. They take det ...
Starlix DESCRIPTION (nateglinide) tablets
... In a randomized, double-blind, placebo-controlled, 24-week study, patients with Type 2 diabetes with HbA1C ≥ 6.8% on diet alone were randomized to receive either Starlix (60 mg or 120 mg three times daily before meals) or placebo. Baseline HbA1C ranged from 7.9% to 8.1% and 77.8% of patients were pr ...
... In a randomized, double-blind, placebo-controlled, 24-week study, patients with Type 2 diabetes with HbA1C ≥ 6.8% on diet alone were randomized to receive either Starlix (60 mg or 120 mg three times daily before meals) or placebo. Baseline HbA1C ranged from 7.9% to 8.1% and 77.8% of patients were pr ...
COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP)
... blind, placebo controlled studies as suggested in ICH E-4, Dose Response Information to Support Drug Registration. This guideline also states that it may be useful to include one or more doses of an active control drug, as the inclusion of a placebo and active control allows the assessment of assay ...
... blind, placebo controlled studies as suggested in ICH E-4, Dose Response Information to Support Drug Registration. This guideline also states that it may be useful to include one or more doses of an active control drug, as the inclusion of a placebo and active control allows the assessment of assay ...
Guidance for Industry Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment
... The dose or doses of drugs for definitive phase 3 efficacy and safety studies should be selected based on pharmacokinetic considerations and from earlier phase dose-ranging studies using a pharmacodynamic (PD) or clinical efficacy endpoint that is consistent with the expected benefit to be derived f ...
... The dose or doses of drugs for definitive phase 3 efficacy and safety studies should be selected based on pharmacokinetic considerations and from earlier phase dose-ranging studies using a pharmacodynamic (PD) or clinical efficacy endpoint that is consistent with the expected benefit to be derived f ...
HIGHLIGHTS OF PRESCRIBING INFORMATION __________________ CONTRAINDICATIONS ____________________
... The serious adverse reactions seen with FEIBA are hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed ...
... The serious adverse reactions seen with FEIBA are hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed ...
Requirements for Muscle Relaxants during Radical Retropubic
... NONDEPOLARIZING muscle relaxants are used routinely for many procedures in modern anesthetic practice. The indications for their use have expanded considerably from the original goal of providing adequate muscle relaxation to facilitate surgical exposure for selected surgical procedures. In particul ...
... NONDEPOLARIZING muscle relaxants are used routinely for many procedures in modern anesthetic practice. The indications for their use have expanded considerably from the original goal of providing adequate muscle relaxation to facilitate surgical exposure for selected surgical procedures. In particul ...
The effect of oral N-acetylcysteine in chronic bronchitis: a
... eight NAC trials [12]. These reviewers excluded one paper [53] because "it did not report the standard deviation for the outcome measures of interest", and their search strategy failed to retrieve two further reports [40, 54], one of which was in German [54]. Thus the present analysis included three ...
... eight NAC trials [12]. These reviewers excluded one paper [53] because "it did not report the standard deviation for the outcome measures of interest", and their search strategy failed to retrieve two further reports [40, 54], one of which was in German [54]. Thus the present analysis included three ...
The effect of oral N-acetylcysteine in chronic bronchitis:
... eight NAC trials [12]. These reviewers excluded one paper [53] because "it did not report the standard deviation for the outcome measures of interest", and their search strategy failed to retrieve two further reports [40, 54], one of which was in German [54]. Thus the present analysis included three ...
... eight NAC trials [12]. These reviewers excluded one paper [53] because "it did not report the standard deviation for the outcome measures of interest", and their search strategy failed to retrieve two further reports [40, 54], one of which was in German [54]. Thus the present analysis included three ...
Clinical Trial Feasibility Checklist
... number of patients seen at site with a specific diagnosis code. Review and evaluate the inclusion and exclusion criteria to see if realistic. Consider if study includes treatment-naïve population? Determine if the trial requires too much of the study patients or volunteers: – in time or cost i.e. so ...
... number of patients seen at site with a specific diagnosis code. Review and evaluate the inclusion and exclusion criteria to see if realistic. Consider if study includes treatment-naïve population? Determine if the trial requires too much of the study patients or volunteers: – in time or cost i.e. so ...
Reference:
... High-energy ESWT is effective in treatment of calcific tendonitis of the shoulder. Ultrasound-guided needling in a combination with shock-wave therapy is more effective than shock-wave therapy alone in patients with symptomatic calcific tendonitis. A combination of ESWT with ultrasound-guided needli ...
... High-energy ESWT is effective in treatment of calcific tendonitis of the shoulder. Ultrasound-guided needling in a combination with shock-wave therapy is more effective than shock-wave therapy alone in patients with symptomatic calcific tendonitis. A combination of ESWT with ultrasound-guided needli ...
Comparison of dose-related ocular side effects during systemic
... P URPOSE . To compare the effects of high- (Group 1) and low-dose (Group 2) isotretinoin treatments for acne vulgaris on lacrimal functions and other ocular complications. M ETHODS . Twenty-six patients receiving high-dose (>0.5 mg/kg per day) systemic isotretinoin treatment and 25 patients treated ...
... P URPOSE . To compare the effects of high- (Group 1) and low-dose (Group 2) isotretinoin treatments for acne vulgaris on lacrimal functions and other ocular complications. M ETHODS . Twenty-six patients receiving high-dose (>0.5 mg/kg per day) systemic isotretinoin treatment and 25 patients treated ...
CEO Investor presentation
... 1. 2005 survey conducted by Asthma and Allergy Foundation of America, found >50% patients were dissatisfied with current medication; 60% indicated they were interested in new treatments 2. Cardell L, et al. (2016) Primary Care Respiratory Medicine 26. TOTALL: high cost of allergic rhinitis—a nationa ...
... 1. 2005 survey conducted by Asthma and Allergy Foundation of America, found >50% patients were dissatisfied with current medication; 60% indicated they were interested in new treatments 2. Cardell L, et al. (2016) Primary Care Respiratory Medicine 26. TOTALL: high cost of allergic rhinitis—a nationa ...
Data and Safety Monitoring Committees-Full Slides-508
... Recommending termination or continuation of study Recommending other study modifications Reviewing study protocol Assessing study conduct Recommending additional analyses Statistical Concern Repeated testing for efficacy over time inflates Type I (false positive) error rate if no adjustment made In ...
... Recommending termination or continuation of study Recommending other study modifications Reviewing study protocol Assessing study conduct Recommending additional analyses Statistical Concern Repeated testing for efficacy over time inflates Type I (false positive) error rate if no adjustment made In ...
Review of cough and cold medicines in children: Tabulated
... study). There is no good evidence for or against the effectiveness of OTC medicines in acute cough. The numbers of studies in each group were small, and studies often showed conflicting results. Effect sizes in many studies were unclear and it is questionable as to whether all of the positive result ...
... study). There is no good evidence for or against the effectiveness of OTC medicines in acute cough. The numbers of studies in each group were small, and studies often showed conflicting results. Effect sizes in many studies were unclear and it is questionable as to whether all of the positive result ...
Augmentation Strategies Treatment
... double-blind, placebo-controlled trials is the addition of an atypical antipsychotic, specifically risperidone (McDougle et al. 2000) or olanzapine (Bystritsky et al. 2004), to an SSRI. Open-label trials and case series also support the use of quetiapine (summarized in Koran et al. 2004). The respon ...
... double-blind, placebo-controlled trials is the addition of an atypical antipsychotic, specifically risperidone (McDougle et al. 2000) or olanzapine (Bystritsky et al. 2004), to an SSRI. Open-label trials and case series also support the use of quetiapine (summarized in Koran et al. 2004). The respon ...
SAS® Programmer to Clinical SAS Programmer
... The protocol is the detailed document that contains all information about conducting the trial, such as inclusion/exclusion criteria, drug dispensing, study design, protocol deviations etc. Based on the protocol the CRF is designed to collect the required data that will be needed for the analysis. O ...
... The protocol is the detailed document that contains all information about conducting the trial, such as inclusion/exclusion criteria, drug dispensing, study design, protocol deviations etc. Based on the protocol the CRF is designed to collect the required data that will be needed for the analysis. O ...
Product Monograph
... Women of Childbearing Potential: Women of childbearing potential must use effective contraception during and up to 3 months after treatment. KEVZARA is generally used in combination with disease-modifying antirheumatic drugs (DMARDS). Product monographs for certain DMARDS, such as methotrexate, reco ...
... Women of Childbearing Potential: Women of childbearing potential must use effective contraception during and up to 3 months after treatment. KEVZARA is generally used in combination with disease-modifying antirheumatic drugs (DMARDS). Product monographs for certain DMARDS, such as methotrexate, reco ...
Emerging Therapies
... the study continue to accrue information or is there sufficient data to stop the trial either for futility or efficacy? The diagram follows the passage of 1 patient through the system. In reality, several patients will be progressing through the system at any one time and the database will contain d ...
... the study continue to accrue information or is there sufficient data to stop the trial either for futility or efficacy? The diagram follows the passage of 1 patient through the system. In reality, several patients will be progressing through the system at any one time and the database will contain d ...
3rd submission Non-attendance CBCS paper (IJMS)
... We commenced a randomised controlled trial to study the effectiveness of cognitive behavioural coping skills (CBCS) in reducing cocaine usage in methadone maintained patients in a clinical setting, by assessing attendance at treatment sessions and outcomes in terms of cocaine use. The definition of ...
... We commenced a randomised controlled trial to study the effectiveness of cognitive behavioural coping skills (CBCS) in reducing cocaine usage in methadone maintained patients in a clinical setting, by assessing attendance at treatment sessions and outcomes in terms of cocaine use. The definition of ...
Bi treatment with hydralazine/nitrates vs. placebo in Africans
... The HYIS combination was also compared with placebo with respect to the following pre-specified secondary endpoints: (i) change in symptoms of HF from baseline to 7 days post-randomization or discharge, as assessed by dyspnoea severity and global well-being on a visual analogue scale (VAS); (ii) cha ...
... The HYIS combination was also compared with placebo with respect to the following pre-specified secondary endpoints: (i) change in symptoms of HF from baseline to 7 days post-randomization or discharge, as assessed by dyspnoea severity and global well-being on a visual analogue scale (VAS); (ii) cha ...
Atopic Dermatitis Update
... Adapted with permission from Gittler JK, Shemer A, Suarez-Farinas M, et al. Progressive activation of T(H)2/T(H)22 cytokines and selective epidermal proteins characterizes acute and chronic atopic dermatitis. J Allergy Clin Immunol. 2012;130(6):1344-1354; with additional information from Leung DY, ...
... Adapted with permission from Gittler JK, Shemer A, Suarez-Farinas M, et al. Progressive activation of T(H)2/T(H)22 cytokines and selective epidermal proteins characterizes acute and chronic atopic dermatitis. J Allergy Clin Immunol. 2012;130(6):1344-1354; with additional information from Leung DY, ...
Herbs for the Treatment of the Symptoms of Menopause
... an adaptogen and tonic indicated for physical or mental exhaustion and depressive states associated with sexual inadequacy.5 Korean Ginseng is highly regarded in traditional Chinese medicine (TCM) as a tonic and restorative, to calm the nerves, to improve libido and is useful in fatigue and debility ...
... an adaptogen and tonic indicated for physical or mental exhaustion and depressive states associated with sexual inadequacy.5 Korean Ginseng is highly regarded in traditional Chinese medicine (TCM) as a tonic and restorative, to calm the nerves, to improve libido and is useful in fatigue and debility ...
Placebo-controlled study
![](https://commons.wikimedia.org/wiki/Special:FilePath/Cebocap.jpg?width=300)
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"".